Podcasts about Medtech

Melissa Muller, Founder and Principal Consultant at Muller Advisory Company, joins Duane Mancini for a practical conversation on what medtech founders must know before scaling beyond early adopters. Melissa breaks down why FDA clearance is only the starting line and why true growth depends on adoption readiness across clinical, financial, and commercial stakeholders. They dive into mapping the full clinical workflow end-to-end (including setup, IT, biomed, and reprocessing), identifying who must say yes (and who can still veto) through contracting and value analysis realities, and clarifying exactly how customers pay across hospitals, ASCs, and other sites of care. The conversation closes with how to drive repeat use, build advocates, and avoid “scaling assumptions” as care shifts and teams beyond the founder must carry the story.Melissa Muller LinkedInMuller Advisory Company LinkedInMuller Advisory Company WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Stephanie Rupp (Hoffmann Eitle) and Ryan Phelan (Marshall Gerstein) explore how AI is reshaping medtech innovation and the IP strategies founders need to know. They break down key trends, from traditional model training to today's generative AI workflows, plus common pitfalls like novelty-destroying disclosures in pitch decks, websites, and investor conversations. Ryan explains why “file early” matters in the U.S. (and how provisional applications can backfire if they're too thin), while Stephanie shares how Europe's strict novelty rules and EPO “technical effect” requirements change how AI patents must be drafted. The conversation also covers cross-border collaboration, the Unified Patent Court, and why strong IP can become a startup's moat for investors and future growth. Guest links: https://www.marshallip.com | https://www.hoffmanneitle.com/ | rphelan@marshallip.com | srupp@hoffmanneitle.com  Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 089 - Stephanie Rupp & Ryan Phelan [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference.  Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guests Stephanie Rupp and Ryan Phelan. Stephanie's technical expertise stems from working in various fields of electrical engineering and information technology. She is particularly interested and experienced in communication technology, telecommunications engineering, and artificial intelligence due to her time at the university and various projects in the industry. For example, Stephanie gained industry experience with a leading technology company of measurement and high-frequency technology in the field of measurement technology for LTE. Working with a variety of clients from all over the world, Stephanie specializes in prosecution and oppositions at the European Patent Office and German Patent Office, freedom to operate, and patent drafting, in particular in the fields of computer-implemented inventions. Stephanie studied electrical engineering at the Technical University of Munich. She wrote her master thesis at the Chair of Communication Networks in the field of artificial intelligence with a focus on reinforcement learning. Ryan is a registered patent attorney who counsels and works with clients in all areas of intellectual property with a focus on patents. Clients enjoy Ryan's business-focused approach to IP. With an MBA from Northwestern's Kellogg School of Management, Ryan works with clients to achieve their business objectives, including developing and protecting their innovations and businesses with IP. Ryan has been published in several well-known IP publications, including World Intellectual Property Review, Bloomberg Law, and IP Litigator, and has spoken as a panelist at various IP conferences, including for the International Intellectual Property Law Association and for the University of Illinois Chicago Annual IP Conference. Since 2024, Ryan has been selected for inclusion in The Best Lawyers in America list in the practice of patent law. All right, Ryan and Stephanie, welcome to the show. I'm so glad that you are here. Ryan, this is your second time. Delighted to have you return, and Stephanie, I can't wait to learn more about you and all the ways that you both contribute to the industry. So thank you both so much for being here. [00:02:54] Ryan Phelan: Yeah, thank you. Yeah. Glad to be back. [00:02:56] Lindsey Dinneen: Awesome. [00:02:56] Stephanie Rupp: And thank you v- very much for having me. [00:02:58] Lindsey Dinneen: Yes, of course. Well, I would love, if you don't mind, starting off by sharing just a little bit about yourself, your background, and what led you to medtech. [00:03:09] Ryan Phelan: Yeah. So I'll kick it off. My name's Ryan Phelan. I'm a partner at Marshall Gerstein, which is an IP boutique here in Chicago. I have a computer science background, so I see the world through, you know, everything computers and, of course, nowadays that means AI. On the, the medtech side you know, I, I have, experience in robotics and so, a lot of medtech devices are in the robotics field, so it's very natural for me to apply my skill set, to that, area of expertise, one of which is, prosthetics. So you have a robotic, prosthetic medical device, and that lends itself to, you know, some type of computational control. And there's certain, legal issues that usually come up in, the US practice. So I enjoy, applying that skill set, to the, to medtech space. also, you know, family members als- have, you know, ailments and things that, I have, grown up with, you know, as a, you know, young boy and, now I'm very happy to you know, give back in my own way. I'm not a doctor. I'm just a-- I'm a, I'm a humble patent attorney, but, helping the, IP world, and, doctors and physicians, with not only, you know, in the robotic space, but also, software medical inventions as well, and I, enjoy working in this space. [00:04:22] Lindsey Dinneen: Love it. Thank you so much. Stephanie? [00:04:26] Stephanie Rupp: Yes. So as you hear from my accent, I'm from Germany, specifically from Munich, so that's a city in the southern part of Germany, close to the Alps. people might probably know Munich from the Oktoberfest that we have each year. And, so I'm a German and European patent attorney at Hoffmann Etile. I also throw it in as well, I'm also UPC representative, so we have, for three years now, we have the Unified Patent Court, so a really new court in Europe for centralized litigation for infringement and revocation actions. So I can also represent clients there. yeah, Hoffmann Etile is a, also a p- a IP boutique firm. not only in Germany, we also have offices, in other places in, Europe. And, yeah, my technical background is electrical engineering and information technology. And, during my studies, I just didn't work a lot in the medtech space. I was, ... my work concentrated more on the telecommunications side, working in a, bigger f- company that, concentrated on measurement and high-frequency technology. But, my master thesis was already about AI, so it was at the Chair of Communication Networks, and it was about, like, reinforcement learning, virtual network embedding. I won't say too much about that. I think it will bore the listeners. But so I didn't know at that time, but it opened my way to the medtech space afterwards. because when I joined Hoffmann Etile nine years ago with my training, the partners were really happy to hear that I have experience in the AI field and the technical background on that. And, around nine years ago, we saw a lot of patent applications being filed in the AI space, like using AI technology in different technical fields, and especially also in the medtech, field. And, so I had the opportunity to jump in there, like, right away when I started and was really happy to do that and also, like, still very glad to have that opportunity to work with the medtech, companies and to get the best patents for them in that, especially in that field. [00:06:26] Lindsey Dinneen: Awesome. Thank you so much. Yeah, thank you both. So, all right. I have so many questions, but I will start here. I'll just, 'cause I'm curious. So how, how did you two meet? Do the firms come together and, and, collaborate? [00:06:38] Ryan Phelan: Yeah, absolutely. so Marshall, Gerstein and Hoffmann, Eitel had a relationship prior with, attorneys, that go back a generation or two, before Stephanie and I met. And so, their-- one firm would send attorneys to the other and vice versa. And then, after a while, given that Stephanie and I have similar backgrounds, it was very, simple just to connect us. And then we've worked together on matters, before and have similar backgrounds like Stephanie mentioned. She has electrical background, but has done a lot of stuff with AI. And so whenever you're doing, matters across the pond, as they say, you need expertise, in the EPO and the US and the laws are different, so you have to collaborate. And it's great to have, have people that you can collaborate and work with. [00:07:21] Stephanie Rupp: Yeah, and a lot of clients, they're not only interested in getting an EP patent, but they also want to get a US patent. And, I'm not a US patent attorney, so, usually tell them, "Oh, yeah, I know a really good patent attorney in the US." And, thank you ... so I will, like, hand over the work to him and then the other way around if they have, like, clients that they want to get a EP patent, and that's how we work together and, also dis-discuss these cases together. And, so yeah, I'm currently in Chicago for a week, also to meet Ryan in person again. I do that, usually once a year. And, yeah, just have time to discuss some cases more regularly. [00:07:55] Lindsey Dinneen: I love that. That's cool. [00:07:56] Ryan Phelan: Yeah, I was in, And I was in beautiful Munich last year, so it was, it was great. [00:08:00] Lindsey Dinneen: Very nice. That's wonderful. Okay. So again, so many things to talk about, but I, I, I'm curious in your interpretation of how AI has affected, especially the legal components of, say, filing a patent or IP protection or all of those things. When it comes to medtech founders, what are you seeing the trends to be, and also, what are some of the pitfalls to avoid? [00:08:29] Ryan Phelan: Yeah. So I've seen AI affect everything from filing strategy or information, gathering, like on the pre-stage of a patent, and then also, the invention itself, has also included AI. I think about it as like AI 1.0 and 2.0. before, 1.0 AI is, a lot of software inventions would train their own models with their own data. Maybe you have a, a cardio, application or something like that, that would use existing, information from patients and, that information, would be used to train a model, and that model would be able to output some type of response for a future patient. Maybe that model was inside of a device that was, implanted or, put on top of, a patient where that sensor data would be collected.  Nowadays, in, in tho-those inventions, usually incorporated some type of trained model. Nowadays, you have a lot of generative AI, where newer inventions are using out-of-the-box models from OpenAI, ChatGPT models, or Anthropic's Claude models. And, a lot of the same issues are still being addressed, where data will, will come from various sources, whether it's a patient's data or clinician's, or maybe it's, a diagnostics or maybe it is more in the robotic space for, prosthetics. But that data is now, instead of being pushed into more traditional models that would be trained, is now being used by these generative, LLMs. And then you can have combinations of the two. So it's, become an explosive field in AI at least from what I have seen. People are getting excited that you have these large treasure troves of data that you can synthesize, the information inside of it and then get some type of, useful output, and then you also have inventors that are seeking solutions, asking, LLMs to help find a particular solution, and they'll add to it. And our invention disclosures that we get, I, I typically joke and say, "Used to, it was hard to get an invention disclosure from an inventor." They would send you, like, a paragraph or two of the invention, and you'd be, "Well, is there anything else?" And now it's, they'll send you 100 pages of stuff. And like, "Well, let's, well, let's talk about what's relevant. Let's find the needle in the haystack here." So AI is, is influencing all sides of the invention from when it's coming in the door and then how, how, what the invention makeup is itself and how that's gonna be protected in the future. I, I see a lot-- In, in the future, I, I can predict or hopefully predict, there's gonna be, a lot of litigation or a lot of, like, questions about who owned what in the future for patents. So that's, that'll be interesting to see, too. [00:11:06] Lindsey Dinneen: Yeah. Absolutely. [00:11:07] Stephanie Rupp: Yeah- I think what I just want to add is, that it also changes how we work. I think in the past it was, so we had, like, these different departments. We had mechanics, e-tech, biotech, chemistry, and it was, like, very clear when you get a new patent, like an invention disclosure in which department you will push it and, like, who will work on that. But now we have, like, more these interdisciplinary inventions especially, like, in medtech, pharmaceutical companies that are using AI and, and that also changes how we work, that we are trying to then find a interdisciplinary team as well, having, like, patent attorneys from different technical backgrounds, because I'm looking at a invention disclosure differently than a patent attorney with a chemistry background. And, so that makes very interesting for us as well, 'cause we have to work together and, that's why sometime I get a call from the biotech department saying, "Oh, we have a invention disclosure with a lot of AI in there. Could you maybe help us out?" And, so that, yeah, it, like, changes our way of working in there as well. That makes it very interesting. [00:12:12] Lindsey Dinneen: Yeah. That's very interesting, and I actually love that. It seems like a lot of, ability to learn from each other in that way, and so yeah, I love that exposure. So, okay, when it comes to filing patents, and protecting your IP in general, I'm, I'm curious what your advice is for, for founders that maybe have, like, basically timeline, when should they be thinking about engaging with you all, and h- how do they go about that? Just what is, especially for these younger startup founders, what's some advice that you just, you go, "Okay, now's the time. Here's what we need," and, and whatnot? [00:12:51] Ryan Phelan: Yeah, I always advise as early as possible. Okay. usually it's-- usually most founders or startups are not thinking about patents in the beginning. But, you know, I always like to, to tell them when, when I'm speaking to a founder of a startup, think about it as insurance or similar to insurance, because at the end of the day, if you become very successful with your, medtech product, whatever it may be, people are gonna wanna copy you. [00:13:13] Lindsey Dinneen: Yeah. [00:13:13] Ryan Phelan: And, that, that's probably not only important to you, but also to your investors, if you have them. If, like, you're seeking money from others, whether it be seed money, angel money, or series A, series B the, these people are probably gonna ask you what's your moat, what's your, what's your barrier to entry for others, so if your product, takes off, because they're thinking in terms of, "How much money will I get back if I invest?" It's gonna be s- 20x. And so, it-- they know, and the startup founders should also be aware that if somebody else comes into the market, especially a big player, and they, replicate your product or your software, then that could take market share from you. And so having a patent or building that patent portfolio at the same time, it protects you, from that. It also, of course, there's times, timing, that you have to be mindful of. As soon as you disclose something in the US, it kicks off a, a one-year clock... [00:14:04] Lindsey Dinneen: Hmm ... [00:14:04] Ryan Phelan: ...for you to file something. Just to get an invention in the US, and Stephanie, can let you know about, you know, elsewhere- Mm-hmm ... and in the EU, I understand that there's an absolute bar. Yeah. But for that reasons, for that timing purpose of when someone discloses your invention, and that can be a part of a pitch deck to a set of in- investors, if you don't have a non-disclosure a- agreement, an NDA, then that could also start that clock ticking. So you wanna be mindful. Do this in parallel at the same time, seeking to get your, patent, at least a provisional patent, on file before you go forward. [00:14:37] Stephanie Rupp: Okay. Yeah, as Ryan said, at the, in Europe, we don't have this kind of this year to file a application. Once you publish something, then it's out on, out there in the world and, endangers your own patent application. Because if you want to get a patent the claimed subject matter needs to be novel and inventive. And if you have, like, published this before, then that's prior art with respect to your own patent application. So you always have to keep that in mind and, that's why it's so important to file the patent application first before you use that information for advertisement, for example. And I, we see that often, with startups, and I complete- completely understand. They're super excited with regard to their, like, great idea, and they want to shout it out to the world. But once it's out there that hinders you to get a patent. so- As Ryan said, it's good to think about patents from the beginning and also, the market you're interested in, maybe about competitors and where they're in, which countries they're involved, and then you could also think about, okay, maybe, that is a market of your interest, and then also get advice from patent attorneys in that country because it's different from which d- like, from jurisdiction to jurisdiction how to get a patent, and you want to get the broadest patent as possible. And, especially with AI inventions, where they're the requirements are so different in the different countries, it's, good to have the advice from the beginning on so the patent application is written in the right way. Because once the patent application is filed, we cannot add anything anymore, or we cannot change it. That's why it's, like, good to have really a, like, a well-written patent application also for the jurisdiction you want to go in. [00:16:25] Lindsey Dinneen: Okay. Yeah. Thank you both. That was really insightful. I'm, I'm curious about the patent application itself. Is there-- Well, two questions, I suppose. Is there also a kind of provisional patent opportunity outside of the US, just out of curiosity, as, as well as in the US? And then also, you know, you mentioned being very careful and cognizant about the way that it is written, which of course now you two being experts in this, you know, back, you know, like the back of your hand. But I wonder, if people try to do it themselves. I would love just to hear some advice about that as well. [00:17:06] Ryan Phelan: Yes. Stephanie, do you wanna talk about the provisional outside the US and- [00:17:09] Stephanie Rupp: Yeah. So in Europe, we don't have that provisional applications or non-provisional applications. what you have though is the priority year. So you can, like file an application, for example, first in Europe, and then you have a year to decide which other countries you want to go to, and then claim priority from that European patent application. So, I file a EP application, then after a year I think, okay, I want to go in other countries, I want to maybe file it, one in the US, then you can claim the priority from there. And the previous patent application that you filed will not endanger the other patent application. So that's one way of doing it, to buying yourself a little bit of time. Also, sometimes clients when they're like very cost sensitive, especially for startups, would first think, okay, we file a patent application first to Europe, and you get a, a search report within the priority year from the EPO. And then you already know the prior art that is out there, and you can assess how strong your patent application is, and then you can still decide, how to proceed from there. So there are like some ways of how you could do that. [00:18:19] Lindsey Dinneen: Awesome. Thank you. [00:18:22] Ryan Phelan: Yeah. In the US, of course, we have provisional applications. It, it causes a great, amount of confusion, though, the provisional applications. A lot of startup companies will think that they can file a provisional application and it'll be, you know, a page or two in length, and then they can wait a year and inflate that to 20 pages or, or something like this. And of course, the, the trap for the unwary is, of course, if the claims, when you draft those for the non-provisional or the conversion application, if they are not grounded in that first provisional application, if one element of one of the independent claims, for example, is, s- solely supported by the new material added in the, the new, you know, 20 pages or whatever it may be, then the support gets you the date of your non-provisional conversion filing and not of the provisional. So, usually for startup clients, I have to-- we ta- we have this conversation called the delta. What's the delta between your provisional and your non-provisional? If there's a lot of it, then, that could be a problem because if your claims aren't supported by the text of that provisional application, you're not gonna get that original date. And so, usually that kicks off a conversation of how much of a provisional that you want, or do you just wanna go all non-provisional. Now, I do litigation as well, and I can tell you, the, the, the pitfall is if you file that provisional and you file a non-provisional later and you end up getting that later date, if there is intervening prior art in between, the provisional date and the non-provisional date, that comes before your non-provisional date, that could invalidate your patent despite your provisional. And there's, parties debate this. They, excuse me, fight about this in court all the time. Now, did you have sufficient written description and enablement in your provisional application in order to substantiate your claims later? And if they can find intervening prior art between that year or whatever the time may be, that can be a real problem. So, I, I always c- I always tell clients, like, the, the more you can file up front, the better, because you're gonna get more support or more, possibility to have that support earlier in time. Of course, it takes more work. Most startups don't like to hear that, but it is, but it is the truth, and it does, it does protect them against that insurance policy. You, you add it up front. Like Stephanie said, you wanna, put that information, on file before you go out and do your advertising and marketing. That's also true in the US. Just filing a provisional application, does not in and of itself somehow protect you if, if you don't, if you don't say what it is that you're trying to protect. [00:20:48] Lindsey Dinneen: Yeah. Okay. That makes a lot of sense, and thank you so much for that insight. So you mentioned a couple of times that sort of disclosure component, and so just to d- just be very specific about that whole thing you mentioned that could be-- that could look like even just a, a pitch deck where you think it's potentially within a, a private setting thing. Of course, I would imagine that also extends to talking about it on social media or a website or something like that. So I'm just curious what are some of the things that you see besides maybe perhaps the broader, more obvious, like a website, what are some of those things that you see that people don't think to, be