Episode Transcript
<intro> How do I get FDA approval for a medical device? How do I get funding? How do I sell a medical device? How do I how do I how do I? I'm Kayleen Brown, managing editor for DeviceTalks. We are on a mission to unravel the complexities of the medical device product development cycle. In each episode, we take a deep dive into a specific stage of this journey, guided by the expertise of senior medtech leaders who have not only experienced it, but have mastered it. This is MedtechWOMEN Talks. <end intro>
Rebecca, welcome to MedtechWOMEN Talks. I'm so pleased that you're here.
Thank you. I'm excited to be here.
Would you take a second and just give your name or title and a little bit about your background?
Sure. So Rebecca Whitney, and I lead our global spine organization at ZimVie. We were part of Zimmer Biomet until about 18 months ago. So ZimVie is the newly formed, but I'm not that new anymore. But spine and dental organization. And I feel very lucky to lead that global organization since we've been. I've been in medtech, my whole career 20 plus years, always more focused on the sales, marketing, commercial strategic side of things, and have felt very lucky to have worked in a whole range of small startups to the largest companies out there and kind of everything in between. So this to me is kind of a culmination of all of the different experiences I've had that have led me to to this and just having an absolute blast.
I had to dig in. So you have 20 years of experience in the industry. But what was that door, you walked through? What was the entrance into medtech?
So this was kind of a happy accident way back when, and I feel so fortunate that I found myself in this space, because I can't imagine doing anything else. But essentially what happened is I thought I was going into finance, I've always been a pretty data driven person and was interning at Merrill Lynch when I was in my undergraduate education, and went to grad school to further that finance career. And it was during grad school where I realized I was getting my MBA. And I realized I can take this analytical data driven approach, and couple it with this more customer facing kind of more strategic commercial side of things. And that could kind of be a sweet spot. So that's how I kind of moved into more of a marketing path still in school. And I ended up interning at BD, Becton Dickinson, my second year of grad school. And that's what got me into the med device space. I didn't know what I didn't know, I was very young. And I took the internship because it sounded like a fun space to learn. And I loved every second of it. So from there, it just kind of built and grew and one thing has led to the next and I've never left medtech. And I don't think I ever Well, I think it's just a fascinating, exciting space. And I think for me personally, it feels good to know, I know, it's very cliche, but it feels good to know that at the end of everything we do, there is a patient whose life is hopefully getting better because of the products that we bring to market. And so that really matters to me. And I know for my team as well, that's kind of what helps keep us going when, when work gets to be, you know, a bit much as it always can from time to time. So knowing there's a greater purpose behind that is what's kept me in it's been really fun.
Oh, Rebecca, you're speaking my truth. I couldn't agree more. And I find that our industry, so familial, and once you're in it, it's impossible to leave because your heart is here. Yeah. And you're around to other enthusiast who are so smart to do anything with their lives. And they're choosing a hard road, because what you just said, because of those outcomes. So it's such a privilege to be with you here today. And to be in this industry. Yes. Agreed. Agreed. That being said, let's talk a little bit about the medical device product continuum. So beyond your title and your specific position, can you describe your role in the broader sense of the medical device product continuum? Yes,
definitely. So I always look at my position as being primarily responsible for two big things. One is setting the strategic vision of the organization. So who do we want to be? What is our identity? How will we make a difference? It's not that exciting to me to just be part of an organization, and I never have that where we're just kind of going along with the status quo. So what is that vision? What's gonna set us apart? And then two, which is equally important is how do we drive that execution and turn that vision into life? So and into reality, I should say. And the way to do that I have found over the years is through other people, there's no way that I on my own, can do that. So team building is a big deal to me, making sure I have the right leaders in the right roles to help craft that vision, and then take that vision back to the various parts of the organization to drive that execution. So in super simple terms, it's setting the strategy, rallying people behind that strategic vision, and then driving the execution to actually deliver results and turn that into a reality.
