Garth Sundem   0:06
Welcome to this episode of the Medical Affairs Professional Society podcast series. I’m your host, Garth Sundem, and today we’re talking about driving the business impact of medical affairs, specifically in med tech organizations. Joining us are Dr. Aarathi Cholkeri-Singh, Executive Director & Chief Medical Officer, North America, at Carl Storz, and Marceline Treneff, Director of Medical Strategy, Veeva. And so Veeva is going to help us look out at the landscape of medical affairs within MedTech. I know that there is a recent benchmark that just came out. Marceline, can you tell us about this benchmark and what it tells us about medical affairs in medtech?

Marceline Treneff   1:04
Absolutely so. Part of Veeva’s remit is that we have partners in many parts of life sciences, both pharma and med tech. I’m lucky enough to focus on the med tech side of the house. And we did this industry overview because we see that on the pharma side, medical affairs is generally understood. It is universally adopted.
It becomes inherent in the operational model of any organization. However, we don’t see that same consistency on the med tech side. And so as we watch organizations choose to implement medical affairs, we were starting to see some consistencies and some
unique points about those. And so we sent out a survey to do this industry overview and get an understanding of what is the state of medical affairs, specifically in med tech. And we were both surprised and not surprised by some of those results that came through. And we’ve been having some really exciting conversations about these results with our partners. So 25% of the organizations that did reply to this survey said that they understood that medical affairs is essential for evidence generation. They talked about things like KOL engagement and building out those scientific communications. But there is some discrepancies across organizations about where does safety fall within that. How does market access, reimbursement, sales and clinical support fall within those. And so we were really intrigued to get this kind of snapshot of where the med tech organizations are today with medical affairs. And then we’ll continue running benchmark surveys and things like that so that we can kind of track over time how things are changing. But we’re starting to see more and more frequently that organizations really do understand the benefit of having a medical affairs function as a strategic pillar and not just as a support.

Garth Sundem   3:07
Okay. Oh my gosh. So yeah, okay, that’s so interesting. I do tend to see things mostly from the pharma perspective. So it’s interesting to hear the med tech perspective. 25%, but growing. So Aarti, it seems like, you know, you represent this change. You’ve been able to build medical affairs.
Was the first step in your experience of building Medical Affairs showing the value, showing the impact? Did your organization understand that at first, or did you need to message it?

Cholkeri-Singh, Aarathi   3:53
So the way Medical Affairs actually started at Carl Storz, so Carl Storz is an 80-year-old young med tech device company, but Medical Affairs actually only started in January of 2019.

Garth Sundem   4:01
Yeah.
Oh, wow.

Cholkeri-Singh, Aarathi   4:11
Clinical Affairs was established in headquarters to support the EUMDR requirements and changes. So that basic function resided there, but their focus was purely on the EUMDR. And when we established the North America or the US chapter for Medical and Scientific Affairs, it was really actually focused on risk mitigation.
So back then, we were seeing marketing commercial because there was no medical affairs that existed, taking on research grants, educational grants, when they should be not, when they should not be doing any type of grant work and really focused on selling and marketing. So from that standpoint, medical and scientific affairs was actually grown out of need.
for risk mitigation. And then when we got here, it was more, okay, well, what more can we do than just, you know, sign off on grants and applications? And it was from there that actually my previous CMO

Garth Sundem   4:56
Ohh.

Cholkeri-Singh, Aarathi   5:12
connected us with Medical Affairs Professional Society. And that’s when we started to connect with colleagues and understanding what other growth opportunities there were for Medical Affairs and MedTech gave us the insight enough to go back to the organization and say, wow, we have these gaps.
And how do we start to build out value for the organization so that we can also, you know, deliver impact into that, into the, sorry, deliver impact into the organization the way pharma has done?
In the past.

Garth Sundem   5:52
I never would have thought that safety would be the seed of a medical affairs organization. You know, for pharma, the seed of medical affairs was customer engagement. And then it, you know, grew into evidence generation and now insights and strategy and all these other things. But you’re saying that for your organization, safety was the seed of medical affairs.

Marceline Treneff   6:02
Okay.

Garth Sundem   6:12
Now, was that communicating safety? Was it the customer engagement side of safety, or was it pharmacovigilance? Was it, what do you mean when safety was the start of medical affairs?

Cholkeri-Singh, Aarathi   6:26
Actually, Garth, it wasn’t actually safety risk mitigation in the sense that marketing should not be owning grants processes. So it was a company risk. It was a company de-risk initiative. And it was just a way of maturing the organization into becoming a more compliant organization for the time.