aware of, I guess? [00:21:34] Ryan Phelan: Yeah. I've seen websites. It's super easy to create a website nowadays. You can ask ChatGPT or Claude to generate a website, and if you're putting your invention out in a website form before you file a patent, that could be a novelty-destroying disclosure. if you have a detailed pitch deck that you give to, potential investors without some type of control, like an NDA, that could also be a novelty form of disclosure. Like in the US, for litigation, I, I can tell you one of the questions that always gets asked in discovery is, "Did you disclose this prior to the, the filing date?" And, if that person, that person will be required to answer under oath, and if they're, "Yes, I had a website," or, "I, I gave this pitch deck to 50 people for investing," usually that's a problem because that--the opposing side that's defending against that patent will do a, a deep analysis and, and look-- and try to find when that was disclosed, and does it map up to the claims, and that could, create a problem with, validity in the US. [00:22:31] Lindsey Dinneen: Oof. That's no fun. That's why they should talk- Yeah ... to you early and often. [00:22:37] Ryan Phelan: Yeah. Yes. Again, another example of filing early, you know, eliminates some of those issues. i-in fact, I tell a lot of the startup companies or any, any client, like, before you go out there and, you know, have your conference or your, your pitch, then file. Most sophisticated clients know this, but a lot of times startups do not. [00:22:54] Lindsey Dinneen: Sure. Yeah, and if you're a first-time founder or something like that, you wouldn't-- you don't know what you don't know for many different categories, so I can see why that is so critical. Yeah. Okay. So, I was wondering if both of you could talk a little bit about maybe, maybe a moment that has stood out to you as, as you've worked, especially with-within medtech and, and working with some of these founders. Are there any moments that really stand out as just affirming that, "Wow, I, I am doing the right thing in the right industry at the right time"? [00:23:28] Stephanie Rupp: Shall I start? Yeah. yes, I, I've-- So for me it was, like, never the plan to become a patent attorney and, and, like, never had that in mind. And, so it was more of a coincidence that I stumbled upon that and did the training and became a patent attorney and... But I still remember my first day in the office and having the feeling of, "Yes, I think that's what I want to do for the rest of my life." Like, continue learning, like, having, like, this incredible opportunity to speak with so many great inventors. Having, like, I don't know, it's always amazing, to see how their mind works and that they're, like, finding solutions for s- like, very complex problems. And, so that, like, from the day, first day on, I had, like, the feeling, okay, I think I can really help here and, protect their asset the best way possible. And then especially within the medtech field, I think what Ryan also said in the beginning, there's like, it's also for me, sometimes it's a kind of s- scary part thinking about, okay, what if you get sick at one point, or like from closer family that got really sick, and, having like this helpless feeling like that you maybe can't change anything here. And then when you work with the medtech industry and you see that they are working on that problem and have these great idea- to help people to like, that there's also k- some kind of involvem- like involvement in this technology. And, so for example, I, there's like one of my clients, they are, working on histological images and analyzing them also with respect to cancer types, and how AI can be such a great help there. And of course, there are like a lot of these discussions about, how we should be careful with the new technology and how we could re- regulate that and stuff like that, but there's also like so much good in there that can really help people's lives. And I think that's like for me, always very nice that yes, Ryan said we're no doctors. So like, we're just like patent attorneys, but still we could contribute a little bit to that too. Yeah. [00:25:34] Lindsey Dinneen: Love it. [00:25:35] Ryan Phelan: Yeah. I would just, I would just echo everything that Stephanie said. That certainly is why I enjoy working in this space too, is, you, you feel like you have a, a little bit of contribution that you make. [00:25:44] Lindsey Dinneen: Yeah. Absolutely. I, I couldn't agree more. I think, to your point, Stephanie, it's, it's so inspiring to see the innovation that's coming out, and it makes you feel like, especially when there's difficult world news, it makes you think, "Okay, but at least there are still these change makers who are really trying to make the world a better place and, and improve patient lives." And I think that's just a, a wonderful thing to get to witness and be a, a part of. It helps the soul. So, I'm always curious about the personal side of things as well. So just what are, what are some of the things that you all en- enjoy doing, say, outside of work? maybe some hobbies or volunteering or interests and things like that. What are... Let's, let's talk about the people as well behind these amazing patent attorneys. [00:26:36] Ryan Phelan: Yeah. everybody has a hobby, so I, I was, I like to run. I was running since high school, so I like to do that. And then, in the winter I like to ski. and then I'm, recently getting my scuba cert, with my daughter. So we're having a good time doing that this summer. So just trying to stay busy and active. I like to learn always, and so I, I, I love learning, I guess. and one of the reason why medtech is interesting to me 'cause I like to apply that, computer science skill to, the medtech field and continuously learn, in that space and also give back, like we talked about before. So, yeah, I guess I would lump in learning as one of my hobbies as well. I like... I, I'll say, and I, I'm not sure if we'll get into this later I think you had a question about, poss- if we, if we could teach one class or- No, we'll get into that ... [00:27:20] Lindsey Dinneen: Something like that. Yeah. [00:27:22] Ryan Phelan: Yeah, okay. I'll, I'll save that for a later time. So. [00:27:23] Lindsey Dinneen: Okay. Yes. Excellent. Stephanie? [00:27:28] Stephanie Rupp: Yeah, I think that's, one common thing that we have, Ryan and I. It's, skiing. That's also what I enjoy a lot. so as I said, I'm from Munich, and it's very close to the Alps, so it takes us only, like, about, like, two hours to go to Austria. and so, but I really enjoy going there for the weekend, clearing my mind. Yeah, especially when the week was very busy with work. so it's like, thinking about something else. And, besides that, yeah, spending time outside, going hiking at the weekend, like when it's... there's no snow. Also, I picked up some hobbies that I had when I was younger. So for example, I had, piano classes for, like, when I was five years old, and then once I had, like, the training and everything else going on, paused that because, like, so much else going on. But then last few years I, taught myself, "Oh yeah, it would be such a waste not to do that anymore." And, so I'm, like, started playing piano again. I'm not good in it. It's more really as a hobby. And, but yeah doing something else in the evening and clearing my mind. So that's what I usually like to do as well. [00:28:35] Lindsey Dinneen: I love that. That's wonderful. I, yes, I, I understand that sometimes picking up a hobby that you sort of set aside for a while is really fun as an adult, 'cause you have a different way of interpreting that learning, back to your point, Ryan, of how it, it it changes. And I, I actually really enjoy that, of, of revisiting something where I might have thought g- especially growing up. Like for instance, I remember thinking I just could not paint for the life of me, like it was never gonna happen. And then as an adult, with a, an instructor who was... maybe s- spoke a slightly different, in a different way, and then getting to like go, "Oh, maybe I can" is always a nice thing to learn too. But anyway. [00:29:17] Stephanie Rupp: And also taking, taking the pressure out of it. Yes. So it's like, as I said, like piano class is just a hobby. I don't have to be good in it. It's just should give me some joy in it. And so yeah. [00:29:27] Lindsey Dinneen: Love that. Yeah. Yeah, okay. So now you've both been in positions of leadership, and I'm curious, and, and I know it's hard to boil it down to maybe one thing, but what is one or two, three things that you would say is your top leadership advice, especially for those who maybe are more in, middle management trying to continue to build their leadership skills? And what, what makes a good leader, in your mind, and then maybe what's one or two pieces of advice? [00:30:02] Ryan Phelan: Yeah. What makes a good leader in my mind is something that somebody that can lead by example, I guess. On like a first project or a new client or a new matter, I like to do it, do it myself once so I can go through it and, get the feeling for the new technology, that may be at play or the new matter, maybe the client's preferences whether it's a startup or a large company. And then once I have that kind of lead from the front, then I like to do, I guess, a military word, dis- decentralized command, which is get people that I trust and who I have a great assistant. I have attorneys that I work with European attorneys such as Stephanie, and then give them work with them and give them free reign and control, whether it's a colleague like Stephanie or a associate here at Marshall Gerstein to, work with the client or have agency over, what they do, 'cause I think it can also teach in that capacity, like things that I learned from the lead from the front can flow, down or through or out and then, that person can also learn on the job doing it themselves. I believe that, people doing, instead of just listening is the, a best way to learn for them and then also get better. And so I, I tend to approach, leadership, from that perspective. [00:31:12] Lindsey Dinneen: Love that. Yeah. Stephanie? [00:31:15] Stephanie Rupp: Yes. I see myself like still more at the beginning of my career, so I can, talk a little bit more of how I, see or like, yeah, see leadership or like, how I experience it. Yeah. it's more also I... like everything what Ryan said, I completely agree. And also like seeing the person behind that. It's like everyone is like very busy, especially when you're in leadership positions and, very busy schedules and, But also seeing the person as a whole- Mm ... and how could you like support them to be better, to grow and, how to also, yeah- lead them or like, yeah, lead them in the way they w- where they want to be at some point. And, I think that's, yeah, what you should not forget e- especially when you have a really busy schedule. That's it. [00:32:11] Lindsey Dinneen: Yeah. The, the person behind... Yeah. That, that's an interesting theme that continues to come up, time and time again, is, you know, if one of the tricks to being a good leader is to care. It seems so straightforward, but it's if you care about the person and you, you want the best for them, you are going to naturally be a better leader because you're investing in them and, and in their success and goals, and, it's, it's just cool to see. Okay, and then, all right, I'm just going to pivot the conversation a little bit for fun, and this is where exactly what you were referring to earlier, Ryan. So if you were to be offered a million dollars to teach a master class on anything you want, could be in your industry, but doesn't have to be, what would you choose to teach? [00:32:58] Ryan Phelan: I would teach a class called Patenting Software Inventions and, I'm actually currently teaching that class. Oh. they're not-- I'm not getting paid a million dollars to do it, unfortunately. [00:33:07] Lindsey Dinneen: Dang. [00:33:07] Ryan Phelan: But, but it is a, a, a passion and a love. I teach it at, Northwestern Law, where I went to law school. I-- it's, it's my pleasure and joy every year to go back. I teach a power course there every year, I think for the past eight years on, teaching students how to patent software inventions in the US, and I think, elsewhere there's a, you know, there has become, by at least some people, the belief that you can't patent software, you know, which of course is, not true. And so, you know, I teach methodologies in my class about how to, patent software inventions in the US using you know, guidance from the courts, from the Supreme Court, from the Federal Circuit, from the district courts here, in the US. A lot of it covers, things such as Section 101 you know, that changed, in 2014, from the Supreme Court's decision in Alice v. CLS, and how to address, issues, about what the, the court said there. And then also what later courts, the Federal Circuit, said that they wanted to see in order to overcome, Section 101 issues, in the US. A lot of times, too, it's interesting, we have, like, a small slide like that, that deals with EPO-- which Stephanie's much more adept than, than I am-- but what we tell our students is, and maybe Stephanie can address this, is that, you know, there seems to be a convergence, between Section 101 law and, something called a technical effect, an EPO, where it seems like both jurisdictions are wanting to see more of a technical disclosure incorporated into the application rather than just kind of claiming functionally or a high level language. So you need to be very careful in crafting these applications so there's-- they're successful when you're in front of the the patent office in the US. And if you, you do it right, you can, create, you know, not only a US-centric application, but one that might, withstand, the strictures of the EPO. In my opinion, I think that the EPO can sometimes-- and maybe this is just me being a US practitioner-- but the EPO can be somewhat more difficult, to get a patent, application. Maybe Stephanie would disagree and say it's the other way around, but but it's always good, and clients usually, even if they're not thinking about it, to have an application that could survive both places 'cause they tend to be, I think, the, the two more, more difficult, if not most difficult jurisdictions in the world to get a patent application. And if you go into it knowing and how to craft a patent application and you're ready, and you put into that application the right, material, then you can be successful. [00:35:40] Lindsey Dinneen: Awesome. Stephanie, what would you teach? [00:35:44] Stephanie Rupp: Yeah, maybe we, Ryan and I, could do a master class together then because he said, like, then we could explain the similarities or the differences between, US patent law and European patent law, and can also maybe, also add something about the UPC that we have now, the U- Unified Patent Court, and have a, maybe a lively discussion about all of that and, how to get the strongest and broadest, patent in the different jurisdictions. And as Ryan said, there are, like, some similarities, and I also have the feeling when I discuss with Ryan that, when we have a patent application where we struggle to get a patent on, then we usually also struggle with that in the US- Mm-hmm ... or the other way around. And, but of course, there are, like, differences in how the EPO and how the USPTO, like examine these AI inventions and, in the US you have these 101 objections that you usually get. In, Europe it's, they apply the so-called two hurdle approach where they, especially the second hurdle is usually harder to overcome. Mm. And that's also what, Ryan mentioned, is that you have to show the EPO that your AI invention or your AI steps contribute to the technical character of the invention. And that's, often, and I totally understand that, hard to grasp for an inventor because they think we have all these technical means here. We have a server, we have a processor, we have a memory, we have sensors getting data. Do you tell me now that that's not technical? [00:37:18] Lindsey Dinneen: Mm. [00:37:19] Stephanie Rupp: And, but that's not how the EPO thinks. It's, for them, they say, "What is your motivation for that invention?" Or, or in other, more their words, "What kind of technical problem you try to solve?" [00:37:32] Lindsey Dinneen: Mm. [00:37:34] Stephanie Rupp: And that is, what we also usually ask the inventors in our f- like, first meetings with them, "What is the technical problem you're trying to solve with that, and how does the, your AI steps, your method steps contribute to that?" Because that's, if you cannot show that to the EPO, then it's very hard to get a patent on. so maybe my combined master class- yeah ... where we show that and- It, [00:37:59] Ryan Phelan: It would- ... [00:38:00] Stephanie Rupp: Explain that, yeah. So ... [00:38:01] Ryan Phelan: Definitely it would, it would help out my meager EPO slide, any additional information on this, especially the, the UPC, which I'm glad you mentioned. But, maybe, we could take a minute to talk about the UPC and in, in the European area since that's like a new, newer, from what I understand, a newer avenue, the era approach in Europe. [00:38:20] Stephanie Rupp: Yeah. Yeah. It's, so as I said, we have, like, for now three years now, the, Unified Patent Court. And, before that we also had European patents, but once it was granted, was divided into national patents. So if you wanted to, file an infringement action or a nullity action, you had to do that in each specific country. And that made it very complicated because I, I'm a German patent attorney. I don't know anything about Italian law, so you would then need an Italian patent attorney or French and so on. So it was, like, very complicated. And, so what we now have, and that is, like, very exciting to live at that time now, is, the Unified Patent Court, where it's, like, now centralized and you can attack patents at the, like, Unified Patent Court, like, for the whole patent, and you don't have to go to these before the national courts anymore. And, so that's, like, very exciting for us as well because case law is evolving now and, there's, yeah, you can see how, like, how it changes and how the judges are handling these cases and it's, like, also very, like, for us, a lot of new things to learn. [00:39:32] Lindsey Dinneen: Yeah. [00:39:32] Stephanie Rupp: Yeah. [00:39:33] Ryan Phelan: Yeah, I was gonna say, I, I also heard, and, Stephanie can certainly chime on this, that certain cities in Europe, like Paris, or Munich, may have different judges that specialize in different arts or disciplines. I think, was it, w- what Munich was, I can't remember, is that the mechanical or- Yeah. [00:39:49] Stephanie Rupp: Yeah. So that's, like, for the central division, but we also have then local divisions- Mm-hmm ... as well. So we have, four local divisions in Germany, but also in other countries. And that also, changes, of course, a little bit of how they handle the cases because the judges, they often came from the, like, the national courts. So they, like, when you're in Germany, of course, they still have little bit, little bit more of the German thinking in them. When you're going to a Dutch, local division, then they have a little bit of, like, another, like, view on that. And I think over time it will, like, unify a little bit. but these are, like, also differences that, makes it very interesting, to see. [00:40:27] Lindsey Dinneen: All right. Okay, so next question is, how do you wish to be remembered after you leave this world? [00:40:35] Ryan Phelan: I hope that people remember me as, somebody that was fun, like to, you know, either work or hang out with that regardless of whether we're working hard or, you know, playing hard, that, that it was just fun. So that, that's my only wish. So or, or main wish. [00:40:50] Lindsey Dinneen: Love it. Steph? [00:40:52] Stephanie Rupp: Yeah, I think for me that I was maybe, like, a fair and trustworthy person. I think it sounds a little bit boring, but, more when people work with me and they, like, say, "Oh, when she gave me advice, I knew that she had, like, my best interest in mind as well, and not only, like, filling her own pockets or, like, trying to, like, improve it for herself, but having like..." Yeah, when they remember me of a person that you could trust with the advice, I think that would be, like nice to know for me. Yeah. [00:41:26] Lindsey Dinneen: Yeah, for sure. All right. Excellent. And then final question. What is one thing that makes you smile every time you see or think about it? [00:41:37] Ryan Phelan: I guess just sticking with our current theme, if in a work capacity, when a client gets a victory of some type certainly makes me smile. A lot of clients are happy when they get their patents allowed, or if you win that litigation case or you, you do things, a lot of times in the US we'll, we'll have these decisions or these patents, and it it, it, it makes me smile to think that, you know, I helped their business in that way to protect their, their IP and just going forward. I, I imagine it's a pretty standard answer, but, you know, certainly in the context of this podcast, that's absolutely one thing that makes me happy. [00:42:10] Stephanie Rupp: Mm. Yeah. I'm a person, I get excited very quickly or, like, really small things make me smile already. So I arrived on Saturday in Chicago, and I, for example, didn't expect to have a gym in the hotel, and then suddenly I discovered that and was really happy about that. So these are these small things that other people say, "Oh, yeah, whatever." but I think what makes me smile the most is, like, knowing that I have a weekend ahead of me with, like, my family and my partner, and we go ski. And I say that now we have, like, summer outs and, like, very warm temperature here in Chicago. I think it's about 80 degrees, and I'm already thinking about skiing and snow, but it's, more of... [00:42:52] Ryan Phelan: It's never too early. [00:42:53] Stephanie Rupp: Yeah. But more of, like, not the skiing per se, but just having time with family and- yeah ... clearing my mind and stuff like that. So, yeah. [00:43:02] Lindsey Dinneen: Excellent. Excellent. Well, thank you both so much for being here. I've so enjoyed the conversation, and you gave so much amazing advice and guidance, so thank you so very, very much for all of that. If folks who should be looking out for services such as yourselves, how do they get in touch with you? [00:43:25] Stephanie Rupp: I think like through the website, that, I think will be- mm-hmm published, with the, podcast. And, also my email address as well. You can find me on the website, or we can also add it to the, to the podcast info. yeah. [00:43:38] Ryan Phelan: What is your... [00:43:38] Stephanie Rupp: It's the easiest ... [00:43:38] Ryan Phelan: What is your email address, Stephanie? [00:43:41] Stephanie Rupp: It... Hopefully I say it correct now. It's, S for Stephanie, S Rupp, my, last name, @hoffmanneitle.com, so very easy. Yeah. [00:43:53] Ryan Phelan: Perfect. Excellent. Yeah, same thing for me. I believe the contact information will be at the with the podcast, but I can be reached at RPhelan R-P-H-E-L-A-N @marshallip.com, and welcome any questions or comments. [00:44:08] Lindsey Dinneen: Awesome. Well, thank you both so much again for your time today. We really appreciate it. We are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. Love learning about you, about your areas of expertise, and just really appreciate you, being willing to share with us. So thanks again, and, I suppose until next time. [00:44:51] Ryan Phelan: Thank you. Love to come back. [00:44:53] Stephanie Rupp: Thank you. Awesome. Yeah. Thank you so much. [00:44:55] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

