(Editor’s Note: This “Essenvia voiCEOver” is the first in a series of monthly online journal entries by Essenvia CEO Soumya Mahapatra.)
As RAPS Euro Convergence 2024 slides into history, and to help prep MedTech industry experts for the organization’s North American-based Convergence in September, I’ve pinpointed a handful of noteworthy regulatory topics that were of much discussion at last month’s meeting in Berlin.
Two of the topics I singled out for my five-point Euro Convergence epitaph should not surprise any tuned-in MedTech regulatory professional. I’m sure every conference attendee’s look-back list, were they to make one too, would include the accelerated spread of artificial intelligence (AI) and industry’s clunky, lumbering transition to the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
But the remainder of my list is made up of topics that surprisingly had traction with conference attendees, including a wider embrace by medical device manufacturers of Regulatory Information Management (RIM) platforms, the use of digital solutions for an array of regulatory activities, and a spotlight on the use of real-world evidence (RWE).
Below are my five key takeaways from Euro Convergence that should be top-of-mind for anyone touched by MedTech regulation which, if you’ve read this far, is likely you.
1. The MDR and IVDR continue to challenge manufacturers and regulators alike. It’s no secret that the transition in the EU to the MDR and IVDR has been bumpy at best and a downright nightmare at worst. Discussions at Convergence revealed that while some MedTech companies have successfully navigated to the MDR, others are still considering the most effective and optimized compliance approach to take. It was particularly interesting to learn that some device companies have been learning from other manufacturers that have already gone through MDR/IVDR conformity assessments.
As I wrote in a recent Essenvia Expert Article, many innovative device manufacturers view the MDR as an opportunity to streamline and modernize their regulatory processes and technology to gain a competitive edge. The shift toward compliance with the MDR necessitates not only adherence to requirements but also innovation through the adoption of modern regulatory technology. Companies that are strategically embracing these RA transformations are well positioned to thrive in the ever-evolving MedTech landscape.
2. Transformation of regulatory processes and information is a must for companies playing in the MedTech space. Device manufacturers that have a 20th Century mindset when handling 21st Century regulatory workflow are behind the digitalization 8 ball and are strongly advised to modernize ASAP, speakers said at Convergence. They pointed out that a company’s dated way of handling regulatory activities can cause myriad problems, chief among them documents and/or data that can’t be found, document inconsistencies, zero traceability, and obsolete data when implemented changes are not complete.
In a 2023 survey by Deloitte Life Sciences, 51% of people working in the MedTech industry said digital innovation is a long-term investment, while 18% said it was necessary at any cost. Another 53% said they have a leadership-driven digital innovation agenda. Despite this, device firms often put off modernizing reg processes and information because as a whole, this type of transformation can seem daunting and appear to take several years to complete.
The first step in the process is for the manufacturer to recognize a business problem or opportunity that can be directly attributed to one or several critical business processes within RA. The RA leaders must then fully understand, align and build consensus on the opportunity with their mid-level management and RA leads and specialists.
While a business transformation is not a digital transformation, it is worth noting that technology-enabled transformation is at the center of almost every transformation happening today in large enterprises. An emerging topic at Convergence for most manufacturers was RA digital transformation with tools that can accelerate and de-risk their journey.
While digital transformation of regulatory affairs can indeed be a massive undertaking, savvy manufacturers understand that they don’t have to modernize all at once. Rather, they break down modernization activities into smaller, more palatable bites. This transformation will be an incremental, continuous improvement journey for companies – it’s not a “one-and-done” type of initiative.
3. Industry is becoming increasingly receptive to RIM platforms as enablers of digital transformation. A special shout-out for RIM on this list felt appropriate and necessary given its hand-holding with transformations both digital and regulatory. Through conference sessions and conversations both personal and overheard, it is more apparent than ever that medical device manufacturers are receptive to using a RIM platform. But there’s a catch: One of the more interesting notes that came out of Convergence is that despite identifying a need to transform RA processes, many MedTech companies aren’t sure where to start and how to evaluate the different approaches and platforms on the market to feel confident that they’re investing in the right one.
