Episode Transcript
[00:00:01] Speaker A: Hey everybody, this is Tom Salome of Device Talks. Welcome back to the Device Talks weekly podcast. Fantastic episode coming your way. A little later in the podcast, I will talk with Michael Carter. He is senior Vice President of Cranial and Spinal Technologies at Medtronic. We'll talk about his path into medtech, how it helped him find and refocused his mission after his time in the military and what's coming up for Medtronic before that. The one and only Kayleen Brown will sit down with the one and only Etion Nichols. He is the head of industry insights and education at Greenlight Guru. Thank you Greenlight Guru, for being part of Device Talks Weekly. It's an honor to have you here. And then of course, we'll kick the whole thing off with the Newmarkers and newsmakers with the another one and only Chris Newmarker, the editor of Mass Device. He and I will review the top news from the pages of Mass Device. So before we begin this episode, I want to invite you to Device Talks Minnesota, it's happening on May 4th, and Device Talks Boston, which is happening on May 27th and 28th. Yes, two conferences. My Hair is not only on fire, it is nearly gone. It's been an interesting spring, but I can't wait to see everybody at Device Talks Minnesota and Device Talks Boston. If you haven't yet registered, please use the code DTW25 to save 25% off the price of registration.
We'd love to see you in person. All this digital stuff is neat, but there's nothing like saying hello and shaking a hand. So I hope you'll join us at one of our upcoming events. We just concluded our Device Talks virtual series, Surgical Robotics Week.
Great conversations with Steve Bell and Prash Chopra of Petal Surgical and Haral Godot of Micropot. And finally today on Friday, as I'm recording this, just a few hours ago, I spoke with Jean Pierre Hubsman. He is the co founder of Horizon Surgical. Really fascinating looks into Surgical Robotics. If you didn't have a chance to watch these live for those who did, thanks for your questions. You were just great contributors to the conversation. I'm really grateful to those who couldn't participate live and still want to take part. You can go to device talks.com and register and watch on Demand. We won't be able to answer your questions, but you will learn a lot, I guarantee. So thanks of course, to all the great sponsors of that series. Thanks again to Greenlight Guru for supporting this episode of the Device Talks weekly podcast. Hope to see you at our Device Talks conferences coming up. And now we're going to get this podcast started.
All right, you ready for this?
[00:02:49] Speaker B: Ready.
[00:03:09] Speaker A: Chris Newbaker. How are you, sir?
[00:03:11] Speaker C: Hey.
[00:03:11] Speaker B: Doing well, Tom. Doing well.
[00:03:14] Speaker A: How are things over there in Minnesota? I'll be there in a couple of. Couple of weeks.
Minnesota, May 4th.
[00:03:19] Speaker B: Weather's been getting better and better.
It looks like we're going to have a cold snap this weekend, but hopefully, fingers crossed, that's the last really good cold weather. So, yeah, this is going to be.
It's going to be really nice, really good weather, hopefully for.
For, you know, the, you know, Device Talks Minnesota at the McNamara, like, on May 4th over at the U.
[00:03:41] Speaker A: Sure hope so. Your Minnesota Twins weren't particularly Minnesota nice to my Red Sox this week. They knocked them around pretty good. Kicked Garrett Crochet's butt. I don't know what the hell happened there, but that was. That was shattering.
[00:03:57] Speaker B: So they're doing okay so far, though.
I did notice. I mean, it looks like the stadium seemed a bit empty, so.
[00:04:04] Speaker A: I did notice that as well. Yeah, it was certainly emptier than we were there last year. Year. During the drubbing we witnessed after Device Talks Minnesota last year.
[00:04:12] Speaker B: But, you know, hopefully, yeah, they win more games. Wins. Win more games like that. Like, maybe we'll get some more people in the stadium and get some energy going.
[00:04:21] Speaker A: Hope so. Hope so. It's a great ballpark. All right, Crystal marker. We're both very busy and important people in case people listening aren't aware of
[00:04:29] Speaker C: how important we are or at least we're busy.
[00:04:33] Speaker A: Shut up, Chris. I'm trying to tell people we're important. All right, fine.
[00:04:38] Speaker B: You know how people could feel even more important when they come to Device Talks Minnesota?
[00:04:42] Speaker A: Oh, yeah. It's where all the important people gather, for sure. Device Talks Minnesota, May 4th.
We only murder people, actually.
We'll make sure we vet you before you're allowed to attend to see how important you are.
[00:04:53] Speaker B: Yeah, totally. Yeah, absolutely.
[00:04:57] Speaker A: If you're as important as we are, you're in. So good news is the bar is very low.
[00:05:06] Speaker B: They're important as us, you know, and they're, like, listening to us going like, yeah, we'll be fine.
[00:05:13] Speaker C: These guys.
[00:05:13] Speaker A: I'm definitely in. I'm definitely in.
[00:05:16] Speaker B: Definitely.
[00:05:17] Speaker A: All right, you got some great news this week from the pages of Mass Device. Mass Device industry's leading news source for medtech information.
[00:05:28] Speaker C: What's do it?
[00:05:29] Speaker A: Number five.
[00:05:32] Speaker B: We got, like, Stereotaxis.
They're going to acquire Robocath for up to $45 million. And France based Robocath is the creator of the R1 plus surgical robot.
So, yeah, gosh, the Surgical Robotics space is just so exciting right now. There's so many different companies and yeah, you're seeing even companies like merging and banding together to you to do even more. So, yeah, this is exciting.
[00:06:04] Speaker A: We had Harel Godot, the CEO of Microbot, on our device talks Surgical Robotics Week yesterday and he and I talked. I don't think we talked during the presentation, but we talked before about the Stereotaxis acquisition. And he was excited. He thought it was a good move for Stereotaxis, knows the company well. So definitely this is the way it's going to happen, right? We got to see some consolidation, we got to see some combined efforts. So makes a lot of sense.
[00:06:30] Speaker B: And we just gated a Surgical Robotics report on Mass Device just a few weeks ago and it had listings of all the companies we've covered in recent years. There's like 73 companies on there and that's just a portion of what's out there right now. So, yeah, that definitely seems like we're going to see more consolidation.
You can't have dozens and dozens and dozens of companies forever.
[00:06:51] Speaker A: Folks can go to Mass Device to download your report on Surgical Robotics. But yeah, looking at Stereotaxis, I mean, it is sort of one of the few companies, I think the surgical robotics company that's going into the sort of the vascular space. So it's got that feel to itself.
So between that and Microbot and others, we'll see some movement in the endovascular robotics space. We had Steve Bell on episode one of the Surgical Robotics Week this week. All of this is available on demand. If you missed it, go to devicetalk.com to register. Steve gave a great overview of the soft tissue market and where things are headed. So exciting times. And I did not get to ask him about the.