When exporting your MedTech product to Europe, should you focus everything on one market first or test several countries at the same time?That's exactly the unresolved question. We're not telling them the answer.Choosing where to start in Europe isn't simply about finding the country with the biggest MedTech market. Different countries can have very different reimbursement pathways, adoption barriers, competition, KOL support and routes to market. In this Decision Point episode, Hakeem revisits his conversation with Laurent Laffineur to explore whether your European export strategy should focus on one market, test several carefully selected countries, or start somewhere smaller where you can prove your commercial model before scaling. In this episode you'll discover:Why the biggest European MedTech market isn't automatically the best place to invest your export budget first.The advantages of testing your go-to-market strategy across two or three carefully selected European markets rather than assuming success in one country can simply be duplicated elsewhere. How customer access, adoption barriers, competition, KOL relationships and the cost of proving commercial traction can help you decide where to concentrate your investment. Listen now to discover how to approach your first European export markets and decide where to invest your MedTech go-to-market budget before committing significant resources to expansion.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

If you're planning to export your MedTech product to Europe, how do you decide which countries you should actually enter first?This doesn't assume they're making a mistake. It poses the central decision the episode helps them make.Europe may look like one export opportunity on a map, but the commercial reality can be very different from country to country. Reimbursement, clinician adoption, buying pathways, language, culture and routes to market can all change as you cross a border. In this episode, Hakeem speaks with Laurent Laffineur, founder of Prime MedTech, about how to build a European go-to-market strategy, prioritise the right export markets and start commercial preparation before you're ready to launch. On todays episode you'll discover:How to prioritise European export markets based on the factors that matter for your specific MedTech product rather than simply choosing the biggest countries. Why reimbursement, KOL support, clinician adoption, language, culture and available budget can dramatically change where your best European opportunities are.Why your European commercialisation and go-to-market work should begin during the regulatory process rather than waiting until you've received EU MDR approval and want to launch immediately. Listen now to learn how to choose the right European export markets for your MedTech product and build your go-to-market strategy before committing significant time and money to launch.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

MAPS Chief Medical Officer Charlotte Kremer sits down with Dr. Bjorn Oddens, Senior Vice President, Value and Implementation at Merck, for a candid conversation on the career-defining moments, hard-won lessons, and mentors that shaped his path — plus his view on where Medical Affairs is headed over the next decade. About the Medical Affairs Professional Society (MAPS)The Medical Affairs Professional Society (MAPS) is the leading global authority and community for Medical Affairs professionals, uniting over 18,000 members across 400+ organizations in Pharmaceutical, Biotech, MedTech, and related industries. Founded in 2016, MAPS is a 501(c)(3) nonprofit dedicated to advancing careers and elevating the Medical Affairs profession worldwide. 

