Medical technology is moving quickly, and the companies that succeed will be the ones that stay connected, think strategically, and solve the right problems.
In this live episode from DeviceTalks Boston, Etienne Nichols, MedTech Guru at Greenlight Guru and host of the Global Medical Device Podcast, discusses the major shifts shaping the medical device industry. He shares insights on global regulatory harmonization, tougher funding conditions, the growing role of AI, and why data strategy matters more than ever. Etienne also explains why companies need to understand their true user population, challenge assumptions in product development, and prepare for a future where medical devices work together as connected systems.
Tune in to learn how medical device companies can navigate change, use data more strategically, and build solutions that better serve users and the broader healthcare ecosystem!
Resources:
[00:00:03] Hello everyone and welcome back to the Outcomes Rocket, recording live from Device Talks in Boston. I'm excited to be here with Etienne Nichols. He is the MedTech Guru at Greenlight Guru. Welcome to the podcast. Thank you. Great to be with you, Saul. Likewise, finally, man. Yeah, I know. We've kind of talked about this intermittently every now and then, but it's great to finally be together. Likewise, likewise. And folks, I'll give Etienne a chance to introduce himself, but he's one of the guys I follow in the space.
[00:00:31] He does a lot of great thought leadership in MedTech. You'll see him a lot on LinkedIn. If you don't, we'll put his info in the show notes. Because I get a lot of insights from him, so I'm excited to finally get him on the podcast and share some of his thoughts with you. So, Etienne, with that, give us a little bit about you, Greenlight Guru, what you guys are up to. Okay. As I said, or as you said, my name is Etienne Nichols. I work at Greenlight Guru. And one of the things that we do primarily at Greenlight Guru is our goal is to help companies get to market faster and stay there longer.
[00:00:59] And the way we do that is a couple of different ways. We have an EQMS quality management system platform and EDC, but we also have an educational arm. And that's really where I'm focused. So I help with a lot of our webinars, our podcasts, Global Medical Device Podcast is the podcast that I host. And just getting to come to events like this, talking to professionals in the field really gives me a lot of insight into what's going on out there. It's been really great.
[00:01:22] That's great, man. And this content piece, I think, is often underrated and an opportunity to really get in front of your end customer, get known in the market. Talk to us a little bit about what you're seeing in MedTech in particular, any shifts and how what you're doing is making a difference. There's a couple of things. So, number one, from a regulatory standpoint, there seems to be a kind of a global harmonization happening.
[00:01:48] And you can point to a couple of big things that have happened that might make somebody say that. But there's a lot of little things that have led up to those big shifts. But the number one big shift would be QMSR, Quality Management System Regulation, being instituted by the FDA, which was a harmonization of the FDA's old QSR with ISO 1345. That's a lot of numbers and letters, I suppose.
[00:02:09] But just take it. It's a little bit of a reshuffling of the deck, but more than anything, it's the FDA saying, hey, we know there are other regulations out there that are working for these other countries and we don't need to be duplicative. So that's one instance. There are a couple others in different ways, but there seems to be a desire to be more harmonized from a regulatory standpoint. From a financial standpoint, I keep hearing different things from different people.
[00:02:35] I've talked to a lot of investors lately about how many meetings does a company have to have before they actually get a check. And earlier this morning, I was talking to an investor. I won't say the name necessarily or who they're from, but she was saying it's almost double the number of meetings that an early stage founder has to have before they get to that check. And what's the number? She was saying it used to be 99 to 1. Now it's like 200. So I tried to verify this. 200 meetings to get a check? To get one check.
[00:03:02] So a medical device founder meeting with 200 people to get one check. That's the expectation. We're going to meet that many times. I want to make sure I was understanding. Right. And that number, the way I look at it, like, okay, so they're averaging off. Here's a founder. Here's a founder. Maybe there's a founder over here who maybe the idea is not that great. And so they've got so many meetings. And then this one, hey, it's really good. We're going to know things. So you take an average. That's an average. But it's still, there's lots of different ways you can come up with the average. Have we increased the pool of founders?
