November 10, 2021
In this episode focused on Structural Heart, Nina Goodheart, president of Medtronic’s Structural Heart and Aortic Operating Unit, takes listeners – valve by valve – through Medtronic’s growing toolkit of replacement heart valves, an increasingly competitive space in medtech. Goodheart also talks to the company’s commitment to ensure greater access to better healthcare. Goodheart, so-chair of the Medtronic Women’s Network, also speaks to the importance of opening doors for female executives.
Tom Salemi (00:00):
Hey, when this is Tom Salemi of DeviceTalks. Welcome to our newest member of the DeviceTalks 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 (00:43):
Hi, everyone. This is Tom Salemi. Welcome back to the MedtronicTalks podcast. Our guest today is Nina Goodheart. Nina Goodheart may have the best name in medtech. She also has a really great job. She is a senior vice president at Medtronic. She's also president of the Structural Heart and Aortic business at the company. In this episode, we'll talk extensively about Medtronic's heart and valve business. We'll go over its entire portfolio and really discuss where Medtronic is making a difference here.
Tom Salemi (01:17):
We'll also talk about how Medtronic is working to improve access to quality care and Nina discusses her role as co-chair of the Medtronic Women's Network. So far ranging conversation, great to talk with Nina who has an interesting degree, at least to me. So I really enjoyed this conversation. Before we begin, though, I'd like to bring in Kevin Hartke. Kevin is the chief technology officer at Resonetics. Resonetics is sponsoring this episode of MedtronicTalks. Kevin, tell us about Resonetics.
Resonetics is headquartered in national Hampshire with a total of 11 locations across the US., Costa Rica, Switzerland and Israel. We have 1500 plus team members with over 10% holding a technical degree. We are a hundred percent focused on the medtech market and provide industry leading advanced engineering and manufacturing solutions in raw material, components and sub assemblies with a technology focus in thin wall stainless steel tubing, and precious metal marker bands, laser processing, nitinol processing, metal fabrication and smart device sensors. We provide additional services and complete device design and development and finish cleaner assembly. And we also have an in-house automated solution group, which designs and manufactures all of our capital equipment.
Tom Salemi (02:33):
We'll hear more from Kevin Hartke a little later in the podcast. If you want to find out more about Resonetics go to resonetics.com. Well, Nina Goodheart, welcome to the podcast.
Nina Goodheart (02:47):
Thanks so much for having me.
Tom Salemi (02:49):
So I have covered medtech for a long time. I say it a lot on this podcast, it makes me sound really old, but I have to say, I think your name is probably the best medtech name I've ever heard, any story behind it.
Nina Goodheart (03:01):
No real story, but with a name like this, I'm not sure there was anything else I could have done, but work in cardiovascular.
Tom Salemi (03:09):
It's very true. It's tough when you get typecast, but you seem to be working through it. So I'd love to find your about, a bit about your background and how you found your way into medtech. And I was excited as all heck to see that you have a journalism degree. I think you may be the first person I've encountered with a journalism degree in this space. So tell me a bit about your path into the medical device industry.
Nina Goodheart (03:33):
Sure. So I do have a journalism degree from Northwestern. I then got my MBA from NYU and when I think about my career path into med devices, really three parts, first part was consumer. So I left college and grad school went to work for advertising agencies that focused in package goods and consumer marketing. I then went on to do a big pharma strategic consulting, and from there made my way to Medtronic for med device.
Tom Salemi (04:03):
Excellent. And did you ever have a journalism degree in mind or were you just more interested in communications?
Nina Goodheart (04:09):
I went in thinking I was going to write for the New York Times. So you just never know how things are going to go.
Tom Salemi (04:14):
That's very true. That's very true. Well, great. Well, let's talk a bit about your business at Medtronic, the business that you oversee. Tell us a bit about the areas that you cover, and then we'll obviously drill down and I can't wait to talk about TAVR and some of the other exciting spaces you're in.