You're speaking a lot about collaboration. So how does your role fit within the larger medical device product continuum? Yes,
so I've got a very close knit leadership team. And I've learned over the years that that's a critical element to this entire recipe for success. And so I have representation from all of our global regions as well as all of our functions. So my sales leader in Europe, for example, talks to my r&d leader on a daily basis, if not more frequently, and vice versa. So we've got this connective tissue that allows us to really focus on driving innovation and product development from the very getgo. So as we're setting our strategy, we've got that key input from all the different parts and pieces. And then product innovation, of course, is so critical to anything in medtech. But I think particularly in spine, there's a need to be constantly addressing some of these, these clinical problems that still linger. So we're very focused on finding those unmet needs and bringing unique novel solutions that truly do impact patients lives. So as a leadership team, everything we do, but it's kind of embedded in how we think about it. And there's that constant back and forth feedback loop between the commercial leaders and the product development engine. So we get that constant energy and momentum that is kind of always in motion.
Also, you were talking about the feedback loop. So you and your constant communication, constant collaboration, how do you have a strategy in place or sort of steps in place where you take that feedback and implement it?
iYes, so we have a lot of process. And we're not a big bureaucratic organization. But I have found a, we have found that that process helps us, it either validates the decisions that we've made, or brings new ideas to the table. So, of course, it always starts with the customer. And I would define our customers in three major buckets, we have the end users and patients. And I do think that's critical. It's sometimes easy in med device to think of the physician as the end user customer. But ultimately, if the patient is not getting the outcomes they need, I don't know that we've done our job to the full extent that we can or should. So patient is kind of stakeholder number one, in this case, the surgeon, the clinician, for us as a surgeon, so that's stakeholder number two. And then the third piece is our Salesforce, because Salesforce are the ones that are out interfacing with the surgeons every day in the operating room, supporting the surgeries as they take place. So we are constantly seeking feedback from all three of those stakeholders that gets fed into our product development process. Again, we capture that feedback very formally. But then also on an informal basis, every time we're out in the in the field, talking to customers talking to patients, or gleaning those insights and bringing that back to this leadership team, where my r&d leader is primarily responsible for kind of housing all that which then translates into future ideas to make our existing products even better, or potentially go into new spaces to address problems that haven't yet been solved.
So, on the ground feedback, real world feedback is vital to your operation.
Absolutely. And I'll just one quick point on that. Our engineers as well as our marketing team, not just our salespeople, they're in the field all the time, they're in the operating room, watching how the surgeons are performing the surgeries, building those relationships with our customers, so that they're getting that and they're hearing it without the filter, so nothing's lost in translation.
Excellent. Well, thank you for that. Yes. Let's shift a little bit that we talked about on the ground boots, how important is to have that vital feedback. So let's talk about you specifically and your role. So at what point in the product development cycle, do you personally get involved with a go no go decision.
