Ep 301 - Medtronic’s Grubb on Bringing a Structuralist Perspective to a Growing Structural Heart Portfolio

0:00Hi everyone, Tom Salemi here. Welcome back to the Device Talks Weekly Podcast. Before we get into this week's episode, I wanted to take a moment to thank you, our listeners. Last week's episode was our 300th episode, and I did not realize it at the time. Kayleen Brown pointed it out and promoted it as such on social media, but I wanted to take a moment to speak directly to you, our loyal listeners. It's been six years putting out Device Talks Weekly. it's been a real honor and pleasure of mine to tell you these, to share these stories every week and to form the connections with all of you, the folks I see at our conferences, the folks I see at other conferences, those who connect on LinkedIn and elsewhere.

0:41It's just really fantastic experience. So thank you for being along for the ride, no matter when you hopped aboard this Device Talks Weekly train. Great to be able to bring you these stories every week. This week's episode is brought to you by Cortland Biomedical. I will have an interview with our friends at Cortland a little later in the podcast. I know you'll enjoy that. And thanks again to Cortland Biomedical for sponsoring this episode. We'll kick the episode off with Chris Newmarker and I delivering this week's Newmarkers Newsmakers. And then a little later in the podcast, our keynote interview, I spoke with Kendra Grubb.

1:19She's the chief medical officer of Medtronic's structural heart business. She has an interesting background, has moved into industry only recently, and has a fantastic perspective on where structural heart is headed. So I know you will learn a lot from that conversation with Dr. Kendra Grubb. So without any further delay, thanks again to Cortland Biomedical for sponsoring this episode of the Device Talks Weekly Podcast. Oh, join us next week for the Min-Evasive virtual series brought to you by our good friends at Medical Design and Outsourcing. Go to medicaldesignandoutsourcing.com to register for conversations that we'll be having.

2:06Skylar Rivera will talk with the med tech legend, Manny Villafana, uh jim hammer and the managing editor of of metal design and outsourcing has a cool company called doppler that he'll be talking to and then i'll wrap things up with a conversation with one of my new favorites eoc bar of lem surgical we'll talk about uh lem's humanoid surgical robot in the spine and talk about opportunities the in the hard tissue robotic space so uh lots going on next week. I'll put a link to the registry. I'll put a registration link in the show notes, but you can also go to medicaldesignandoutsourcing.com and, uh, hit the webinar tab and you can, uh, you can register there as well.

2:50All right. Now let's get this podcast started. All right. You ready for this? Ready.

3:12Chris Neumarker, how are you, sir? Hey, doing well, Tom. Doing well. Chris Neumarker, I forgot last week was our 300th episode on Device Talks. I know. I just completely lost. Me too. We don't do episode numbers on the titles, and I knew we were approaching, but I had completely lost track. So happy 300th. I'm so happy that our wonderful colleague, Kayleen Brown, pointed that out to everybody. Kayleen was counting, darn it. Kayleen was good. She has the benefit of when we have the Device Talks Podcast Network and the Device Talks Weekly Podcast channel. And so she updates the Device Talks Weekly Podcast channel, which is just Device Talks Weekly.

3:52And in that title, she puts the episode numbers. So that's how she tracks it. She knew it. She had it down. She's smart, though, that one. She's on top of it. Totally. Yeah. So, yeah, 300. Yeah, that's awesome, man. I did the math, assuming like each one was an hour and usually they're more than an hour. It's like 14 straight days of a podcast. Like you could, for two weeks, you could just listen to us talking. Would that be like all around the clock for two weeks? Wow. Yeah. Yeah. It's like, yeah, yeah. And not just work days. I'm talking like 24 hours. Nope. No meal breaks. No other types of, no, you just.

4:34You could send someone in a rocket capsule to the moon and back while they listen to all of our device talks weekly. That's a great idea. I think we should somehow get our podcast on Starship. Make sure it gets launched into space. Sounds great, yeah. We're a good representative for humankind, I think. It's a good time. Everything going well over in Massachusetts. Yeah, you know, mid-August is the time. I don't know if you feel this way in Minnesota, but like where you started like, you know, some fall crisp fall air wouldn't be the worst thing in the world. State fairs coming up. I was going to say I had a nice moment.

5:12I woke up at six in the morning, you know, you know, to, you know, like start looking up stories for mass device and just have my little cup of coffee looking out. The back window saw a fawn at the edge of the, you know, like a baby deer. Very nice. Bambi. And then another one came out, and then mom came out, and then they just walked over to my garden, started eating my cucumbers and lettuce. But yeah, there was a nice moment. They're like, oh, it's a fawn. It's cool. I like how you mentioned that you grew up at 6 o 'clock in the morning to look at stories from Ask Device. You could have just mentioned the fawn thing without explaining to everyone how dedicated a journalist you are.

5:52A little humble brag right there. That was pretty good. It's like the old Ben Franklin idea that you should make sure your wheelbarrow is squeaky so everybody can know that you're up getting here doing the work. I'm reading Isaacson's biography of Franklin right now. Oh, that's a great one. I love it. That's a good one. Yeah, that's a good one. That's great. All right. Well, I was up at six in the morning watching the Red Sox condensed game and drinking coffee. so I was not not doing podcast research but I was up early as well and I did not see a fawn though. I'm sorry man. Yeah. Yeah. It's okay.

6:27Squirrel. I saw a squirrel instead of the dog but. Squirrels are great. Yeah. All right. Our people are like oh these guys. Yeah. 14 hours of listening to us. We just added another 14. Yeah. One Newmarket Newsmakers. All right. What's number five on the Newmarket Newsmakers Chris Newmarket? Number five on the list. This is from Associator Skylar Rivera. And this is about Alcon and it's a recent earnings call, you know, said that they're going to be, you know, getting rid of their PowerVision intraocular lens technology program. You know, they're just saying that recent clinical data just showed unpredictable post-operative outcomes.

7:07But, you know, Skyler also did like QN that, I mean, they're not giving up on this technology, which I mean, yeah, they spent$285 million for PowerVision. I remember it. Yeah. I was working on the OIS events around that time, so I knew Power Vision pretty well. That was a big deal. It was really cool technology. The fact that they're just saying, like, yeah, we got to move on, but they do have, like, this exclusive collaboration now with RX sites. So, I mean, they're still at it, and they're saying that they learned some stuff from it. But, yeah, unfortunately, just the Power Vision, you know, just didn't work out for them.

7:42I mean, I think the trick, it's a accommodating lens and it's adjustable for presbyopia correcting IOL. I think that's sort of the value add of the lens. So it's a huge deal. And iTech is super fascinating. I honestly lost track after the acquisition. I assumed six years later. that it would have been on the market. I didn't realize it was still, they were still sort of, well, still monitoring and that wasn't a sure thing. So, big deal for certainly for Elcon to write that off over$400 million. Yeah. But like you said, they're not giving up. So, hopefully they'll be able to move forward. Yeah, I mean, it's definitely a technology that is needed out there.

