November 17, 2021
A life-saving intervention for his newborn son convinced David Moeller to steer his career into Medtech. Now he oversees Medtronic’s peripheral vascular group which helps keep blood flowing to the body’s vital organs. In this episode, Moeller lays out the health crisis brought on by poor vasculature and how Medtronic is targeting five critical areas to help people live fuller lives.
Tom Salemi (00:00):
Hey, everyone. This is Tom Salemi of DeviceTalks. Welcome to our newest member of the DeviceTalk's podcast family. It's called MedtronicTalks. Our constant search to find new ways to bring insights in the medtech industry led us to the fine, fine folks in Medtronic. They've agreed to make their senior leaders available to us and to you. In each episode, we'll discuss the opportunities and challenges facing one of medtech's clear leaders. So you'll have an inside view on what makes Medtronic go. We'll ask the questions. Medtronic will provide the answers, and our great network of sponsors makes it all possible. So sit back, hop on a treadmill, take the dog for a walk, whatever you do when you listen to a great podcast, and let's listen to how Medtronic is getting the job done. Let's go.
Tom Salemi (00:45):
Hey, everyone. This is Tom Salemi of DeviceTalks. Welcome to the MedtronicTalks podcast. In this episode, I'll speak with David Moeller. Dave is a Senior Vice President at Medtronic. He's also President of the Peripheral Vascular Health group. In this interview, I will talk with David about his path into medtech.
Tom Salemi (01:04):
His introduction started with a lifesaving procedure that needed to be performed on his newborn son. That experience allowed David to see the importance of the medtech industry. And he has been a crucial part of it ever since now. He oversees Medtronic's Peripheral Vascular group, which of course, helps keep the blood flowing to the brain, the heart, and other vital organs.
Tom Salemi (01:23):
In this episode, David lays out the health crisis brought on by poor vasculature and explains how Medtronic is targeting five critical areas to help people live fuller lives, and of course, to grow the business. Before we start this episode, I'd like to bring in our sponsor, Tegra Medical. I'm here with Mike Treleaven. Mike is Senior Vice President of Engineering at Tegra Medical. Mike, why don't you tell us about your company?
Mike Treleaven (01:48):
Tegra Medical is, as our tagline says, where medical devices come to life. We contract manufacture complex components and devices exclusively for the medical device industry. We have a large range of manufacturing technologies like laser processing, precision machining, and injection molding. And we make single-use and reusable devices, many of which are for minimally invasive surgeries in areas such as cardiovascular, orthopedics, spine drug delivery, and many others. Tegra Medical was created by combining companies that were experts with certain manufacturing technologies. It was all part of a strategy to create a single contract manufacturing organization with the synergies to offer true end-to-end contract manufacturing.
Tom Salemi (02:29):
We'll hear more from Mike Treleaven of Tegra Medical a little later in the podcast. If you want more information on Tegra Medical, go to Tegra... Tegra is spelled T-E-G-R-A... Medical.com.
Tom Salemi (02:43):
Well, David Moeller. Welcome to the podcast.
David Moeller (02:45):
Thank you, Tom. Thank you for having me. I should be thanking you. I've been reading your articles for several years, so.
Tom Salemi (02:51):
Oh, very cool.
David Moeller (02:52):
Thanks for keeping me informed and educated.
Tom Salemi (02:54):
That's awesome. Now it's been a nice, interesting topics to write about. I've had a few great opportunities. So I appreciate that comment, but I do want to follow up on or learn more about the Peripheral Vascular group that you lead. But first, I'd like to find out how you found your way into the medtech industry. You didn't start right from the beginning, correct?
David Moeller (03:15):
You know, I had coming out of undergraduate, I had very little interest in healthcare, to be honest. It was while I was in graduate school when my oldest child was born. He was actually diagnosed in the womb with a critically severe heart defect.
Tom Salemi (03:33):
Oh my gosh.
David Moeller (03:33):
And so we knew that an intervention would be required just within a few hour as of being born, or it would be fatal. And so...
Tom Salemi (03:44):
Oh my God.
David Moeller (03:45):
For whatever reason, the doctors allowed me to be in the room after his birth as they decided what approach to take, whether to do an open heart surgery or at least to attempt a minimally invasive approach to open up his heart valve. And so they decided on the latter, and they used, I think, they used a coronary balloon to open up his heart valve and was actually very successful. And so he's now a healthy, in his late teens. He loves to run and play sports. And I remember thanking Dr. Nyhill who performed the procedure, and I'll never forget what he said at the time because he said it's not rocket science, it's just plumbing. And that's really what got me excited about medtech. And, and so, that's what got me here.
