[00:00:00] Speaker A: Hey, everyone. Tom Salemi here. Thanks for joining us on the Device Talks weekly podcast. A little later in the podcast, I'll speak with Darla Hutton. She's the global vice president of cardiac surgery at Intuitive. We'll talk about Intuitives, move back into that critical space. Before that, Bill Frey, regional sales engineer of Harmonic Drive, joins us in the FOMO studio. We'll talk about the future of surgical robotics from Harmonic Drive's perspective. But we'll kick it all off with the conversation between me and. And not Chris Neubarker, but the amazing Sean Hooley, senior editor of Mass Device. Sean's filling in for Chris, and he's going to focus on the news that came out of the American Diabetes association meeting.
Before we let you go, Please go to devicetalks.com and register for our upcoming webinar on biocompatibility. You can go to devicetalks.com for more information. Now, let's get this podcast started.
All right, you ready for this?
Ready.
Sean Hooley, welcome to the podcast, my friend.
[00:01:19] Speaker B: Thank you very much for having me. Good to be back.
[00:01:21] Speaker A: Yeah, it's nice that we got rid of that old guy Newmarker, finally made him take some time off, celebrate his big 50th birthday. But very happy to have you filling in. And we're gonna do things a little bit differently. We're gonna have a little bit of a tighter focus on this week's newsmakers.
Sean Hooley, what have you chosen for our focus of the episode?
[00:01:46] Speaker B: I got big shoes to fill with Chris gone, so I decided to just go in a different direction so it didn't look like I was trying to fill them at all.
[00:01:53] Speaker A: There you go.
[00:01:54] Speaker B: No, as sort of the de facto cover of diabetes tech news within the Mass Device drug delivery business, medical design outsourcing enterprise.
ADA was this past weekend, and I wasn't there, as I have been the past couple years, but I was still keeping an eye on all the reports and data coming out of there. So quite a few stories over the weekend that cover some really interesting diabetes tech at the American Diabetes association scientific sessions. So we're gonna talk about five stories from that.
[00:02:29] Speaker A: You're more than de facto, my friend. I think you are in facto our diabetes lead. Correct?
[00:02:36] Speaker B: Sure, why not?
[00:02:37] Speaker C: I'll take the nickel.
[00:02:38] Speaker A: You are the one.
So you've been to ADA before? I think because of Device Talks, Boston, you weren't able to make it this time around. But we'll. What.
What was. What has been your takeaway from. From these meetings? I mean, these meetings can just sometimes be so, so big that you're almost. There's too much to cover and you can get lost in it all.
[00:02:59] Speaker B: Definitely. I mean, it's. And it's one of those things that, that's probably not smart for me to admit on these airwaves, but the scientific sessions. So sometimes the data can be a little bit out of my league in terms of some, some of the things they're talking about. I am not a scientist to.
[00:03:14] Speaker A: I cover the. I follow those entire conversations now. I, I hear you. You kind of sit there. You're like this title, like, Almost Understood. So I was hoping I could get a glimpse of what was being hap. Of what was being said.
[00:03:26] Speaker B: I heard Glucose in there somewhere.
Everything else, no, but it, it's, you know, they're interesting to sit in on and, and try and wrap your head around. But for the most part, when I've attended, you know, it's been about taking the opportunity to actually meet in person with a lot of the companies. And, you know, they have really cool, you know, expo floor setups where you can, you know, it's my first experience holding an Omnipod or, you know, seeing sort of some of these devices up close.
So that, that's, you know, really the, the best opportunities for someone like me or someone like you at ADA would be, you know, being up close and personal with some of the shakers and movers in the industry.
[00:04:05] Speaker A: Absolutely. No, that's always a good thing. And it's, and it's great to meet the people you, you talk to via Zoom, to meet them in person, even connect with the comms folks who always kindly return emails and set up dolls. It's nice to put actual people to the, to the. Used to say faces to the names, but now I guess we have to say people to the Zoom images. Right.
[00:04:26] Speaker B: As a short man, I often find that people are a lot taller than they look on Zoom, so that's usually my takeaway.
[00:04:33] Speaker A: All right, well, you've chosen five winners, I see.
Let's start with number five. What is the fifth biggest piece of news coming out of ada?
[00:04:45] Speaker B: Yeah, well, it was from Abbott, and it sort of came on the heels of something that had happened the week prior. But the company released some data on the importance of managing diabetic ketoacidosis, or dka, which, you know, is timely for the company because it won CE mark for its dual glucose ketone sensor. So it's the first sensor available anywhere that can, you know, track multiple analytes and effectively, you know, go beyond just traditional glucose monitoring to monitor something else that does affect people, diabetes and can lead to pretty serious injury or death if not treated. So Libre Duo is what they're branding it as.
It looks just like a freestyle Libre and all that. It's really interesting sort of technology they've been talking about for a while I think two years ago at ada I spoke with Chris Scoggins, who leads Abbott's diabetes business about the technology and they were really excited about it then.
So they're still looking to bring it to the US now. But basically know the, the data was about the burden of DKA and sort of highlighting, you know, hey, here we have this great technology that can, you know, make a difference here.
[00:05:58] Speaker A: Was there a way to, to measure ketones before? And it just. This is a combination of this with glucose.
[00:06:04] Speaker B: Yeah, I hope I'm not speaking out of turn. I believe it was similar to, you know, they had testing strips, you know, maybe blood, blood draws or finger pricks, but not a continuous like they used to first. Yeah, no, not as far as I'm aware.
[00:06:17] Speaker A: Wow, that's huge. All right, well, Abbott, I mean we had Lisa Earnhardt at Device Talks Minnesota a few months ago. We had her or a few about a month ago. We had her podcast on last week.
Abbott's really, really taking, I don't know if they're taking a commanding lead in this industry, but they're certainly really establishing themselves as one of the leaders for sure.
[00:06:40] Speaker B: And it's worth noting that they're, you know, the dual monitor, they have a bunch of agree already with various pump makers to have that dual monitor made for, you know, for integration with their insulin pumps. So they're prepared to bring it to the wider diabetes population.
So it's definitely something that they've been waiting for.
[00:07:02] Speaker A: Excellent. All right, well great. Number five, Sean Hooley.