Industrial Talk is onsite at MD&M West and talking to Alexander "Alex" Shaw, CEO at Archimedic about "Medtech design, regulatory and go-to-market strategies". Overview Archimedic's discussion focused on helping medical-device founders move ideas from concept through design, FDA regulatory approval, and commercialization. Core Approach Alexexplained thatArchimedicsupports three connected areas: design, regulatory strategy, and go-to-market planning.Most product failures occur because commercialization is not defined early enough; Alex estimated 70% fail for go-to-market reasons, compared with 20% for regulatory issues and 10% for design. Examples And Outlook Active Protectivesuccessfully developed a wearable fall-detection airbag belt, but had to shift from a consumer product strategy to a regulated medical-device pathway to generate clinical evidence.A smart pill case worked technically but failed commercially because insurers could not support the infrastructure needed to assemble individualized blister packs.Open question: Can medical-device startups regain sufficient venture-capital and grant funding to sustain early-stage innovation? Outline Event And Company Context AlexdiscussedArchimedicat MDNM West and described the event's growth following the pandemic. Alex's Background Background in biochemistry and drug development consulting.Later moved into medical devices because of similarities in FDA regulation and development processes.Became CEO ofArchimedicapproximately one and a half years ago. Medical Device Development Archimedichelps clients advance ideas through design, regulatory approval, and commercialization.Early attention to market demand is emphasized before committing heavily to design and development. Case Studies Active Protective: wearable airbag belt for nursing-home residents; ultimately required clinical evidence and FDA approval.Smart pill case: technically feasible, but the insurance-based commercial model was not viable. Market Outlook Early-stage medical-device companies have faced weak venture-capital and grant funding.Alexexpects renewed funding could support additional innovation and patient benefits. If interested in being on the Industrial Talk show, simply contact us and let's have a quick conversation. Finally, get your exclusive free access to the Industrial Academy and a series on “Why You Need To Podcast” for Greater Success in 2026. All links designed for keeping you current in this rapidly changing Industrial Market. Learn! Grow! Enjoy! ALEX SHAW'S CONTACT INFORMATION: Personal LinkedIn: https://www.linkedin.com/in/m-alexander-shaw-3a7076a/ Company LinkedIn:  https://www.linkedin.com/company/archimedicdevice/ Company Website: https://www.archimedic.com/ PODCAST VIDEO: https://youtu.be/ekfbquOon-o THE STRATEGIC REASON "WHY YOU NEED TO PODCAST": OTHER GREAT INDUSTRIAL RESOURCES: NEOM: https://www.neom.com/en-us Hexagon: https://hexagon.com/ Arduino: https://www.arduino.cc/ Fictiv: https://www.fictiv.com/ Hitachi Vantara: https://www.hitachivantara.com/en-us/home.html Industrial Marketing Solutions:  https://industrialtalk.com/industrial-marketing/ Industrial Academy: https://industrialtalk.com/industrial-academy/ Industrial Dojo: https://industrialtalk.com/industrial_dojo/ We the 15: https://www.wethe15.org/ YOUR INDUSTRIAL DIGITAL TOOLBOX: LifterLMS: Get One Month Free for $1 – https://lifterlms.com/ Active Campaign: Active Campaign Link Social Jukebox: https://www.socialjukebox.com/ Business Beatitude the Book Do you desire a more joy-filled, deeply-enduring sense of accomplishment and success? Live your business the way you want to live with the BUSINESS BEATITUDES...The Bridge connecting sacrifice to success. YOU NEED THE BUSINESS BEATITUDES! TAP INTO YOUR INDUSTRIAL SOUL, RESERVE YOUR COPY NOW! BE BOLD. BE BRAVE. DARE GREATLY AND CHANGE THE WORLD. GET THE BUSINESS BEATITUDES! Reserve My Copy and My 25% Discount

Are you spending too much time telling customers about your MedTech product and not enough time talking about the problem they actually care about?When you've spent years developing a medical device, it's natural to want to talk about the technology, the clinical evidence and why you built it. But your customers haven't been on that journey with you. If you're trying to commercialise or export your MedTech product, your go-to-market strategy needs to start with the problem through the customer's eyes, the value of solving it and whether that value is strong enough to make them change what they're doing today.In todays episode you'll discover:Why the story behind your MedTech product can create interest without necessarily giving customers a reason to buy.How to understand the clinical problem through your customers' eyes and communicate it using the language and outcomes that matter to them.How to determine whether the value of your solution is strong enough to overcome the effort, disruption and behavioural change required for adoption.Listen now to discover how putting the customer's problem at the centre of your MedTech go-to-market strategy can strengthen commercialisation, support adoption and give your medical device a better chance of succeeding in export markets.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Plus: French startup Mistral AI tops $24 billion valuation in latest funding round. And Boston Scientific issues profit warning after cyberattack. Imani Moise hosts. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

How do you know whether your MedTech commercialisation strategy is actually working?Regulatory approval, clinical evidence, distributor appointments, customer meetings and even your first sale can all feel like signs of commercial progress. But for MedTech founders trying to build, commercialise and eventually export a medical device, there's a difference between creating the conditions for commercial success and proving you have a sustainable business. In this episode, Hakeem uses an unlikely lesson from 90s hip-hop to explore what really counts as commercial success—and why the ability to repeat a sale matters so much.In this episode you'll discover:How to distinguish between activities that support MedTech commercialisation and the evidence that your commercial model is actually working.Why making your first medical device sale is only part of the story—and what repeatability tells you about whether you've built a sustainable business.How working backwards from the money can help you understand the decision-makers, budgets, beliefs and buying process required to generate sales repeatedly.ActionListen now to discover how to measure whether your MedTech commercialisation strategy is genuinely working and identify what needs to happen to turn individual sales into a repeatable commercial model.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

What if the biggest barrier to medtech innovation isn't the technology, buti fear? In this episode, Merom Klein explores how entrepreneurs can recognize hesitation, build trust, and move investors, customers, and teams from “wait and see” to active champions of innovation. From raising capital to changing the standard of care, Merom shares practical insights on building courage, understanding incentives, and creating the conditions for meaningful adoption. Tune in for a conversation about the human side of medtech innovation and what it really takes to change the game.Merom Klein LinkedInCourage Growth Partners LinkedIn Project Medtech Podcast Episode 249"Biotech in the Balance: Saving a Strategic Industry in an Age of Distrust" by Jeremy M. Levin "Leadership the Hard Way" by Dov Frohman and Robert Howard "Start-Up Nation: The Story of Israel's Economic Miracle" by Daniel Senor and Saul Singer Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