Nina Goodheart (04:30):
Yeah. So thank you. So the big business that I cover for Medtronic is Structural Heart, which is one of our fastest growing businesses within Medtronic. We've been really at the forefront of innovation for a number of decades now. And these innovations include the first transcatheter pulmonic valve, which is mostly for congenital heart disease for children. The first self expanding and recapturable transcatheter aortic valve, or TAVR, which is the big business here for Medtronic, and then moving now into the big spaces of mitral and tricuspid. So if you think about the heart, it has four valves and we essentially have programs in all four of those valves.
Tom Salemi (05:12):
That's excellent. All right. Well, let's talk a bit about the structural heart component. I think I had read that this is one of the fastest growing businesses in Medtronic. Tell us a bit about the advances there that you're overseeing.
Nina Goodheart (05:26):
Yeah. So you're right. TAVR or transcatheter aortic valve disease, the program there is the fastest growing and biggest opportunity, I think in all of medtech. This is a program that treats severe aortic stenosis. So essentially if you think about the aortic valve in your heart, if it gets narrow and blood can't flow through, you start to have aortic disease and you may need to have your valve replaced. And so since 2007, when the CoreValve was first approved in Europe, and then 2009 when Medtronic acquired CoreValve, we've been iterating on those platforms in order to really provide what we think is the best technology in the TAVR space.
Tom Salemi (06:11):
Well, let's focus on the TAVR space. I want to drill down into your very broad portfolio in the space, you've got several programs. Can you kind of tick walk us through bit by bit? I know you had recent news on the Evolut that we can talk about, but what are your various products in that space?
Nina Goodheart (06:31):
So in the aortic space, really, we have been focusing on what we call the Evolut platform. That's the newest platform that we have. The newest product that will be coming out, we're expecting to bring that to market very quickly, is the FX valve, and that is a valve that is focused on ease of use, making it easier for physicians to be able to use that valve, deploy that valve and provide what we call enhanced visualization so that you can really see what you're doing for orientation and depth of the valve.
Tom Salemi (07:04):
And you've got several clinical trial programs going on in this space. Is that correct?
Nina Goodheart (07:08):
We do. We have a number of clinical trials. In the aortic space, we've got the first trial that we're very excited about is a trial called Optimize PRO, and there we're really looking at how we think about pacemaker pathways. There are very often a patient with aortic disease who receives a TAVR valve may require a pacemaker. What we're looking at is can we provide a technique that physicians can use that's called cusp overlap. Can we use that technique to bring down the number of pacemakers, to bring down the rate of pacemakers? And so that is a trial that's currently enrolling. We also have... we're very excited about a new trial that we've just started called the SMART trial. And this is really the first head-to-head trial in the TAVR space and here we're really looking at the clinical question of which valve is best for which patient.
Nina Goodheart (08:00):
And when we think about patients, a number of patients have what we call a small annulus, as we want to make sure that you have the right valve for these patients. And so we've got this head-to-head trial with Edwards Lifesciences, their valve is called SAPIEN. And so we've got a head-to-head trial with the SAPIEN valve to take a look at whether or not Evolut performs better in these small annulus patients. We believe that it does. We also believe that women primarily have a small annulus. And so we think about 80% of the patients in this trial will be women, which means we'll get really strong data on what's an underrepresented population in clinical trials.
Tom Salemi (08:42):
What went into the decision or talk a bit about the decision to do the head-to-head trial with SAPIEN, that's not common, not seen often in medical devices, at least as far as I know. Why was that necessary and what is that, how do you sort of put a program like that together?
Nina Goodheart (09:01):
No, you're exactly right. It's not very common. Like I said, this is the first head-to-head trial [crosstalk]. And so, no, you're absolutely right though. But what we started to see was that there was clinical equipoise around this, physicians were really starting to think about which valve they should use. And because there's no head-to-head data, it was really hard for them to make that decision. So we had a number of physicians coming to us, asking us whether or not we would think about a head-to-head trial, especially in this very critical patient population. And so we do as we normally do, we put a group of physicians together. We debated how we should think about this. We thought about the fact that this is not done very, very often, but we thought that the question was so important that it would be a really good idea to do something different in this space and really prove, I believe we will prove beyond a shadow of doubt that the Evolut platform is really the best technology for these patients with a small annulus, especially for women.