I would say all throughout, there are a couple of reasons for that. One, I think it's just the right thing to do. But spying specifically is a very high touch sport. So you've got to have that very deep knowledge and understanding working knowledge of what our customers are looking for. So the way we do this is we'll set a strategic plan, I was talking earlier about the need for setting that vision. And what we have done is identify opportunities were a few things have to line up for us. We're a major player in the spine space, but we're not the biggest. And so for us to go up in what we call the messy middle and try to compete and bring innovation into an already very cluttered space, it's probably not going to be the best path for success for us. And on top of that, we're going to dilute a lot of resources where we could be spending our time and energy really making a difference. So we are all about motion preserving solutions. And essentially what that means is the gold standard for spine surgery is you fuse the vertebrae. So if somebody's having pain or discomfort, the clinical gold standard historically, is to just fuse, it just put screws and rods in kind of an internal bracing system and stabilize the spine by fusing it. And that usually solves part of the problem. But the problem or the challenge with that approach is that you you limit or reduce motion in the neck, for example, or the lower spine. So we've got these devices that allow us to actually solve the clinical problem while at the same time preserving motion. And we have one really cool device for pediatric scoliosis, kids seeking treatment, and then one for adults who have neck related injuries. The reason I bring this up is we have decided and we are very committed to continuing to drive our innovation in those key categories where we have a market leadership position. It's an underserved market where most patients aren't aware yet that these solutions even exist. And we know that we've got capabilities to innovate in a space more effectively than our competitors. So that's We start and we kind of set the strategy and say, Okay, we're passionate about this, we believe we've got expertise that will lend us very well to serving this patient population. And we're actually making a difference for people. So once that's done, then we kind of look to round out our innovation into the other parts and pieces of our portfolio. But it takes a lot of discipline to say, we're gonna do this first, even if it's at the expense of these other things. And then we'll get to this prioritized list once we kind of move down the ranks. And so we always look at every opportunity through that lens of does it fit with that mission and vision we're trying to achieve. So anyway, that's a little bit about how we do that. So I get involved very early, with setting that strategic direction. And then we have a lot of fun with the way these projects come to light, we've actually we call it Shark Tank, but it's kind of that internal phase Gate Review, which is very standard for a big med device company. But at every step of the way, I'm in those phase gate reviews, as are all of my leaders, both the regional commercial leaders, as well as the functional leaders. And we are not afraid to course correct, or cancel or initiate projects at any step along the way. So that's some of that feedback loop we were talking about, where we're constantly seeking feedback on these prototypes and these ideas. And then we have these formal reviews to say, do we continue with this? Do we tweak it? Or do we kill it? And I'm involved in all of those as well as my leaders, because we just think it's such a critical element of putting our strategy into action.
Rebecca, you had mentioned that you, during this kind of Shark Tank and these reviews, you don't hesitate to kill an idea. Is there a tipping point where you know, you've gone so far, you've invested millions you've invested time, effort years even, is there ever a point where you say, there's enough clinical evidence that there's better outcomes, let's move forward or based off of that feedback loop? If it just isn't the right move? You and your team still feels like it's time to kill the ideas as you put it?
Yeah we do. And I think that's a really hard thing for leadership team to do. But it's absolutely essential. So we had a major project that we had dumped years and millions of dollars into just two years ago that we ended up moving in a different direction, and it was absolutely the right call. But it's very difficult to do that, because you have team members who are emotionally invested to your point that the money has been spent. But to me, that's a classic sunk cost fallacy. And if you continue to double down on something, regardless of years and dollars that have been put into it, if you know what no longer makes sense. And there's also an opportunity cost there that gets freed up, when you're able to make those tough decisions could you can redeploy the resources and the energy and the focus elsewhere. So those are always the toughest decisions. Obviously, it's a lot better when everything continues to fly through. But not every product development initiative will be a homerun, it just won't. And so I think it takes that discipline and that active portfolio management to constantly assess and go into every one of these reviews with a fresh set of eyes. That's where I tell my team, we need to act as though we've never seen this before. And we're reviewing this for the very first time in today's market with today's competitive landscape with today's solutions.
That's so encouraging from being on the other side of the industry where I get to see it from this 40,000 foot level. And I feel like it really builds trust in these larger organizations where sometimes there's questions you don't really know. Yeah, my so this is really encouraging to hear. And I applaud you and your team for taking that perspective.
Yeah, not always easy. But I have found over the years, it's the only way to ensure that we're doing right by ultimately, the patients and our customers and everybody else.
Here Here. So let's shift a little bit we talked about, we talked about a lot of things, but maybe the talk about the market and somebody's global footprint. So how do you tailor product development for various global markets? You have diverse health needs regulatory? How do you navigate that?