8:33So, have the best luck. next on the list this is from yours truly that's right I caught a note about Intuitive Surgical from Oppenheimer like Intuitive has been having some like challenges you know I mean their stock's been kind of down I mean there's been you know some talk about how they kind of have some like at least short term headwinds around like the Affordable Care Act like actually with you know the subsidies going away for it. That could maybe hold down U.S. procedures some, but the Oppenheimer analysts up their rating on intuitive stock to outperform, and I just thought they had some really interesting arguments in their report, and so I blew that out into a story on MassDevice.

9:23One of the things that really stuck out to me was that they were talking about their field checks, going out into the actual health care environment and, you know, finding out, like, what people on the ground think about things. And, you know, they're, you know, we have J &J coming out with a TAVA, but they were kind of pointing out some talk about, like, potential, like, workflow problems inside health providers using a TAVA, you know, like, that kind of design it has with the arms coming out of the table that, you know, there could be, you know, certain unique challenges around getting that sterilized for procedures, perhaps.

9:58So, you know, they're pointing that out. they're pointing out that Hugo, even though it's modular, I mean, like Medtronic really talks a lot about how, look, these are modular arms, you know, we can roll around here in different configurations, that the footprint's bigger than overall in Givenchy, you know, so they were kind of saying they thought the big competition for intuitive was outside the U.S., that's more like intuitive having to compete against homegrown companies in China, you know, with this China part. Competing for markets outside the U.S., not O.U.S. companies coming here, yeah.

10:27Yeah, the U.S., they're really, you know, thinking that Intuitive is a really good long-term bet. I mean, that's consistent with what has been said. You know, Intuitive has had time to build really a moat, to build a strong foundation. Flip side, though, I mean, you know, Hugo's been improved for two years, Otava just a couple of weeks or a month. You know, things sort, things change, but definitely a long climb uphill for anyone trying to take on intuitive head-to-head. Yeah, absolutely. I think the opportunity in the U.S. will be in the ASCs and the smaller spaces. Maybe that's where, well, certainly it's where a lot of the procedures will be going.

11:11maybe that's where a big opportunity is for not only for Johnson & Johnson, for Medtronic, but also, you know, CMR and Distal Motion and others as well. Yeah. So, so it's intuitive is firmly entrenched in the larger primary settings. And we'll have to see how that changes. You know, the Oppenheimer analyst, that was the other challenge they were saying, like along with outside the U.S. competition, especially in China, Yeah, the intuitive trying to play in that ASC space outside of the hospital. So yeah, that's kind of the place where maybe some competition could really happen. Absolutely. Yeah.

11:50So a good report. You can read some more insights from me on mass device. Number three. Number three, man, more cyber techs. Like MedTech has really been getting a good amount of those this year. And, you know, Skylar was on top of the news of Cook Medical reporting a, you know, a cyber attack compromising, you know, customer information. This looks like it's one of these social engineering attacks. You know, an employee accidentally inadvertently gave someone access to systems. So to me, that's just another good reminder for people inside medical device companies. Like, you know, listening to the, you know, it can be hard sometimes to find time to listen to those corporate trading videos.

12:37But, you know, the ones like kind of like reminding you not that, you know, someone is like, hey, Chris, like I'm so don't. Yeah, you got to like watch out for that kind of stuff, even if you're really busy. Yeah, for sure. You know, you can get a hacker getting you to disclose access to stuff that you shouldn't be. Now, Cook Medical did say in the article by Schuyler, based on our review to date, we have no evidence that sensitive or protected data was accessed. The Bloomington, Indiana-based company said so. But no, definitely, I mean, it's good for any company. I'm sure MedTech isn't, I know MedTech isn't targeted, and you and I get always on the Slack channel, at least once a week, there's, dude, don't answer this email from me asking for whatever, gift cards or whatever.

13:22We get that once a week. So maybe that's maybe not once a week, maybe a couple of times a month, but it seems frequent. So yeah, no. Interesting times to be on email. I was, I read this and it got me thinking, I think I mentioned previously, I just finished watching, re-watching Battlestar Galactica and like the Cylons wouldn't have had to make all that effort now. They could have just sent Gaius Baltar like an email promising him something and he would have clicked on the link and they would have access to the colonial defensive mainframe. so yeah times are uh are fraught yeah it's fraught times yeah fraught times what's number two chris newmark are you gonna get a lighter story for us what do you got oh yeah um yeah yeah this is uh no not really uh this this is uh actually courtesy of julia rocktor simia who is uh you know our associate editor over at r &d world and drug discovery and julia has been helping us out some on a mass device.

14:20And she was writing about, like, the chief revenue officer of CBRX, you know, being let go. And this came not only after a disappointing earnings report, but they also, around the earnings report, disclosed that there was some kind of U.S. Department of Justice civil investigation, you know, like going on with the company. So, like, concerning, like, some sales and marketing practices. And just to be clear, this is them saying that the Justice Department was requesting information. You know, it's not like nothing's been filed. This is, you know, sometimes they look into stuff and, you know, nothing comes of it.

15:02You know, there's nothing to see. But, yeah, they, you know, obviously they decided it was time they needed a new top salesperson over at CVRX. yeah cvrx is one of those uh companies that's been uh been around for a long time is is starting to see some some uh some success so it's unfortunate to uh to see uh but it looks like their their stock's also taking quite a dip over the past week or so as a result of all this so uh hopefully they'll uh they'll be able to to right the ship for sure yeah you know john was an Abbott veteran and now they've got somebody internally like Paul Verasto assuming the role of interim head of sales but it looks like they're looking around now for a permanent successor so we'll see who they can and Verasto by the way my gosh he's had sales and marketing leadership positions and scientific, electronic, guidance so they obviously had at least a deep bench over there even though they're still a really young, grown company.

16:13So yeah, we'll see. Hopefully things can be better going ahead. Yep. And Kevin Hikes, president and CEO, has had some good deal of success in MedTech as well. So they have a strong team over there. Totally. So we'll see if they're able to turn things around. Number one on the list, also from me, I noticed when we covered G Healthcare earnings recently, that there was like a little message, just a little thing in the news release, like, oh, by the way, we're, you know, looking at strategic options with our patient care solutions business. That's a$3 billion a year business. So, you know, I went back and, you know, really looked at the earnings transcript and, you know, like pulled out a new story kind of like about the fact that, you know, they could be selling, you know, this business.

