Medical 3D Players: 3D Printing and Building Value with Economic Evidence

Sebastian De Boodt  00:06

Welcome to the 3D Players Podcast, where we explore personalization in healthcare through advancements in 3D technology. We’ll talk to industry leaders championing more predictable and sustainable patient care. I’m Sebastian De Boodt, and I’m joined by my co-host Pieter Slagmolen.

“Why should personalization be a pillar of my medical device business strategy? And how can I do this successfully?” In this episode, we’re welcoming Masha Dumanis, Vice President at the US-based strategy consultancy firm Health Advances, where she leads the musculoskeletal practice area and is the MedTech and Digital Health Strategist. After graduating as a human evolutionary biologist at Harvard eleven years ago, she started at Health Advances, where she became a trusted adviser to clients in the medical device industry (having supported over 100 of them as a strategy leader). She also has a strong interest and expertise in the burgeoning women’s digital health space. Welcome, Masha.

Masha Dumanis  01:09

Thank you, Sebastian. And thank you, Pieter. I’m so happy to be here. Really honored to join you on this podcast and excited about all of these topics today. And I’m really looking forward to discussing personalization in musculoskeletal and in medtech more broadly.

Sebastian De Boodt  01:26

All right, before we dive into that first question, just out of curiosity, it feels like a big leap going from Harvard studying human evolutionary biology and then to quickly shift to a medtech strategy consultant. How did that happen?

Masha Dumanis  01:41

So with Health Advances, we actually operate across all healthcare fields, industries, so medtech, biopharma, diagnostics, and increasingly digital health and HIT. And when I started my career there over 11 years ago, I started as a generalist. I sort of fell into the medtech field and musculoskeletal in particular. I started on a few projects, and I really fell in love with the field of orthopaedics and med devices. It’s sort of perchance, as many of us know that you can’t always carve the path going forward, you can only really see what it looks like going back...I didn’t really say those words. As many of you may know, Steve Jobs said those words at his graduation speech at Stanford, although more eloquently than I just did... So it’s a little bit of chance and a little bit of deciding that I really liked the space and doing more and more projects in the orthopaedic space. But I’ve always had a passion. It’s a very unique space; it has unique features different than other spaces within med device, in particular the focus on sales and marketing. And personalization is actually a big feature of musculoskeletal. We haven’t had as much clinical research in the musculoskeletal field in the past, and it’s evolving so rapidly, right? So if you look at orthopaedics, 20 years ago, there were very few clinical trials. The bar has risen a significant amount in about, I would say, medtech overall; in musculoskeletal, particularly in terms of the rigor of the research that we’re seeing, I think it’s a very exciting time and space to be here. There’s a lot of evolving technology. So I’ve followed my interests and my passion, and this is where I’ve landed. You can’t always predict where you’re going to land. But that’s how I landed here.

Sebastian De Boodt  03:42

Exactly. You need to follow the stream and your passions! Are there any things that you still use from your education in evolutionary biology today? Or is that far away from what you’re doing now?

Masha Dumanis  03:52

One of the things that was foundational, well, really two things: one, in evolutionary biology, we study skeletal biology. And in fact, I have a colleague of mine, a mentee of mine, who did her PhD in skeletal biology in the same department. So we work closely together in the evolution of bipedalism and why we’ve evolved the way we have. And the other: is just this kind of critical thinking and being able to critically analyze research. It is a foundation of life sciences and having an understanding of the life science space, which is pretty essential to our whole practice. At Health Advances, we hire those with a background in the life sciences so that we can critically look at the science part and the clinical part of all of these types of questions. Then we layer on the business and the strategy piece. So, I would say I’ve walked away with a sound understanding of the science piece.

Sebastian De Boodt  04:52

Yeah, as you mentioned, it is indeed true that evidence-based thinking is becoming more and more important.

Pieter Slagmolen  04:56

If you look at where you are now, how would you describe to our audience what your current job entails? What does a strategy leader in medical technology do on a daily basis?

