Insights from 5 recent Let's Talk Risk! conversations: Apr-May 2023

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. FMEAs are useful but not sufficient for analyzing safety risks of medical devices

A dominant practice in the medical device industry is to use a Failure Mode and Effects Analysis (FMEA) for analyzing safety-related risks. When used correctly, an FMEA is a highly effective technique for identifying and implementing appropriate control measures to improve product quality and reliability.

However, often it is the only technique used for risk analysis in the industry. The main problem with this approach is that system level hazards and hazardous situations cannot be easily linked to individual failure modes identified in an FMEA. Further, harm can occur even when a medical device is operating in the normal mode.

A side effect of this practice is confusion between risks of failure and risks of harm to the patients or users. Excessive use of an FMEA to the point of excluding other more appropriate techniques for hazard analysis turns this into mostly a paper exercise!

Roger Hill, shares some of the challenges in overusing FMEAs and offers a few best practices in this Let’s Talk Risk! discussion. Listen to the full audio recording of our conversation embedded in this article.

Best practices for using FMEAs for medical devices

2. Engineers and clinicians both care about safety but they look at risk differently

Generally speaking, industry practice of risk management is driven by an engineering approach, which focuses primarily on risks arising from potential device failures. Clinical input is often absent during the early phase of risk identification, which tends to underestimate the potential impact of clinical risks associated with the medical procedure itself.

EU-MDR, the European medical device regulation now in effect, emphasizes the need to align the risk management system with the clinical evaluation process so that all relevant clinical risks are adequately addressed. However, there is a lot of confusion in the industry about the interface between clinical evaluation and risk management.

Alexej Agibalow highlights the need for a close collaboration between engineers and clinicians throughout the design and development process. Planning for the clinical evaluation, including synchronizing different activities during the post-market phase is essential. Listen to the full audio recording of our Let’s Talk Risk! conversation embedded in this article.

Understanding the interface between clinical evaluation and risk management

3. Lab-based diagnostic devices need a different approach to risk management

In-vitro diagnostics (IVDs) devices are used to perform specific tests on blood and tissue samples taken from the human body to detect diseases or other conditions. IVD-related risks to patient safety are considered to be indirect risks, because they are often characterized by extended sequence of events that involve “competent intermediaries” such as trained users who is the IVD medical devices and clinicians who rely on the examination results to make patient management decisions.

That is why you need a slightly different approach to analyzing safety-related risks associated with IVD medical devices. Annex H in ISO/TR 24971² provides useful guidance for IVD risk management.

Shree Koushik emphasizes the need to adequately identify user needs for an IVD and integrate them correctly through design inputs in the design and development process. This is a significant gap in the IVD industry, which often results in missing design inputs. Listen to the full audio recording of our Let’s Talk Risk! conversation embedded in this article.

Risk management of IVDs requires a different approach

4. Risk-based auditing focuses on high-risk processes of a quality system

Manufacturers of medical devices have to routinely go through many audits and regulatory inspections to maintain regulatory compliance. A culture of compliance prevails in the industry, rather than that of quality, because manufacturers are afraid that they would be found non-compliant during regulatory inspections.

Regulatory authorities across the world are recognizing this issue and a new approach to auditing quality management systems is now gaining momentum in the industry. Instead of the old checklist-based approach, auditors are now using a risk-based approach, which focuses on evaluating the effectiveness of on high-risk process of a quality system. Generally speaking, most medical device companies would have 6-10 high-risk processes such as risk management, design control, production process, clinical evaluation and post-market surveillance.

This new way of auditing is not a linear process. It requires a systematic process-based approach. It is like examining a weave with a complex pattern, looking at various strands to figure out their connectivity, and to see if there might be a crack that could compromise the whole pattern! It needs a different approach to audit preparation and audit management.

Rick Rios shares practical tips based on many years of auditing experience in this Let’s Talk Risk! conversation. Listen to the full audio recording of our conversation embedded in this article.

Tips for a risk-based approach to auditing Quality Systems

5. Risk management requires a more holistic view of risk, not just limited to safety

In the medical device and pharma industries, risk is generally associated with harm to patients. Regulatory agencies expect the benefits of a medical product to outweigh the risks associated with its use before it can be considered as safe and effective. As a result, the dominant view of risk in the medical device world is that risk needs to be controlled and minimized for patient safety and regulatory compliance.

In the business context, it helps to look at risk management in a more holistic way. Safety is important, but not the only objective for risk management. As practitioners of safety risk management, we should be aware of the practical reality that understanding of technical details of safety risks decrease as we go up the management chain. There is always tension and competition among different business objectives. It is our role to collect, analyze and present information in a holistic to facilitate business decisions that do not undermine safety and reliability.

In this Let’s Tal Risk! conversation, Jayet Moon and Arun Mathew share some of the real world challenges in risk management and offer a few best practices. Listen to the full audio recording of our conversation embedded in this article.

Safety is important, but not the only objective for risk management

1. Connect with Dr. Naveen Agarwal on LinkedIn to be notified of announcements of the weekly Let’s Talk Risk! events.

2. ISO/TR 24971:2020: Medical devices - Guidance on the application of ISO 14971.