17:00And, you know, they're also doing a bit of other reorganizing around the company right now. So, yeah, that's going to be interesting to see if they sell patient care solutions and who the buyer might be. Absolutely. So patient care solutions includes patient monitoring, diagnostic cardiology, maternal infant care, and anesthesia, which is a big business, obviously. You know, I guess$3 billion sounds like a job for private equity to me. Thanks. Yeah. We've been seeing more and more deals, so. Oh, yeah. I mean, I don't know. So I'm not quite sure. I mean, maybe Danaher would want to move in, but they're looking at the businesses.

17:44I'm not quite sure who steps in. That would be interesting. Yeah, I mean, everyone here, don't count us as experts. But I mean, we did. I'm sure they don't. I mean, Danaher acquired Massive. You made sure of that. Yeah, please don't buy any stock. I've got to count on me if you're – but I mean, you know, it is interesting. Danaher acquired Massive. I mean, that would be interesting. Like, okay, we got this, you know, this business over at GE Healthcare that, you know, might, you know, fit in with this in some way. We're going to bring this in as well, like kind of build something there. But yeah, private equity as well.

18:19And I should also mention that our medical design outsourcing managing editor, Jim Hammerand, has an article up on MDO. He spoke to some people active in the private equity space about why we're getting more deals lately in med tech. So I thought there were some good insights about kind of what's going on there. He spoke with some shareholders at law firm Fredrickson, which represents some major private equity outfits that have been looking at MedTech. So it's a good dive into that. Yeah. So interesting top five. So Valcon discontinuing a PowerVision. So sort of a good question, kind of a post-acquisition.

19:10How long do you kind of stick with the technology you bought? Intuitive, you know, how powerful can it be with its installed base? How much can it defend Cook? I mean, I think that's just something everyone has to be mindful of, the cybersecurity. Cook medical, like how much can things get messed up when somebody answers the wrong email or whatever. And CBRX, again, we fall in love with technology. but at the end of the day you have to overcome your commercial execution and you have to succeed there so hopefully they'll be able to turn it around and gee healthcare I mean that could that could really upend the metal device industry so big news on mass device this week for sure yeah news is not slowing down here at the end of the summer nope not at all alright Chris Newmarker oh and I would be amiss that if you want to get even more like cool insights and like excitement we just we have the invasive webinar series coming up on medical design outsourcing.

20:08And that's going to be, you know, like Jim has a great lineup, including you're helping out. You're going to be. I'm helping out. I'll be talking to me and Yossi Barr, my new best friend from Lem Surgical, talking about humanoid robotics, the real kind, humanoid surgical robotics, not the stuff I've been posting about on LinkedIn, but they've got a really cool surgical robot that could really upend the spine industry. And we'll talk about the heart tissue surgical robotic space. I mean, all the conversation we have tend to focus on soft tissue, but it would seem to me there's a real opportunity there for heart tissue robots to come in and really change the spinal surgery space.

20:51It's been a while since there's been, Mazer was the last acquisition in that space. Yossi was part of that. That was 10 years ago. It was bought by Medtronic. So there's certainly some room there for disruption. I know Skylar Rivera, is she kicking things off with her conversation with the one and only? She is kicking things off on August 18th, interviewing the living legend, Manny Villafana. And, you know, what he's seeking to do with his Medical 21 company, you know, really exciting technology, you know, about, you know, kind of like these kind of like artificial graphs. And then, you know, moving on August 19th, we're going to have Jim with, you know, Doppel, co-founder and CEO, Ryan James.

21:35Doppel. Doppel, sorry. Sorry about that. Doppel. I got to get this. Yeah. Remote cardiac ablation, you know, and robotic ultrasound. Like, so talking about teleprocedures. So, and then, yeah, and then you wrapping up on August 20th with Yassi Barr. So, yeah, just a great lineup. And, you know, you can go on the medical design outsourcing and register for that for free. It'll be a good series, kind of like a really cool virtual event that, you know, we can have a really good gathering there and, you know, talk about some of the really cool innovations in our industry. No, absolutely. And folks should, I mean, it's really a great opportunity for people to be part of the conversation.

22:15I mean, if they're listening to us and kind of want to scream at us, and it's a great opportunity for folks to actually be part of the conversation. Skyler, Jim, and I will be hosting. and you should certainly be, go to, where do they go? Medical Design and Outsourcing to register for that? Absolutely. Just see, we have a link up on Medical Design and Outsourcing. So go and check that out. So I'll put a link in the show notes. Folks, if you're on the Medical Design and Outsourcing page, go to MedTech Resources and then go to webinars and you can click there and that's another way to find it. But again, just take a look at the show notes and we'll have a link to the series there.

22:55You can register for all three and be part of the conversation next week. Yeah, fantastic. Well, good as always, Tom, and catch you again next week. We'll see what the news next week is. Great job, as always, Chris Newmark. And now it's time for our sponsor message. Once again, let's hear from our great friends at Cortland Biomedical. Hi, everyone. Tom Salami here. Happy to be joined by Tara Youngkunist, Director of Commercial at Cortland Biomedical. Tara, we're going to talk a lot about some of the great work you do in structural heart. Before we go there, though, I think folks would like to learn about Cortland Biomedical.

23:28Can you tell us a little bit? Yeah, perfect. Thank you, Tom. Thanks so much for having me. So, Cortland Biomedical, we've been applying decades of experience in textile engineering to a variety of industries, but first and foremost, cardiovascular. So, we can support structural heart, electrophysiology, peripheral vascular, as well as other spaces like robotic surgery, orthopedic sports medicine. So it's quite exciting to be able to support such a broad spectrum of medical applications at Cortland. Excellent. So how do you engage with the medical device industry overall? Yeah, sure. Absolutely.

24:05I really love this question because I think it plays right into our mission statement. And our mission is to collaborate to solve complex biomedical textile challenges with agility, credibility, and curiosity. So I think first and foremost, agility. We know our customers are trying to move quickly and speed to market is super important to making sure that their application is getting to market as soon as possible. So we pride ourselves on being responsive, on getting samples out to them quickly, prototypes to them quickly, jumping on the phone whenever they need, being flexible, and maybe changing a design in the middle.

24:40So we definitely have close relationships with our customers to make sure that we're serving their needs. And then secondly, credibility. Of course, we're in the medical device space. We have ISO 13485, and we have a consistent history of performing well in on-time delivery and quality performance. So this is absolutely needed in the space. And then lastly, curiosity. So this is the most fun. I am a biomedical engineer by nature, even though I'm more on the sales side now, but you can't get the engineer out of me. And it's super fun to have other engineers from customers come to our site. We brainstorm together.

25:15We go into the clean room. We make prototypes. So it's really, really fun. And it's really effective to have the customers on site to enable them to stay curious. We want to make sure that we can get their design on the machine, try it out, and see if we can produce that next innovation in the market. So it's really close to collaborative relationship with our customers. And we think that transparency is really what can help set us apart because we really want to be there on the ground solving the problems with our customers. I love talking to biomedical engineers. They just have the best energy.

