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ANALYZING PATENT TREND RELATED TO MEDICAL DEVICE INNOVATIONS
AMITKUMAR PATEL1, KINJALBEN PATEL2, JIGNESH PATEL3
1. Gujarat Technological University, Chandkheda, Ahmedabad, India
2. Registered Indian Patent Agent (IN/PA/2873), Ahmedabad, India
3. CEO, Cureill Pharma, Ahmedabad, India
Accepted Date: 19/06/2018; Published Date: 27/08/2018
Abstract: Medical devices play an important role not only in diagnosing, screening and treating patients but also in restoring patients to normal lives and in regularly monitoring important health indicators to prevent diseases. Medical devices have emerged as an important clinical route to diagnose and treat certain serious diseases for which there are no equally effective surgical or pharmaceutical alternatives are available. Development and diffusion of novel innovative medical devices have been slower than for many consumer goods due to the obstacles to innovation, but the industry is keep innovating for development of cutting edge product to solve various problems. And such latest technologies are been protected by effective means of Intellectual Property Rights (IPRs). Patent data from 1999 to May 2018, related to medical devices were analyses on following parameters Priority Country, Current Legal Status, Patenting Trends, Major Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group Data, and Technology Topics.
Keywords: Medical Device, Patent, Patent Analysis, Patent Trend, Medical Device Innovation
INTERNATIONAL JOURNAL OF
PHARMACEUTICAL RESEARCH AND BIO-SCIENCE
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Corresponding Author: AMITKUMAR PATEL
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Amitkumar Patel, IJPRBS, 2018; Volume 7(4): 8-36
Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713 Amitkumar Patel, IJPRBS, 2018; Volume 7(4): 8-36 IJPRBS
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INTRODUCTION
The global economy is now becoming more connected, although vast differences persist
between the developed and the developing countries. This is observed in all facets of life,
maybe nowhere advanced than in medical care, where malnutrition, communicable diseases,
perinatal mortality and other public health issues dominate in poor and diseases in the
wealthier countries issues of noncommunicable diseases.1
A gap between the medical and technological societies is common, making translation of
scientific conclusions into practical medical devices and procedures slower than essential.
Issues related to intellectual property rights (IPRs) are another challenges. The widespread
testing required by the health regulating agencies signifies huge and risky financial
commitments. Even afterwards fruitful clinical testing, the definitive financial outcome of
investments may be disputed, since expenses for products and services through compensation
means are not guaranteed. 1-2
Implanted medical devices denote relatively new clinical tools for the treatment of disease.
Although quarantined examples can be found in historical accounts (e.g., dental implants in
Mayan civilization and hip implants dating back to 100 years), it was in the 1950s and early
1960s that grafts gained cautious acceptance as therapeutic options for certain disorders.
Implanted cardiac pacemakers, intraocular lenses, prosthetic heart valves and aortic grafts
were introduced as breakthrough inventions. Each device addressed a previously unmet clinical
necessity. The types of therapeutic devices have expanded distinctly and today serve patients
with ophthalmic, cardiovascular, endocrine, orthopedic, renal, gastrointestinal, auditory, and
neurological disorders.3
Medical devices play an important role not only in diagnosing, screening and treating patients
but also in restoring patients to their normal lives and in regularly monitoring important health
indicators to prevent infections and diseases. With technological developments, the role of
medical devices is now expanding to advance quality of care across each phase of the
healthcare continuum.4
Medical devices have emerged as a significant clinical option to treat certain serious diseases
for which there are no equivalently effective surgical or pharmaceutical alternatives are
available. Although all clinical activities impose increased level of ethical standards of
comportment to protect patients, medical device research and development, and product
application have a number of relatively distinctive aspects that differentiate them from other
technologies such as pharmaceuticals. These include the following: R&D project selection;
regulatory necessities, and their intended and unintended properties; when is a new product
design sufficiently safe and effective for routine usage in patients; and, physician–industry
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relations in the innovation development in the context of real or perceived conflict of interest.
