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Technological Innovation and
Medical Devices
EDWARD B. ROBERTS
About 5 years ago, Robert Levy—then the director of the National
Heart, Lung, and Blood Institute and I cochaired a meeting that
attempted to assess the state of knowledge about the development,
dissemination, use, and acceptance of biomedical innovation. Having
recently reread the proceedings of that meeting (Roberts et al., 1981),
I perceive that much progress has been made during the past 5 years
in our understanding of these critical aspects of medical technology.
I will illuminate the process of technological innovation in the field
of medical devices by posing five questions. I would prefer to provide
empirical answers to these questions and to use evidence drawn
entirely from experiences with medical devices to identify what matters,
what works and what does not work, and what the obstacles are to
achieving more effective innovation. But the field of medical devices
has not been researched as carefully or as thoroughly as one would
have liked. Thus, I am going to draw upon some studies that have
been done on innovations outside of the medical device field, on the
few works that recently have been carried out on technological
innovation in the medical device field, and on my 20 years of experience
in this area.
WHAT IS TECHNOLOGICAL INNOVATION IN MEDICAL DEVICES?
Innovation can be classified in several ways, many of which are
relevant to innovation of medical devices. For example, innovations
in products, manufacturing processes, and modes of practice are all
35
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
important. Both invention of new devices and modification of existing
devices occur. Radical innovations that introduce dramatic new ca-
pabilities are important, as are incremental innovations in existing
products and processes. Invention that is wholly original certainly
takes place, but innovation also includes modifying, upgrading, and
improving existing devices. Innovation also means adoption taking a
device that someone has developed previously and applying it to a
different situation. A final way to distinguish among innovations is to
recognize that some are based upon the application of new knowledge
from scientific research, whereas others are clear cases of engineering
problem solving, in which existing knowledge or techniques are applied
to newly defined problems.
An overriding issue with these topologies is that our thinking about
innovations in the medical field is dominated by images that come
largely from the pharmaceutical industry. If most of us were asked to
describe technological innovation in medical devices, we would speak
about basic research that is carried out in large organizations and that
generates fundamental knowledge used to create radical innovations
in medical devices. Often, our managerial and policy approaches also
reflect such images.
Yet, my personal experience, supported by the few relevant studies
on innovation, indicates that the medical device field contradicts all
of these images. Instead, innovation in medical devices is usually
based on engineering problem solving by individuals or small firms, is
often incremental rather than radical, seldom depends on the results
of long-term research in the basic sciences, and generally does not
reflect the recent generation of fundamental new knowledge. It is a
very different endeavor from drug innovation, indeed.
Table 1 displays data gathered a number of years ago on innovations
in 77 companies and in five different (all nonmedical) fields of activity
(Myers and Marquis, 19691. In attempting to look at the amount of
TABLE 1 Technological Change Embodied in Successful
Innovations
Percent Distributiona
Degree of Inventiveness
Little
Considerable
Invention required
aX2 = 19.1 ; p < .001.
SOURCE: Original data from Myers and Marquis (1969). Analysis from Utterback and
Abernathy (1975).
Stage 1 Stage 2 Stage 3
14
41
45
19
50
31
33
48
19
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TEClINOLOGICAL INNOVATIOIV AND MEDICAL DEVICES
TABLE 2 Degree of Functional Advance Embodied in British
Medical Equipment Innovations
Advance
37
Number Example
First time provided to
equipment user
Major improvement in functionality 8
Minor improvement 10
Failure
Total
SOURCE: Shaw (1986).
10
34
Neonatal oxygen monitoring system
Radio pill telemetry system
MiniatuIization of radiography
equipment
Nasal airways resistance tester
technological change embodied in these innovations (degree of inven-
tiveness), James M. Utterback of the Massachusetts Institute of
Technology (MIT) and the late William J. Abernathy of the Harvard
Business School clustered the data into three stages in the evolution
of technology (Utterback and Abernathy, 19751. Stage 1 was emerging
new technology; stage 2 was technology that was growing in adoption
and use; and stage 3 was mature technology that was widely diffused
and used. Utterback and Abernathy found that the characteristics of
technological innovation depended upon the stage of evolution of the
technology.