Tom Salemi (04:40):
So how did you act on that? What were you doing at the time? What was your first job in medtech?
David Moeller (04:46):
Yep. I was in business school at the time. He was actually born between my first and second years of business school. I knew at the time several people who had actually gone to intern at Medtronic and people a year ahead of me who had gone to work for Medtronic and came back, and they were raving about this mission-driven company. And they seemed very, very happy. They seemed happier. I was on my way, probably most likely, to Wall Street, and they seemed happier. So I... That's what led me to Medtronic.
Tom Salemi (05:23):
All right. Well, you've been there close to 20 years or over 18 years. So I guess you're happy as well.
David Moeller (05:31):
That's right. That's right. Over 18 years. And it's been quite a journey.
Tom Salemi (05:35):
Well, let's talk about your Peripheral Vascular Health group. Give us an overview. This is one of the new groups created during the reorganization, correct?
David Moeller (05:44):
Tom Salemi (05:45):
It's an interesting group because I never really thought about it. We talk about all these destination places, the heart, the lungs, the brain, but there's a highway in between at all. Is that all your domain?
David Moeller (05:55):
That's exactly right. That's exactly how I think of it. Medtronic has other businesses that are really dedicated to optimizing blood flow to the brain, and a business dedicated to optimizing blood flow to the heart. And we're, for the most part, we're pretty much everything else. Optimizing blood flow elsewhere. We have a purpose statement in our business. It says we get people back to fuller lives, the right blood flow for the right patients. And so, and the right blood flow is both for arteries and veins, but it's also more flow in some cases stopping flow, in some cases diverting flow. So it's pretty diverse. And I think what's most exciting to me, Tom, is in this space, when you think about it, the degree of unmet needs that remain in this space are pretty exciting.
David Moeller (06:51):
So, I can give you a couple examples. One is just the number of amputation. I think in the United States alone about 140,000 amputations a year in the US caused by peripheral artery disease. And we think that a lot of those are really avoidable, and over half of those people getting amputations are not getting revascularized or having their blood vessel opened for the year prior to getting an amputation.
David Moeller (07:21):
Another example is chronic venous insufficiency. If you think about varicose veins, and a lot of people think of that as more of a cosmetic issue, but it's a progressive disease. It leads to pain and swelling and discomfort and less mobility and even venous ulcers. And in many parts of the world today, vein stripping, which is as barbaric as it sounds, it's still the standard of care. And so, there's some glaring unmet needs. So we're trying to solve those unmet needs with evidence, with technology, and with market development.
Tom Salemi (08:01):
What are the challenges of focusing on this area? Is it that there's no... I mean I'm sure there are medical societies that cover, but is there a community like there would be for the heart or the lungs, the brain, or other organs? Is there just little attention paid again because it's the in between space between all those organs?
David Moeller (08:22):
Yeah. The way we look at it, Tom, is in, I would say, in five distinct markets. So I think each of those markets has their own societies and advocacy. So it's not probably one that crosses all of them. And that's what I think what makes it complex, but also it makes it very interesting. And so those five distinct markets that we play in are... The first two, I've highlighted two. One is peripheral artery disease. The other is superficial venous. Those two make up the majority of our current business today. The other three are really exciting high-growth markets that we're trying to really accelerate our participation in those markets. So those would be the arterial venous fistula market or AV fistula space, the deep venous space, and the peripheral embolization space.
Tom Salemi (09:18):
And well, I guess maybe we should just kind of walk through the challenges of each. But before we do that though, what clinicians service all those spaces? Is it one or two specialists, one or two physicians that you're targeting when you're trying to get information about your products into hands, or is it as many different specialties as you've just outlined diseases?
Tom Salemi (09:45):
We're going to take a quick break from this conversation to bring back our sponsor Tegra Medical. I'm here again with Mike Treleaven, Senior Vice President of Engineering at Tegra Medical. Mike, you mentioned end-to-end solutions. Tell me more about what makes Tegra Medical's end-to-end solutions different than other companies?
Mike Treleaven (10:05):
Well, many contract manufacturers claim to offer end-to-end solutions. But in reality, their expertise is focused in one area like plastics or assembly and packaging. When they say end-to-end, what they really mean is they offer supply chain management. And we like to differentiate ourselves because what we offer is far from just supply chain management.
Mike Treleaven (10:24):
Tegra Medical is vertically integrated, allowing us to do the metal and plastics. We support our customers beginning with our GENESIS Tech Center product development services and extending all the way through manufacturing, finished devices, packaging, and sterilization management. This is really helpful in today's environment where regulatory processes are so stringent. It allows us to be under a single quality management system for an entire project.