Each of these factors has implications for the delivery of care, patient well-being, and health
care leadership.2, 5-6
The past decade has brought extraordinary change to the medical device sector, and the pace
seems to be accelerating. New regulatory requirements, severe competition, and rapidly
developing technologies are creating new complications and challenges for those operating in
the sector.1, 7
Medical device innovation has raised huge benefits to patients, especially in the developed
countries, while the population in developing countries and poor countries have experienced
much lesser benefits in comparison. Development and diffusion of novel medical devices has
been slower than for many consumer goods of household due to the barriers to novelty and
innovation. Although some of the challenges are necessary and must remain for ultimate
patient welfare and for of device efficacy, other hurdles could be removed or made lower by
better policies and closer association between various stakeholders. Combination of medical
and technological know-how may lead to faster and intensive development, thereby improved
accessibility of investment. Early R&D may happen through linkages including academia,
industry, and government agency, thereby lowering investor risk aversion. Rationalizing clinical
testing, including a more standardized process to the health technology assessment
mechanism, may speed up launch and penetration of cost-effective devices. Amendments and
changes in to patent laws and the system for such laws to be practiced may lower cost and raise
competition. Although condensed prices may encounter the current business model for medical
device companies, improved sales could recompense them financially by the formation of a
true global marketplace. Numerous lifesaving significant medical devices have the prospective
to become sensibly priced mass-produced products. For the medical occupation, such progress
would make it simpler to its simple ethical values when functioning with cutting edge medical
know-how and technology.1, 3, 8
A medical device is any apparatus, material, appliance, software or other article—whether used
alone or in combination with others, including the software proposed by its manufacturer to be
used specifically for diagnostic and/or therapeutic uses and necessary for its proper
application—intended by the manufacturer to be used for human beings or animals for the
purpose of:4, 9
Diagnosis, monitoring, treatment, prevention, or alleviation of disease;
Diagnosis, monitoring, alleviation, treatment or compensation for an injury or handicap;
Replacement, Investigation or modification of the anatomy or of a physiological method;
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Control of conception; and which does not accomplish its principal intended action in or on
the human body by pharmacological, immunological, or metabolic means, but which may
be supported in its function by such means
Medical devices differ according to their intended use and indications. Examples range from
simple devices such as medical thermometers, tongue depressors, and disposable gloves to
advanced devices such as computers which assist in the conduct of medical testing, prostheses
and implants. Items as complex as housings for cochlear implants are manufactured through
the deep drawn and shallow drawn manufacturing methods. The design of medical devices
includes a major segment of the field of biomedical engineering.10
Products which may be considered to be medical devices in some jurisdictions but not in others
include: aids for persons with disabilities, disinfection substances, devices for in-vitro
fertilization or assisted reproduction technologies, devices incorporating animal and/or human
tissues.11
World health organization has defined ‘Medical device’ as, any instrument, apparatus, machine,
implement, implant, appliance, reagent for in vitro use, software, material or other similar or
related article, intended by the manufacturer to be used, alone or in combination, for human
beings, for one or more of the specific medical purpose(s) of:4, 8
1. diagnosis, prevention, monitoring, treatment or alleviation of disease,
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
3. investigation, replacement, modification, or support of the anatomy or of a physiological
process,
4. supporting or sustaining life,
5. control of conception,
6. disinfection of medical devices
7. providing information by means of in vitro examination of specimens derived from the
human body;
And does not achieve its primary intended action by pharmacological, immunological or
metabolic means, in or on the human body, but which may be assisted in its intended function
by such means.
According to US Food and Drug administration, Medical devices range from simple tongue
depressors and bedpans to complex programmable pacemakers with micro-chip technology
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and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such
as general purpose lab equipment, reagents, and test kits, which may include monoclonal
antibody technology. Certain electronic radiation emitting products with medical application
and claims meet the definition of medical device. Examples include diagnostic ultrasound
products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a
manner that meets the following definition in section 201(h) of the Federal Food Drug &
Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a
medical device and is subject to premarketing and post marketing regulatory controls. A
Medical device is:4, 11-12
"An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including a component part, or accessory which is:
1. recognized in the official National Formulary, or the United States Pharmacopoeia, or any
supplement to them,
2. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals, or
3. intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on
the body of man or other animals and
Which does not achieve its primary intended purposes through chemical action within or on the
body of man or other animals and which is not dependent upon being metabolized for the
achievement of its primary intended purposes. The term "device" does not include software
functions excluded pursuant to section 520(o).
This definition provides a clear distinction between a medical device and other FDA regulated
products such as drugs. If the primary intended use of the product is achieved through chemical
action or by being metabolized by the body, the product is usually a drug. Human drugs are
regulated by FDA's Center for Drug Evaluation and Research (CDER). Biological products which
include blood and blood products, and blood banking equipment are regulated by FDA's Center
for Biologics Evaluation and Research (CBER). FDA's Center for Veterinary Medicine (CVM)
regulates products used with animals. If your product is not a medical device but regulated by
another Center in the FDA, each component of the FDA has an office to assist with questions
about the products they regulate. 12
The USFDA allows for two regulatory pathways that allow the marketing of medical devices.
The first, and by far the most common is the 510(k) process (named after the Food, Drug, and
Cosmetic Act section that defines the process). A new medical device that can be established to
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be "substantially equivalent" to a previously legally marketed device can be "cleared" by the
FDA for marketing as long as the general and special controls, are met. The vast majority of new
medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely
requires clinical trials. The second regulatory path for new medical devices is the Premarket
Approval procedure, which is similar to the path for a new drug approval. Typically, clinical trials
are compulsory for this premarket approval pathway.12
The FDA created a three tier risk-based regulatory process to accommodate the respective
potential harms posed by medical devices. Class I products pose the lowest risk; Class II
moderate risk; and Class III the greatest risk. These are based on the level of regulation
necessary to assure safety and effectiveness. The classification procedures are described in the
Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). 12
Class I: General controls
Class I devices are subject to the minimum regulatory control. Class I devices are subject to
"General Controls" as are Class II and Class III devices. General controls include requirements
that relate to adulteration; device registration and listing; misbranding; premarket notification;
notification, including repair, replacement, or refund; banned devices; restricted devices;
records and reports; and good manufacturing practices. Class I devices are not projected to
help support or sustain life or be significantly important in preventing damage to human health,
and may not extant an unreasonable risk of illness or injury. Most Class I devices are exempted
from the premarket notification and a few are also exempt from most good manufacturing
practices regulation. Examples of Class I devices include examination gloves, elastic bandages,
and hand-held surgical instruments.