Masha Dumanis  05:07

That’s not an easy question to answer. I think, you know, part of what I’m tasked with, like I said, is following my passion in staying on top of how much the space is evolving. And so medtech is very broad, even within musculoskeletal. If you look, we have regenerative biology, we’ve got implants, we’ve got metal implants, we’ve got PEEK and polymer implants, we’ve got so many different technologies... We’ve got robotics, we’ve got navigation. Staying on top of what’s happening in those spaces, from a technological standpoint, from a regulatory standpoint, from a market access and reimbursement standpoint. So part of my job is just kind of in line with my own intellectual curiosity, staying on top of the trends and following those interests, and so that when a client comes to us with questions in that space, I can say, here’s what I’m seeing, here’s what I’m thinking. But when I’m actually engaged with clients and helping answer their questions, then what I’m doing is speaking with industry experts, often clinicians in the space, thought leaders, and key opinion leaders trying to understand the unmet needs in the industry right now. What their thoughts are on certain competitive technologies, products that are out there? Where are we looking to in the future, how to meet those unmet needs, and helping our clients work through them? What are their priorities from a strategic standpoint? And how do we get them to where they want to be in the future?

Pieter Slagmolen  06:40

One of the trends that you’re talking about, and actually — it’s the topic of this podcast — is the idea of mass personalization. It will be part of our summit in April. And we asked our audience, an assembly of industry experts about their belief in the future, sustainability, mostly on personalization, and it was interesting to see that nine out of ten actually saw a much, much broader adoption than we see today. And 43% was even of the opinion that personalization will really become the new standard going forward. Actually, we felt that it was driven by that sustainability argument. What do you see driving that belief that personalization will really move forward?

Masha Dumanis  07:25

Personalization has a very broad meaning. And we won’t necessarily make personalized implants for every single application in the future. My personal belief is that it doesn’t necessarily make sense. But personalization in the sense, I think one of the top applications when we polled the audience was preoperative planning, I think that rose to the top as one of the applications of personalization that is really going to see a lot of adoption. I think that does make a lot of sense. And we already see a shift there. And obviously, as we see the rise of things like robotics and navigation, there’s a natural marrying of the two. You can’t do one without the other. One enables the other. But it enables us to better plan for surgery. And I think with time, a big topic of the summit was how can we show that there are better outcomes because I think there are pockets of data that show that there are better outcomes with preoperative planning, with personalization, whether that is a personalized device or not. I do think that there’s a lot of room for broader adoption. There are certain areas throughout medicine, throughout medtech technology, where the applications of personalization are not just going to thrive but are really necessary. And where we haven’t applied them today. We talked about, you know, complex trauma, like reconstructing an elbow, for instance, where a standard implant today just isn’t sufficient. Or when you put that implant in, the outcomes are just not as good as if you’re able to, for instance, take an image of the opposing elbow and plan such that you’re able to reconstruct and create an implant that mirrors the other (assuming there isn’t a significant amount of deformity) and have much better outcomes. Do we have sufficient data across many cases that the outcomes are better? Perhaps not. But I think we’re starting to gather that evidence. So, evidence generation is going to be a key to broader adoption. And hand-in-hand with the broader adoption is probably reimbursement and market access for these products.

Sebastian De Boodt  09:45

I think it’s a very strong point. And what you mentioned is that we started to have those pockets of evidence about the value personalization can bring and that’s often what we also hear is at the same time still a challenge to capture this data and how to monitor that. In your experience, what are the typical actions that a medical technology company undertakes to prove this economic but also clinical value of a personalized solution? Have you seen any convincing examples? Maybe of companies or studies?

