Roundtable Discussion: In Medical Device Risk Management, Patients Take On Increased Importance

The HTM Industry must continue to think outside the box and ask, “How do we contribute proactively to the healthcare ecosystem?” We really must expand our thought process in areas like operations, safety, strategic initiatives, finances, human capital, and technology advancements Similar to software quality assurance, we should proactively practice human factors engineering tools (e g , robust use risk analysis, expert reviews, virtual studies), have a robust postmarket surveillance program, and empower the industry to be creative in solutions but with adequacy argument using assurance case method For more than 20 years, ANSI/AAMI/ISO 14971, Medical devices — Application of risk management to medical devices, has been the global standard for assessing medical device risks, utilized by both manufacturers and regulatory authorities to prevent patient harm A new edition, published in late 2019, ensures that state-of-the-art practices are being employed and expands the role of risk management with respect to post-market surveillance and cybersecurity