Impact of regulations on innovation in the field of medical devices
Rosa Mayelin Guerra-Bretaña, Andrea Lucía Flórez-Rendón
Abstract
Introduction: The regulatory framework and standardized assay methods for classical biomaterials and implantable devices are harmonized at the international level, based on the risk assessment. However, innovative products need the development of more appropriate assay methods and streamline regulatory and scientific evaluation to encourage innovation and ensure more expedite delivery of novel, safe and effective innovative medical devices to patients. The aim of this work is to review the latest focus on the conflicting issues that are involved in the evaluation of recently developed biomaterials and medical devices. Methods: This paper is based on a review of the relevant academic literature regarding the field of medical devices over the last ten years (2008-2017). A systematic search was conducted in Medline data base for articles using “medical devices” + “regulations” + “innovation” in the title or abstract. Discussion: There is the widespread perception that research and marketing of innovative medical devices are moving swifter, even more so than the issues concerning evaluation methods and regulations. Collaboration among all the stakeholders could contribute to overcome the existing problems in medical device
innovation.
Keywords
References
Abbott Curry J, Goos S. Medical devices. In: Duvall MN. FDA regulation of nanotechnology. Washington: Food and Drug Administration; 2012. Chap. 8, p. 94-106.
Adami S, Ciampalini S, Dell’Aera M, Di Turi R, Ferrarese A, Messori A, Palozzo A, Polidori P, Romero M, Venturini F. Defining innovations of therapeutic interventions: a position paper by the Italian Society of Hospital Pharmacists. Int J Clin Pharm. 2012; 34(2):259-62. http://dx.doi.org/10.1007/s11096-012-9618-2. PMid:22382884.
Amato SF, Ezzell RM Jr. Regulatory affairs for biomaterials and mediunifiecal devices. Boston: Woodhead Publishing; 2014.
Asian Harmonization Working Party – AHWP. Playbook for implementation of medical device regulatory frameworks. AHWPTC/OB/R001:2014. Hong Kong: Asian Harmonization Working Party; 2014.
Bajaj P, Schweller RM, Khademhosseini A, West JL, Bashir R. 3D biofabrication strategies for tissue engineering and regenerative medicine. Annu Rev Biomed Eng. 2014; 16(1):247-6. http://dx.doi.org/10.1146/annurev-bioeng-071813-105155. PMid:24905875.
Basu S, Hassenplug JC. Patient access to medical devices — a comparison of U.S. and european review processes. N Engl J Med. 2012; 367(6):485-8. http://dx.doi.org/10.1056/NEJMp1204170. PMid:22852882.
innovation. Med Devices (Auckl). 2014; 13(7):205-9. http://dx.doi.org/10.2147/MDER.S43369. PMid:24966699.
Bonutti PM, Seyler TM, Bianco PD, Ulrich SD, Mont MA. Inventing in orthopaedics: from idea to marketed device. J Bone Joint Surg Am. 2008; 90(6):1385-92. http://dx.doi.org/10.2106/JBJS.G.01407. PMid:18519334.
Buenos Aires. Ministerio de Justicia y Derechos Humanos. Mercosur/GMC/Res. N° 40/00 Reglamento Técnico MERCOSUR de Registro de Productos Médicos (Derogacion de la Resolucion GMC Nº 37/96) [Internet]. Buenos Aires: Grupo Mercado Común; 2000 [cited 2018 Mar 9]. Available from: http://servicios.infoleg.gob.ar/infolegInternet/anexos/60000-64999/63755/norma.htm
Camp MW, Gross AE, McKneally MF. Patient views on financial relationships between surgeons and surgical device manufacturers. Can J Surg. 2015; 58(5):323-9. http://dx.doi.org/10.1503/cjs.000815. PMid:26384147.
Center for Devices and Radiological Health – CDRH. Innovation initiative. Silver Spring: Center for Devices and Radiological Health, U.S. Food and Drug Administration; 2011.
Chatterji AK, Fabrizio KR, Mitchell W, Schulman KA. Physician-industry cooperation in the medical device industry. Health Aff (Millwood). 2008; 27(6):532-43.
Chatterji AK. Spawned with a silver spoon? Entrepreneurial performance and innovation in the medical device industry. Strateg Manage J. 2009; 30(2):185-206. http://dx.doi.org/10.1002/smj.729.
Chen L, Wang C, Xi T. Regulation challenge of tissue engineering and regenerative medicine in China. Burns Trauma. 2013; 1(2):56-62. http://dx.doi.org/10.4103/2321-3868.118927. PMid:27574626.
