In this episode, Adam Saltman reminds us to not consider risk as an absolute concept; rather think about it in the context of the end user or the patient who is being asked to take the risk in return for a benefit to their health.
There is a disconnect in the medical device industry between patients, manufacturers and regulators. By considering the question “who is taking the risk?”, we can stay focused on the end user or patients as we build and launch medical devices.
About Dr. Adam Saltman
Dr. Adam Saltman started his career as a clinician practicing heart surgery for about 20 years. Later he joined the US FDA as a medical officer where he developed policy frameworks on post-market benefit-risk considerations and patient perspectives. Most recently he served as the Chief Medical and Regulatory Officer in the medical device industry. Currently, he is a Principal Strategy Consultant at NAMSA, the industry leader in offering coordinated medical device product development consulting activities under one roof to achieve accelerated outcomes. He has published more than 100 peer-reviewed articles, served on editorial boards, conducted competitively funded research projects, completed advanced training in Health Informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR14: The most important question for risk management: who is taking the risk?