Dr. Andrew Holman is a rheumatologist and the CEO of Seattle-based Inmedix, which recently received FDA clearance for the first cloud-based heart rate variability (HRV) diagnostic platform. Dr. Holman shares how a “detective” mindset led him from early interests in orthopedics and cardiology into rheumatology, fibromyalgia research, and ultimately entrepreneurship. He explains how chronic stress, the autonomic nervous system, and conditions like sleep apnea and restless leg syndrome can influence cardiovascular risk and autoimmune disease outcomes, and why measuring stress biology with medical-grade precision matters. Dr. Holman also offers hard-earned advice for physician-innovators, reflects on pivotal study results, and shares what he hopes to be remembered for: never dismissing patients in distress.  Guest links: https://www.inmedix.com | https://www.linkedin.com/company/inmedix-inc Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 088 - Andrew Holman [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to be welcoming as my guest Dr. Andrew Holman. Dr. Holman is a rheumatologist and the CEO of Inmedix, a Seattle-based medical diagnostics company that recently received FDA clearance for the first cloud-based heart rate variability diagnostic platform. He has 25 years of clinical experience with 16 peer-reviewed papers and clinical trials demonstrating that measuring stress biology with medical grade precision can improve success rates in autoimmune diseases. All right. Andrew, welcome to the show. I'm so glad you're here today. [00:01:30] Andrew Holman: Yes, happy to be here. Thank you for inviting me. [00:01:33] Lindsey Dinneen: Course, of course. Well, I would love, if you wouldn't mind starting out telling us a little bit about who you are, what your background is, and what led you to medtech. [00:01:44] Andrew Holman: Sure. Well, I'm a, a guy from Seattle, Washington. Grew up here, but trained everywhere else, became a rheumatologist. We study autoimmune diseases, lupus, rheumatoid arthritis. I also was very interested in fibromyalgia and pain. We're the immunologists of medicine. So, I started my practice, golly, a while ago. 1992, I finished my prac- my training, and I was the main rheumatologist at a large suburban hospital at the southern end of Seattle. So hometown, circle back to the hometown. I went into rheumatology because you have many choices when you do internal medicine. You can go be a specialist in many things. But I like the puzzles. The immunology has grown and it's a, it's a particularly sort of detective-oriented specialty. So, I didn't set out to be an entrepreneur. That came 25 years later. I was an in-the-trenches doc trying to help the person in front of me with these devastating diseases that are crippling diseases, usually of young women mostly. [00:02:45] Lindsey Dinneen: Yeah. Okay, and I'm sure there's, there's much more we're gonna dive into, but one thing that really stood out really fast was you, you kind of called yourself a detective, which I really love that term. And so I'm curious, is that something that you always thought you wanted to specialize in, in medicine, or was this, you know, detectiving to come later? Was this something that, you know, you ended up learning more about while in med school and thought, "Oh, this sounds really cool. I could put really two interesting passions together"? [00:03:19] Andrew Holman: Yeah, it was-- you know, things just sort of come into play sometime. For those who are not in medicine, they may not realize it takes about ten years to go to college, med school, re- internship, residency, fellowship, you know, and then you, then you finally get to go be a doctor, and you have to go learn how to be a doctor s- a little more. The patients teach you a lot more than people realize. So I was gonna be an orthopedist. I liked orthopedics. I liked architecture, bones, joints. I thought it was a lot of fun. I just had very little aptitude for what they do. I, I don't-- I, I'm not very g- a good carpenter. I just, you know, I didn't-- just wasn't gonna be a great orthopedist. So then I thought, "I really love cardiology." Rhythm disturbances, all kinds of things. In the 1980s, when I was in medical school , all the new stents and procedures and non- less invasive things than bypass surgery were all coming up. Joint valve replacement. You know, it's really exciting. But I never... and I never took a, a f- a course in rheumatology until I was actually an intern in internal medicine program in Denver, all set to be a cardiologist. And there were 12 of us in the, in the program per year, and s- five of us became rheumatologists because of this one doctor who took us out, a guy named Daryl McCarter. Prob- maybe people who know him, he's retired recently. He would bring us in the office, and we'd see every other patient with him because in between the patients, he would give us an X-ray, say, "I want you to look at this. There's a clue here. See if you can find it." Or, "I want you to look at this pathology slide," or something. "There's a secret, you know, to figure this one out." And I go, "Wow, this is really fun stuff." And once you figured it out, we weren't as good at treating it yet, but we were getting better. We were getting better. So it was the cutting edge and very fertile ground for discovery. So, rheumatologists are called the consult of last resort for a reason. There aren't very many of us. You've usually seen everybody else first, and by the time they-- you see us, we're pretty good at figuring out the rare diseases that are not in other people's board exam. But we're also pretty good at figuring out the common disease that presents in a very strange way, you know? And, and that's what our strength is. So we may... Everybody who sees us who gets diagnosed may not have a rheumatology answer, but we try to get them an answer. And now we're really in the golden age of rheumatology in the last 20 years of really making a difference for so many people. The downside, we don't make a difference for enough people, you know? We, we... That's the problem. So we've got these very motivated doctors out there, eager, and we just need, you know, more. And that's why I became an entrepreneur, because I learned more neurology than I was supposed to know and more sleep physiology than I was supposed to know. You just follow the breadcrumbs, you know? [00:06:17] Lindsey Dinneen: Yeah. Okay, so I know you didn't start out wanting to, or maybe even being interested in being an entrepreneur, but that is the path that you chose, and I would love to hear about that, the company, and what you're all doing. And then also would love to hear about your journey into deciding that this is the next right step for me. [00:06:38] Andrew Holman: Yeah. Well, thanks for asking it. It is a little unusual. So I was actually studying and trying to help patients with fibromyalgia about 30 years ago. And fibromyalgia patients terribly dismissed till they're all making this up. There's not 10 million people that can make anything up and be consistent. I mean, they all say the same thing. So I thought that was nonsense, and I was really thrown into the crowd of, you know, "You're, you're crazy too." And I go, "Well, I'm board certified in crazy." So I w- I was interested in it, and I was irritated that these people were dismissed. And I was around other doctors in Seattle who were similarly that way, which was very, very unusual. It's unusual to find people in the '90s who had an avid interest in that disorder. And so I started doing what rheumatologists are good at, incrementally advancing ideas and therapeutics very carefully, very cautiously. We do a lot of things off-label. When I was-- finished my fellowship in 1992, half the diseases on our board exam had no FDA-approved treatment. We had to do something, right? You couldn't just say, "Well, come back when there's a couple of articles in the New England Journal of Medicine." You, you can't do that, right? People are depending on you. So rheumatologists are particularly good at that, and that's not something most doctors want to do. Most doctors find that very uncomfortable. They're very, very careful people. And, and rheumatologists are careful too, but we take this mission seriously that we need to do something for you. So basically, I was looking at off-label ideas and work on fibromyalgia, and I'll share this with your audience. I was actually pulled up-- pulled in by some senior doctors who said, "We wanna talk with you." And I'd been there about three years as a new doctor. Oh, you know, seem to be doing a good job. Maybe they wanna pat me on the back or something. No, not that. It was actually an intervention, which I had never... I mean, I had no familiarity with what an intervention was. And they said, "Look, we like you. You're a great doc, but you're gonna ruin your reputation if you believe all these people, mostly women And you really need to not take it so seriously or write prescriptions for this c-- this and that." I said, "Well, thank you very much." That's polite. That's not what I was thinking. And I, I... But it prompted me to pull all the charts and say, "You know, I think I'm making some progress here with some ideas here, and let me see if I'm getting fooled and just seeing the people who get better to come back. Let me really honestly look at my performance." And so I pulled about 200 charts. It was my first abstract at the national meeting. And you know what? We were making progress. That had morphed into more progress, following the breadcrumbs, looking at neurology, looking at the autonomic nervous system. So that was about a five-year process. Y-you know, I didn't lose my reputation, obviously. I lecture around the world now. But it led to being very careful about getting clinical evidence if I had a hypothesis. And so we were using the office, and we actually finally did a double-blind prospective study where I bought all the drug myself, had it reformulated, little capsules that, you know, and, and worked with the FDA to get permission to do the study. And that study in fibromyalgia to this day has the highest response rate of any fibromyalgia study for pain that's ever been done. Now, we don't use that treatment anymore. It's 20 years later, we have other things to do. But it did prompt Pharmacia, got bought by Pfizer, I believe, and Boehringer Ingelheim, which co-marketed the drug I was using and reporting on, to pay me $10 million for the patents that I had filed, utility patents. I didn't own the drug. I didn't use it for Parkinson's disease, but I thought there was use in fibromyalgia. So before I told the world, I filed utility patents, and they wanted to exploit that discovery. So did two other pharmaceutical companies, and they had to pay for the privilege of doing it. So at 46, I retired. So I didn't intend to do that, but I do come from a family of lawyers and judges, and so the idea of having a utility patent on a n- a new innovative idea was not a foreign concept to me. [00:10:40] Lindsey Dinneen: Yeah. [00:10:41] Andrew Holman: That is something I teach all young doctors. [00:10:46] Lindsey Dinneen: That is awesome, and I, I was thinking, okay, this is a great segue because first of all, that's an incredible story. Secondly, I, I would be very curious to know exactly that, what is your advice for some of these incredible physicians, great ideas, that are potentially going to end up becoming an entrepreneur just because that's the path that, that is sort of presented to them? What is some of your advice for that? 'Cause that can't just be... you, you had the privilege at least of, of, of knowing and having some background in that, the legal aspects of IP protection and whatnot, but what are some of the things that you tell people? [00:11:22] Andrew Holman: Well, a couple things I would say and I have these conversations often 'cause I really like the younger people coming along. I say, first of all, don't define yourself as an ent- as being an entrepreneur. Make sure you have other things in your life that are more important to you. Now, the investors are not gonna like to hear that. They, they want you to live and die on your, on your company, right? But I'm saying, you know, you don't have to tell the VCs, but have other things that matter more in your life. You still gotta work really hard because you may, you may find that it's really a slog, and it's very long, and it's very hard. But, you know, make sure that, that, that what you-- though is important, your family, you know, your integrity the scientific problem at hand, the patients, you know, they're number one. Make sure we don't lose sight of all that, and do a few things. Go for a walk. Do something for yourself. Something. I do this twenty-four seven for the last 10 years, you know, every day 'cause I love doing it. It does wear you out, though. Even if you make-- even if you're successful with milestones, it does wear you out. But that's what I tell them. I say, "You know, make sure that you take care of yourself a little bit, too." It's kinda like a analogy. What do you do for a pregnant woman who has a, who has a, a lupus? Lupus is terribly dangerous for the fetus and for the mom. Though the worst thing you do to-- for the baby is not take care of the mom. Take care of mom, [00:12:44] Lindsey Dinneen: Mm-hmm. [00:12:45] Andrew Holman: then get the baby delivered. So, you know, everybody's talking about the baby, but take care of mom. That's the most important thing you do for that baby. So that's kinda what I would say. [00:12:54] Lindsey Dinneen: Yeah. Yeah, that's great. I appreciate that. Yeah, that, that makes a lot of sense too. We've been talking, actually it's been a, a bit of a theme too lately in some of the conversations that I've been having with folks, especially leaders, to talk about that identity component and, and be aware that your job isn't the only thing that defines you or needs to. There's a lot more to your life. There's a lot more to who you are. And so also, you know, our identities change over time and how you refer to yourself and th- those are, those are good things. That's growth, that's movement. So, being comfortable with who you are outside of your career. Yeah. [00:13:33] Andrew Holman: The other thing too is, you know, people used to joke 20 years ago that participation mem- medals were like a farce and what. That's the l- that's the last thing I would say to anybody. Give yourself a pat on the back for going out there trying to attack the castle, you know. Give yourself some credit there because a lot of people just wouldn't do it. My middle daughter was a hundred-meter hurdler at Boise State. She's a Division I athlete. There's a lot of sprinters out there that don't wanna get anywhere near that hurdle 'cause it really hurts when you hit it, right? And so half of that was not-- was being brave. So be brave, be brave, you know. My other daughter was a Division I athlete at Rice. She was a h- she was a volleyball player. Yeah. So, yeah. So I, I, I, I watch other people, see how they persevere and, you know, okay, gotta pick yourself up. Gotta go. Gotta get up this morning. Gotta go. [00:14:23] Lindsey Dinneen: That's right. That-- Yeah. [00:14:25] Andrew Holman: Then remember, people are depending on you, not just your investors. I take that so seriously. But the s- the people who have decided that they're gonna hook their wagon to you. [00:14:34] Lindsey Dinneen: Yeah. [00:14:35] Andrew Holman: You know, that's a lot of responsibility. [00:14:37] Lindsey Dinneen: It is. Yeah. [00:14:38] Andrew Holman: Give yourself a little credit that you're stepping up. [00:14:41] Lindsey Dinneen: Yes. Great advice. Yeah. Okay, so all right. So let's talk about your company now. So now you're an entrepreneur, in addition to obviously the rest of who, what makes you, you. But and I know that you're also a clinical professor, and I would love to hear about both of those things if you don't mind sharing. [00:14:59] Andrew Holman: Yeah, sure. So, technically I'm an associate clinical professor at the University of Washington. A, a lot of private docs do, and they participate in helping teach the y-young residents and fellows and so forth. So it's a joy to me. I, I think my job is a job of teaching. I'm constantly talk... I'm not-- I don't see patients anymore, although I do maintain my license in malpractice 'cause I get, I get contacted for the fibromyalgia work I did. So it's, my email's on the papers, right? So I, I don't wanna let that go. People need help. But basically, we're constantly teaching patients, you know. Now, we're listening, hopefully do better and better at that, but then I have to make a case. You know, I'd, the-- I'd like you to try this or that. Why do I wanna do that and so forth. We're constantly, you know... We don't-- It, it sounds too trite to call it selling something. We're not doing that. We're in there with you. We're collaborating. But I have to be, I have to have a reason and be persuasive and all that, so that, that academic teaching part's kind of fun. Now, sometimes I go into the lion's den. I will tell you, it's a little nerve-wracking to give rheumatology grand rounds at Harvard. Yeah, yeah, okay. You know, and the University of Washington, they're a little friendlier. It's my hometown. But Guy's Hospital in London and the Hospital for Special Surgeries, I... My first rheumatology grand rounds came at the HSS in 2009. I get there, I completely bomb. All these famous people are in the front row. I'm... They're, they're just not buying any of this thing we call immunoautonomics and how stress affects the immune system. I'm quoting the NIH. I'm doing everything I... I know how to do it, right? Pathology slides, I'm there. Then I find out the way they pick the speakers is the fellows get to find something interesting, and they pick the speakers, not the not the high mucky-mucks. So the only reason I was there is because the fellows, the young folks, thought, "This is an interesting topic. We'd like to hear more." And it turns out they were 15 years ahead of the rest of the world, because this is the most fascinating topic of how the immune system affects the autonomic nervous system affects the immune system, so it inflames it. [00:17:03] Lindsey Dinneen: Yeah. Oh my gosh. Actually, that is one thing I wanted to talk about, 'cause I, I noticed on your LinkedIn profile there was, you know, a reference to how much stress affects cardiovascular health maybe particularly chronic stress. And I would just love to hear more about that and, and maybe some ways... I know there's like, y- of course you always get your standard, "Here are some things that you could do to lower your stress." But, but from your perspective as a physician who's studied this, I'd love to hear more from you about, okay, how does this affect health, especially cardiovascular health, and then really what are some practical things that we can do? [00:17:39] Andrew Holman: Yeah, let me see what I can do. Now I wish I could fast-forward because we will have some magnificent things in the next five to 10 years based on what's being discovered now. But the bottom line is, stress and pain are awful things, but they have a purpose in the near term. So pain is good because it'll keep you from putting your hand back in the fire, right? Just don't do that again. But chronic pain is terrible and not productive. Stress is the same thing. You wanna get away from the lion. You, you, you need to perform. If your child needs you, whatever, you, you need to perform on it instant. But chronic stress is not productive. The problem with the stress response is it's controlled in the brain by the autonomic nervous system, which is called the ANS, and it's divided into two components, the sympathetic fight or flight, which we all know what that feels like. You know, ooh, scary. And the other is the parasympathetic, which is getting more talk now, which is the opposite, which is related to rest, restorative, sleep, recovery, growth hormone, all these things. And both of these systems are on simultaneously all the time, but they jockey for predominance depending on what the demands are around you, right? So turns out the sympathetic part has a significant negative impact on cardiovascular health, as you might expect, right? If you're driving your car at five thousand RPMs-- now, nobody has a stick shift anymore-- but if you're driving at five thousand RPMs, you're gonna wear down your engine, even if you go at the same speed as someone who has a two thousand RPMs, right? It, it's, it's what's going on inside the hood there is really important. So stress responses chronically do have measurable, tangible, well-published effects on cardiovascular mortality in long prospective studies. So if we had a magic something, we would do something to lower that epinephrine adrenaline response. Unless, of course, you're in the military, where someone's-- you need every heightened, m-- you know, response that you can get to survive. But for the rest of us, it's better that that system does not ramp up and activate. And we all have a different propensity to how powerful it is and how much it turns on, and also how poorly it turns off. So the stress response, we think of it like epinephrine, adrenaline. That's the easiest way to do it. So what you'd wanna do is to make sure this magnificent part of your brain that is your-- does all your housekeeping functions, this autonomic nervous system, the command and control center that you just wanna work, you don't wanna think about it, is not on a turbocharged, right? And there are people I take care of that they were just born that way. A lot of them, by the way. So things like all the wellness opportunities you can think of are, are targeted just to simply calm the autonomic nervous system. Tai chi, meditation, diet, exercise, all these things have been around for thousands of years because of that. That's what they do. And the practitioners will share that with you. I mean, the there are monks that can lower their heart rate, you know, to like, you know, what would seem lethal to the rest of us, right? That's the parasympathetic drive that lowers heart rate, lowers blood pressure. So those wellness opportunities are real. It will be important that you can manage whether the-- what you're doing is working or not. [00:21:04] Lindsey Dinneen: Mm-hmm. [00:21:04] Andrew Holman: Right? And that's where my company comes in. But the other is things like obstructive sleep apnea. You might think heavy guys... See, someone's gonna send me for a sleep study for sure, but they're not gonna send you. Big mistake, because it turns out that fifty-three percent of Japanese women with rheumatoid arthritis have unexpected obstructive sleep apnea. Oops. And, and we were just taught that we wouldn't even check those people. Well, turns out sleep apnea untreated is a major cardiovascular risk factor equal to cigarette smoking, according to the Sleep Heart Health Study in 2004. That's a big deal. And also, we learned in rheumatoid arthritis, getting back to my work, world, that patients with rheumatoid arthritis don't die from joint disease, they die from premature heart disease. They can also get cancers. So why is that? Well, there's been a lot of effort to try to figure that out in the last twenty-five years, and their risk factors for cardiovascular disease are not explained by the Framingham risk factor of hypertension, cholesterol, smoking, and all the things we, we look, see. But nobody looked at sleep apnea. [00:22:15] Lindsey Dinneen: Mm-hmm. [00:22:17] Andrew Holman: The other reason it's so relevant, though, is sleep apnea is a potent sympathetic arousal. It, it-- You struggle to breathe, right? You kind of obstruct. And what part of your brain tells you to breathe? Your autonomic nervous system. Breathe, right? And it stimulates this adrenaline response over and over and over, and it pounds your heart over the years, and it can lead to sudden death and arrhythmias. So there's a, there's a link there. Never miss sleep apnea. The other one is we found in our office and published about restless leg syndrome. You know, people tap their toes in the airport or they kick the covers around at night. It's pretty benign for most people, but it looks like it very well might be a sympathetic arousal, and there may be relevance there. The therapies for that may have relevance to what we're talking about. Again, very off-label. We're not talking about FDA-approved here. But it-- You ask what can you do? The other one that's coming is vagus nerve stimulation. That is FDA-approved now for rheumatoid arthritis, and they're going to other opportunities to, again, to, to increase the parasympathetic and to lower the sympathetic, right? So that background activity doesn't harm you. The autonomic nervous system may be the primary reason that two patients respond differently to the same treatment. What you bring to the table. It's no different than if I have two people coming to me for a back problem. One is five foot three and one is seven foot three. The way their spine is designed makes it a whole lot harder to treat the seven-foot back, right? I'm not surprising anybody here. So there are things that the patients can bring to the table that matter. Here's the irony. Ninety-seven percent of patients with rheumatoid arthritis in a survey in England said that stress affected their disease activity. It's no surprise to them. And sixty-five percent said they thought it predated getting the disease, that it actually contributed to getting it in the first place. And now there's evidence to suggest that may be true. [00:24:17] Lindsey Dinneen: Oh, boy. [00:24:19] Andrew Holman: So we can't miss sleep apnea just out there. We can't miss restless leg. We can't miss Ehlers-Danlos type three hypermobility type where people can... you can't see me here, but my fingers can bend backwards. But it's, it basically it's very, very common, and those people tend to have increased sympathetic activity naturally. [00:24:39] Lindsey Dinneen: Fascinating. [00:24:39] Andrew Holman: So yeah, so we're, we're waking up a little bit to some very important features here of individuals that may help us do better with the diseases they also come in. [00:24:50] Lindsey Dinneen: Yeah. Wow. [00:24:52] Andrew Holman: Sorry, long answer. Sorry, but there's a lot. [00:24:54] Lindsey Dinneen: No, that's great. I appreciate it, and yeah, well, then there you go. Managing stress is critical to, to your health. It's not just a nice to have, like yeah, yeah, kind of thing. Okay. Whew. [00:25:07] Andrew Holman: Good learning. [00:25:08] Lindsey Dinneen: Okay, awesome. Yeah, so, I'm curious... Okay, so, so again, I like, I like looking at guests' LinkedIn profiles and, and learning more about, you know, what makes you tick outside of your career as well, and I noticed some very fun things that you have listed. So we've got creative writing, horsemanship, golf, and vintage passenger rail cars. I feel like this warrants... [00:25:33] Andrew Holman: Yeah, it's called... Yeah, the American Association of Private Railcar Owners. Yeah. I get ribbed a lot for that, but they're a great bunch. There are about --I don't know if I know all the numbers now, but about 75 to 80 vintage cars from the '20s, '30s, '40s, '50s, who tag on the back of Amtrak, and Amtrak drags them around, and you can actually go rent them, stay in them, whatever. And they have a a annual meeting where they just get on a private train, and they go on tracks that you wouldn't go on naturally, like private rails in the, you know, middle of nowhere. So that's what they like to do. And it's just a lot of fun, especially the dome cars. [00:26:12] Lindsey Dinneen: Okay. That's so cool. [00:26:14] Andrew Holman: I've been a handful of times. I've got a lot of friends there. I don't own a car, but boy, I'd sure like to have one. [00:26:19] Lindsey Dinneen: Yeah. Okay. That is so cool. And then how about horsemanship? How did you... Have you been riding horses your whole life, or how did that come about? [00:26:29] Andrew Holman: So I went to a high school called Thatcher School in Ojai, California, where there are 50 in a class, and there was a requirement, this is over 100 years old, this school, that you had to have a horse. And they would say s- that something about the "outside of a horse is good for the inside of a boy," right? I was the last all-male class in 1977. Now young women get to go there too. It's of note that I have 15 people from Thatcher investing as family and friends in, Inmedix. So, th-they that, that's pretty special. But it's a boarding school. I was there for four years. My dad had gone there, so I'd heard of it. But I got a tremendous education. Th-there aren't a lot of prep schools on the West Coast, but there are some. And, and that's where I learned how to ride a horse like riding a bicycle. My sister is a thoroughbred horse trainer for 40 years. She's retired. She had three or four or five horses, a har-- not the fancy kind of stuff at the Derby. But they, you know, get up at 4:00 a.m. and ride, you know, that kind of... Tough life, but she loved horses. So yeah, I, I'm as, I'm more comfortable on a horse than I am around anything, probably. [00:27:34] Lindsey Dinneen: That's so cool. Okay. Well, this has been really fun to, to get to hear your incredible life story so far, and I'm excited to see where the company continues to advance medical technology. So, you know, I really appreciate everything you're doing. But I do want to ask, is there a moment that stands out to you along your career path so far where you just thought, "Wow, I am in the right industry at the right time"? [00:28:02] Andrew Holman: Yeah, I'd, I'd say there probably was. When we unblinded the prospective double-blind study that we did looking at this five-minute next generation heart rate variability, this HRV we got through the FDA last year. When we unblinded the study, and although that's not part of the FDA clearance, it was a very important moment for me because it showed that it predicted a year in advance who would respond to treatment of rheumatoid arthritis with ninety percent sensitivity, ninety-five percent specificity. So I wanna emphasize that is not what it's cleared for. It's cleared as an HRV tool that doctors can use at their discretion. But that study is what you asked me to answer. And when you unlock a study and you see the results, two things happen. One is we were happy that I was on the right track. That was nice. You know, positive study. Your hypothesis is valid. But it completely changed the view of immunology, [00:28:58] Lindsey Dinneen: Hmm. [00:28:59] Andrew Holman: Because we would have a test now that could measure the autonomic nervous system with exquisite precision. Nobody cared except me. About 10 years ago, we were waiting for better biologics, the things on TV, right? They asked, "Ask your doctor if it's good for you." Nobody realizes that they work about twenty-five percent of the time in terms of disease control. That's a big gap, but it looks like it's the brain that monitors inflammation. The inflammation the immune system is not firewalled against everything. The brain c-controls it, and it's not the endocrine so much with cortisol, it's the autonomic that works in milliseconds that, that epinephrine response. So that's a... You know, you're pretty nervous when you un-- when you-- someone tells you, "Okay, here is the results." [00:29:48] Lindsey Dinneen: Yeah. Wow. [00:29:50] Andrew Holman: And, and, and that was it. And then it turned out in 2015, the other moment was when I was going through the airport at Seattle and I saw the cover of of Scientific American, Bioelectric Medicine, Setpoint Medical's vagus nerve stimulation, hacking the the vagus nerve to fix the autonomic nervous system to reduce the burden of rheumatoid arthritis. I go, "Okay, now it's time." We had the patent on it. Okay. Ten years forward, we're where we are now. We're launching in June, and we have a software juggernaut here and a literally a vital sign. So, th-the doctors decide what to do with this, but we've put it in their hands, and it's paid for by insurance. So yeah. [00:30:34] Lindsey Dinneen: Amazing. Well, that's, that's so cool. Congratulations on that. That's fantastic. Okay, so to pivot the conversation a little bit just for fun, [00:30:43] Andrew Holman: Hmm? [00:30:43] Lindsey Dinneen: imagine that you were to be offered a million dollars to teach a master class on anything you want. What would you choose to teach? [00:30:53] Andrew Holman: Well, I, I learned that you've all had professors that didn't probably know as much as they should about a subject, but they thought it was just fun. I would probably stick with what I know. So I would do a master class on fibromyalgia because you can actually treat it. And there's published data, but it's very-- it's not widely known. We will be using Inmedix and autonomic testing to do research to validate and get that problem finally solved and put to bed. And then the other is this thing called immunoautonomics. It, the term-- I made up the term 15 years ago. It's in the medical literature. So that's what I would teach. Teach what I know. [00:31:27] Lindsey Dinneen: I love that. Okay, excellent. And how do you wish to be remembered after you leave this world? [00:31:34] Andrew Holman: Well, I, you know, it all come... I define myself by what the patients, how they do and what they say. It's not about five stars and all that, you know, you know, there's plenty of those. But it's, it's... I made a, a commitment if somebody says anything about me, I made a commitment when I was a rheumatologist with all these mostly young women upset, that I would never leave the room with them crying. Didn't matter how far behind I was, didn't matter. We went through a lot of Kleenex. There's a l- it's devastating to get these diseases when you're a young woman. And they can put that on my tombstone, not to dismiss people. We had a saying in the office, "It's gotta be something." You know? It's, it's always something. Drives me crazy when doctors will say, "Oh, that's nothing." Well, well, first of all, we know it's not nothing. It, it is always something, and there's something that defines your success, and there has to be things that define your failure. So let's figure out what the something is, but let's not argue that there's nothing there. So let's not dismiss people who are frightened and worried, and maybe they don't tell the story as clearly as we'd hope. But you know what? It's not, it's not their fault. They're in distress. It's amazing what people are like after you help them with their chronic pain. [00:32:45] Lindsey Dinneen: Yeah. Yeah. That is really cool and makes so much sense. Yeah. Thank you. Okay, and then final question: what is one thing that makes you smile every time you see or think about it? [00:32:59] Andrew Holman: It's making me smile right now. When I talk to the young fellows that are in their training and they're finishing up, so they've done three years or four years of medicine, three years of internal medicine after that, and then they do three or two, three, four years of rheumatology, and then they're gonna go out, I tell them how jealous I am of what they're gonna see. The, the last, the last 40 years we had these young men mostly coming in with terrible weight loss and immune systems, falling apart, and these strange tumors, and they're dying of, of infections like yeast and candida that, you know, everybody did fine with, and it was HIV, right? It had to be figured out. Now HIV is a chronic disease. It's like diabetes. We had so many people die in the '80s. Hepatitis C was... You'd have liver enzymes up, and it wasn't hepatitis A 'cause we could test for that, and it wasn't hepatitis B 'cause we could test for that. So we just called it non-A, non-B. Literally, that's what we called it. And then that got to be called hepatitis C, right? 'Cause it was too embarrassing to call it n- what it wasn't. And now hepatitis C is curable with antiviral agents in, like, three weeks. I mean... And then the biologics showed up. They're not perfect, but they were a big step. And then this immunoautonomics and, and understanding how pain and sleep and the autonomic nervous system work. I'm just really jealous of what those young clinicians are gonna get to see. [00:34:27] Lindsey Dinneen: Yeah. Yeah, that's really... Yeah, I can see why. But it sounds like you are, you know, keeping, keeping your what, what would they say? Like, toe in the water or something so that you're able to, to watch some of this as well and be a part of that next [00:34:40] Andrew Holman: I feel like I'm a ne- I feel like I'm neck deep and I'm just hoping I don't go down any lower. [00:34:47] Lindsey Dinneen: Fair enough. [00:34:48] Andrew Holman: 'Cause I have to find a way to pay for it. [00:34:50] Lindsey Dinneen: Oh, yeah, yeah, yeah. The details, you know. Yeah, yeah. [00:34:53] Andrew Holman: You got those details, yeah. [00:34:54] Lindsey Dinneen: Yeah. Oh my gosh. Well, this has been an incredible conversation. I really appreciate your time today and sharing your insights and, and stories and, yeah, I'm so excited to see the future of medicine, and I appreciate perspectives of, like yours, where you just, you share a lot of hope and optimism, and you're actively working to change lives for a better world. So, thank you. [00:35:16] Andrew Holman: Yeah, I, I irritate a lot of people with that optimism, but I'm sorry, it's just there. I can't fix it. [00:35:22] Lindsey Dinneen: Brilliant. Well, I love it. It makes my heart happy, so thank you so much again, and I hope you have the best rest of your day. [00:35:31] Andrew Holman: Thank you so much. Thanks for having me. [00:35:32] Lindsey Dinneen: Of course. [00:35:34] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