25:48We were talking earlier, you mentioned you work in cardiovascular, structural heart, robotics. So you've got a great perspective over some of the hottest sectors in medtech. What are some of the biggest challenges facing companies out there? Yeah, absolutely. Like you, I do get to travel to a lot of different conferences. And one of the main themes that I hear is, you know, everything is moving toward more minimally invasive surgeries. It makes sense, right? People want to be recovering quicker. They don't want to be in the hospital as long. They don't want to be in recovery as long. So really, a lot of these procedures are focused on being more minimally invasive.

26:21And that means that the implants need to be smaller. That means the delivery systems need to be more reliable. And luckily, we can actually participate on both sides because at Cortland, we work on designing custom device, custom components, I should say, for both implantable but also the non-implantable applications. So the delivery systems, steerable catheters, robotic surgery systems. So things that also can aid with the procedures, but also the implants themselves. Wow, you're in everything. So what are some of the, I guess, hottest or most popular solutions you're providing to the medtech industry right now?

26:58Yeah, absolutely. I think Structural Heart tends to be one of the most fun for me to talk about because it's the one that we, our textiles, can help across the board. So I didn't talk too much about the technologies we provide yet, but we do support braiding, knitting, and weaving capabilities, which are the three core textile capabilities. And Structural Heart uses all of them. So you can use what's called a low-density braid, which you might picture like a suture or a cable. Those can help in the delivery systems. Those can also support ice catheters, which are also used for visualization for a lot of these different surgeries.

27:36And then we can also use a variety of textiles in the implant themselves. So high-density braids, various types of knit structures and woven structures, all can be used in the implant itself. So if you're looking at a heart valve and you see a lot of the white fabrics, those are textiles. They're often used to prevent paravalvular leakage and also to support endothelization. So they really have a critical component in ensuring that the device is functioning properly. So a lot more we could talk about, but those are sort of the highlights for how our textiles can support structural heart. Yeah, we'll definitely need to have you back to talk about cardiovascular and surgical robotics.

28:15Tara, thank you so much for joining us on the podcast. Yeah, thank you so much, Tom. I appreciate it. All right. Thanks again to Terry Angunis for joining us on the podcast. And thanks, of course, to Cortland Biomedical for sponsoring. If you want more information, go to cortlandbiomedical.com. That is C-O-R-T-L-A-N-D biomedical.com. All right. Now it's time for our keynote conversation. Once again, I really enjoyed this conversation with Dr. Kendra Grubb. She is a fairly new chief medical officer for Medtronic Structural Heart. She joined last year, and she just brings a really broad perspective, both a medical perspective, a business perspective, administrative perspective, to building out one of Medtech's great businesses, Medtronic Structural Heart.

29:07So I know you'll enjoy this conversation with Dr. Kendra Grubb, chief medical officer of Medtronic Structural Heart.

29:17Well, Dr. Kendra Greb, welcome to the podcast. Thank you. I'm happy to be here. The structural heart space is exciting and exploding, and I'm anxious to unpack your work that you've done in this space and the work you're going to be doing, are doing, and will be doing for Medtronic. But let's look at your path first. Dr. Greb, how did you find your way into practicing medicine? Why did you decide to be a doctor? Well, Tom, that's a really long story, and I'll try to keep it to the short version. It goes back to my childhood. I was raised in a home where my father's veterinary practice was in our home when I was young.

29:57Oh, my gosh. Watching him operate on animals was the initial spark, and I wanted to be a surgeon. And he tells the story that I was about three years old when I started telling people that I was going to be a surgeon. Of course, not a cardiac surgeon, no three-year-old, what that means. But yeah, it was that initial encounter. I like to fix things. I like to teach. And it all fit together into a career that ended up being structural-based, but cardiac surgeon in an academic setting. So I could teach cardiac surgery and I could do research and then just help disseminate new knowledge all over the world.

30:39So it was a wonderful career. And then about 18 months ago, I had the opportunity to join Medtronic. I had done some consulting for them. And, you know, it was probably the once in a lifetime chance to put all of the pieces together. I had gone to business school before I went to medical school. And then I had, you know, more recently gone to Oxford and finished a master's of science and clinical trials. So all of those is trying to fit into what am I going to do next in my cardiac surgery career? I'd already made professor. What's next? And then this opportunity came along and it's been absolutely an amazing opportunity.

31:19That's great. There's a lot of great things to cover there. I'm trying to imagine your childhood of having a veterinary practice in your house. It sounds almost like a TV show. I mean, was it as comical as I'm envisioning? Were there animals everywhere and just sort of a nice vibe? We had a farm too, so there were always animals everywhere. But yeah, so if you can imagine, sometimes the kitchen counter became the operating room and the kitchen floor became the ICU. and so you just make it work. But yeah, I was, I think, nine or 10 when his practice moved to a standalone hospital facility and clinic not too far from our home.

32:04But as a child, it's pretty magical to watch your father take a little critter that is in and then watch that little animal heal and get better. And it's pretty magical. That's great. Looking at your career a bit, I don't often talk to even CMOs who have gone to business school and got an MBA. And that doesn't happen very often, I don't think. Folks are pretty busy performing surgery and all that. What led you to know at the time that an MBA would be a benefit to you? Did you always have an interest in the business side of medtech as well? Well, growing up with a small business in your home, you appreciate the importance of business knowledge.

32:52And we had enough physician friends growing up that they said you really need to go and understand the business of medicine. So I don't actually have an MBA. I have an MHA, which is like an MBA specific for healthcare. Oh, okay.

33:34and medicine also tell me, you know, smart kids go to business school. They don't go to medical school anymore. And I don't know that I considered myself a quote unquote smart kid, but I certainly wanted to make sure that I was making the right choice. And I knew the struggles that my father had running the business because it's not taught in veterinary school either. My mother was his office manager for a really long time and she had no business degree. So I felt like it was an important piece of it. What it taught me most is that you need to develop a niche. And then it further confirmed that, no, I didn't want to go into business.

34:10I wanted to go into medicine, specifically surgery, but with a business mindset. And so taking that knowledge, I was able to build a program, not completely for scratch. They had a little startup in Louisville, Kentucky, and then we took it to as big as it was ever going to get. And then take my business knowledge and then the knowledge from building that program to Emory, where we were going through a major restructure. And I was brought on board to help with that restructure. So very much used that business mindset. And then as you can imagine, it just compounds when you're in a position, you know, as a VP CMO of Medtronic Structural Heart, right?