Class II: General controls with special controls
Class II devices are those for which general controls alone cannot guarantee safety and
effectiveness, and existing methods are available that provide such guarantees. In addition to
complying with general controls, Class II devices are also subject to distinct controls. A few Class
II devices are exempted from the premarket notification. Special controls may contain
mandatory performance standards, special labeling requirements and postmarket surveillance.
Devices in Class II are believed to a higher level of assurance than Class I devices, and are
designed to accomplish as indicated without causing injury or harm to patient or consumer.
Examples of Class II devices include powered wheelchairs, acupuncture needles, air purifiers,
infusion pumps, and surgical drapes.
Class III: General controls, Special Controls and premarket approval
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A Class III device is one for which inadequate information exists to assure safety and
effectiveness merely through the general or special controls adequate for Class I or Class II
devices. Such a device needs premarket approval, a scientific evaluation to ensure the device's
safety and effectiveness, in addition to the general controls of Class I. Class III devices are
typically those that support or sustain human life, are of significant importance in preventing
damage of human health, or present a potential, unreasonable threat of illness or injury.
Examples of Class III devices that require a premarket notification include pulse generators,
implantable pacemaker, automated external defibrillators, HIV diagnostic tests, and
endosseous implants.
Advances in patient care often develop from keen clinical insights and a needs-based method to
innovation. Although there is a vital role for incremental improvements to present solutions,
transformational innovation is what actually drives real shifts in clinical outcomes and
subsequently patient satisfaction, market access, and economic value. Innovation programs are
focused on unmet needs reasonably than solutions, call for a careful articulation of the specific
problems to be solved, involve a deep dive within a clinical area, and seek to prioritize research
and development funding into areas where the greatest impact can be expected.13-15
Best practice in the modern medical device industry has shifted to more closely align with
greatest practice from the consumer sector, and a third iteration of the typical model is being
adopted by leading companies. Now the procedure begins with Voice of the Customer, ie, what
do people actually need? This is followed by invention, to meet those needs, and then
implementation, secure in the knowledge that the underlying demand is real. 16
This approach moves all risk to the front of the process and all costs to the back end. This is a
far more prudent method when budgets are limited and cost to execute is at an all-time high
due to numerous factors, including cost of resources to regulatory load. It also enables a team
to iterate between invention and Voice of the Customer as essential in order to build
confidence in an implementation strategy and required investment.16
The US is the predominant player in the $350 billion global medical device business. But
emerging economies—in particular, China, India, and Brazil—are catching a growing market
share. Under the current model in the developed world, once a new product is presented,
companies crowd the market with “add-on” innovations to the product that often rise costs
with only marginal benefits to patients. 5, 17
China’s and India’s huge populations alone represent large new consumer bases. While the
growth rate of medical technology in the US stalls, a study on innovation forecasts that the
Chinese medical device market will expand 15 percent annually during the next five years.
India’s market is predicted to expand 23 percent each year. China and India also show the
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highest rapid rates of growth in triadic patent families (A series of corresponding patents filed
in the US, Europe, and Japan for the same invention.), with China growing 34 percent per year,
and India 10 percent per year. 17-18
Although the US invests more in R&D than any other country, US investment in R&D as a
percentage of GDP is decreasing. China’s R&D budget, on the other hand, is growing both
absolutely and relatively. By 2020, China’s R&D expenditure as a percentage of its GDP will
reach US 2010 levels. China has also eclipsed all nations except the US in terms of its number of
research publications, and the quality of China’s research institutions is improving. As a result,
the US expects China to become a global competitor for talent, resources, and output.17-18
Faced with aggressive competition and pressure to decrease costs across the healthcare
spectrum, medical device manufacturers are banking on growth through breakthrough
innovations and engineering in the field.13
Sustained success needs a more expansive, forward-thinking development approach. Product
development is no longer purely within the dominance of science — technology and marketing
deliberations, consumer preferences and data innovation are also driving developments. With
most medical device companies having 3–5 year development life cycles, new products have to
be forward-thinking and designed to suite technologies that will be in place 5 years from now.7
New medical devices are commonly a result of cooperation between academia and commercial
interests. This may cause clashes between the wish to publish and the concern in patenting and
acquiring IPRs. Previously, the IPRs of hospital employees and academicians may have been
inadequately protected, leaving the scientist with the option to keep an innovation secret or
bring it out in public domain, risking loss of protection by the later. Medical device companies
forecast partnerships, rather than in-house struggles, which will drive the future of innovation
and speed up to market. Ongoing cooperation and innovation through partnerships in an
extremely competitive and specialized industry needs new business models for joint projects,
new ways of making strategic fundings, and new approaches to R&D that encompass a broader
spectrum of partners and a more capacious mindset.1, 19
The speed of innovation will continue to rise as new innovations and players revolutionize
product development, manufacturing processes, and business models. Technology transfer
organizations are helping cooperation between corporations and universities, thereby reducing
this barrier. Small companies, developing pioneering devices, may be in an unfavorable
situation to protect their IPR against business organizations with vast legal and financial
resources. Big corporations often cover their products by wide and general patents, inhibiting
new innovation. Physicians are important contributors to device innovation and insufficient IPR
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regulations may present additional barrier to innovative progress unless technology transfer
organizations vigorously assist in protecting IPRs.13-15
Obtaining a patent may boost innovation by giving patented product exclusivity for the time of
the patent protection. On the other hand, patents expressively increase the price of devices
and may decrease innovative efforts in the similar field. 1, 14
Most medical device and diagnostics invention is based largely on some understanding of the
vital laws of nature with respect to biology. However, while most medical device patents define
tangible products or diagnostic methods, natural phenomena, laws of nature, and abstract
ideas are not patentable. Whomsoever invents or discovers any new and useful machine,
process, manufacture, composition of matter, or any new and useful development thereof, may
obtain a patent therefor, subject to the conditions and requirements of this title.6, 20-21
The aim of the present paper is to review the patent filing trends and analyze the patent data
on following parameters: Priority Country, Current Legal Status, Patenting Trends, Major
Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group
Data, and Technology Topics related to medical device related innovations.
