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Medical Delivering value through complex product development
Medical
Delivering value through complex
product development
Sagentia has more than 25 years experience working with clients as an end-to-end product development partner.
Medical
While the recent economic climate has generally affected most market sectors, cutbacks at hospitals and other healthcare centres, new regulatory policies and changes to reimbursement strategies are having a particularly strong effect on companies in the medical device sector.
In parallel, there are growing babyboomer healthcare needs, a marked transition of point of care towards the home environment and a variety of emerging markets to consider. This combination of changing market and user characteristics and increasing cost and price pressures mean that the underlying demand for innovative products and solutions is only going to increase. This innovation will now, more than ever, also need to result in cost effective products that demonstrate higher levels of usability and health effectiveness.
With more than 25 years experience working with clients as an end-to-end product development partner, Sagentia is well placed to help medical device companies respond to the industry’s challenges. We focus on delivering innovative medical products in three key areas: point of care diagnostics, surgical devices and patient care.
We have delivered innovation and value to a wide range of clients including: Johnson & Johnson, AstraZeneca, St Jude Medical, T2 Biosystems, Titan, Prosurgics and Photocure.
MedicalDevelopment with St Jude Medical of a system to transmit implantable cardioverter-defibrillator (ICD) data between patient and clinician.Sagentia co-developed the transmitter, from initial specification through to transfer to manufacture, providing expertise in the selection of low-cost products, consumer product design and electronics and software development.
Medical
Design and development of a real-time PCR-based diagnostic unit .
Sagentia developed the system and its high volume consumable from initial thermal concept and modelling through to transfer to manufacture. In order to meet clinical trial deadlines Sagentia supplemented its standard transfer to production activities with the manufacture and build of the first batch of systems. The system has successfully completed clinical trials and was showcased at Medica in November 2009. It is now being commercialised in countries including India, Brazil and Russia.
A multi-award winning robotic endoscope camera controller for laparoscopic surgical procedures. Sagentia was involved throughout the design and development of the device for Prosurgics, a venture funded medical device company. Now with FDA and CE approval, the device has provided a range of benefits to surgeons including better image visualisation and reduced camera shake. It is also contributing to improved surgical efficiency through reduced operating times.
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Surgical
Technological advances in medical device instrumentation and systems are changing the face of surgery. Increasing sophistication in sensing and intelligence, computer assistance and robotics, and the relentless drive to miniaturise and optimise are making surgery truly minimally-invasive.
Meanwhile, surgical device companies are being pushed to demonstrate higher levels of safety and efficacy against a background of economic and regulatory constraint. This is resulting in more complex product development requirements and is also leading many companies to look for growth in new and untapped markets.
Sagentia partners with surgical device and systems companies to tackle complex, technically challenging product developments. We understand the complex stakeholder, commercial and regulatory environments in which our clients operate. Our aim is to achieve robust, innovative
solutions in a responsive timeframe, and to ensure end products achieve a seamless transition to volume production by early integration with your in-house or partner manufacturer.
Of key importance, we are fully ISO accredited for medical development. Coupled to our links with clinicians, teaching hospitals and academia, this presents a clear point of differentiation over non specialist consultancies.
Patient care
The patient care sector, perhaps more than other areas of the healthcare industry, is facing a dramatic period of change. The drive towards more cost effective and efficient healthcare provision is forcing device manufacturers to provide products which not only optimise patient outcomes but also provide greater value.
Sagentia helps companies develop transformational medical technology that helps to shape a new age of patient care. We specifically work with companies to develop products that treat acute and chronic conditions within the hospital, emergency, home or specialist environments. This includes medical devices in the areas of critical care, patient monitoring, alternate care and drug delivery.
Sagentia’s work can often start with front end innovation workshops that help identify next generation transformational patient care devices. Most of our work revolves around the application of science and technology expertise to help address fundamental health issues. Our core capability lies in the development of complex physical devices that are both clinically and cost effective, from concept design through to prototype and transfer to manufacture.
Areas of expertise:• Single use instruments
• RF electrosurgical devices
• Robotics
• High performance surgical lighting
• Ophthalmic surgical systems
• Imaging systems
Areas of expertise:• Patient monitoring devices
• Renal care
• Blood & fluid management
• Drug delivery devices
• Cell therapy & oncology
T2 Biosystems case study
Diagnostics
Due to cost and efficiency pressures, we are seeing a transition from ‘traditional’, largely immobile lab-based equipment to portable devices in both the home and the hospital.