What's the number four? The fourth biggest piece of news coming
[00:07:10] Speaker B: out of ada number four is another glucose monitor is Senseonics implantable year long device. They had data so of showing the performance of Eversense 365 in multiple different insulin treating regimens. So you know, they had open loop insulin delivery users which is, you know, just delivering your own insulin effectively. And then they also had data from an additional 153 closed you closed loop users. Excuse me, with CGM used as part of the SQL MedTech Twist automated insulin delivery system, the companies have actually launched their integration. It's the first pump integration for Senseonics, you know, a Lot of the pumps currently pair with the traditional Abbott and Dexcom, you know, interstitial fluid measuring CGMs. But ever since 365 is implanted beneath the skin and it has an external sensor component that then, you know, transmits your glucose data to a phone and it lasts for a whole year. So it's a quite different sort of proposition. But Senseonics is just sort of floating out more, more information that sort of shows people that, you know, this is another option for not only monitoring their glucose, also pairing with an insulin delivery system.
[00:08:24] Speaker A: So this is a way of just ensuring steady monitoring. Is there a feeling that if it's, they're not, if they're shorter term monitors, people might not use them for a day or two or what's. How is this seen as being an improvement?
[00:08:38] Speaker B: I would say from Senseonics standpoint it's more of a, you know, convenience factor. Whereas you know, with Abbott and Dexcom you're replacing the sensor every now it's up to 15 days, so every two weeks or so. Whereas you have one, one procedure where it's implanted and they, you know, from there it lasts for a year. It still is a similar mechanism in terms of where it measures the glucose. It's still in the interstitial fluid, but it's just implanted beneath the skin. So that, you know, makes it less of a day to day task for, for people to manage in terms of the actual device itself.
[00:09:13] Speaker A: Very cool.
I mean folks have different preferences for how they want to interact with their devices, so makes perfect sense. All right, what's number three, Sean? Holy.
[00:09:23] Speaker B: Well, number three is sort of building off of that. So the company that Senseonics pairs its sensor with SQL MedTech, which is a Manchester, New Hampshire based company. So almost local, pretty local to us, but in Massachusetts here. But they had data that sort of showed how their twist automated insulin delivery system which is currently available for type 1 diabetes, launched fully in the US earlier this year, can actually help people with type 2 diabetes as well. So that was something. SQL is pretty new on the insulin pump scene compared to some of the existing leaders. That was something that was a really big push for Insulet Tandem Medtronic a couple years ago. And SQL was just sort of trying to establish a foothold in the market with Type one to start. So now they're showing that their pumpkin delivery deliver positive outcomes in type 2 diabetes as well. And we actually have concurrently with that post covering the data Q and A with the company's chief medical officer Joanna Mitry. So, you know, something interesting to learn more about that technology. For anyone listening.
[00:10:29] Speaker A: Excellent. All right. Yeah. SQL is of course another company coming out of the Dean Cayman universe.
So great to have them. I mean, they sort of, I think, reemerged two years ago or so and they've really made a lot of headlines ever since.
[00:10:46] Speaker B: Yeah, it was FDA clearance, I think March of 24 for twist and there were probably people with their ear closer to the ground that had an inkling of what was coming, but I certainly had never been made familiar with any of it. So it sort of came out of nowhere and all of a sudden there was this new automated insulin delivery players. So yeah, they're an interesting one to watch.
[00:11:06] Speaker A: Absolutely. All right, let's roll on to number two. What's number two? Shanouli?
[00:11:10] Speaker B: Number two is Dexcom, another type two related study. They showed the highlight. They highlighted their benefits of their G7 CGM, the current generation. Obviously they unveiled the G8 recently, which is another article I would implore anyone interested to read. But the G7 is the current offering available and it highlighted the benefits of the CGM in non insulin using type 2 diabetes. So basically what the reason for this study is that Dexcom is trying to get more reimbursement coverage, whether private pharmacy coverage or Medicare coverage for the type 2 diabetes population. Because right now CGM is covered for type 1.
So showcasing the benefits of this technology in that population is something that the company is, you know, been really, really trying to do for, for a couple years now. Something I've spoken with CEO Jake Leach about a few times. You know, they've really been pushing forward in the type 2 population and they, they expect some things to happen in the coming year, I think. And I was able to speak with Leach again via Zoom because I wasn't at ada. But over Zoom on Sunday we have an interview on drug delivery business news as well that covers all sorts of things from companies, acquisition of Nutrisense, which is a wellness tracking company, as well as the data from ADA and G8 as well. So lots, lots to unpack there.
[00:12:37] Speaker A: Cool. All right, working on a Sunday. Sean Hooley, you are unstoppable.
What is, what's number one on, on your ADA newsmakers?
[00:12:47] Speaker B: Number one is Insulet data for its next generation Omnipod 6. So it's something company sort of laid out its roadmap for the next few years at Investor Day in 2025 and they talked about Omnipod 6 really the first time publicly.
So that, that's Something that people are obviously anytime.
Omnipod 5 has been on the market since 22, I believe.
And so, yeah, people are sort of waiting for the next generation. So they expect Omnipod 6 to launch next year, but they had data sort of supporting the technology behind that and then also fully closed loop algorithms. So, you know, technology for type 2 diabetes that the company hopes to launch in 2028 that would, you know, further improve glycemic outcomes with less burden. So it would eliminate user interactions for bolusing and mealtime announcements, which is, you know, they're just trying to make these systems even smarter and more autonomous and take the, you know, management portion out of the user's hands as much as possible.
[00:13:52] Speaker A: So Omnipod 5, the current version, came out in 2022, you said.
[00:13:56] Speaker B: Was it 2 or 3?
[00:13:58] Speaker A: Either one. I'm not sure.
For some reason I thought it was newer than that. That's interesting. Okay. And I'm not challenging you, I just thought they were updating more frequently than that.
[00:14:07] Speaker B: Well, you know, they've had enhancements over the years. Yeah. January 28th, 2022 is FDA clearance for the Omnipod 5.