Tom Salemi (10:03):
Interesting. Interesting. So talk a bit about the space in general. I mean, we saw Abbott move in. Obviously a few companies have moved out, but this is an area that's getting more attention, more competition. I'm sure this, a study like this may not be the first time we see this, but how competitive is this space getting and what does the new players mean to you, one of the established competitors in this space?
Tom Salemi (10:32):
We're going to take a quick break from this conversation to bring back Kevin Hartke, chief technology officer at Resonetics. Kevin, how does Resonetics help companies in the R & D space? And what has your company done to support the work of developmental engineers
Tom, we offer development engineers access to our light speed lab. The light speed lab provides quick turn, prototyping services, employing over a hundred engineer and technicians with dedicated processing and support equipment across multiple locations. Now the primary focus of this team is to shorten the design cycle. And we do this through engineer to engineer communication, quick turn quoting, and prototype delivery. If your device development is successful and requires volume manufacturing, we provide the direct path to production through our phase gate transfer process.
Tom Salemi (11:21):
And Kevin final question, Resonetics has invested heavily in developing new technologies in medtech. What are some of the unique capabilities that you're working on that will benefit the medical device industry?
I'd like to highlight a few of our latest technology developments that support the structural heart market. Now the first is nitinol valve frames. Resonetics has advanced nitinol processing through the implementation of our in-house built customized femtosecond laser cutting systems, which provide a near net shape part with no internal honing or debarring require. We've also engineered and manufactured our own automated salt bath for heat setting, which provides consistent and repeatable phase transformation performance. And finally, we've progressed the electro polishing of nitinol through an automated system designed and built by Resonetics. In addition to nitinol valve frames, we also offer design and development services. Our design and development services group provides truly innovative delivery system designs for the structural heart customer, employing the latest in catheter fabrication capabilities, including prime laser cut two. Prime laser cut two is a service in our delivery system component in sub-assembly business.
And this starts with our light speed lab engineers who transform your catheter function requirements into a customized laser cut pattern. This pattern is transferred to a functional part, employing both our metallic precision tube and an advanced high speed laser cutting process. This process is very efficient to quickly prototype a variety of catheter designs and transfers directly to production with our high volume manufacturing capability. In addition to laser cut tubing, we also offer assembly and laser welding services. Resonetics has a long history of assembling and laser welding implants and delivery systems for the structural heart market. We employ in the industry proven, laser weld verification and validation process that ensures repeatable and consistent weld performance. Now finally, I'd like to highlight our smart device sensor platform. Resonetics has completed two acquisitions in the smart device sensor space, which provides our customers with access to customized micro electrical mechanical and optical based sensor platforms. These sensors can be integrated into catheter delivery systems to provide physician feedback on force, temperature and pressure.
Tom Salemi (13:47):
All right, well thank you, Kevin Hartke for joining us in the podcast and thank you Resonetics for sponsoring. Once again, if you'd like more information about Resonetics, you've can go to resonetics.com. How competitive is this space getting and what are the new players mean to you, one of the established competitors in this space?
Nina Goodheart (14:11):
Again, you're exactly right. This is essentially been a duopoly. There have been two players in the space, Edwards and Medtronic. We are now seeing Abbott come into the space. I think for patients, it's always good to have more technologies that physicians can evaluate, make good decisions about which valve is best for their patients. The Abbott technology, we should think about it as first generation technology, it's designed differently. And if you think about the Medtronic valve, it's what we call super annular, which essentially means it sits a little bit above the annulus. The AVID valve is what we call intra annular, which means it sits a little bit deeper in the annulus. So if you think about blood flow, Tom, if you put something inside that annulus, it makes it narrower. The Evolut valve sits a little bit above. So it allows the orifice space to be a little bit wider, so it allows for better blood flow.
Nina Goodheart (15:07):
The more blood flow you can get through the valve, the better for patients, the better their exercise tolerance, et cetera. And so we think we've got a really good advantage here with that super annular design. We also have to remember that the new AVID valve is indicated only for extreme and high risk patients. The Evolut technology is now also indicated for those patient populations, but also for intermediate and low risk. So a much broader patient population. And so we think the Evolut valve is still a much better choice for physicians to make, but it will be great to see the continued evolution of new devices coming into the space. It's always good for patients.