I did not get to ask him on air, quote, unquote, about SSI Innovations Drone surgical robot, which is obviously not in use, it's not commercial. But the plan is exactly as you suggested on LinkedIn battlefield emergency scenes, you know, get a surgical robotic system out to someone who needs it as quickly as possible. So as Steve said, they're pushing the envelope, they're trying new things.
[00:08:00] Speaker B: So it's really fun too because, I mean, at a conference years and years and years, I think over a decade ago, somebody played like an old DARPA video from the 1990s that had this really bad animation. It was Showing some armored vehicle, like, thing pulling up and some robot coming out and taking a soldier into it and doing.
Doing robotic surgery, you know, work on the. On the soldier. And, I mean, this was kind of the roots of intuitive, like, you know, like the program.
[00:08:32] Speaker A: It was golden something. But Steve said, I think the plan called for.
I don't know if it was microwaves, whatever signal was going to be used to control the robot. It would be, like, bounced off planes that would be flying overhead, and that's how you'd get the signal to the robot. Like, there was this whole.
[00:08:47] Speaker B: Wow.
[00:08:48] Speaker A: Intricate infrastructure that obviously never came to be, but wow. But who knows? I mean, why not?
[00:08:54] Speaker B: We just fly a drone over and the drone does something. So here we go. All right, here's some stuff.
[00:09:00] Speaker A: What's number four?
[00:09:02] Speaker B: Hey, number four on the list. We've got.
Let's see if I can pronounce this right. Pro Somnus.
[00:09:08] Speaker A: I'd go with that. Sure. Prosonus.
[00:09:10] Speaker B: Let's do it. They got their FDA 510k clearance for their.
Oh, goodness. RPM 02 obstructive sleep apnea therapy device. I thought this is really interesting technology because, I mean, we're seeing, like, companies like Inspire Medical, Nixoa, Livinova, they all have come out now with these implantable devices that help treat sleep apnea. But this isn't an implant. This is kind of like a mouth guard that has electronics in it that is providing the needed stimulation to keep airway paths open.
[00:09:51] Speaker A: No, it's an interesting idea. Yeah, it is RPMO2. And the 2 is kind of like H2O. Like, it's lower 2 on there.
So I'm guessing that's how it's said. But this is interesting in that, I mean, there's all the folks out there who may or may not have sleep apnea not severe enough, at least for them to commit to a cpap or perhaps just the chronic snorers out there.
This is certainly something that I think a lot of people could easily turn to. Retainers aren't really that big of a commitment. I'm still using my Invisalign. I wear them every night. It's not a really big deal. So if my Invisalign kept me from snoring, I think that would be an added plus. I'm sure my wife would appreciate it.
[00:10:35] Speaker B: It's a lot more of a commitment to have something like a pacemaker implanted in you with a lead running up something in your neck, but to have something that's like a mouth guard with Electronics embedded inside of it. I mean, that's pretty.
[00:10:49] Speaker C: Yeah.
[00:10:49] Speaker B: As you said, that's like, you know, that it's not too bad.
[00:10:53] Speaker A: Yeah, I don't think, I don't think it'll be used by anyone who's got, you know, chronic apnea or real severe apnea. I think you probably need, I think that'll, I think the, the, the resmed of the world will have that market. But for, for the folks that ResMed have been trying to get to commit to a CPAP who maybe don't want to because they don't feel they absolutely need it, this might be a good bridge for folks certainly again, not as big a commitment.
The electronics look a little bigger than I thought they would, just looking at the picture of it.
[00:11:26] Speaker B: Yeah.
[00:11:26] Speaker A: But I'm sure that'll get smaller over time.
[00:11:29] Speaker B: Yes, we'll get next generation devices as time goes along. I'm sure. That seems to be where it always goes. Like more miniaturization.
[00:11:37] Speaker A: I would certainly try it.
[00:11:39] Speaker B: Here we go. Hey, maybe they'll, maybe you could, you know, do it.
A celebrity endorsement time.
[00:11:48] Speaker A: There we go.
[00:11:50] Speaker B: Oh, that's nice. Yeah.
[00:11:52] Speaker A: Number three.
[00:11:54] Speaker B: Number three on the list. You know, it's, you know, we're once again in quarterly earnings season and yeah, there's good news for Johnson and Johnson, they up their outlook for the year at a Q1 beat. Medtech sales were up 7.7%.
You know, and you know, the electrophysiology products, including like Verapals, you also have Abimed heart pumps, the Shockwave, IL and ivl. I mean that all helped drive the growth. I mean it's kind of cool. Like Abio mad shockwave. So those recent acquisitions are paying off for J and J and they had a good quarter.
[00:12:42] Speaker A: Kayleen Brow will be interviewing Debbie Govinder of Abiomed at Device Talks Boston. That'll be our opening keynote. So folks should definitely check that out.
Related to this, what's interesting, two things. One, we had Tim Schmidt at Device Talks west talking about their growth strategy. They definitely wanted to increase their growth and they clearly did that in this quarter.
But what I think is interesting is that they have not yet divested depusinthes. So this is still even with deputy synthesis on board. And the point of that divesting, that is to move to a higher growth status.
Speaking of depusinthes, we'll have Namal Nawada. He is currently the Worldwide President of DepuSynthes at Device Talks Boston. He'll be part of a closing keynote panel talking about the Massachusetts medtech industry, so folks can check that out.
[00:13:32] Speaker B: Yeah, that's awesome.
Just a little bit of related earnings news.
Abbott had their earnings out this week as well, and their stock took a big bit of a head because they're having some dilution on their EPS guidance after acquiring Exact Sciences. However, their medical devices sales of 13.2%.
So.
[00:13:55] Speaker A: Yeah, that's great.
[00:13:57] Speaker B: Yeah, really awesome.
That'll be really cool to talk about all the ways they're driving growth with the closing keynote at Device Tech Minnesota with Lisa Earnhardt.
[00:14:07] Speaker A: Exactly. Yep. Boy, we're really.
I do not tell Chris to pick these stories, by the way. These are legitimately the biggest stories, but we'll just have. We will have newsmakers all over our Device Talks events.
[00:14:17] Speaker B: Exactly. Tom just happens to pick all the newsmakers for the show, so it's fantastic.
[00:14:21] Speaker A: Yeah, definitely. It's what I'm doing. I'm looking six months ahead. I'm saying who's bound to have the biggest news right around the time of our conference.
It's pretty.
[00:14:29] Speaker B: The detailed forecast, the map that you
[00:14:32] Speaker A: do, I got chatgpt working on it. I get the back computer. We're all ready all synced up here@device dot.