[00:14:15] Speaker A: Okay. And they've, and they've, as you were saying, they've done additions and sort of improvements upon that in new iterations of
[00:14:22] Speaker B: it, algorithm enhancements, you know, making. It started out similar to some of these other pumps for Type one. They added Type two a couple of years ago as well. So yeah, it's definitely, you know, it's not just they launched it four years ago and it's been the same ever since. They've definitely built upon it.
[00:14:39] Speaker A: So. Cool. No, in any. We had Eric Benjamin at Device Talks Boston, obviously we talked a bit about their recent correction, their recall. Any more news on that or is that pretty much been resolved?
[00:14:53] Speaker B: I mean, you know, it's, I think it's the same as it was a couple of weeks ago. Basically they're, they're working through, you know, their quality management or quality assessment things and as far as, you know, things, things are still moving on the other fronts. They're still trying to show that they're, you know, that one, one recall isn't going to hold back innovation, I suppose.
[00:15:13] Speaker A: Absolutely not. All right. All right. Sean Holywell, I'm sorry you weren't able to make it down to New Orleans, but I'm glad you're with us at Device Talks Boston and I'm glad you're, you're still staying on top of all the news coming out of ada, so thanks for for joining us in the podcast.
[00:15:29] Speaker B: My pleasure. And as a shameless plug because most of this information will also be in our diabetes tech special report, which is scheduled to release in August on the Mass Device website. So full, full report, there'll be a few interviews, you know, longer form stories about some of the technology and then, you know, some of the details and then a list of the 10 largest diabetes tech companies in. So feels like it's worth, worth a moment to plug for that as well. That's coming out in a couple months.
[00:15:58] Speaker A: Absolutely. Now that's a, that's an update, right? You did one last year as well.
[00:16:01] Speaker B: Yep, Yep, it's the second, second one. So 2025 was the first and yeah, we'll have the second annual edition coming out this year.
[00:16:09] Speaker A: All right, well we'll definitely have you back on the podcast when that comes out. All right, now it's time to bring our FOMO to you. It's brought to you by Harmonic Drive. You can find out more information about Harmonic Drive on their website. Harmonic Drive is your one stop headquarters for miniature speed reducer products designed for applications that require smaller space saving components. You can see a lot
[email protected] that's H A R M O N I C drive.net now we'll have our conversation with Bill Frey of Harmonic Drive. Let's listen. Well, Bill Frey, regional sales engineer at Harmonic Drive, welcome to the podcast.
[00:16:50] Speaker C: Well, thank you, Tom.
[00:16:52] Speaker A: So when people talk about surgical robotics, I think we've been talking a lot more about visualization and software. But give us a sense of how foundational, the mechanical precision layer underneath all of that. How important is that?
[00:17:05] Speaker C: Oh, it's very important. You may have seen a test apparatus where they're simulating an operation by picking up little tiny objects.
And it's very hard for the end effector to actually pick up these objects. And operator, the surgeon is operating them remotely. They're not actually, their fingers aren't in there. So the reliability, the repeatability and the backlash is very important.
[00:17:32] Speaker A: So in surgery, I think, well, you could either the expert on me, but surgical robotics, I imagine that the arms, the devices, the instruments that are being used in the procedure need to move more smoothly than in other industries. True or false? But let's unpack that first.
[00:17:50] Speaker C: Well, it is true. There are exceptions. There are some industries where you do want very smooth motion.
[00:17:56] Speaker A: Yeah, sure.
[00:17:58] Speaker C: And if you picture a camera that's, that's looking at an object far away, if there's any vibration, you'll see that in the Camera, for example, and that can be fixed up, you know, electronically throughout the camera software. But in the case of a medical device, it's very, very important to have smooth motion.
[00:18:17] Speaker A: So Bill, if we could sort of unpack specifically what goes into eliminating the backlash and the vibration and I guess you could describe it as a herky jerky sort of feel in surgical robotics. Maybe we could sort of talk about the various elements and I guess procedures that you folks do and you folks support and let's just focus on that. And then I have a follow up question. What goes into stabilizing the surgical robotic arm?
[00:18:46] Speaker C: Well, in the case of our products, the gearing itself has a very high accuracy and high transmission accuracy.
So when they're driven by a motor, you tend to have a very smooth output on the output side from the gear.
And being a, you mentioned an arm, you have that extra distance where any kind of lost motion or vibration is amplified by that arm.
[00:19:12] Speaker A: So as we talked about, you've worked in other industries, surgical robotics or I'm sorry, robotics everywhere, I think needs to operate at a degree of smoothness and precision. In surgery though, smooth motion, I think it's more critical, no pun intended, more life saving technology. What actually goes into what parts and what process goes into ensuring that you're able to eliminate backlash and vibration and any kind of herky jerky feel. And then maybe after we can sort of unpack. What are some of the products that help us get there?
[00:19:47] Speaker C: Well, there's a few things. So the mechanical transmission for one. So from the motor side into the actual output as well as the position feedback. So the mechanism needs to know where it is at any given moment. You have some sort of feedback mechanism, for example an encoder. You may have a torque sensor involved as well.
[00:20:09] Speaker A: So with surgical robotic systems and surgical robotics arms, I would think that you're working at a much smaller scale. How difficult it is to build something that has all these components and elements that are necessary for that smooth motion in something that must exist at such a small scale.
[00:20:29] Speaker C: Well, a lot of this is designed by the medical device manufacturer because there's, there's nothing that just exists on the market in this case. Typically a lot of different components are assembled and tested to achieve what they're looking for.
[00:20:46] Speaker A: One thing that's always fascinated me about surgical robotics is that industrial robots, they sort of are execute to program motions that are necessary to sort of complete something, complete a car or now move a box or whatever they're doing. In other industries, surgical robotics sort of amplify the human hand, the surgeon's hand.
How does this fundamentally change sort of the mechanical requirements of a surgical robotic system? And how does harmonic drive help with that?
[00:21:14] Speaker C: Well, you have a good point. It's not just a mechanism that's just picking up something, repeating the same motion over and over.
In this case, it's driven by an operator surgeon. And they need to be able to control the device as if their hands are at the end of factor.
When they want to make a move, they want to have very quick and accurate movement on the output, which is to what the move that they commanded.
In addition, a lot of these devices may have haptic feedback where they actually have some sort of resistance at the control, which is proportional in effect to what's seen on the up on the end effector.