Tom Salemi (10:47):
Mike, tell me. What are some of the deciding factors that go into an OEM's decision to choose Tegra Medical to make their device?
Mike Treleaven (10:53):
We're known, for not only creating sharp devices, but, and this is more difficult, keeping them sharp. We're able to manufacture the metal business end of a device, and then keep it sharp all the way through the entire manufacturing process, including insert molding, which often causes issues with other manufacturers. No surgeon wants to find out an instrument isn't sharp enough while in the operating room.
Mike Treleaven (11:16):
The other thing our customers really appreciate is that we're willing to manufacture the devices others find too difficult to make. For example, creating devices and implants with anatomical bends is very precise work. We've developed a proprietary process for creating the anatomical bends in intramedullary nails without compromising the implants, holes, and slots. We often taken on work that other manufacturers walked away from because it was too difficult and, or too hard to do efficiently. Our years of experience making implants has positioned us well for challenges like this. And we look forward to tackling more of them.
Tom Salemi (11:52):
That's great stuff, Mike Treleaven. Thank you for joining us on this episode of the MedtronicTalks podcast. And thanks of course, to Tegra Medical for sponsoring. If you'd like more information, you can find it @teramedical.com. That's T-E-G-R-A medical.com.
Tom Salemi (12:13):
What clinicians service all those spaces? Is it one or two specialists, one or two physicians that you're targeting when you're trying to get information about your products into hands? Or is it as many different specialties as you've just outlined diseases?
David Moeller (12:29):
Yeah, it's a lot of different specialties. Our predominant customers would be vascular surgeons, interventional cardiologists, interventional radiologists. And those three specialists do, for example, peripheral artery disease procedures, all three of those specialties and in different levels of concentration, in different parts of the world. And now we're working even more so with interventional nephrologists as well now as we get into that AV fistula space. So lots of different physician specialties, lots of different sites of care. It's complex.
Tom Salemi (13:11):
Let's talk about the different spaces in your offerings there? What are you offering the AV fistula space?
David Moeller (13:16):
Yeah, we're really excited about the AV fistula space. We, about a year ago, we acquired a company called Avenu, and Avenu is a company that offers a really great device for a percutaneous creation of AV fistulas. So AV fistulas have basically been created the same way surgically for about the last 50 years with very little innovation.
David Moeller (13:45):
And now along comes this technology that with one needle stick and inserting a catheter in the arm into the vein, and then through the vein into the artery, and then pull the two together, and using thermal energy can fuse the two together to create a durable fistula. And by doing so, they can do this in a way that heals faster, that matures faster, and leaves less scarring. And I think importantly, if you know, anyone who gets hemodialysis, it's hard to keep these fistulas open, and they're frequently going back for maintenance procedures to try and keep these fistulas active and open.
David Moeller (14:33):
And so fewer repeat procedures as well. So another area in that AV fistula space, we've applied our drug-coated balloons to those AV fistulas. And we now have really exciting clinical data in that space as well. Where if you compare a drug-coated balloon to an uncoated balloon, it requires fewer than half the number of interventions to keep those fistulas open. So the combination of creating the fistula with the Ellipsys™ device from Avenu and then using our drug-coated balloon to keep it open is a really powerful combination. And now that data is really, really groundbreaking data that has been published in the New England Journal of Medicine.
Tom Salemi (15:20):
So with the Avenu acquisition that was last year, last September, are they... I'm just curious. Are they operating as a separate entity or have you brought them, integrated them into Medtronic?
David Moeller (15:30):
Yeah, we're in the process of integrating them into Medtronic. It was a relatively small company, and we've had a very successful integration, and they're largely integrated into our processes. And that's, as I said, we have those five spaces, and now we take the AVF space, both the maintenance and the creation of those fistulas, is one of those distinct markets that we look at.
Tom Salemi (15:57):
Excellent. All right. Well, let's move into the peripheral space next. Talk about your offerings there.
David Moeller (16:03):
Yeah, sure. You know this is today our largest of those five markets that I talked about. But surprisingly, a lot of still unmet needs and a lot of under penetration. So let me just maybe highlight two of the significant unmet needs that we're working on. The first is peripheral artery disease in the lower leg or below the knee. And this is a really complex problem. Many of these patients also have diabetes. They have diffuse disease. It's calcified. And for many of them if not treated, it can lead to amputation and also a much higher likelihood of death. And so the outcomes there are still far from optimal. And stenting in these long lesions has really not been associated with strong outcomes. And we think that drug-coated balloons and our drug-coated balloon in particular has a lot of potential here.