[00:14:37] Speaker B: Yeah, the lights are dimming around Boston as you like, crunch these forecasts.
[00:14:41] Speaker A: I've got one of those ticker tapes.
[00:14:44] Speaker B: Yeah, that's like more like old school.
You've got a. You've got a Magic 8 ball.
[00:14:52] Speaker A: That's more like a Ouija board.
A lot of begging. A lot of begging.
[00:14:58] Speaker B: Please.
Oh, my God.
[00:15:01] Speaker A: What's number two in the new newsmakers?
[00:15:04] Speaker B: Number two, unless. Let's hurry up before we just. People just just can't stand us anymore.
Avanas Medical, they're going to be acquired by a private equity firm for $1.3 billion. So, you know, private equity strikes again in the, in the device industry with, with acquiring OEMs.
[00:15:22] Speaker C: So.
[00:15:23] Speaker A: All right, well, I'm big and yeah, it's a big deal. 1.3 billion.
Interesting play by the private equity group. Obviously. We've talked about hologic, their acquisition earlier. So, you know, we'll.
I don't know what this. But how this bodes for M and A, you know, you maybe like to see some smaller companies with, with venture capital investors, privately held that are getting acquired by private equity also.
Maybe that's maybe sort of, that's the next phase of this.
But another, another privately held, publicly held company goes private, though, so.
[00:15:55] Speaker B: Yeah, exactly. And they, and they make like a whole range of, you know, technologies for you know, pain management, chronic care, digestive care. I mean it's, you know, stuff like feeding tubes and medication dosing solutions and fusion tech and yeah. Ra ablation, you know, technology. So, yeah, that's all, that's all going private. So.
[00:16:16] Speaker A: All right, well, Chris Newmarker, what is the big giant? Number one of this week's Newmarkers News.
[00:16:20] Speaker B: Yeah, yeah. I mean, number one on the list. We've got Stryker. They're making a play in the IVL space.
You know, they're going to be acquiring Amplitude Vascular Systems for an undisclosed amount. But this really got your attention on LinkedIn, I saw.
[00:16:35] Speaker A: Yeah, well, abs is a good friend of Device Talks. We had Robert Tresina, the co founder at Device Talks Minnesota last year. You were on the panel. You co moderated that panel with me on ivl.
So happy for them.
Happy to see this happen. But what struck me as most interesting is you just don't see Stryker buy anything that isn't commercial. I mean, they have no interest in regulatory reimbursement risk. I don't know if the reimbursement risk is there. I'm guessing the pathway is pretty clear thanks to Shockwave. But something must have happened. AVS had some preliminary has a pivotal trial going. According to ClinicalTrials.gov, they had some sort of primary or preliminary closing of data in March. And I'm guessing something good came. I'm guessing. I don't know how this thing works. I'm not a clinical trial guy, but I think the trial is supposed to close out officially and August. But someone must have seen something for Stryker to go preclinical on this. And they obviously wanted to get in there before it became a bidding war.
And good for Stryker. Good to see them go preclinical again. Good to see them take a chance on early stage. And it's clearly a space they need to be with moving the Venus play and with Boston Scientific, adding Bolt and all the IVL programs out there.
Exciting time.
[00:17:57] Speaker C: Exactly.
[00:17:57] Speaker B: Yeah.
Really exciting.
[00:17:59] Speaker C: Yeah.
[00:17:59] Speaker B: Yeah. And I hope we see more types of deals like that. That'd be fantastic, you know, for everybody, like building young companies.
[00:18:06] Speaker A: Absolutely. All right, Chris Newmarker. Great, great. Top five. Of course, folks can get the top five news every day though, right? They don't have to wait for this silly podcast.
[00:18:15] Speaker B: Oh, yeah, you just go to, you know, Mass Device and I mean, the podcast isn't silly. Tom, come on. This is great. We're giving people good stuff.
[00:18:22] Speaker A: This part is silly. The good stuff coming.
[00:18:24] Speaker C: That's pretty silly.
[00:18:25] Speaker B: Yeah, just don't, yeah, listen to the
[00:18:26] Speaker A: news, but don't listen to the interviews.
[00:18:29] Speaker B: You can fast forward now, everybody, it's all right. But yeah, you can just go to Mass Device, and right at the top we have like a, you know, a button to sign up for our newsletter. So sign up for our daily newsletter and you'll get like top Medtech news in your inbox every day.
[00:18:42] Speaker A: Absolutely. And of course, we would love to see you at Device Talks Boston and Device Talks Minnesota. Chris and Kayleen will be at Device Talks Minnesota on May 4th. Our entire news team, assemble the news team.
[00:18:53] Speaker C: Chris Newmarker, the news team assemble.
[00:18:56] Speaker A: We'll be at Device Talks Bots on May 27th, 28th. Use the code DTW25 to save 25% off the price of registration.
We've talked about Debbie Govender. We'll have Ashley McAvoy of Insulet, and we'll have Brian Miller now of Svato. He'll be joining us as a keynote. I'll be sitting down with him in the afternoon and much, much more. So go to devicetalks.com, you can connect to both conference websites from there.
[00:19:23] Speaker B: Yeah, it's going to be fantastic, Chris,
[00:19:26] Speaker A: the marker go red.
Onward and upward.
You have to go get twins.
[00:19:31] Speaker B: Like, they might actually have a chance. Who knows?
All right, take care, man.
[00:19:35] Speaker A: All right, thanks for those newsmakers. Chris Newmarker, now it's time for our FOMO interview. The fantastic Kayleen Brown, managing editor of Device Talks, is speaking with an equally fantastic guest, Etienne Nichols. He is head of Industry insights and Education at Greenlight Guru. Thank you, Greenlight Guru, for being a sponsor of this episode of the Device Talks weekly podcast and providing these great insights from Etion Nichols. Let's listen.
[00:20:02] Speaker D: Etienne Nichols, med tech connector at Greenlight Guru and host of the Global Medical Device Podcast, a fellow podcaster. Welcome to the future of Medtech opportunities. I'm so pleased to have you here today.
[00:20:16] Speaker C: Great to be with you.
[00:20:17] Speaker D: Kayleen, there is a need for why I asked you specifically to join us.
A lot has changed recently when it comes to design and development planning, and most recently, we had a big change with the fda. We'll talk about that shortly and I'm hoping you could help us unpack it and help us set up for a more successful future in medtech. But before getting in there, what is your experience when it does come to medtech design and development?