Methods
In present work, we applied patent analysis to identify the innovation trends in medical device
domain Comparing and analyzing the basic data set on different parameters. The results are
showing the patent trends in medical device innovations. Present study provides data and
analysis based on the following parameters: Priority Country, Current Legal Status, Patenting
Trends, Major Current Owner of Technologies, Assignee Type, International Patent
Classification (IPC) Group Data, and Technology Topics.
In order to get a quantitative estimation of such patent data, we have analyzed the patent data
available on Patent research and collaboration platform PatSeer. PatSeer is a one-stop analysis
and collaboration platform for Patent and Non-patent Literature search. PatSeer offers various
search, analysis and visualization tools for effectively looking in to large volume of data. We
found that most patents filed, published or granted are captured in to the database with very
short period of time after their original release by various publishing authorities. PatSeer
includes full text patent data from 51 countries, it also includes searchable English translations
and bibliographic data from 104+ countries as part of INPADOC data. It includes approximately
74 million full-text records in a database of 115 million+ records. This ensures coverage of
required patent data for trend analysis of related technologies on various parameters.10
To analyze the patent data and trends related to medical device innovations, records till a
period of 15th May 2018 was analyzed on PatSeer, the method for selection of relevant patent
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data and documents was made based on Medical Device as key word in Title, Abstract, Claims
and Description (TACD) of all patent records available on PatSeer database. Further the
available dataset was analyzed based on the selection of most appropriate International Patent
Classification (IPC) Code of most relevant patent documents in the area of medical devices.6, 21
With the Search Terms TACD: (Medical Device), initially we found 586561 total records from the
database, further these records were deduplicated based on simple family members
parameter, so as to eliminate repetitive multiple records from same patent family and only one
record per patent family will come out. We had received total 190292 records from the whole
dataset, based on de duplication of records on the basis of simple family members. Further
from all available results, they were analyzed based on most prevailing International Patent
Classification (IPC) Codes of each patent document, and most relevant IPC classes were been
identified related to medical device domain. This has led to finalizing of following major IPC
Main Groups as: A61F2/00, A61B17/00, A61B5/00, A61N1/00, A61M25/00 and A61M5/00.
RESULT AND DISCUSSION
To analyses the patent trends in the area of medical device via PatSeer database, we had
carried out search using following IPC Main Groups: A61F2/00, A61B17/00, A61B5/00,
A61N1/00, A61M25/00 and A61M5/00 and data collected as on 15th May 2018.
The search for said IPC Main Groups were conducted on PatSeer database with two strategies,
direct search with IPC Main Group without any deduplication of results, and search with IPC
Main Group with deduplication of results based on simple family members to narrow down the
results as well to remove the duplicate values. The results of such search, along with the
detailed technical definition for each of these most relevant IPC main groups related to medical
device related patents is mentioned in below Table 1.
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Table 1: IPC Main Group based patent search for medical device patents on PatSeer database.
IPC Main
Group
IPC Main Group Definition With no
deduplication
of result
records
With
Deduplication
of results
based on
simple family
of records
A61F2/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
FILTERS IMPLANTABLE INTO BLOOD VESSELS;
PROSTHESES; DEVICES PROVIDING PATENCY TO,
OR PREVENTING COLLAPSING OF, TUBULAR
STRUCTURES OF THE BODY, E.G. STENTS;
ORTHOPAEDIC, NURSING OR CONTRACEPTIVE
DEVICES; FOMENTATION; TREATMENT OR
PROTECTION OF EYES OR EARS; BANDAGES,
DRESSINGS OR ABSORBENT PADS; FIRST-AID
KITS;
Filters implantable into blood vessels;
Prostheses, i.e. artificial substitutes or
replacements for parts of the body; Appliances
for connecting them with the body; Devices
providing patency to, or preventing collapsing
of, tubular structures of the body, e.g. stents
94427 25169
A61B17/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
DIAGNOSIS; SURGERY; IDENTIFICATION;
Surgical instruments, devices or methods, e.g.