As depicted in Table 1, situations requiring original invention
dominated stage 1 innovations only; much less invention typified
innovations arising in stages 2 and 3. This suggests that an important
dimension is whether the underlying technology of a particular medical
device is newly emerging or not. If it is, then one should expect that
a high degree of technological change will be required- possibly true
invention and perhaps providing a real opportunity for basic scientific
and engineering research to play an important role. If, however, a
medical device is based on a technology that is well founded and
widely diffused, the device innovation will likely merely involve
upgrading, enhancing, and expanding current applications.
In a doctoral dissertation, Shaw (1986) shed light on this issue from
the perspective of a small, randomly selected set of 34 innovations of
medical equipment in Great Britain. The results of this study, sum-
marized in Table 2, indicated that only 10 of the 34 innovations
represented the first time that a particular function was provided to
the equipment user (for example, a neonatal oxygen monitoring
system). Of the remaining cases of (supposedly) significant innovations
in medical devices, six were market failures (for example, a nasal
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
airways resistance tester) and 18 were improvements on functions that
had been previously available (8 were major improvements, such as
the radio pill telemetry system; 10 were minor improvements, such as
the miniaturization of radiography equipment). If Shaw's findings can
be applied generally, then only a minority of medical device innovations
bring a new functionality to health care providers.
In the same study, Shaw attempted to identify sources of key
technological information that were embodied in the 34 innovations.
Only 10 products were closely associated with original medical re-
search. (Here, the term "associated" is used quite loosely, and includes
all cases in which the innovation was developed in the course of
carrying out medical research. Thus, the 10 cases were not necessarily
devices that embodied recent results of original medical research.) For
five innovations, clinical studies were an important source of ideas.
But engineering and development were the major sources of innovative
ideas for 19 products, clearly dominating the technological sources of
ideas for medical device innovations.
WHO BRINGS ABOUT MEDICALDEVICE INNOVATIONS?
It is commonplace in the field of innovation to talk about the
importance of the relationship between the manufacturer and the user.
The correct and well-supported presumption is that when a potential
innovator focuses on needs and is attentive to the marketplace of
prospective users, he or she can acquire insight into what products
ought to be developed. As a consequence, resulting innovations are
more likely to be successful.
One can go beyond this rather simplistic characterization, however.
In many areas, including medical devices, the user is not merely a
source of information about his or her needs to a manufacturer who
innovates. Frequently, the user is the innovator. The innovative user
not only defines a need, he or she also identifies the solution to that
need. The innovative user often develops the initial innovation, places
it into first clinical use, and makes copies or detailed specifications of
the innovation available to other practitioners. Only later, in many
cases, does a manufacturer acquire the user's innovation and begin to
engage in the serious and important problems of commercial devel-
opment—among them, engineering for manufacturing and for reliable
field use, and service and volume scale-up.
Eric van Hippel of MIT has conducted a series of studies on sources
of product innovations. His first four analyses focused on innovations
in scientific instrumentation: gas chromatography, nuclear magnetic
resonance, ultraviolet spectrophotometry, and transmission electron
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TECHNOLOGICAL INNOVATION AND MEDICAL DEVICES
TABLE 3 User Domination of Instrument Innovations
39
Percent No. of No. of
Category of User- User- Manufacturer-
Instruments Dominated Dominated Dominated
Gas chromatography
Nuclear magnetic resonance
Ultraviolet spectrophotometry
Transmission electron microscope
SOURCE: van Hippel (1976).
82 9 2
79
100
79 11
11
4 0
microscopy (von Hippel, 19761. Despite a strict definition of what
constitutes domination of an innovation, von Hippel concluded that
80 to 100 percent of the key innovations in these four scientific
instruments were dominated by the user (Table 31. To qualify as user
dominated, von Hippel insisted that the user had to have identified
the need, developed the technical solution, put the solution into
practice, and made the solution available to others in the field—all
before a manufacturer played any role in these activities.
With the van Hippel study as a background, we can return to Shaw's
recently completed study of British medical innovations (Straw, 19861.