Tom Salemi (15:51):
Always have trouble sort of tracking or keeping track of valve to valve. So we were talking about, we've talked a lot about the aortic valve. What are some of the other opportunities and I think you've hit upon them already, but in the other valves, is the aortic valves the largest opportunity, or are there equally large opportunities in tricuspid, pulmonary and mitral?
Nina Goodheart (16:12):
So Tom in the mitral valve, which is really the next big opportunity in medtech, our focus here is on mitral and tricuspid. We know that over 2 million patient or 20 million patients I should say, suffer from mitral and tricuspid valve disease in the US and Europe, which is an enormous, enormous population. And so we're in the process of developing technologies, both for mitral and tricuspid. In the mitral space, we have a product called Intrepid™, this is a valve replacement for mitral. We are looking, we are in the process of developing a transcatheter approach for that valve.
Nina Goodheart (16:51):
And we're in early feasibility trials now to test that. We currently have a trial called Apollo, that's a pivotal trial, that's a global trial that's currently running about 300, 350 patients already treated. That's a transapical approach. And so that's really looking to test the efficacy and the safety of the valve, but our approach for bringing this to market will absolutely be through transcatheter. In the tricuspid space again, we also have an early feasibility trial also looking at that same Intrepid™ valve in that tricuspid space. Right now, there really are no options for patients with tricuspid disease. So it'll be exciting to see whether or not we can bring a technology forward that can really help these patients.
Tom Salemi (17:37):
And how many of these valves could be delivered in a transcatheter fashion?
Nina Goodheart (17:42):
The goal is to have all of them delivered through transcatheter. The entire market is moving to transcatheter. And so our goal is to make sure that all of our valve programs, all of our bowel technologies are able to be delivered through a transcatheter. So in our pulmonic program, those valves are delivered through transcatheter TAVR, of course, transcatheter. And now we're doing trials in my mitral and tricuspid to bring transcatheter technologies to the market. In the mitral space, we're also looking at repair technology. So if you think about mitral, you have the opportunity to potentially repair a valve or if needed to replace a valve. Because the space is so complicated, we've really been focused on what we've called this toolbox approach to bring multiple modalities into the market. And so on the repair side, we have a research development partnership with a company called The Foundry.
Nina Goodheart (18:41):
They're very well established in this space, and they are working with us to develop a new repair technology. The goal for that technology, of course, again, also going to be transcatheter, but we're also looking to see whether or not it can be as safe as the current product on the market, to be even more effective than the current product on the market, and to give physicians what we call room for intervention. So right now, Abbott has a product that once you repair the mitral valve, the only other thing you can do is to send that patient to surgery. There's no opportunity for re-intervention. So with the technology that we're in the process of creating, you will have that opportunity. So that is again in early feasibility trials. And we're very excited about seeing what that will do.
Tom Salemi (19:33):
I'd love to follow up on the work with The Foundry. This is a Half Moon project that you developed and how did this relationship come together? I mean, traditionally, a larger company will obviously track an early stage technology startup, you may invest, you may even have a membership represented on the board. This sounds a lot more connected than any of those. How did you come to decide on this approach and please describe the relationship a bit?
Nina Goodheart (20:04):
Sure. So, because Structural Heart is such a large program, we have essentially had three approaches to our research and development. We have the work that we do organically, what we use our own engineers to help us create and develop. We look at small companies that we use as incubators to help us create new technologies where appropriate. And then we've looked at research and development partnerships like we have with The Foundry. We've known The Foundry well, so they have worked with us on renal denervation another technology, of course, that we have here at Medtronic. And so, as we were thinking about how to create this new repair technology, we thought that they would be really great partners. They've got deep, deep experience developing technologies in the mitral space and given our very close relationship with them on other working technologies. We thought that this would be a great partnership and I have to say, it's proven to be just that.
Tom Salemi (20:59):
And what do you think the outcome looks like? Are they building the product for you or do you acquire the product if it becomes what you hope it'll become?
Nina Goodheart (21:14):
We have an investment, we've made the investment with them. We're working very closely with them, and then we will have the rights to that product.