34:49I use that knowledge literally every day. That's great. I'm sure you're asked for advice a lot. What advice are you giving younger people who are coming to you and asking perhaps that very question, should I do medicine or not? Or should I go into something else? Well, I think for the people who really believe that they want to fix things, they want to help people, medicine is the career for them. It's an incredibly rewarding career. It is also incredibly demanding. You don't have the nine to, well, I guess if you're a dermatologist, you do, but oftentimes you don't have the nine to five. No matter what, you're going to be working 60, 80 plus hours a week.

35:30It doesn't matter if you're a hospitalist or if you're a cardiac surgeon. Your nights, your weekends, they may not be your own. But there are many practice models and you get to choose, once you finish your training, you get to choose what type of practice model that you want to have and what type of lifestyle you want to have. But by and large, you are going to be hospital-based in some respect. And so you just have to think through, is that the lifestyle that I want? Is that the life that I want? And for me, it was incredibly rewarding. And I love to teach. And so that was a great opportunity to be teaching in medical school, teaching cardiac surgery, teaching physicians all over the world.

36:09As we all learned together what structural heart even meant. If you think about when I got involved into the space, TAVR was still just for high risk or inoperable patients. And I was part of that journey for intermediate risk, low risk. And now basically anyone over 65 who has aortic stenosis gets to have a choice. I was very lucky in that I got to offer those choices as part of my whole quote unquote portfolio of offerings to patients and talk to them about the risks and the benefits and the tradeoffs of the different therapies and then teach that to the next generation. So I think that, you know, for the young people that aspire to be physicians, it's still an incredibly rewarding career.

36:53And there are many new areas that we're getting into that we will still need to understand. Where does robotics play in to something like transcatheter therapies? Where does AI fit in? All of this is current generation and the up-and-comers, they're going to answer these questions. They're going to be very different physicians than I ever was. And the amount of knowledge that we're generating, it's just incredible. The trials and then just the amount of knowledge that we can understand just by harvesting data that already exists, it's going to be a completely different career than what I had. That's really fascinating.

37:34And I'm glad you hit upon my next question. If you could unpack a little more, what's it been like being on the front lines of structural health, treating the patients at a time when all this new innovation, all these new devices came and gave you greater options and greater options? Because I'm not sure if there's a space within MedTech that's been transformed as much as the structural heart space over the past decade or so. Yeah, it was incredibly exciting. If you think back to when I first got involved, you know, we had major randomized control trials that were going to build the body of knowledge, not only for transcatheter therapies, but also for surgery.

38:16If you think about what we were doing in surgery, it was predicated on what we did with very little evidence from randomized control studies. Most of the knowledge that we had were observational studies or industry-sponsored indication studies that you just followed out that particular type of valve, that company's valve, for a certain number of years, but with no control arm. And in those initial early trials, we would all get on calls once a week to try to get patients approved for the studies. and the field would change about every six months, land the valves higher, land the valves lower, pre-dilate, post-dilate.

39:00There was literally learning along the way as we did the trials and it was incredibly exciting. That hasn't changed. We are still continuing to learn. You think of transcatheter aortic valve replacement or TAVR as a mature technology. It's been around for 20 years, but it's far from mature. There's still so much we're learning. And now we have the addition that the patients are young enough that they're going to outlive their first valve. So now we're learning what's the right first valve so that we can do a second valve. Where does surgery fit in? So everything that we learned about high risk, intermediate risk, 80-year-olds doesn't necessarily apply when you bring the age down to 65.

39:47So it's continuing to evolve. I still say every six months there's something new, more disruptive. TAVR is due for a disruption, and whether it's one of the newer Valve platforms that starts checking the boxes of all of the unmet needs that physicians and patients are bringing forth, or if it's a totally different concept, like using artificial intelligence and navigational technology and robotics, it's due for disruption, and it's really exciting to be part of. That's great. Could you just take a moment to give us sort of an overview of the structural heart space, maybe a tour of the heart and the challenges that come with each of the valves?

40:31Yes. Well, I've over-indexed on talking about TAVR thus far, just because, you know, it's kind of where I started in all of this. Of course, there are four valves in the heart. And interestingly, the first transcatheter valve replacement was actually Medtronic's technology for congenital patients in the pulmonic valve. So Melody and Harmony are the original transcatheter valves. We oftentimes forget that. But now we're into replacement in the TAVR space for aortic stenosis. So the valve is too tight. It calcifies over time. But also now newer technology for leaky valves or regurgitation. The other valves, the mitral valve and the tricuspid valve, those are still kind of the new frontier, especially tricuspid.

41:22So interesting, mitral technology started at about the same time as TAVR. It's just taken a lot longer. There's a surgical precedent that is truly excellent in terms of repair of the mitral valve. And so the bar is set really high for new therapies. And it's just a hard place in the heart to work on. From a transcatheter standpoint, there isn't that direct access. You have to go either through the apex of the heart where the patient doesn't tolerate that very well, or come up through the venous side, so the right side of the heart, and then puncture to get to the left side of the heart in order to be able to deploy the therapy.

42:07So clip therapy or transcatheter edge-to-edge repair. Tear was the original technology. Now we're just starting to get into replacement. So Tear is a repair technology, clip the leaflets together to stop the leak. There are patients that are not candidates for that therapy, or they just don't have a very good long-term durable result and are going to be best treated with a replacement. So just now, we're getting into the replacement technology. And I'm excited to say that it's been a long journey for Medtronic, but the Intrepid system, the first look at the newest generation, we've reached 250 patients.

42:50And so we will be hopefully able to be presenting that data and then get the indication for Intrepid TMVR, transcatheter mitoval replacement, very soon. And so it's really, really exciting time. The final piece is the tricuspid valve. Very similar difficulty in treating tricuspid pathology. It comes in a lot of different ways that the valve fails, similar to the mitral valve. There are four main ways that the mitral valve fails, and you treat each one a little differently. Tricuspid even becomes more challenging because we have even less data from a surgical standpoint. We don't have that surgical bar that sets the criteria for what good means.

43:35And so for tricuspid patients, we have a few technologies, none of which are perfect. And so we'll be starting our Pathfinder study with a bespoke tricuspid replacement technology in the fall. It's actually started for a current generation, but we really want to bring forth the next generation of what's called Triton into a trial with a replacement technology. And it's just a challenge. You have imaging limitations. You have sick patients. These patients right now that are eligible for these studies are only the high-risk or inoperable patients. And so you're balancing, are they too sick for treatment?

44:18And we're starting to really understand who is going to benefit most, but we're only scratching the surface. And we're probably still treating patients who are too far along in the disease process and won't derive the maximum benefit in the tricuspid space especially. And what are the, and Adam, you've introduced some of Medtronic's portfolio. I want to make sure we cover the rest of it as well, but I would love to just get into the experience of a surgeon. What is it like for you to be working on that organ in this way? What are the challenges? What's the environment like? I mean, the heart is still beating.

