Medical Device ASIA (Sept-Oct'14)

Smartphone-b a s e d E C G Takes India b y S t o r m

MEDICAL FAIR ASIA 2014

MEDICAL MANUFACTURING ASIA 2014

SHOWREPORT

India’s pharma exportgrowth slowest in 15 years

wireless smartphone access for existing blood glucose monitors

3-D printed hands for pediatric patients

medical devices'cybersecurity

MEDICA 2014 innovations

SO 15–FLED - Focusable LED lamp for universal applications

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Vol.6 No.5 |Sept-Oct 2014 | Annual Subscription: Rs.2000Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

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Managing Editor Sarvjit

Associate Editor & Public Relations Director

Reny

Joint EditorsVishwapreet

Amrita

ProductionRakesh

Marketing & CommunicationsLovleen

Web EditorRavindar

CirculationSurekha

Secretary & Legal AdvisorSurinder

China CorrespondentsYing Wei / Adrian Liu

h i g h l i g h t s

e d i t o r i a l

Medical Device ASIA | September-October 2014 | 3

4 EKF Diagnostics collaborates with MGH to detect treatable cancer

mutations in blood samples

8 Waldorf Technik re-invents highflex® IML

12 Medical Products

14 Show Report - MEDICAL MANUFACTURING ASIA 2014

16 Show Report - MEDICAL FAIR ASIA 2014

19 SOLED15–F - Focusable LED lamp for universal applications

20 Frost & Sullivan Applauds MobileHelp

25 GE Healthcare and GSK to improve access of diagnostic testing for

cancer patients

28 MEDICA 2014 preview

31 The New FDA Cybersecurity Guidance You Need to Know

35 Smartphone-based ECG Takes India by Storm

38 Apple Has a Bug to Exterminate from Its HealthKit Apps

42 FDA sets guidelines for medical devices’ cybersecurity

51 Prostate cancer: gentle removal with irreversible electroporation

54 Gene interacts with stress and leads to heart disease in some

people

There might be a possible association between breast

implants and a form of lymphoma that may develop

tumors at a later stage; © panthermedia.net/Lars Zahner

An international research group including Viennese pathologist Lukas Kenner has reviewed cases of possible association between breast implants and a form of lymphoma that may develop tumors at a later stage. The researchers conclude that breast implants can cause a new subtype of the rare yet malignant lymphoma known as

ALCL. The research results have been published in the journal Mutation Research.

Worldwide there have been 71 documented cases of patients with anaplastic large cell lymphoma (ALCL) in which researchers suspected breast implants to be the cause. ALCL is normally found in the lymph nodes, as well as in skin, lung, liver and soft tissue, but not usually in the breast.

Cases in which ALCL developed in the breast region almost exclusively involved patients who have had breast surgery. In these cases, ALCL developed around ten years after the operation. The tumors grew in the scar tissue around the implant.

Breast implants are generally safe and studies have found no association between

breast surgery and other forms of cancer. ALCL itself is also an extremely rare occurrence. Among three million breast implants, there are between one and six reported cases of ALCL.

ALCL is divided into two subtypes. In one subtype, the cancerous cells produce an abnormal form of the protein ALK (anaplastic lymphoma kinase). The other type does not express ALK in tumor cells at all. While patients with ALK-positive lymphoma have a better chance of survival, the cancer is considerably more aggressive in ALK-negative cases.

Implant-related ALCL appears to form a third group. The cells do not express ALK, but patients have good survival rates. “This is a previously unrecognized, new subtype of ALCL,” Lukas Kenner explains. “We must now determine the exact causes behind its occurrence.”

The actual reasons why implants can cause lymphoma remain unclear. While some patients were successfully treated with chemotherapy and radiation therapy, the lymphoma in many cases subsided on its own following removal of the implant and the surrounding tissue. An abnormal immune response from the body could therefore be a cause of the cancer. Kenner and his team are now preparing for further studies in which implants and dentures will be examined in other parts of the body.

Lukas Kenner from the Medical University Vienna, the University of Veterinary Medicine, Vienna and the Ludwig Boltzmann Institute for Cancer Research cooperated for this study with scientists from Cambridge, Liverpool, Swansea and Australia. The project was funded by the British organization Leukaemia & Lymphoma Research.

MEDICA.de; Source: Medical University Vienna

Link between breast implants and cancer under investigation

The collaboration agreement has been signed following a detailed evaluation of PointMan DNA enrichment technology by MGH and will cover a two year long project focussing on lung, breast and skin cancer.

MGH will use PointMan DNA enrichment technology for the detection of genetic variation in circulating tumour cells (CTCs) isolated from a patient’s blood using MGH’s CTC-Chip instrument. CTCs are shed by primary tumors allowing the cancer to metastasise. CTCs are extremely rare in whole blood and their isolation and characterisation could offer clinicians a routine

method with which to diagnose, treat and monitor the progress of various cancers. The main difficulty in successfully analysing CTCs has been the ability to detect low level mutations sufficiently and to create assays that are sensitive enough to provide meaningful data; difficulties which PointMan may be able to effectively overcome.

EKF Molecular will design and develop high sensitivity assays which will be utilised by MGH with a view to clinically validating PointMan in the detection of existing and novel mutations, a major step towards the improvement of patient outcomes in the hospital.

Andrew Webb, CEO of EKF Molecular Diagnostics Ltd, commented: “The results of an initial assessment, and now this two year collaboration, moves us even closer to the routine use of blood based tests for cancer rather than a tissue biopsy. The combination of MGH’s CTC-Chip instrument and the easy to use and quick to perform PointMan technology should make this approach to cancer detection and monitoring available, ultimately, to the majority of molecular testing laboratories.”

Dr Daniel A. Haber, Director at Massachusetts General Hospital Cancer Center and Kurt J. Isselbacher, Peter D. Schwartz Professor of Oncology, Harvard Medical School, commented: “We have been studying the sensitivity of DNA enrichment technology as a way to detect and monitor specific mutations in cancers from patients utilising circulating tumour

cells isolated from a simple blood sample. I am hopeful that the combination of such technology with our CTC-Chip technology will have the potential to improve the clinical management of our patients.” Dr Shyamala Maheswaran, of the Massachusetts General Hospital Cancer Center and Associate Professor of Oncology at Harvard Medical School, who was principal investigator for the collaboration, commented: “This study demonstrated incredible sensitivity for mutations that are relevant to lung cancer, breast cancer and melanoma. During the course of the two-year research collaboration, we will look for other potential target genes associated with these and other cancer types.”

The initial proof of concept data produced by Dr Shyamala Maheswaran’s research team at MGH using PointMan DNA Enrichment assays to detect EGFR sensitizing, as well as resistance (T790M), mutations associated with lung cancer and BRAF V600E associated with melanoma have proved enlightening. These experiments involved spiking as few as 3-10 tumour cells harbouring the appropriate mutations into white blood cells. PointMan enrichment assays reliably detected both T790M and V600E at a frequency of 10 mutant alleles (gene copies) in a background of 10,000 wild type (normal) alleles. Ongoing pilot studies have suggested an even more robust detection sensitivity of three mutant alleles in a background of 30,000 wild-type alleles. v

EKF Molecular and Massachusetts General Hospital Announce Circulating Tumour Cell Clinical Research Collaboration

Research to confirm clinical utility of PointMan™ and CTC-iChip technologies for non-invasive cancer diagnosis and monitoring

PointMan™ provides a reliable and highly sensitive determination of the presence or absence of a mutation in the DNA sequence.

EKF Diagnostics, the global diagnostics company, announces that it has entered into a two year research collaboration with Massachusetts General Hospital (MGH), a global leader in successfully bridging innovative science with state-of-the-art clinical medicine, to develop PointMan™ assays that can effectively detect treatable cancer mutations in blood samples.

4 | September-October 2014 | Medical Device ASIA

ACD’s RNAscope assays represent a major technological advance for

in situ RNA detection. For the first time, robust single RNA molecule detection is available for formalin-fixed, paraffin-embedded (FFPE) tissue. Since their commercialization three years ago, these assays have been adopted across the globe by major pharma biotech companies and leading research institutions for drug discovery, translational research, and the development of clinical and companion diagnostic tests. The RNAscope LS assays are fully automated on the BOND RX

in response to the needs of our rapidly growing customer base.”

Dr. David Atkins, VP Advanced Staining at Leica Biosystems added: “Leica is excited to announce the availability of ACD’s RNAscope Assays fully automated on the BOND RX. This is another example of how, with its openness and flexibility, the BOND RX is providing researchers with enhanced tools to help speed-up important discoveries and improve cancer diagnostics”.

About Leica BiosystemsLeica Biosystems is a global leader in workflow solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. Leica Biosystems provides anatomical pathology laboratories and researchers a comprehensive product range for each step in the pathology process, from sample preparation and staining to imaging and reporting. Leica’s easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is

represented in over 100 countries. It has manufacturing facilities in 7 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Further information can be found at www.LeicaBiosystems.com.

About Advanced Cell DiagnosticsAdvanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell and tissue-based diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the first automated multiplex chromogenic and fluorescent in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single-molecule sensitivity. RNAscope assays are currently used by hundreds of customers, including all of the global top 10 pharmaceutical companies, world leading academic institutions and many cutting edge biotechnology companies to validate biomarkers for the management of cancer and other diseases. ACD’s industrial partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop and commercialize proprietary diagnostic tests in cancer management. Learn more about ACD and RNAscope technology at www.acdbio.com.

*For Research Use Only. Not for use in diagnostic procedures.

Learn more about ACD at www.acdbio.com and about RNAscope® Automated Solutions at acdbio.com/products/automated-assays.

Further information about Leica Biosystems can be found at www.LeicaBiosystems.com.

Advanced Cell Diagnostics and Leica Biosystems Begin Co-marketing Fully Automated RNA in situ Hybridization Assay

platform. This open and flexible system automates staining to provide a fast, high-throughput workflow with exceptional consistency and minimal hands-on time.

“Automation is essential for pharma, biotech, translational labs and academic institutions to apply the RNA ISH technology to a wide range of biomarker analysis applications.” said Dr. Yuling Luo, President and CEO of ACD. “We are very pleased to work with Leica Biosystems to expand our automated RNAscope solutions

Leica Biosystems and Advanced Cell Diagnostics, Inc.

(ACD) have announced the co-marketing of ACD’s

RNAscope® LS ISH assays with Leica Biosystems’

BOND RX research staining platform*. This agreement

provides researchers with an integrated and fully

automated ISH solution. The market-leading RNAscope

LS reagent kits and ISH probes are available from

ACD while the BOND RX instrument and associated

reagents are supplied by Leica Biosystems.


In time for the Fakuma 2014, the automation specialist Waldorf Technik GmbH &Co. KG uses

its innovative force to develop entirely new technologies for the production of pack-aging solutions in injection moulding. The classic highflex® IML comes with entirely new features, while barrier coating is set to revo-lutionise the whole field of food packaging.

The modern world of packaging is now incon-ceivable without inmould labelling, as the brilliant printing and cost-efficient flexibility of this decoration method is quite simply too attractive for a variety of print images. Instead of decorating the cup and lid in downstream printing processes, this method involves the insertion of printed foils into the injection moulding tool to create an integrated process in just one operating step and to deliver an attractively decorated cup or lid. Unlike in alternative methods such as offset or silkscreen, post-printing and sleeving, the print image can be switched with practically no setup times, which makes it a particularly inexpensive procedure.

Waldorf Technik has worked assiduously over the last two years to develop and consistently expand its product segment of IML automation. Now the portfolio covers more than five different

IML automation occupies extremely compact space and still offers this facility at approximately the same invest as systems that due to a restricted budget have merely possessed the capacity to reject the entire batch.

As an optional module for the highflex® IML se-ries, Waldorf Technik has now included entire packaging stations in its programme, with which vetted products can be packaged in transport containers or boxes, practically without human involvement. For many customers, this option may be a good response to the constantly spiral-ling price pressure in the packaging business.

The IML method is increasingly winning over admirers in export markets, also. Compared with IML users in central Europe, they appreciate it even more when automation and tools come synchronised in a one-stop solution. This is why Waldorf Technik has now teamed up with Roth Werkzeugbau GmbH to offer its international customers automation on a double bill with first-class thin-wall tools.

And soon the fanbase will have the opportunity to experience all this at first hand during a variety of events scheduled for this autumn. A world première will be on show at the Fakuma in Friedrichshafen, for instance: a 100 % circumferentially decorated cup with rounded base edges, manufactured in a process that is simple for the operator and realised using a highflex® IML robot from the standard programme.

Another highlight will be the presentation of bar-rier coating as an industrial method of equipping injection moulding receptacles with unbeatable barrier properties at low cost. The first industrial system with a cycle time of less than four se-conds is already installed on the market; project planning for systems with up to 64 cavities is also underway with international customers.

What is so special about barrier

coating? This method permits the combination of benefits of-fered by glass jars (for instance the outstanding gas and water vapour barrier, taste preservation, protection against the migration of outside sub-stances into the food and such like) with the ad-vantages of cost-efficient plastic packaging (un-breakable, does not splinter, stackable, compact space requirements and good for logistics).

For instance, coffee in a capsule form remains fresh and preserves its aroma, even without so-phisticated secondary packaging. Fresh products also keep their attractive look. The shelf life of all kinds of food products is extended significantly compared with current plastic solutions. In turn, this enables food manufacturers to produce substantially more efficient batch sizes, thus saving logistic costs in restocking retail shelves.

Unlike the other methods of manufacturing plas-tic barrier containers available today (e.g. EVOH deep drawing), barrier coating provides packaging designers with a hitherto unseen level of freedom when it comes to the forms. The coating process fits seamlessly into the container geometries, so even entirely asymmetrical forms and receptacles with ribs or stacking edges can be made into barrier packs with no difficulty at all. And the costs are unbeat-ably low, as the barrier layer is a mere 0.1 mi-crometres and hence comes with practically no material expenditure at all. All this means that the method has a promising future that may well just revolutionise the market of food packaging.

Waldorf Technik develops and builds high-performance automation systems for injection moulding companies worldwide. The core com-petencies centre around projects in the field of packaging and medical consumer items with short cycle times.

Waldorf Technik re-invents highflex® IML

standard series to meet an array of customer needs such as reduced invest, stack moulds, extremely compact space, systems for consumer goods packaging and also bulk packs.

Indeed, the traditional flagship at Waldorf Tech-nik, the highflex® IML robot has also been fun-damentally reworked in the second system gen-eration to add a variety of new features, also. For instance, it now occupies 30 % less space than before. The automation system is able to process cups and lids in all IML label geometries. Furthermore, it is entirely at the discretion of the injection moulder to use the highflex® IML automation for tools with a variety of cavity numbers and cavity intervals – and all this with a mere 20-30 minute setup time between different products. In extreme cases, even the manufacture of products injected from inside and outside is possible using just one highflex® IML automation. This means that the system concept remains unique throughout the world – so far, all other manufacturers of IML systems can only offer restricted flexibility.

And whereas camera monitoring with ejection of individual bad parts has so far substantially in-creased both the size of invest and the system itself, the new highflex®


A showcase of new-in-Myanmar manufacturing solutions from well-known

international brands opens in Yangon today. With the aim of encouraging greater adoption of new technologies by local manufacturers to improve productivity and increase output, Manufacturing Myanmar 2014 held at the Myanmar Convention Centre (MCC) from today until Saturday 4 October gives local firms the opportunity to source for machinery and equipment, and tap knowledge of international suppliers on how to improve their current operations.

More than 85 exhibitors from 15 countries and regions, including four international pavilions from China Taipei, Germany, Singapore and Thailand, have come together for the first time to create an international business platform and knowledge sharing hub for the local manufacturing industry. Government, local suppliers and manufacturers alike laud the staging of Manufacturing Myanmar as an indication the manufacturing industry in Myanmar is headed for an era of industrial transformation.

“Ensuring development, attractiveness and competitiveness of the manufacturing industry sits high on the government’s list of priorities. Having taken steps to

everything is relevant to our business. We are looking forward to be able to meet the regular suppliers for our projects as well as products or technology which will be useful to us. I hope Manufacturing Myanmar 2014 can bring new technologies to inspire, new opportunities to be taken and open doors for the local manufacturing industry to expand internationally.”

Mr. Philip Seah, Director of Assurich Myanmar, who supplies machine and tools technology to the oil and gas, marine, fabrication and manufacturing sector in Myanmar comments on their participation at Manufacturing Myanmar 2014, says, “We have been in Myanmar for two years, and as the industry develops with more joint ventures opening up, we have witnessed an increase in demand for technology across many sectors we supply to. Manufacturing Myanmar is a good platform to introduce good working systems to improve the productivity of Myanmar’s industries. In time, we will begin to see more semi and fully automated production lines. With the increase use of technology also fetches the need for manpower with the correct technical capabilities, as such, we also have set up a new company providing training courses for local engineers and technicians.”

Welding electrode manufacturer YAWATA, who has had a decade long presence in Myanmar comments on the inaugural edition of Manufacturing Myanmar, Mr. Sittiboon Abhinorasaeth, General Manager of YAWATA says, “We have been in Myanmar for almost 10 years supplying to shipbuilding and construction businesses. In the last few years, the market has grown very fast and we have since partnered up with a local agent. We believe that Manufacturing Myanmar is a match-up between user and supplier for both service and goods. From this event, the local manufacturing industry will be able to source for what it needs and learn from what is available abroad in order to satisfy the needs of the domestic consumers.”

In conclusion, Ms. Lindy Wee, Deputy Chief Executive of organiser Singapore Exhibition Services says, “Manufacturing Myanmar will present many viable options for local businesses looking to upgrade existing operations and processes, as well as expand capabilities through investment in technology. We are certainly glad to receive such a warm reception from the local industry and are looking forward to working with the government, and supporting organisations to herald in a new era in Myanmar’s manufacturing industry.”

Local Industry Welcomes New Manufacturing Solutions to MyanmarManufacturing Myanmar 2014 opens today in Yangon to bring international manufacturing technology marketplace to local industry players

implement reform strategies and invest in infrastructure to make Myanmar a favourable location for international manufactures as well as to create a conducive business climate for local production to flourish, the Ministry of Industry welcomes Manufacturing Myanmar as it further value adds to our efforts,” says His Excellency U Maung Myint, Union Minister, Ministry of Industry.