Masha Dumanis  10:16

Yeah, I mean, I think that in today’s world, obviously, with medical devices as compared to drugs, we have historically had a much faster path to market with, you know, 510K. Even with personalized devices, the FDA has created paths for personalization that gets them to market faster. It is critical for medical device companies to think about their commercialization strategy and their clinical strategy, not just in ‘how do we get to market?’ What’s going to get you to market isn’t necessarily what’s going to get you that mass adoption. That’s what we spend a lot of time thinking through with our clients because designing those trials, you know, obviously, it’s an investment. But, how do you think about the return on that investment? Sometimes that might be a registry and making sure that you have set up approvals from your patients, the right design. Every clinician is going to tell you that the gold standard is a randomized control trial, though that’s not always feasible in today’s world. What can we achieve with what we have? Obviously, in Europe, we have instant joint registries. And that’s a fantastic opportunity to use real-world data, to look at outcomes, whether we can match patients and cases with existing registry data to potentially similar cases with custom implants or personalized implants. And that’s something that, for instance, a company like Conformis has done. They have been able to show lower revision rates. I think one of the examples that I showed in my presentation was over the course of a five-year time period. And then now they’ve continued down to seven years, they’ve shown that they do have lower revision rates; revision rates are already quite low and aseptic. And that’s fantastic. But they’ve shown, I think it was, 2.2 versus 2.5% for a personalized implant. Continuing to work with thought leaders to design the right trials, trying to take advantage of real-world data, trying to understand what’s going to be accepted by clinicians, what’s going to be accepted by the financial stakeholders — and remembering that financial stakeholders, in some situations are pair organizations, but in other situations are not pairs, particularly in the US, when you’re talking about implants. The financial stakeholder is often the hospital or the facility because we’re still often in a bundled environment or in a DRG environment. The facility is getting a single payment for the implant procedure, and they’re having to allocate the money. That’s one of the things that we’re educating companies: who are the stakeholders that they have to work with?

What are the arguments that are going to convince those stakeholders that investing in that technology is the right thing to do? And as we mentioned earlier, personalization takes a lot of forms, right? There’s surgical models, there’s preoperative planning and the software around preoperative planning. There’s tools to execute. So sometimes, that’s navigation and robotics. And then there are implants themselves. All of those tools can enable potentially better outcomes—but you also need to make arguments for all of them that they’re somehow creating better outcomes for the patient and potentially better financial outcomes for whomever that financial stakeholder is.

Pieter Slagmolen  14:04

It’s an interesting discussion: payments in general and how it will be achieved with this kind of new technology and solutions. Reimbusement in general is a hot topic in this space. In one of our earlier talks, we actually spoke to the chair of the RSNA special interest group Andy Christensen, specifically about the path that he’s laying out in terms of getting the point-of-care applications cleared for reimbursement. What you’re describing now in terms of the stakeholders being involved, you see a big difference between how the path towards reimbursement for point of care is laid out versus what a company typically undertakes to get reimbursement for their products.

Masha Dumanis  14:44

I think the point-of-care reimbursement pathway, it seems like we’re still sort of early in that curve of getting there. We’re early both in the technology curve for a lot of those pieces but also in that discussion. I think it’s going to take a number of steps; it’s going to take collaboration between thought leaders in the space. Those who are on the manufacturing side, I know that the regulatory bodies are creating pathways for point-of-care manufacturing. So that’s a piece I’m really hopeful that we can get there. But at the same time, point-of-care manufacturing...I think there’s still a lot of room potentially for innovation, but that’s probably going to be one of those higher price points. I’m just positing. The one thing that I was going to say is, as this technology matures, as all these technologies mature, the other hope that we have is that the price points will come down, right, on personalization.

To your point — I mean, your whole thesis is around mass personalization — if we can mass personalize the economic argument, if you can do something on a mass scale, you can bring down the cost. And we know that with 3D printing, we’ve enabled some of that. But, for instance, at least in the US, I know this was disappointing for a lot of people, but recently, CMS announced that it’s not, it’s no longer going to separately reimburse an additional value for computer-assisted procedures. So whether you’re going to navigate or do robotics, I think this is a proposed rule. But it is a little bit of a shocker because up until now, everybody’s sort of built their P&L, built their assumptions around acquiring robotics, around the fact that like, “Hey, I’m gonna get additional payment for this.” Now, you have to go in with the assumption that this is going to be an equivalent cost to me, whether I do a manual, say, joint replacement or a robotic joint replacement, I’m not going to get additional reimbursement. I have to decide whether there’s value intrinsically to me at the institutional level. And this is where I’m hoping that, from a technological standpoint, the costs are going to continue to drop on these technologies because we’re moving up the technological curve. There’s sort of the adoption curve, but there’s also the technology curve. And I’m hoping that we can kind of see those two things converge and we’ll see costs reduce such that we’re able to start to adopt these technologies, at costs that are not astronomical. Because unfortunately, we do live in a cost-constrained society.