Results were similar to those observed in van Hippel's study. For half
of the British medical innovations (18 of 34), a prototype was developed
and produced by a user. In another third of the cases (11 of 34), the
innovative idea was transferred directly from the user to the manufac-
turer at the user's initiative, to satisfy the user's needs.
For only 4 of 34 devices was the innovation developed by a
manufacturer who had performed market research to determine the
nature and magnitude of a potential need, and then had developed a
product to satisfy that need. In one case, the manufacturer went
forward without the benefit of market research to push a technology
that the manufacturer believed was desirable. Perhaps only coinciden-
tally, that device was 1 of only 6 cases of market failure among the 34
medical innovations studied by Shawl
Additional information about user and manufacturer initiatives for
the 34 British medical equipment innovations was gathered by Shaw
but not published with his dissertation. Four users started their own
companies to manufacture their innovative devices. One new company
was established by a potential user who was in contact with the
innovative user. In six cases, the inventor contacted existing companies
and asked them to develop and manufacture the invention. In four
cases, a user approached an existing company after he had identified-
but before he had invented—the solution. In one case, a government
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
agency took the initiative and selected a firm to develop the device.
In seven cases, there was an existing long-term relationship between
an active user and a company working in the same field of medicine.
For only 15 percent of the devices (5 of 34) did a company take the
initiative in approaching a user for assistance in product development.
And in even fewer cases (4 of 34) was the project initiated and carried
out within the firm, without benefit of user relationships.
Another study by van Hippel and Finkelstein (1978) showed that
user innovation can be encouraged or discouraged by medical equip-
ment manufacturers. They demonstrated that the design of Technicon's
auto-analyzer permitted nearly all of its test procedures to be developed
by users, whereas DuPont's clinical analyzer had a closed design that
produced dependency on DuPont's internal research and development
professionals for supportive innovations.
Although the specific results may be somewhat different in a more
comprehensive analysis of U.S. medical device innovations, these data
clearly identify the locus of innovation for medical devices. The
process of medical device innovation is dominated primarily by
individuals, usually in academic and clinical settings, who are involved
in the development and use of new technology in their respective
fields. The role of the device manufacturer tends to be supportive and
secondary—not primary for most innovative medical devices.
For companies that are trying to innovate in medical fields, it is
critical that they relate closely to the clinical scene. I recently completed
a study of all new medical companies formed in Massachusetts between
the years 1970 and 1975 (Hauptman and Roberts, 1987; Roberts and
Hauptman, 1986, 19874. The study focused on the companies' activities
in developing and marketing new products. A major finding was that
the degree of clinical contact between those companies and, particu-
larly, teaching hospitals was strongly correlated with the degree of
technological innovation embodied in the products that the companies
developed. It is nearly impossible for a biomedical company to be
successful if it does not retain close ties to a clinical environment.
And yet, courting academicians as potential sources of new ideas is
not an easy pathway to innovation. To illustrate this point, I rely on
studies I performed a number of years ago using MIT faculty members
in three departments physics, electrical engineering, and mechanical
engineering. Table 4 depicts what faculty members did with ideas that,
in their judgment, had the greatest commercial potential (Roberts and
Peters, 19811. Only about one-third took any strong steps to transfer
their ideas to commercial manufacturers. Similar studies by researchers
in MIT's two largest research laboratories replicated these findings
(Peters and Roberts, 19691.
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TECHNOLOGICAL INNOVATION AIDED MEDICAL DEVICES
TABLE 4 Academicians' Exploitation of Their Commercially
Oriented Ideas
Academic Ideas
41
Degree of Commercial Exploitation No. Percent
None 32 . 47
Weak 10 15
Strong 26 38
Totals 68 100
SOURCE: Roberts and Peters (1981).