tourniquets
158272 67226
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A61B5/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
DIAGNOSIS; SURGERY; IDENTIFICATION;
Measuring for diagnostic purposes
200426 98991
A61N1/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
ELECTROTHERAPY; MAGNETOTHERAPY;
RADIATION THERAPY; ULTRASOUND THERAPY;
Electrotherapy; Circuits therefor
18304 11645
A61M25/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
DEVICES FOR INTRODUCING MEDIA INTO, OR
ONTO, THE BODY;
Catheters; Hollow probes
87859 32952
A61M5/00 HUMAN NECESSITIES;
MEDICAL OR VETERINARY SCIENCE; HYGIENE;
DEVICES FOR INTRODUCING MEDIA INTO, OR
ONTO, THE BODY;
Devices for bringing media into the body in a
subcutaneous, intra-vascular or intramuscular
way; Accessories therefor, e.g. filling or cleaning
devices, arm rests
49572 23674
The information collected is based on most relevant IPC Main Group data, which was further
analyzed on various parameters: Priority Country, Current Legal Status, Patenting Trends, Major
Current Owner of Technologies, Assignee Type, International Patent Classification (IPC) Group
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Data, Technology Topics related to medical device innovation patents and results were found as
following:
Priority Country
To analyze the countries, where in the major innovations were been developed in these areas,
in present study we had analyzed the top countries from where the innovations are first
generated, the priority country. This represent the key countries where in maximum R&D was
involved for development of new technology in said domain of medical device. Data was
analyzed to sort top fifteen innovator countries jointly for the listed IPC Main Groups.
In Table 2 data for top fifteen priority country is provided for medical device related patents in
descending order of filled patent applications. In Figure 1 represents a Graph for top fifteen
priority countries for Medical Device Innovations. Figure 2 represents a density of medical
device related patents filled by various countries of the world.
Table 2: Data for top fifteen priority country
Sr. No. Priority Country Priority Country Code Total Applications
1 USA US 101655
2 Japan JP 31611
3 China CN 28281
4 Germany DE 14225
5 Russia RU 10006
6 Ukraine UA 7501
7 Korea KR 6270
8 Soviet Union SU 6129
9 Europe EP 5153
10 France FR 4997
11 U.K. GB 4306
12 Australia AU 1839
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13 Taiwan TW 1707
14 Sweden SE 1304
15 Italy IT 1173
Figure 1: Graph for Top 15 Priority Countries for Medical Device Innovations
Figure 2 Density of medical device related patents filled by various countries of the world.
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Current Legal Status
To analyze the current legal status of available large number of patent documents, which were
filled across the world by various applicants. They were further analyzed to check how many
patents were in force, how many were expired, and expired for what reasons, How many were
withdrawn etc.
The available patent data set was further analyzed to obtain details related to current legal
status of said patent documents in all jurisdictions where ever they had filled patent
application. All patents were grouped based on their status of applied, active, inactive, expired,
withdrawn, surrendered, granted, revoked, refused, SPC etc. Here SPC is to be considered as
patent term extension. Table 3 below represent the statistics for Current Legal Status of all
relevant patents data set. Figure 3 below represent the graphical representation for Current
Legal Status of all relevant patents data set.
Table 3: Current Legal Status of all relevant patents data set
Sr. No. Current legal status Total
1 Inactive - Expired 87043
2 Active - Granted 76286
3 Active - Applied 72193
4 Inactive - Nonpayment 47169
5 Inactive - Withdrawn / Surrendered 39113
6 Inactive - Rejected / Refused / Suspended 13775
7 Inactive - Opposition / Revoked 366
8 SPC Inactive - Expired / Rejected 4
9 SPC Active - Granted / Applied 1
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Figure 3: Graphical representation for Current Legal Status of all relevant patents data set
Patenting Trends
Further analysis was made to check for the patent filing trend in these domains for data
available on PatSeer from time period of 1st January 1999 till 15th May 2018. To this we have
analyzed the data for how many patent applications were filed and how many patents were
granted in total, on yearly basis during said time period. Cumulative data for filing and grant of
patents from all countries across the world, available on PatSeer database was analyzed.
Further the data set is analyzed to check for the total number of patent applications were filed
in all jurisdictions in a defined period of time, and total number of relevant patents granted by
all jurisdiction in to same amount of time period. The data were been analyzed on yearly basis
starting from January 1999 to 15th May 2018. Table 4 below represents the patenting trend,
data for total number of patent applications filed and total patents granted on yearly basis by
all jurisdictions in cumulative manner. Figure 4 represents the graphical representation of
patenting trend, data for total number of patent applications filed and total patents granted for
same data.
Table 4: Patenting Trend
Year Applications Filed Grant Published
1999 14517 9671
2000 21301 10084
2001 20357 11974
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2002 22221 13191
2003 22206 13186
2004 17280 13990
2005 12783 13431
2006 12921 6279
2007 11206 6550
2008 11057 6374
2009 10923 6471
2010 10311 6744
2011 11080 6717
2012 12881 6977
2013 14968 7011
2014 14529 6865
2015 13647 4586
2016 10218 3020
2017 2468 2024
Till 15th May 2018 42 462
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Figure 4: Graphical Representation for Patenting Trend for Medical Device Patents
Current owner (Assignee):
From initial screening of records related to top priority countries, current legal status of filed
patent applications, patent filing trend now further analysis was made to identify the major
current owner of technologies. It was analyzed to identify who holds the maximum number of
patents in said area of medical device innovations.