Sebastian De Boodt  17:29

Of course, we do want to constrain those costs for very good reasons. Now, at the cost of the personalization as such is one thing, and I definitely agree that you look at advancements in AI and automation, things like that, that there’s definitely very concrete ways in which those costs can be brought down. Should we also look at it differently? Are there ways that personalization as such can bring down the cost of the procedure as a whole for a medical device company? For example, the huge SG&A spend. Basically, the cost that a company has to just sell the product, is especially in orthopaedics, quite high. Is this an area where maybe personalization could bring down that cost in one way or another? Or are there other areas where we should look at?

Masha Dumanis  18:13

It’s certainly one of the hypotheses that we hold, and we’d like to continue to see evolve. But as many of you know, everybody who works in this space knows if you’re going into spine or trauma or joint replacement, it doesn’t matter. When you go into one of those cases, you are going in (or the reps are going in) with multiple trays of instruments and trials.

Trials are actually what makes up a huge amount of the inventory that they bring. Inventory obviously costs the OEMs a fair amount of money to manufacture, so they spend millions of dollars upfront to manufacture them. And then, they have to be autoclaved and sterilized before every procedure. They have to be carted around and either stored at the hospital, or you know, for smaller volume surgeon facilities. The sales reps are carting them around in their trunks between facilities, which both contributes to high cost of the sales rep’s time and logistics costs because sometime they’re actually being shipped through institutions like FedEx. I think some of the large orthopaedic OEMs are FedEx’s largest customers. There’s a huge amount of shipping costs associated with these. There’s manufacturing costs, there’s shipping costs. On the hospital side, there’s the sterilization costs. There’s also maintenance costs. So those instruments, things like torque wrenches, sharp instruments, they need to be calibrated and maintained. We’ve already established lots of costs; if you can get to a personalized system, where you know the patient’s size and you are, for instance, manufacturing to that patient, one implant per patient, then you only need the instruments for that size. Oftentimes, those instruments that can be also 3D printed are also manufactured sort of on demand, which means they go through probably one sterilization cycle. That means you’ve reduced the weight of shipping by orders of magnitude, and you’ve reduced the upfront manufacturing costs. Companies are still unsure of whether they’re going to be charging for that instrument set incrementally or not...whether they’re going to, because they don’t actually charge separately for the instruments. Usually, they’re sort of rolled into the cost of the implant. But the economics are definitely different. It stands to bear out to what extent they’re better. But there’s an opportunity to potentially improve the economics, certainly to improve the logistics of today’s cases.

Pieter Slagmolen  21:09

I feel in a way that as an industry, we may have neglected that economic evidence a bit too much over the past decade or so. It seems the way that you’re describing it now, that with specific technology payments disappearing again from the market, that we should as an industry probably spend even more time on generating the economic evidence of our solutions.  Is that a correct observation?

Masha Dumanis  21:35

I don’t disagree with you. I think the challenge becomes that, for instance, on the hospital side, a lot of OEM companies will say, okay, yes, I want to generate the economic evidence to show that my solution or my new solution is better than my previous solution, or than a competitor solution. And so now, let’s make a budget impact model that we’re going to bring to the facility. And we’re going to show them what the impact on their budget is...the challenge is that hospitals and facilities are often challenged to understand their own economics and do not have a good sense of the economics of running an autoclave or, you know, a sterilization cycle... or what the actual economics are. And there are general numbers thrown out for, “Hey, this is the cost in OR per minute,” or “This is the cost of an autoclave cycle.” But the reality is, it varies widely by institution. At a large academic institution, it’s going to cost you one amount. At a small rural community hospital, it’s going to cost you another amount, so you have to account for that. But because of how hospitals are run, generally they have charges that they charge to the insurance company. They say, “Oh, we’re charging you this amount for this product,”  that doesn’t necessarily correlate to how much it actually cost them to run the OR. Nobody really knows the numbers really well. So it ends up being very challenging to do the actual accounting. And if you come to them, and you say, “We’re saving you whatever it is... $70 per minute, and they say, but that’s not my number. This is where it becomes challenging to do these financial models, which is not to say that you shouldn’t try, but you have to have a very thoughtful approach in doing these economic analyses.