Ciani O, Armeni P, Boscolo PR, Cavazza M, Jommi C, Tarricone R. De innovatione: the concept of innovation for medical technologies and its implications for health care policy-making. Health Policy Technol. 2016; 5(1):47-64. http://dx.doi.org/10.1016/j.hlpt.2015.10.005.
Courvoisier A. The future of academic innovation in the field of medical devices: is innovation still possible in orthopedics? Expert Rev Med Devices. 2016; 13(9):807-13. http://dx.doi.org/10.1080/17434440.2016.1219944. PMid:27484288.
Curfman GD, Redberg RF. Medical devices — balancing regulation and innovation. N Engl J Med. 2011; 365(11):975-7. http://dx.doi.org/10.1056/NEJMp1109094. PMid:21830959.
Davey SM, Brennan M, Meenan BJ, McAdam R. Innovation in the medical device sector: an open business model approach for high-tech small firms. Technol Anal Strateg Manage. 2011; 23(8):807-24. http://dx.doi.org/10.1080/09537325.2011.604152.
Erdman AG, Keefe DF, Schiestl R. Grand challenge: applying regulatory science and big data to improve medical device innovation. IEEE Trans Biomed Eng. 2013; 60(3):700-6. http://dx.doi.org/10.1109/TBME.2013.2244600. PMid:23380845.
European Commission. Working Group on new and emerging technologies in medical devices. Report on nanotechnology to the medical devices expert group, Findings and recommendations [Internet]. Brussels: European Commission; 2007a [cited 2018 Feb 21]. Available from: http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=4865
European Commission. Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC. and Regulation (EC) No 726/2004. Official Journal of the European Union [Internet], Brussels, 2007b [cited 2018 Feb 21]. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF
European Commission. Regulatory aspects of nanomaterials [Internet]. Brussels: European Commission; 2008 [cited 2018 Feb 21]. Available from: http://ec.europa.eu/nanotechnology/pdf/comm_2008_0366_en.pdf. Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee.
European Union. Council directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the member states relating to active implantable medical devices. Official Journal of the European Union [Internet], Brussels, 1990 [cited 2018 Feb 21]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF
European Union. Council directive 93/42/EEC of 14 June 1993 concerning medical device. Official Journal of the European Union [Internet], Brussels, 1993 [cited 2018 Feb 21]. Available from: http://eur-lex.europa.eu/ LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
European Union. Council directive Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of the European Union [Internet], Brussels, 1998 [cited 2018 Feb 21]. Available from: https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:31998L0079
European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union [Internet], Brussels, 2017a [cited 2018 Feb 21]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/? uri=CELEX%3A32017R0745
European Union. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union [Internet], Brussels, 2017b [cited 2018 Feb 21]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0746
European Union. Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council. Official Journal of the European Union [Internet], Brussels, 2017c [cited 2018 Feb 21]. Available from: https://eur-lex.europa.eu/eli/reg_impl/2017/2185/oj.
Fleming JJ. The decline of venture capital investment in early-stage life sciences poses a challenge to continued innovation. Health Aff (Millwood). 2015; 34(2):271-6. http://dx.doi.org/10.1377/hlthaff.2014.1051. PMid:25646107.
Food and Drug Administration – FDA. 21 CFR Part 820 - FDA Quality System Regulation. Silver Springs: FDA; 1997.
Food and Drug Administration – FDA. Priority review of pre-market submissions for devices: guidance for industry and food and drug administration staff [Internet]. Silver Springs: FDA; 2013 [cited 2018 Feb 21]. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089643.htm
Food and Drug Administration – FDA. Expedited access for premarket approval and de novo medical devices intended for unmet medical need for life threatening or irreversibly debilitating diseases or conditions [Internet]. USA: FDA; 2016a [cited 2018 Feb 21]. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf
Food and Drug Administration – FDA. Factors to consider when making benefit -risk determinations for medical device investigational device exemptions [Internet]. USA: FDA; 2016b [cited 2018 Feb 21]. Available from: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm451440.pdf
Gagliardi J. The global harmonization task force: what you need to know. Biomed Instrum Technol. 2009; 43(5):403-5. http://dx.doi.org/10.2345/0899-8205-43.5.403. PMid:19842776.
Gelberman RH, Samson D, Mirza SK, Callaghan JJ, Pellegrini VD Jr. Orthopaedic surgeons and the medical device industry: the threat to scientific integrity and the public trust. J Bone Joint Surg Am. 2010; 92(3):765-77. http://dx.doi.org/10.2106/JBJS.I.01164. PMid:20194337.