[00:03:33] Or has it really gotten that much more difficult to get investment? So it's hard to say. But as a general rule, I keep hearing that there's a gap somewhere where the smaller checks, okay, it's easy to get that angel money. Easy, easy, relative. And the larger checks, Series A, Series B. But somewhere in the middle, that seed to Series A is a difficult gap. That's a gap. Yeah. That's a difficult. I've heard that too. I was at LSI earlier this year. And having a lot of those types of conversations with founders. Yeah.
[00:04:02] About that bridging the seed to the A. It's hard. It's hard. Those two things. The last thing I would say is, across all the different industries, we're being impacted by AI is obviously a hot item. What I look at it more as, we are a data-rich environment right now. We really want the data on so many things. And I would give the example of if you're wearing an Oura Ring or a Whoopstrap or whatever else, you want to own your own health outcomes. Yeah.
[00:04:31] We've always been able to collect data. So I was a mechanical engineer in college. I put strain gauges on bicycle stamps and everything. And you can collect data out the wazoo. But what do you do with it? You had to be selective about what you're actually, the conclusions you draw because you just can't crunch that much data. There's a way to do that now. And it's through AI. So we're sort of drowning in this. We need to collect the data. But we're not being as selective.
[00:04:57] So I guess if you extrapolate that to the individual, because I think that's where it really hits home is the AI capability and how you apply it. You need to be a little selective. But it is important that you do it. So we're in a data rich. I mean, if you're kind of let me torture the analogy. Yeah. The actual professional needs to be able to augment themselves with AI now. I have a lot of different thoughts on that. I know it's starting to get a little scattershot. But I guess those are three of the main things I see going on in MedTech right now. That's cool.
[00:05:27] No, I think. And you are right. We are data rich now. And so being thoughtful about what you do with that data. We were having a conversation about data strategy earlier. Right. And I think that a lot of organizations, as well as, to your point, individuals, are being tactical about their data versus strategic. So there's an opportunity there. Yeah, for sure. Yeah. But I think there's a it's a really good thing. Whether investment is going to change or not is still to be seen.
[00:05:57] I actually have heard some investors say that there are some investors, almost like during the dot-com bubble, when a lot of investors were kind of moving out of other industries into this one isolated thing. There's a lot of that happening with AI. And money is moving into AI work that might have been injected into MedTech. So that's that's fair. But I still think there's a lot of good things that are happening and a lot of exciting things. One other thing I'll say about maybe from the product side, if we want to just cover the whole gamut. Yeah, let's do it.
[00:06:24] I hear some companies now, especially when the software is a medical device, you almost need that prescription. But you also have an over-the-counter version of your product as well. So an example of that might be Akili. I don't know if you've heard of that company. It's for I believe it's ADHD. So it's a prescription product. Yeah. But you can also just buy the app and you get some utilization out of it from that perspective. So that's been interesting to me to see how many over-the-counter opportunities there are. Interesting. So, yeah, no, I love it, man.
[00:06:54] And so as you think about we're about mid-year already, like as you think about back end of the year, next year, what's working really well for you right now? I think more than anything right now, what's really important is connection, like true connection. I get to go to a lot of these live events, and I think that's – it's been really beneficial for me. It gives me a good landscape view of the ecosystem. Where do you live? I'm outside Nashville. Oh, you're in Nashville? Yeah. Dude, I was just there when – we were there last week. No kidding.
[00:07:24] I love Nashville. One of my favorite cities. That's awesome. Yeah. Yeah. So we moved there. You guys are getting the Super Bowl. I – yeah. It's going to be – That's massive. It's going to be good. It's going to be good. Man, we'll have to actually meet in Nashville next time. We're going to. We're going to. That's what surprises me that we actually met in the United States. It seems like any time somebody's in Tennessee, I have to meet them in London or Portugal. I thought we were destined to meet in Barcelona or something. No, you're really good. I'm excited that we have to finally be here. Likewise. Likewise.
[00:07:53] The connection is key, and I'm glad we're doing this live in person. As you think about roadblocks and challenges for the market and companies, what stands out to you? It's interesting. It's going to sound like I'm talking on both sides of my mouth because earlier I talked about global harmonization. But I still think a global strategy is one of the biggest challenges and really identifying your true user population and solving that true problem. So that's the biggest problem I see with medical device companies facing. Yeah.
