MAPS: COVID vaccines have certainly raised the profile of Medical Affairs teams on the biopharmaceutical side – has COVID fueled similar growth in MedTech?

Joao: There are many medical devices that are being utilized in the management of COVID patients, for example ventilators, protective equipment, dialysis, etc. In addition, there are also diagnostics for COVID-19 detection and for COVID-19 patient management. These crises have given the Medical Affairs group more footprint and status within MedTech companies. Typically, Med Affairs is at the forefront of identifying new possible applications for current products or identifying the needs of patients and users for new product developments. Therefore, COVID brought Med Affairs very close to the C-suite at a strategic level in many companies. How do you navigate through uncertain times? How can the product be safest and best utilized? Medical Affairs was and is a central pillar in these discussions.

MAPS: And on top of that, there are new compliance considerations in Europe…

Greg: It’s all about data on products. Historically, MedTech companies would do the bare minimum data collection needed to get to market then do after-market studies to fill in the gaps. Europe is saying get us the data and only then you can get the approval. It’s interesting for us who have global companies to figure out where and how to do the research. And it’s been especially hard during COVID. MedTech relies much more on access to hospitals for data generation and during the pandemic that access has been restricted. In terms of clinical research, we’re struggling to get up and running again and the question becomes, with restricted access, with additional regulations, how do we get the data we need? Or how do we get more creative with the data we have? These questions have raised the profile of Med Affairs in MedTech, but it’s still a big challenge.

MAPS: Are companies finding ways to answer the challenge of increased data requirements?

Marc: Well, somewhat. European evidence requirements have the potential to slow time to market of MedTech products, especially for smaller companies that don’t have the budget to do the studies needed to reach the new bar for data. They’ll be affected the most. It used to be that you’d go to Europe, get enough data for European approval, then jump back to the U.S. with that data in hand. Now small companies will have to find strategic partnerships with bigger companies to reach the new data standards for European approval.

MAPS: Does a higher bar for approval mean more confidence in the safety of a new product?

Marc: Twenty years ago, it was 20 patients for a certification and it was kind of scary. It’s important to find a middle ground. On one hand, there’s a point when asking for too much data becomes unrealistic. But on the other hand, approving based on little data can put patients at risk. And at the end of the day, if we improve patent care, it’s a win.

Greg: One problem with smaller companies struggling to meet new evidence requirements is these small companies have been a major source of innovation. Now you see a shifting landscape in MedTech with little companies either not surviving COVID or being acquired. I worry that 3-5 years from now, we could see a dip in the innovation curve. Without these little companies, what’s the new source of innovation?

Raphael: The new evidence requirements will certainly increase confidence in device safety. I agree however, that it may hamper groundbreaking innovation that mainly comes from small start-up companies as they may have difficulties finding the resources or funding to conduct extensive studies themselves. On the other hand, it will stimulate early collaborations between mature companies and start-ups under the condition that those large companies are willing to carry the financial risks.

MAPS: What other changes have you seen in response to the pandemic?

Greg: Well, MedTech relies on conferences from a commercial delivery standpoint and that lifeblood has been taken away. So much of MedTech is hands-on, about actually getting in front of healthcare providers. And it’s difficult for companies to invest in virtual conferences.

Joao: The education piece is a big change, too. There’s usually a user curve to these products whether diagnostic or device. It’s not just how you press the button or implant the device, but overall how it fits with the rest of the treatment paradigm, not just with patient flow, but the whole workflow on how MedTech products are used. All of these aspects depend on education and Med Affairs is positioned to drive a lot of this content.

Marc: We have an opportunity, especially in MedTech, to show the value of Medical Affairs. This is our opportunity to showcase what we bring to the table. The door is open to the C-suite.

MAPS: Do Med Affairs groups in MedTech have the potential to be overwhelmed by opportunity?

Greg: You can never have too many opportunities – it only overwhelms you if you can’t cut through the noise. With the product situation and the personnel situation, there are many levers and you have to prioritize which ones to pull. Med Affairs is a revenue eater and not a revenue generator, but we’re a value generator — how do you show that? How do you show we’re consuming things up front to create opportunity later? That’s where we have to facilitate and bring the trust of an institution along with us.

Joao: Cutting through that noise is part of the new skillset. Cutting through the noise, prioritizing, bringing along the buy-in of the organization – Med Affairs individuals and teams need these strategic skills. There are more strategic demands from Med Affairs functions than before, but we still need to be tactical and execute. Therefore, the skillset to be able to identify what is of most importance and follow through by a focused execution is key.

MAPS: And it seems like Med Affairs in MedTech is trying to manage these strategic and tactical roles with far fewer resources than their peers in pharma.

Marc: Med Affairs in pharma, you have 10 Medical Affairs professionals for one product. In MedTech, I’m one person and I manage five products.

Greg: You have to be broad-disciplined. In MedTech, you can’t just be an expert in one molecular pathway for drug delivery. And the devil’s not in the details; the devil’s in capacity. I’ve got 50,000 products that need support. It takes finding people who love the challenge of lifelong learning. We look at our peers in pharma and we’re cut from the same cloth, but the MedTech design of that cloth is drastically different. It’s the chaos of MedTech.

Joao: You need a special skillset to constantly learn, evolve and adapt. You learn on the job and agility is one of the key skillsets for MedTech.

Raphael: One role of Med Affairs is to make sure the voices of the customer and patients is included in knowing what’s next. With this and the aforementioned more stringent evidence requirements, a C-suite representation would reflect the strategic role that Medical Affairs currently holds. Medical Affairs should seize the opportunity to claim that strategic role and assess whether current capacity and capabilities should be extended.

MAPS: That sounds like a lot to navigate…

Joao: It is a lot to navigate. It’s exciting, fun, and interesting for all these reasons but challenging too. That’s what it takes to drive innovation and that’s what it takes to improve patient care. That’s why we’re in Medical Affairs.