[00:21:56] Speaker A: Let's drill down a little bit on haptic feedback. That's become, obviously it's been a point of conversation for years, but I think more importantly, more recently, it's become seen as sort of a differentiator between surgical robotics, some surgical robotic systems, one from another, as haptics and force feedback evolve. How important is the sort of the ultra precise gearing that goes into providing that, that enable that surgeon experience, that allow them to sort of quote, unquote, feel the tissue that they're working on?
[00:22:28] Speaker C: It's very important because if you have any kind of backlash or lost motion in the system as you're to, to operate it, you're now missing your, your, your spot on the output side on the end factor. So this, you know, applies to even like a pick and place type of unit where if you picture that you're here, you are with the joystick trying to pick something up and you, you, you're trying to go to a certain spot, but you have, you have lost motion, you have some backlash, you have trouble achieving what you're trying to do.
And in this industry, it's even more important than what you might see in other industries.
[00:23:08] Speaker A: Is that sort of feedback unique to surgical robotics? That sort of, you need to feel what you're quote, unquote touching? Or have you seen that in other industries as well?
[00:23:18] Speaker C: Well, typically in an industry where it's a human operating it, yeah, obviously, I suppose, but like a pick and place device or a, some kind of thing where the operator is actually trying to have dexterity on the output.
[00:23:39] Speaker A: Interesting. So, I mean, we've seen a lot in other industries or in other technologies that things develop faster in industries outside of medical devices for the simple fact that, well, I think the Stakes are higher, maybe here than elsewhere, and it's also highly regulated.
And as a result, I think medical device companies are able to learn lessons that have been experienced in other industries.
Final question. What lessons from aerospace or semiconductor precision systems can surgical robotics learn from and maybe adopt more aggressively?
[00:24:18] Speaker C: Well, it's certainly an industry that's growing and utilizing a lot of knowledge from other industries.
Mm. And it's a case where the lessons learned from robotics field is being applied into new industries such as this one specifically. There's probably a lot more behind the scenes than I'm aware of. Usually I have, you know, customers asking questions for the various applications, but why they have their. Their requirements, sometimes I. I'm not fully aware of.
[00:24:51] Speaker A: Do you think other areas within surgical robotics that are blazing new trails and are doing things that you have not seen or others have not seen in other robotics industries, or are our experiences, again, paths that others have already sort of blazed or trails that others have already blazed?
[00:25:10] Speaker C: Certainly there's new developments coming out, new new technology being used and new applications, new types of approach to achieving solutions.
So it's exciting. It's always growing and it's always different.
[00:25:32] Speaker A: And as, again, we're seeing a lot of. Final question. I do that sometimes. We're seeing a lot of innovation and a lot of advancement, I think, in surgical robotics of different form factors and different applications over the last five years. In particular, where do you think that energy is coming from that's drawing all of these new technologies, both from larger companies and small, into our consciousness and eventually onto the marketplace in the future? Is it just. Do we see from other industries? Maybe you've seen it before. Do you see a critical mass of great ideas just sort of coming together, coalescing, and just pushing an industry forward? And are we at that point with surgical robotics?
[00:26:11] Speaker C: I think we are at that point.
A lot of these ideas have been floated around for years, but now the technology's caught up.
And so now with the products that are available now, the technology, the capability of computers and everything, and also the general acceptance of the concept of medical devices being automated, it's a whole new world now for this.
[00:26:38] Speaker A: That's great. It must be an exciting time for you to be part of surgical robotics right now.
[00:26:43] Speaker C: Yes, it is.
[00:26:44] Speaker A: Excellent. All right, Bill Frey. Well, thanks so much for your vision of the future and for joining us on fomo.
[00:26:50] Speaker C: Thank you, Tom.
[00:26:52] Speaker A: All right, well, thanks again to Harmonic Drive for providing this week's fomo. If you'd like more information about Harmonic Drive, go to its website harmonicdrive.net that's H A R M O N I C drive.net we'll continue our surgical robotics conversation. Now is the time for my keynote talk with Darla Hutton. She is Global Vice President of Cardiac Surgery at Intuitive. We'll talk about Intuitive's returning to its roots.
Darla Hutton, welcome to the podcast.
[00:27:31] Speaker D: No, thank you so much for having me, Tom. It's great to be here.
[00:27:34] Speaker A: It's an important conversation, a timely conversation. We'll be heading into SRS in July in Southern California. I'm sure this will be a hot topic as it's been the past couple of years.
But before we get into robotic cardiac surgery and where Intuitive is at and where it's going, I'd love to unpack your journey a bit. Darla, how'd you find your way into the medtech industry?
[00:28:00] Speaker D: Ah, such a good question. Because the journey has maybe not been completely normal, I guess. You know, I grew up in Tampa Bay, Florida, and with kind of early aspirations to become a physician and a surgeon. I think a lot of those motivations came from the fact that my father's family for generations had struggled with cardiovascular disease, but also with early onset Alzheimer's.
So I think it fascinates me just the connection between the heart and the brain and certainly the discussions that we're having today about that.
But, you know, sometimes when you're in high school, I think life can take you in maybe some different directions than you originally wanted. And my mom got sick and I had to stay home and stay close to home, and I needed to get through school quickly. And nursing gave me the opportunity to be in health care, to be in patient care, but to do just that, to get out in the workforce.
And so I went to nursing school. I graduated and started working at one of the large academic centers in Tampa Bay, Tampa General.
And I was lucky enough to work on the heart transplant floors and the cardiac surgery floors right out of school, pre and post. Yeah, very exciting. And got to work on the night shift, too, to put myself through the master's program there and to become a certified advanced nurse practitioner.
You know, those years, I think, shaped you. And really for me, what it told me is I like working in high stakes, high pressured environments where people's lives were on the line.
I liked being there for their families and supporting people through those journeys. And so it ended up being a really good decision.
But there came a point after a few years of doing that where I just didn't know what I wanted to do next. And I knew I wanted to have a broader impact than what I was able to have in that role. And so I made kind of some decisions about maybe going back to med school.
And this is where I had a mentor, coach, sponsor kind of step in to this discussion with me, somebody that wasn't in healthcare. I think that's very important for young people as they're making decisions in their careers. Because she introduced me to med device and said, have you ever thought about this? I think you'd be a great fit to go into that industry. And so I started exploring it.
