Insights from 5 recent Let's Talk Risk! conversations
Catch up on recent conversations you may have missed.
Note: Each week, we talk to risk practitioners and thought leaders in a live LinkedIn audio event1. These are very casual and informal conversations about practical challenges and best practices for risk management of medical devices. Key highlights are published each week on Saturdays. Here are highlights from 5 recent Let’s Talk Risk! conversations you may have missed.
1. Safety cannot happen as an afterthought. It needs to be designed in.
Serious safety-related recalls are common in the medical device industry. It is not unusual to hear about a Class I recall2 due to device related issues which seem reasonably preventable in hindsight. The issue is not that engineers are failing to design safe products. Rather, the design and development process in the industry is mostly focused on clearing the regulatory hurdle of “safe and effective” as quickly as possible to gain marketing approval and launch the product. Safety and reliability are not “designed in”; they are simply tested to ensure that certain minimum requirements are fulfilled for regulatory purposes. As a result, many unanticipated failures are identified during the post-market phase when a medical device is operating in a complex use-environment in the hands of different users.
System safety can help identify safety-critical requirements in the early phase of design and development. This approach can help engineers anticipate system level hazards and identify design solutions to mitigate the risk.
Jon Ward, Senior Manager of Risk Management and Patient Safety at Abbott, talks about system safety in this conversation.
2. Critical thinking helps keep Quality simple.
A compliance-focused approach to computer system validation (CSV) has resulted in a heavy burden of software testing and documentation even in applications that do not directly impact product quality or patient safety. The term Quality has become synonymous with Compliance. As a result, we are not applying a risk-based approach to computer system assurance (CSA), which slows down adoption of new technologies in the medical device industry.
Regulatory authorities are promoting a risk-based approach3 to software testing and appropriately adjusting the extent and formality of testing required to ensure product quality and patient safety. The focus is on Quality, and not on testing for the sake of testing and documentation.
Kieran McKeever shares his insights on applying critical thinking in this conversation, and how it can help us keep Quality simple by focusing on what matters the most.
3. FDA is open to having a risk-based conversation in regulatory decision-making.
Whether you are seeking approval to market a new medical device, or addressing concerns about a currently marketed product, it helps to be aware of how FDA factors in risk when making regulatory decisions.
Based on his experience with both the FDA and the industry, Steve Silverman recommends that you consider risk across all phases of the device lifecycle. Consideration of risk is central to effective implementation of Design Controls during design and development. In the post-market phase, you need to monitor complaints to make sure device performance and estimated level or risk continue to meet baseline expectations. FDA’s expectations of risk are factored in throughout the Quality System Regulation (QSR), which forms the basis of concerns and observations during inspections. FDA does not consider risk as a separate entity.
Make sure to understand the rationale when concerns related to risk are raised in the context of QSR. In case of a disagreement that cannot be resolved during an inspection, it is perfectly legitimate to request a supervisory level discussion while maintaining full transparency with the FDA investigator.
4. Risk is about uncertainty. It helps to think about it in a probabilistic way.
As individuals, we make thousands of decisions on a daily basis using heuristic-based thinking, following rules of thumb we have learned through experience. But, when it comes to formal risk-management of medical devices, a rule-based heuristic thinking can lead to bias and errors in judgment.
Engineers prefer to think in terms of cause and effect. They use a model-based approach to relate inputs to outputs so they can make predictions about how a system is likely to behave. This model-based deterministic approach to risk is useful, but not sufficient to consider all possible unforeseen scenarios.
Eric Maass recommends combining a probability-based approach to the model-based engineering approach in this conversation.
5. Risk-based thinking leads to optimal and defensible business decisions.
Risk-based thinking is really a process of decision making, which involves a careful consideration of risks in the context of anticipated benefits.
As Bijan Elahi explains in this conversation, business decisions related to medical devices have legal consequences. Medical devices are subject to strict regulatory requirements to make sure they continue to remain safe and effective. When we use a risk-based approach to decision making, our decisions are based on a careful balancing of benefits and risks applicable to all stakeholders including patients, healthcare providers and regulators. These decisions are more likely to both optimal and legally defensible.
Connect with Dr. Naveen Agarwal on LinkedIn to be notified of announcements of the weekly Let’s Talk Risk! events.
FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequence or death.
See for example, FDA guidance document General Principles of Software Validation
Thank you so much for summarizing the recent talks, helped a lot to learn about the models to approach. To learn in detail, did you publish any article related to Risk based approach proceedings in DhF remediation, PMS ?