[00:20:47] Speaker C: Thanks for asking. So I started out as a mechanical engineer and worked for both Fortune 500 and startup companies, neurological equipment is what I kind of cut my teeth on cranial fixation, then went on to a drug delivery combination product. And throughout the process I've worked in manufacturing, product development, project management, got my PMP and managed, you know, teams of engineers and it was a really fun journey. Finally, I came to Greenlight Guru, where I got to consult with about 40 to 50 medical device companies and saw their unique challenges. And one of the reasons that I went to Greenlight Guru was as a product development manager as I was leading that development project when I left that company. So I was managing our product development cycle and design controls in Excel when I went over to the engineer who I handed it off to and told her I felt so bad, I looked at her eyes and I said, well, okay, the design controls, documents and risk management, I just assigned those to you, so those are going to be yours. Seeing her die inside is made me realize, wow, what, what we, the industry needs is an improved process here. And so we do offer that. But to your point, things are changing in the industry and I'll throw one other thing out there. You mentioned relevance. As the host of the Global Medical Device Podcast, I've hosted over 250 medical device professionals from all over the world. Different walks of life, different tiers, and I get to see a lot of different things. So it's an interesting vantage point that I have both from the regulatory boots on the ground and the hands on experience.
So I, I feel like I do have that unique perspective to share.
[00:22:20] Speaker D: So you really have seen the medical device design and development process evolve. And to that point, and before we get into what changed this year, I want to know why it's changed. So what has been the challenge with the design control process in the United States?
[00:22:36] Speaker C: Great question. And really what it boils down to is medical device companies who are trying to bring a medical device to Europe, to Brazil, they're dealing with disparate countries, regulations. So each one of these countries has a different requirement for you to bring your medical device to market. And so what the FDA is doing, and I really commend them for doing this, taking a step towards harmonization of regulation. Because ultimately, if you think about it, a medical device that's built in South Africa or Brazil should have the same level of quality of a medical device that's built in the US and so that's ultimately what the goal is, a harmonization so that we're all sort of doing the same things and a step towards true quality.
[00:23:17] Speaker D: I think that the industry at a whole can really respond positively to that, it just makes sense. So as I understand it, up until February we were following the FDA QSR process.
So what has changed in February of 2026?
[00:23:33] Speaker C: Yeah, so previously the QSR, it was fully self contained, 21 CFR part 820.
It is still, if you go to that same code of Federal Regulation 21 CFR Part 820, a lot of it has been removed and now it points to ISO1345, 2016 and they call it incorporation by reference. So it's pointing to an international standard which a lot of medical device companies already followed. But for those primarily US focused companies, there's going to be more change than those those who are outside the U.S.
understood.
[00:24:08] Speaker D: Can you give us some examples of what we've historically known as part of the process and what we should expect moving forward?
[00:24:18] Speaker C: Yeah, great question. So previously with qsr, some of the specifics were, some of the acronyms are changing. So dhf, dhr, dmr, those are changing. DHF is now going to be the medical device file. Previously design history files and ISO 1345 calls it the medical device file, the DHR, the device history record, now the lot or batch record. And so some of the ultimately the acronyms are changing and I can give some tips as to what they need to do about that. The other thing that's changing and more of a holistic thing is ISO 3145 is very adamant about risk management.
Previously risk analysis was mentioned one time in 21 CFR predict 20. Now it's throughout. It's woven into every process, whether it's purchasing, production, CAPA training. You have to apply risk proportionate to the process and process involved. And then maybe one of the other things that's more immediately changing is previously the FDA, when they came to inspect companies, they wouldn't look at management review. If you had a management review and you say, oh, we have these really big problems. They wouldn't look at supplier quality audits and they wouldn't look at internal audits. Well, now all of that is fair game. So make sure that all of your management review that you recognize that the FDA could potentially ask, hey, I'd like to see your management review, I'd like to see your internal audits. I want to see, you know, open the kimono. Whereas previously we sort of kept those things close to the vest, now companies have to show that to a FDA inspection when an investigator comes to look at their company. Those are some of the biggest things I would say.
[00:25:59] Speaker D: I think that you Promised to give a couple tips for implementation. So I'd love to hold you to that. Later on I'll share those tips.
[00:26:06] Speaker C: So if I were a medical device company, right now, the first thing you need to do is understand that it happened in February of 2026. So this is, it's a cliff. This is not a gradual change. It's a on, off, previously year QSR after you're under qmsr. So you are today under qmsr. If you're marketing in the US if you haven't already. The thing that I would suggest is do a formal gap analysis. What's the difference? And we have some different gap analysis checklists at Greenlight Groove. Feel free to reach out to me or my team and we can hand you those for free. We produce those. But do that gap analysis and do a clause by clause procedural change that you can map what are your current QSR procedures to ISO 1345?
Most QSR compliant companies are probably 70 to 80% there. The gaps are usually around risk integration and maybe management review evidence, as I mentioned.
So that's one of the biggest things.
The other thing is you'll have a likely a terminology change. So some of that nomenclature is changing that I mentioned and that's okay. I think one of the things that I throw around is if in the US we're driving around, I'm going to stop and get gas. And suddenly they say, no, it's not gas anymore, it's not gasoline, it's petroleum.
And if you told me that is what it is now, it's a regulatory requirement that that's what we call it now, I'd say, well, okay, I'm going to be calling it gas for a while with my family. And that's the way medical device companies are. You're going to call it design controls for a while and that's fine. Just have a glossary. This is what we mean. And we're going to point to how we meet the ISO 3145 requirements. So have that map that maps from what you are today and how you meet those ISO1345 requirements. Requirements. I would put that in the quality manual section, some, some nomenclature section there. And maybe the third thing I would say is you need to get your leadership on record. QMSR auditors are going to likely be looking at that management review, those minutes assigned quality objectives and they're going to document the leadership involvement. So if it's a quality unit that's handling everything, that's likely going to Be a red flag. You need to brief your exec team and make sure that they recognize that this is a recurring cadence.
[00:28:18] Speaker D: I suspect that this checklist you mentioned is going to be incredibly handy. So with your permission, I will put a direct link into the show notes here to the checklist for our audience so you can make sure to do the best practices.
All right, let's talk about the whole reason we're here. The future of Medtech opportunities.