[00:30:17] Speaker A: Wow.
[00:30:19] Speaker D: The hard part is it wasn't easy to break into it.
[00:30:22] Speaker A: I'd love to understand that in a bit. Just going back though, you'd mentioned the family disease history you had, I think, was on your father's side. Did your mother. Was it something completely different? You don't need to give total details, but I'm just kind of curious as to what was your experience like supporting her and what was that like?
[00:30:40] Speaker D: Yeah, I'm completely different. It was a little bit of a rare condition called tetany at the time, but it was just that I needed to be home to take care of her and to be closer to her, close to her.
So that, I think, was the important part of that is just having to stay home and make a different decision
[00:30:58] Speaker A: and the nursing that's. I mean, such an intense lifestyle.
You mentioned you like sort of the pace and the need for immediacy.
I'm curious as to. As you moved into medical devices or consider that movement to medical devices, what was that decision like to leave? If you're in a state in a place where you like the atmosphere and it's something that drives you, there's a great deal of uncertainty to go into something completely different. How did you sort of weigh that transition? And then I'd like to unpack the mentorship relationship in a moment.
[00:31:34] Speaker D: Yeah, I think that decision was actually hard and scary to leave clinical practice and to go do something that I really didn't know a lot about, because I didn't have people in my life that were in med tech or engineering at that time, and so really had to rely on mentorship and a lot of discovery in that space. And I think when you start to explore whether it was pharmaceuticals or med tech, you start to see that these companies can have such a huge impact on patients, but you can do it beyond the four walls of the hospital that I was working at. And so that started to be what excited me about being able to just maybe have a broader Impact and get to be in more ors than I would get to be as just a nurse in one institution.
[00:32:21] Speaker A: Interesting. How did you identify the mentor or how did she identify or he identify? You?
[00:32:29] Speaker D: Came into my life as a friend, and she was in the finance industry on Wall street at the time. And we formed a phenomenal friendship and just she was someone that I could call to ask many questions about life. And this was certainly one of them. And I think it probably started out as a finance discussion about going back to med school and what that was going to cost and could I do.
And that's where, you know, other opportunities were able to be explored and med tech being one of them.
[00:32:57] Speaker A: Interesting. I imagine you must put make yourself available as a mentor as well.
[00:33:03] Speaker D: I do because I just. And I have so many points through my career where that was just very important. And even just recently, I had a chance to mentor a young female professional from the time she was in high school, help her stay in engineering and tech. And she actually just got hired with Intuitive a couple weeks ago.
[00:33:23] Speaker A: Amazing.
[00:33:24] Speaker D: I think it's important that you have these types of people and they don't have to be in your industry.
[00:33:29] Speaker A: That's great. So talk then about the transition to Medtech.
What was the first move and you mentioned it was difficult to get into?
Help me understand that challenge a bit.
[00:33:41] Speaker D: Yeah. Back 25 years ago, if you didn't have an engineering background or you didn't have a commercial kind of sales and marketing background, those jobs were highly competitive. And I thought it was gonna be a little easier to get the job because of my clinical background and because of my nursing, and that proved to be not true.
So I went to so many job fairs trying to get someone just to hire me and take a chance on me, and was getting pretty disillusioned again. While you have a mentor in place to help keep you on that path. And finally had a pharmaceutical company, Black says Smith Klein, at the time, that took the chance on me. And it just because the stars aligned and they were trying to launch a heart failure drug. And I had a lot of experience in that, probably more than a traditional sales or marketing person.
So I went to work in pharmaceuticals for a few years and that gave me the opportunity and the commercial experience to start to apply to MedTech.
And then I was able to transition to Boston Scientific because I wanted to be in the ors.
And interesting thing about life is that I joined Boston Sci because I knew that they had cardiac division and I wanted to be back in cardiac surgery. But I had to start in urology and gynecology.
And what I learned in just the two years that I was there is how to take a technology and move sites of care, how to work in kind of benign surgery and cancer surgery in those disciplines. And then Intuitive found me in 2006 and said, wait a minute, you've got cardiac surgery experience clinically, you've got urology and gynecology, commercial experience.
That's exactly what we are doing and you should be over here, come working with us and come on board with us. And I leaned on that mentor that I talked to you about in the beginning and called her because within Medtech now, a lot of people were telling me I was crazy. I had a great career.
[00:35:38] Speaker A: Yeah, I mean Boston was not. It was, it was Boston Scientific then. It's not the Boston Scientific it is today, but it certainly was a major player. And Intuitive was still, although it was publicly traded, was kind of still an unknown and an uncertainty. But just listening to your story about how you found your way into pharma and then eventually into Medtech, it just resonated with me. I've got a son in college, some kind of attuned to the workforce today. And your mentee who was able to get the job at Intuitive.
I think the story you told resonated with me because I think it's increasingly difficult out there for younger people leaving college right now in finding those jobs. What advice do you give? I mean, yours was just kind of the advice I think we all give. Kind of just keep going, keep going, keep going. Don't, you know, take the no's, keep looking for the yeses. But if you were advising someone today and you have been as to finding a job that they want to do, do you have any sort of go to strategies or anything that.
No tricks, of course, but just anything that you, you share with people, any lessons that you share?
[00:36:45] Speaker D: I think one that the people that have been around me have heard before, but it's bloom where you're planted.
I'm having this conversation actually with my 21 year old daughter right now that's a junior at NYU.
You know, I think in this day and age you have to take every chance you get. So whatever job you get, you have to be thinking about not just the job that you're doing, but what skills can you be developing in that job for the next job.
It may not be what you want to do today, it may not be where you end up, but there are skill sets that you can be building.
And so a Lot of what the coaching I do is trying to find out what is the industry that you want to be in and what are the skills that you would need and how can you start to craft those skill sets through whatever job opportunity you have.
And I think the people that take advantage of that, you can move into different roles and then into a role like mine that probably weren't possible because you're focused on skill development and experience versus just title and job.
[00:37:46] Speaker A: That's a great point. No, I think there's a danger of being singularly focused. Oh. That internship isn't exactly what I want to do, so therefore it's not worth my time or.