Garth Sundem   6:34
Oh, I’m sorry. I’m with you now. Okay.
I got you.

Cholkeri-Singh, Aarathi   6:47
So I think that that’s where it was, oh, you know, we had legal and compliance coming in and saying, wait, who’s managing the grants process? And so we need to de-risk the company from a compliance standpoint, and we need to bring in medical affairs to manage that as a separate and independent department.

Garth Sundem   6:48
Ohh.
I see.

Cholkeri-Singh, Aarathi   7:06
In decision-making, not influenced by commercial and sales revenue and generation.

Garth Sundem   7:12
Okay, so thank you for that. So you had a very distinct purpose when Medical Affairs was created within your company. You know, you were going to bring the company into full compliance and de-risk the grants management process. So then
you had the opportunity to build. What did that look like? So you said that the gaps were identified, and then you said, hey, we could do that gap, we could do that gap, we could do that gap. What did that look like?

Cholkeri-Singh, Aarathi   7:43
Yeah, yeah. So aside from clinical affairs and headquarters focusing on the EUMDR, so you’re right, Garth, two foci, right? Clinical affairs, focusing on the EUMDR requirements, and then we were focusing on company de-risk from the compliance standpoint. What was unique

Garth Sundem   7:55
Yep.
Yep.

Cholkeri-Singh, Aarathi   8:02
I will tell you what was absolutely unique in our growth. So remember what I said, medical and scientific affairs in the US started January of 2019. And what was so pivotal that was happening throughout that year and then the following year was COVID. I got hired and started February of 2020.

Garth Sundem   8:12
Yeah.

Cholkeri-Singh, Aarathi   8:22
My last day in the operating room was the 14th. First day in the office was the 18th and March 11th, the pandemic hits and it was COVID. And it was just two doctors. We had two doctors in the entire organization trying to understand COVID as every single healthcare professional, industry, team members,

Garth Sundem   8:27
But.

Cholkeri-Singh, Aarathi   8:41
and the communities in general, were trying to understand what is this virus and this pandemic that we’re living through, you know, trying to support family members, protect everybody. And so quickly, my CMO, and I was a medical director at the time, we became virologists and immunologists, and we were trying to protect our employees.

Garth Sundem   8:59
Course.

Cholkeri-Singh, Aarathi   9:02
We were trying to understand product safety. You know, how do we clean these products? We don’t, we didn’t have, nobody understood viruses. I mean, I don’t know if you remember the days where we were washing our apples and touching our groceries with gloves and we had masks on. And I saw people putting things in dishwashers, their vegetables in dishwashers to

Garth Sundem   9:02
Mhm.

Cholkeri-Singh, Aarathi   9:21
sanitize them. And, you know, I mean, nobody really knew what was happening. And so we put so much focus on how to protect our employees, how to protect the healthcare staff with our products. What do we do with contaminated products and SPD, reprocessing, really just trying to learn the world as everybody else is trying to learn the COVID world.
And in that short, short snapshot of that.
unexpected and unpredictable environment, we realized 2 clinical individuals in an organization of over 8,000 people was simply not enough.

Garth Sundem   10:00
Yep.

Cholkeri-Singh, Aarathi   10:01
And what we were trying to do, and we were already doing some marketing work, research work, evidence generation work, you know, we were doing that in the background, but there just wasn’t enough of us. And so we start to go and socialize the value that we were playing with specific projects here and there, regulation, you know, regulatory,
work with product expansion of indication, evidence generation for another product, et cetera. But how do we scale that when there’s only two of us in a pandemic? And we socialized the value. So we did interviews with our colleagues and partners on other projects that were non-COVID related.

Garth Sundem   10:41
Cool.

Cholkeri-Singh, Aarathi   10:41
We got their input, and we basically put together a business case. I don’t know, as a clinician, I don’t know what a business case even looks like. I do not have an MBA as a background. My CMO did, and I learned a lot from that opportunity because we really were able to
build that narrative of how we’ve created impact in small projects here and there. I mean, pretty large, but in very focused projects. But how could we scale that? And so we wanted to establish a medical science liaison program where we could bring in more clinicians to
to really engage the KOL community, to engage our sales force, our marketing teams, do internal education, external education, and really grow the voice of the clinical side of med tech versus just the commercial side and the engineering side of med tech. And so

Garth Sundem   11:33
Ann.

Cholkeri-Singh, Aarathi   11:43
We wanted to become, we wanted to change the organization from an engineering company into a medical solutions provider. And we framed that narrative and the growth opportunity by developing this business case based on examples that we had done with project work within the organization.