“Learning from international best practices is one way to progress and Manufacturing Myanmar presents a universal benchmark for manufacturing, operational and service excellence, factors which are critical to setting the stage for Myanmar’s manufacturing sectors. With the knowledge base and exposure to new technology Manufacturing Myanmar can bring on board, I am confident that our manufacturing sector will continue its growth and contribute heartily to the economy,” he adds.

Royal Marine Group, one of Myanmar’s leading engineering service providers for the marine and oil and gas sector will be visiting Manufacturing Myanmar 2014. Mr. Ye’ Wint Kyaw, Sales Engineer of Royal Marine Group says, “The exhibit profile of this event really caught our eye, design soft wares, tools, machinery and welding equipment, almost


Paramount Surgimed Ltd., a leader in Healthcare & Medical Disposables, introduces “AroKleen” Disposable Adult Diapers with (ADL) acquisition distribution layer, wetness indicator and leak proof. The Diapers are user friendly, affordable and highly beneficial to both male and female persons with bladder problems commonly known as Urinary incontinence.

Arokleen Adult Diapers provide affective incontinence management for those who require or prefer an all in one product. The (ADL) acquisition distribution layer, brings feeling of softness and comfort, sanitary and refresh. Arokleen Diapers offer increased absorption and leakage protection by using materials of the highest quality and including super.

The Paramount Unisex, Disposable Aro Kleen Adult Diapers are user friendly and give the user long-lasting comfort and maintain a high standard of hygiene at the same time makes the user feel secure and continue normal daily activities. Paramount Surgimed Limited, as a part of their Corporate Social Responsibility mandate, is working actively with Age-Care India to provide Adult Diapers to needy old age people and help them lead a better quality of life.

AroKleen Adult Diapers are the perfect solution to the problem of urinary incontinence increasing in elderly population both in males and females. Urinary Incontinence is an involuntary leakage of urine and can occur in all age groups. The usage of Adult Diapers is very vast and not just restricted to senior citizens. Women may need adult diapers during pregnancy sometimes, uterus removal or normal aging post 60. Men may need adult diapers again due to aging, prostrate removal etc. These Diapers are also beneficial for a person with Alzheimer or for a person on a wheelchair who may be unable to reach and use a toilet on time.

The AroKleen Adult Diapers come equipped with a wetness indicator that indicates optimum utilization and indication of correct time for change thus keeping a check on the hygiene and wellbeing of the wearer. The Waist band at the back gives a perfect fit in all positions. Paramount’s state-of-the-art production facility has the capability of producing very high qualities with smart leak guards. Smart leak guards prevent leakage from sides and a back lamination sheet helps to prevent hypersensitive reaction and allergies.

Paramount Surgimed Ltd launches AroKleen Adult Diapers with ADL for Extra Dry Feeling

Netherlands’ leading medical chair manufacturer Score starts distributing in Asia-Pacific

Score is Netherlands’ leading manufacturer of medical and dental seating. For over 37 years Score has been developing ergonomic chairs and accessories that enable people to work in a healthy way.

Score’s R&D department is constantly developing new and improved hi-quality seating solutions. The famous saddle seats, the Score Jumper ® and Score Amazone ®, are Europeans’ standard in Dental and medical seating.

New branch in Taiwan

Score is experiencing more and more demand for her products from the Asia-Pacific region. Therefore Score recently set-up a branch in Taiwan. This branch is responsible for the sales in the region and operates as a logistic hub to save transport costs and –time to the Asia-Pacific customers. Also the level of service is highly increased by operating in the applicable time-zone and in English-, Mandarin- and Japanese language.

Score solely operates with distributors and is currently looking for business partners supplying the dental and medical market in the Asia-Pacific region. For more information please visit http://www.scorenl.com


With the significant increase in Asia in the number of downstream medical manufacturers and enhanced manufacturing capabilities on the back of global growth in the medical device sector, Asia represents exciting opportunities for companies keen to tap into the region. This increased focus on the region by medtech manufacturers has spurred national pavilion participation from Austria, China, Germany, Japan, and Singapore at MEDICAL MANUFACTURING ASIA 2014, contributing to the increased internationality of the exhibition, drawing 6,218 quality trade visitors, of which 35% came from the region. “We are pleased with the success of MEDICAL MANUFACTURING ASIA 2014. The second edition has not only seen a significant increase

in the number of exhibitors but also a very good mix of Singaporean and international companies. Visitor numbers have also been very positive, and we are greatly encouraged by the interest shown,” shared Jeremy Fong, Chairman, SPETA. Addressing the challenges of accessing Asian markets, with its differing market characteristics, MEDICAL MANUFACTURING ASIA serves as the central meeting place in Asia for the medical manufacturing industry to enhance capabilities and insights and to establish key business networks, providing the critical launch pad into Asia and particularly, the ASEAN region. Gernot Ringling, Managing Director, Messe Düsseldorf Asia, said “MEDICAL MANUFACTURING ASIA plays a significant role in bringing the latest medical manufacturing processes and technological capabilities to the fore, providing medtech manufacturers the opportunity to discover a suite of manufacturing solutions and develop business connections necessary to grow their business successfully in the region.” Enhanced business opportunities abound at MEDICAL MANUFACTURING ASIA 2014

Committed to advancing the manufacturing capabilities of the medtech industry, MEDICAL MANUFACTURING ASIA 2014 provided the ideal platform for medtech manufacturers and industry players to engage in meaningful trade and collaborative discussions. For Sunningdale Tech, a leading Asian tooling, plastics injection moulding and precision assembly company, MEDICAL MANUFACTURING ASIA 2014 was a very important exhibition to showcase their capabilities. “We’ve had many people come to us with their designs and discussions to mass produce, and we’ve engaged with many interested customers”, said Simon Tan, Senior Vice President. IVAM, a German association of micro technology and micro-nanotechnology companies and the organiser of a medical device symposium at the inaugural edition of MEDICAL MANUFACTURING ASIA, returned to the exhibition this year as a pavilion organiser as it aimed to foster better business relations between Southeast Asian companies and Germany.

“80% of our members produce

MEDICAL MANUFACTURING ASIA 2014 records strong growth in 2nd instalment, sets focus on 2016 edition

Encompassing a diverse and vibrant marketplace

for the rapidly growing medical technology sector,

MEDICAL MANUFACTURING ASIA 2014, jointly

organised by Singapore Precision Engineering and

Tooling Association (SPETA) and Messe Düsseldorf Asia

came to a close on 11 September amidst resounding

approval from visitors and exhibitors. Powering ahead

from its successful inauguration in 2012, the 2nd

edition of MEDICAL MANUFACTURING ASIA achieved

strong growth, returning with 200 leading exhibiting

companies from 20 countries.


s h o w | r e p o r t

products for the medical technology sector, and that is why we are here because we want to support our members to do business in Asia, as well as help Asian companies do business in Germany and Europe,” said Dr Thomas R. Dietrich, Chief Executive Officer. He added, “Our experience this year has been very good, and we have seen plenty of regional Asian visitors, particularly from Japan, China, Taiwan and Korea, making this a good hub for German companies to start their business in Asia.”

Exploring the next evolution of medical manufacturing with co-located conference Further bolstering the medtech experience at the exhibition was the concurrently held MEDICAL MANUFACTURING ASIA 2014 conference, themed ‘Reaching New Horizons in Medical Manufacturing’ which attracted 154 delegates over three days. A renowned panel of 15 international speakers came together to discuss the present and future of additive manufacturing in medical applications, exploring how additive manufacturing is causing a paradigm shift in medical manufacturing with wide-ranging topics covering many aspects including legal and policy implications, established and exciting future applications, clinical trends, new technologies, and the evolution of processes and materials.

Delivering the keynote address was internationally renowned speaker Professor Stuart Williams, Director, Bioficial Organs Program, University of Louisville, USA. “It’s a wonderful opportunity to see the interaction from people all over the world coming to Singapore to learn about the world-class state of the art capabilities here,” he said. Speaking on the exhibition, he added, “This is a great opportunity to explore the many manufacturers and instrument developers at this exhibition – it’s an overwhelming breadth of technology that you see from the medical device manufacturing sector.” The conference culminated in an insightful learning journey which saw delegates embark on visits to two additive manufacturing centres here - the NTU Additive Manufacturing Centre and the NYP Additive Manufacturing Innovation Centre.

Next Edition of MEDICAL MANUFACTURING ASIA

The next edition of MEDICAL MANUFACTURING ASIA will take place from 31 August – 2 September 2016 in Singapore. Trade visitors can expect a bigger and more dynamic exhibition showcasing even more medical technology players and a diverse line-up of regional visitors. -End-

For more information, please visit www.medmanufacturing-asia.com or contact:Zarina Ann MuhammadMarketing Communications ManagerMesse Düsseldorf AsiaTel: +65 6332 9624Email: [email protected] CherSenior Marketing Communications ExecutiveMesse Düsseldorf AsiaTel: +65 6332 9652Email: [email protected]



ttracting a notable 10,780 trade visitors of which 40% came from outside of Singapore, MEDICAL FAIR ASIA 2014 has proven to be the preferred strategic business and procurement platform for the region’s medical and health care industries. Representing a 20% increase in visitor attendance from the previous edition, this year also attracted a strong line-up of government

level delegations and hospital management personnel from Hong Kong, India, Malaysia, Philippines, Turkey and Vietnam.

“MEDICAL FAIR ASIA’s continuing and growing importance to the region and beyond has been demonstrated by the success of this year’s exhibition which continues to attract an increasing number of companies looking to do business in Asia as the region’s healthcare sector continues on a robust growth path,” said Gernot Ringling, Managing Director, Messe Düsseldorf Asia.

“The introduction of new initiatives such as the m-Health showcase focusing on ICT innovations and a robust business matching service which saw more than 55% of exhibitors participate in the programme, as well as visits to medical facilities organised as part of the concurrently run Singapore Medical & Healthcare Conference,

have played a significant role in providing value-added touch-points to the exhibition which we hope to expand for the 2016 edition,” he added.

For German exhibitor specialising in medical packaging - Vereinigte Papierwarenfabriken GmbH, a returning exhibitor who has been participating at MEDICAL FAIR ASIA over the last eight years, according to its Area Sales Manager, Manfred Blunk, the exhibition serves as “a very important exhibition in Asia, and has international appeal. We have received a lot of good contacts and expect positive results, and we’ll be here again in 2016.”

Echoing this sentiment was Singapore based company, ITS Science & Medical who showcased their modular operating theatre. According to Dennis Tan, Business Development Director, the exhibition was a “very good

MEDICAL FAIR ASIA 2014 SETS NEW RECORD IN EXHIBITOR AND VISITOR PARTICIPATION

The tenth edition of MEDICAL FAIR ASIA was a sell-out success, reaffirming its position as Asia’s premier medical exhibition. With a 50% increase in exhibiting companies compared to the previous edition in 2012, this year 800 exhibitors from 35 countries showcased the latest medical technologies at Suntec Singapore. Anchoring the international line-up of companies was a record-setting 15 national and group pavilions from Austria, Canada, China, France, Germany, Hungary, Italy, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, UK and USA.


A


platform for us to advertise our services and products and it’s a great meeting spot for all our customers to come here and visit us and understand this new technology.” The ITS Group is a fully integrated scientific solutions group and was recently awarded the project to design, fabricate and build some twenty modular operating theatres in the upcoming Ng Teng Fong General Hospital.

For JETRO (Japan External Trade Association) and its eleven exhibiting companies, Mr. Yukihide Nakayama, the Japanese pavilion organiser, commented that with its particular focus on Singapore and the Asia market, MEDICAL FAIR ASIA 2014 is the right platform and “we have seen many companies from various countries, particularly from India, Malaysia and Thailand, and have had many successful business meetings here.”

m-Health showcase - a successful look into the future of Healthcare

Anticipating the next evolution in healthcare and the industry’s shift to a more patient-centric approach, the m-Health showcase introduced new technologies that included telemedicine, digital and wireless healthcare applications to home-care monitoring devices and breakthrough innovations in rehabilitation. Technical Innovations, a Bulgarian exhibitor within the m-Health showcase introduced an innovative remote assistance system for the elderly and disabled, and was remarkably pleased at the exposure generated. Daniel Tsanov, its Chief Executive Officer said: “This is our first time in Singapore, and we are surprised by the great interest in our products. We have chosen to be here at MEDICAL FAIR ASIA as we believe the Asian market is a big and strategic market and the event provides great opportunities.”

Singapore-based company Neurostyle, manufacturer of neuro rehabilitation and diagnostic medical devices, said



that the m-Health platform was a unique showcase and was able to bring “many quality visitors from different countries and definitely met our expectations”, said Dr Johnson Lu, Managing Director.

As for Hippus NV with their handshoe computer mouse which was ergonomically designed in collaboration with a medical university in the Netherlands, the m-Health showcase provided the ideal opportunity to tap into the Singapore and Asian market. Drs Sjoerd W. Eisma said: “We are really happy to be here and with the number of contacts and new leads we gained from Singapore, China, and the Philippines. We will definitely be back in two years’ time.”

National groups from Canada and Thailand looking to grow its medical sector at the exhibition

MEDICAL FAIR ASIA 2014 was delighted to welcome first time representation from Canada with seven participating companies across various sectors; B+H Architects, Covalon Technologies, Leafsprout Technologies, Mobilewellbeing, Nutralab, and Otosim, as well as the Canadian organiser from its Ministry of Economic Development Trade and Employment.

For MobileWellbeing, MEDICAL FAIR ASIA 2014 provided the perfect stage to promote their patient monitoring systems to hospital and homecare health providers in Asia, and they received “many interested parties who have asked for various product demonstrations, and we have gained great experience as a first time participant,” said its President and Chief Executive Officer Rajiv Muradia.

This year also marked strong Thai participation under the auspices of the Thai National Innovation Agency which featured eight outstanding local companies highlighting their latest innovations. According

to Kant Weerakant, Design and Solutions Manager for the National Innovation Agency, Singapore proved to be the right platform to showcase Thai innovations and to promote the made-in-Thailand brand as “the right profile of customers can be found at the exhibition.”

Diverse international representation draws approval from visitors, spurs business opportunities

Visiting MEDICAL FAIR ASIA for the first time, Khairil Anuar Khalid, Senior Manager, Faber Group Berhad, commented he was very impressed with the representation of companies, products and services which spanned across four continents. “We also saw a good number of Asian companies exhibiting alongside the European countries. It is truly a convergence point for the medical industry and this will benefit the ASEAN medical sector even further,” he said.

As for Cesar O. Salazar, President, Surgico Phils Inc, who returned to MEDICAL FAIR ASIA 2014 having first visited in 2012, he was very impressed with the latest edition. “There were many new products and innovations on display. The exhibition floor was buzzing with discussions between exhibitors and visitors and this is truly the place to be for the medical industry. The organizers have done a good job in organizing a well presented exhibition”, he said.

Exploring new frontiers with co-located conference Held concurrently with MEDICAL FAIR ASIA 2014, the Singapore Medical & Healthcare Conference, themed ‘New Paradigms in Healthcare’, featured speakers showcasing cutting edge advancements in Singapore’s medical and health care arena, ranging from innovations in healthcare funding to next-generation healthcare technology. Presentations included an exploration of Google Glass and its Application to Healthcare and

a look at future possibilities for smart glasses in hospitals. The conference culminated with a facilities tour that presented the 223 delegates with the unique opportunity to go behind the scenes and visit three leading healthcare facilities in Singapore – Fortis Surgical Hospital, Kwong Wai Shiu Hospital and the NUHS Advanced Surgical Training Centre.

Next edition of MEDICAL FAIR ASIA The next edition will take place from 31 August – 2 September 2016 in Singapore. Prior to this, Messe Düsseldorf Asia will organize MEDICAL FAIR THAILAND 2015, the 7th International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical & Rehabilitation Equipment & Supplies, from 10 to 12 September 2015 in Bangkok, Thailand.



SOLED15–F is the focusable LED examination light for diagnostics, minor surgery and universal applications. It can be used for minor precision surgery, intensive care, recovery room, first aid, cosmetic surgery and dental sector. SOLED15–F supplements the Starled Series range of lamps manufactured by ACEM Medical Company. SOLED15–F contains all the advantages of LED technology and is suitable for multi purpose uses thanks to its flexibility.It assures:

• excellent light intensity • IR-free light beam • colour temperature (CCT) of 4.500°K • colour rendering index (CRI) of 95 • long life • low power consumption

- SOLED15–F grants a uniform distribution of light and can focus the light beam with a perfect illumination both on the surface and in depth providing the operator with the best working conditions.

- The high technological level combined with the use of high-powered LEDs allow the lamp to have a very linear yield and a negligible performance decay for its entire life duration.

- SOLED15–F has a light intensity of 50.000 Lux (large spot light beam) increasable up to 77.000 lux (small spot light beam) and a low power consumption (24 W).

- The LEDs layout gives a visual comfort and produces a uniform, homogeneous and shadowless light.

SOLED15–F - Focusable LED lamp for universal applications

- SOLED15–F has a round shape that makes it handy and functional both in use and move.

Its easy-to-move structure is suitable for diagnostics, test labs and dental surgery and its easy-to-grip removable and sterilizable handle makes it suitable even for critical sanitary applications.

- SOLED15–F is provided with an I-Sense@ touch panel to control all the functions of the lamp:

• ON/OFF• Light intensity adjustment• Light beam focusingThis last function makes SOLED15–F particularly suitable for applications in the dental sector, minor surgery, gynecology where a focused and deep illumination is required.

SOLED15–F is available in the following versions: Ceiling mounted (single or double configuration) , Wall mounted, Trolley mounted ( ABPS battery on demand)

ABPS is a new rechargeable battery powered system made by ACEM Medical Company dedicated to power surgical lamps as by European Directive 93/42/EECSOLED15–F with ABPS supplies efficient light for every condition of use: in humanitarian interventions, in developing regions, in critical regions, in emergency situations, in case of sudden black-outs, where light has great importance but electrical power supply is not available and as a back-up lamp on field hospitals without UPS or power generators.

