Journal List > J Korean Med Assoc > v.61(12) > 1109397

Lee: Advanced medical devices and regulatory innovations in new health technology assessments


Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.


1. Cooksey D. A review of UK health research funding [Internet]. London: Her Majesty's Stationery Office;2006. cited 2018 Nov 13. Available from:
2. Park S. Analysis of policy on the adoption and diffusion of new healthcare technology [Internet]. Sejong: Korea Institute for Health and Social Affairs;2014. cited 2018 Nov 13. Available from:
3. Osler W, Bean RB, Bean BW. Sir William Osler: aphorisms from his bedside teachings and writings. New York: H. Schuman;1950.
4. Global Harmonization Task Force. Post-market clinical follow-up studies [Internet]. Canberra: International Medical Devices Regulators Forum;2010. cited 2018 Nov 13. Available from:
5. Global Harmonization Task Force. Medical devices post market surveillance: global guidance for adverse event reporting for medical devices [Internet]. Canberra: International Medical Devices Regulators Forum;2006. cited 2018 Nov 13. Available from:
6. Guyatt GH. Evidence-based medicine. ACP J Club. 1991; 114:A16.
7. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ. 1996; 312:71–72.
8. Centers for Medicare & Medicaid Services. Guidance for the public, industry, and CMS staff: coverage with evidence development [Internet]. Baltimore: Centers for Medicare & Medicaid Services;cited 2018 Nov 13. Available from:
9. Brugger U. A review of Coverage with Evidence Development (CED) in different countries: what works and what doesn't [Internet]. Quebec: Health Technology Assessment International;2014. cited 2018 Nov 13. Available from:
10. Brugger U, Horisberger B, Ruckstuhl A, Plessow R, Eichler K, Gratwohl A. Health technology assessment in Switzerland: a descriptive analysis of “Coverage with Evidence Development” decisions from 1996 to 2013. BMJ Open. 2015; 5:e007021.
11. Park EC. A study on the improvement of new health techno-logy assessment system for the early utilization of health technology and public safety [Internet]. Sejong: Ministry of Health;2016. cited 2018 Nov 13. Available from:

You Kyoung Lee

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