So ideally, you'd have one product for a global market, that would be Nirvana, that is obviously not reality. So to your point, I mean, the regulations alone differ quite a bit by region and by country. On top of that customer needs are different. So sometimes it's the product features and benefits. And I'll talk about how we solve for that. But a lot of times too, is the the economic barriers to entry, and making sure that we are not developing products that are going to cost us out of certain markets. So we're very cognizant of that. And it's something that we incorporate into the Stage Gate reviews where every regional leader will weigh in on where the applicability is for any solution we're considering. And we try to be very mindful to serve a global market, while at the same time catering that to make sure that we do have individualized solutions where we have to So it's a balance. We start with a global footprint and a global roadmap, but then we will supplement, augment, subtract as we need to address these various markets. So just one example of that. In Europe, tenders are very, very important. So getting onto these long term contracts, very important and a lot of that is cost driven. And a lot of that is having very specific company Let's have the spinal implants to compete. So that's not any that we necessarily have in most parts of the United States. So we have sourced specific solutions for that part of our business so they can compete effectively at a price point that makes sense for that market. So we do, we definitely try to be flexible. And we are at the same time, sometimes we have to make the tough decision, just like do we kill a project to say, does it really make sense for us to pursue product x into country why? So having that discipline, again, to kind of look at selling the right product into the right countries, and then filling the gaps that makes sense, is really appropriate. And doing it all at a price point, that is also going to be acceptable? It's about market and following the regulations. So it's complicated, but that's what makes it fun.
I like your perspective on that. If you don't laugh, you cry.
That's right.
So we talked about collaboration, we talked about on how you really looking deep on developing new products and making hard decisions. When we're talking about product development? How do you strike a balance between developing in house or externally?
Great question. And that is something that we look out for every single growth initiative we take on. So I like to start by being very agnostic and identifying the need first. And as I was saying earlier, do we have a right to win in that space? And do we have basically that, that subject matter expertise that will help us a lot of times, what we will learn is, there's a real need here, we don't believe we're the best people to bring this to markets, because of just the way our team is wired, I'll give you a real life example. The project that we killed that we walked away from was an enabling technology space, this is navigation and robotics. And we knew our engineers, their their primary skill, set our implants and instruments, and they're amazing at it. They are the inventors of some of our best flagship products internally. So the more we looked at this, we said, You know what, we're gonna have to teach our internal team how to become software engineers, when really they're biomechanical engineers, and that's where their sweet spot really resides. So we walked away from the internal development. And we instead sourced an external partnership with BrainLab, which is truly the best in the world when it comes to enabling tech. And when we put this partnership together, we realize our engineers can focus on what they do best that bring them engineers can do what they do best is this wonderful, complementary relationship. On top of that, it gets us to market with a very relevant, very competitive platform pretty much overnight, because we're able to leverage BrainLab, versus trying to build it internally. So I think knowing your strength, and knowing when it's better off to partner externally, is really, really critical. Because now those engineers, they're super excited about this is a great partnership. And we're able to accelerate internal development of some of those very unique devices in the motion preserving space, because our team is not trying to teach themselves how to be software engineers. So I think when done with the right lens, and kind of that critical approach to say, Can we do it better than anybody else? Or is there somebody else out there who has a passion for the space we're trying to get into, and then not having the pride or ego to try to hang on to Bob. So our engineering team was fantastic at that kind of knowing, here's where we can do it best. Here's where they can do it best. And then collectively, we all win.
Well said. And that's a bigger question than a lot of people have is, so I'm sure that there's a lot of a hopeful potential partner if you want to get in front of you. So do you seek out partnerships? Or you invite potential partners who think they can help move development along or help support ZimVie? How do you navigate that?
both both. So sometimes, we're very strategic and intentional, like this enabling technology, we canvassed the universe and eventually ended up with bring lab which we're very excited about. But we are constantly being approached by everything from a small product with one inventor behind it to smaller organizations, we look at everything. That's another part of our Shark Tank kind of review process is we have a business development pipeline that includes all of these opportunities, whether we seek them out, or others are coming to us. Sometimes opportunistically, it works out. Other times, we have a need to drive that conversation. But again, it's all part of that feedback loop. Keeping our eyes and ears open. And always being open to considering some of these technologies is critical, because you just never know when the right fit might come along.