How do you know which international markets actually give your MedTech product the best chance of success?This avoids the problem we've discussed before: it doesn't tell the listener what they're doing wrong. It opens the question the episode answers.When you're ready to export your MedTech product, it's tempting to start with the biggest healthcare markets, the fastest-growing countries or places where you already know distributors. But the right export market for one medical device could be completely wrong for another. In this episode, Hakeem explains why effective international market selection starts by understanding your product, what drives adoption and the specific commercial conditions that need to exist in each market before you decide where to expand. In todays episode you'll discover:Why the biggest or most attractive-looking international market isn't necessarily the best export opportunity for your MedTech product.How factors including clinician adoption, competition, evidence, reimbursement, pricing, buying pathways and your commercial model can change which markets you should prioritise. How to assess both market potential and your probability of successfully entering it, rather than choosing countries based on market size alone. Listen now to learn how to choose the right export markets for your MedTech product by focusing on where you have both an attractive commercial opportunity and a realistic probability of achieving adoption.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Everyone is racing to add AI to healthcare. But what if the bigger problem isn't adopting AI… it's the fragmented systems underneath it? In this episode of Med Tech Gurus, we sit down with Nader Fathi, serial entrepreneur and CEO of Enlil, to explore why the future of MedTech innovation may depend less on adding more intelligence—and more on creating integrated foundations that allow innovation to scale. With decades of experience spanning AI, big data, IoT, and regulated product development, Nader makes a compelling case that many MedTech companies are solving the wrong problem. While others rush toward AI tools, he argues the real risk is fragmentation across compliance, engineering, quality systems, and manufacturing—creating hidden vulnerabilities that slow innovation and threaten scale. We explore why integrated compliance is becoming a strategic advantage, how private AI models and agentic AI may reshape product development, and why "customers, customers, customers" remains timeless advice for founders building scalable companies. From FDA readiness and change control to product-market fit and investor storytelling, this episode is a masterclass in moving from product innovation to enterprise execution. If you're interested in AI in healthcare, MedTech quality systems, regulatory strategy, SaaS for medical devices, or startup scale-up strategy, this episode delivers a powerful blueprint for building innovation that lasts.

Your medical device has regulatory approval, clinical evidence and manufacturing in place but does that actually mean customers are ready to buy it?This doesn't diagnose their problem. It challenges the assumption that the three green ticks automatically equal commercial readiness.A MedTech product can be completely ready to launch and still not be commercially ready to sell. Before spending heavily on salespeople, distributors, exhibitions or new export markets, you need to know whether customers have genuine demand, how your medical device actually gets bought, and what could make adoption harder than expected. In this episode, Hakeem explains how to assess your commercial readiness before scaling a go-to-market strategy that may not yet work.In this episode you'll discover:How to distinguish genuine customer demand from positive feedback and interest before investing heavily in commercialisation.Why understanding the complete buying pathway—from clinicians and other decision-makers to evidence, procurement and budgets—is critical to turning interest into revenue.How to identify adoption friction and stress-test your go-to-market model before adding more salespeople, distributors or export markets.Listen now to discover whether your MedTech product is genuinely ready to sell—and what you need to fix before investing more money in commercialisation, adoption and international growth.Message me via DM on LinkedinTake the CPI Quiz to see how commercially ready your product isThis podcast is for clinicians feeling stuck in turning medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, and to scale up their international sales in MedTech.