What do you think we can expect in the future when it comes to medtech design and development planning in the next five years? What's going to impact, what do you
[00:28:46] Speaker C: see changing the future is already here to a certain degree and I see things changing in the future even more rapidly. So right now if you're just using Excel and for your design controls and risk management, you're already behind because managing traceability is the name of the game for medical device design and development. You have to be able to show that I'm producing these user needs in a certain way. The design inputs map to those. The design outputs map to those. The verification shows me that the outputs meet the inputs. The, the validation shows that the outputs meet the user needs. All of that has to kind of wrap around, weave into itself in this tightly woven fabric. And so there's software tools that do that. Okay, that's, there's already ways to do that right now when I see the future, the this is going to be a little pie in the sky. But I see a future where healthcare already has note takers to recognize the gaps in procedures and sees the different things that need to take place. Because currently current process medical device professionals will often say, oh man, this is a problem. Eventually someone needs to fix this and maybe they themselves get motivated to do that and produce a medical device to fix their own problem. Scratching your own itch is great if we have ways of documenting that and analyzing it and seeing the trends that could input to using an AI or whatever else, input to a system that builds out those user needs, says this is what needs to happen, this is how it can happen and this is how it will happen. That's that design inputs, design outputs for those of you who are familiar with that process. And then it gets to a point where it can be handed off to an engineer and say finish building this thing and we are already filling out true gaps in the market. Not a science project that some engineer came up with on a bench top benchtop in a science lab, but something that actually is built on evidence from the healthcare industry that's what I see happening in the future.
I don't know exactly how far away we are from that, but it's exciting to me to see how a convergence of technology is coming together. Both AI the ability to pull that data, to analyze that data, and then to use that data and turn that raw data into actual information an engineer could use.
[00:30:56] Speaker D: J' adore Etienne Nichols, MedTech Connector for Greenlight Guru and host of the Global Medical Device Podcast. Thank you so much for joining us on the future of medtech opportunities and for our audience. Just as a reminder in the show notes, I did add a link to the the checklist for best practices. Make sure you check that out. And to learn more about Green Light Guru, make sure you check out their website at www.greenlight guru. That's G R E E N L I G T. G U R U. It was such a pleasure. Thank you so much for joining.
[00:31:33] Speaker C: Thank you so much, Kayleen.
[00:31:35] Speaker A: All right, Great job. Kayleen Brown. Thank you, Etion Nichols and Greenlight Guru for supporting the Device Talks weekly podcast. Now it's time for our keynote conversation. I sat down with Michael Carter, the senior vice president of Cranial and Spinal Technologies at Medtronic.
Well, Michael Carter, welcome to the podcast.
[00:31:56] Speaker E: Thank you for having me.
[00:31:57] Speaker A: Psychedelic Excited to learn what's new at Medtronic's CST business. You guys have had some great news. I know you talked to my colleague Sean Hooley a few weeks ago about your recent release and your approvals, and we can unpack all of that in a moment and see where the whole portfolio is headed. But first, I'd love to understand your path to where you are today. Michael, how'd you find your way into the medtech industry?
[00:32:21] Speaker E: So grew up in Oakdale, California. I had no idea what medical device was at the time. And then, you know, after for college, I went to West Point and then served in the army for five years after that. And when I was getting out, you know, I kind of bounced around for about a year. I was in pharmaceuticals for a bit, and I just kind of lacked that same sense of purpose I had when I was in the military and my first job in Med Device. I got recruited to get into Med Device. My first job was at Seattle Children's Hospital, and I was working in the cranial maxillofacial area and just watching what those surgeons do with kids with ape syndrome, Crouzon syndrome, cranial vault remodeling, and understanding, you know, how important my job was to get the product where it needs to be. When it needed to be there. And then, you know, the two surgeons that I work with the most were Joe Gross and Rich Ellenbogen.
And I just thought it was magical, right? These patients would come into the room one way and they leave the room, changing their lives forever. And that's what really got me hooked in medical device.
[00:33:32] Speaker A: How did you get into that room?
Who were you representing? Or what was your first sort of contact in medtech?
[00:33:39] Speaker E: Yeah, my first contact was in the cranial facial business.
[00:33:42] Speaker A: But the person. How did you get into. Did you get it. Was that her job that you took with the. Yeah.
[00:33:46] Speaker E: Well, there's a guy by the name of Mike Landa who called me up and say, I don't know if you've ever run across Mike, but he said, hey, I, you know, I've gotten your name. I think you'd be a great candidate for this. And I said, well, I'm not sure what I want to do. And he goes, just show for the interview.
And so it's like, just like most things and early in life, you know, you. You just kind of. It was, it was a desire. I'd heard about, you know, some of these companies. I'd heard about the technology, but I didn't know enough about it at the time, like really go hard charging. So I was kind of pulled into it and lucky enough, I. I owe him a lot, actually.
[00:34:24] Speaker A: That's great.
[00:34:25] Speaker E: And not taking no for an answer.
[00:34:27] Speaker A: Have you tried paying that forward with young people? Are you looking to lift people up 100%?
[00:34:33] Speaker E: I mean, I love listening to and talking to young people coming out of college. A lot of these kids, I mean, they're my kids age now, right? And so, you know, you see the same types of personalities, right? I'm ultra competitive, but also a high degree of empathy, care about people, huge commitment to duty and making sure that things are done. You know, when you look at the sales reps who are, you know, shoulder to shoulder, elbow to elbow with the surgeons in the or, that's an important part of the ecosystem.
And that's something that I'm excited to give kids this opportunity to come in here and enter this bay.
How was the recruit, a lot of people from the military question, I was
[00:35:23] Speaker A: going to ask that, how was the transition from the military? We know about Medtech, vets and some of the organizations out there that are trying to smooth the path. What was that transition like for you?
[00:35:32] Speaker E: For me, it was just kind of like what I said. All of a sudden I went from the military. I was a Bit lost right the first year out until I, I found Medtech, which, you know, I don't want to sound like it was a savior kind of story.
It was definitely something where all of a sudden I'm in a job again with an incredible mission, right. To, you know, alleviate pain, restore health.
And you're. It's high pressure situation, high stakes situation.
So I, I really enjoyed it, quite frankly. You know, I. There's, there's definitely, you know, they say pressure is a privilege and there's you, you are privileged to be in that environment and you better show up, but you better do your job. And so there was a lot of commonalities between med device and the military also putting, you know, what your, what your, your mission is or your job is above some of your, you know, what you want to do personally.
[00:36:31] Speaker A: Right.
[00:36:31] Speaker E: If a surgeon calls you a Saturday at noon, you know, you better be in the car pretty darn quick and getting the product that they want. So there was a lot of similarities that I really enjoyed being, being part of that team.
[00:36:45] Speaker A: Yeah, I never, in talking with folks until recently, I wasn't aware of sort of the various different, the very different lifestyles you have based upon the areas in which you sell, whether it's ortho, whether it's obviously trauma, things like that.
You're making a lifestyle decision by choosing one specialty over the other. How would you, how would you describe cst? What's that life like?
[00:37:08] Speaker E: I think CST is pretty full on, right. There's different CST like the, the spine wrap is continuously in the room with the spine surgeon.
And it really, you know, like I said, elbow, the elbow, the surgeon. Not literally because it's, you know, really close. You know, we have our, our enabling tech salesforce that is working with the surgeons clinically, but a lot of their work is, is done more at the suite C suite level. So there are vastly different lifestyles. I mean, I think all of them with the same idea is that we want to provide the best patient care. We want to reduce the cognitive load for the surgeon, we want to provide solutions for the hospital.