Global Harmonization Task Force – GHTF. Essential principles of safety and performance of medical devices. USA: GHTF; 2012. GHTF/SG1/N68:2012.
Gollaher DL, Goodall S. Competitiveness and regulation: the FDA and the future of America’s biomedical industry. La Jolla: California Health Care Institute; 2011.
Ho M, Saha A, McCleary KK, Levitan B, Christopher S, Zandlo K, Braithwaite RS, Hauber AB. A framework for incorporating patient preferences regarding benefits and risks into regulatory assessment of medical technologies. Value Health. 2016; 19(6):746-50. http://dx.doi.org/10.1016/j.jval.2016.02.019. PMid:27712701.
Howard JJ. Balancing innovation and medical device regulation: the case of modern metal-on-metal hip replacements. Med Devices (Auckl). 2016; 9:267-75. http://dx.doi.org/10.2147/MDER.S113067. PMid:27563260.
International Medical Device Regulators Forum – IMDRF. List of international standards recognized by IMDRF management committee members. USA: IMDRF Standards Working Group; 2014. IMDRF/Standards/N15FINAL:2014. Final Report.
International Medical Device Regulators Forum – IMDRF. Statement regarding use of ISO 14971:2007 “Medical devices - Application of risk management to medical devices”. USA: IMDRF Standards Working Group; 2015. IMDRF/MC/N34 FINAL:2015. Final Report.
International Organization for Standardization – ISO. ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good clinical practice. Geneva: ISO; 2011.
International Organization for Standardization – ISO. ISO 13485 Medical devices — Quality management systems -- Requirements for regulatory purposes. Geneva: ISO; 2016a.
International Organization for Standardization – ISO. ISO 16142:2016 Medical Devices – Recognized Essential Principles of Safety and Performance of Medical Devices – Part 1: General Essential Principles and Additional Specific Essential Principles for all non-IVD Medical Devices and Guidance on the Selection of Standards. Geneva: ISO; 2016b.
International Organization for Standardization – ISO. ISO/TR 10993-22 Biological evaluation of medical devices – Part 22: Guidance on nanomaterials. Geneva: ISO; 2017. Technical report.
Kramer D, Xu S, Kesselheim AS. Regulation of medical devices in the United States and European Union. N Engl J Med. 2012; 366(9):848-55. http://dx.doi.org/10.1056/NEJMhle1113918. PMid:22332952.
Krouse JH. Balancing evidence, innovation, and regulation. Otolaryngol Head Neck Surg. 2015; 152(4):579-80. http://dx.doi.org/10.1177/0194599815572798. PMid:25833920.
Krucoff M, Brindis RG, Hodgson PK, Mack MJ, Holmes DR Jr. Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective. JACC Cardiovasc Interv. 2012; 5(7):790-6. http://dx.doi.org/10.1016/j.jcin.2012.03.023. PMid:22814785.
Kunzmann A, Andersson B, Thurnherr T, Krug H, Scheynius A, Fadeel B. Toxicology of engineered nanomaterials: focus on biocompatibility, biodistribution and biodegradation. Biochim Biophys Acta. 2011; 1810(3):361-73. http://dx.doi.org/10.1016/j.bbagen.2010.04.007. PMid:20435096.
Lamph S. Regulation of medical devices outside the European Union. J R Soc Med. 2012; 105(S1):S12-21. http://dx.doi.org/10.1258/jrsm.2012.120037.
Lind KD. Implantable devices: regulatory framework and reform options. Vol. 130. Washington: AARP Public Policy Institute; 2017 [cited 2018 Feb 21]. Available from: https://www.aarp.org/content/dam/aarp/ppi/2017/08/implantable-devices-regulatory-framework-and-reform-options.pdf
Markiewicz K, van Til J, IJzerman M. Early assessment of medical devices in development for company decision making: an exploration of best practices. J Commer Biotechnol. 2017; 23(2):15-30. http://dx.doi.org/10.5912/jcb780.
Mokhtarzadeh M, Eydelman M, Chen E. Challenges and opportunities when developing devices for rare disease populations. Expert Opin Orphan Drugs. 2016; 4(5):457-9. http://dx.doi.org/10.1517/21678707.2016.1166948.