44:57Is it really, is the intensity off the charts? Is it a very calm and measured tone? What is difficult in terms of physicality for the surgeon? What are some of the things that medical devices can perhaps help in the future with some of the tools that we'll be talking about? Well, the interesting part is that the beating heart is actually very advantageous because in Real time, whether or not your therapy worked. You think about cardiac surgery, the heart stopped for the most part. Now, there are some beating heart operations or what we call either off pump or pump assisted. But for valves, pretty much the heart is arrested.

45:36And so once you reanimate the heart, you only then know, did you get the result that you wanted? Where with transcatheter therapies, although the heart is beating, you can modulate that by either pacing the heart to decrease the motion or use medications temporarily. So you can rapid pace that gives you a stable landing environment for the valves. But you get real time. The second you release that valve and you come off pacing, for example, the heart's reanimated and you know, did I get a good result? And so that's actually really rewarding. Unlike cardiac surgery where you have, you know, you wait and then sometimes it's in the next day or 30 days that you realize what your actual impact is.

46:22So I think that the intensity is very much the same. Most of transcatheter therapies, most of that planning comes before the patient ever gets to either the operating room or the cath lab or the hybrid room. It's all pre-planning. Do they have the right anatomy for the valve, transcatheter valve, that I'm planning on implanting? or is there some other device or trial device that would be better for this specific patient's anatomy? And so where we are now is not only using kind of rudimentary measurements on CT scans, but then getting into algorithm, AI-assisted algorithms to really decide, is this the best implant for this particular patient?

47:10So it's a really exciting time. Once you get to the procedure, It's about execution. Can I navigate this patient's anatomy in such a way that I can then put the valve where I had simulated based on that pre-case planning? And we're getting better at it. Certainly in TAVR, I think that we're very much able to do that. For the mitral and tricuspid, there are still a lot of variables. One of the big variables is that we don't necessarily have the imaging capabilities to truly be able to implant the valve precisely the way that we want. So we're looking for solutions to that. Are there newer imaging modalities?

47:53Or using the patient's own CT, can you kind of create the driverless car where I'm still using my judgment for the final deployment? But how I get there and navigate that patient's anatomy, can we make that easier? and then be able to offer it to more centers that don't have the advanced capabilities of our big academic centers. So we're at an inflection point right now in structural heart. And how would you classify surgeons in this space in terms of adoption of new technologies? Are they quick to adopt? Is there a lot of show me before they step forward? What's the attitude like? Well, I think that for, and I'm going to talk about two different groups.

48:37First, I'm going to talk about surgeons that are not involved in structural heart. Surgeons who are not involved in structural heart, everything that a surgeon does is based on years and years of evidence and data. We've been doing the same procedures for 60 years with very little difference. So I'm not going to change what I'm doing until there is evidence suggests that there is something equally as good. So when you think about TAVR, we started with a patient population who are high risk or inoperable. They didn't have the choice of surgery. They were already excluded from that pathway. Now there is choice.

49:14When you think about where we are with the transcatheter, mitral, and tricuspid devices, again, high-risk or inoperable patients are the patients who are eligible for these therapies. So it's still kind of that generation of evidence to show that it's similar outcomes. Only now in the mitral space do we have two studies that were going head-to-head, clipping of the patient versus surgical repair. So your surgeons that's not involved in structural heart wants to see that evidence to understand where there actually is equipoise. And I think that if you're in the structural space, someone like me, where I was trained in cardiac surgery and then went and trained in interventional cardiology at Columbia, someone like me who did both my entire career, I need less evidence.

50:04I want to understand which patients benefit most from which therapy. But offering each is an easy thing for me to do because I'm still studying. I'm still curious. I'm still answering unanswered questions. When you think about interventional cardiologists that are structuralists, they just want to be able to help more patients in more ways that they can't help today. So I sit in the middle of that. As mentioned, I'm a cardiac surgeon by training. I also trained in interventional cardiology. I thought of myself my entire career, not as just a cardiac surgeon, but as a structuralist. And what do I want?

50:42I want to be able to offer to patients the same portfolio of options, repair, replacement, mitral, tricuspid, aortic, pulmonic, same portfolio, whether it be open heart surgery or whether it be transcatheter therapies, having solutions for all patients out there, and then being able to decide with that patient and their anatomy, what is the best therapy for them. Many of the therapies that we're talking about, the patient is going to outlive that first therapy with the exception of like a mechanical valve, which no patient wants to be on Coumadin, without exception, anything biologic, tissue-based, the patient is often going to outlive when we talk about younger patients.

51:28So it's not only the strategy of what treatment do I offer you today, but it's if and when this fails, what's that next step? And if you have enough years, what's the lifetime management of the third option? And so we're learning all of that real time. So where does the surgeon fit in? The surgeon that's not a structuralist wants the evidence. The surgeon who is a structuralist like me, they want to be pushing this field forward and understand which therapy is the right therapy for this patient's anatomy at the right time. So we build that lifetime plan for this patient. also knowing that new things are coming.

52:06So whenever we build that plan, it's based on what I have today, knowing that the field changes so rapidly. Think about just in the time that I've practiced, we have six generations of the Evolute platform, right? Six generations. And think about MitraClip, they're on generation five, and it changes so quickly. All of this is due for disruption. So a newer technology or a newer thought about how to fix these valves could come in and disrupt all of this tomorrow. It's exciting, exciting space. Very exciting. And it's actually, it might be a great time to, you alluded to that you're joining Medtronic earlier.

52:50And I've read a few stories about how you were recruited to join Medtronic by Nina good heart what was uh what was that conversation like what and and did you always it's not it feels as if you perhaps had this as a as a as a potential path career path for you uh moving into industry or did it was it more serendipitous than that it was a little bit of both um one i have always been someone who when the when the door of opportunity opens you walk through it right? I mean, especially women in particular, we have to feel like we have 100 % of the qualifications before we'll take that next opportunity.

53:30And it's just, especially in cardiac surgery, when you're in the minority, you're less than 10 % of the cardiac surgeons out there. In interventional cardiology, it's even lower. And I have always been of the mindset, you know, when the door of opportunity opens, you walk through it. And I had hit a place in my career where I didn't know what I really wanted to do next. I had gone to Oxford to do a master's of science in clinical trials because I had thought I wanted to be a trialist. And I had made professor. And so the next move is really to be a chief or a chair at a program if I was going to continue the academic ladder.

54:04And I started applying for these positions and it was a wrong fit. It just didn't make sense. I would be just leading cardiac surgeons. You know, maybe there would be an opportunity at a heart and vascular institute where a structuralist who is a cardiac surgeon may be the right person, but it just didn't seem to fit with what I wanted to be doing for the next 10 plus years of my career. And I started exploring other options and I had consulted for a lot of the strategics, Medtronic being one of them. And so I'd known Nina for a really long time. And I had asked her a few years prior to us sitting down and having this particular conversation that I'll walk you through to mentor me.