Patent data set was analyzed further to check for the top assignee/current owner of maximum
patents in these areas. The top assignees had been find out based on the maximum number of
patent applications filed and granted, holds by any assignees from all relevant patents data set.
From the whole patents data set attempt was made to identify top fifty assignees in key
technology areas related to medical devices. Table 5 below represents the patenting trend,
data for top fifty assignees worldwide who holds maximum number of patents in these
domains. Figure 5 is a graphical representation to show the top fifty current owners of patents
with number of patents hold by each owner in medical device domain.
Table 5: Top Fifty Current Owners for Medical Device Related Patents
Sr. No. Current Owner Total
1 JOHNSON & JOHNSON 5944
2 BOSTON SCIENTIFIC CORP 5313
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3 MEDTRONIC INC 4640
4 ABBOTT LAB 3694
5 COVIDIEN PLC 3446
6 KONINKLIJKE PHILIPS NV 2976
7 TERUMO CORP 2634
8 NIPPON LIFE 2609
9 TOSHIBA CORP 1596
10 PANASONIC CORP 1397
11 BECTON DICKINSON & CO 1293
12 SIEMENS AG 1287
13 STRYKER CORP 1247
14 GENERAL ELECTRIC CO 1199
15 SCIMED LIFE SYSTEM INC 1096
16 BOSTON SCIENT LTD 1093
17 ZIMMER BIOMET 1063
18 BARD INC 1033
19 B BRAUN MELSUNGEN AG 1026
20 HITACHI LTD 997
21 SAMSUNG GROUP 991
22 COOK MEDICAL TECHNOLOGY LLC 789
23 CANON INC 778
24 FUJIFILM HOLDING CORP 760
25 SIEMENS AKTIENGESELLSCHAFT ÖSTERREICH 734
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26 BAXTER INTERNATIONAL INC 673
27 G OBRAZOVATEL NOE UCHREZHDENIE 673
28 TYCO HEALTHCARE GROUP LLP 668
29 SMITH & NEPHEW PLC 611
30 SEIKO GROUP 610
31 SANOFI SA 590
32 UNIV CALIFORNIA 574
33 COOK GROUP INC 565
34 ROCHE HOLDING AG 555
35 KONICA MINOLTA HOLDING INC 547
36 OMRON TATEISI ELECTRONIC CO LTD 520
37 NOVARTIS AG 502
38 EDWARDS LIFESCIENCES CORP 500
39 BAYER AG 473
40 SUMITOMO GROUP 428
41 ROCHE DIABETES CARE INC 408
42 FUJIFILM HOLDINGS CORP 389
43 BECTON DICKINSON & COMPANY NEW JERSEY 381
44 NIPRO CORP 374
45 GEN HOSPITAL CORP 373
46 SUMITOMO BAKELITE CO LTD 359
47 STORZ KARL GMBH & CO KG 341
48 FUJITSU LTD 338
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49 LIVANOVA PLC 326
50 SONY CORP 323
Figure 5: Top Fifty Current Owners for Medical Device Related Patents
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Assignee Type
After analyzing the patent data set for top current owners of patents, to check the share of
patents holding by various broad categories of assignees, a further analysis of patent data set
was made based on the basis of assignee type. The patents were been grouped in to following
groups of assignees: Firm, Individual, University, Government, Hospital, Institutes and Others.
Table 6 below represents a total number of patents hold by each type of the assignee. Figure 6
below represents a graphical representation to show the total number of patents hold by each
type of the assignee.
Table 6: Assignee Type
Sr. No. Assignee Type Number of Patent Applications
1 Firm 131012
2 Individual 60292
3 University 19250
4 Hospital 4877
5 Government 1477
6 Institutes 79
7 Other 42508
Figure 6: Total patents hold by each type of assignee
51%
23%
7%2%
1%
0%
16%
Assignee Type - Number of Patent Applications
Firm
Individual
University
Hospital
Government
Institutes
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Key IPC Classes
Further to analyze the micro areas of innovations in these broad fields of innovation, the patent
data were been analyzed based on the International Patent Classification (IPC) system. IPC
analysis of the data set was performed on the IPC Sub Group Data to define micro technical
domains of each innovations protected by patents. And attempt was made to identify the total
number of patent applications filed in particular technology domains.
All patents are systematically classified according to their specific technical field. Though
various existing national classification systems, the International Patent Classification (IPC)
system is a common system shared by all patent offices. Further information on the IPC,
including how to use keywords to find the right classification, is available at,
http://www.wipo.int/classifications/ipc. To present research study further attempt was made
to analyze the micro areas of technologies, based on the IPC sub group code assigned to each
patent by respective authorities. A definition for each of those IPC sub group codes are
provided in below mentioned Table 7. Attempt was made to identify top fifty such IPC sub
groups which have maximum number of patents classified with said such IPC codes. Based on
the aspect and scope of each patent application, respective authorities may assign one or more
IPC sub group codes to each of these patents. This will reflect the core major domains in the
field of medical device, where in maximum research is been carried out and innovations were
developed.
Table 7: Top IPC Sub Group with Definition.
Sr.
No.
