With an ever-increasing pipeline of medtech regulations, regulatory and quality professionals must consistently level up their industry expertise to keep in-market devices and diagnostics compliant. This requires a balance between technical and soft skills as teams often manage ambiguous guidance and shifting timelines.
At the recent Veeva MedTech Summit in Amsterdam, two industry leaders shared their insights into this evolving landscape. Leo Louis, director of regulatory affairs at Philips, summarized the challenges that medtechs are facing, “It’s getting very complex for regulatory affairs today, with all the new regulations and the pace in which the regulations are published. Plus there are the questions that come back from the notified body and their interpretations.” Elena Kyria, CEO of medtech recruiting company Elemed, also noted how this complexity is driving the need for more specialization, “Skills are changing. Historically, companies would say I need a regulatory person that has experience bringing a product to market. Whereas now, we’re starting to see, Okay, I need a regulatory person that has worked specifically with this type of product in this specific type of market and who has done it before.” When surveyed, about two thirds of the Summit session attendees agreed with these sentiments, noting that the increasing volume and complexity of medtech regulations were their top challenges, closely followed by lack of resources. Surprisingly, only 30% of the audience identified stakeholder management as a top challenge, but Philips and Elemed stressed that this is critical, especially in regards to innovation and getting products to market faster. Leo expanded on this point, “Nothing is going to happen if regulatory doesn’t come in front and start supporting that.” Another tactic that may help companies maximize their existing resources is to re-position regulatory and quality teams as strategic partners to the business. Leo shared, “It’s becoming more and more clear that the regulatory and quality teams need to have a seat at the table and discuss the roadmaps, the problems, the approach and the strategy from a marketing standpoint.” Elena added, “I see people really motivated by the chance to make a difference, make a change, and make an improvement… You don’t necessarily need to hire from outside. The people that know your processes best are the people that already sit in your company.” In order for regulatory and quality teams to be successful in these new roles, they also need to develop soft skills like communication and problem solving. Elena described these as “transverse skills that underpin every function… things like persuasive skills, negotiation skills, being able to connect with people that aren’t in your department and aren’t doing the job that you’re doing.” Leo went on to say, “Each day, we walk into the office and we have a problem in front of us that’s totally new. So, general stakeholder management and building that internal network, especially in large organizations, it’s really important.” Finally, the session leaders discussed how RIM technology can be a great enabler in these upskilling efforts. Philips is investing in things like regulatory intelligence to better prepare for future regulations and compliance needs. Leo stated, “I need to know what’s coming in the next six years so that I can incorporate it into my design today.” Elena agreed that technology can help companies better utilize resources, adding “How can you free up your best people? How can you free up their hands so they can focus on more strategic things that are actually adding value?” To learn more about how leading medtechs are leveraging RIM technology to stay ahead of increasingly complex regulations, read this white paper.