More recently, I repeated the study with 75 full-time physicians at
two major medical centers in the Boston area—one directly linked to
a major medical school and the other a Veterans Administration
hospital. More than half of the physicians (44 of 75) claimed to have
come up with ideas that, if developed, would be worthwhile. Yet, less
than half of those who had ideas had attempted to transfer them to
commercial manufacturers. Of the 44 physicians who had ideas, 19
engaged in discussions with outside companies; 9 of them even entered
into what they regarded as negotiations: 4 developed patent applica-
tions, and 1 formed a new company to try to commercialize the
technological innovation. Academics at universities or in clinical
settings may have productive ideas, but they infrequently exploit those
ideas.
An important secondary finding in these studies was the lack of
statistical correlation between the perceived potential benefits or
medical importance of the ideas and the degree to which they are
pushed toward commercial development. Routine academic ideas with
little anticipated impact were as likely to get transferred to commercial
firms as were exceptional ideas with excellent commercial prospects.
Transfer depended more on the situation and the individual who
developed the idea than on the quality of the idea itself. This was true
both for MIT faculty members and for clinical and academic physicians.
Results of these studies permit us to conclude that inventive users
are the principal driving force behind most medical device innovations,
either as developers and initial implementers or in close association
with commercial developers. Unfortunately, the data also demonstrate
that a large number (perhaps most) of the potentially valuable ideas
from users lie dormant in academia, in large part because academicians
do not know about commercial technology transfer. This situation
needs to be carefully examined in light of the increasingly favorable
relationships between universities and industry. Such ties may permit
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
a larger fraction of academic ideas to move toward commercial
development.
WHICH COMPANIES CONTRIBUTE TO
MEDICAL DEVICE INNOVATIONS?
An earlier study of innovation in nonmedical fields may provide
some insight into the characteristics of firms that innovate in the field
of medical devices. The information contained in Table 5 indicates
that as new technologies emerge (stage 1), a number of small firms
(each selling less than $10 million worth of products) dominate corporate
sources of innovations. However, larger companies (those selling more
than $100 million worth of products) account for most of the innovations
during growth and development stages (stages 2 and 3) of technologies.
There is general misunderstanding in the United States and abroad
about the relative roles of different-sized firms in the innovation
process. Much of the talk about small companies being more innovative
than large ones should be replaced by more accurate statements about
how small companies are likely to be innovative at very early stages
in the development of new technologies and how large companies are
likely to be primary sources of innovation at later stages in the
development of new technologies. Large companies that are particu-
larly innovative have a special competitive edge for dominating later
stages in a technology's evolution.
A similar phenomenon is likely to be true for innovation in the area
of medical devices. Here, too, important differences in the timing and
TABLE 5 Firm Size and Successful Innovation as a Function of
Stage of Technology
-
Stage of Evolution of Technology
Stage 1
Size of Firms
(Sales $ x 106)
Unclassifieda
<10
10-100
>100
NOTE: A total of 77 firms were studied (X2 = 11.2; p < .01).
aUnclassified firms are private companies that refused to provide sales data; they are
all assumed to be doing less than $10 million in sales.
SOURCE: Original data from Myers and Marquis (1969). Analysis from Utterback and
Abernathy (1975).
No.
Stages 2 and 3
Percent No.
8
o (?)
2 8
15 60
Percent
32
o
18
12 23
34
12
31
16
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TECHNOLOGICAL INNOVATION kD MEDICAL DEVICES
TABLE 6 Technology Development Milestones in Diagnostic
Ultrasound
43
Year Milestone
Developer
Market
Introduction
Physionics
1963
1969
1972
1973
1975
1976
1977
1983
SOURCE: Friar (1986).
Commercial 2-D
scanning
Mech. real time
Electronically switched
real time
Stored gray scale
Electronic focus
Microprocess controls
Digital scan converter
Computed sonography
U. of Colo.
U. of Colo.
Dutch medical
researchers
Rohe Scientific
Diagnostic Electronics
Searle Ultrasound
Searle Ultrasound
Acuson
Magnaflux
Organon Teknika
Rohe Scientific
Diagnostic Electronics
Searle Ultrasound
Searle Ultrasound
Acuson
type of a firm's innovations will depend on the size of the firm. These
distinctions are critical for health care policymakers, since about 50
percent of U.S. medical device manufacturers have fewer than 20
employees. In a doctoral dissertation recently completed by John Friar
(1986), eight major developmental milestones in the field of diagnostic
ultrasound were identified. Table 6 lists these milestones; all occurred
between 1963 and 1983 and were derived from careful assessment by
experts. In only two cases did a large company (Searle) initially develop
a key technological change. The three other cases in which companies
were identified as innovators are intriguing: Each of the companies-
Rohe Scientific, Diagnostic Electronics, and Acuson were founded
approximately at the time of development of the milestone that they
subsequently introduced to the market.