I love that bloom. When you're planted.
Is it more difficult mentoring your daughter than it is someone else?
[00:38:03] Speaker D: Yeah, it is a little bit. And that's why it's important to find her other mentors.
[00:38:08] Speaker A: Exactly. Yeah, I know.
Please listen to me. I actually know what I'm talking about in this case.
[00:38:15] Speaker D: So the good News is the 21 year old listens to me a little bit more than the 12 year old does right now. So it comes full circle.
[00:38:21] Speaker A: That's great.
But let's talk about the move to Intuitive. What was it about Intuitive that drew you away? Because it wasn't. I mean, they're both great companies now, but back then it wasn't a clear.
Absolutely. Yes. Sort of thing. It was definitely a different path.
[00:38:36] Speaker D: Yeah. It definitely wasn't proven. And that was part of people's caution to me about going over there. Is it just hype? Is it marketing? Is it a billboard? Right. Is there real value?
But I was in the ors, so the good news is, with the companies I were with, I got the chance to go into the ORS before I got hired. And I saw the impact of the surgeon and the patient, even in those early cases, even on the standard system, you know, that we were operating with the first generation, the urologist at the time and gynecologist and those early heart surgeons, there was value in converting open surgery to minimally invasive.
Patients were doing better. They were going home sooner. And you could just see that if we could do this right and you could support time for that innovation to mature, it was a chance worth taking. And I'm so glad that I did it because 19 years later, I'm a little humbled by the whole experience that I've been able to have. Have.
[00:39:36] Speaker A: That's amazing. So you were at Boston Scientific. You were still in urology or had you moved over to cardiac at that point?
[00:39:42] Speaker D: Nope. I was in urology and had taken on some gynecology work.
[00:39:46] Speaker A: So moving over to Intuitive, were you sort of resigning yourself to.
I know cardiac was an early part of Intuitive story, and I like to understand that a bit more in a moment. But where you're saying, okay, if I move to Intuitive, urology is sort of my path going forward. Or did you see that as a bridge to.
To heart surgery and to Cardiac?
[00:40:08] Speaker D: I mean, at the time, if I'm honest, today, I joined because I believed that Intuitive was going to be a cardiac company in the end.
It was certainly in its early innovation at the time, but I had hoped that that's where my career would go.
Coming over, I knew that I'd have to work in urology and gynecology, and I enjoyed that work very much. And so I think my career and Intuitives, I think, had the same story. Right. We were aiming for the heart, and then we had to land in the pelvis for a while, with the prostate specifically at the time that I joined.
But I always thought we'd be going back to the heart or we would continue to innovate in that space.
And so it's good today to see what we're now doing.
[00:40:57] Speaker A: Absolutely.
So talk a bit about that.
The initial target was the heart. Move to the prostate or move to the pelvis.
Why was that the more prudent path for Intuitive to go and talk about the challenges of heart at the time? Because I think it's going to be important to explain why we're sort of where we're at today and on a surer path.
[00:41:22] Speaker D: Yeah, I think that, you know, it's interesting and we can only tell the story because we now can look back at what happened. I don't think we knew when it was going on all of the challenges that we were really up against.
I think the first thing is for cardiac that the problem that we were trying to solve for hasn't changed. The problem is still there. Right. Cardiovascular disease is the leading cause of death worldwide today. 18 million people, you know, suffer from that every year.
I think, you know, 2 million patients are still being opened. They have an open sternotomy with a large incision in their chest. That was the same problem we were trying to solve back then.
What I don't think we realized as a company was that cardiac is one of the most complex procedures that you could do in the operating room, outside of maybe neurology and neurosurgery and transplant, but that it wasn't just about the surgeon, it was about the Entire team that had to come through a learning curve at the same time.
And so if you contrast that, what's happening to urology, oncology and general surgery, that business was easier to adopt on the technology because it was really about training the surgeon and getting the surgeon proficient to be able to do those cases. And so that business in those first 10, 15 years was taking off much faster than cardiac surgery was.
Intuitive at that time was also a relatively a startup company.
I mean, when I joined there was like 200 people.
And so we had to make some very hard choices with resources and focus back then. And so the company's decision to sort of pivot away as cardiac kind of stalled. And we can talk about why it was the right one because the other disciplines and the other surgical disciplines were adopting much faster and it became a better business model.
[00:43:22] Speaker A: Sure. No, that makes sense. The path of least resistance. So why was cardiac stalling at the time? What were the challenges?
[00:43:29] Speaker D: Yeah, so I think if you look back at kind of phase two, I guess, of our 30 year journey from 2008 maybe to like 2016, the business had grown and then it started to sort of plateau and even decline. And I think there was a lot going on. And I can talk about it in two ways because we've learned through lots of discovery over the last year worldwide about this.
Cardiac surgery as a discipline was going through their own disruption.
So they had the rise of PCI at the time with interventional cardiology. TAVR was also launching.
That was changing a lot of the referral patterns for cardiac surgery, which was forcing consolidation, which was changing the way that they operate with the help, with the hospital executives on the technology that they needed, changing reimbursement. So they were going through their own disruption.
They were also trying to take a team through minimally invasive cardiac surgery learning curves, even separate from robotics, learning how to go on pump.
You know, you're taking a perfusionist, an anesthesiologist and a surgeon all through this learning curve at the same time. And that was very hard.
And then here's intuitive. This young company with what we believe to be the model of success for training. And yet we didn't have a global infrastructure. We didn't really know how to train the whole team. We knew how to train the surgeon and we didn't have support for longer than those first cases. So we didn't have people that could offer 612 months of support as somebody got fully through their learning curve. And so all of those, those factors I think were like this perfect storm for the technology was right.
The infrastructure, the timing, the willingness for people to adopt was not.
[00:45:19] Speaker A: Were the surgeons ready? Were the cardiac surgeons ready?
[00:45:23] Speaker D: I think you had at least your early adopters like you do in any technology and early majority around you did not have society support that this should be what we were investing in and moving. A lot of that had to do with the lack of clinical evidence that we have today.
So I think it was varied if we're honest at the time and that differs from what it looks like today.
[00:45:47] Speaker A: So where did you. I'm looking at your background. I would intuitive what positions, sort of what areas were you focused on prior to taking your current role as the global vice president of cardiac surgery?