54:47And we would meet periodically and, you know, trying to find women that are successful in med tech. Once you find one, they're your mentor forever because they have so much knowledge. And it doesn't necessarily have to be about being a cardiac surgeon or being in academic medicine. It's bigger. It's about how do you navigate a career in medicine, med tech, healthcare, STEM, whatever, you know, it kind of applies to all of that as a woman, because what got you to where you are mid-career is not going to be what gets you to leadership levels after that. And I needed help. I needed help navigating that.

55:27And so Nina was amazing in that regard and mentoring. So I had prepared to sit down and tell her, Nina, I'm exploring other things. What other opportunities would be out there? And, you know, I was thinking small startups, you know, be a part-time CMO and still a cardiac surgeon, get involved in trials. And she frankly said, have you ever thought about working for me? And I'm going to be honest, the thought hadn't really never crossed my mind. Jeff Potman was already in the role and extremely well-respected trialist CMO extraordinaire doing it all. And I didn't know there would be an opportunity at all.

56:07So, um, certainly, you know, something like that down the road after I retired from cardiac surgery was always where I was headed. So it wasn't like a completely foreign thought, but working for Nina, I hadn't really thought about that. And it took me a few minutes to even appreciate what that opportunity would mean and what it would mean at this stage in my career, which is pretty early for someone to leave clinical practice and go into industry. And I was intrigued. And again, that door of opportunity was there. And I said, well, tell me a little bit more about what you're thinking. And the more she talked, the better it got.

56:50And we didn't know exactly what it would look like in the beginning. Jeff was clearly in his role. And then a few months later, Jeff announced that he would be going to CRF and leaving that role. And then it all kind of fell into place. So more luck than anything. And, you know, just that opportunity. I was asking about, you know, career opportunities. And then it just came, it landed literally on my plate.

57:21And what was it about the portfolio? You've done such a great job of introducing us to many parts of the portfolio, but are there other parts that you're excited about that perhaps we should be covering? I don't want to leave anybody out. Yeah. Well, that was the most exciting part about the job was that you had your legacy products, as I mentioned, the congenital, Harmony and Melody, right? That as, you know, the foundation of all of it. And then you had TAVR, but you weren't really, Medtronic wasn't really a structural heart company. You're not really a structural heart company if all you have is TAVR and two congenital valves and a couple other little things all inside.

58:03And so to come to Medtronic at this point where you had trials for mitral replacement, trial EFS, early feasibility study for tricuspid, so much opportunity. But knowing to truly be a structural heart company, you need repair technology that fits in mitral and tricuspid. You needed probably a designated valve for aortic regurgitation. You needed so many things and to be at that inflection point in Medtronic's progression to becoming a real structural heart company where you have all of the portfolio, you have all of the tools in your toolbox that I had as a cardiac surgeon. And I could be part of shaping that, making the decisions about which things fit and what we wanted to do and what the future of Medtronic Structural Heart would be.

59:02Incredibly exciting. So what you're going to see from us now is a big investment in accessories to make Evolute, our legacy product, easier. Indication expansions like RedoTav and then how does that fit into the future of TAVR leaflet modification. Investments in short frame or balloon expandable valves for aortic stenosis. We have replacement for mitral and tricuspid, and we're already looking at next generation. And then not necessarily accessories, but that ecosystem that I mentioned. How do you get the driverless car, robotics? What does that look like? And then add to that replacement technologies.

59:45And we are actively looking to build that piece of our portfolio, the repair in addition, the complement to replacement, so that we have all of the tools in the toolbox. So incredibly exciting time in MedTech and very much an incredibly exciting time for Medtronic right now. That's amazing. No, you're right. A lot of CMO roles I would see more as, not maintenance, but they've got an established business that they're helping to move forward and to engage the patients, engage the physicians. you don't very often have an opportunity to help really build out a franchise. So what is this going to look like in the future?

1:00:27And I'll ask kind of two sub-questions to the questions. Number one, looking at the patient population, you mentioned a few times how you're able to treat patients younger. I mean, 10 years from now, what does the structural heart patient population look like? Yeah, well, structural heart means different things depending on which valve you're talking about. But for aortic stenosis, it is a disease of the elderly. Most of the patients who are going to have aortic stenosis, you have to live long enough for your valve to stenose. So for that patient population, what you'll see is younger patients, patients who have traditionally been mostly treated by surgery.

1:01:06We're going to start looking at those patients. You have new populations of patients like patients with moderate aortic stenosis, but who have symptoms already. This was the patient population that I could treat as a surgeon if I was already going to the operating room. So let's say they had coronary disease and moderate aortic stenosis. I would change out their valve while I was there. But they were not a target for transcatheter therapies because it was felt it was too early in the disease process. Well, we have two large trials, one that you'll hear about this fall, and then our trial you'll hear about in the spring, where we're treating new populations of patients that we may find that earlier treatment leads to better long-term outcomes.

1:01:50We don't know that to be true yet, but we're continuing to study that. You're going to see in the mitral space, I mentioned that those head-to-head trials of clipping versus surgical repair, with surgical repair being the gold standard. Those two trials are going to help us understand which are the right patients for each therapy. Newer generations of replacement devices, especially in the tricuspid space, we may learn that tricuspid repair with a transcatheter valve is even better than clipping the patient. and because that surgical bar is so low and so few patients are treated with surgery and only specific types of patients are really treated with surgery that we can help even a broader range of patients who are suffering from that disease and that's where it starts going from just valvular disease to heart failure therapies so both mitral and tricuspid bridge into a lot of heart failure because one of the ways that the valves can fail is because of dilation of the ventricle or of the atrium.

1:02:56And so that's a heart failure patient. So it's not just the valve was bad, but the structure around the valve started to fail. And can we help those patients? So newer technology, newer patient populations, certainly younger, lower risk patient populations when you get into mitral and tricuspid therapies. So tremendous opportunity to really learn about the disease process, the patients we treat, and then define who is best treated with which therapy. From a medtronic standpoint, I brought it up a couple of times, this ecosystem and the driverless car and the robotic technology, that is a future that then becomes democratizable.

1:03:40Right now, the mitral and tricuspid therapies really are at the higher volume centers, and it's very US, Western Europe, Japan, Australia-based. You have to have advanced imaging. You have to have expert technical skills by an individual operator. And in order to normalize the skillset, democratize the therapy, we're going to have to do something different. The technology has to catch up and we're not there yet. And so we're looking at new ways to be able to bring this technology to a global patient population in a way that you do not have to have the advanced academic centers in the United States be the only places where these therapies can be offered to patients.