SOLED15–F with ABPS has the same performance and appearance, since the structure containing the

battery is within the trolley base. The structure which covers and protects the battery is made of resistant plastic, and its dimensions are: 550 x 340 x 240 mm. The control panel on the structure allows managing all fundamental parameters, such as residual charge, type of power supply, recharge status and electrical power supply presence, amongst others. ABPS has an electronic control which allowts for automatic switch from electric power supply to battery power supply so that SOLED15–F can be used as a high performance mobile unit and is recharged by an automatic charger and requires no specific maintenance. Its autonomy may vary depending on the battery model, which can be from 12 Ah to 28 Ah with maximum charging time of about 8 hours.

ACEM SpAMedical Company DivisionVia della Tecnica 29 - 40050 Argelato Bologna – ITALY Ph +39 051 721844 Fax +39 051 721855 [email protected] www.acem.it/en


Based on its recent analysis of the personal emergency response systems (PERS) market, Frost & Sullivan recognizes MobileHelp with the 2014 North America Frost & Sullivan Award for Price Performance Value Leadership. MobileHelp’s leadership in flexibility across in-home and mobile usage directly captures expectations for tech progression in personal emergency response, and exemplifies key demands of US consumers for these solutions. MobileHelp is at the forefront of convenience and utility in the M-PERS market and offers a simple two product option covering the range of use cases, with a uniform cellular rate plan. MobileHelp has been active in its dedication to broader mobile medical device product goals that augment its core capabilities in emergency response. Frost & Sullivan believes that both its referral branding within facility-to-home care as well as its increasing direct-to-consumer presence will allow it to expand a cost-effective product base across the medical and monitoring spectrum over time.

Primary consumer interest factors in PERS include price, reliability, contract flexibility, and customer experience of the emergency response. MobileHelp has delivered a strong value story for buyers with its simple interface and top-class emergency referral, including robust features and services provided in system pricing for its DUO series.

MobileHelp has been a pioneer in wearable devices with its wristwatch, which greatly reduces product bulk, damage through movement or falls, and issues related to daily forgetfulness of use. Secondly, the two-step transition between the Classic and DUO product suites allows customers to seamlessly upgrade from

indoor-only to mixed indoor/outdoor use, with no interruption to service. MobileHelp also focuses on return guarantees, low obligatory service commitment and easy product upgrade, making its solutions very attractive for new buyers that are seeking emergency care support without product risk.

“Mobility is a key component of shifting customer expectations in personal emergency response systems,” said Frost & Sullivan Research Analyst Daniel Ruppar. Providing systems which broaden flexibility, while offering important ease of use, service support, and other high value factors supporting solution purchase decisions are key characteristics of leadership in this important Senior focused market. Each year, Frost & Sullivan presents this award to a company that has developed a product that offers price competitiveness, ease of use, as well as service effectiveness. Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for outstanding achievement in areas such as leadership, technological innovation, customer service, and product development.

About MobileHelpMobileHelp is America’s leading provider of M-PERS (Mobile-Personal Emergency Response System) technology based in Boca Raton, Florida, and services clients in all 50 states. MobileHelp develops and distributes market-leading products such as Cellular DUO, the first and only fully integrated medical alert system with GSM/GPS technology, which provides an in-home cellular base station and a mobile device to protect customers away from home; and the Cellular Classic system, an in-home, cellular-based Medical Alert System. MobileHelp’s M-PERS devices are integrated with nationwide wireless voice, data and GPS technology to provide real-time medical monitoring services and location tracking for expedited personal emergency assistance. MobileHelp also offers Fall Button™, an automatic fall detection pendant and MobileHelp Connect ™ , an innovative event notification and web portal for customers, families and caregivers. MobileHelp has built a reputation for quality and affordable solutions for personal protection and peace of mind in or away from home and is the first FDA registered mobile medical alert system provider. For sales or more information about MobileHelp, call 1-800-800-1710 or go online to www.MobileHelp.com .

About Frost & SullivanFrost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies? Contact us: Start the discussion .

Contact:Mireya Espinoza, P: +1-210-247-3870, F: +1-210-348-1003E: [email protected]; MobileHelp: [email protected]

SOURCE Frost & Sullivan

Frost & Sullivan Applauds MobileHelp for its Targeted Supplies for the PERS Market


he Intellectual Property and Science Business of Thomson Reuters, the world’s leading source of intelligent information for businesses and professionals, today released a new study in recognition of World Hepatitis Day on Life Sciences Connect , a blog exploring the latest news and trends in Life Sciences and updates on the drug pipeline identifying multiple treatments in development that may serve as potential alternatives to Gilead’s Sovaldi, currently priced in the United States at $84,000 for 12 weeks of treatment -- $1,000 per pill.

Hepatitis is an inflammation of the liver and there are five main hepatitis viruses, referred to as types A, B, C, D and E -- plus types X and G. The five main types are of the greatest concern because of the burden of illness and death they cause and the potential for epidemic outbreaks. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer, killing close to 1.4 million every year according to the World Health Organization (WHO).

In late 2013, Gilead dramatically changed the hepatitis C treatment landscape with the launch of Sovaldi, an effective cure for many when used in combination with ribavirin. However, the high cost of the treatment keeps it out of reach for the majority of the estimated 130-150 million individuals suffering from the disease.

To raise additional awareness for World Hepatitis Day, Life Sciences Connect analysts complied Sovaldi-Innovative, Cost Effective, Unaffordable, utilizing Cortellis™Competitive Intelligence , the pharmaceutical industry’s leading source for drug pipeline, deals, patents, and company content, to evaluate the current outlook of therapies in the pipeline. The analysis revealed several alternative treatments in various stages of development. This high activity is expected to create competition that will lessen costs of treatment, making it more

affordable and accessible to patients.

The following were among the key treatments found in different stages of development:

Outlook for Hepatitis Patients Set to Improve with Development of Accessible Treatments

Developer Drug & Mechanism of Action Indications Under

Development

Roche mericitabine a nucleoside analog NS5B polymerase inhibitor (similar to Sovaldi) Phase II for Hepatitis

Bristol Myers-Squibb orally available combination therapies based on the NS5A inhibitor daclatasvir, the NS3 protease inhibitor asunaprevir and the non-nucleoside inhibitor of HCV NS5B Phase III Potential launch in 2015

Abbvie dasabuvir (non-nucleoside NS5B polymerase inhibitor) veruprevir (HCV NS3/4A protease inhibitor) and ombitasvir (NS5A inhibitor), boosted by ritonavir (+/-ribavirin) Expected launch Q1 2015

The analysis also includes an infographic illustrating significant shifts in the Hepatitis drug market.

“We conducted this study in recognition of World Hepatitis Day to help raise awareness around this potentially devastating disease and spotlight some drugs in development that may help eradicate it,” said Jon Brett-Harris , managing director of Thomson Reuters IP & Science.

“One of the largest barriers in treating hepatitis is accessibility, therefore it is critical to identify the key drugs in development that may help make treatment more attainable.”

T


Veronica (name changed), a school teacher, had been living with a chronic

headache disorder for years. Every Monday, she would return from school with a throbbing pain in her head that would continue for two days, deny her sleep, often cause her to vomit, and make her pop painkillers as a matter of routine.

Yet, for years, she or her family did not care to see a doctor, shrugging off the routine pain as just another headache. After 7 years of suffering when pain killers stopped proving any relief, she finally consulted a doctor who diagnosed her with migraine and suggested injections of OnaBotulinum toxin type A, popularly known as Botox, to relieve her pain.

A large number of people, especially in India, continue to suffer from the awful migraine pains that hamper productivity and disrupt normal life, without ever consulting a doctor. More women than men suffer from these intense bouts of pain, and continue to believe them to be just another form of headaches.

neither eat, nor get a sound sleep and even the slightest of sound can irritate them no end. In some people the pain is so excruciating that they feel like pounding their head on the wall. In a large number of cases women keep suffering from the pain without giving it due importance because women have a habit of keeping their own self at the last priority. Many people have no idea that migraine is a different neurological disorder and is not like other forms of headaches.

What is chronic migraine?Chronic migraine is the term referred to migraine headaches that have lasted more than 3 months. Migraine headaches result from a combination of blood vessel enlargement and the release of chemicals from nerves that causes the sympathetic nervous system to respond with feelings of nausea, diarrhea, and vomiting. The exact cause of migraine is not yet clearly known.

The pain typically starts with severe ache on one side of the head, and may spread to the entire head later. In some people, the pain may start due to exposure from the sun. Some may have extreme intolerance to heat in general. Some people may find that stress, tensions or an emotional trauma may trigger their headaches. Consumption of certain food items is another factor that triggers pain in some people.

What can be done?Doctors often focus on preventive treatments of migraines to prevent the pain from starting and to keep triggers at bay. This is why an antacid is always prescribed by a doctor treating migraine so as to prevent acidity which is a major

trigger.

Other solutions include medication, nutritional supplements, lifestyle alterations, such as increased exercise, and preventing triggers. The aim of such measures is to reduce the frequency and duration of migraines, and if possible also its intensity. These steps help in the overall treatment of the problem. Some people find these therapies effective and see radical improvement in their lives. However, in some people traditional methods do not yield results.

For such people OnaBotulinum toxin type A, popularly known as Botox, can be helpful. Approved by the Food & Drug Administration of the USA for prophylaxis in adult patients who suffer headaches on 15 or more days per month, each lasting more than 4 hours, the drug proves of great help in managing the severe pain in many people.

The drug works by temporarily blocking nerve signals that release such chemicals that cause inflammation and pain. Though chronic migraine cannot be cured permanently, OnaBotulinum toxintypeA can significantly decrease the severity and frequency of migraine attacks. In ideal patients, the drug is administered in prescribed doses at specific sites on patient’s head and neck. The effect of this treatment lasts upto 3 – 6 months and the need for pain preventive and pain relief medication is dramatically reduced resulting in less side-effects and improved quality of life of patients. The patient might require a lower dose of this in the subsequent sittings. v

Migraine is not just another headacheit needs special attention and specific treatment writes Dr. Rajashekar Reddi, Head of Unit

and Principal Consultant, Department of Neurology, MAX Hospitals, New Delhi

• On Migraine Awareness Week (Sept 7-13), doctors educate people about the debilitating disorder that can jeopardize normal life• Chronic migraine can be controlled by medication and advanced treatment solutions like OnaBotulinum toxin type A

Lack of awareness also means that the society remains indifferent and unsympathetic to the condition of the patients suffering from the neurological disorder.

As we observe the Migraine Awareness Week, neurologists stress that it is important to educate people that ‘migraines are not just another headache’, and they require special attention and treatment to be managed and controlled.

We come across patients who have been living with migraine for years. They keep popping pain-killers regularly to be able to carry on with their lives. Only when the pain becomes unbearable and painkillers too stop having any effect, do patients see a neurologist, if at all. It is unfortunate that a large part of their lives is spent in pain, many hours of productivity lost, pleasure forsaken, when this can be treated if medical help is taken. At the same time more intake of pain-killers have long-term side effects such as kidney damage as well as damage to the lining of stomach resulting in ulcer.

Invariably, women are more prone to suffer migraine as against men, with as many as 70 per cent of the sufferers being women. It is believed that hormonal ups and downs make women more prone to it. Sometimes the pain can even lead to sensitivity towards light and sound and cause dizziness and nausea.

The headache occurs at least two days a week; it is severe and difficult to bear and often forces the patient to find solace in a dark and solitary room. Till the headache lasts, some people can


Dr Supriya Shidhaye wins award for research on novel drug delivery system

Dr Supriya Shidhaye, a veteran in pharmacy education, has been chosen for the award for the best research by the Indian Pharmaceutical Congress Trust for her project to combine orally disintegrating tablet to treat paediatric asthma.

Dr Supriya, currently the principal of Vivekanand Education Society’s College of Pharmacy in Mumbai, has been selected for national award for the best research project. The award will be conferred to her next month at Pune.

According to her research, the two commonly prescribed prescribed drugs --Theophylline and Levocetirizine dihydrochloride –can be combined as a disintegrating tablet in a particular dosage regimen for the cost effective and patient compliant treatment of paediatric asthma.

“Theophyliine is incorporated as sustained release microcapsules and Levocetirizine dihydrochloride is incorporated as immediate release taste masked component. The novelty of combining orally disintegrating concept with sustained release is to provide benefit in many aspects to the patients. It will provide a benefit of pleasant taste, sustained action along with reduced frequency and convenience of administration. No such formulation of combination of these drugs is available in the market,” she said, adding that she had applied for a patent for the same.

Indian Pharmaceutical Congress Trust awards are given in various categories to honour the professionals in the pharmacy sector.

A Ph.D holder in pharmaceutics, Dr Supriya has been in the profession of pharmacy teaching for over two decades and she has over 40 published papers to her credit. She has been engaged in development of novel drug delivery systems. She is also an expert in stability study guidelines and protocols, validation techniques for dissolution and analytical methods, drug excipient compatibility studies and statistical data evaluation. She received best paper award for poster presentation at 50th IPC and 17th Asian Congress of Pharmaceutical Sciences on `Reorienting pharmacy education: need of today.’

For more details: Dr Supriya Shiadhaye: -022-25543600, email: [email protected]

Transasia Bio-Medicals Ltd. launched Customer Call Centre on August 8, 2014 at Transasia House, Mumbai. This was officially inaugurated by the prominent and renowned (Hony.) Brig. Dr. Arvind Lal, Padma Shri, Chairman & Managing Director, Dr. Lal Path Labs.

At the opening function, Dr. Arvind Lal unveiled the plaque through remote access and made the

first inaugural call to the centre declaring the Call Centre open. This was followed by the lighting of the auspicious lamp by Mrs. Mala Vazirani, Executive Director - Transasia Bio-Medicals Ltd.

With an enviable track record of over 35 years in the Industry, Transasia is a leader in Clinical Diagnostics and provides Total Solutions for Clinical Diagnosis in Biochemistry, Hematology, Immunology, Critical Care, Coagulation and Urine Analysis.

The inauguration of the Transasia Call Centre will add further value to our prompt service delivery. It will open new vistas in customer care. This would facilitate a swifter response time, technical help; prompt handling of customer calls, improved coordination leading to better deliverables, reaching out even to the far-flung areas.

Transasia’s Call Centre will extend its dedicated service to customers regularly between 8.45am – 7.15pm. Call toll free 1800 103 8226.

About Transasia Bio-Medicals Ltd.

Incepted in the year 1979, Transasia Bio-Medicals Ltd., is headquartered in Mumbai, India. It is one of India’s largest In-vitro Diagnostics Company and offers solutions and products in Biochemistry, Hematology, Coagulation, ESR, Immunology, Urinalysis, Critical Care, Electrophoresis, Molecular Diagnostics, Diabetes Management and Microbiology. Infact, Transasia is the first Indian company to manufacture and export sophisticated, state of the art blood analyzers and reagents.

Transasia is a part of the global ERBA Diagnostics Mannheim GmbH Group. The ERBA Group has spread its footprint across USA, Europe, Turkey and Eastern Europe, Russia and France, by means of various acquisitions – ERBA Lachema s.r.o.(Czech Republic), ERBA Russia (Russia), ERBA Diagnostics, Inc. (USA),

Diamedix Corporation (USA), Delta Biologicals,S.r.l (Italy), ImmunoVision, Inc. (USA), Erba DDS (Turkey), ERBA Diagnostics France (France), JAS Diagnostics Inc. (USA) and Drew Scientific (USA).

Transasia manufactures and markets equipment and reagents, with an impressive install base of above 40,000 equipments across India. Transasia also exports to more than 94 countries in five continents.

The vast network of more than 150 service engineers, 350+ Sales and Marketing Team, 14 zonal offices, and 300+ Distributors allows us to reach out to customers across the length and breadth of the country.

Alliances with international partners like Sysmex Corporation (Japan), Medica (USA), Diesse (Italy), Immco (USA), Helena Bio-sciences (UK), Genprobe (USA), have ensured that cutting edge technology and solutions can be brought to India. Transasia markets, services and supports the Sysmex products and solutions in India. (www.transasia.co.in)

With a vision of being recognized as a ‘local for global’ organization, Transasia continues to provide doctors and patients with reliable, affordable and innovative Medical Diagnostic Systems.

Transasia launches Customer – Call Centre by (Hony.) Brig. Dr. Arvind Lal, Padma Shri, Chairman & Managing Director, Dr. Lal Path Labs


Metropolis Healthcare Ltd conducted a comprehensive study, ahead of ‘World Hepatitis Day 2014’. The study observed a worrying trend of Hepatitis B & C in major cities of India like Mumbai, Delhi and Chennai. Hepatitis B is an infectious inflammatory condition of the liver caused due to Hepatitis B virus that spreads through exposure to infectious blood, vaginal fluid, and semen.

In order to understand the intensity of the disease in Mumbai, Metropolis Healthcare conducted an inclusive survey on 78, 102 samples. Out of the samples studies, 20.28% of the total sample was found positive for Hepatitis B.

HBsAg Screening (January 2012 to December 2013)

The survey unveils the worrying trend of Hepatitis B in kid’s population of Mumbai, over 32.74% of children identified with the symptoms of Hepatitis B. Second maximum samples for the Hepatitis B belonged to 20 to 40 years. Since the younger age group is a sexually active group, and given the fact that Hepatitis B is a silent disease; the chances of infection spread are high. The disease can remain undiagnosed for years together, until the associated symptoms get pronounced. Also, the fact that this is the economically productive age group the economic loss to the country because of the disease is undisputable.

A significant finding of the survey also reported 17.97% of the total sample was found Hepatitis C positive. Hepatitis C Virus (HCV) is leading cause of chronic liver disease worldwide which may ultimately lead to liver cirrhosis or fibrosis or hepatocellular carcinoma.

HCV Total (January 2012 to December 2013)

The maximum positive samples for Hepatitis C belonged to the age group of 20 to 30 years. HCV is spread most commonly through unintentional exposure to infected blood. This was followed by a fairly substantial number of kids examined during the survey showed the symptoms of HCV positive. Out of 10,534 the tested sample in the age group of 0 to 10

years, 3254 samples tested positive with Hepatitis C.

Note: (The above mentioned statistical data is just a representation from Metropolis point of view and cannot be considered as or indicative of National statistical data *)

ABOUT METROPOLIS HEALTHCARE LTD.At Metropolis, what we believe is what we say and what we say is what we do. Being empathetic to our customers and being committed to their needs is in our DNA. Metropolis has grown to harness a culture that is open, synergistic, progressive and scientific in nature.