Pieter Slagmolen  23:29

It almost requires like a dialogue with every individual institution to figure out how it works for them?

Masha Dumanis  23:37

Certainly, perhaps a range of inputs where you could have, like, “Let’s talk about what your numbers are,” to your point, a dialogue? Or “What do you think your inputs are?” potentially building a tool where they could put what they think their inputs are. The reality is, I mean, if you’ve seen some of the publications, like the cost of a total joint replacement at two different hospitals, even in the same state in the US, can be wildly different. Like 10s of 1,000s of dollars apart, which may be shocking for you guys in Europe. I don’t know to what extent it’s more standardized, but this is some of the challenges that we face economically in the US.

Sebastian De Boodt  24:24

Is there any light at the end of the tunnel? It seems like it’s a systems problem that we have. And I guess, today, all the medical device companies would kind of do this convincing on their own. Is this even realistic? Is there just something more on how the ecosystem is organized that needs to be improved?

Masha Dumanis  24:43

Sebastian, I feel like you’re asking me questions that if I knew the answer to I would be something like the President of the United States. They are fair questions. We admittedly live in a flawed system. I think some health systems do a better job than others at controlling their costs and understanding their costs, but those systems tend to also be very strict and careful with the technologies that they bring in and are very rational about the added costs. I think there’s a trade-off to being very regimented with your economics, but also having that understanding and being the door to innovation at facilities and systems, like that can be a little bit harder to get through. But do I see a systems-wide, a country-wide solution in the very near future? I’m not sure that I do. These are probably outside the scope of this discussion. I don’t think that means that we shouldn’t keep trying. I think that, on the whole, getting back to this question of evidence generation: if we are creating a better product clinically, first and foremost, that’s our first argument, right? And then can we show that it is improving other things? Like, is it improving workflow? Is it like reducing time spent, you know, surgeon fatigue? Are there other downstream implications and, ultimately, economic implications that can be improved? But I think first and foremost, we have to show that these technologies are having some impact on the clinical outcomes

Sebastian De Boodt  26:39

Yeah, let’s bring it back to that, right? Because it’s the goal of what we do want to achieve. Through your role, you’re being exposed to a lot of different ideas and early products that people want to get into the market and into patients. Do you have any recent personalization-related devices and innovations where you feel, “Okay, this really taps into a very clear unmet clinical need and looks really promising?” What are the big stars that you hope will be emerging in the coming years?

Masha Dumanis  27:13

That’s an interesting question. We’ve seen implants that are shaped in a personalized way. And now one thing that we’ve recently seen, are materials that are personalized. For instance, and I apologize, because I don’t remember the name of the company, but essentially, it’s 3D printing. I think it’s a spine spacer, an interbody spacer, but with the modulus appropriate to the bone of that patient. It’s there to address patients who have either osteoporotic bone. It’s interesting. We’re getting into, not just geometries, but also, you know, material properties. Is this the innovation that’s going to drive excitement? — I’m not sure. But I just think it’s interesting what we can do with personalization, being able to modify not just geometry but also materials. I know that in the last five years, we’ve done a lot with metal on the 3D printing front, and we’re now moving into more 3D printing of polymer and PEEK, which people will say what they will about it, but there’s definitely advantages and disadvantages—but there’s the radiolucency piece of it.

And I think in the future, we’ve always talked about bio-printing. I don’t know of any one particular company that’s at the forefront. But I think that potentially it’s still one of the things that could be really exciting. Could you print, for instance, could you take an imprint of a cartilage defect, and then print something that fits into that cartilage defect that has regenerative properties? I think we’re still a little bit of a ways away from understanding how that would be regulated; we probably already have some of the material, you know, given what we have on the market today (or what’s emerging on the market). We have some really great approvals in the cartilage regeneration space. I think we probably are starting to get the materials together. But I think the next step is understanding, “Okay, how do we manufacture that, and then how do we get through a regulatory approval to do that?”

Pieter Slagmolen  29:38

Those are areas that we’re also very excited about, obviously, in the expansion of the materials, the fact that you can start personalizing function rather than just shape. And then indeed, the whole concept of regeneration and what’s going to be required to actually realize that, rather than just put it on a slide — that’s going to be extremely exciting in in the years to come. I think with that, maybe one of the questions we had on our list to ask as well is: knowing that this is coming and that this space is evolving still, what are the main recommendations you would give to industry leaders at this point if they’re looking to determine their priorities?