The global point of care diagnostics market continues to grow rapidly. This is resulting in devices needing to be smaller, faster and more cost effective. As home use diagnostics also develop, human factors is becoming increasingly important. Combining product development with voice of the customer research and user validation is crucial to ensure the final product is fit for purpose.
Whether there is a need to achieve cost reduction on an existing portfolio, develop next generation products or address the opportunity presented by the emerging markets, Sagentia is ideally placed to help clients. We develop innovative and successful diagnostics products – from novel consumables through to complex systems integrated with simple user interfaces.
With a focus on delivering practical but commercially viable solutions within demanding timescales, we work with both start ups and multinational companies to develop complex diagnostics products from front end innovation, through product design and development, to transfer to manufacture.
Sagentia has been hired by T2 Biosystems to work on the development of its next generation of medical diagnostic products to improve medical care worldwide.
T2 Biosystems’ proprietary technology combines nanotechnology and the miniaturisation of proven MR technology to develop rapid, accurate and portable diagnostics. T2 Biosystems’ underlying technology has been validated in multiple published journal articles and has shown to accurately analyse viruses, bacteria, proteins, hormones, DNA, small molecules and other diagnostic targets. Diagnostics systems are typically restricted to the use of optics or the electrical signals that can be derived from an assay, whereas T2 Biosystems’ technology uses magnetic resonance to quickly detect the presence of the assay’s target substances in extremely low concentrations.
Sagentia is working with T2 Biosystems towards the complete development of its benchtop instrument for clinical trials and commercial release. We were chosen as the development partner due to our track record in running agile development projects that aim to bring new technologies and breakthrough products to market within short timescales. Developing this novel diagnostics platform technology offers improved
speed, accuracy and efficiency as well as portability to a broader range of settings including doctors’ offices, homes and hospitals.
In helping us develop our diagnostic system, Sagentia’s team has showed that they are willing to own the problem, ensuring that our product development continues to meet aggressive timescales in preparation for our clinical trials.
John McDonough, CEO, T2 Biosystems
Areas of expertise:• Complex automated
instrumentation
• Handheld diagnostics devices
• Thermal & fluid flow modelling
• Microfluidic design within high volume consumables
• Assay development
We work in partnership with our clients to add value at any stage of the innovation and product development process
Sagentia’s ability to call upon a deep pool of scientific talent in-house has been a cornerstone of the company’s success.
Why Sagentia?
• Experts in complex medical device developments that meet aggressive timescales
• Accreditation to ISO 9001:2008 and ISO 13485:2003
• Deep science and technology expertise
• Multidisciplinary and cross sector teams providing broad insights
• Delivery of practical and commercial solutions that meet real user needs
• Global perspective and experience and worldwide delivery capability
• Customer friendly approach to IP
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Concept generation and technology invention
Front end needs and market analysis
We understand the stringent needs of the highly regulated medical device environment
• ISO 13485:2003 certification and extensive industry expertise
• Compliance with international market regulations
• Product development leading to fully validated manufacturing processes
• Controlled DHF to support regulatory submissions
• Support or fully manage ancillary activities
• Device development spanning risk classifications from Class I to Class III
Needs identifi
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Voice of t
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Mark
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Tech
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IP stra
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Tech
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Concept v
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Human fa
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Tech
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Realisatio
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Optical &
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Delivery and transfer to manufacture
Technology and product development
Medical
Sagentia
Sagentia is a global innovation, technology and product development
company. We provide outsourced R&D consultancy services to start
ups through to global market leaders in the medical, industrial and
consumer sectors.
With global headquarters in Cambridge, UK, and US headquarters
in Cambridge, Massachusetts, Sagentia works with clients from front
end market needs analysis through to transfer to manufacture.
We deliver innovation around new technologies and new generation
products and services that provide commercial value and market
advantage. The company also assists business leaders to create
strategies for technology, innovation and growth.
Sagentia Ltd | Harston Mill | Harston | Cambridge | CB22 7GG | UK T. +44 1223 875200
Sagentia Inc | One Broadway | 14th Floor | Cambridge | MA 02142 | USA T. +1 617 401 3170
www.sagentia.com
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