Risk Management in Medical Device Industry

Tushar Khinvasara *

Starkey Hearing Technology, United States of America.

Stephanie Ness

Diplomatische Akademie, Austria.

Nikolaos Tzenios

Public Health and Medical Research, Charisma University, Grace Bay, Turks and Caicos Islands.

*Author to whom correspondence should be addressed.


In spite of the fact that risk management has developed into an essential component of the process of developing medical devices, as mandated by both domestic and international regulations and standards, there is still no all-encompassing model that describes how risk management in the development of medical devices ought to be approached, particularly in terms of the types of risks that ought to be addressed. This is due to the fact that risk management has developed into an essential component of the process, which is mandated by both domestic and international regulations and standards. The present focus of risk management in the industry of developing medical devices is on technical risks, such as product, usability, and development process hazards. This is done in compliance with the norms and laws of standards. On the other hand,  non-technical risks, such as those associated with businesses and projects, are not given  nearly enough consideration. This review focuses on the risk management in medical device industry.

Keywords: Risk management, medical devices, medical device industry, risk management steps

How to Cite

Khinvasara, T., Ness, S., & Tzenios, N. (2023). Risk Management in Medical Device Industry. Journal of Engineering Research and Reports, 25(8), 130–140. https://doi.org/10.9734/jerr/2023/v25i8965


Download data is not yet available.


Kheir O, Jacoby A, Verwulgen S. Success factors impacting nowadays technologically driven medical devices. in Advances in Manufacturing, Production Management and Process Control: Proceedings of the AHFE 2020 Virtual Conferences on Human Aspects of Advanced Manufacturing. Advanced Production Management and Process Control, and Additive Manufacturing. Modeling Systems and 3D Prototyping. USA. Springer. 2020;16–20.

Sametinger J, et al. Security challenges for medical devices. Communications of the ACM. 2015;58(4):74-82.

Thirumalai S, Sinha KK. Product recalls in the medical device industry: An empirical exploration of the sources and financial consequences. Management Science. 2011;57(2):376-392.

Medina LA, Wysk RA, Kremer GEO. A review of success factors in NPD: Medical device domain. in IIE Annual Conference. Proceedings. Institute of Industrial and Systems Engineers (IISE); 2011.

Gray CF, Larson EW, Desai GV. Project management: The managerial process. McGraw-Hill/Irwin New York. 2008;97.

Galli BJ. The effective approach of managing risk in new product development (NPD). International Journal of Applied Management Sciences and Engineering (IJAMSE). 2017;4(2):27-40.

Kayis B, et al. Development of an Intelligent Risk management system for minimising problems in new product development; 2004.

Jaafari A. Management of risks, uncertainties and opportunities on projects: Time for a fundamental shift. International journal of project management. 2001;19(2):89-101.

Mobey A, Parker D. Risk evaluation and its importance to project implementation. Work study. 2002;51(4):202-208.

Carvalho MMD, Rabechini Junior R. Impact of risk management on project performance: The importance of soft skills. International journal of production research. 2015;53(2):321-340.

Regulation (EU) /… of the European parliament and of the council 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; 2017.

ISO 14971: Medical devices - Application of risk management to medical devices; 2007

FDA. Manufacturer and User Facility Device Experience database.


IEC TR. 62380: Reliability data handbook – Universal model for reliability prediction of electronics components, PCBs and equipment; 2004.

Siemens SN. 29500 Failure rates of components.

Handbook of Reliability Prediction Procedures for Mechanical Equipment NSWC-11.

IEC 62304: (Ed 1.1) Medical device software – Software life cycle processes; 2015.

ISO 26262: Road Vehicles - Functional safety; 2018.

DO-330/ED-215 Software Tools Qualification Considerations.

GHTF/SG1/N41 Essential principles of safety and performance of medical devices; 2005.

ISO/TR 24971: Medical devices — Guidance on the application of ISO 14971; 2013.

Green PE. Enterprise risk management: A common framework for the entire organization; 2015: Butterworth-Heinemann.

Smith PG, Merritt GM. Proactive risk management: Controlling uncertainty in product development; 2020: CRC Press.

Guerra-Bretaña RM, Meizoso-Valdés MC. La gestión integrada de la calidad y los riesgos. bases para la efectividad y seguridad de las tecnologías médicas. Memorias Convención Internacional deSalud Pública. Cuba Salud 2012. La Habana 3-7 de diciembre de; 2012. ISBN 978-959-212-811-8.

CCEEM. Reglamento para la Evaluación y el Control Estatal de Equipos Médicos. Gaceta Oficial 1424-36. Cuba.

ANVISA RDC n 185/ Registro de produtos médicos. Brasil; 2001.

ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes; 2016.

ANVISA RDC nº 16 Boas Práticas de Fabricação. de 28 de março de; 2013. Brasil.