We are the Pathology Specialists delivering over 15 million tests a year, catering to more than 10,000 Laboratories, Hospitals, Nursing homes and 2,00,000 Consultants. With 33 years of experience in delivering accurate reports, Metropolis has earned the reputation of being India’s most respected and only multinational chain of diagnostic centres with presence in UAE, Sri Lanka, South Africa, Kenya, Mauritius and Ghana.

Driven to make a difference, our wide network includes 105 state-of-art Laboratories across India with over 700 collection centres, processing over 4500 varieties of tests and supported by an efficient team of more than 3000 people. Equipped with cutting edge technology, innovative work equipment, expansive logistics network and rigorous processes, Metropolis ensures and delivers precision and accuracy in every single test; each time, every time.

In the last 10 years, Metropolis has expanded into new service lines like Clinical Trials, Hospital Lab Management, Home Health Services, Preventive Health Check-ups and Corporate & Wellness Solutions. Metropolis is at the forefront in adopting cutting edge technologies and services that contribute new revenue streams and has positioned the company on the pedestal it is today.

Today, we are one of the few laboratories that has received the CAP (College of American Pathologists), accreditation, the global gold standard in Laboratory Accreditation. 12 of our laboratories in India has received the NABL Accreditation (National Accreditation Board for testing and Calibration Laboratories). In addition, the central laboratory in Mumbai also adheres to CLIA (Clinical Laboratory Improvement Amendments) program and also follows the guidelines laid by GCP and GLP. Our unit in South Africa is accredited by SANAS (South African National Accreditation System is the only accreditation body approved by South African Government).

Metropolis has been awarded numerous accolades like the ‘Best Diagnostic Company of the year’ by Modern Medicare in 2006 and ‘Best Diagnostic Company of the Year’ in 2010 by Frost & Sullivan. Metropolis was also bestowed with ‘Best IT Integration in Customer Service Management’ at the e-Health World Expo 2011. Metropolis was also honoured with the ‘Quality Brand Award’ by NEHRDO in 2012. Metropolis won the ‘CMO Asia Award’ for Best IT practices in Healthcare in 2012.

Metropolis Healthcare is led by Ameera Shah, Managing Director & CEO. An International & National Award winners, she was conferred with ‘The Young entrepreneur of the Year Award’ by GE in 2006 and ‘The Young Achiever of the Year Award’ at the CMO Asia Awards in 2011. She was also the recipient of the prestigious ‘Young Entrepreneur of the Year Award’ in 2011 organised by Entrepreneur India and Bloomberg. She has been honoured with ‘Women Leadership award’ at the World Women Leadership and Congress awards 2014. Recently she has been chosen as one of the most respected leaders under 40 years by Economic Times & Spencer Stuart (2014).

Gen Next At The Risk of Hepatitis: Metropolis

Metropolis study released on the occasion of ‘World Hepatitis Day 2014’


GE Healthcare subsidiary

Clarient Diagnostic

Services has entered a

partnership with GlaxoSmithKline

(GSK) to improve access to

diagnostic testing for cancer

patients.

Under the deal, a network of clinical

laboratories will be established to

identify genetic mutations

associated with different tumour

types, and will be made available as

a subscription-based service.

These laboratories will be operated

by GE Healthcare, as per the terms

of the partnership.

The deal will allow GE to develop a

broader laboratory and data analytics

service that will enable better

efficiency in the healthcare MARKET

related to oncology precision

medicine.

"The commercial testing

infrastructure created through this

collaboration will enable advanced

diagnostic solutions that should

improve how patient care is

delivered, where the certified

laboratories are operational."

Clarient Diagnostic Services CEO

Cindy Collins said: "Our arrangement

with GSK will enable us to leverage

GE Healthcare and GSK to improve accessof diagnostic testing for cancer patients

our clinical, technical and quality

management expertise to credential

laboratory partners worldwide.

"This global network of high-quality

diagnostic capability can be

leveraged with confidence by all

pharmaceutical companies in search

of rigorously standardised oncology

diagnostic services and data."

The deal will see Clarient use GSK's

clinical laboratory, pathology and

genomics expertise to certify

laboratories and generate diagnostic

data on metastatic melanoma

patients.

Initially, laboratory testing will be

focused on more than 70 mutations

relevant to melanoma, including

BRAF V600E and V600K, and will be

expanded to other tumour types, as

the network of clinical laboratories

develops. The first Clarient certified

laboratories are expected to start

operations in different countries in

early 2015.

GSK oncology companion

diagnostics and disease strategy

head Jonathan Pan said: "Through

this agreement, we hope to better

address the variability in access and

quality of diagnostic testing which is

a common problem seen with

targeted oncology therapies and

related companion diagnostics

globally.

"The commercial testing

infrastructure created through this

collaboration will enable advanced

diagnostic solutions that should

improve how patient care is

delivered, where the certified

laboratories are operational."

Medical Device Asia | September-October 2014 | 25

Swedish developer of NIOX

brand medical devices

Aerocrine has entered into

partnership with US-based

Microsoft for its secure cloud

services that will help transfer device

telemetry data.

The device's telemetry data will be

transmitted from physician and

company sites in Sweden, the UK

and US back to Aerocrine for

analysis.

The Swedish firm intends to use this

information to deploy its field

resources for customer service and

sales support in the future.

Physicians use Aerocrine's devices

to measure fractional exhaled nitric

oxide (FeNO), a biomarker for

allergic, airway inflammation which is

linked with asthma.

Aerocrine CEO Scott Myers said:

"The ability to collect vital telemetry

data from deployed devices has

been a key objective of ours.

"A cloud-based solution allowing us

to collect data on device perfor-

mance in real-time helps us to be

more proactive in our customer

support and ensure that our NIOX

devices help the physicians deliver

Aerocrine and Microsoft to test cloud-based remote medical device monitoring

the best possible outcome for the

patient."

"A cloud-based solution allowing us

to collect data on device perfor-

mance in real-time helps us to be

more proactive in our customer

support and ensure that our NIOX

devices help the physicians deliver

the best possible outcome for the

patient."

With the FeNO-testing device,

physician can accurately identify the

patients, the type of medication they

should receive, as well as monitor

the patients' progress helping them

to maintain adequate control and

minimise exacerbations.

For this pilot project, proof-of-

concept will be conducted in

autumn this year, and the data will be

collected from Aerocrine devices

deployed in Sweden, the UK and

US.

In the first phase, Microsoft will

connect the Aerocrine devices to its

secure cloud analytics platform,

Microsoft Azure, to show the

secure and accurate transmission of

telemetry data.

Microsoft Sweden Industry

MARKETING development manager

Mathias Ekman said: "We are excited

to work with Aerocrine on this

project as part of the CityNext,

Healthier Cities initiative to show the

potential of new technology to drive

productivity and patient safety as we

move towards a mobile-first and

cloud-first world."

26 | September-October 2014 | Medical Device Asia

US-based Synapse Biomedical has completed patientenrolment in its post-

approval trial of its NeuRx DiaphragmPacing System (DPS) system for thetreatment of amyotrophic lateralsclerosis (ALS).

The system is a four-channel, batterypowered neurostimulator withimplanted electrodes and itprovides electrical stimulation to themuscle and nerves of the dia-phragm.

NeuRx DPS is the only medicaldevice approved by the US Food

and Drug Administration (FDA)specifically for ALS patients.

This humanitarian device securedapproval at the end of 2011 with thedemonstration of safety andprobable benefit.

"NeuRx DPS is the only medicaldevice approved by the US FDAspecifically for ALS patients."

The post-approval study, validatingthe safety, is also intended to helpidentify the patient population thatmay benefit most from this therapy.Synapse Biomedical president and

chief executive officer AnthonyIgnagni said: "When we see theimpact that this device can have forindividual patients, we know thatproviding this supporting therapy ismeaningful for ALS patients.

"Our FDA approval demonstratedthe safety of the device andprovided evidence of improve-ments in survival and sleep for thesepatients.

"It is our mission to make the NeuRxDPS available for the people with thisdevastating disease and to continueto advance the knowledge base of

how and who to best use it in."The NeuRx technology wasoriginated at Case Western ReserveUniversity and University HospitalsCase Medical Center (UHCMC) forspinal cord injured patients andfurther it was developed bySynapse for ALS patients.

UHCMC chair of Surgical Innovationand Synapse Biomedical co-founderRaymond Onders said: "DPS has aproven safe role in maintainingrespiration in ALS patients with oneof our initial pilot patients using DPSfor six years without the need forinvasive ventilation."

Synapse completes enrolment in FDA post-approvaltrial of NeuRx DPS system in ALS patients


“Seeing that in previous years the new forums integrated into the trade fair had been initiated successfully and the internationalisation of the points in the program with many English-speaking presentations had been promoted, e.g. through the MEDICA TECH FORUM and the relaunch of the MEDICA HEALTH IT FORUM, this year’s conceptual focus is on the continuation of the live-cell therapy for the conference program started in 2013.” With these words, the trade fair director Joachim Schäfer summarised the crucial changes to the MEDICA 2014 – World Forum for Medicine (12 – 15 November).

The further development of the program particularly concerns the

networking technical expertise and medical user knowledge. The four days of the MEDICA EDUCATION CONFERENCE are dedicated to each area of focus respectively. Planned topics for this include infection and inflammation, telemedicine and robotics, cancer of the intestinal tract, as well as interventional medicine (surgical intervention).

With reference to the MEDICA conference program, other highlights include the 37th German Hospital Conference, as the leading event for the directors and management of German hospitals or also international conferences that were started last year, i.e. DiMiMED (military medicine) and MEDICA MEDICINE SPORTS +

CONFERENCE (preventive and therapeutic sports medicine).

This year, the MEDICA PHYSIO CONFERENCE, which is organized by Thieme and the training centre FiHH, is new in this year’s program with treatment-oriented lectures for the professional scene of physiotherapists. The main topic here being focused upon: Pain treatment and sports physiotherapy.

Innovations for the entire treat-ment process With topical information in connection with MEDICA presentations of the exhibitors and the MEDICA conference program, significant trends also convey numerous forums that

MEDICA 2014 preview: Conference program with many highlights – providers with many innovations

MEDICA EDUCATION CONFERENCE. For this reason, the German Society for Internal Medicine (DGIM) was acquired as a partner. It has a network of 23,000 members in the fields of science, medicine and health services on a European-wide basis.

The motto of the content orientation of this year’s conference is “Science Meets Medicine” and provides a thematic integration between the conference program and what the trade fair offers. This is because medical advancement is often closely associated with technical developments. Heart catheters, synthetic joint replacements, modern medical imaging would not be established standards nowadays without


are integrated in the trade fair. These include MEDICA HEALTH IT FORUM and MEDICA TECH FORUM (developments in the field of high-tech medicine) in addition to, among other things, the MEDICA PHYSIO FORUM (on professional questions of physiotherapists) as well as the MEDICA ECON FORUM, which was successfully initiated by the Messe Düsseldorf and the “Techniker Krankenkasse” (TK, a German health insurance company), on issues regarding benefit assessment and funding of innovations, primarily from the standpoint of patients and those who bear the costs.

In turn, as the world’s largest and leading market platform (again with around 4,600 exhibitors), the MEDICA will be used by medical technology suppliers to present the entire spectrum of new products, services and procedures to raise efficiency and quality in outpatient and in-patient care on almost 116,000 square meters of booked space.

Focuses of the MEDICA trade fair include: Electromedicine/medical technology (more than 2,500 exhibitors), laboratory technology/diagnostics, physiotherapy/orthopaedic technology, commodities and consumables, information and communication technology, medical furniture and specialist furnishings for hospitals and doctors’ offices.

A central strength of the MEDICA is that it not only deals with solutions for individual medical specialist disciplines, but for the complete “workflow” of patient treatment.

In reference to product developments, the advancements made, for example, in imaging technologies are impressive. Today, ultrasound devices of the best class offer a resolution and, at the same time, contrast with a penetration depth that would have seemed unimaginable just a few years ago. There are already some systems that even have built-in “anatomic intelligence” consisting of an integrated database with anatomic structural models. In this way, better balance can be achieved if the transducer does not sit entirely right. Advantages also result in the creation of tomographies. As a result, an image quality is achieved that is even suitable for the high requirements of cardiology.

Automation and digitalisation in the operating theatre As a further crucial trend in light of the innovations of the MEDICA exhibitors, the advancement of digitalization and automation in the operating theatre can be accounted for. Altogether, information and medical technology continue merging with each other more and more. In operating theatres equipped with the state of the art and so-called hybrid operating rooms (with equipment for medical imaging “on the spot”), surgeons can fall back on a continuously growing number of systems that are able to facilitate intervention and patient monitoring in addition to even being able to assist in the process.

Systems that are established include those that are computer-based and navigate surgeons very precisely, controlling incision, on the basis of data of medical

imaging and a defined planning and marking of the “target area” before operation. Medical technological equipment in the operating theatre is increasingly networked with one another and can exchange required information among each other or between the hospital operating system for intervention or for creating documentation. The various equipment can be centrally controlled by (touchscreen) panels that are easy to operate.

Marching on: “Wearables” Furthermore there is already a conceptual approach on how data glasses (“Google Glass”) could optimally support surgeons in connecting to patient monitoring systems on the head-up display, showing the most important vital signs.

By the way, wearables: Advancements in the field of sensor systems, material development, energy storage, and chip technology are motors for growth belonging to this diagnosis and communication “all-rounder” used

close to the body. The spectrum of current technology developments ranges from a chip-sensor band-aid to determining specific body parameters by connecting to a smartphone app, all the way to an application for use in the ear that is already ready for market. Thereby, heart frequency, core body temperature and oxygen saturation can be determined.

The Wearable Technologies Show being held in hall 15 communicates to MEDICA visitors a selection of wearables that possess a lot of market potential from a medical perspective.

Together with the supplier trade show, COMPAMED and its more than 700 exhibitors (12 – 14. November 2014/ halls 8a + 8b), the MEDICA is occupying the entire Düsseldorf fairground. The target audience of both events exclusively include experts in the field.

Opening times: 10:00 am - 6:30 pm, Saturday 10 am - 5:00 pm (MEDICA only).


Coating is one of the mostcomplicated steps in theproduction process of

ignition coils. Many believe it is alsothe most expensive. As a result, alarge number of automotivesuppliers hesitate to implementcomplex machinery to avoidprocurement costs.But there is an alternative toexpensive custom-built systems,which has been around for sometime now.

A cutting-edge economic solutionfor small to medium-sized automo-tive suppliers In addition to itsproven vacuum dispensing systems,Scheugenpflug AG offers bespokeequipment modules customised forignition coil production.

The system is a standardised set ofmodules which can be combinedinto a repeat-accurate vacuumproduction system sizeable to suitany budget.

The production line modules aremanufactured in volume production,which gives them a major advantageover custom systems.

THE IDEAL PROCESS

A vehicle that starts rain or shine andtakes us reliably to our destination?This is a matter of course for everycar or lorry driver, whether airtemperature is -40°C on ice andsnow or 40°C on sandy roads withwind blowing. To master extremeconditions such as these is a qualitystandard for the automotive industry,which is a compulsory conditionthat ignition coil manufacturers mustmeet in all circumstances. Even thetiniest inhomogeneity, bubble or

cavity will result in a reject duringproduction or in failure in the field.To guarantee maximum operability ofan ignition coil dispensing must bedone in a vacuum. However, it doesnot suffice to merely carry out thedispensing action in a vacuum.Ideally, the process starts with theproper preparation of the dispens-ing material.

Custom-built stirring mechanisms,tank degassing and material feedlines, pumps and valves sealedairtight are the minimum require-ments to begin with. Dispensers inairtight design and a parametrisedvacuum control round off theultimate vacuum process. Mostdispensing materials for pottingignition coils contain jagged fillers forbetter heat dissipation.

Conventional machines sufferincreased wear and tear, whichraises costs for spare parts.Therefore, we use low-wear spareparts instead of expensive ceramicseals and robust pumps anddispensers. When potting ignitioncoils it is essential to remove all airfrom the delicate coils of thecomponent. To get rid of even thetiniest bubbles of air deep inside thecoiled section of the part airpressure is lowered to about onemillibar or less (absolute pressure)during the dispensing process. Thisis a much lower pressure than inconventional vacuum applications.

A STANDARD SYSTEM WITHMODULAR DESIGN

In addition to the proven andcompact-sized vacuum systemsScheugenpflug AG offers severalproduction modules optimised for

ignition coil encapsulation. Theirmaterial preparation units andvacuum chambers are equippedwith more efficient pumps. Theirdouble-walled hoses and lines (witha vacuum between the two tubewalls) prevent air from diffusing intothe dispensing material through thehose wall. Using these highlyaffordable accessories, everystandard vacuum chamberbecomes suitable for fine and highvacuum applications. Which meansit can be used for filling ignitioncoils.

This modular plant design concept,which has already been imple-mented by many renownedautomotive suppliers, usesstandardised modules which can beflexibly combined with one another.Since these modules are manufac-tured in volume production, theyshow a major advantage overcustom-built systems. Thanks totheir universal interfaces they can beeasily adapted to requirements andretrofitted or converted should theneed arise due to newly emerging

Vacuum Dispensing of Ignition Coils:Sophisticated Technology Made Affordable

production requirements. If thesystem needs to be modified, thenecessary module is added withouthaving to discard existing machinery.

The controls are intuitive and theiroperation is easy to learn forhandling personnel. This saves costsof training and familiarisation. It is anoverall economic system whichdelivers output of highest repeataccuracy and superior processreliability, both in its semi-automatedand its fully automated versions.

Scheugenpflug AG recommendsconsulting with a vacuum dispens-ing specialist from the planning stageof the system onwards. Manydetails, such as the design andshape of the substrate, upstreamand downstream productionprocesses, curing, etc. haveconsiderable impact on thedispensing process. Therefore,professional analysis combined withmature processing technology andthe correct choice of machinery canconsiderably lower INVESTMENTcosts and reduced project planningtimes.


The U.S. Food and DrugAdministration wants medtechdevice makers to forearm

themselves and their end usersagainst cyber attacks. In a guidancestatement, the agency said thatalthough there has been noapparent security breach affectingmedical devices, it recommendsthat medtech manufacturers“consider cybersecurity risks as partof the design and development of amedical device, and submitdocumentation to the FDA aboutthe risks identified and controls inplace to mitigate those risks.”

Manufacturers can further reducethe vulnerability in their medicaldevices by having a plan to managesystem or software updates, theagency said.