Several factors play a role in selecting a RIM tool, but the most important factor is the return on investment that companies have incurred from implementation and ongoing maintenance costs associated with traditional RIM tools. An additional burden can also be attributed to onboarding new users since these systems also have high training needs and upkeep effort.
Device manufacturers often recognize the advantages of using a RIM that is purpose-built for medtech, as well as the disadvantages, including substantial investment of resources required to customize a general-purpose system to meet the needs of a medical device RA process and platforms that often fail to deliver desired business results. An important consideration for manufacturers is to embrace technology and a risk-based approach to accelerate implementation and adoption of RIM solutions.
Companies should put in place a RIM solution that addresses their specific needs and built with MedTech companies in mind to de-risk their RA transformation efforts. As with most things in device manufacturing, properly investing on the front end inevitably saves precious resources down the line.
4. AI was a major topic at Convergence for not only the obvious reasons, but also because of the rapid rise and use of generative artificial intelligence (GenAI) to assist in regulatory affairs activities. Conversation and presentations at the RAPS conference made crystal clear that MedTech companies must fold GenAI into RA departments or risk being left behind and losing their competitive edge in the global marketplace. In fact, it’s becoming almost downright impossible for device firms to efficiently operate if they aren’t incorporating these cutting-edge technologies into their everyday work.
Manufacturers that streamline and modernize regulatory operations by using GenAI can ensure better efficiency and process harmonization across the lifecycle of the products they make. GenAI, which in the very simplest of terms creates new content and data by analyzing currently available datasets, can be used to support the creation of new product submissions, help identify production and quality trends, pinpoint device safety risks, develop adverse event reports, and draft responses to regulators like the US Food and Drug Administration (FDA) following an unfavorable facility inspection, just to name a few core MedTech RA activities. As we’ve said before, achieving regulatory excellence hinges on, among other things, a company’s wiling embrace of vital tech like AI and GenAI.
Another key AI topic at Convergence was the EU’s recent effort to regulate artificial intelligence, called the AI Act. It was particularly noteworthy that a product that falls under the purview of the new MDR and is a high-risk AI system under the AI Act will have to meet requirements under both regulations. An AI MedTech product is deemed high risk if AI is used as a product’s safety component or if an AI system is its own product, and the product falls under the umbrella of Annex I of the Union harmonisation legislation and can be assessed by a third party as part of that law.
In a presentation on the topic in Berlin, Inma Pérez Ruiz, the BSI Group’s AI Regulatory Lead, warned that “the classification of an AI system as high risk under the [AI Act does not] necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered high risk under the MDR.”
5. Real-world evidence (RWE) is being used and adopted around the world as key regulatory and policy decisions are made. Collecting and handling RWE – clinical evidence that comes from analyzing real-world data around the benefit/risk portfolio and use of medical devices – can be tricky for even the most experienced of manufacturers. Perhaps recognizing this, regulators, health technology agencies (HTAs), international standards organizations, and MedTech groups have rolled out a number of guidances, guidelines, and other educational documents over the past few years to help steer companies on the topic and highlight the importance of RWE to industry and other stakeholders.
Meanwhile, a new project was launched in Europe last year to specifically tackle challenges posed by RWE and other health data, called the Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IDERHA). The project, which is pushing for the wider adoption and use of real-world evidence by regulators and HTAs as they make decisions that can impact manufacturers, is hosting a webinar on June 4 in an effort to pinpoint gaps in RWE policy. All of these moving parts around RWE is a strong indicator that regulatory professionals should keep an eye peeled for more information or important changes coming down the pike that could impact their company around the use of this data.
The Bottom Line
Now more than ever, it’s essential for those in RA to make sure they’re paying attention to every topic on this list to ensure compliance and stay out of hot water with regulators. Good luck – and see you at the next RAPS Convergence event!
