It’s another beautiful day to be working in the medical device industry!
With the rapidly evolving regulations, it is possibly the most exciting time to be associated with this industry.
Most of us, including me, have been obsessing over the EU medical device regulations (MDR) and closely monitoring updates over the past months. As we head into the implementation phase of the MDR with a tight timeline and see all our planning materialize, it’s important now, more than ever, to get together at summits and conferences to exchange ideas and effectively move forward.
I had the privilege of virtually attending the EU MedTech Summit last week (12 Oct -16 Oct). The summit saw a wide range of speakers, including representatives from contract research organizations (CROs), with vast experience in dealing with a variety of medical devices and experimenting with different strategies; device manufacturers, with in-depth specialized experience in their specific domains; and notified body representatives, who’ve seen it all. These experienced professionals expressed their views on the recent changes in the field of medical devices, particularly focusing on the MDR (for the most part, or at least that’s what drew my attention the most).
Various topics under the following streams were discussed: biocompatibility for medical devices, clinical evaluations and investigations, drug device combination products, EU in vitro diagnostic medical device regulation (IVDR) and strategy, EU medical device law, EU medical device regulation, medical device regulations in global markets, post market surveillance, and software and artificial intelligence (AI).
I know, sounds exciting, right? Here are some highlights and my personal top 3 takeaways from the summit. Let’s dive in!
During a panel discussion, with representatives from notified bodies (Bart Mersseman [SGS Belgium], Daniele Bollati [IMQ], Jayanth Katta [BSI], and Yvonne Ndefo [NSAI]), the following were discussed as the top 3 gaps in the implementation of MDR — clinical evaluation, verification and validation testing, and software. Being most closely associated with clinical evaluation, I wanted to focus my energy on that piece; however, I soon realized that an understanding of the other QMS activities is just as important, given the emphasis MDR places on cross-functional alignment (across QMS activities).
In addition, the newness and scarce guidance on implementation of the MDR has led to it being interpreted in different ways, thereby making communication the need of the hour. The little guidance that is available, in terms of MDCG documents, is given its due importance.
My top 3 takeaways from the summit are summarized below:
1. Cross-functional alignment
A common theme that resonated across most individual talks as well as panel discussions was the cross-functional alignment across various quality management system (QMS) activities. It is no longer practical for, say, the marketing team to work independently of the risk management or clinical evaluation team; the MDR emphasizes alignment across activities. This cross-functional collaboration was encouraged by several speakers, including Josephine Sommer, Senior Associate; Daniele Bollati, Product Conformity Assessment, IMQ; and Juliana Witte, clinical evaluation manager, Institut Strautmann AG.
2. Communication, communication, and communication
Communication within the manufacturer’s organization, between manufacturers and notified bodies, within notified bodies, and across different notified bodies was stressed throughout MedTech, including in a panel discussion of industry representatives (Daniela Leal [Zimmer Biomet], Juliette Cook [EMEA], Sholoufeh Khodabandeh [Strautmann], and Vandenbussche Inge [Medtronic]). Manufacturers are unsure about implementation expectations, which is why proactively communicating every learning can go a long way in improving efficiency, be it in terms of getting clarity on strategy for similar devices or understanding investment needs. Communication with notified bodies is essential in understanding these expectations better. Although not consulting, notified bodies are still talking to device manufacturers to answer their questions. Communication within and across notified bodies is also a challenge that is being mitigated by training and setting up knowledge-share modules. As clients of the notified bodies, device manufacturers can direct reviewers to notified body position papers to help them follow up with the presenters and align on strategy.
3. MDCG documents
The MDCG guidance documents, although not legally binding, provide practical direction on how regulations can be implemented. Following these guidance documents was recommended unanimously across the industry, from notified body representatives (e.g., Melania Battistella, TÜV SÜD) to CROs (e.g., Bassil Akra, QUNIQUE GmbH).
Bonus takeaway
I also attended quite a few talks in the AI stream to learn more about it since I am yet to gain any experience here. Summarizing my preliminary understanding, AI is currently considered part of software when it comes to regulations, but this may not be the best fit. With a lot of software companies moving into healthcare, advanced technology is being introduced in this field that our regulations are probably not equipped to handle, even with the MDR. Some of the challenges include, validation of a black box, adaptivity of AI and the substantial changes clause of the regulations, and new potential hazards with AI that haven’t been considered earlier. While solutions and ideas like using explainable AI were discussed, the need for more creative and updated regulations remains in this field. Most of the speakers seemed optimistic about it, with some of them going as far as saying that they do foresee a trustworthy deep learning medical device software.
In conclusion, I particularly appreciated how various streams got together at this conference, which gave me an opportunity to explore AI, which I probably wouldn’t have done myself! The enriching talks and insightful panel discussions at MedTech have definitely changed the way I think in some aspects, e.g., communication with notified bodies with the understanding that they may not be completely aligned amongst themselves, and validated my thoughts on others, e.g., aligning various QMS activities and following the MDCG guidance documents as closely as possible.
Find out how Cactus Life Sciences can help you keep your devices compliant with rapidly changing regulations by supporting you through the entire CER process. Email us at inquiry.lifesciences@cactusglobal.com.
Ridhima Kumar
Ridhima Kumar is Manager, Scientific Writing, at Cactus Life Sciences.