Garth Sundem   12:03
So, Aarti, you know, if an organization is led by business leaders, did you then, in order to grow the medical affairs function, have to learn to speak in the language of business priorities? You know, you have clinical expertise,
Did you then have to become a business expert or at least speak? Yeah, okay.

Cholkeri-Singh, Aarathi   12:27
That’s correct.
Yeah, yeah. I feel like I went through a crash course and I got my Carl Storz MBA. I learned A lot. But, you know, learning the perspectives, I think one of the successes we’ve had is really cross-functional collaboration. And being a leader in medical affairs, it’s, I think, one of the

Garth Sundem   12:34
Yeah, nice.
Mhm.

Cholkeri-Singh, Aarathi   12:49
Pivotal.
pivotal learning opportunities is really understanding the perspective of your business colleagues and your cross-functional leadership colleagues as well. So when you sit in a room and you’re listening to what regulatory has to say and their perspective and what legal has to say and compliance has to say, and when you’re listening to the business side and how they have to grow the organization and

Garth Sundem   12:58
Mhm.

Cholkeri-Singh, Aarathi   13:12
do year over year growth and the revenue and the, and then you’re hearing operations with their backorder challenges, especially with COVID. I mean, everybody was in the backorder situation. And when you’re learning that supply chain and how everything connects and it’s a holistic approach, you really start to understand, okay, where do we prioritize medical affairs?
We cannot work in a silo. Say, I want five MSLs, I want six people for evidence generation, and I want, you know, I need five people for product innovation, et cetera, et cetera. You cannot just ask that. You need to really understand where are the gaps within the organization that medical affairs could provide that value and impact.

Garth Sundem   13:48
Mhm.

Cholkeri-Singh, Aarathi   13:58
And when we started to see that we were able to deliver on some of these gaps, or identify, correctly identify the gaps, and then create projects and deliver to reduce that gap or solve for that gap, that’s when we start to build advocates within the organization. And then those business leaders or those

Garth Sundem   14:11
Mhm.

Cholkeri-Singh, Aarathi   14:18
support leaders, enabling function leaders, they were the ones that said, okay, you know, Medical Affairs is a growth strategic department that we had not necessarily considered in the past, but now we’re seeing that value and how do we help them scale?

Garth Sundem   14:29
Yeah.

Cholkeri-Singh, Aarathi   14:37
And so they were actually helping to build a business case for us.

Garth Sundem   14:43
Well, right, because if gaps exist, so you’re saying, here’s the business gap, we can help address that. Not, hey, here’s all the things we can do, which of these do you want us to do? It’s like, look, here are our business strategic priorities that are not yet being sufficiently addressed. Medical affairs can do that. You know, Marceline,

Cholkeri-Singh, Aarathi   14:49
Right.

Garth Sundem   15:04
Is this what you’re seeing across industry? Does the growth of medical affairs, or I should say the development of medical affairs, is impact in areas of business gap or business need, you know, is that the path forward for medical affairs growth?

Marceline Treneff   15:25
Absolutely, that’s what we see from teams that are growing despite being in challenging circumstances. So in our industry overview, one of the top answers for challenges to growing your medical affairs team is that lack of strategic influence or visibility in the organization.

Garth Sundem   15:33
Yep.

Marceline Treneff   15:45
And what Aarthi walked us through, probably without even realizing that she was following the industry overview, is that she identified those gaps and then did those project-based experiments to say, can we assist in this way?
and proved time and time again that they could, which then raised that visibility in the organization. And by doing those projects as well as the interviews that they were having with senior leaders to understand how they slotted in to the overall business objectives, now all of a sudden,

Garth Sundem   16:06
Cool.

Marceline Treneff   16:26
there are advocates that are outside of the medical affairs team speaking for the benefit of having additional headcount to help fill more of those gaps that have been identified. So, and I promise that we didn’t plan that. That was just Arthi’s example, and it worked beautifully

Garth Sundem   16:44
Yeah.

Marceline Treneff   16:46
with what we see across the industry.

Garth Sundem   16:49
Well, that’s a really interesting model. So identifying business gaps and then not only saying, oh yeah, Medical Affairs could do this and that and that and that and that, but saying, you know, here’s a business gap. Here is one thing that Medical Affairs, here’s a project that we can take on right now to address this specific gap.
and then continue to build from there, whether that’s, you know, into more customer engagement, like you point out, Arthi, with an MSL team, or maybe then into more evidence generation. Well, so here’s an example.
or a question, I should say. Aarthi, as you expand your capabilities in medical affairs, are you finding it challenging to work with established structures? I’m thinking about your clinical development team, who is, you know, leading the evidence generation for EUMDR.
All of a sudden, I can imagine you look at that and you say, well, in pharma, medical affairs does that.
As you grow, are you finding some of these frictions as well?