Masha Dumanis  30:19

That’s a great question. I had talked about a few of these in my summit presentation. Evidence generation we’ve talked about as a theme, I think, in order to generate evidence, you have to have a focus area. Right? So once you’ve identified the focus area, then you can generate evidence. But I think going back before we talk about evidence generation, to talk about how to identify focus areas, you need to understand areas of unmet need. And as I talked about earlier in this chat, I don’t think that personalization is going to be the answer to every issue in medicine. Right? I think we need to understand where does personalization and issues in medicine today, where do those issues cross?

There are places where we can create a geometry, or we can create a material or a material property that we couldn’t previously do. Or can we image something and now understand something new about that anatomy that we couldn’t previously do with the off-the-shelf technology? Does that somehow enables the patient to get better, faster, or, you know, heal faster—or get back function in a new way, in a better way, reduce their morbidity? Once we’ve sort of identified those areas, and I think that’s an ongoing task, it’s not necessarily like, yes, we’ve done it! Now, we’re good. Now, we move on... I think it’s an ongoing task, because we’re going to end the technologies improving. And so maybe we’ve identified a few areas, now we’re going to do the evidence generation and the commercialization.

In parallel, we can continue to discover other areas that better technology can address. There’s sort of this continuum that’s continuing to happen. I do think that it’s this sort of progression of identify the unmet need and match it to technology and then sort of prove your point through evidence. You know, in parallel. I mentioned working with regulators, ensuring that there’s either already a framework, or as you’re developing this technology, working with the community, working with others in the space to communicate with regulators. Whether that be key thought leaders who are really big proponents of personalization or medical societies and associations, really ensuring that there’s a path forward. Once you have that, once you’ve developed that technology, making sure that there’s a path forward to clearance. And also think as you’re doing the evidence generation for clearance, making sure that you have commercialization in mind, too. I think that’s the one thing that we’re always talking to our clients about, is that when you’re creating your clinical plan, you have an opportunity to create a study that’s going to be impactful for those who are not just going to approve the technology, but are going to adopt it and pay for it. You don’t want to have to do that twice or three times. Once it’s already approved, you don’t want to be like, “Oh, it’s approved. Now what? Why isn’t it getting used?” You want to develop that clinical study correctly the first time around. So no, that was a lot. But I think there’s this continuum of activities that we have to that we have to build on.

Sebastian De Boodt  33:53

I think it’s a very nice answer. And I think it’s also a very good illustration of what you said in the beginning of things you took away from your studies into your current role. You clearly have a very systematic scientific approach to how you think it should evolve, I can definitely relate to that! Now, as we’re almost getting to the end of our episode, we would like to discuss an issue that’s a bit off topic, but we’re all aware of it. It rarely seems to be discussed on air. Peter and I, we are very lucky to be in an organization where there’s a nice equal leadership ratio between men and women, perhaps you have some thoughts on making medtech in general, more friendly and exciting for women to join the industry because, in truth, if we look around us, and also in when we’re thinking of guests to have on our podcast, for example, we need to acknowledge that today there are still a lot of men in the industry, and maybe women bring an important perspective that we lose or an innovation arrives from a majority in one gender. Very curious to get your thoughts on this topic.

Masha Dumanis  34:59

Well, it’s a surprise topic to me, but I’m so glad that you’ve mentioned it. I am also really lucky, truly blessed to be in an organization where we have a lot of female leadership; we were kind of founded with that mentality. And we’ve always had at least 50 (or more) percent female leadership. And it’s part of the appeal of my organization to me, and I think all of our medtech leaders in our medtech team are all women. So for me, I don’t think about it on a day-to-day basis, because I’m surrounded by female leaders. But if I go to a conference in the med-tech space, particularly in the musculoskeletal space, for sure, I see what you’re talking about.

