J Korean Med Assoc.  2014 Nov;57(11):919-926. 10.5124/jkma.2014.57.11.919.

Medical technology development and globalization: the role of the medical device industry

• Lee SS

• KMID: 1958392
• DOI: http://doi.org/10.5124/jkma.2014.57.11.919

Abstract

Modern medical technology aligns with medical device advancement, and new medical devices create the need for new procedure techniques. Unmet needs that physicians experience in clinical practice suggest solutions to problems; to solve these, collaboration between medical device manufacturers and physicians becomes a starting point for new medical device development. Commercialization of medical devices is greatly impacted by the product regulatory approval system, health technology assessment, and reimbursement system. Speed to market plays a far greater role in the medical device market than in the pharmaceutical market. Considering the current trend of evidence-based medicine and value-based pricing, efforts to generate clinical evidence should be strengthened even further while a greater focus should be placed on efforts to introduce global multicenter pre-market clinical trials in the Republic of Korea through strong collaboration with global companies. Since the strength and quality of clinical evidence is comparatively low in medical device studies, this could affect the decision making process and raise the issue of uncertainty. To overcome this issue, a risk-sharing system in the medical device field and 'coverage with evidence development' should be introduced; by doing so, evidence generation opportunities can be created without burying innovative technology and solving the issue of uncertain decisions. In addition, reimbursement coverage to support the costs of clinical studies needs to be established for early evidence generation, as seen in other countries.

Keyword

Medical device; Patient access; Evidence; Clinical study; Risk sharing

MeSH Terms

Biomedical Technology
Cooperative Behavior
Decision Making
Evidence-Based Medicine
Internationality*
Republic of Korea
Uncertainty

Figure

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  Figure 1 Total product life cycle (From US Food and Drug Administration. Medical device innovation initiative white paper: CDRH Innovation Initiative [Internet]. Silver Spring: US Food and Drug Administration; 2011) [5].

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  Figure 2 Medical device development pathway from discovery and ideation to product launch and post market monitoring (From US Food and Drug Administration. Medical device innovation initiative white paper: CDRH Innovation Initiative [Internet]. Silver Spring: US Food and Drug Administration; 2011)[5].

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