Cholkeri-Singh, Aarathi   18:05
You know, it’s not really friction, Garth, because I think we’re at a point right now where we have to work as one team. So I don’t see the clinical affairs team as a separate team, as the medical affairs team. It’s just more how can we operate synergistically? What are their strengths?
and what are their weaknesses or gaps? I won’t say them in weaknesses, but what are their gaps? What are our strengths and what are our gaps? And how can we actually help fulfill the gaps together? And so we have our team members actually work together to say, look, you guys have strengths in this area.

Garth Sundem   18:24
Mm-hmm.
Yep.
Cool.

Cholkeri-Singh, Aarathi   18:43
of evidence generation. And these are some of the gaps that we’re seeing that we need, at least for the North America region, which will resonate globally as well. But we have our team members here. So we’d like to start with a project and we’d like to take this on. But your input is so important that we’ll take the leadership on it.
because they’re so stretched with their tasks as well, but with your input. And so that nobody’s, again, I think the key here, Garth, is that nobody is working in silos. And that’s how we maximize our efforts without duplicating or eliminating key aspects of the project or key aspects of the job that we need to do for the organization and for our health.

Garth Sundem   19:15
Yeah, I hear them.

Cholkeri-Singh, Aarathi   19:28
Healthcare community.

Garth Sundem   19:30
Right, so then it’s not just you looking at the gaps in the business and saying, oh, you know, we can address that. We’ll take it back to our silo to address it and then hand you the solution when we’re done. You know, it’s also in a way being, maybe this isn’t quite the right word, but being vulnerable with your own gaps.

Cholkeri-Singh, Aarathi   19:49
Mhm.

Garth Sundem   19:49
and looking for collaboration opportunities and saying, you know, here’s what we don’t do well, and here’s how the organization could help to support these medical affairs initiatives through supporting our gaps to create, you know, a real shared vision forward for
for, you know, again, business priorities.
All right, so now, now you’re at the point of trying to trying to scale. What are you seeing as your as your kind of your next challenges? Do you feel like you’re now established and you have this medical affairs department and the value is recognized and you’re doing
somewhat discrete things. What do you see as your next challenges?

Cholkeri-Singh, Aarathi   20:37
Yeah, really timely question, Garth, because I have been tasked to build out a five-year plan. This is the first time that my department has been asked this. The commercial functions and the business units have been asked to do this year over year. But this is our first time for medical affairs, again, kind of a newer department.

Garth Sundem   20:51
Yep.

Cholkeri-Singh, Aarathi   20:56
to build this out. And our previous CMO left and then I became the CMO of the US and then we merged with Canada last year. And so now I’m CMO of North America. And with that leadership hat on, you know, I’m now not just the chief medical officer, I’m also a North American leader.
for the organization. And so I have to look at it with the perspective, again, that business lens, which is a muscle I’ve built right through the organization throughout my years here. And what I’ve recognized is, you know, every business line and unit needs to hit certain targets.

Garth Sundem   21:19
Mhm.

Cholkeri-Singh, Aarathi   21:37
but I can’t double my team in the next five years. I think that it’s a reasonable ask in the sense that that’s what the organization needs to do. But as a North American leadership, is that where we need to put our investments in wholeheartedly? And is that, you know, do we need more resources in the commercial side? Do we need more resources on the compliance, legal, regulatory?
where else do we need resources? Maybe even in the operations side as well. IT obviously is another big one, especially with AI coming through. You know, should I be taking all those resources? And so how do I really streamline, but yet at the same time, respectfully and…
reasonably scale the organization. And so what I’ve done is I’ve interviewed with our finance department, our head of business transformation and strategy. I’ve interviewed with our head of commercial, and I’ve even talked to the president of North America.
and really just trying to understand, okay, what direction do we want to go in as a business, as an organization, for us to hit our growth targets? And where can Medical Affairs really grow in scale? And so I’ve identified 3 strong pillars, but also in a phased approach.

Garth Sundem   22:59
Yeah.