David Moeller (17:04):
And we've been working on that for a while. And we think it has a lot of potential, including the fact that you can leave nothing behind in case you need to do a future intervention. But this hasn't yet been proven in a randomized controlled trial, and that's where we're going next. We'd like to really prove that.
David Moeller (17:25):
I think another that I'd really like to highlight another significant unmet need in peripheral artery disease is accurate diagnosis of peripheral artery disease and its severity and when you think you've done enough to treat it. And we have a technology called FlowMet™, and this is a very simple device. If you place it on the patient's toe and it has a laser diode on one side, a camera on the other, and it can measure both the flow and the pulsatility or the wave form of the patient.
David Moeller (18:01):
We think the combination of those two can really be effective, more effective than standard of care of diagnosing the patient. This, Tom, this could be analogous to fractional flow reserve or FFR, and what that did in the coronary space to give a threshold of when you need to intervene. And so we've launched that device for physicians at least to be able to monitor intraprocedurally the blood flow and to see the change in the blood flow in a procedure whose goal is all about improving the blood flow so they can see how much did they improve the flow. And we're in the process of conducting the clinical trial to provide the proof of it as a diagnostic as well to show how severe the disease is and when you need to intervene.
Tom Salemi (18:55):
So it's interesting. So you're doing the clinical trial on this device, and it's undergoing currently?
David Moeller (19:01):
Tom Salemi (19:02):
And how is that structured, and who are the clinicians managing that for you? Are they venous specialists or is that something you get in a GP checkup kind of thing?
David Moeller (19:17):
Yeah. The physicians who are doing this study for us are the interventionalists. So it would be-
Tom Salemi (19:22):
David Moeller (19:23):
The vascular surgeons or interventional cardiologists or interventional radiologists who do the procedure, and they're comparing the device. It's similar to the way you would do an FFR study where they were comparing to the pressure to the standard of care. Here they will compare it to the diagnosis that they get from an ankle brachial index or a toe brachial index, an ABI or TBI, and to prove that correlation. And then, follow up the patient to see the progression of the disease.
Tom Salemi (19:58):
And you spoke earlier about the clinical trial you want to run on your drug-coated balloon. What is the status of that?
David Moeller (20:08):
We're still in the process of designing that study. As you probably know, Tom, we've done a couple of trials already with previous technology and now with newer technology, and we feel like we've proven that we can get the effect, the desired effect below the knee. And now we have to design the larger pivotal randomized control trial.
Tom Salemi (20:31):
How receptive or how hungry are these physicians for this type of technology? Now, do they see the need for better ways to diagnose and to treat? And do you anticipate with the right data that this will get traction?
David Moeller (20:47):
I absolutely do. I think there's for both. First, I'd say for below the knee, it's probably the largest unmet need. And I think there are lots of different technologies and clinical trials ongoing or about to be run. I think the next five plus years is going to be a really exciting time in improving the care for below the knee. So there's a big hunger for that. And then with regards to the diagnosis, with something this simple, a device that's this simple to use, and if the clinical data can then prove it out, that can be really, really exciting.
Tom Salemi (21:23):
Well, let's cover superficial venous. I'm having trouble saying that today. What products are you offering there, and where are you making progress?
David Moeller (21:32):
Yeah, we are the market leader there. We have multiple technologies. We have both thermal and non-thermal technologies. Let me talk about our non-thermal product. It's called VenaSeal™ for closing the unhealthy superficial veins, and then diverting the flow over to the healthy, deep veins. And this technology, so it doesn't use heat. It uses a medical adhesive so it immediately closes those unhealthy veins. And so it avoids those multiple needle sticks that are used in some alternative procedures that are necessary to apply the local anesthesia.
David Moeller (22:15):
So it's a much more... It's a simple, comfortable procedure. The recovery is quick, and the patients aren't required to wear the compression stockings. But what I want to say about this is the adoption is really currently hindered by limited coverage and reimbursement with the commercial payers. And so, we're in the process of collecting the clinical data to add to the body of existing clinical evidence to really prove it out to support reimbursement.
David Moeller (22:49):
The other thing I'll say about this, I think combined with the clinical data, this is one of those areas that I think will be really interesting with direct-to-consumer advertising, direct-to-consumer marketing as well, just because of how effective and comfortable and how fast the recovery is for this procedure.
Tom Salemi (23:13):
And is that something you've started? And what would that look like? Is this for people who are suffering some discomfort to alert them to the idea that there's a way to ease that pain, or are you already reaching out to people who are in the treatment process for this?