Again, very encouraging. And talking about the industry and its current landscape. When we move into AI and machine learning, I think you would agree that it sort of all bets are off and we need to rethink everything. And generative AI in particular is really democratizing AI for people like me, that being being said, how has and maybe how will one of two parter AI machine learning change your role or your responsibilities or how you approach what you do?
Yeah. So I think we've just started into his collective journey. It's going to be really fascinating to see how it all plays out. But I've said for many years now, I think the best future innovation at least when it comes to spinal implants will take place beyond the implants and AI is a big part of that. So all of us enabling technology, this made their way into spine surgery is just the first step. And I think AI specifically as it relates to predictive analytics, in terms of predicting how a patient is going to do once they receive a certain type or style of surgery is going to be absolutely critical. One example on that. So patient selection is really important. And this pediatric scoliosis device we have called the tether indicates it well, it's indicated for patients who are within a certain window of time left to grow to skeletal maturity. And we believe that by using these algorithms and AI, we can start to predict outcomes based on the size and growth rate of the patient. And by doing that, we'll be able to dramatically improve outcomes. So I think AI is going to play a huge role, not just for us as as the device manufacturers, but also for surgeons and the way they approach treating their patients. It's exciting. And I think it's going to make us better, at least from a spine perspective, the clinical outcomes still have so much room for improvement. And I think AI and predictive analytics is kind of the last piece of that puzzle. So really excited to see where we go next.
I have to echo your sentiments. Kind of from my perspective, I feel like AI is allowing us to do more human things more human.
Yes, yes.
So it's kind of saving that time. Well, Rebecca, I've enjoyed our time together. So I've just one last question for you. And I wish I could keep you here forever. However, you have a big job. So that being said, is there one thing you want our audience to know about the medical device products cycle?
It takes a long time for a reason. That's what I would say, I get asked all the time by our sales force, sometimes by surgeon customers, why does this take so long. And having done this for a long, long time, it takes a long time for a reason. And I think I know I'm not the only company, we're not the only company who feel this way. There's a huge responsibility that comes along with bringing medical device technology to the market, because our products go inside of patients. And so it takes a long time, we're very thorough, the FDA is very thorough, for a reason. So I think it's worth the weight, but kind of setting expectations both internally and with our customers to help people understand everything that goes into it. It's very thorough, and there's a lot of work from a lot of people that are taking really close looks at this to make sure that by the time it hits the market, it's safe and effective, first and foremost. And then hopefully, it's also truly making a difference and changing the paradigm and the standard of care.
Thank you so much for joining us on MedtechWOMEN Talks. So Rebecca, thank you again for spending your time with us. It has been an absolute pleasure.
Thank you. I really appreciate it. Happy to talk anytime.
<outro> And that's a wrap. Thank you so much for joining us on this episode of MedtechWOMEN Talks. Please share this episode on social media to your co-workers to that new hire who's overwhelmed by the nuances of medtech. And to that seasoned executive who is looking for a way to educate and inspire. Please like follow and subscribe to the DeviceTalks Podcast Network to never miss an episode. Our next will feature YJ Oh, senior vice president upstream brand, global and US marketing at Edwards Lifesciences from the perspective of the "go to marketer." But before I let you go, I'd like to shout a big thank you from our figurative rooftop to our sponsors Aptyx, Catalyze Healthcare, Confluent Medical and Cretex. It is only with their support that we've been able to create this incredible series. Want to join the best sponsors and medtech? There's still time to connect with me on LinkedIn or reach out to our DeviceTalks editorial director Tom Salemi. Once again, I'm Kayleen Brown of DeviceTalks and we'll be back with YJ Oh, Edwards Lifesciences. <end outro>