To be honest, I have a daughter, I have a young daughter who just started first grade. I think part of it starts with the education of our next generation and making sure that STEM, (or STEAM as they’re now calling it, in which the a in steam stands for arts) but making engineering and science an appealing and exciting place for our young girls and young kids to go into and make sure that they have mentors and leaders that they can look to. That’s part of it, right? We have a shift in generations, we have a shift in mentality. So that sort of thinking about the future, I think that we are well set up for that and enabling those programs, building programs around that and mentorship. Within what we have today, I think it’s creating peer networks and creating mentorship networks trying to show women in business and in medtech and in engineering that there is opportunity, that women are respected. I think part of it is just honoring the equality, the promise to equality. And again, for me, it’s a little bit foreign because I’ve grown up in an environment from a career standpoint where it’s a non-issue. I am very lucky to not have to live those challenges. For me, the reality has always been equality. Of course, there’s equal opportunity. Of course, it’s a meritocracy. And we have lots of women engineers, biomedical engineers, so I’m surrounded by that on a day-to-day basis; it’s really exciting. But I think it’s showing others that these environments exist, that women can be respected leaders, thought leaders, and really trying to grow a new generation — whether that new generation is today in college or early in their career or whether that new generation is like my daughter in first grade.

Pieter Slagmolen  38:00

Lead by example, in the short term, that’s something that you can do by your own. That’s great to hear.

Sebastian De Boodt  38:06

To conclude the show, I’m curious to hear your perspective on your future, and maybe also a bit about your personal future. Or on topics which you are advising companies today that you think you will no longer have to advise them within five years? And what are some of the questions you hope to be able to focus on at that time?,

Masha Dumanis  38:28

Topics I hope to no longer advise on in five years? Um, well, you know, this topic that I mentioned that we are continually telling them that they have to plan for commercial evidence generation within their clinical plan. I feel like we’ve been talking about that for ten years. So, I’m kind of hoping the message comes across. But frankly, I think that the topics will evolve, but they’re not going to radically change. I think that we’re still going to be talking about evidence generation. I think that, you know, one of the topics that we’re talking about today a lot is the rising consumerism and rising role of the consumer decision-making and whether that is things like out-of-pocket pay or just the role of the consumer in their own medical decision-making, even in surgical decision-making where they didn’t previously have a role. I think that that’s going to continue to be a topic of interest. It’s inevitable, right? Because today’s consumers have access to more information from a medical standpoint.

Pieter Slagmolen  39:49

Are you advising companies to already take that into account into their current strategies? To think about rising consumerism?

Masha Dumanis  39:56

We have companies who are certainly asking about it. And certainly, as I think Sebastian mentioned, one of my areas of interest is women’s digital health. I do collaborate with our digital health practice and do some work on the digital health side. The consumer obviously makes a lot more decisions on the digital health side than they do on the medtech side. We see that permeating into medtech, as well. We’ve certainly done a number of projects trying to understand both direct-to-consumer marketing, like trying to understand self-pay products, off-the-shelf products. I think it’s going to continue to be an increasing topic in medtech and the intersection of medtech and digital health in the future.

Pieter Slagmolen  40:43

Okay, I think we’re pretty much at the end. Thanks a lot for joining us, Masha. I think for me, our three key takeaways from this conversation are probably: one, personalization is not necessarily about personalized implants, we should definitely look at it at a broader level. Two, I hear a lot about evidence and evidence generation, both from an economic and clinical perspective. That continues to be a key driver that we should all focus on. Maybe lastly, I’m not sure whether I want to say it like this, but essentially, we all live in a flawed system. Somehow we make it work as long as we find ways to improve the care for patients. Which, in a way, is the light that we also put up for ourselves in our everyday work. So that’s what keeps us going. Thanks a lot, Masha. This was a really exciting talk with you.

Masha Dumanis  41:38

Thank you so much for having me, and continue to do the great work that you are doing! I agree on your last point. I think what we all do, we come from different directions. But our goal is all to make a society and technology that improves patients’ lives. I think that’s why we’re all gathered around this table.

Pieter Slagmolen  41:58

Thanks, Masha. We appreciate your sharing your insight with us on 3D Players, a podcast where we explore trends, insights, and innovations in personalized and sustainable healthcare. We’re your hosts, Pieter Slagmolen and Sebastian De Boodt. Thank you for listening, and join us for the next edition!