The most important question for risk management: who is taking the risk?
Insights from a Let's Talk Risk! conversation with Dr. Adam Saltman
Note: this article highlights key insights gained from a conversation with Dr. Adam Saltman as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
Key takeaways
Risk is evaluated in the context of benefits: risk of a medical device should not be considered as an absolute concept. Rather, an important question to ask is “who is taking the risk?”. A physician’s view on risk1 is in the context of benefit-risk balance for an individual patient, having considered their health condition and expectations. ISO 14971 requires the overall residual risk of a medical device to be evaluated with respect to clinical benefits of its intended use. However, it leaves the benefit-risk judgment in a specific clinical situation out of scope for the manufacturer. It does not mean that individual patient perspectives are not important; rather we are expected to have a broader understanding of benefit-risk within the overall scope of the intended use for the target population. Physicians, on the other hand, should not assume that a certain device may be “too high a risk” for a patient without first understanding their perspective on benefit-risk. In this way, the physician serves as a facilitator in the decision making process for the benefit of their patients.
Regulators review clinical data as a proxy to evaluate benefit-risk: patient perspective is important, and FDA has several programs to gather patient perspectives to inform high level policy decisions. But when it comes to evaluating benefit-risk of individual medical devices, data from clinical trials or other sources such as clinical literature are used as a proxy. Direct patient input is generally not available at the review stage for a new or modified medical device. FDA has created several patient engagement advisory committees2 to seek expert advice on complex issues related to medical devices and their use by patients for regulatory decision making.
There is a disconnect between patients, manufacturers and regulators : patients are considered to be the most important stakeholders by medical device manufacturers and regulators. However, as noted above, patient perspectives are only indirectly represented through proxies. Many manufacturers do not have a dedicated medical safety officer role to represent the voice of the patient to inform key decisions. Risk management is still mainly driven from the engineering point of view3 with a focus on reducing the risk of failure. It is necessary but not sufficient. FDA has taken steps during the post-market phase to drive a more patient-centric view in risk assessments, especially in light of a safety related recall. However, the regulatory decision making during the pre-market phase is still based on proxies and not direct patient input. Industry stakeholders are beginning to realize this disconnect. As a result of this higher awareness, there is now an expectation of adequate clinical input during all phases of a device lifecycle.
Engage top management to gain buy-in for voice of the patient throughout device lifecycle: an interesting feature of the medical device industry is that patients don’t select or purchase the device even though they are taking the risk. It is not usual to see a patient ask for a pacemaker of a specific brand before surgery! As a result, device manufacturers generally consider healthcare providers to be their primary customers. They represent the voice of the patient for the manufacturer. But their role during design and development, generally speaking, is non-existent, or limited at best. Devices are developed based on many assumptions about user needs, which leads to surprises during the post-market phase when there are unanticipated safety issues or malfunctions. It is not uncommon to find top management taken by surprise when a recall decision has to be made. There are a lot of best practices and guidance available, but short-term industry pressures and incentive structure hinder their adoption. As risk practitioners, it is our responsibility to engage key decision makers early and get their buy-in for integrating physician input throughout the design and development process, and thereafter, during the post-market phase.
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 article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
Let’s Talk Risk! discussion: Understanding a physician’s view on risk
Let’s Talk Risk! discussion: Understanding the interface between clinical evaluation and risk management