David Moeller (23:29):
Yeah, it would be a very targeted approach to... Number one, I mentioned earlier, patients can go 10 to 20, 30 years with this disease and just not decide to go get any treatment. So part of it is just the awareness, but I think specifically this technology, if people understood that there was a technology this simple, and this nearly pain free with such quick recovery, that they would actually prefer this approach. And so, it'd be targeted at both awareness but also this specific approach.
Tom Salemi (24:04):
So let's moving into deep venous. What do you have going on there?
David Moeller (24:09):
We recently launched a self-expanding stent called the Abre™ stent. I don't think that everybody appreciates that stenting the deep veins is... How Different that it is from stenting the arteries. And so this is a device, both the stent itself but also the delivery system, designed specifically for stenting in the deep veins. The texture is different. It's more pliable. It's important to select the right patients, get the sizing appropriate, and accurate deployment. And so, this is a technology that does that particularly well. And we're really excited for the continued, I would say, safe and responsible growth in this space.
Tom Salemi (24:57):
Where are our deep veins? In our legs or...
David Moeller (25:00):
Yeah. So mostly we're talking about where this Abre™ stent would be used predominantly would be in the iliac vein, which is down in the upper part of your thigh.
Tom Salemi (25:12):
Is there any current treatment for... Can anything be done for those veins at this point, or is this a new technology?
David Moeller (25:20):
So stenting has been done there for quite a long time, but it's been fairly under penetrated because the stents for other parts of the body were used there and not used totally effectively. And so there have been very few that were really designed specifically for this until very recently. So it has really started to grow dramatically very, very recently with better technology that are dedicated for this space.
David Moeller (25:48):
Another key area that we're investing in the deep venous space is venous thromboembolism extraction. And so we're taking a two-pronged approach there. And so when we talk about venous thromboembolism, that's a fancy way of talking about mostly DVTs or deep vein thrombosis and pulmonary embolism.
David Moeller (26:10):
And so we're interested in the space, and we're taking a two-pronged approach with technology, leveraging technology from other parts of Medtronic for aspiration as well as investing in the mechanical extraction of a clot. We think it's a large enough market with different enough needs for both of those approaches. And so we have investments in both and are excited to enter that space.
Tom Salemi (26:39):
So you made the successful acquisition of Avenu. I'm just curious. What is the opportunity like for acquiring other smaller companies? Are there a lot of startups addressing these diseases? Do you see a lot of opportunities for future tuck-ins?
David Moeller (26:53):
Yeah, absolutely. Thanks for asking that question because we have had a fairly regular cadence at least over the last couple of years of tuck-in acquisitions. Where there's a technology that's differentiated that solves a need that we haven't been able to solve yet, we're on the prowl for those technologies. And I anticipate to continue. There are a lot of startups that are solving these problems, and I would anticipate a continued cadence of those tuck-in acquisitions.
Tom Salemi (27:29):
Well, that's great. And final question. I've asked others how the reorganization has worked for them. This is an interesting alignment, I think. And how are you viewed in the constellation of operating units at Medtronic? And what do you see the future looking like for this business?
David Moeller (27:46):
As I've described, Tom, we work and operate in five distinct market segments. And in each of those, there are some significant unmet needs, and unmet needs that we feel like we can solve. And I really believe that over the next five to 10 years in this space, it's going to be an exciting time to see the improvement. And in three ways that I've talked about, improvements in the technology, improvements in the clinical evidence, and clinical evidence not just to prove where we are today but expanding into new areas, applying existing technology into new areas, and then market development, just making sure that all of the patients who could benefit from our therapies can receive it. So we're really excited to lead the way.
Tom Salemi (28:38):
Fantastic. Well, it's been great to hear your story and to have you on the podcast, Dave. Thanks for joining us.
David Moeller (28:44):
Thank you very much, Tom.
Tom Salemi (28:45):
Well, that is a wrap. Thanks for joining us on this episode of the MedtronicTalks podcast. Once again, my name is Tom Salemi. I am Editorial Director of DeviceTalks. You can find this and other DeviceTalks podcasts @devicetalks.com. You can find past, present, and future episodes of the MedtronicTalks podcast on medtronic.com. You can also subscribe at any major podcast application, Google, Spotify, Amazon, Apple.
Tom Salemi (29:13):
We're out there. So please do subscribe. Please do share this episode of the MedtronicTalks podcast. Please do connect with me as you share this episode on social media. I am on LinkedIn, Tom S-A-L-E-M-I. I am on Twitter @MedTechTom. Would love to be part of your future medtech conversations. We'll be back with a new episode of the MedtronicTalks podcast after Thanksgiving. So I hope you all have wonderful Thanksgiving holiday and well deserved break. Take care.