The FDA is worried about:Malware infections on network-connected medical devices orcomputers, smartphones, andtablets used to access patient data;Unsecured or uncontrolleddistribution of passwords;Failure to provide timely securitysoftware updates and patchesamong medical devices andnetworks;

And security vulnerabilities in off-the-shelf software designed toprevent unauthorized access to thedevice or network.

Other concerns include medicaldevice malfunction; disruption ofhealthcare services, includingtreatment interventions; inappropri-ate access to patient information; orcompromised electronic healthrecord data integrity, the agency saidinannouncinga public workshopheld recently.

The FDA has been working withother federal agencies and themedical device industry to identify

and communicate with stakeholdersabout vulnerabilities. The agency isplanning a public workshop this fallto discuss how government,medical device developers,hospitals, cybersecurity profession-als, and other stakeholders cancollaborate to improve thecybersecurity of medical devicesand protect the public health. It isaccepting comments on theguidance at http://www.regulations.gov.

The industry has not been waitingfor FDA to issue the call to arms.Qmed reported in January that asearch engine called Shodan isadept at discovering hard-codedpasswords, permitting hackers togain control of a medical device.

Types of medical devices withknown vulnerabilities (based onShodan searches and a June 13,2013, Industrial Control SystemsCyber Emergency Response Team(ICS-CERT) report include:

Glucose meters;Surgical and anesthesia devices;Fetal heart monitors;Ventilators;Drug infusion pumps;External defibrillators;Patient monitors;And laboratory and analysisequipment.

The New FDA Cybersecurity GuidanceYou Need to Know


New president and CEO Keith Grossman served in those roles at the

Pleasanton, CA–based company from 1996 to 2006, when

Burbach took over. The shakeup follows the deaths of four patients

and reduced blood flow or lost consciousness in five others while using the

company’s HeartMate II left ventricular assist device. The company and the

FDA said the device was not at fault; rather, it was patients’ misunderstanding

of how to use a new controller.

The company announced in March

its plans to update labeling and

training materials for the HeartMate II

LVAS Pocket System Controller

because some patients and

caregivers had trouble with the

process of changing from a primary

system controller to their backup

system controller.

Of these nine cases of death or

serious injury, eight occurred in

patients who began using the

Pocket Controller after having been

trained on an older model, the EPC

System Controller, according to a

Qmed report. Two of the deaths

involved patients who attempted to

exchange system controllers while

alone and, contrary to the labeling,

without contacting the hospital first.

Thoratec announced the release of

an updated version of the Pocket

System Controller on September 18.

The company said it would provide

the latest version free of charge to

cardiac centers and patients upon

request. The exchange could cost it

up to $11 million pretax in the third

quarter.

In August, Thoratec’s STOCK fell to a

six-month low of $24.05, after

having peaked in July at $24.71. It

After Patient Deaths, Thoratec ReinstatesFormer CEO

has slowly regained momentum,

with an uptick to $27.74 following

the announcement of Grossman’s

return.

Burbach left his executive and board

roles but will remain an advisor to

the company through the first

quarter of 2016, according to a

Thoratec statement.

Grossman has worked in the

healthcare industry for 30 years,

most recently as president and CEO

of Conceptus, Inc. The Mountain

View, CA–women’s health medical

device company’s MARKETvalue

tripled as its sales and profits grew

during Grossman’s tenure, Thoratec

said. Bayer Healthcare LLC pur-

chased Conceptus in 2013.

During Grossman’s previous turn at

Thoratec’s helm, the company made

advances in the mechanical

circulatory support MARKET,

boosting revenues and market value

significantly, the company said.

Grossman has continued to serve

on Thoratec’s board since leaving

the company. From 2007 to 2011,

Grossman was a managing director

at private equity firm TPG, where he

initiated and co-led the medical

device venture investing effort, and

served as a senior advisor to the

firm’s buyout FUND.

Thoratec Corp. has replaced CEOGary Burbach with the man whopreviously led the company for adecade.


Despite recent changes in U.S.tax rules that make corporatetax inversions less lucrative,

neither Medtronic nor Covidienappear to be backing away fromtheir $43 billion deal.

The new rules make it moreexpensive for Medtronic (Fridley,MN) to buy Ireland-based Covidien,potentially requiring Medtronic toborrow MONEY instead of usingcash held abroad, according to aReuters report.

The Treasury Department, forexample, is cracking down on manyof the FINANCIAL mechanisms—from so-called "hopscotch loans" toSTOCK transaction mechanisms—that inverted companies use toaccess the overseas earnings offoreign subsidiaries of the U.S.company that inverts without payingU.S. tax. It is exactly such financialmechanisms that Medtronic wasexpected to utilize after mergingwith Covidien and moving its officialheadquarters to Ireland.

A Medtronic spokesman declinedto comment on the Reuters report,reiterating the company’s initialstatement.

"We are studying Treasury’s actions,”said Fernando Vivanco. “We willrelease our perspective on anypotential impact on our pendingacquisition of Covidien followingour complete review.”

Vivanco declined to comment onhow long the corporate reviewwould take.

Covidien did not immediatelyrespond to Qmed’s request forcomment on the future of the deal.However, Covidien CEO JoseAlmeida wrote in an SEC filing lastweek that Medtronic and Covidienare moving toward consummatingthe deal and are continuingintegration planning while evaluating

the new tax rules.

President Obama has definedcorporations that pursue inversionsas “moving their tax residenceoverseas on paper to avoid payingtheir fair share in taxes here at home."

Reuters quoted unnamed “peoplefamiliar with the matter,” whospeculated that Covidien may needto lower its asking price and acceptmore STOCK and less cash tocomply with the new rules.

If the rules had been laws, thecorporations’ deal would haveallowed Medtronic to walk awayunscathed, the Reuters report said.However, because the U.S.changed the rules, Medtronic couldbe out $850 million if it abandonsthe arrangement. That breakup feewould vanish if shareholders ofeither corporation vote down thedeal, the Reuters story said.

The companies had expected themerger to close in late 2014 or early2015.

Tax inversion deals, which havebeen termed the “holy grail of taxavoidance” by a number of U.S.politicians, have been picking uprecently as a growing number ofcompanies look for ways to reducetheir tax burden, Qmed hasreported. As many as 25 U.S.companies are consideringrelocating their headquarters to low-tax destinations, according to theIrish Times.

The corporate tax rate in the UnitedStates is 35%—the highest nominalrate in the world, leading a numberof companies to look for newdomiciles in low-tax nations such asIreland, the United Kingdom,Switzerland, and the Netherlands.Medtronic has also pointed out thatthe U.S. is one of only six OECDcountries that impose on itsbusinesses the worldwide taxation

of corporate profits.

Medtronic has an effective tax rate of18 percent, similar to that ofCovidien, according to the Reutersreport. Medtronic has said thecombined company's tax ratewould decline by one or twopercentage points.

Inversion was supposed free upbillions of dollars for Medtronic thatcompany officials say could then beINVESTEDback in the United States.

Medtronic May Have to Pay a Lot More forCovidien


Smart clothing could helptransition wearables frombeing a separate device to

being one that users naturally wear.The technology, which is alreadygetting the attention of athletes,features sensors that disappear intoclothing.

Wearables may need such atransition—because while they wereall the rage at CES this year, it remainsto be seen how popular

smartwatches, headset devices likeGoogle Glass, and other body-worndevices will be with mainstreamconsumers.

While fitness trackers like the FitBitand the Jawbone have proliferated,their popularity is limited to arelatively narrow demographic.What’s more, the bulk of wearablesdeveloped so far have troublepresenting the data they collect inmeaningful ways.

Smart clothing DeviceFOURNIER

Fournier show off his company'sHexoskin smart shirt at the Designersof Things event in San Francisco.Enter smart clothing, which itself isanything but new. With rootsstretching back to NASA’s HumanFactors Group in 1985, smartgarments have still not becomemainstream. Even today, a NASAsmart garment—known as E-SEWT—looks like something out ofa science fiction movie. Developedin collaboration with the PrattInstitute, the University of NewHampshire, and the British firmRotite, the E-SEWT features anonboard battery and electronics.The technology could assistastronauts in monitoring thespacecraft and performing emer-gency procedures while away fromthe cockpit.

It is worth pointing out that in thepast several decades, many othergovernment-sponsored technolo-gies have become a staple ofmodern day life. GPS technologywas developed in the 1970s by theU.S. Department of Defense. AndU.S. government-collected weatherdata gives millions of consumersaccess to real-time downloadableweather information and forecasts.

Perhaps NASA’s E-SEWT willultimately provide the inspiration forsmart garments for consumers thatcould track health metrics, humanperformance, and other variables.

Sister publication EE Times coversone consumer-facing wearabletechnology known as Hexoskin thatpacks two microcontrollers, aBluetooth radio, A USB controller,memory, and a battery in thepackaged roughly the size of a stack

of BUSINESS CARDS.

“We'd like this part to disappear intothe clothing, so you don't thinkabout it,” said Pierre-AlexanderFournier, chief executive of Hexoskinin an interview with EE Times. “Itcould be the size of a button, runon a coin cell so you don't need tocharge it, and be something you canput in a washing machine.

We are not there yet, mostlybecause of power consumption,which determines the battery sizeand device form factor.”The device can gather a range ofhealth metrics including ECG,respiration, temperature, and bloodoxygen level. In addition, thetechnology can come up with anestimate for blood pressure as well.

While the potential is there for this tobe an important health monitoringtechnology for the mainstream,challenges certainly exist. For onething, there is the gap between theclothing and electronics industries.“It's like traveling back to the 19thcentury when you visit [clothing]factories,” said Fournier, in theaforementioned EE Times piece.

The technology is also still expen-sive. At present, the Hexoskin smartshirt costs $399 with onboardelectronics included. But like nearlyall electronics, those costs are set toplummet with time, which couldmake for an array of interestinghealth- and medical-trackingapplications at some indeterminatepoint in the future. In the meantime,we can see whether the latestgenerations of smartphones, whichinclude the ability to track users’activity levels and other healthmetrics, will have a measurableinfluence on their user base.


A network of hospitals in Indiahas agreed to use AliveCorInc.’s smartphone-enabled

heart monitor to screen patientsacross that country for heartarrhythmia and risk of stroke,according to a joint announcement.

Apollo Hospitals will providepatients with the AliveCor heartmonitors, which attach tosmartphones, as part of itsarrhythmia screening and strokeprevention program. The monitor iscompatible with iOS and Androidmobile devices to wirelessly record,display, store, and transfer heart rateand single-channel electrocardio-grams (ECG), according to SanFrancisco–based AliveCor.

Terms of the deal are confidentialsaid AliveCor spokespersonRebecca Phillips in an email.

“Apollo is our exclusive reseller/distributor in certain south Asian

countries,” Phillips added. “They areauthorized to sell and distribute ourproduct through their channels,which include the pharmacies,physicians and hospitals.”

"We recognize the pioneering workthat has been done by AliveCor inthe U.S. and also the great value thatthis technology can bring to patientsas we work to address theproblems of arrhythmias in India,"said Prathap C. Reddy, MD, chair ofApollo Hospitals, in the announce-ment. "It's extremely important for usto provide access to medicaldevices that are both clinicallyproven and cost-effective to helpour patients manage their cardiachealth.”

Apollo Hospitals operates 51hospitals, 1,503 pharmacies, 92primary care and diagnostic clinics,and 100 telemedicine units in 10countries, according to theannouncement.

Smartphone-based ECG Takes Indiaby Storm

AliveCor’s smartphone-based heartmonitor was used in an Australianstudy to capture 30–60-secondelectrocardiogram (ECG) recordingsand then wirelessly transmit them tothe study's participating cardiolo-gists for interpretation. The research-ers reported that previouslyunknown AF was identified in 1.5percent of the people screened; allwere said to be at high risk ofstroke.

AliveCor began working withPractice Fusion—the largest free,cloud-based Electronic HealthRecord (EHR) community in theUnited States—in February to enableheart patients to upload data directlyfrom their devices to their EHRs. Thisuploaded data will be available tophysicians and healthcare providerswithin seconds.

The company said in February that itis also creating a dedicated app forprimary care physicians using the

Practice Fusion EHR. This will allowthem to collect patient ECGs andrequest an analysis or "over-read"from licensed technicians or board-certified cardiologists. This app willalso keep track of patients' historyover time. AliveCor says thesubscription-based program willcost less than the price of a singledevice, which lists for $199 on thecompany's website.

The FDA approved the company’ssmartphone-based heart monitor in2012 and allowed it to be sold overthe counter earlier this year.

AliveCor makes three versions of itsheart monitor. It is available mountedin a case for the iPhone 5 and 5S orfor the Samsung Galaxy S4, and witha universal attachment plate to fitother smartphones. The company'sfree AliveECG app is available in iOSand Android flavors. The app canemail or print ECGs, or can savethem as PDFs.


Oh, my beating heart! One

day, its image may be

captured in 3-D by a

high-speed microscope designed

by German researchers. Max Planck

Institute Beating Heart

Scientists at the Max Planck Institute

of Molecular Cell Biology and

Genetics in Dresden combined

Selective Plane Illumination Micros-

copy (SPIM) and inventive image

processing to reconstruct multi-view

movies of the beating heart of a

zebrafish.

Each movie covered an individual

plane of the heart. They then used

the correlations between the

individual planes to generate a

synchronized 3D image of the

beating heart.

Their work may help advance the

understanding of heart defects and

further experiments on cardiac

function and development,

according to a press release from

the institute. It may also allow for

imaging of hearts with arrhythmia.

The research team stopped the

heart from beating by illuminating it

using optogenetics. (Zebrafish

embryos can survive several hours

of cardiac arrest.)

They employed this non-invasive

technique to gently illuminate the

fish heart with a thin sheet of light,

then observed the fluorescence

with a fast, sensitive camera. High-

speed volume scanning using a

liquid lens can resolve non-periodic

phenomena such as irregularly

beating hearts and the flow of

blood cells.

“These renderings allow us to further

follow characteristic structures of the

heart throughout the cardiac cycle,”

said Michaela Mickoleit, a PhD

student who performed the

experiments.

This technology will allow scientists

to observe cardiac contractions and

the distance between endocardium

and myocardium throughout the

heartbeat. They might achieve better

resolution by manipulating the

exposure time and magnification of

the images, enabling views of fine

details such as sarcomeres and

filamentous actin.

The German research is among the

latest to use 3D technology for

medical purposes. In May, research-

ers at the MIT Media Lab's Camera

Culture group said they built a

prototype of a glasses-free 3-D TV

projector that can improve the

resolution and contrast of conven-

tional video.

The researchers hope this could

make it an attractive transitional

technology, cheaper and more

practical than holographic video, as

content producers gradually learn to

harness the potential of

multiperspective 3-D.

3-D Imaging Method Unmasks Secretsof the Beating Heart


Medtech giants jockeyedfor attention to theircoronary catheterization

products at the 26th TranscatheterCardiovascular Therapeutics (TCT)meeting held this week in Washing-ton, D.C., according to a report onbidnessetc.com and companyannouncements.

Minneapolis-based Medtronic hadlots to talk about. The Food andDrug Administration gave 510(k)approval last week to its NCEuphora Noncompliant BalloonDilatation Catheter for use in heartreplacement surgeries. Thecompany received the CE Mark toMARKET the device in Europe inMay.

Among the new products launchedby Medtronic this year is the theReveal LINQ, the smallest insertablecardiac monitor now available.

The NC Euphora is inflated with highpressure to ensure that a drug-eluting stent inserted to reopen anarrowed artery is fully expanded,aiding transfer of the drug to theartery wall, according to a companystatement.

Medtronic also used the conferenceto tout the results of a study of 305high-risk patients who received itsCoreValve transcatheter aortic valvereplacement (TAVR) device. TAVR isindicated for patients who sufferfrom narrowing of the aortic valve,or aortic stenosis, according toanother company statement. It isless invasive than open-heart surgery

to remove and replace an oldervalve. The company recommends itfor patients who cannot withstandopen-heart surgery.

“Consistent with the positive one-year clinical results, all-causemortality (36.5 percent) and majorstroke (5.1 percent) at two yearswere low for this extreme riskcohort,” the company said.

After two years, the CoreValuedemonstrated good blood flowperformance, consistent with one-month and one-year rates, it noted.The FDA approved the CoreValve onJanuary 17. A Zacks Equity Researchblog reported that Medtronic hasevidently captured almost 40% ofthe U.S. MARKET in just two quartersafter launching CoreValve in the U.S.

Not to be outdone, EdwardsLifesciences, Medtronic’s primarycompetitor in this space, presentedfive-year trial data for its Sapientranscatheter heart valve at theconference. Inoperable patientswho received the company’sSapien heart valve experiencedsustained improvements in heartfunction and fewer repeat hospital-izations, Edwards (Irvine, CA) said ina statement.St. Jude Medical (Little Canada, MN)and Boston Scientific Corp. alsopresented data on their less-invasiveheart valves at TCT. However,Medtronic scooped both compa-nies, launching the first U.S. trials forits Evolut R transcatheters onWednesday, Zacks reported.

In other news this week, Medtronicannounced the launch of itsexternal, wire-free, adhesive heartmonitor, the SEEQ Mobile CardiacTelemetry System. Patients can wearthe device for up to 30 days – evenin the shower – to help detect anddiagnose the cause of irregularheartbeats. Medtronic announced itwas acquiring Corventis, Inc., whichdeveloped the technology, in June2014.

The SEEQ system automaticallysends cardiac data to the MedtronicMonitoring Center, where cardio-graphic technicians monitor dataaround the clock. Patients may alsouse a trigger button to alert themonitoring center to symptoms, thecompany said in a statement.

Medtronic Hopes to Expand CardioBiz

Minneapolis-based Preventice,which Qmed.com reported lastweek had merged with eCardio(Houston, TX), also makes a patch-based wireless heart monitoringsystem, the BodyGuardian. Worn onthe chest, the BodyGuardian deliversinformation to a dedicated Samsungsmart phone that conveys it to thepatient’s physician.

Topping it all off, Medtronic thisweek was named one of theworld's leading companies forsustainability on the Dow JonesSustainability World Index for thefourth year in a row, according to aThomson Reuters report. Criteriainclude economic performance,environmental stewardship andsocial responsibility.


