Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework.

Introduction: Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices' development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices' development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards' requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations' compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products' chances of success.

Methods: A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.

Results: Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.

Discussion: A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.