Were you focused in urology all the time, that entire time? And kind of walk us through, through your experiences there a little bit.
What departments were you focused in? What businesses were you leading?
[00:46:13] Speaker D: Yeah. So again, I think it leads up to being able to take on this global role with this operating unit. Now I was able to lead in sales and marketing across urology, gynecology, general surgery, colorectal thoracic, ent. So kind of our whole base of business business for years in the US and in multiple sales and marketing roles, I had the opportunity to kind of transfer and take over our data and analytics and custom hospital analytics groups. That was the groups that were working with hospitals on data sharing, pulling the data out of the robot, putting that with outcomes data with hospitals to validate in real world evidence what we were doing during da Vinci. And that comes into play. I think today I was able to take on global roles. So I went to Asia for about three and a half years doing commercial operations and learning a lot about product operations, clinical and regulatory affairs.
And then I got the call right at the end of 2024 that we were going to be going back into this.
They were going to pull me back to the US to do this, which I, I couldn't have been more thrilled about. It's really a full circle moment.
[00:47:30] Speaker A: This entire time as you're working in these areas, focusing on these different businesses blooming where you were planted, did you have in the back of your mind, these are all things that I'll need when I get back into cardiac? Or did you sort of just put that cardiac hope and dream aside entirely and just say this is I'm going to focus on this and where it leads me, it leads me? Or did you always sort of have the hope that cardiac would be your future future?
[00:47:54] Speaker D: No, I didn't know that this was going to land back kind of in my lap. So it was really just, how do you become the best kind of medtech executive leader that you can?
And Intuitive does a really nice job, I think, at developing their leaders with that mentality where we can become an enterprise leader because we've got all these skill sets, and then they can ask us to do a number of different things. Opportunities arise.
This just happened to be one that fell right center of really everything I've done in my career.
[00:48:25] Speaker A: That's great. So talk about. You got the call. You're excited to move into this area, not only because it's been your lifelong passion, but also because this feels like the right time for cardiac surgery. What's different today? We're hearing a lot about it, as I alluded to at the start. A lot of companies talking about working in this space.
What's changed since those.
Well, what hasn't changed? What specifically has changed since those early days when you joined Intuitive? And it wasn't quite right. The time wasn't quite right yet.
[00:48:54] Speaker D: I feel like this is a story of just, you know, right innovation, wrong time. And, you know, you've kind of seen this. I like to use the electric car, the EV analogy right now, where, you know, back in the late 90s, early 2000s, like the. There was early EV cars that worked. The engineers were excited, the people that leased them wanted them. But the infrastructure, the regulation, the incentives, the customer mindset and willingness to adopt just wasn't there.
That's very similar to what we see with robotics, cardiac surgery. And what changed in kind of from 2000 entering and exiting Covid to 24 when Intuitive made the decision to go back, is that we had about 400 surgeons that continued to operate to have very successful outcomes for patients in 51 countries around the world. So this was happening and the momentum was gathering coming out of COVID because patients now were demanding minimally invasive cardiac surgery. They didn't want to have a sternotomy. And so those dynamics were changing. You also had ors that knew how to do minimally invasive cardiac surgery. Now, for the most part, they weren't going through these big learning curves all simultaneously.
And so you have all of that in place. You have all now the expertise of Intuitive. Right. We've treated over 3 million patients now a year. We've trained over 100,000 surgeons. So we have expertise in training and. And if you can put that all together, we knew that we could do something very different than we'd ever done in the past, and we could actually deliver on this original promise of Intuitive.
[00:50:37] Speaker A: And how about the. I imagine this groundswell of support or preference from patients and others. It's also changed the opinions of societies and of medical societies and such that there's just a. Is this a broader holistic support for. For this.
[00:50:55] Speaker D: Yeah, very important element as well, where, you know, global societies, which, you know, throughout my career at Intuitive, it's always been hard to get global surgical societies to all collaborate and align on things. And we're not seeing that right now with cardiac surgery. You're seeing the STs and EACs and ACTDs all want to collaborate ismics on how to do this the right way because they do see this as the future.
And so now it's not a matter of if anymore, it's just a matter of how do we do this and how do we do it with patient safety in mind.
And so I think it's going to be launching technology, but also launching training and that's going to be the key to our success this time around.
[00:51:39] Speaker A: And you've also, of course, Intuitive has a much larger footprint than you did 20 years ago. A lot of more systems out there.
So for you leading this business now, is it merely a.
You're creating an opportunity for people who have systems to sort of use them differently or are you treating this as a new business, new sales channel? How, how does Intuitive approach cardiac sales now and how does that footprint fit into that strategy?
[00:52:06] Speaker D: Yeah, so I think the first thing we learned from the past was that we needed a full dedicated team to do this because cardiac surgery is different and it is more complex and it just requires a different set of resources globally.
And so we have h now a team internally from product development and product design to clinical regulatory affairs, evidence generation to all the supporting enabling functions that we need. And now we're also hiring a commercial team that is in the field with customers. And that structure is a bit different because of the training principles that we want to be able to follow this time around.
And so those things are really important.
We can support existing customers on 4th gen X and XI technology because we have all the core instrumentation to do the cases that are being done today.
I think what DV5 and the 10 times compute power gives us is the ability to now to move beyond the one or two procedures historically that you've seen us focused on to moving into more of a vertical strategy where we can start to develop instrumentation and solutions for structural solutions. Heart beyond the mitral valve for revas to get us to totally endoscopic beating heart cabg finally multivesal, hopefully. And then to look at our customers and surgeons want to be able to do concomitant arrhythmia and aphid management and I think we have the ability to do a lot of this.
[00:53:39] Speaker A: So what are you currently able to provide in those areas?
[00:53:46] Speaker D: Well, a lot of that is driven by our regulatory clearances.
[00:53:50] Speaker A: I guess that's what I was asking.
[00:53:52] Speaker D: Yeah. In each of the markets. And they're different right now across the world as we introduce kind of DD5 and so we follow that. I think globally there's a focus on mitral valve and getting the team training for mitral valve perfected. And then globally for cabinet and specifically right now that's an IMA takedown with a mid cab.