IPC Sub Group/Full Class Total
Patents
1 A61B5/00 - Measuring for diagnostic purposes 92364
2 A61B17/00 - Surgical instruments; devices or methods 63075
3 A61M25/00 - Catheters ; Hollow probes 29397
4 A61F2/00 - Filters implantable into blood vessels ; Prostheses 23314
5 A61M5/00 - Devices for bringing media into the body in a subcutaneous;
intra-vascular or intramuscular way ; Accessories therefor
16808
6 A61B19/00 - Instruments; implements or accessories for surgery or diagnosis 10832
7 A61N1/00 - Electrotherapy ; Circuits therefor 9723
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8 A61F2/30 - Joints 7745
9 G06F19/00 - Digital computing or data processing equipment or methods;
specially adapted for specific applications
7676
10 A61B5/11 - Measuring movement of the entire body or parts thereof 7439
11 A61B17/34 - Trocars ; Puncturing needles 6285
12 A61B5/145 - Measuring characteristics of blood 6141
13 A61M25/01 - Introducing; guiding; advancing; emplacing or holding catheters 6122
14 A61B17/32 - Surgical cutting instruments 5817
15 A61B1/00 - Instruments for performing medical examinations of the interior
of cavities or tubes of the body by visual or photographical inspection
5528
16 A61M1/00 - Suction or pumping devices for medical purposes ; Devices for
carrying-off; for treatment of; or for carrying-over; body-liquids ; Drainage
systems
5282
17 A61B5/0205 - Simultaneously evaluating both cardiovascular conditions and
different types of body conditions
5260
18 A61B10/00 - Other methods or instruments for diagnosis 5184
19 A61B5/01 - Measuring temperature of body parts 5004
20 A61B17/22 - Implements for squeezing-off ulcers or the like on inner organs
of the body ; Implements for scraping-out cavities of body organs
4986
21 A61B5/024 - Measuring pulse rate or heart rate 4810
22 A61B6/00 - Apparatus for radiation diagnosis 4807
23 A61B5/04 - Measuring bioelectric signals of the body or parts thereof 4695
24 G06Q50/22 - Health care 4685
25 A61B18/14 - Probes or electrodes therefor 4643
26 A61B18/00 - Surgical instruments; devices or methods for transferring non-
mechanical forms of energy to or from the body
4499
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27 A61B17/12 - For ligaturing or otherwise compressing tubular parts of the
body
4384
28 A61F2/46 - Special tools for implanting artificial joints 4361
29 A61B5/02 - Measuring pulse; heart rate; blood pressure or blood flow ;
Combined pulse/heart-rate/blood pressure determination ; Evaluating a
cardiovascular condition not otherwise provided for
4340
30 A61B17/04 - For suturing wounds ; Holders or packages for needles or suture
materials
4331
31 A61F2/02 - Prostheses implantable into the body 4139
32 A61M5/32 - Needles ; Details of needles pertaining to their connection with
syringe or hub
4102
33 A61B5/055 - Involving electronic magnetic resonance 4074
34 A61B5/1455 - Using optical sensors 3971
35 A61M31/00 - Devices for introducing or retaining media 3613
36 A61F2/06 - Blood vessels 3602
37 A61B5/08 - Measuring devices for evaluating the respiratory organs 3597
38 A61B5/05 - Measuring for diagnosis by means of electric currents or magnetic
fields
3489
39 A61B17/28 - Surgical forceps 3400
40 A61B8/00 - Diagnosis using ultrasonic; sonic or infrasonic waves 3380
41 A61B17/56 - Surgical instruments or methods for treatment of bones or joints
; Devices specially adapted therefor
3241
42 A61F2/958 - Inflatable balloons for placing stents or stent-grafts 3042
43 A61N1/05 - For implantation or insertion into the body 3001
44 A61B90/00 - Instruments; implements or accessories specially adapted for
surgery or diagnosis and
2991
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45 A61F2/28 - Bones 2989
46 A61M37/00 - Other apparatus for introducing media into the body 2959
47 A61B5/0402 - Electrocardiography 2916
48 A61N1/36 - For stimulation 2900
49 A61B5/107 - Measuring physical dimensions 2892
50 A61B5/103 - Measuring devices for testing the shape; pattern; size or
movement of the body or parts thereof; for diagnostic purposes
2834
Technology Topics:
After analyzing the full patent data set to find out top fifty IPC groups to identify the micro
areas of research, further attempt was made to define a macro level areas of all these patent
documents. To see the macro areas of research, the patent documents data set was further
been grouped into various groups of Technology Topics, the total area of records related to
particular technology topics were been shown based on the total number of patent documents
pertaining to said domain in present study dataset, which is shown in below Figure 7.