What if quality management could be the key to driving medtech innovation, not holding it back? In this episode, Ashkon Rasooli, Founder and Principal of EnGenius Solutions Consulting, breaks down how medtech companies can build quality systems that go beyond compliance to support innovation, efficiency, and long-term growth. The conversation dives into the challenges of keeping quality and regulatory strategies ahead of rapidly evolving technologies like software, cloud platforms, and AI, while exploring how companies can avoid costly mistakes, scale effectively, and prepare for the complexities of entering the U.S. market.Ashkon Rasooli LinkedInEnGenius Solutions LLC LinkedIn "Never Split The Difference" by Chris Voss "Million Dollar Consulting Toolkit" by Alan Weiss Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

In this episode of Medsider Radio, we sat down with Deanna Harshbarger, CEO of Cala Health.Cala Health developed the Cala kIQ® System, a prescription wearable therapy for action hand tremor.Deanna holds a degree in chemical engineering and brings more than 20 years of commercial medtech experience to Cala. Before joining the company, she held senior leadership roles at Johnson & Johnson, Boston Scientific, and Medtronic, and helped develop and commercialize technologies across interventional cardiology, neuromodulation, and diabetes care.In this conversation, Deanna shares how she empowers leadership teams to execute, building clinical evidence step-by-step, how patient observation shapes product development, and why raising capital is both a sprint and a marathon.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Deanna Harshbarger, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:34) - Deanna's journey from J&J, Boston Scientific, and Medtronic to Cala Health (08:16) - How Cala personalized therapy around each patient's unique experience (11:53) - Operating lessons Deanna carried from strategics to startups (22:27) - The unboxing interview that changed Cala's product design (29:16) - How Cala balanced feasibility studies, RCTs, and real-world evidence after its commercial launch (34:33) - Years of clinical evidence helped Cala win reimbursement for a new therapy (38:52) - The case for holding back when you're ready to commercialize (44:30) - Why fundraising is both a sprint and a marathon

Chelsea Cornelius is an award winning Australian biomedical engineer who is focused on improving women's health by developing innovative medical technologies such as PeriCoach. Designed by women, for women, this FDA- approved pelvic floor training platform is wireless enabled and delivers real time biofeedback and clinically proven results to strengthen women's pelvic floor muscles and improve bladder control.  As the CEO of Stratos Medtech, Chelsea joins the podcast to tell us about the challenges and rewards of her medtech start-up journey, from building clinical evidence, setting up device manufacturing in Maryborough Queensland, meeting with payers and insurers, to expansion into the US market. She also shares insights into why she has joined AUScelerate international trade mission(s) to The Medtech Conference in the US and how her experiences as part of a delegation have been so beneficial.Chelsea serves on the Board of the Medical Technology Association of Australia and Chairs its Women in MedTech Committee.More information for women and clinicians at www.Pericoach.com

If you had £500,000 to enter the US with your MedTech product, where would you spend it first?For clinician founders looking to export a medical device to the US, the size of the opportunity can make it tempting to think big from day one. But entering the US MedTech market and scaling across it are two very different decisions. In this episode, Hakeem and international growth and commercialisation consultant Craig T. Ingram explore whether you should build a US sales team, appoint a distributor, raise more capital or prove your commercial model in one defined market segment first. In this episode you'll discover:Why treating the US as one enormous MedTech market can lead to expensive commercial and export decisions.How proving your commercial model in one defined US customer segment can help you understand acquisition costs, adoption pathways and whether your product can actually make money before you scale. Why hiring a sales team, appointing a distributor or raising more capital shouldn't substitute for first understanding exactly where, how and why your medical device will sell in the US. Listen now to discover how to approach US MedTech market entry, prove your commercial model and make your export budget work harder before committing significant capital to scaling.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Howie Chan is an influence strategist, branding expert, and marketing consultant who specializes in the psychology behind human decision-making. After losing a $10 million pitch early in his career, Howie became obsessed with understanding the invisible forces that shape behavior, communication, leadership, storytelling, and negotiation. Today, he helps MedTech companies and professionals build stronger brands and attract better opportunities by applying behavioral science and influence psychology. On this episode we talk about: The $10 million pitch Howie lost and how it sparked his obsession with influence psychology How getting laid off after 20 years in the corporate world pushed Howie into entrepreneurship Why experts should use LinkedIn to build a professional brand and attract opportunities The difference between a personal brand and a professional brand—and why solving problems matters more than follower counts How podcasts, strategic associations, and social proof can build trust and accelerate your influence Top 3 Takeaways Turn failure into a learning opportunity. Instead of dwelling on a loss, ask, “What do I not know?” and figure out what you can learn to prevent the same mistake from happening again. Make your professional brand clear, not clever. Your LinkedIn profile should immediately communicate who you help and what problems you solve. Focus on the quality of opportunities you attract rather than vanity metrics like follower counts. Build influence through a flywheel of visibility, trust, and association. People first need to notice you, then remember you, trust you, and ultimately choose or recommend you. Podcasting can accelerate that process by allowing you to consistently demonstrate expertise and associate your brand with respected experts. Notable Quotes “There are a lot of hidden things that we don't know about. We think we know, but we don't, that's influencing decision making every single day.” “Make it clear. Not clever.” “Every transaction moves at the speed of trust.” Connect with Howie Chan: LinkedIn: Howie Chan Website: https://www.howiechan.com/ Other: Expert Influence Quiz — Take Howie's free quiz to identify gaps in your influence flywheel. Podcast: Influence Anyone A Word from Our Sponsors: - The most successful business owners don't do it all themselves — they delegate. Upwork lets you build a team of highly skilled specialists for every function your business needs, so you can focus on what you do best and let experts handle the rest. Visit Upwork.com right now and post your job for free! - Go to Leesa.com for 30% OFF select mattresses (through September 13, 2026) PLUS get an extra $50 off with promo code TMM, exclusive for my listeners Learn more about your ad choices. Visit megaphone.fm/adchoices

Clinical efficacy doesn't matter if the patient won't use the device. In this episode of Med Tech Gurus, we sit down with Anat Shani, biomedical engineer and CEO of Synchrony Medical, to explore a critical but often overlooked truth in MedTech: adherence is everything. Anat led the development of Liberty, a patient-centered airway clearance device designed to help individuals with chronic respiratory conditions manage mucus buildup and reduce infection risk—all from home. What makes this story unique is not just the speed to market—FDA authorization and commercialization in under five years—but the relentless focus on real-world usability. We dive into why many clinically effective respiratory devices fail in practice, how patient feedback reshaped Liberty's design from day one, and why comfort, simplicity, and workflow integration must be engineered—not added later. From iterative prototyping with patients to refining even the language used in instructions, Anat shares how small design decisions can drive massive differences in outcomes. We also explore the realities of launching in the U.S. market, aligning messaging across stakeholders, and building a lean, disciplined team that can move quickly without losing focus. For MedTech founders and innovators, this episode delivers a powerful message: the best product isn't the most advanced—it's the one patients actually use. If you're interested in respiratory care, home healthcare devices, patient adherence, MedTech design, digital health, or medical device commercialization, this episode offers a practical playbook for building products that succeed beyond the clinical trial.

What if spending more money on sales isn't actually the fastest way to grow your MedTech business?For clinician founders looking to commercialise and export a medical device internationally, growing a MedTech business takes more than regulatory approval, investment and an expensive sales team. If the market doesn't understand the problem your product solves or have a reason to change, adding salespeople can simply increase your burn rate without increasing adoption. In this episode, Hakeem speaks with international growth and commercialisation consultant Craig T. Ingram about creating demand before launch, entering new export markets and building a commercial model capable of sustainable international growth.By listening you'll discover:Why MedTech commercialisation needs to start long before regulatory approval and product launch.Why spending heavily on salespeople isn't the same as building a market—and what needs to happen first to create demand.Why proving your commercial model, controlling your burn rate and executing consistently can be more important than trying to scale quickly.ActionListen now to discover how to grow your MedTech business by creating demand first, spending your commercial resources more intelligently and building a model that can scale sustainably.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Michael Mangano, President and CEO of ABK Biomedical. ABK's Eye90 is an investigational Y90 radioembolization device for treating unresectable liver cancer.Michael brings over 30 years of medical device experience, including 15 years at Boston Scientific in commercial and international leadership roles. He previously served as CEO of ReShape Medical and as President of the Americas for Sirtex Medical, scaling regional revenues from $34 million to over $130 million.In this interview, Michael discusses the thinking behind ABK's pivot into Y-90 radioembolization, what it takes to execute a 120-patient pivotal trial while retaining ownership over the clinical function, how to build capabilities that competitors can't quickly catch up to, and why the player-coach culture gives startups an execution advantage.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Michael Mangano, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:09) - Michael's journey from Boston Scientific and Sirtex to leading ABK Biomedical (04:54) - Why Michael pivoted ABK from embolization to radioembolization as soon as he joined as CEO (09:24) - How ABK reimagined Y-90 around physician control and patient-specific dosing (21:08) - What a functioning player-coach culture looks like inside a startup (27:26) - Lessons learned from a complex 120-person pivotal trial and how ABK remained the face of the study while partnering with a CRO (37:13) - How ABK is building advantages competitors can't easily replicate (42:50) - Michael's framework for choosing the right investors

In this episode of SCW for Pharma, host Evren Ozkaya welcomes Robert Hayes, Founder and Principal of Hayes Healthcare. Drawing on more than 30 years of experience across pharmaceutical manufacturing, MedTech, supply chain, commercial leadership, and executive management, Robert shares the lessons that took him from the shop floor to leading a publicly traded company.The conversation begins with Robert reflecting on his manufacturing roots at companies including Fresenius Kabi, Boston Scientific, Cardinal Health, and Amcor. He explains how hands-on experience in high-volume manufacturing and pharmaceutical quality helped him build the technical expertise and problem-solving skills that later enabled his transition into business development and executive leadership.Evren and Robert then discuss how the COVID-19 pandemic reshaped pharmaceutical manufacturing and supply chains. They explore how exposed vulnerabilities accelerated reshoring efforts, increased investments in domestic manufacturing capacity, and prompted companies to rethink long-term supply chain resilience.Looking ahead, Robert identifies home-based therapies and drug delivery devices, such as auto-injectors, as one of the next major opportunities and challenges for the industry. As treatments increasingly move closer to patients, manufacturers and CDMOs must develop solutions that combine reliability, scalability, and ease of use.The discussion then turns to the future of CDMOs. Robert argues that capacity and quality are no longer enough to stand out. Instead, CDMOs must become strategic partners by understanding their customers' products, strengthening risk management, and helping pharmaceutical companies solve broader operational challenges. They also discuss how digital transformation, connected data, and AI can improve agility, quality, and decision-making, enabling CDMOs to deliver greater value in an increasingly competitive market.Evren and Robert conclude the conversation by emphasizing the importance of building strong technical foundations, staying close to customers, and embracing continuous learning. Robert encourages the next generation of leaders to pursue work they are passionate about while remaining adaptable in a rapidly evolving pharmaceutical industry.

Jaarlijks krijgen in Nederland 3.200 mensen de diagnose hoofd-halskanker. Voor veel van hen is opereren de belangrijkste behandeling, met blijvende gevolgen voor spreken, slikken, eten en uiterlijk. Bestralen kan bovendien maar één keer op dezelfde plek, terwijl juist deze patiëntengroep vaak een tweede of derde tumor krijgt. In Utrecht werken onderzoekers daarom aan een medicijn dat de tumor zelf opzoekt en pas actief wordt als de arts er licht op schijnt. In deze aflevering van BNR Beter bespreekt Nina van den Dungen de ontwikkeling van fotodynamische therapie met nanobodies. Te gast zijn Remco de Bree, hoogleraar Hoofd-Hals Chirurgische Oncologie en afdelingshoofd bij het UMC Utrecht, en Sebas Pronk, CEO en medeoprichter van biotechbedrijf Lumox. De Bree legt uit waarom het hoofd-halsgebied zo lastig te behandelen is. Vitale functies liggen dicht op elkaar, chirurgen moeten een veiligheidsmarge aanhouden rond zenuwen en de halsslagader. Hij verwacht dat lichttherapie geen bestaande behandeling overbodig maakt, maar een extra pijler wordt in het arsenaal, in eerste instantie voor grote, oppervlakkige tumoren die van buitenaf belicht kunnen worden. Pronk beschrijft hoe Lumox twee bestaande technieken combineert. Een nanobody, een mini-antilichaam dat tien keer kleiner is dan een gewoon antilichaam en oorspronkelijk uit lamabloed komt, brengt een lichtgevoelig medicijn naar de tumorcel. Rood licht activeert het middel alleen daar. Omdat het nanobody snel weer uit het lichaam verdwijnt, hoeft een patiënt ongeveer een uur voor en twee tot vier uur na de behandeling uit het licht te blijven, in plaats van dagen. De therapie is getest in muizen en bij kattenpatiënten. Het onderliggende onderzoek loopt al ruim tien jaar in de groep van Sabrina Oliveira aan de Universiteit Utrecht. Verder gaat het over de financiering en de stap naar de kliniek. KWF Kankerbestrijding investeert ruim 4,5 miljoen euro in de eerste patiëntenstudie, maar Lumox heeft in totaal ongeveer 20 miljoen euro nodig tot en met fase 1. Pronk zoekt aanvullend geld bij investeerders en moet de productie opschalen van milligrammen naar tientallen grammen. Een fase 3-studie kost honderden miljoenen, waarvoor een farmaceut nodig. Ook komt de overstap van onderzoeker naar ondernemer aan bod, en de vraag hoe het Utrechtse medicijn zich verhoudt tot een Japanse concurrent die met gewone antilichamen werkt. Over de vraag waarom nieuwe kankermedicijnen in Nederland zo laat bij patiënten belanden, is deze eerdere aflevering van BNR Beter terug te luisteren. Over deze podcast BNR Beter is het wekelijkse programma van BNR Nieuwsradio over een toekomstbestendige zorgsector. Elke week bespreekt presentator Nina van den Dungen met zorgprofessionals, ondernemers en beleidsmakers hoe de Nederlandse zorg met technologie, innovatie, regelgeving en wetenschap beter kan worden. BNR Beter is elke maandag om 15:30 op de radio te beluisteren bij BNR Nieuwsradio, en vanaf dat moment ook als podcast via deze feed. Over de makers Nina van den Dungen (1987) is freelance journalist en als radio- en podcastpresentator al ruim 15 jaar verbonden aan BNR. Zo is ze regelmatig te horen als presentator van de nieuwsprogramma's in de ochtend- en avondspits en daarnaast presenteert ze wekelijks de beleggingspodcast Doorgelicht en BNR Beter over de zorgsector. Stijn Goossens (1996) is de redacteur van BNR Beter en plaatsvervangend presentator. Bij BNR houdt Stijn zich bezig met onderwerpen over tech, wetenschap en innovatie. Hij presenteerde de podcast Op de zaak en test elke vrijdag een nieuw techproduct in de Ochtendspits op BNR. Hiervoor was Stijn werkzaam voor NTR Wetenschap en techplatform Bright.See omnystudio.com/listener for privacy information.