Fanfare for the iOS 8 debut ofApple’s HealthKit apps fizzledthis week when the company

announced a software bug woulddelay the apps’ availability for abouttwo weeks when it would beoffered as part of a softwareupdate.

Regardless, the iOS 8 operatingsystem debuted September 17.

“We're working quickly to have thebug fixed in a software update andhave HealthKit apps available by theend of the month,” a companyspokesperson said in an email onWednesday, Reuters reported.

HealthKit is now being tested byclinicians at Stanford and Duke.Apple has touted the health–and–

fitness tracking software in HealthKitfor its potential to communicatepatient health data to hospitals anddoctors.

After Apple’s iCloud suffered itsown security breach, doubts werecast regarding the security of theHealthKit health-tracking platform.Apple, however, has bannedHealthKit apps from using theiCloud.

After Apple announced theHealthKit delay, several softwaredevelopers took to Twitter, positingthat data management may becausing the problem, according to areport on medcitynews.com. High-profile organizations, includingStanford and Duke universities, arealready working with Apple on

Apple Has a Bug to Exterminate fromIts HealthKit Apps

HealthKit, according to a previous

HealthKit is “already helping tophospitals fight cancer, diabetes,”said Cult of Mac recently. Forbesresponded that neither Stanford norDuke have confirmed that asubstantial number of patients areinvolved in HealthKit trials.

The app works by gathering datafrom multiple sources and poolingthem in a central location sohealthcare professionals can analyzehealth metrics. Regulated medicaldevices such as glucose monitors,heart and respiratory monitors, andother medical devices, would allconnect to Apple’s platform andconstantly stream data that patientscan make available to healthcareprofessionals for monitoring

purposes. Apple removed someiOS 8-enabled health and wellnessapps that would connect withHealthKit from its app store,including MyFitnessPal and Carrot Fit,Reuters reported.

Electronic health record companies,including Epic, Cerner andAthenahealth, are working withApple to develop apps to integrateHealthKit with a number of hospitalsacross the United States, Reutersreported. In June, Qmed.comreported that Apple announced asimilar partnership with the MayoClinic.

Apple promises on its website thatthe information transmitted viaHealthKit will be private, andcontrolled by the end user.


A method of detectingdepression in adults fromblood could be the first

objective way to diagnose thecondition, which affects almost 1 in10 people in the United Statesaccording to the CDC.

The test could be truly revolutionary.While depression has become morewidely diagnoses over the past fewdecades, its diagnosis is oftenbased on vague criteria. WebMD, forinstance, notes that doctors look todiagnose the condition by askingpatients to self report “sadness ordepressed mood most of the dayor almost every day” or “loss ofenjoyment in things that were oncepleasurable.”

Recently Eva Redei, a professor ofpsychiatry and behavioral sciencesat Northwestern University’sFeinberg School of Medicine, hasdeveloped a test which could pointtowards an objective method ofdetecting depression. In addition,the method could also helpimprove doctors and mental health

experts ability to identify which typeof therapies will work best.

A study supporting the test isunderway at NorthwesternUniversity’s Feinberg School ofMedicine, as researchers haveidentified nine RNA blood markersthat can be used as part of a panelto diagnose the mental disorder.

The study included 32 patients whohad been independently diagnosedwith depression in a clinicalinterview, along with 32 non-depressed patients as a controlgroup. The study found the nineRNA blood markers at significantlydifferent levels in the patientsdiagnosed with depression than inthose in the control group.

According to the Anxiety andDepression Association of America,almost 15 million Americans sufferfrom major depression each year,however diagnosing depression cantake anywhere from two to 40months, resulting in delayedtreatments. The hope is that this test

A Blood Test for DiagnosingDepression

could provide a more timely,accurate manner with which todiagnose the mental condition,accelerating both treatment andtherapy.

“This clearly indicates that you canhave a blood-based laboratory testfor depression, providing a scientificdiagnosis in the same way someoneis diagnosed with high bloodpressure or high cholesterol,” shesaid. “This test brings mental healthdiagnosis into the 21st century andoffers the first personalizedmedicine approach to peoplesuffering from depression.”

Redei previously worked on adifferent kind of blood test to helpdiagnose adolescent depression,citing that many of the markers thatindicate depression in children weremuch different than the markers onthe adult depression panel. Thiscould eventually pave the way fordoctors to test individuals early inchildhood, as well as into adult-hood for severe depression. Ofcourse there is still a lof research left

to be done for Redei and her team.Researchers plan to continue to testthe panel on larger population sizes,as they continue to gather data andrefine the method.

The team indicated that the studywas supported by grants from theNational Institute of Mental Health,and the U.S. National Institute ofHealth.

Redei is still hopeful that identifyingthe presence of depression is justthe beginning.

Researchers maintain hopeful thatthe test can not only help identifydepression and therapy solutions,but also help distinguish betweenmajor depression and bipolardepression.

As we move forward into the realmof mental health discovery, Redeiand her team look to establish someof the early building blocks ofmental health diagnosis, helping uslive healthier lives both physicallyand mentally.


University of Houstonresearchers are usingnanoscience to extract

molecules from live cells withoutkilling or damaging the cells. Theirmethod could lead to newpossibilities for diagnosing cancerand other diseases.

The scientists used magnetizedcarbon nanotubes to retrievemolecular information safely from thecells. Nanoengineering allowedthem to keep the cells alive and toassess changes in the cells overtime, Zhifeng Ren, a physicsprofessor and principal investigatorat the university’s Center forSuperconductivity, explained in arecent news release.

Ren was lead author of a paper onthe breakthrough published thisweek in the Proceedings of theNational Academy of Sciences. His

lab collaborated with that of PaulChu, founding director of the TexasCenter for Superconductivity.

The current research builds on apaper Red’s group published in2005 in Nature Methods, establish-ing that magnetized carbonnanotubes can deliver molecularmaterial into cells. Now researcherscan move molecules out of cells bymagnetically driving them throughthe cell walls.

The researchers grew the carbonnanotubes with a plasma-enhancedchemical vapor deposition system,enclosing magnetic nickel particlesat the tips. Each nanotube had alayer of nickel deposited along thesurface to enable it to penetrate acell wall guided by a magnet.

The magnetized carbon nanotubesacted as the transporter and a

How Nanotubes Could ImproveCancer Diagnostics

polycarbonate filter collectedmaterial from cells derived from ahuman embryonic kidney cancer cellline. It was a “relatively straightfor-ward” method, the researchers said.

The technology allowed theresearchers to draw informationfrom a single cell rather than takingan average of many cells. Previousmethods, which damaged or killedcells, obscured the specificity ofbiomarker profiles, challengingresearchers and limiting theirefficiency, said assistant physicsprofessor Dong Cai.

Cai said the new method would behelpful for cancer drug screeningand carcinogenesis study.

Scientists will now be able to furtherstudy and analyze the biological andchemical processes of the cell,holding out promise for biomedi-

cine, according to Ren. “Theindividual cells may be different, butyou cannot see exactly how theyfunction,” added Chu.

Nanoscience is enabling all kinds ofmedical innovations.Other research-ers have shown they can use adesigner nanoparticle, which is onlya few billionths of a meter, or thesize of a few molecules, to attachmolecules that perform differentfunctions.They can also design and fabricate ananoparticle that contains a numberof drugs, a cell-targeting vector, andan imaging component, as well asmolecules that improvebiocompatibility and uptake.

These precision-engineerednanoparticles may help performimaging, drug-delivery, andcytotoxicity studies, according toresearch at Syracuse University.


A new device could light

the way to combating the

most common form of

cancer in the United States. The skin-

cancer detection tool combines

three light modalities into one

device for better detection, thereby

subjecting only the most likely skin

abnormalities to biopsy—the next,

more invasive and expensive stage,

of diagnosis.

The multi-modal spectroscopy

(MMS) device was conceived by

University of Texas at Austin

researchers, whose results were

published online on August 5 in

Review of Scientific Instruments,

from AIP Publishing. The researchers,

from the university’s Cockrell School

of Engineering, say the combined

light modes improve diagnosing

malignant melanoma and non-

melanoma (basal and squamous cell

carcinomas) skin cancers.

Multiple spectroscopic techniques

enable the instrument to detect

changes in cells: diffuse reflectance

spectroscopic light, for cell changes

in tissue microenvironments; laser-

induced fluorescence, for altered

tissue matrix, such as with collagen;

and Raman spectroscopy, for

finding vibrational modes of

chemical bonds like those in

Shining a Light on Skin Cancerconnective tissues, lipids, and cell

nuclei. Pilot clinical trials are

underway for the 3-in-1 device and

FUNDING agencies and start-up

companies have been reached to

help get the device to dermatolo-

gists.

The American Academy of

Dermatology reports that one in five

people will develop skin cancer at

some time; by 2015, one in 50 will

develop melanoma. Reducing this

rise requires new techniques that

can reach more people, faster.

Other recent innovations in skin

cancer detection have put early

diagnosis in the hands of the public,

more than figuratively. New

smartphone apps allow users to

photograph suspicious moles and

have the images algorithmically

referenced against a database of

dangerous or benign skin abnormali-

ties. Other apps share the photos

directly with dermatologists, who

provide a rudimentary diagnosis.

Even present detection tools

available to dermatologists inspect

potential cancers more superficially

than the MMS device.

Dermoscopes shine light on the skin

with enough magnification to see

pigment and structures. MMS, on

the other hand, can detect cell

changes in tissue microenviron-

ments. A dermatologist still must

biopsy all potential skin cancers for

definitive results. The improvement

in early stage detection, however,

could mean substantial reduction in

the nation’s most widely-spread

cancer.


The Food and Drug Administration has released long-awaitedguidelines on the cybersecurity

of medical devices.

"There is no such thing as a threat-proof medical device," said SuzanneSchwartz, director of emergencypreparedness at the FDA's Center forDevices and Radiological Health.

"It is important for medical devicemanufacturers to remain vigilantabout cybersecurity and toappropriately protect patients fromthose risks," she said in a statement.

The agency is recommending thatmanufacturers considercybersecurity risks as they designand develop medical devices.

Further, companies should give theFDA information about the potentialrisks they found and what controlsthey put in place to mitigate them.The FDA will hold a national

workshop on medical devices andcybersecurity on Oct. 21 and 22.

"Guidelines," for companies coveredby the FDA, are in effect rules.Because the agency has the powerto approve or disapprove therelease of new medical devices,companies know they must followits guidance.

While the FDA hasn't had any reportsof specific medical devices beingtargeted by those wanting to doharm, concern over what couldhappen has been building for sometime, because medical devices areincreasingly connected to computernetworks.

"Many devices are poorly securedand do not require a lot to hack. Ifthere is sufficient incentive to do so,it will happen, causing harm topatients," said Shel Sharma, directorof product MARKETING for Cyphort,a threat-detection company.

There are many ways a medicaldevice could be subverted. It usedto be that medical devices werestand-alone and relatively untouch-able machines, unless someonewith intent on harm was in the roomwith them.

"When it's specialized equipment,especially when it's not connectedto the Internet, how do you hackthat?" Chris Wysopal, chief technol-ogy officer of app security companyVeracode.

Speaking at a round-table discus-sion on medical device security atthis fall's Black Hat security confer-ence in Las Vegas, he describedone company that used to makeanesthesia carts that were all "fiddlydials and knobs interface," with noInternet access.

The company has now moved to aniPad interface that allows wirelessaccess. "Now the hackers can

FDA sets guidelines for medical devices'cybersecurity

manipulate those devices," he said.

That's what the FDA is hoping toavoid, by pushing medical devicemakers to think about possibleproblems and their solutions beforegoing to MARKET.

At a minimum, medical devicesshould require secure authenticationfor access, use encrypted commu-nication and make sure that securitypatches are always added. That willrequire device manufacturers "tochange their mindset and buildsecurity from the ground up in thedevices," said Sharma.

The guidance is better late thannever, said Chris Petersen, chieftechnology officer for LogRhythm, asecurity company. "Many existingmedical devices are runningcommercial or open sourceoperating systems such as Windowsor Linux," he said.

New vulnerabilities in these systemsare being constantly discovered andpatched. That's a problem, becausemany medical devices weredeveloped "assuming they wouldnever be patched, or patchedrarely," he said.

The new FDA guidelines shouldbegin to change that. But for nowhealth care organizations mustoperate assuming "the adversary isinside now, or will be tomorrow.They will need to deploy securitystrategies that address the fact theylikely have thousands of insecure, IP-enabled devices in their network,"Petersen said.


As the med tech industryaddresses a growing needfor devices geared toward

children, a Baltimore, MD-basedphysician is creating 3-D printedhands developed specifically for

pediatric patients.

Johns Hopkins trauma surgeonAlbert Chi created custom handsusing a low-cost 3-D printer,producing a device that is morechild-friendly and affordable than atypical prosthetic, the Baltimore Sunreports. The U.S. Centers for DiseaseControl and Prevention reported thatfour in 10,000 children are born withsome form of congenital hand loss,and insurance does not alwayscover pediatric prosthetics, costingpatients and their families up to$40,000.

Chi produced the prosthetic handsfor less than $20, and is workingwith nonprofit e-NABLE to distributethe devices at a much lower cost.Children can put on the prostheticthemselves and easily manipulate itwith palm muscles, providing amore wearer-friendly model than

Hopkins physician creates 3-D printedhands for pediatric patients

traditional devices which typicallycover the child's entire forearm,Quinn Cassidy, the mother of one ofChi's patients, told the Sun.

The innovation comes at a criticalmoment, as federal regulators anddevicemakers are pushing for thedevelopment of next-generationdevices created for pediatricpopulations. Last year, the FDAhanded out $3.5 million in grants to7 research consortia in September2013 to spur the creation ofpediatric-friendly devices.

The industry took note, andcompanies like DexCom ($DXCM)and Minnesota-based SmithsMedical are rolling out newproducts with pediatric populationsin mind. Earlier this year, Smithsadded tracheostomy tubes fornewborns and pediatric patients toits product line, and in February,

DexCom won FDA approval for apediatric version of its G4 Platinumcontinuous glucose monitor fortoddlers.

Meanwhile, smaller operations andresearchers are delving into 3-Dprinting as a viable therapeuticsolution.

In August, Chinese physicianssuccessfully implanted the first 3-Dprinted vertebrae in a young patient,replacing a section of cancerousvertebrae with a 3-D printed piececreated from titanium powder. Lastmonth, British startup Andiamolaunched a crowdfunding effort todevelop 3-D printed orthoticdevices for disabled children.

The company plans to use FUNDS toreduce wait time for pediatricorthotics and test its products inpatients to attract future investment.


Blood glucose monitors thatwork with smartphones aren'tnew. But taking an existing

blood glucose monitor, notdesigned to work with asmartphone, and enabling it towirelessly sync up to a smartphone--now that is new.

GLOOKO METERSYNC BLUE--COURTESY OF GLOOKO

This is the task that startup Glookohas undertaken--making tens ofmillions of existing blood glucosemonitors transmit wirelessly to

smartphones. The company haslaunched a small device that plugsinto more than 30 existing bloodglucose meters that can transmitdata wirelessly to a smartphone. LastOctober, Glooko launched the firstversion of the device, whichrequired physical attachment via asecond connector to thesmartphone.

The startup's expectation is thathealth systems and payers will jumpat the chance to collect data on theirdiabetes patients with the monitorsthey already have. Dubbed the

Glooko enables wireless smartphone accessfor existing blood glucose monitors

Glooko MeterSync Blue, the devicetransmits data wirelessly to acorresponding smartphone app. Itdoes so after each reading, whichlets patients view, analyze andannotate their blood glucosereadings on their smartphone. Thedata is then transmitted to the cloudand the Glooko Population Tracker,which allows healthcare providers toidentify patients with high or lowblood glucose events. The trackercan be used to issue reminders topatients for timely blood glucosedata. "Glooko's ability to sync bloodglucose data from several meters

and analyze trends has addedefficiency within my clinical practice,"Dr. Zachary Bloomgarden, anendocrinologist and professor atMount Sinai Medical Center, said in astatement.

He added that the device ensures"that patients can more seamlesslyshare their data with me betweenvisits, particularly those at higher risk,including women during pregnancyand poorly controlled patientsinitiating treatment with insulin. Itshould also help with patients whoare not at high risk but for whom theability to review home glucosemonitoring results will improveadherence to the increasinglycomplex regimens of moderndiabetes management."

The Glooko MeterSync Blue is FDAcleared and HIPAA compliant. Theapp is available for both iPhone andAndroid devices. It works withseveral models of blood glucosemonitors from each maker includingAccu-Chek, Bayer, Abbott, Nipro,CVS, Walgreens and Rite Aid.

The startup recently partnered withthe Joslin Institute for TechnologyTranslation at the Joslin DiabetesCenter to create a HypoMap to trackand predict patients at greatest riskfor hypoglycemia. As many as269,000 U.S. diabetes patients werehospitalized last year due tohypoglycemia, according toStanford University data cited by thecompany.

Founded in 2011, Glooko raised $7million in January in a Series A-1financing from new investors suchas Samsung Venture INVESTMENTand Lifeforce Ventures, as well asexisting investors including TheSocial+Capital Partnership.


In a diversification bid, Charlotte,NC-based Carlisle Companiespurchased Singapore's LHi

Technology, a device industrysupplier focused on cablemanufacturing, for $195 million.

Carlisle CEO David Roberts said theacquisition helps the company"further penetrate the targetedhealthcare MARKET by adding scaleand technological capabilities whilebroadening service ranges to ourcustomers in this very attractivemarket sector. This acquisition alsofurthers our strategy to diversify theend markets of Carlisle InterconnectTechnologies into other higher

Manufacturer buys Singaporean deviceindustry supplier for $195M

margin sectors that reduce ourdependence on aerospace forgrowth," in a statement.

With annual sales topping $100million, LHi Technology makes leadsand cables for ECGs, ultrasoundmachines, surgical tools and imagingmachines, according to its website.The company operates a 150,000square foot facility in Shenzhen,China, from which it manufacturesand tests its products. The plant alsohas an external test lab for clients totest their own products.

Singapore-based LHi also has fiveoffices in the U.S., as well as

Mexico, Germany and Japan. Thecompany says its products meetInternational Organization forStandardization (ISO) standards.

LHi was formerly a portfoliocompany of international investor 3iGroup plc. Its medical device focuswill supplement publicly TRADEDCarlisle's manufacturing businesses

focused on construction materials,defense, and foodservice, to namea few industries.