[00:08:22] Is actually solving the problem that really needs to happen. I'm going to throw out a half-baked idea. I love it. Earlier today, I was sitting in a – Let's cook. I was sitting in a panel, and somebody said something that I've said many times before, and that is it's great that we have so many doctors and physicians and clinicians. Working on the products because who better to work on the products than the people who actually are doing the work? To a certain degree, I agree. I do agree with that.
[00:08:47] But at the same time, I got to thinking, what other industry do we expect the driver to build a car? Or the – I don't know – the airplane pilot to build an airplane? Or come up with the problems and then let someone come up with solutions. So I do think some of the solutioning – I hate that word, but I hear that sometimes. But the ability to come up with a true solution, that's – we shouldn't necessarily leave that in the hands of the person who identifies the problem. So I –
[00:09:16] No, hey, listen, man. I think it's important to be – to challenge thinking here because that's how we move forward. So I love it. Make sure your assumptions on a lot of what you're currently doing with your product build or your go-to-market. What if you just changed it a little bit just for the sake of thinking differently? I think you'll be surprised with what you get. Courtesy of Etienne here on thinking for go-to-market. What's one thing that you're betting on or excited about here in the new year?
[00:09:45] I think the ability for medical devices themselves to start working together more than they ever have before. I think that we're coming to a convergence of technology, whether it's with AI or other big data. I think we're closer than maybe we've ever been before for the medical devices to be less disparate and to be more of a system. So I'm excited about that. Is there any particular examples that you're thinking about of devices coming together?
[00:10:11] I think the technology around non-invasive continuous glucose monitoring is one of the ones that is maybe a good example for this. For the last several years, I've been hearing about different ways of collecting that data, not through a microneedle, but actually using microscopy or I'm outside my realm telling how to do it or whatever. But that's an interesting one because it's also a good example of how data that was or a problem for like diabetics. Yeah.
[00:10:40] That was a really excellent solution for them because it was a user population that was used to sticking themselves, used to knowing what they needed to do. So they've simplified their lives and really improved their lives. So that was a really good example. But now that is extending downstream to other users who are now just using it for fitness. That's one of the examples I guess I would give in the ability for a technology to have wider impact of in just the user population that it was intended for. I love that. Yeah. That's cool, man. That's cool. Yeah.
[00:11:10] I'm like impressed with that whole segment and how they've taken it from diabetes indications to now so much like wellness pretty much. Right. Yeah. Fitness and wellness. Yeah. The applications are there. And when the applications increase, innovation also gets introduced on the consumer side of the equation. So, yeah, I think that's really cool. Look, man, I'm so excited we got to do this. I was looking forward to it. And we moved it ahead of schedule when we kind of ran into each other here.
[00:11:38] I was great when I was looking at the magazine. Yeah. I was looking at the map here. And I did not realize, I don't know, it's my first time at Device Talks, that there are two shows going on. We have robotics and we have device talks. And I looked at the map. You have orange and red. And thankfully, I'm colorblind. So, I have to look at every booth because I don't know which one's which. So, that's been really good. Do you see any colors? I do see colors. I actually did not know I was colorblind until this strange story.
[00:12:06] But before I went to become a mechanical engineer, I had no intention to do that. Really? I went to become a helicopter pilot. No way. My brother was a fixed swing pilot. Wow. They sent me to get my physical. And colorblindness kind of got me kicked out of helicopter school. Holy smokes. So, I got to fly once. But then said, all right, engineering it is. All right. All right. So, like, all colors or? Blue, violet, some red, some oranges. Do they look red? What do they look like? Are they?
[00:12:34] They just sort of blend together. So, they look exactly the same on those. Okay. Wow. Well, hey, you know what? You looked at the map and you ended up here. So, that worked out. Yeah. All roads lead to outcomes rocking. I love that. That's great. Etienne, thanks so much for doing this. If people wanted to get in touch with you, learn more about your work, where can they do that? Well, you can email me at etienne.nichols.greenlight.guru or find me on LinkedIn. I'm very active on LinkedIn. He definitely is. So. He definitely is.
[00:13:08] That was a good post. Follow his work. Etienne is one of the best in the biz. Check out the show notes for all that. Etienne Nichols, the MedTech Guru at Greenlight Guru. Thanks for being with us. Awesome. Thanks for having me.