But there are different and you know, there's pluses and minus to everything. I think it really depends on, you know, the fit. You mentioned trauma. You know, trauma is you're on call. You're like a trauma that pretty much, you know, all throughout life. But then when you're selling capital, you know, you're also up against, you know, the threshold of making it or breaking it hinges on one or two deals. And so there's a different type of thing. So it really depends on the psychology of the person.
[00:38:21] Speaker A: I think is the most really interesting. So looking at your LinkedIn profile, you spent nine years at Stryker, you spent a few years at Nevro.
Talk quickly about those experiences. What was the striker like? Was that your first?
[00:38:34] Speaker E: That was my thing. That was actually I spent 18 years, so I got checked.
Maybe only got on LinkedIn nine years in, but yeah, it's overall kind of the same theme across the board in different specialties obviously different call points, different markets, but the overall experience is the same. I mean you want to be able to bring the best quality products to the surgeons that are going to be best for the patient. Working with the hospital systems to get the right solutions. And it's been nice for me over the years. I've been lucky enough to be in the craniofacial cranial maxillofacial space and the joint replacement space, spine, you know, the pain interventional space. So it's been, you know, vast, vast amounts of experiences on the medtech space.
[00:39:38] Speaker A: Interesting. And I see you moved over to Nevro, vice president of global sales.
Very cool company there. What was different about Nevro from, from Stryker in terms of the specialty you were functioning in?
[00:39:50] Speaker E: Yeah, yeah. I think that the, the specialties and what the needs are, is, is very variable. Just like the patient. Right. So with the pain, when you mentioned earlier, what do the sales reps do? Like in joint replacements, it's a subject matter expert continuously in the or a lot of the work is done in the.
Whereas with Nevro there's, there's a huge amount of patient interface in the, in the pain space where you're, you're set the ipg, getting the IPG ready. So it's kind of a different type of rep that you get a type of personality. But you know, it's all about the same end state goal. And you know, I, I've, I've enjoyed
[00:40:32] Speaker A: both of them and I see a stint as a CEO at Nexor Health Systems.
Talk about that for a moment.
[00:40:40] Speaker E: I tried to start up a company.
It's not as easy as it looks on tv, but it was a great experience. It probably was a huge growth for me is really being able to dive in. You don't have a big team, a team of less than 5. So you go from this gigantic organization to a much smaller organization and it was, it was a different market. But you know, then, you know, as, as things come about, when got the opportunity to move to Medtronic where, you know, most of the spaces we're in, we actually created.
[00:41:17] Speaker A: Right.
[00:41:17] Speaker E: If you look at with, you know, back to the founding of the company, you know, 1959 and you know, Halloween, when Earl Bakken's metronome was used to save a kid's life during a power outage in Minneapolis. Right. And I kind of started the whole pacemaker cardiovascular business.
You go back to, you know, how spine really became what it is today with the fixation systems and the instrument in spine cases. That goes back to Ron Picker back in the 90s when really fighting, you know, with the, the spine surgeons to bring instrument, instrumented spine cases into the forefront.
You had the, you know, the, I'm sure you know, the pedicle screw litigation that Ron fought and on.
If, if they would have lost that, we'd be looking at a whole different business right now, you know, and then you bring in, you know, the acquisition of Stealth and then the O arm. So a lot of the things when, when you look at Medtronic and what excited me about it was there's a history there of inventing the spaces and then going into those spaces and being the number one or two with everything.
[00:42:29] Speaker A: I've never heard the detail about the metronome. I have to look that up.
That specific story. Yeah, that's a great detail.
Just looking back at the startup effort, I assume you're glad you tried it.
[00:42:44] Speaker E: 100%. 100%. There were some really good ideas working with great people. You know, the, the more, the more, you know, I'm not exactly a rookie in either career or life right now.
What you, you recognize is the importance of working with good people, having good people around you. That's a lot of, that's what brought me to Medtronic.
[00:43:07] Speaker A: Yeah.
[00:43:07] Speaker E: Is you know, you want to have be, you know, you want to respect the people that you work for.
Really enjoy the people I work with. And then obviously I feel very lucky right now that I have a great team. So it's been a nice gift.
[00:43:21] Speaker A: Great. Well, before I pushed record, we talked a bit about Kirnill's buying. Business is represented broadly, geographically. You're in a lot of places, you're going to a lot of, you've got a lot of different presence here and there. Talk a bit about the business and about the, the portfolio.
[00:43:42] Speaker E: Yeah. So we're, we're a five billion dollar business global, as you mentioned, we have everything from instrumented spine to cranial solutions. Very heavy right now on the navigation robotics, the intraoperative o Arm imaging and then our partnership with Siemens, which kind of being put in place on the, you know, you have the preoperative weight bearing scans and then the post operative scans. So essentially the entire continuum of care really is what we're focused in on, on both spine and cranial.
[00:44:21] Speaker A: So what is the largest part of the, of the CST business? What's your biggest product portfolio?
[00:44:30] Speaker E: Largest part is spine.
[00:44:32] Speaker A: Right.
[00:44:33] Speaker E: The instrument inspired and, and then you have the enabling tech. But you know, the, the way that I think about it is there's, there's no, there's no way to separate those two. Right. So you, you know, the instrumented spine from a revenue perspective is the largest part of our business.
However, the way that we approach the business isn't in the way that I look at it, my team looks at it, is now, okay, we have our spine business, so we have our nape tech business. It's really, we have spine procedures and we have cranial procedures and then we have the procedural solution for everything. So we have a procedural solution, a T lift procedural solution.
That's how we consider it. I think the days of a spine company just being a widget company are over. Right? You really need to have that comprehensive solution that then we're working on.
[00:45:30] Speaker A: Talk a bit about the cranial space. What goes, I mean, I know, I'm guessing what part of the body we're referring to, but what are the products up there? What sort of, when are you called into to help patients in that space?
[00:45:44] Speaker E: So we have the Stealth Navigation, which is pretty much ubiquitous throughout the ORs. Right. Between Stealth, ORM, Mazor Robotics, we have about 12,000 units placed globally. So it's a pretty wide swath. Now, cranial specifically, especially with this new stealth access launch, we're really focusing in on cranial or, excuse me, tumor resection, deep brain stimulation, which we also have, which is a sister business of ours, Hydrocephalus, where we have the CSF product line.
And I think the biggest breakthrough right now for us and that we're going to continue to build on is a tractography. So the surgeon can actually decide, okay, this is the trajectory I want to enter into, reset the tumor or place the DBS lead.