1:04:28And so that's kind of the future of this technology. Fortunately, there's work being done globally. Lots of companies are already doing this, but we know at Medtronic we have all the pieces already. We're already doing this in other areas, other businesses under Medtronic So why not bring that same type of technology to structural heart and transcatheter valves? We have a robot for surgery. We can use those concepts. We have the navigation in spine and in neuro. So bring those together under Medtronic's already existing umbrella. So it's exciting to be able to work cross-functionally, coming up with global solutions for patients.

1:05:11Two more questions. Sorry, I only had one more, but I just I wanted to follow up on clinical trials, given your experience. I mean, the clinical trial strategy you're deploying seems really innovative. And I almost use the word aggressive. I mean, I love the head to head trials. I love the different sort of ways you're looking at things. Is that unique to this business? First of all, am I classifying this right? Do you feel like this is a different approach to clinical trials? How do you see the clinical trial strategy sort of playing out? Yeah, I think that the clinical trials that we've done across structural heart are innovative in that they kind of went after the gold standard.

1:05:48They started with high-risk patients and started then moving down to lower-risk patients. I don't know that you'd seen that before because there wasn't anything as disruptive. PCI, so the coronary side of things, I think that's probably the closest example when you started having stents versus traditional coronary artery bypass or CABG. That's a similar type of mindset. Our trials aren't really that much different than that stent versus CABG philosophy. When you think about the trials of the future, though, we do need to be thinking of newer ways to bring forth data. right now you have a trial and then 10 years later, you understand your long-term results and durability.

1:06:34Well, 10 years later, you're six generations further in the device. And so is it really comparable? We're not implanting the device the way we were in the devices that you started with the trial. They don't exist anymore. And so there's some theories and some ways that we're thinking about how do we better understand long-term durability and whether that's using simulation or digital twins. It's a predictive model that we still have to prove with real patient data. We still have to prove that. But we have collected in Structural Heart so much data. We have over 10 years of data from our early generation devices.

1:07:14Can we use what we've learned to better build newer technology and then build appropriate trials. Are there better ways of doing trials where we use a common comparator and then we just compare to that quote-unquote gold standard? This is all theoretical at this point, but the amount of investment in clinical trials suggests that there is a tremendous amount of room to do it better. So although you may think of our trials as innovative, it's really the same way that pharma has been doing trials, or if you go back to stents versus cabbages, it's the same theories that really haven't changed over decades.

1:07:57So there's room to be innovative in this space. Interesting. And final, final question. We talked about the changing demographics of the patient. Talk to me for a moment just about the interventional cardiologists, the interventionists who are working on this, the surgeons. How is that population changing? What demands, will they have in the future? Will there be fewer of them? Do you need to account for that? Will they need, I don't know, will they be more attuned to surgical robotics and therefore easy to sort of bring those products to market? What is the future of this physician specialty look like?

1:08:35Yeah, I think that, you know, we envision a space that, first off, let me backtrack, the patient population continues to grow at a rate that we can't keep up with. Right now, today, even with TAVR being around for 20 years, we estimate that we are only treating somewhere 40 to 50 percent of the patients who are out there that should have treatment right now. Sometimes they never make it to the right referring physicians. We are not diagnosing their disease fast enough. I mean, aortic stenosis takes years to develop. We shouldn't be diagnosing it in the emergency room with a heart failure hospitalization.

1:09:18Still today, we are, right? All it takes is someone to put a stethoscope to that patient's chest and hear their murmur, then refer them. But patients aren't even getting that level of care. They may not be going to the doctor at all, or their doctor isn't listening to their heart and listening for a murmur doesn't think about that this could be a risk. So right now, patients are already underdiagnosed and undertreated in all of the valve therapies. Then you look at certain patient populations, specifically women and then minorities, and that gets even compounded more. It's even worse. So I think that first we need to address the patient population that should be getting the treatment.

1:10:00We should not be diagnosing them in the emergency room or in the hospital setting. This should be something that's diagnosed as an outpatient. They get plugged into the pathway for treatment of their disease. When we think about just something like aortic stenosis, if you have severe symptomatic aortic stenosis and heart failure hospitalization, that's a worse diagnosis than any cancer that you could be diagnosed with. Your mortality is about 50 % at two years. So other than stage four cancers where they're picked up super late, you think about these therapies, we're missing so many patients. Now you have mitral tricuspid and other valves.

1:10:39We don't have the capacity even to treat all of the patients that should be getting into the system and into those funnels. So we're going to have to really think about how we divide up those patients and where do we treat them? Do they come in and they get same-day discharge like what we proved during COVID was feasible? Currently, it all requires at least a one-night stay. So the model of how we treat them for the interventional cardiologist and the surgeon, it's going to be figuring out which patients are candidates for structural heart therapies versus traditional surgery. And a surgeon has a seat at the table currently as part of the heart team.

1:11:21Robotics could play in robotic surgery, but robotics could also play in robotic interventional transcatheter therapies. Those are just starting in their infancy now. But if we could be more efficient, we could treat more patients, more patients in a day, you know, and be able to get more patients through the system. So I think this entire field is going to be disruptive. It's going to be disruptive just by the sheer number of patients who enter the system, by newer technology that's identifying those patients, and then getting them to the appropriate treatment and appropriate care centers faster.

1:11:58And then we, as Medtronic, are going to have to come up with devices that treat broad ranges of patients efficiently, safely, and effectively. Amazing. Well, I've thoroughly enjoyed this conversation, and I'm really grateful for the time you've taken. I'm glad you've joined. I guess it's been a little bit of time, but I'm glad you're part of the medtech industry and look forward to talking to you again in the future. Thank you, Tom. I appreciate this opportunity. You have a great day.

1:12:56look forward to sharing stories with you, great medtech stories with you in the future. So please do subscribe to the Device Talks Weekly podcast. You can subscribe directly to Device Talks Weekly or to our Device Talks Weekly podcast network. You'll get Device Talks Weekly sent to you. Either way, if you subscribe to the network, you'll get our other great podcasts, including a Women MedTech podcast episode that'll be coming out very soon. Kayleen Brown has been working a lot on that program. So please do subscribe in one form or fashion. Please do connect with me on LinkedIn. Please connect with Chris Newmarker on LinkedIn, connect with Kayleen Brown on LinkedIn, and we'd love to be part of your future MedTech conversations.

1:13:41And of course, please follow link, I'm sorry, follow Device Talks and follow MassDevice. I do hope you'll join us next week on medical design and outsourcing's minvasive episode, including my conversation with Yossi Barr of LEMSurgical. You can find the registration link in the show notes, or you can go to medical design and outsourcing and look for the webinars tag and go to that page and you can register right there. It's free. You can watch live, watch on demand, and you'll learn a lot and you'll get to be part of the conversation, as I said. So, all right, folks, thanks again for being part of this episode and of this wider device talks weekly program.

1:14:21And we'll talk to you next week.