In the first half of 2014, Carlislereported profits of $112.1 million onrevenues of $1.51 billion. It hasabout 11,000 employees in 75locations around the world.


Women's fertility appmaker Glow raised $17million to expand upon its launch a year ago,just as at-home pregnancy monitoring player

BellaBeat rolled out three new products. Both 1-year-old startups are backed by high-flying tech VCs andare making sophisticated, consumer-friendly productsaimed at helping women better manage and monitortheir health that circumvent traditional healthcareproviders.

Glow's financing was led by Formation 8, a $450million tech-focused FUND that launched last year.Peter Thiel's Founders Fund and Andreessen Horowitz.Thiel is well known as a co-founder of PayPal, whileHorowitz was a Netscape co-founder. BellaBeatemerged from well-regarded tech accelerator Y-Combinator; it got a $4.5 million seed round in Mayfrom backers, including SVAngel, CrunchFund,Universal Music Group, Cherubic Ventures and PromusVentures.

Both startups aim to provide health information toconsumers, but it's unclear as yet how they willnavigate regulators. Reportedly, Glow has said its appmay not need FDA clearance, while BellaBeat receivedFDA clearance for its smartphone-connected Dopplermonitor to listen to the fetal heartbeat.

Glow has an app to track several fertility indicatorsincluding menstrual cycle, basal temperature andcervical mucus quality; it also has a day-by-daypregnancy app with tracking and information aboutmother and fetus. The startup also has a non-profitprogram that allows couples pursuing pregnancy topool their pregnancy risk.

Each couple in a group contributes $50 monthly forup to 10 months toward a pool that goes to help payfor fertility treatments for the couples unable toconceive. Ultimately, the startup expects this detailedaccess to a massive amount of data on conceptionand pregnancy will allow it to provide better insightsinto fertility. After its first year, Glow said its users had atotal of 25,000 pregnancies since last summer; butabout half of its users are actually trying to avoidpregnancy.

"Glow is in a unique position to be a contributor towomen's health worldwide. With its data scienceapproach, they're putting together one of the largestfertility studies in human history, which has potential toimpact countless women and couples," Joe Lonsdale

of Formation 8 said in a statement.Glow also has ambitions to servecorporations, as well as individuals.It is offering its service as a benefitemployers can offer employees. Thestartup also hopes its data andanalysis might be useful for insurers.The company's co-founder andCEO Mike Huang told VentureBeatthat providing detailed individualdata to an insurer could result inbetter health insurance.

But that expectation runs counter tothe ongoing concern that insurersand employers can use access todetailed individual health data todiscriminate against them. Huangdescribed the current insurerattitude as, "Don't tell me what youhave because if you tell me whatyou have, I'm not going to helpyou."

Glow has raised a total of $23million. It will use the latest financingto advance its big-picture ambitions;"To name a few, we'd like to doubledown on the product, on our dataand research, and on insurance,"Huang said in a statement.. Anotherconsumer-focused pregnancydevice startup, BellaBeat, rolled outthree new products. All aredesigned to be attractive and appealto consumers, and are made ofwood, as opposed to the metaltypically used in medical devices.They include an updated version ofits fetal heartbeat monitor, awirelessly connected scale and awearable activity, sleep and stresstracker. That last product comes aseither a necklace, bracelet orpendant. And the scale is pur-ported to provide separate weightsfor mother and fetus.

Founded last year, BellaBeat has sold35,000 units with 200,000 down-loads for its accompanyingsmartphone app.

Top VCs nurture consumer pregnancystartups, Glow and BellaBeat


To strengthen the safety ofmedical devices, the U.S. Foodand Drug Administration

finalized recommendations tomanufacturers for managingcybersecurity risks to better protectpatient health and information.

The final guidance, titled “Content ofPremarket Submissions for Manage-ment of Cybersecurity in MedicalDevices,” recommends thatmanufacturers considercybersecurity risks as part of thedesign and development of amedical device, and submitdocumentation to the FDA aboutthe risks identified and controls inplace to mitigate those risks. Theguidance also recommends thatmanufacturers submit their plans forproviding patches and updates tooperating systems and medicalsoftware.

As medical devices become moreinterconnected and interoperable,they can improve the care patients

receive and create efficiencies in thehealthcare system.

Some medical devices, likecomputer systems, can bevulnerable to security breaches,potentially impacting the safety andeffectiveness of the device.

By carefully considering possiblecybersecurity risks while designingmedical devices, and having a planto manage system or softwareupdates, manufacturers can reducethe vulnerability in their medicaldevices.

“There is no such thing as a threat-proof medical device,” saidSuzanne Schwartz, M.D., MBA,director of emergency prepared-ness/operations and medicalcountermeasures at the FDA’s Centerfor Devices and Radiological Health.“It is important for medical devicemanufacturers to remain vigilantabout cybersecurity and toappropriately protect patients from

The FDA takes steps to strengthencybersecurity of medical devices

those risks.” The FDA’s concernsabout cybersecurity vulnerabilitiesinclude malware infections onnetwork-connected medicaldevices or computers,smartphones, and tablets used toaccess patient data; unsecured oruncontrolled distribution ofpasswords; failure to provide timelysecurity software updates andpatches to medical devices andnetworks; and security vulnerabilitiesin off-the-shelf software designed toprevent unauthorized access to thedevice or network.

The FDA has neither an indicationthat specific devices or systemshave been purposely targeted, norreports that any patients have beenharmed as a result of cybersecuritybreaches, but remains concernedabout device-related cybersecurityvulnerabilities and their potential toadversely impact public health.

The FDA has been working closelywith other federal agencies and the

medical device industry to identifyand communicate with stakeholdersabout vulnerabilities.

The agency is planning a publicworkshop this fall to discuss howgovernment, medical devicedevelopers, hospitals, cybersecurityprofessionals, and other stakehold-ers can collaborate to improve thecybersecurity of medical devicesand protect the public health.

The FDA, an agency within the U.S.Department of Health and HumanServices, protects the public healthby assuring the safety, effectiveness,and security of human and veterinarydrugs, vaccines and other biologicalproducts for human use, andmedical devices.

The agency also is responsible forthe safety and security of ournation’s food supply, cosmetics,dietary supplements, products thatgive off electronic radiation, and forregulating tobacco products.


Today the U.S. Food and DrugAdministration cleared a newindication for the Nova StatStrip

Glucose Hospital Meter System,extending its use to critically illpatients who have been hospital-ized. This is the first blood glucosemonitoring system (BGMS) clearedby FDA for use in these patients.

Blood glucose monitoring systems,also called blood glucose meters,are handheld devices that measurethe amount of sugar (glucose) inblood by analyzing a small drop ofblood that is placed on a test strip.After inserting the test strip into thedevice, the system displays aglucose level reading. Bloodglucose measurements are used inthe management of many patients inthe hospital, including patientsrequiring insulin to manage bloodsugar, and in the assessment ofblood glucose levels in newbornbabies.

The Nova StatStrip Glucose HospitalMeter System is the first FDAclearance of a device specificallyindicated for use in all types ofhospital patients, including critically illpatients.

Users of BGMS with manufacturerinstructions that do not provide foruse with critically ill hospital patientswould be subject to the highcomplexity testing requirementsunder the Clinical LaboratoryImprovement Amendments (CLIA) ifsuch systems were to be used inthe critically ill hospital population.Those requirements include thevalidation of how well the BGMSworked in that patient population.

The FDA determined that the NovaStatStrip Glucose Hospital MeterSystem is simple to use and has alow risk for false results, and grantedwith the clearance “waived” testsystem status under CLIA. Thiswaived status will allow a broad

variety of health care professionals,such as nurses and technicians, toperform the test at the point-of-care,such as at a patient’s bedside,instead of requiring that the test beperformed in a hospital lab (or otherlab) that meets the CLIA require-ments for high complexity testing.The CLIA waiver will also allowhospital labs to safely provide bloodglucose monitoring to their criticallyill patients without having to meetthe significant CLIA requirements forhigh complexity testing.

“This device provides an importantpublic health resource for critically illhospitalized patients, who oftenhave conditions or are takingmedications that can cause incorrectblood glucose reading,” saidAlberto Gutierrez, director of theOffice of In Vitro Diagnostics andRadiological Devices at the FDA’sCenter for Devices and RadiologicalHealth. “It is important for manufac-turers of glucose meters used inhospitals to design and test their

devices for use in all hospitalizedpatients.”

The FDA originally cleared the NovaStatStrip Glucose Hospital MeterSystem in April of 2006 for use inhospitals as an aid in monitoring theeffectiveness of a diabetes controlprogram, but not for use withcritically ill patients. The devicemanufacturer submitted a newpremarket submission to the FDAseeking clearance of the device withthis new indication.

Today’s clearance is for indicationsthat include using arterial or venouswhole blood from patients in allareas of a hospital with variousconditions, including: trauma,cancer, sepsis and infection;cardiac, kidney, neurological,obstetric, gynecological,gastroenterological, endocrine, andlung issues; and people recoveringfrom general or cardiothoracicsurgery. Data supporting thisclearance included a study of more

FDA clears glucose monitoring system for usein hospital critical care units

than 1,650 patients with a range ofmedical conditions, taking variousmedications, and being treated in avariety of hospital departments,such as cardiac, emergencyintensive care, and surgical. Resultsshowed agreement in bloodglucose results compared to acomparator laboratory glucoseanalyzer in all patients types tested.

The Nova StatStrip Glucose HospitalMeter System is manufactured byNova Biomedical in Waltham,Massachusetts. The FDA, an agencywithin the U.S. Department of Healthand Human Services, protects thepublic health by assuring the safety,effectiveness, and security of humanand veterinary drugs, vaccines andother biological products for humanuse, and medical devices. Theagency also is responsible for thesafety and security of our nation’sfood supply, cosmetics, dietarysupplements, products that give offelectronic radiation, and forregulating tobacco products.


FDA allows marketing of the firsttest to identify five yeastpathogens directly from a bloodsample

The U.S. Food and Drug Administration today allowed marketing inthe U.S. of the first direct blood test for detection of five yeast

pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis, Candida glabrata and/orCandida krusei.Yeast bloodstream infections are a type of fungal infection—they canlead to severe complications and even death if not treated rapidly.These yeast pathogens may cause serious bloodstream infections inpeople with weakened immune systems, including patientsundergoing cancer treatment, receiving immunosuppressive therapyfollowing an organ transplant or severely ill patients in intensive careunits.

Traditional methods of detecting yeast pathogens in the bloodstreamcan require up to six days, and even more time to identify thespecific type of yeast present. The T2Candida Panel and T2DxInstrument (T2Candida) can identify these five common yeastpathogens from a single blood specimen within three to five hours.Because yeast bloodstream infections are uncommon, and becausefalse positive results are possible with the T2Candida, physiciansshould perform blood cultures to confirm T2Candida results.

“By testing one blood sample for five yeast pathogens—and gettingresults within a few hours—physicians can initiate appropriate anti-fungal treatment earlier, and potentially reduce patient illness anddecrease the risk of dying from these infections,” said AlbertoGutierrez, director of the Office of In-Vitro Diagnostics and Radiologi-cal Health at the FDA’s Center for Devices and Radiological Health.T2Candida incorporates technologies that break the yeast cells apart,releasing the DNA. It then makes many copies of the target DNA, anddetects the amplified DNA using magnetic resonance technology. Ifyeast DNA is found, T2Candida will also presumptively determine thespecies category to which it belongs, information that helps to guidehealth care providers to provide appropriate treatment.

The FDA reviewed T2Candida through its de novo classificationprocess, a regulatory pathway for certain novel low- to moderate-riskmedical devices. FDA based its review on a clinical study of 1,500patients, in which T2Candida correctly categorized nearly 100percent of the negative specimens as negative for the presence ofyeast. In a separate clinical study of 300 blood samples with specificconcentrations of yeast, T2Candida correctly identified the organismin 84 to 96 percent of the positive specimens. T2Candida ismanufactured by T2 Biosystems, Inc. in Lexington, Mass.

The FDA, an agency within the U.S. Department of Health and HumanServices, protects the public health by assuring the safety, effective-ness, and security of human and veterinary drugs, vaccines and otherbiological products for human use, and medical devices. The agencyalso is responsible for the safety and security of our nation’s foodsupply, cosmetics, dietary supplements, products that give offelectronic radiation, and for regulating tobacco products.

Drug resistant bugs on therise: MalaysiaThe Malaysian Health Ministry has warned that indiscriminate use of

antibiotics must be stopped as antimicrobial resistance could be a majorpublic health SECURITY concern in future. The Ministry further said that over-prescription of antibiotics for common ailments resulted in the DEVELOP-MENT of antimicrobial resistant strains in the society. Dr Azman Abu Bakar,director of the medical DEVELOPMENT division of the Health Ministry, said,"The medical fraternity must preserve the efficacy of antibiotics and fightantimicrobial resistance by providing prescriptions for antibiotics only whennecessary."

Dr Christopher Lee, senior physician, said that there is a substantial increase inresistant strains in Malaysia. He indicated that the levels of resistant Strepto-coccus pneumonia strains have increased by 18 percent in the last six years,while in case of Acinetobacter baumanii the resistant strains increased by 10percent. Dr Lee added that the resistance of bacteria strains in the ICU andCCU has gone up by 50-60 percent resulting in the use of fourth generationantibiotics to treat simple illness. These in turn promote antimicrobialresistance, he stated. Dr Lee emphasized,"There has not been manyantibiotics discovered in recent years, the US, one of the LEADING countriesin drug discovery, has only released two new antibiotics. Things can turnfatal if people become resistant to the antibiotics that we have." -

India’s pharma exportgrowth slowest in 15 yearsThe Indian pharmaceutical industry exports will miss the target of USD 25

billion that was set for this fiscal as it witnessed the slowest growth ever in15 years At 1.2 percent growth, to USD 14.84 billion last fiscal, regulatoryissues and the increasing tension with the US over intellectual property rightshave resulted in the slump Related Articles Jordan pharma revenue to reach$1 bn by 2015 India to join PIC/S to safeguard drug exports PHARMEXCILkick starts India-APAC pharma meet Egypt seeking Indian pharma investmentSingapore: The Indian pharmaceutical industry exports have registeredslowest growth in at least 15 years, a news report explained.

At 1.2 percent growth, to USD 14.84 billion last fiscal, regulatory issues andthe increasing tension with the US over intellectual property rights haveresulted in the slump. The industry is said to miss the target of USD 25 billionthat was set for this fiscal. The government strategy paper had set the targetof USD 25 billion for pharma exports during 2014-15. According to theCommerce Ministry data, in 2012-13, the country's pharma exports aggre-gated USD 14.66 billion. The growth registered in 2013-14 is the slowest innearly 15 years.

The previous slowest was in 2009-10 when the pharma exports grew by just5.9 per cent. In calendar year 2000, they grew by 7 per cent. "2013-14 hasseen slowdown in growth because of the U.S. raising concerns and due toincrease in global competition," Mr PV Appaji, Executive Director, Pharmexciltold PTI.

The US accounts for about 25 percent of India's pharma exports butshadowed by regulatory issues, the Indian industry is now facing a turbulentgrowth period. With further Indian patent process troubles for the industry,reports said that analysts are predicting more slow growth.


Canada bans three IndianAPI manufacturersApotex Pharmachem India, Apotex Research and IPCA Laboratories are

temporarily banned in Canada for data integrity issues Health Canadahas raised its concern on data integrity Related Articles Aus Govt, Apotexsue Sanofi for extending patent Apotex recalls injection on behalf ofHospira Vietnam evicts substandard imported drugs FDA approves genericversions of Plavix Singapore: Health Canada, national health agency, hasbanned the import of health products from three different companies inIndia including Apotex Pharmachem India Private Limited (APIPL), ApotexResearch Private Limited (ARPL) and IPCA Laboratories after USFDA spotteddata integrity issues at their sites.

Health Canada has raised its concern on the manner in which data arecollected and reported, raising serious doubts about the quality and safetyof finished products and APIs produced at these sites. The agency has notrecalled any of the products but has stopped imports as a temporaryprecautionary measure until it is satisfied of the processes followed at thesesites. According to Health Canada, the action would apply to finishedproducts from Apotex and active pharmaceutical ingredients (APIs) andproducts made with APIs from APIPL and IPCA. Health Canada has clarifiedthat certain medically necessary products may be excluded from the actionon the condition that they are tested by an independent third party beforebeing released for use or sale.

Singapore scientists findnew pattern in immune cellmechanismScientists from A*STAR's Bioprocessing Technology Institute (BTI) have

identified relationship between two cells which serve human body'snatural defence mechanisms against diseases and infections.

Natural killer T (NKT) cells and B cells are two of many immune cell types thatwork in tandem to help the body fight against foreign infectious agents. NKTcells have very potent functions and are crucial to the immune systemdespite making up only a small percentage of white blood cells. Whilescientists have established that NKT cells can promote the production ofantibodies by B cells to combat infection, little is known about the effect ofB cells on NKT cells until now. Patients with autoimmune disorders havebeen observed to have drastically reduced numbers of NKT cells.

The study conducted by BTI scientists revealed that autoimmune B cells hadaltered lipid compositions, causing NKT cells to be over-activated andresulting in their eventual death and depletion in numbers. The scientistsfurther found that removal of a lipid-presenting molecule from B cellsresulted in recovery in the numbers of NKT cells. Lipids are a group ofnaturally occurring molecules that include fats as well as fatty acids. Lipidsform part of each cell membrane and allow cells to store energy andmediate cellular responses. Dr Andy Tan, a research scientist at BTI who ledthe study, said, "Our findings provide an alternative theory to currentunderstanding of how autoimmune B cells affect NKT cells. This will allownew therapeutic strategies to be devised, rectifying NKT cell deficiency inautoimmune patients and improving their health".

Satish Jindal, BMS IndiaR&D head, to lead USinnovation venture

Allied-Bristol Life Sciences, a jointly owned enterprise betweenAllied Minds and Bristol-Myers Squibb, has appointed MrSatish Jindal, formerly Vice President of R&D within Bristol-

Myers, to LEAD the company's efforts to identify and foster DEVELOP-MENT of biopharmaceutical innovations from top US universityresearch institutions.