Neugebauer EAM, Rath A, Antoine SL, Eikermann M, Seidel D, Koenen C, Jacobs E, Pieper D, Laville M, Pitel S, Martinho C, Djurisic S, Demotes-Mainard J, Kubiak C, Bertele V, Jakobsen JC, Garattini S, Gluud C. Specific barriers to the conduct of randomised clinical trials on medical devices. Trials. 2017; 18(1):427. http://dx.doi.org/10.1186/s13063-017-2168-0. PMid:28903769.
Organization for Economic Cooperation and Development – OECD. Guidelines for collecting and interpreting innovation data — The Oslo Manual, 3rd ed. Paris: OECD; 2005.
Pane J, Coloma PM, Verhamme KM, Sturkenboom MC, Rebollo I. Evaluating the safety profile of non-active implantable medical devices compared with medicines. Drug Saf. 2017; 40(1):37-47. http://dx.doi.org/10.1007/s40264-016-0474-1. PMid:27928726.
Paradise J, Diliberto GM, Tisdale AW, Kokkoli E. Exploring emerging nanobiotechnology drugs and medical devices. Food Drug Law J. 2008; 407(2):417-20. PMid:18561467.
Pombo ML, Porrás A, Saidon PC, Cascio SM. Regulatory convergence and harmonization: barriers to effective use and adoption of common standards. Rev Panam Salud Publica. 2016; 39(5):217-25. PMid:27706409.
Rivera GP, Oberdorster G, Elder A, Puntes V, Parak WJ. Correlating physico-chemical with toxicological properties of nanoparticles: the present and the future. ACS Nano. 2010; 4(10):5527-31. http://dx.doi.org/10.1021/nn1025687. PMid:20973573.
Smieliauskas F. Conflicts of interest in medical technology markets: evidence from orthopedic surgery. Health Econ. 2016; 25(6):723-39. http://dx.doi.org/10.1002/hec.3177. PMid:25845858.
Stern AD. Innovation under regulatory uncertainty: evidence from medical technology. J Public Econ. 2017; 145:181-200. http://dx.doi.org/10.1016/j.jpubeco.2016.11.010. PMid:28652646.
Tarricone R, Boscolo PR, Armeni P. What type of clinical evidence is needed to assess medical devices? Eur Respir Rev. 2016; 25(141):259-65. http://dx.doi.org/10.1183/16000617.0016-2016. PMid:27581825.
Taylor PL. Innovation incentives or corrupt conflicts of interest? Moving beyond Jekyll and Hyde in regulating biomedical academic-industry relationships. Yale J Health Policy Law Ethics. 2013; 13(1):135-97. PMid:23815042.
Van Drongelen A, Hessels J, Geertsma R. Comparison of market authorization systems of medical devices in USA and Europe. Bilthoven: National Institute for Public Health and the Environment; 2015.
Van Haute A. Managing perceived conflicts of interest while ensuring the continued innovation of medical technology. J Vasc Surg. 2011; 54(3 Suppl):31S-3S. http://dx.doi.org/10.1016/j.jvs.2011.05.108. PMid:21872113.
Van Norman GA. Drugs, devices, and the FDA: Part 2. An overview of approval processes: FDA approval of medical devices. JACC Basic Transl Sci. 2016; 1(4):277-87. PMid:30167516.
Vijayavenkataraman S, Lu WF, Fuh JY. 3D bioprinting – an Ethical, Legal and Social Aspects (ELSA) framework. Bioprinting. 2016; 1-2:11-21. http://dx.doi.org/10.1016/j.bprint.2016.08.001.
Williams DF. Regulatory biocompatibility requirements for biomaterials used in regenerative medicine. J Mater Sci Mater Med. 2015; 26(2):89-90. http://dx.doi.org/10.1007/s10856-015-5421-7. PMid:25649511.
Williams DF. There is no such thing as a biocompatible material. Biomaterials. 2014; 35(38):10009-14. http://dx.doi.org/10.1016/j.biomaterials.2014.08.035. PMid:25263686.
Wizemann T. Public health effectiveness of the FDA 510(k) clearance process: balancing patient safety and innovation. Washington: The National Academies Press; 2010. Workshop report.
Zhang Z, Wang XJ. Current progresses of 3D bioprinting based tissue engineering. Quant Biol. 2017; 5(2):136-42. http://dx.doi.org/10.1007/s40484-017-0103-8.
Zuckerman D, Brown P, Nissen S. Medical device recalls and the FDA approval process. Arch Intern Med. 2011; 171(11):1006-11. http://dx.doi.org/10.1001/archinternmed.2011.30. PMid:21321283.
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