Those types of solutions.
Quite frankly, our spinal ABL ecosystem is built out more than our cranial ecosystem. But there's so many advances coming down in cranial. Right now everybody is talking about brain computer interface.
You got gene therapy, delivery, focused ultrasound, things that we aren't in right now, but we definitely have our eye on, on the Future where we could build more of a cranial ecosystem around that.
[00:47:07] Speaker A: It's really interesting. I guess I've always, and not giving it a lot of thought, I've always counted spine and cranial as a hard tissue sort of space, but it's really a blend of both hard tissue and soft tissue. Right.
How do you categorize the areas you work? Working?
[00:47:24] Speaker E: No, I think you did a nice job there. I mean, I think that there's definitely with the spine, as far as alignment goes, there's a lot focused in on the hard tissue.
With regards to cranial, there's definitely an element of hard tissue. But if you're really going to go in there and resect the tumor, there's going to be. It's multifactorial, as is everything. Right. Soft tissue management and spine is very important. So the ability to be able to preoperatively plan, figure out what you're going to do, where you're going to release, where you're not going to release.
Those are the types of solutions that we're trying to create and we are creating with our surgeon. Right. It's about how do you have less variability, how do we reduce the cognitive load on the surgeon and have more consistent patient outcomes.
And I think if you look down the road, some of those technologies I mentioned, like gene therapy, delivery, are, you know, are we going to be a gene therapy company? Likely not, but so it's going to be how do we work and work with partners to help because the end state is, you know, they're again, brain tumors multifactorial.
So for us to think that we're going to be able to come up with a med device solution for it is not realistic. Right. We're going to need to be able to work with other kind of modalities, other, you know, other technologies, biotech, pharma, whatever, down the road if we're really going to get to a solution.
[00:48:53] Speaker A: That's fascinating. Yeah, no, I guess I hadn't seen you as sort of a gateway business and I hadn't really connected BCIs to what you folks do. Obviously they're still very early stage almost. They're not science project anymore. They're getting implanted, they're doing some good.
But do you sort of see this business moving in that direction? BCIs, you mentioned sort of the focused ultrasound, you know, used in surgery. I imagine that could be an opportunity. Do you see yourself as sort of a gateway franchise to a whole new slew of technologies out there?
[00:49:24] Speaker E: I think that there's a lot of technologies out there to pick one that we're going to be. Okay, sure, this would be.
But I think one of the advantages that we have, or I know one of the advantages we have and something we pride ourselves in is staying very close to our surgeons.
[00:49:42] Speaker A: Right.
[00:49:42] Speaker E: And at the teaching institutions. Last night I was having dinner with someone who predominantly works out in asc.
We have an OR in Mexico looks a lot different than an OR in Europe. And so it's important for us to continue to develop solutions that include all the customers democratizing medicine. But what those technologies are going to be on the cranial side or even in the spine side, A lot of it just requires us picking up more information.
Decide, okay, yeah, this is actually, this is the solution we want to move with.
[00:50:20] Speaker A: Interesting.
You referenced stealth axis earlier. That was your news of late. I know again you talked to Sean Hooley at Mass Device about it. You had recently received FDA clearance for stealth access robotic system for spine surgery. Then FDA approval for an expanded indication for the use of it with your infused bone graft and TLIF procedures.
Talk a bit about stealth access. What is it and how does it fit into your portfolio, into your other offerings?
[00:50:50] Speaker E: Yeah, so stealth access is the intraoperative portion of the able ecosystem.
[00:50:56] Speaker A: Now what does that mean, intraoperative? This is the system you're using to run an operation, basically.
[00:51:01] Speaker E: So if you look at the entire able ecosystem, it's really about AI planning, Combined navigation, combined with robotics is the first one that kind of ties that all together.
But when we talk about the ecosystem, we talk about from the origin of the imaging with Siemens and our partnership there to preoptively planning the case where you can send in an image, the surgeon works on what the plan needs to be.
And also we can pre bend the rods such that they know exactly what that plan is. And then the stealth access, the big jump is really that we're able to transfer that data into the stealth access. So the surgeon goes into the procedure knowing exactly what they want to do.
So that was. We call that converged planning. I think the other two big advances that we've got with stealth access is it's a modular system such that, you know, stealth is fairly, you know, as I said earlier, fairly ubiquitous in both cranial and spinal procedures right now. It's been around for, you know, well over a decade, almost two decades.
And that interface is what customers are comfortable with and that's what they place in the robot or, excuse me, in their ors. We've used that exact same interface and now if you want to turn to robotics, there's a different, there's an arm that you can purchase that will add on and create the robotic solution. So that's the second big one and I think the third that is really the biggest breakthrough is your ability to segmentally track intraoperatively. So in the past, the surgeon comes out with a plan they lay over as the template. But when you start to decompress, the spine's moving and it's hard for sometimes a surgeon to say, okay, how much move laterally, how much did it move anteriorly? And they'll do other spins on the OR and, and take a look through imaging with, with our technology you can see that in real time and the plan changes and it shows where the segments are moving. There's really. Those are the three big advantages with stealth access that we've introduced the market over the past month.
[00:53:23] Speaker A: So, so tell me how a system like stealth access or stealth access itself, how will it impact surgeries going forward? Is the goal that with this planning, with the ability to sort of for surgeons to know what the plan is going in and what the plan is post op, does it shorten surgical time? Does it improve performance of the implants? I'm sure it's going to be kind of an all above sort of thing. But what are your objectives with stealth axis?
[00:53:54] Speaker E: The way that we look at it is, you know, through the lens of what the impact is on the patient and then, and what the impact is on the surgeon. So I think the best way for me to frame this is, you know, millimeters and degrees really do matter.
Right.
So your ability to dial in the plan and then have that plan transfer directly to either navigation or robotics is a big step forward.
And for the patient it also means, so they're going to have their patient specific plan that the surgeon is going to be able to execute. And with the segmental tracking and what we call libeline is the brand, there's going to be a lot less radiation because they're going to have to be less spins, so the patient's subjected to less radiation and you're going to have more predictable outcomes. So those are three big things for the patient. I mean, and a lot of that also translates to the surgeon. Right. With less radiation. But I think the biggest thing is as we, as we use our unit platform and the artificially or AI based unit platform, you're going to start to reduce a lot of the cognitive load on the surgeon. So the surgeon, we're going to be able to assist using AI tool to help assist with the planning for that particular patient and then also the execution intraoperatively.
So for the surgeon, I think you'll see less cognitive load and we'd expect, because we haven't done a case yet, so I'm not going to make any claims. You expect that that would expedite the cases as well?
