In the advanced medical field, there is a constant need for efficient guidance formulation by regulators. Technology forecasting as a surveillance for regulation needs may be an effective solution by notifying regulatory authorities of the possible future changes in regulations. However, the lack of tangible frameworks has made the relationship between technology forecasting and regulation difficult to comprehend, and has led to an under-analyzed state of how technology forecasts are implemented into the guidance formulation process. In this study, we introduce a framework built specifically for facilitating the comprehension of the relationship between technologies enlisted in technology forecasting and guidances formulated after the forecasting, and applied the framework to a case of technology forecasting conducted by regulatory authorities in Japan. Four patterns of the relationships between a technology forecasting conducted by regulators and the guidances developed after the forecast are identified. The results and discussions provide suggestions of technology forecast design and application in the guidance formulation process by regulators in the field of medical devices.
Deloitte. 2016 Global life sciences outlook: moving forward with cautious optimism. 2016.
Hamburg MA. Shattuck lecture. Innovation, regulation, and the FDA. N Engl J Med. 2010;363(23):2228–2232.
FDA. Innovation or stagnation? Challenge and opportunity on the critical path to new medical products. Department of Health and Human Services; US Food and Drug Administration, Center for Biologics Evaluation and Research, 2004.
Advancing regulatory science for public health—a framework for FDA’s regulatory science initiative. Department of Health and Human Services; US Food and Drug Administration, Office of the Commissioner; Office of the Chief Scientist, 2010.
European Medicines Agency. Advanced therapies—guidances relevant for advanced-therapy medicinal products. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000298.jsp&mid=WC0b01ac05800862bd. Accessed December 21, 2015.
Anderson J. Technology foresight for competitive advantage. Long Range Plann. 1997;30(5):665–677.
Warnke P, Heimeriks G. Technology Foresight as Innovation Policy Instrument: Learning from Science and Technology Studies. Berlin: Springer, 2008.
Science and Technology Foresight Center, National Institute of Science and Technology Policy (NISTEP). The 9th Science and Technology Foresight—Contribution of Science and Technology to Future Society. 2010. http://data.nistep.go.jp/dspace/bitstream/11035/693/3/NISTEP-NR140-SummaryE.pdf.
Science and Technology Foresight Center, National Institute of Science and Technology Policy (NISTEP). The 10th Science and Technology Foresight: Future Perspectives on Science and Technology by Field. 2015. http://data.nistep.go.jp/dspace/handle/11035/3080.
Wild C, Langer T. Emerging health technologies: informing and supporting health policy early. Health Policy 2008;87(2):160–171.
Blind K. New Products and Services: Analysis of Regulations Shaping New Markets: Final Report. European Commission, Directorate-General for Enterprise; Fraunhofer Institute for Systems and Innovation Research. Luxembourg: EUR-OP, 2004.
Herman WA, Marlowe DE, Rudolph H. Future trends in medical device technology: results of an expert survey. 1998. www.fda.gov/cdrh/ost/trends/toc.html. Accessed September 25, 2008.
Herman W, Devey G. Future trends in medical device technologies. 2008.
Regulatory science in FDA’s Center for Devices and Radiological Health: a vital framework for protecting and promoting public health. www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM274162.pdf. Accessed June 6, 2017.
Sunagawa Team (MHLW), and Prioritization Committee for Next Generation of Medical Device (METI). Tentative prioritization results of future medical device [in Japanese]. http://www.jfmda.gr.jp/metis/002/pdf/02_02_01.pdf.
Medical Engineering Technology Industrial Strategy Consortium (METIS). Medical Device Regulatory Science Guidebook. 2012. http://www.jfmda.gr.jp/metis/guidebook/pdf/120801/120801_01.pdf. Accessed December 30, 2015.
Yokoo Y. Does sciences & technologies forecasted in past forecast survey are realized [in Japanese]? Sci Technol Trends. 2010;23–32.
Blind K. Regulatory foresight: methodologies and selected applications. Technol Forecast Soc Chang. 2008;75:496–516.
The Global Harmonization Task Force. Principles of medical devices classification. GHTF/SG1/N15, 2006. http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n15-2006-guidance-classification-060627.pdf (accessed June 10, 2016).
US Food and Drug Administration. Classify your medical device — device classification panels. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm. Accessed December 30, 2015.
Robert G, Stevens A, Gabbay J., “Early warning systems” for identifying new healthcare technologies. Health Technol Assess. 1999;3(13):1–108.
Pound R. Classification of law. Harv Law Rev. 1924;37(8):933.
Mulder LB, Jordan J, Rink F. The effect of specific and general rules on ethical decisions. Organ Behav Hum Decis Process. 2015;126:115–129.
Mahoney PG, Sanchirico CW. General and specific legal rules. J Institutional Theor Econ. 2005;161(2).
Engel C. General and specific rules: comment. J Institutional Theor Econ. 22nd International Seminar on the New Institutional Economics Game Theory and the Law, vol. 161, no. 2, 2005.
Next generation artificial heart. PFSB/ELD/OMDE (Yakushokuki) Notification no. 0404002, 2008. http://dmd.nihs.go.jp/jisedai/tsuuchi/H20.4.4薬食機040402.pdf. Accessed June 16, 2017.
Nerve function repair devices. PFSB/ELD/OMDE (Yakushokuki) Notification 1215 no. 1, 2010. http://dmd.nihs.go.jp/jisedai/tsuuchi/H22.12.15薬食機1215第1.pdf. Accessed June 16, 2017.
Genotyping diagnostics using DNA microarray. PFSB/ELD/OMDE (Yakushokuki) Notification no. 0404002, 2008. http://dmd.nihs.go.jp/jisedai/tsuuchi/H20.4.4薬食機040402.pdf. Accessed June 16, 2017.
Articular cartilage regeneration. PFSB/ELD/OMDE (Yakushokuki) Notification 1215 no. 1, 2010. http://dmd.nihs.go.jp/jisedai/tsuuchi/H22.12.15薬食機1215第1.pdf. Accessed June 16, 2017.
Guidance projects for the evaluation of emerging technology medical devices, regenerative medicine products evaluation, regenerative medicine review working group 2009 report. Regenerative Medicine Review Working Group. http://dmd.nihs.go.jp/jisedai/saisei/H27_saisei.pdf. Accessed June 16, 2017.
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Itoh, S., Kano, S. Technology Forecasting for Medical Devices Guidance Formulation: A Case Study in Japan. Ther Innov Regul Sci 53, 481–489 (2019). https://doi.org/10.1177/2168479018793370
- technology forecasting
- medical device