ISO 14971: Medical devices—Application of risk management to medical devices; 2007.

Kandalam U, Bouvier AJ, Casas SB, et al. Novel bone adhesives: A comparison of bond strengths in vitro. Int J Oral MaxillofSurg. 2013;42:1054-9.

De Sena LA, De Almeida MS, De Oliveira Fernandes GV, et al. Biocompatibility of wollastonite-poly(N-butyl-2-cyanoacrylate) composites. J Biomed Mat Res Part B: Appl Biomat. 2014;102(6):1121-9.

De Sena LA, Guerra-Bretaña RM, De Almeida MS, et al. Functionality of wollastonite/n-butyl-2-cyanoacrylate bone adhesives: Bond strength in vitro. XIV Braz Mat Res Soc RJ; 2015.

Mattheis S, et al. Transoral robotic surgery for head and neck tumors: A series of 17 patients [in German]. Laryngorhinootologie. 2012;91.

Money AG, et al. The role of the user within the medical device design and development process: Medical device manufacturers’ perspectives. BMC Med Inform Decis Mak. 2011;11.

Resnic FS, Normand SL. Postmarketing surveillance of medical devices—filling in the gaps. N Engl J Med. 2012;366.

Bohnet-Joschko S, Jandeck LM. Success through Innovation: The Innovation Management of the German Medical Technology Industry [in German]. Berlin; 2011.

Lüthje C. Customers as co-inventors: An empirical analysis of the antecedents of customer-driven innovations in the field of medical equipment. Paper presented at: Proceedings of the 32nd EMAC Conference; Glasgow; 2003.

DIN EN ISO 14971:2013-04. Medical devices—Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01).

European Commission. Classification of medical devices (MEDDEV 2.4/1 Rev. 9); 2010.

Lettl C, Hienerth C, Gemünden HG. Exploring how lead users develop radical innovation: Opportunity recognition and exploitation in the field of medical equipment technology. IEEE Trans Eng Manage. 2008;55.

Lourenco T, et al. A framework for the evaluation of new interventional procedures. Health Policy. 2012;104.

Hegde V, Konakanchi K. Case study—post market product monitoring system. IEEE: Annual Proceedings of the Reliability and Maintainability Symposium. IEEE; 2011.

Feußner H. Spinal Cord Lesion Following Ostheosynthesis of the Cervical Spine [in German]. 6 Medizintechnik- und Ergonomiekongress. Münster; 2011.

2003/361/EG: Commission recommenda-tion of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises. Brussels: European Commission; 2003.

Directive 93/42/EEC of 14 June 1993 concerning medical devices, as last amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007. Brussels: European Commission; 2007.

Beydon L, Ledenmat PY, Soltner C. Adverse events with medical devices in anesthesia and intensive care unit patients recorded in the French safety database in 2005-2006. Anesthesiology. 2010;112.

Bohnet-Joschko S, et al. Clinical risk management in German hospitals-does size really matter?. [in German]. Z Orthop Unfall. 2011;149.

Bohnet-Joschko S, Kientzler F. Medical doctors driving technological innovation: Questions about and innovation management approaches to incentive structures for lead users [in German]. Z Evid Fortbild Qual Gesundhwes. 2010;104.

Cassidy CJ, Smith A, Arnot-Smith J. Critical incident reports concerning anaesthetic equipment: Analysis of the UK National Reporting and Learning System (NRLS) data from 2006-2008. Anaesthesia. 2011;66.

Hauser RG. Here we go again-another failure of postmarketing device surveillance. N Engl J Med. 2012;366.

Khan W, Farah S, Domb AJ. Drug eluting stents: Developments and current status. J Control Release. 2012; 161.

Kramer DB, et al. Postmarket surveillance of medical devices: A comparison of strategies in the US, EU, Japan, and China. PLoS medicine. 2013;10.

Lauer W, et al. Early detection of risks: Challenges and approaches for BfArM’s tasks in medical device vigilance [in German]. Gesundh ökon Qual manag. 2016;21.

Lauer W, et al. Medical devices: Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application [in German]. Bundesgesundheitsblatt Gesundheitsfor-schung Gesundheitsschutz. 2014;57.

Siekmeier R, Wetzel D. Market surveillance of in vitro diagnostics by the BfArM until end 2010: How safe are products for tumor diagnostics?. Adv Exp Med Biol. 2013;755.

Smith BD, Tarricone R, Vella V. The role of product life cycle in medical technology innovation. J Med Marketing. 2013;13.

Zippel C, Bohnet-Joschko S. What happens in postmarket surveillance-results of a cross sectional study among German medical device manufacturers. Biomed Tech (Berl). 2015;60.

Zippel C, et al. Many critical incidents could be avoided by preanaesthesia equipment checks: lessons for high reliability organisations. Eur J Anaesthesiol. 2014;31.

Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med. 2011;171.