And so those are our global focus areas. I think as we look to the future, with additional clearances coming, surgeons are asking us certainly to get back into beating heart, to move into aortic and to start to look at the surgical aortic valve replacement space. And then like I said, the arrhythmia and afib management. Management.
[00:54:39] Speaker A: How much more challenging is cardiac versus urology or other spaces where you're in, I mean, you say the word beating heart and that just wakes you up. You're like, oh my gosh, there is a beating heart.
There's a lot more involved and a lot more complexity. How different is this than maybe other markets Intuitive has moved into?
[00:54:58] Speaker D: I think it's different. I think it's different because cardiac surgery requires patience and precision, because there's lives that are immediately on the line in these ors, and that does create a different level of high stakes pressure in the space for technology to perform and for the surgeons to get to competency faster.
And so this is the real importance for me in this was that we weren't going to come back and just launch another system or different sets of instruments, but that we had to be able to get buy in to launch a whole new way to train and adopt so that we could do this really safely.
And not that those aren't very important in all the other disciplines, but I think with cardiac surgery, that learning curve, the ability to have support for longer periods of time as those teams are getting up and running is highly important and maybe a little bit more important than the others.
[00:55:59] Speaker A: Interesting. How are the surgeons responding to this? Have they been, I mean, they've been doing some work in this space, but there's a reception you're getting finally you're here. Or is there still some resistance? I mean, cardiac Surgeons are obviously an important demographic to have at a hospital. They obviously influence a lot of decisions. Are they champions of intuitive and or surgical robotics?
[00:56:27] Speaker D: I think it's more today than it ever has been. So certainly we can't say that 100% of the cardiac surgeons around the world believe in this. But from a community standpoint, they are fully aligned with what we're trying to do. And actually they're guiding us. So we're not doing this alone. We're doing this with worldwide advisory groups and the societies helping us understand how to do this this time around safely. And I think that's the difference, is we're doing it together. And the community has been very welcoming and pulling us.
I think our biggest message to them has just been, and I hear this from me, is that we think this time around, all is possible, just not all at once. And so we're trying to make those priority decisions about how to sequence the adoption of cardiac surgery this time around. And how do you do that in multiple countries all over the world that are in different phases of it?
[00:57:20] Speaker A: Very cool. Yeah. How do you see this playing out in terms of adoption and approvals? Do you see this growing OUS first and then finding its way into us, or is it us primary, then growing outward?
[00:57:31] Speaker D: Yeah, I think because we've been doing this for a while, you know, we do have a pretty solid base of business. And what's interesting, Tom, this time is over 50% of that right now, this year in 2026, is OUS.
So, you know, the US continues to grow and is the foundation, But I think a lot of our future adoption is coming out of Europe and is coming out of the Asia market.
[00:57:57] Speaker A: So, Darla, as I said at the top, there's a lot of new surgical robotics companies out there. There's a lot of competition. How do you view the competitive field, I guess, both for surgical robotics and maybe beyond?
[00:58:12] Speaker D: I think we welcome competition. I think one of the things that we think is really important, you've probably heard Gary and Dave speak about this in the past, is that the people entering the industry help push the whole industry to better innov.
And so this is a good thing because I think it validates what we're doing in cardiac surgery. I think it's gonna be really important that as other people want to get into the robotic side of this, that as an industry, we try to set the standard together that it isn't just about launching innovation. It has to be about how we're gonna train on the technology so that we get Proficient, competent surgical teams on the other side, producing great outcomes for patients. And we should all be keeping that in mind as we're innovating in this space.
[00:59:01] Speaker A: Interesting. I was going to ask about telesurgery and such. Do you see that playing into your strategy going forward? And how does it play into your strategy going forward?
[00:59:09] Speaker D: I do. So one of the biggest differences in our cardiac team training model today that I think makes it one of a kind, is the integration of digital technologies into the pathway.
So, and AI and telesurgery, telecollaboration come into this. So, you know, how do we help people train better? Well, you help people train better because you them data and you give them objective performance feedback as they're going through the different phases of learning so that they can learn differently, learn better, learn in simulated environments, for instance.
And then part of that is, how do we help share best practices around the world? How do we shrink the globe in terms of expertise? And we can do that through telecollaboration.
And so we're already starting to do that now in cardiac surgery with DB5, but it is very focused around education.
[01:00:04] Speaker A: Final question. How do you see things playing out over the next five years? Not specifically, I guess, to cardiac surgery, but just surgical robotics in general? What does the world look like five years from now?
[01:00:15] Speaker D: I think we have a lot of ideas about where robotics and AI and all these technologies are going to take us.
I think that innovation is going to happen faster than we're imagining.
And I think we just have to make sure that we're all, as an industry again, just putting the right foundations in place to allow that technology to be implemented and adopted. What you don't want to do is see, like, what we saw in cardiac surgery, where the technology was right, but the infrastructure, the environments, the cultural environments weren't ready to accept it. And so the next five years is going to be about that. It won't be about that. There's not a lot of innovation coming. It's about how do we implement minute.
[01:00:59] Speaker A: Excellent. All right, well, Darla, thank you for sharing your story and for letting us know the future of cardiac surgery and for joining us from the podcast.
[01:01:08] Speaker D: Oh, thank you so, so much. And I enjoy listening to your weekly podcast myself, so keep it up.
[01:01:14] Speaker A: Thank you so much for doing that. Appreciate it.
All right, well, that is a wrap. Thanks so much to Harmonic Drive for visiting us in the FOMO Studios in this episode. And thanks for supporting supporting the Device Talks weekly podcast. We'd love you to support the Device Talks weekly Podcast and our other podcasts by subscribing to the Device Talks Podcast Network. Or you can subscribe individually to the Device Talks Weekly Podcast. But why not get the whole network? We're available on any major podcast player. Please do follow Device Talks on LinkedIn. Please follow Mass Device on LinkedIn. Please connect with me on LinkedIn. Connect with Kayleen Brown. Connect with Chris Newmarker and Sean Hooley. We'd love to be part of your future medtech conversations. Don't forget to join us on Tuesday for our upcoming Device Talks Tuesdays about bio compatibility. And of course, we'll be back next week with another episode of the Device Talks Weekly Podcast.