Even when we focus on market introduction rather than technical
development, the small firm remains the innovator during the early
stages of a new technology. Physionics was a new firm that licensed
ultrasound technology developed by the University of Colorado.
Magnaflux was also a new firm that licensed an important development
by the University of Colorado. Organon Teknika, a major corporation,
licensed a development that came from a university in the Netherlands.
As described in the preceding paragraph, Rohe Scientific, Diagnostic
Electronics, and Acuson were all new firms that introduced their own
new technologies.
These limited data suggest that small, innovative firms and university
or hospital employees trying to satisfy their own needs as clinical or
diagnostic users are the primary contributors to milestone develop-
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
meets in the medical device field. Personal experience and related
research in other countries (Teubal et al., 1976) also support this
conclusion.
HOW DO FDA REGULATIONS AFFECT
MEDICAL DEVICE INNOVATION?
The importance of small firms to innovation in medical devices
highlights concerns about the differential impact of Food and Drug
Administration (FDA) regulations on large and small firms. A recent
study~of innovations in x-ray technology (Birnbaum, 1984) showed
that increased FDA regulations led to decreased innovation of x-ray
devices, especially by small firms. A 1986 study of innovation in
contact lenses by the Office of Technology Assessment also expressed
concern that small firms would be disproportionately affected by FDA
regulations, particularly in the emerging technologies of soft and gas-
permeable contact lenses (U.S. Congress, Office of Technology As-
sessment, 19871.
All this, however, does not mean that the FDA acts irresponsibly
in its regulatory capacity. My recent study of medically oriented firms
in Massachusetts indicated that the risk associated with use of these
firms' new medical products—assessed by an independent medical
panel was significantly positively correlated with the degree of in-
novation embodied in a technology or in its application (Hauptman
and Roberts, 19871. The more new technology that was embedded in
a product, the greater was the product's assessed risk. This relationship
held true for the first, second, and third new products that these
companies introduced to the market, as well as for all of a company's
products, taken together. The degree of assessed medical risk was less
for new products classified as medical supplies than for new medical
devices and pharmaceuticals; this relationship confirms logical expec-
tations.
It is somewhat comforting to the skeptics among us to observe that
the impact of FDA regulation is significantly correlated with the
independent assessment of risk from new products: The greater the
perceived medical risk, the more FDA intervention affected the
companies involved in developing and marketing the product.
I believe this is the right direction for FDA activity, but there is an
important negative side effect. The introduction of the Medical Devices
Amendment in 1976 dramatically decreased the rate of new product
introduction by young biomedical firms in Massachusetts (Hauptman
and Roberts, 1987), and, although lacking empirical evidence, I suspect
this also was true for young medical firms throughout the United
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TECHNOLOGICAL INNOVATION AND MEDICAL DEVICES
45
States. This may explain the negative correlation that exists for poorly
financed biomedical firms between the extent to which a young firm
is technologically innovative and the economic success of the company.
Only in the medical field have I observed this relationship; in all other
studies since 1964 there was a direct positive relationship between the
degree of technological advance and the success of the firm. In the
medical field, if the company is not sufficiently financed to overcome
direct and indirect regulatory costs (particularly delays in generating
product revenues), then being technologically innovative may be a
curse rather than a benefit. This is a serious problem that should be
addressed by both policymakers and managers.
It may be possible to speed up FDA review processes for smaller
firms that suffer because of the costs needed to sustain themselves
until market approval is obtained. This could be achieved by (1)
preferential attention to, but not different standards for, applications
from small companies; (2) expansion of FDA review staff; and (3)
greater flexibility in accepting experimental data, especially overseas
clinical trials.
