Think of post-market surveillance as a value adding business process

Insights from a Let's Talk Risk! conversation with Per Maegaard

Note: this article highlights key insights gained from a conversation with Per Maegaard as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.

We often think of the post-market surveillance (PMS) process as a regulatory requirement for medical devices, especially because of the revised EU-MDR (and IVDR) regulations now in effect in the European Union. It is true that global regulatory authorities are increasingly more sensitive to ensuring continued safety and effectiveness of medical devices throughout their lifecycle in the market. Extensive requirements for post-market surveillance in EU-MDR is an indication of the emerging regulatory expectations for the post-market phase of medical devices¹.

But there is more to PMS than just complaints gathering and adverse events reporting, says Per Maegaard in this Let’s Talk Risk! conversation.

PMS is not just an exercise in meeting regulatory requirements, but intelligence gathering that can help other functions including Marketing. We should think of the PMS process as a value-adding business process, which can provide insights about the real-world clinical experience with our medical device.

Medical device manufacturers are still trying to figure out how best to comply with regulatory requirements, especially because there are significant differences in how notified bodies are interpreting these requirements. Per Maegaard points out that TUV-SUD in particular, is quite aggressive in their interpretation of PMS requirements, and they are expecting more active surveillance methods beyond just complaints trending and monitoring.

As a result, post-market surveillance is turning out to be a significant challenge for medical device manufacturers. It is not a light task; manufacturers need to plan ahead and allocate sufficient resources to create an efficient process that would not only meet regulatory requirements, but also to deliver business results.

Here are a few key points that emerged from our discussion:

1. Think of it as a business process: we need to think of post-market surveillance (PMS) as a business process, not a check-the-box, paper exercise. In this new, more aggressive regulatory environment, we have to manage the expectations of notified bodies, customers, patients, healthcare providers, and our own internal stakeholders. The PMS process is central to managing these expectations effectively.

2. Build a strong link with your clinical operation: current industry practice is to manage the PMS process through the Quality function, generally as an additional responsibility of the Complaints Handling unit. The Clinical Operations team is generally responsible for the required clinical evaluations and other regulatory reporting such as the post-market surveillance reports and periodic safety update reports under EU-MDR. Linking clinical evaluation to risk management is now more critical than ever to achieve efficiency and scale, especially when you are managing a diverse product portfolio.

3. Plan to allocate adequate resources in the post-market phase: generally speaking, the post-market phase of the lifecycle of a medical device is considered to be maintenance only, with a heavy focus on regulatory compliance. In this new environment, it is critical to plan for adequate cross-functional resources to be available to ensure continued safety and effectiveness of a medical device. In particular, it is very important to ensure that clinical/medical and technical experts are available to understand emerging safety risks and to take appropriate timely action, including changes in product/process design.

4. Passive monitoring of complaints data is no longer sufficient: clause 10.1 of ISO 14971 requires manufacturers to establish, document and maintain a system to actively collect and review safety-related post-market information for a medical device. Simply trending and monitoring of complaints data is no longer sufficient. Early signal detection and timely risk-reduction is the main goal of an effective PMS process. It is very important to consider all appropriate data sources² and analytical techniques to achieve this goal.

5. Create and nurture a patient safety culture: in the end, post-market surveillance is all about patient-safety. We have to shift our focus from simply complying with regulations to truly serving our patients, healthcare providers and caregivers. This requires us to create and nurture a patient-focused culture. Generally speaking, we do a good job in product development, but we move on too quickly to the next new product without planning for adequate support to sustain our existing products during the post-market phase. It is not uncommon to see senior executives surprised when they are confronted with a warning letter or a safety-related recall. It does not have to be this way. When we maintain a strong focus on patient safety in all operations, including post-market surveillance, we not only comply with regulations but we also win in the marketplace through better, safer products.

About Per Maegaard

Per Maegaard is currently Director and Lead Auditor at MQC, providing quality consulting, process optimization and auditing services to clients in the medical industry. He has 20+ years of professional experience in Quality and Post-Market Safety and Surveillance at leading multi-national companies such as Stryker, Smith & Nephew and Coloplast. As Director of Post Market Safety at Stryker’s Trauma/Extremity division in Europe, he was responsible for establishing a post-market surveillance program to comply with EU-MDR.

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.

1. See Articles 83-86 in Section I of Chapter VII in the EU-MDR for post-market surveillance requirements.

2. See IMDR guidance document “Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes”.