Mr Jindal recently headed up Bristol-Myers' research and DEVELOP-MENT center in Bangalore, India, that focuses on discovery and earlydevelopment of drug candidates in several disease areas, includingoncology, autoimmune diseases and fibrosis. The center, calledBiocon Bristol-Myers Squibb Research & DEVELOPMENT Center(BBRC), has about 575 scientists who have the expertise to conductdrug discovery and early stage drug development, and have success-fully delivered several clinical candidates, contributing to the Bristol-Myers R&D pipeline. Under Mr Jindal's leadership, Allied-Bristol LifeSciences will have access to the scientific expertise from Bristol-Myersand BBRC, as well as the discovery and development resourcesoffered at BBRC.

Allied-Bristol Life Sciences currently has more than 100 opportunitiesunder consideration. "We have a unique opportunity to create novelmedicines in partnership with Bristol-Myers Squibb," said Mr Jindal,who will be based in Boston. "Through this innovator model of Allied-Bristol Life Sciences, we can fill a critical gap that exists in translatinghighly important scientific discoveries from LEADING academicresearch institutions." Mr Jindal joined Bristol-Myers Squibb in 2011,and was part of the team that collaborated with Allied Minds to createAllied-Bristol Life Sciences earlier this year.

"Satish Jindal has a strong track record of successfully starting andbuilding biotechnology companies based upon scientific discoverieswhich can lead to new medicines for the future," said Mr Chris Silva,chief executive officer, Allied Minds. "We are pleased to have himapply his vision and experience towards the success of Allied-BristolLife Sciences." Allied Minds and Bristol-Myers established Allied-BristolLife Sciences to work with university researchers to identify discoveriesthat have promising therapeutic and commercial potential, and tosupport the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy.Once a program succeeds in identifying a pre-clinical candidate,Bristol-Myers will have the option to acquire the company from Allied-Bristol Life Sciences under pre-agreed terms.


In many cases, a prostate cancer diagnosis leads to the removal of the entire organ. Several therapies involve a severe outcome such as impotence or incontinence. Yet a surgical intervention doesn’t always eliminate the cancer completely. That’s why physicians debate whether radical measures are actually necessary. After all, prostate cancer grows very slowly.

Compared to prostatectomy or radiation therapy, the NanoKnife® therapy practiced at the Prostate Center in Offenbach am Main removes the tumors in a gentle manner. In this interview with MEDICA.de, Professor Michael K. Stehling explains the advantages of this focal therapy.

Professor Stehling, what was the motivation behind the creation of a center that is exclusively devoted to treating and diagnosing prostate diseases?

Michael K. Stehling: I founded the Prostate Center in 2010 and was motivated by my colleague and friend Professor Ducksoo Kim at the Boston University. The idea was based on our joint work at Harvard Medical School in the nineties. Quite early on, it was clear to us that the existing diagnostic procedures and treatment methods for prostate cancer that are connected with massive side effects were imprecise and uncomfortable and are still today.

What technology is used in the NanoKnife® therapy? Stehling: The technology behind the NanoKnife® therapy is called irreversible electroporation (IRE). IRE uses very strong electric fields to induce pores in cell membranes. The stronger the electric fields and the higher the pulses that affect the cells, the larger they become. Eventually they no longer close. Water enters the cells until they burst. What’s crucial about this procedure is that it is a non-thermal ablation method. This way only the affected cells are being destroyed. The advantage is that the tissue infrastructure, that being everything else that tissue is composed of such as fibers, the interstitial matrix or basement membranes remain intact. With other thermal ablation methods such as radiofrequency ablation or cryoablation for example, the tissue is melted away. All tissue components are destroyed and the melted tissue lump is then removed via an external removal process. First, this causes the typical pain from the wound healing process and second, significant scarring. Radiation therapy exhibits similar problems. With IRE on the other hand, there is no pain or scarring, because the inflammatory response is not being triggered. This is also called “induced apoptosis“.

Application of the NanoKnife® therapy during an operation; © Prostate Center

How is prostate cancer removed? Stehling: Unlike with prostatectomy, IRE does not require surgical opening of the abdomen or pelvic area. Instead, you insert electrodes through tiny holes in the

skin via the pelvic floor into the prostrate. The electrodes are exactly positioned to where they generate a treatment area that precisely includes the areas of the prostate that contain tumors. To do this, you need to know exactly where the tumors are located of course. Clinical diagnostics play a decisive role in this. The entire IRE intervention as well as monitoring and checkup subsequently take no more than 24 hours. Which diagnostic procedures were used at the Prostate Center?

Stehling: Diagnostics with focal therapies are more elaborate than with radical therapy options. One essential component of diagnostics at the Prostate Center is magnetic resonance imaging or endorectal MRI. Accuracy is at approximately 85 percent in this case. However, the MRI is only able to illustrate macroscopic tumors, that is to say tumors that are between two to three millimeters in size. If you want to detect microscopic tumors, you can use the so-called transperineal 3D mapping biopsy. This is a systematic biopsy done through the skin of the pelvic floor, where a sample is taken exactly every five millimeters apart. Depending on how many samples are taken, we can put them together again using a special computer program and thus obtain a histological model. With the help of the MRI and the 3D biopsy, we map the relevant tumors or possibly all tumors that are currently in the prostate. These are subsequently removed using the focal IRE method.

Therapy simulation in 2D and 3D. The electrodes embrace the area that includes the tumors in the prostate; © Prostate Center

What are the advantages compared with traditional therapeutic measures such as surgery or radiation? Stehling: There are significantly fewer side effects. In a group of 160 patients, we have treated so far, not one of them exhibits incontinence. What’s more, the percentage of impotence is also less than with other therapies. Oftentimes, impotence is only temporarily. The treatment is also completed within 24 hours. Patients exhibit no wound pain. After IRE, all other therapeutic measures remain an option. That means, if IRE were to fail, you could still perform surgery or radiation on the patient or treat him with HIFU (high-intensity focus ultrasound). That being said, IRE can also be done in succession as often as you like. This is a major advantage, because after all of the other therapy options, in particular radiation therapy, this is no longer possible or just in a very limited way.

Can you envision NanoKnife® therapy being used in a broad clinical field and replacing treatment options such as surgery and radiation at least in the prostate cancer area? Stehling: I sincerely hope that NanoKnife® therapy or a similar gentle procedure replaces radical therapy for prostate cancer. The previously performed procedures are extremely bad and often include significant adverse effects. There are considerable recurrence rates begging the question of whether they actually provide the patient with a survival advantage. This is doubtful in many cancer stages and is proven by statistics. I believe NanoKnife® therapy to be an intermediate stage on our way to tumor-cell specific therapy. I am sure that within the next ten years there will be methods that are able to selectively target tumor cells and spare healthy somatic cells. IRE is already selective on a cellular level, but is actually not tumor-cell specific. The ultimate goal has therefore not been completely achieved yet. Yet I believe this is a very important factor, because there is a paradigm shift in cancer treatment at the moment that comes from the U.S. They assume that cancer is a chronic illness. There is still a lot of work ahead of us in this regard.The interview was conducted by Melanie Günther and translated from German by Elena O’Meara. MEDICA.de

Prostate cancer: gentle removal with irreversible electroporationInterview with Professor Michael K. Stehling from the Prostate Center in Offenbach am Main, Germany

Prof Michael K. Stehling; © Prostate Center in Offenbach am Main


UK-based battery firm Accutronics is set to vitalise the medical

MARKET this autumn when it launches its next range of

batteries at COMPAMED in Dusseldorf. The CMX series will

be launched at a press conference at COMPAMED, the international

TRADE fair for high tech medical solutions on 12 November 2014.

The medical MARKET is currently undergoing rapid evolution with the

likes of portability and freedom from AC power taking centre stage

for doctors and emergency services.

COMPAMED is a fitting location for the CMX launch; a leading TRADE

fair for the medical industry. It hosts 700 exhibitors from 40 countries

in two exhibition halls taking up 10,000m² of floor space. The event

covers the complete spectrum of medical products, from design

and development to manufacturing and servicing. Visitors can expect

to network with fellow production managers, engineers, designers,

researchers and business leaders from across the sector.

Accutronics will be exhibiting in the main hall 8b on stand F30. The

UK based battery firm specialises in the design, development and

manufacture of smart batteries for industries ranging from medical,

defence, industrial and for the portable, handheld MARKET.

Accutronics managing director Rob Phillips said, "Without giving too

much away, the CMX series launch brings together high-voltage,

high-power and smart battery functionality in a package that exceeds

the strict regulatory requirements for batteries used in medical

devices.

"The medical device MARKET is currently undergoing rapid growth

and the CMX series offers tremendous opportunities for OEMs

developing devices for life critical applications."

The launch will spark interest from original equipment manufacturers

(OEMs) in the medical sector, which is already familiar with similarly

innovative launches from Accutronics in the past. Previous products

include a credit card sized battery for handheld portable medical

devices and a multi-battery system for powering medical carts.

All are part of the customisable Entellion range, which also offers

algorithmic security to prevent the use of unauthorised, copycat

batteries.

TDI Power has launched two new products to their medical

portfolio, both are medical and hospital grade devices certified

to be used within the patient care area.

The launch took place at HIMSS 2014 in Orlando Florida,

MediParc&TRADE; and MediPower™.

The products can easily be mounted to hospital mobile equipment,

such as computer carts and other portable equipment to expand

mobility and increase time of use without the need to recharge.

MediParc™ eliminates the use of power cords, making the charging

of carts almost effortless.

The simple act of pushing a cart against the wall activates the charger

without the use of a power cord. The wall docking system complies

with UL1363A and improves the hospital workflow by removing the

need to bend over and manually plug into the wall. MediParc will

mount with any existing medical cart or portable equipment and will

reduce hospital cost of ownership by increasing the life of the battery

and reducing cart downtime.

We spoke to nurses and doctors to better understand their day-to-

day use of Medical Carts and other portable devices. It became clear

to us, that not just Medical Carts, but Vital Sign Monitors, Ultrasound

Machines, and other medical devices require a more user friendly

solution for battery charging. MediParc provides this solution.

MediPower™ next-generation is a fully integrated certified UL60601-1

Mobile Medical Power System. It combines ten+ years of experience

in developing reliable and safe medical mobile power, with new

product design innovation.

It is the lightest and most advanced power system on the MARKET, at

a very competitive price. Its integrated system design provides all the

necessary features to add extended battery life to mobile medical

devices, and its flexible design makes it configurable to customer

specific technologies without added expenses.

The MediPower series of products is reliable taking advantage of TDI

Power's robust design, manufacturing, and test processes built on

years of power system design for demanding MARKETS

Accutronics Set to LaunchSecure CMX Battery Power TDI Power Releases Two New

Products to its Medical PowerPortfolio


Nanavati Hospital opens renovated cath-labCity’s iconic Dr Balabhai Nanavati Hospital has opened its renovated state-of-the-art new-look Cath-lab, as part of revamping its operations and placing it on par with the top healthcare institutions in the world.

Radiant Life Care Private Limited, which recently took over the operations and management of the hospital, has installed the lab on a priority basis to put Dr. Balabhai Nanavati Hospital – Heart Institute (NHHI), one of the busiest in the City, on full stream with comprehensive facilities. Radiant chairman Abhay Soi opened the new Cath-lab recently with all the leading cardiologists of the hospital and other top doctors of Dr Balabhai Nanavati Hospital. “We are introducing the global hospital management best practices and expanding the operations to transform Nanavati into a world class facility. The Cath-lab is just the first initiative in this direction,” Mr Soi said. “The lab has state-of-the-art facilities to make it as one of the best in the country. Our lab is one of the busiest in the City and we perform on an average 3000 procedures every year,” said Dr Lekha Pathak. Dr. Balabhai Nanavati Hospital – Heart Institute is one of the most comprehensive cardiac centers in the city with invasive cardiology, cardiac surgery, non-invasive cardiology and intensive cardiac care unit under one roof.

Weakness of muscles of the faces, caused by facial nerve problems, should not be neglected, but need to be treated early to avoid deformity of faces, warn experts.

According to Dr K P Morwani, head of the ENT department of Dr Balabhai Nanavati Hospital, there is a tendency among the people and also the practitioners to neglect, sometimes due to lack of awareness, such symptoms which can lead to huge problems. “Causes of facial nerve weakness are various ranging from infections, trauma, tumors and also congenital (from birth). Correct diagnosis and management depends on a variety of factors. Facial nerve problems when treated early have an excellent potential for good results compared to longstanding problems. Some facial nerve problems require medical treatment but most require surgical treatment. We have performed the entire range of surgeries for the facial nerve pathologies. Our results have been more encouraging than many published in literature,” he said.

From August 22, the hospital has organised a three-day Facial Nerve Symposium, first time in the country, to educate the doctors on the importance and procedures. It also coincided with 100th Temporal Bone Dissection Course. As many as 250 doctors attended the event that has unique live surgeries.

The experts also lamented on the lack of awareness among the ENT specialists across the country about ear infections which become complicated at later stage putting the life of the patients at risk. Most of the difficulties mainly arise because neither the doctors nor the patients know how to handle the situation. Sometimes ear infection can damage tiny bones in the middle ear leading to rare complications in the bone that is located behind the ear i.e. mastoiditis or damage the tissues surrounding the brain and spinal cord i.e. meningitis, Dr Morwani said.

He informed, “Ear infection can also lead to facial nerve problems that cause weakness of the muscles of the face and is very obvious on seeing the subject. However it is important to notice that problems like facial nerve palsy caused due to complication of ear infection can be successfully treated if diagnosed properly. Likewise, problem also lies in the fact even established ENT surgeons sometimes fail to relate ear infection to complicated problems like facial palsy, making matter worse for the patients.”

This course basically has been designed and tailor-made to train the doctors on the intricacies of conducting ear surgeries, which is not only a complex procedure but also is an area where hardly few ENT specialist have expertise in, according to Dr. K. T. Patil who was also a faculty of the programme. In fact, Nanavati has the distinction of being the only hospital in the country to conduct 100 ear surgery courses over the span of 16 years that has been delivered in shortest possible time by experts like Dr K P Morwani to sensitise and prepare the ENT surgeons to meet these challenges.

Dr. Narayan Jayshankar, Dr. Rahul Agarwal (Gwaliyar), Dr Sonal Modi (Akola), Dr Satish Jain (Jaipur), Dr Mahadeviya (Banglore), Dr Kirtane (Mumbai), Dr Hans (Delhi), Dr Ammar (Muscut), Dr Dipak Dalmiya (Mumbai), Dr Madhuri Mehta (Hariyana), and Dr Santosh Kakad (AIIMS, Delhi) were also among those to speak at the course.

Experts call for early treatment of facial nerve palsy to avoid deformities


BeoCare Expanding Manufacturing Operations

BeoCare Group Inc, a leading US manufacturer of medical textiles and consumables used in long term care facilities and hospitals, just closed on the acquisition of a new 42,375 Sq.Ft. warehouse in Hudson, North Carolina. The new facility at 1904 International Boulevard is across the street from the current 82,000 Sq.Ft. manufacturing plant. The new facility will be used for warehousing raw materials and finished product as BeoCare grows its product offering.

Concrete policy initiatives yet to impact the businessFor the third quarter of Financial Year 2014 ended June 30, 2014, Siemens Ltd. registered an increase in Profit after Tax, which rose to Rs. 13 crores compared to a loss of Rs. 49 crores in Q3 2013. The Company registered New Orders of Rs. 2,744 crores compared to Rs. 2,619 crores in the same period last year. Sales stood at Rs. 2,319 crores in Q3 2014, compared to Rs. 2,588 crores in Q3 2013.

Sunil Mathur, Managing Director and Chief Executive Officer, Siemens Ltd., said, “Overall, the macro-economic situation is still challenging and concrete policy measures will take time to reflect in business.”

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A new genetic finding from Duke Medicine suggests that some people who are prone to hostility, anxiety and depression might also be hard-wired to gain weight when exposed to chronic stress, leading to diabetes and heart disease.

An estimated 13 percent of people, all of whom are Caucasian, might carry the genetic susceptibility, and knowing this could help them reduce heart disease with simple interventions such as a healthy diet, exercise and stress management.

“Genetic susceptibility, psychosocial stress and metabolic factors act in combination to increase the risk of cardiovascular disease,” said Elizabeth Hauser, Ph.D. director of Computational Biology at the Duke Molecular Physiology Institute.

Hauser and colleagues analyzed genome-wide association data from nearly 6,000 people enrolled in the Multi-Ethnic Study of Atherosclerosis (MESA). The MESA study began in 2000 to better understand how heart disease starts, compiling the participants’ genetic makeup as well as physical traits such as hip circumference, body mass index, cholesterol readings, glucose levels, blood pressure and other measures.

In the Duke analysis, the researchers first pinpointed a strong correlation between participants who reported high levels of chronic life stress factors and increased central obesity, as measured by hip circumference.

They then tested genetic variations across the genome to see which ones, in combination with stress, seemed to have the biggest influence on hip circumference. It turns out that variations called single-nucleotide polymorphisms (SNPs) in the EBF1 gene showed a strong relationship with hip circumference, depending on levels of chronic psychosocial stress. What’s more, among those with this particular genotype, hips grew wider as stress levels increased.

“With further analysis, we found a significant pathway from high chronic life stress to wide hip circumference, to high blood glucose and diabetes, to increased cardiovascular disease, notably atherosclerosis,” said Abanish Singh, Ph.D., a researcher in computational biology at Duke and the study’s lead author. “But we found this only in people who were carriers of the EBF1 single-nucleotide polymorphism, and this was limited to participants who were white.”

“These findings suggest that a stress reduction intervention, along with diet and exercise, could reduce the risk of cardiovascular disease and

The researchers reproduced their findings using data from another study, the Framingham Offspring Cohort; © panthermedia.net/Harry Müller

may be most effective in individuals with this specific genotype,” said Redford Williams, M.D. one of the study’s senior authors and director of Duke’s Behavioral Medicine Research Center.

Further studies will focus on additional genetic factors and why there might be differences in the genetic factors among racial/ethnic groups, including African-Americans, Hispanics and Asians.

“We need to figure out how these genetic factors influence the increased accumulation of fat in the central body and increased blood glucose levels in persons exposed to high life stress and why there are also differences with ethnicity,” Hauser said. “This knowledge could help identify targets for behavioral and drug interventions that could reduce disease risk.”


Gene interacts with stress and leads to heart disease in some people

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