WHAT IS THE ROLE OF THE LARGER COMPANY
IN MEDICAL DEVICE INNOVATION?
A comprehensive study of the ultrasound industry provides a basis
for information about expensive new medical devices (Friar, 19861. Of
the 11 largest companies in the ultrasound device field, 9 entered the
field by acquiring an innovator that had developed and commercialized
some ultrasound technology. In four cases, the large company gained
additional competitive technologies by further acquisitions. The only
Japanese company on the list, Toshiba, entered the ultrasound field
on its own and did not acquire outside technology as a major element
of advancing its market position, a situation that contradicts our usual
stereotype of Japanese firms as technologically acquisitive. In addition,
Hewlett Packard entered the field based on its own technology but
acquired Ekoline to strengthen its technological position.
If the larger company's role in medical device innovation is to
acquire other firms (and, thereby, technological innovations), perhaps
we should focus our attention exclusively on the activities of smaller
firms. But large companies clearly dominate the medical device industry
in sales. Most companies in the ultrasound industry are quite small,
with 67 percent of them projected to have less than $5 million in sales
in 1986. Only 20 percent of the firms are projected to sell more than
$10 million worth of ultrasound equipment. The four largest companies
are estimated to have 53 percent of the total U.S. market. Large sales
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MEDICAL DEVICE INNOVATION AND HEALTH CARE
are therefore concentrated in large companies that are not the original
sources of most device innovations and that have usually acquired
their technological base through licensing another firm's innovation or
by acquiring that firm.
My own entrepreneurial experience in areas ranging from clinical
diagnostics to medical information systems reaffirms conclusions drawn
from the ultrasound example: Young, small firms dominate the initial
stages of major innovations, and large companies advance principally
through later acquisition of innovating small firms.
Large and small firms in the medical device industry play different
roles: The small firm is frequently the early-stage innovator and is
most jeopardized by the regulatory process. The large firm can afford
the expense of the regulatory process, but is less likely to be affected
because it is less often a key innovator. The patterns described here
suggest that we need to support potentially synergistic relationships
between large and small companies in the medical device industry.
Potential ties that need to be examined and, perhaps, fostered range
from sponsored research to venture capital to acquisition and alliances,
and have been increasing rapidly in biotechnology and medical device
fields in recent years. A recent study of 34 British medical equipment
manufacturers showed a significant amount of collaboration between
users and manufacturers and between small and large firms. A total
of 25 manufacturers were involved in joint prototype testing and
product evaluation and marketing, 19 manufacturers were involved in
joint prototype development and product marketing, and 13 manufac-
turers were involved in joint prototype specification and marketing.
I believe that the potential benefits to companies and to society of
various alliances between large and small firms are particularly prom-
ising in the field of medical devices. The evidence cited demonstrates
that the primary roles of firms differ greatly as a function of their size.
Younger, smaller firms offer technological innovations and display the
entrepreneurial drive and commitment needed to bring a new medical
device to initial use and early marketing. Large companies offer
different resources: money, manufacturing capability, well-organized
channels of distribution and field service, knowledge and experience
for dealing with regulatory issues, and the opportunity to integrate
multiple areas of technology. Large companies also contribute the
potential for well-organized incremental technological improvements
during growth and maturation of new medical technologies.
Explicit policy attention may be justified to strengthen beneficial
relationships between large and small medical device firms. Areas for
review might include the following: (1) the extent and criteria for
awarding funds from medical devices, such as the National Institutes
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TECHNOLOGICAL INNOVATION AND MEDICAL DEVICES
47
of Health's Small Business Innovation Research program; (2) tax
treatment of expenses incurred by firms in appropriate collaborative
research and development endeavors; and (3) federal funding of
innovation stages beyond research, such as product development and
research on market applications. Programs such as these exist in
several countries that are trying to foster competitive industrial inno-
vation. Additionally, strengthening ties between universities and large
and small companies may enhance the innovation of medical devices
alla, thereby, benefit society.
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Representative terms from entire chapter:
medical device