Cholkeri-Singh, Aarathi   23:02
And, you know, and so what I’ve done is I’ve kind of laid that out, overlapping it in that phased approach. And then I’ve asked for the growth year over year, but by putting in the justification, what if I’m going to do this in this year, this is what I need.
to be able to accomplish this. At the end of the day, I’m happy to run the department with the run rate year over year budget growth and the FTEs that you’re going to allow me. But in order for us to hit the business growth that we want, this is what I feel is going to enable our business to grow collaboratively.
as an organization, not just individually as MSA, because I see now, and as you know, Marcelina has pointed out.

Garth Sundem   23:49
Mhm.

Cholkeri-Singh, Aarathi   23:53
Commercial and R&D have been our growth pillars for years, right, in organizations. But now we’re seeing medical and scientific affairs being that third growth strategic partner. And without it, I don’t know how much, how successful an organization can truly be.
in this current climate. Not only just EUMDR, but we’re even looking at FDA requirements and we’re even looking at hospitals and their value analysis committees and everything is based off of decisions of evidence, evidence, evidence, evidence, and, you know, peer-to-peer communication and understanding that language that

Garth Sundem   24:14
What?
Yep.

Cholkeri-Singh, Aarathi   24:34
bells and whistles on a product anymore just don’t get you across the finish line.

Garth Sundem   24:39
Well, your evolution mirrors really the evolution of the function. You know, you started out fairly executionally, you found opportunities to demonstrate your impact, and that now puts you in a position to think strategically. And I mean, that encapsulates

Cholkeri-Singh, Aarathi   24:47
Mhm.
Mhm.
Correct.

Garth Sundem   25:00
the evolution of medical affairs. Marceline, is that sort of where you’re seeing with your viewpoint at Veeva a across the industry? Is that what you’re seeing in terms of evolution in medical affairs medtech as well?

Marceline Treneff   25:15
Yeah, and that’s part of the reason that I love working with so many different partners is because I get the chance to kind of back up and see that view across many different organizations. And part of our industry overview that we published really kind of laid out some steps
for organizations that they could take moving forward. And one, we’ve mentioned quite a few times today, right? Speak the language of the organization that you’re in so that you can start to prove your value. But then you do want to align internally and for whatever is best for your team and organization on some of those metrics.
right? So that if you do have a leadership change and folks come in who are less familiar with the work you’ve already done, you can share the good news, share those results, and be your own evidence generation and dissemination strategist for how medical affairs can impact the organization.

Garth Sundem   26:00
Mm-hmm.

Marceline Treneff   26:13
And then you want to make sure that you’re making the investments that you need to grow and be successful like Aarthi just discussed. We hear different pain points based on where organizations are in their journey, right? Are they starting or are they really well established? And so our next benchmark survey coming out, we’ll have a focus on roles and responsibilities.
And I’m looking forward to some really great conversations on that, because again, it always matters based on where you are and where you want to go, rather than is a one size fits all perfect for everybody in med tech. I have yet to find a one size fits all in the med tech industry. I don’t know, Aarthi, if you have either.

Garth Sundem   26:57
Yeah.

Cholkeri-Singh, Aarathi   26:57
No, I mean, I think working with our medical affairs professional society members in med tech and then the group of med tech leaders that Veeva brings together at their annual congresses and meetings and roundtable discussions, even at MAPS, you know, you’re learning that everybody has a different approach. But I think we’re learning together and growing together, which is brilliant.
because I do think, as you had mentioned earlier, Garth and Marceline also emphasized, pharma, it’s pretty inherent. It’s pretty built in, whereas med tech, we’re kind of learning and growing. And I use the analogy and we’re trying to find, we’re trying to fly a plane that we’re building at the same time.
you know, which is a very difficult task to do. But I think these benchmarks really help us to communicate what other med tech or med affairs departments are doing in med tech and bringing it back to our leadership for them to understand. And even, I think Marceline shared a draft
of this flow chart that we have. And I actually shared it with my marketing communications and they said, we love this flow chart. And they actually really are very engaged in a lot of the benchmark data that’s coming through because they themselves are learning on how to communicate.
with the healthcare community. And so understanding what this workflow looks like, where are the gates, this checks, when Medical Affairs needs to be involved, regulatory, et cetera, you know, I think has been really very enlightening. And Veeva has been able to bring that to the forefront alongside with the MAPS members and their customers as well. So it’s been a really great collaboration.
and across the med tech industry in general.

Garth Sundem   28:50
All right, well, it sounds like we have ample excuses for more conversations in the future, but let’s leave it there today. So Marceline and Aarti, thanks for joining us. MAPS members, don’t forget to subscribe. And we hope you enjoyed this episode of the Medical Affairs Professional Society podcast series.