[00:55:29] Speaker A: Sure. And you referenced earlier that you're also. You got approval and it was last week or the week before this interview for cranial and for ENT as well. So how does that help surgeons operating in the brain space? What will they get from stealth?
[00:55:46] Speaker E: I think that the biggest leaps forward we've made is just the ease of use that we're moving forward with.
[00:55:55] Speaker A: Right.
[00:55:56] Speaker E: We're still focused on tumor resection. That's always been kind of the hallmark of stealth.
Deep brain stimulation is another big area that we're focused in on hydrocephalus.
So with that and the tractography technology that we have, we're bringing more predictability to cranial surgery. And then when you start to think about what we could do in the next two to three, four years, introducing other things as we talk about with the gene therapy, delivery, brain computer interface, you know, focused ultrasound, all these things we have our eye on as to how. What's the best applications with the stealth and the robotics on the cranial side.
[00:56:38] Speaker A: So where. And we hit. We hit upon a little earlier. But where do you see spine and cranial headed in the future in one case?
I love sort of unpacking the technical possibilities. I mean, as medtech sort of as AI develops, as robotics develop, as all these external technologies develop and find their way into medtech, it just seems as if medtech is becoming more and more powerful and essential in healthcare. And I think that's fantastic. And I think cranial is going to be a great sort of example of that. Where do you see technology taking the cranial and spine space in the future? And then part two of my question, I'd like to unpack sort of where these procedures will be done. We're talking a lot about ASCs in pretty much every conversation now. Two years ago, maybe one in ten now I feel like I'm talking about it every single podcast technically. First. Where do you see that? Just, I guess I'm re asking my question from earlier, but what do you see the cran. What do you see new technologies bringing to the cranial and spine space in the next five to 10 years?
[00:57:43] Speaker E: Our focus right now is to continue to help with working with the surgeons how do you reduce the variability? How do we have more reproducibility in all these procedures? Right. And I think that to say we know what's going to be there in five or 10 years, I think that would be disingenuous.
We're building out the data that will help feed into those solutions and we're going to be working with our surgeons and we're going to be working with, you know, other clinicians to figure out, okay, what, when we have all this data and we have these solutions, what's the best application of that model moving forward?
We'd love to see, you know, spine surgery become much more reproducible, a lot less variability. Like to be able to get to a point where, you know, we don't talk about non operable brain tumors anymore.
Now how we get there, what that pathway is, I'm not 100% clear, but that's what our focus is. Right. If you, if you think of it in terms of where our North Star is, that's what we're looking at do.
[00:58:49] Speaker A: No, that's a, that is a great goal. Especially with spine. It's always, it still remains a bit of a, one of all the specialties. I think the, the, the, as you said, there's a lot of variability in performance. So it would be great to, to bring some uniformity to that. How about in, in the settings, how do you see the business changing, the business side of things changing surgeons, are they operating in different settings than they they have been currently are? What does the future look like?
[00:59:15] Speaker E: Yeah, I mean, I think that there's definitely going to be a movement specifically in the spinal degen space to asc. Right. And I think that enabling technology flows right into that. I was having dinner with somebody last night. We were talking about, if you know, when you think about the ASC setting and there's some spatial concerns and spatial restraints where if you know exactly what you're planning to do and you feel confident that you can execute it exactly to plan with, with the robot or navigation, you're not going to necessarily need to bring in as much as many sets, as many implants because you're going to have that plan. Maybe if we go one up, one down on, on the amount of inventory we bring in, there's, there's specific solutions for that. I think over, over time you're also with, with the use of AI going to be able to tell who's the best patient for this setting versus that setting. You know, you're talking about the big T10 pelvis you know, big cases. I think those are going to be in the hospital study for the foreseeable future.
But I think more and more Degen is going to move into the AS and right now we have about 10%. Over the course of the next five to 10 years, I believe it's going to be 25% higher.
[01:00:35] Speaker A: Fantastic.
I said that was my final question. But I have an unrelated question that you can answer or not answer. You mentioned brain computer interfaces before. You talk to a lot of smart people in the cranial space. Is there an excitement of what may be to come? Is it still wait and see? What is the general tone of BCI is that we're seeing a lot of money committed to.
Feels a little bubbly to me. I don't think there's been some progress, but we're still in the very early stages. But what do folks on the ground say? What do they see coming in this space?
[01:01:04] Speaker E: I think, you know, very high level people are very excited about base. They're excited about what the potential is, you know, whether it's, you know, stroke or behavior or what have you. There's a lot of different how that application is going to be, but it, I, I think what it, it's to be determined what the best applications are going to be or at least the initial applications are going to be that really make the biggest impact. But I don't think there's any doubt that that or something along the BCI continuum is going to change the way we look at the brain. I think over the course of the next 10 years, that's going to be the big revolution.
Cardiovascular Right now there's a lot of great solutions for cardiovascular health that weren't here back in 1970s and 1980s. And with all the focus on the brain and brain health in the cranial space, I feel like we're in a great position to ride that wave over the next five, 10 years.
[01:02:02] Speaker A: You're sitting in a pretty exciting seat with a great view of the future. So, Michael, I appreciate your taking the time to join us on the podcast.
[01:02:10] Speaker E: Absolutely. Thank you for having me.
[01:02:15] Speaker A: All right, everyone, that is a wrap. Thanks so much for joining us on this episode of the Device Talks weekly podcast. It was great fun to have a greenlight guru as our foe. To have the the famous Etion Nichols on our podcast. Was great to meet Etion at the Medtech Innovator Radar forum a little bit ago and happy to have him on this podcast here. If you'd like to join us AT Device Talks Minnesota or Device Talks Boston, make sure you go to DeviceTalks.com, find the websites for both those events and when you register, use the code DTW25 to save 25% off new registration. So if you haven't registered yet, please use the code DTW25 to save yourself 25%.
If you missed our Surgical Robotics Week on Device Talks Weekly, you can still go to devicetalks.com and register for that and watch that online. We had over 1,000 registrations for those four conversations and just great insights on where Surgical Robotics is headed. We'll be resuming our normal device talks Tuesday's conversations on April 28th. We'll be joined by our good friends from Novanta. If you'd like to make sure you don't miss a future episode of the Device Talks Weekly Podcast, best thing to do is subscribe to the Device Talks Podcast Network or the Device Talks Weekly Podcast and they'll get sent directly to you. Of course, you can also just connect with me on LinkedIn or connect with Kayleen Brown on LinkedIn or Chris Newmarker. I'm sure you'll be able to find the podcast and other great medtech insights that way as well. All right, once again, folks, I hope to see you at device talks Minnesota on May 4th. I hope to see you at Device talks Boston on May 27th and 28th. But even if I don't, I'm very glad you're here. Thanks for joining us on the Device Talks Weekly podcast.
Sam.