Figure 7: Technology Topics Related to Medical Device
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CONCLUSION
The present analysis of patent documents between January 1999 and 15th May 2018 in the
area of medical device was carried out by means of patent information analysis so as to get
some insights. The analysis was carried out using most relevant IPC Main Groups: A61F2/00,
A61B17/00, A61B5/00, A61N1/00, A61M25/00 and A61M5/00, which represent maximum
innovations protected by means of patents in the varied domains of medical devices. From the
initial screening of records it was found that in medical device industry maximum innovations
were generated in the areas of prostheses, surgical instruments, measuring instruments for
diagnostic purposes, electrotherapy and circuits thereof, catheters like hollow probes, devices
for bringing media into the body etc. From the priority country analysis of all patent documents
it was evident that maximum patents were been filed by USA, Japan, China, Germany, Russia in
order, followed by other countries. Each of these countries holds more than ten thousand
patents in said domain. It was also concluded that apart from patent applications and granted
patents in this domain, large number of patents are in inactive phase due to the reason either
of withdrawal, surrender, expired, nonpayment of fees, rejected, refused or suspended. From
patenting trend it can be observed that, patent filings related to medical device innovations are
not showing continuous rise or fall, it was observed that during a period of 1999 to 2005 large
number of applications were filed and granted compared to 2005 onwards time period as
under study. Further analysis was made to identify major current owners of technologies in this
domain, and top 50 assignees had been identified with total number of patents they are
holding in this area. Johnson & Johnson, Boston Scientific Corp, Medtronic Inc, Abbott Lab and
Covidien Plc are the top five assignees who holds the maximum patents in the areas of medical
devices. Further analysis was made to categorize the patent applications and patents, based on
the type of assignee. From this it was evident that, majority of patents were hold by firms,
followed by individual and university as assignees. Further the innovations were grouped and
analyzed based on micro level in various technical fields, based on various IPC sub group codes,
to which areas maximum patent applications were been filed. Patent data was also grouped in
various broad technology topics, to identify area of research topics on macro level.
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REFERENCES:
1. Bergsland, J.; Elle, O. J.; Fosse, E., Barriers to medical device innovation. Medical devices
(Auckland, NZ) 2014, 7, 205.
2. Shah, S. G. S.; Robinson, I., Benefits of and barriers to involving users in medical device
technology development and evaluation. International Journal of Technology Assessment in
Health Care 2007, 23 (1), 131-137.
3. Citron, P., Ethics Considerations for Medical Device R&D. Progress in Cardiovascular Diseases
2012, 55 (3), 307-315.
4. Fiedler, B. A.; David, Y., Chapter 1 - Reframing Product Life Cycle for Medical Devices. In
Managing Medical Devices Within a Regulatory Framework, Elsevier: 2017; pp 3-16.
5. Russell, R. K.; Tippett, D. D., Critical Success Factors for the Fuzzy Front End of Innovation in
the Medical Device Industry. Engineering Management Journal 2008, 20 (3), 36-43.
6. Ray, P. P.; Amaral, J. F.; Hinoul, P., Innovation Best Practices in the Medical Device Industry.
Techniques in Vascular and Interventional Radiology 2017, 20 (2), 90-93.
7. Kampfrath, T.; Cotten, S. W., The new collaborative path in medical device development: The
medical device innovation consortium. Clinical Biochemistry 2013, 46 (15), 1320-1322.
8. Foote, S. B., Managing the medical arms race: innovation and public policy in the medical
device industry. 1992.
9. Hirschorn, D. S.; Choudhri, A. F.; Shih, G.; Kim, W., Use of Mobile Devices for
Medical Imaging. Journal of the American College of Radiology 2014, 11 (12, Part B), 1277-1285.
10. Hagedorn, T. J.; Grosse, I. R.; Krishnamurty, S., A concept ideation framework for medical
device design. Journal of Biomedical Informatics 2015, 55, 218-230.
11. Quinn, P., The EU commission's risky choice for a non-risk based strategy on assessment of
medical devices. Computer Law & Security Review 2017, 33 (3), 361-370.
12. Clarkson, D. M., Medical Device Guidebook: A browser information resource for medical
device users. Medical Engineering & Physics 2017, 41, 97-102.
13. Roback, K.; Blume, S. S., Medical device innovation. The integrated processes of invention,
diffusion and deployment. Linköping: Center for Medical Technology Assessment, Department of
Health and Society, Linköping University 2006.
14. Pilot, L. R., Medical Device Innovation. 2011.
15. Holdsworth, J.; Glisson, W. B.; Choo, K.-K. R., Medical device vulnerability mitigation effort
gap analysis taxonomy. Smart Health 2017.
16. Fearis, P. J.; Craft, B., Sustaining the success of medical device innovation. Surgery 2016,
160 (5), 1130-1134.
17. Chatterji Aaron, K., Spawned with a silver spoon? Entrepreneurial performance and
innovation in the medical device industry. Strategic Management Journal 2008, 30 (2), 185-206.
Research Article CODEN: IJPRNK Impact Factor: 5.567 ISSN: 2277-8713 Amitkumar Patel, IJPRBS, 2018; Volume 7(4): 8-36 IJPRBS
Available Online at www.ijprbs.com 36
18. Bagian, T. M.; Jacobs, K.; Lightner, N. J., Purchasing for Safety: Beginning a Conversation
with the Medical Device Industry. Procedia Manufacturing 2015, 3, 264-268.
19. Moultrie, J.; Sutcliffe, L.; Maier, A., Exploratory study of the state of environmentally
conscious design in the medical device industry. Journal of Cleaner Production 2015, 108, 363-
376.
20. Bayrak, T.; Özdiler Çopur, F., Evaluation of the unique device identification system and an
approach for medical device tracking. Health Policy and Technology 2017, 6 (2), 234-241.
21. Privitera, M. B.; Evans, M.; Southee, D., Human factors in the design of medical devices –
Approaches to meeting international standards in the European Union and USA. Applied
Ergonomics 2017, 59, 251-263.