Tom Salemi (21:18):
Very cool. Excellent. Do you see yourselves entering into similar agreements with other entities or perhaps another agreement with The Foundry, is this a new model?
Nina Goodheart (21:28):
It is a new model and we're liking it very much so it's, we're looking very closely at whether or not there are other opportunities to do something very similar.
Tom Salemi (21:37):
It's an exciting program and yeah, The Foundry folks are the best. So I'm looking forward to seeing what becomes of that. Before we let you go, I want to talk about a few issues, I guess aren't directly related to your oversight of the Structural Heart business, but more in your efforts to encourage women to take leadership positions in medtech. And I assume elsewhere as well. What else are you doing or what are you doing in that space? What efforts are you involved in?
Nina Goodheart (22:07):
So as you probably know Tom, Medtronic has had this very significant focus on diversity engagement and inclusion. I have the privilege of co-sharing the Medtronic Women's Network. The Medtronic Women's Network or MWN has about 20,000 members. So extraordinarily large, really focused on gender equality and empowerment of women. We are focused on areas like retention and recruitment of women across all of our functions at all of our levels, focused on development and promotion of women, really focused on ensuring that women's voices are heard in specific policies for Medtronic. Things like return to office and future of work and ensuring pay equity. And so given the size of this network, we've got this really strong and powerful voice that we use to help Medtronic really think about the perspectives of women as they're making decisions about the organization.
Tom Salemi (23:10):
That's terrific. Now, looking through, just scanning the website for the MedtronicTalks podcast and the pictures we have, and it's a really strong representation for the women leaders at Medtronic. The reorganization really, I think, did you get a sense that as it was done to really elevated women into these head of business positions, do you feel like the reorganization really boosted that effort?
Nina Goodheart (23:37):
I think the new operating model absolutely helped women move into new roles all across Medtronic. We have a number of women presidents at Medtronic, which is fantastic. Of course, we want to work to raise women up all throughout the organization so that we can see women in all of our functions and at all levels continue to move forward. And so I think the operating model will absolutely help that, but mostly I think that Geoff Martha's focus on that, our executive committee's focus on that is going to really make the biggest difference.
Tom Salemi (24:07):
And Nina, the final issue I wanted to ask you about, is just a healthcare disparity. It would seem that that Structural Heart business is a business in which this is critical if people are unable to get the healthcare they need, what is Medtronic doing in that area to help ensure that that folks have access to this great technology, other technologies, and folks who need help for their medical issues?
Nina Goodheart (24:34):
In Structural Heart, we've been looking very closely at racial disparities and healthcare disparities in aortic stenosis in particular, wanting to ensure that patients had access to these incredible technologies. We know from all of our data that these underserved communities have had less access. So we're in the process of developing pilots. We currently have four, what I'll call grassroots pilots across the US, really looking at how can we better identify patients? How can we improve referral channels? And how can we make sure that our underserved communities, especially our communities of color, get to a referral physician, get to a valve clinic and ensure that they get the technologies that they need and deserve. And so we'll start with these four pilots. Our intent is to expand them as we go and really work to make sure that everybody who needs a TAVR procedure, a mitral procedure, a tricuspid procedure, or a pulmonic procedure for that matter gets one. And so excited about this work and I'm looking forward to expanding it.
Tom Salemi (25:41):
Fantastic. Well you're working on a lot of important projects over there. A lot of great technology. I really do appreciate you taking some time to share your story and their stories on the podcast.
Nina Goodheart (25:53):
Well, Tom, thank you again so much.
Tom Salemi (25:57):
Well, that is a wrap. Thanks so much for joining us on this episode of the MedtronicTalks podcast. Great to have Nina Goodheart here. It's wonderful to have Resonetics as a sponsor of this episode. Thank you so much to both. And thanks of course, to you, our listeners for continuing to tune in. If you haven't already, please do subscribe. We're on every major podcast application, Google, Spotify, Apple, Amazon, et cetera. We'd also appreciate it if you'd share this podcast on social media, let your friends and colleagues know about it. And if you do, I'd love it if you would connect with me, I'm on LinkedIn, Tom Salemi of DeviceTalks.
Tom Salemi (26:33):
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