Send us Fan MailMichael Brooks is the founder and CEO of BayCath Medical, a Silicon Valley medical-device company specializing in the design, development, and contract manufacturing of catheter-based products. BayCath was created to give startups and fast-moving R&D teams a more collaborative manufacturing partner—one capable of supporting rapid prototyping, iterative development, pilot production, and smoother transfers into manufacturing. Michael launched BayCath after seeing catheter development lead times grow and watching delays interfere with customer timelines. His vision is to create an environment where engineers, physicians, and manufacturing specialists can work closely together, explore multiple solutions, and make informed design decisions without wasting valuable time or capital. Before becoming a founder, Michael held program management, engineering, and manufacturing roles throughout the medical-device industry. Across those positions, he gained experience in braided and coiled catheters, material selection, process development, design for manufacturing, validation, manufacturing transfers, fixture development, supplier management, and regulatory support. He also led high-priority customer programs, helped establish project-management processes, and coordinated complex work across technical, operational, and customer-facing teams. Michael earned his bachelor's degree in biomedical engineering from the University of California, Davis, along with a minor in technology management. His career has placed him at the intersection of hands-on engineering, customer communication, program leadership, and entrepreneurship—giving him a valuable perspective on what it takes to move medical-device ideas from early prototypes toward production and, ultimately, patient care.  LINKS: Michael Brooks LinkedIn: https://www.linkedin.com/in/micbrooks10/ BayCath Website: https://www.baycath.com/ Innovation Week: https://www.baycath.com/workshops MedTech Bay Area Networking LinkedIn: https://www.linkedin.com/company/medtech-bay-area/  Aaron Moncur, host PDX 2026 is October 20-21 in Phoenix, AZ.  Learn more and register at https://pdexpo.engineer/  Subscribe to the show to get notified so you don't miss new episodes every Friday.The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus 

Ofer Shalev, co-founder and CEO of New Phase, shares his journey from leadership roles across high-tech, biotech, banking, and even serving as a fighter pilot, to pioneering a nanotechnology-based hyperthermia treatment aimed at transforming stage four cancer care. Ofer explains how the company's mission focuses on prolonging life while preserving quality of life through a systemic approach designed for metastatic disease. He discusses New Phase's progress, including treating 33 stage four patients (including at Mayo Clinic), achieving stable disease in over 60% of cases after one month follow-up, securing FDA medical device designation and IDE approval, and building a science-driven team supported by patents and peer-reviewed publications. Guest links: https://newphase.co.il/ Charity supported: Feeding America Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 087 - Ofer Shalev [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm delighted to welcome as my guest, Ofer Shalev. Ofer is the co-founder and CEO of New Phase. With more than twenty-five years of management experience in the high-tech and biotech industries, Ofer leads New Phase operations and is pioneering a breakthrough nanotechnology-based treatment to transform the management of stage four cancer. Ofer combines deep technological insight with strategic business acumen. He previously served as CEO of several technology companies, including ReDent Nova, which led innovation in dental medical devices alongside his co-founder, Dr. Rafael Hof. Earlier in his career, he held senior leadership roles in the banking sector, including serving as VP of Operations, which strengthened his foundation in large-scale operational excellence. He holds an MBA from the University of Edinburgh and is recognized for guiding multidisciplinary teams, driving complex R&D initiatives, and scaling companies from concept to global market presence. At the core of his work is a clear mission: to redefine the future of cancer care by offering patients a safer, more targeted, and more effective treatment, one that not only attacks tumors but also preserves the quality of life. All right. Well, welcome to the show. I am so thankful you're here today. [00:02:09] Ofer Shalev: Thank you, Lindsey. Good evening. Very nice to meet you. [00:02:11] Lindsey Dinneen: Very nice to meet you too. So I would love, if you wouldn't mind starting off by just sharing a little bit about yourself, your background, and what led you to medtech? [00:02:25] Ofer Shalev: Well, I would say that during the year, I had extensive managerial experience across many multiple sector, including industry, high-tech, banking, and obvious-obviously life science. I have also to mention that about fifty years ago, in my experience I was a fighter pilot, pilot in the Israeli Air Force. It was, again, about fifty years ago. I would say that it probably significantly shape who am I today. I mean, it's developed my ability to to take a calculated risk, for example, or to act quickly and precisely to plan ahead, to build contingency plans. So all that kind of thing that probably was very relevant to the time I, I w- I used to serve in the Israeli Air Force, but also very relevant to the, to the industry. Okay? And furthermore, I would like to say that probably I am highly motivated by challenge. It, it's make my day. In addition, I am a father to four children and a grandfather of seven grandchildren. And I do hope that at the end, I will have about twelve grandchildren. So, the kids have still to work about it. Yeah. And I would say that you asked about myself, so probably I have a very, very strong belief in the path, in the way that I'm choosing. It's I would say, enabl-enabling to, to overcome about the difficulties, mainly when you're looking for challenge, especially in, in a new and unfamiliar field, like in our case of New Phase And furthermore, I, I, I, I truly believe in the word "never give up." You will find solution to everything. Never give up. I like very much as I mentioned before, to, to meet a challenge and to overcome our challenge many times by breaking some problem into pieces and then to assemble it again. Furthermore, I would say we, we met many, many problems in our life. I, I think that we have to focus about the solution, not about the problems. You cannot change problems. It's happened. But let's try to find and, and to think about how to find the right solution to it. And I would say that I, I f- I feel very, very, very good to to operate or to, to function in a turbulent area. I mean, I like it very much. I, I know that not, not, not anyone like it, but I feel very good in, in this area. [00:04:59] Lindsey Dinneen: Wonderful. Well, thank you for sharing a bit about your background. I have so many questions, but I would love to actually learn about what you're doing right now with New Phase, because I know you're passionate about it. There's, there's a lot that goes into cancer research and treatment, and I know that that's been such a challenge for so many years, and I love the fact that your company is really diving into that challenge and tackling it. And I was just wondering if you could explain where the concept of New Phase came from, and what exactly makes your company so unique in this space? [00:05:39] Ofer Shalev: So the, the idea came that it was 14, 14, 15 years ago, while me and my partner, Dr. Rafael Hof, we were involved with some other company, and after that at that time his mother, her name was Sarah, she wa- she had lung cancer. She passed away. And during that time, we have a very, I mean, many time conversation about the disease. No, no, no, none one, none one of us is, was oncologist, okay, by training. But we have many, many discussion about the treatment what are the relevant treatment that are available, et cetera, et cetera. And after she passed away we, I mean, Rafi, who is a great technology guy, came with this idea of nanoparticles and hyperthermia, and we start to work about it. Again, we have to learn, both of us, we have to learn a new area of technology, of biology, of chemistry, of physics, engineering, regulation, everything. And it was not only that we have read and learn about it, but we decide al-also to, let's say, to, to jump into the pool, into the water. We put each one of them, each one of us put some money. We hire some chemist. We also hire from one of the university in Israel some space. Like you, I mean, usually, I, I believe it's the right way to develop a company. I mean, to start and building it, the company, in the garage, okay? Right. And, and, and sure, you have, you have to-- you cannot just think about it, you have to, to, to do something. And the outcome was actually the proof of concept. We show in the in vitro, under microscope, how some very, very primitive nanoparticles were being irradiate, caused damage to the cancer cells. And that was the time that we founded New Phase. I truly believe that it's the right approach that first you have by yourself to, to deliver, to show the proof of concept, then go to investor and try to convince them to, to invest in your in your company. So that was what we have done. It was a very, very long way. I mean, the company was founded just 13 years ago. The vision didn't change. I mean, from the beginning, the idea was to prolong life of cancer patient, and in order-- and in addition to maintain the quality of life. At that time we used the word of chronic treatment or managing the disease, and many of the people that we met, skeptical one said, "But you, you don't cure the disease." So we explained that as we see in the next twenty years, nobody will cure the disease, but for the meantime, people have to live. [00:08:35] Lindsey Dinneen: Hmm. [00:08:36] Ofer Shalev: Now, the vision is still today. It was implemented into a technology. But yes, the technology was changed several time along the year, but the vision is still here, and that is, that is the, the outcome as of today. We already treated thirty-three patient with stage four, six of them in a Mayo Clinic, very distinguished hospital. I mean, I would say ranked number one worldwide. A great cooperation with them. I would say that till the summertime, we will treat another six patient, and after we move to the feasibility study, where we will have to choose few indication, and we will add another to a US hospital to join to the feasibility study. It become a product. As I mentioned, we treated already thirty-three patient. We have about fourteen patents that already granted. We have about, since we are-- we truly believe that we are in a deep science company, so we truly believe in the, in the scientifics based evidence, and we already publish nine peer review scientific articles. We have done a lot of work and success with FDA. First, and again, it was a breakthrough idea to, to succeed and get designation of medical device. Although we inject infused nanoparticle into the body, but we convinced the FDA that although we infuse nanoparticle, hence our mode of action, primary mode of action is actually engineering one or physical one, and therefore we were, we were designated as a medical device, which again save a lot of budget and, and time while reaching to the clinical study. And then later on, we got the IDE, I mean, the, the approval to start clinical study in the US. So we have done a very, very long way, and I would say that it's very satisfying while seeing today that first of all, we have a product, not only idea, and the vision is still here. I mean, what we can see that we... many of the patient, although it in the early feasibility study, and the main goal is to achieve safety and to show it's non-toxic. So even though we succeeded in more than about sixty percent of the cases we treated in nine different indication of cancer to reach to a stable disease. Let's say after one month of follow-up, the tumor metastasis are the same size, and there were no new lesion during that time. So, yeah, we-- I would say that it start, it start-- it seems that we start to reach to the, to the real game in the feasibility study where we will focus about two to three indication, and the idea is to treat patient for at least, let's say, six months, and to show that we can, we can keep them in a status of stable disease. [00:11:44] Lindsey Dinneen: Yeah. [00:11:45] Ofer Shalev: Further, furthermore, all the patients that we got, all of them are metastatic stage, let's say stage four, which exhausted all other treatment. So many time, you can see that in the retrospective data, before the joining to the study, the tumors or metastases have a progression rate of so and so percent per month, and after our treatment is dramatically reduced or even stopped. So, a lot of enthusiasm with the current status. [00:12:18] Lindsey Dinneen: Yeah, a lot of enthusiasm and a lot of hope. I, I love what you're doing because, yeah, as you said, I mean, at that point, people probably feel so stuck and hopeless. And so to be able to learn that there is technology that is being actively worked on that can... [00:12:36] Ofer Shalev: Yeah. [00:12:36] Lindsey Dinneen: ...really help them [00:12:38] Ofer Shalev: Yeah, yeah. We are-- you also ask what, what we-- what, what is the difference that we bring to the market? [00:12:42] Lindsey Dinneen: Mm-hmm. [00:12:44] Ofer Shalev: So the hyperthermia is well-known for many, many years to be a useful way to treat cancer. Okay? Because cancer don't have resistance to hyperthermia. And let's skip about all the biology factor, but this is a well, well-written evidence in, in the literature. So, but usually all the current hyperthermia methodology is a local treatment, meaning you have to define where the tumor is, CT, MRI, whatever, and to try, try to heat this tumor either by infrared or with-- or inject directly nanoparticles into the tumor, et cetera, et cetera. What we are offering is a totally a new approach of treating systemically in tumors at stage four. Let's say in many cases, you don't know even where the tumors are in the volume of treatment, meaning we treat the torso area. It's not that we are trying to find tumor by tumor. No. We're treating the whole area of the torso, and by that we can destroy the tumor, which in stage four are localized in, in different area in it. So this is one thing. The other thing that I would say that the stage four mainly people that exhausted other treatment is really can be considered as a unmet need. And that's, that's the population that we are focused about. That, that's the population that we are focused about. [00:14:11] Lindsey Dinneen: Yeah. Yeah, that is really incredible to hear. I, I love what you're doing. I'm curious, as you've gone about this process and f- you know, 13 years worth of learnings and growing as a company, what is something that's really surprised you along the way? [00:14:34] Ofer Shalev: Surprise? Well, you know, I said before, when, when you, when you start this this journey with a deep s-- belief in yourself and in your team, you're not really surprised. [00:14:49] Lindsey Dinneen: Hmm. [00:14:50] Ofer Shalev: Yeah, I mean, no, there is a lot of surprise. I mean, we, we went in an area which nobody stepped before in the, in those days. Nobody stepped before. But I would say it was obvious to me at least that okay, we are thinking about the right approach. We are trying to find our way. We invest a lot about trying to read whatever is relevant. We are speaking with oncologists, learn from them in many time about the failure, and try to make sure not to do it. So I'm not surprised. I'm very happy. And again, it's not... It was not by accident. On one hand, a very strong belief, and on the other hand, in-depth learning every piece of knowledge that we were able to collect [00:15:33] Lindsey Dinneen: Yeah. Yeah, that's so important, and I appreciate you saying it that way. I think intentionality is such a key component of leadership, and this is some of the conversations that I'm enjoying having lately is, h- and I'd love to get your input, is how do you go about intentionally creating the right team, the right vision, and the right culture to support the fact that you don't have to be surprised by things? You get to be happy, but you have the right framework in place. [00:16:08] Ofer Shalev: So I would say that in terms of the team, it was changed and replaced along the way. [00:16:15] Lindsey Dinneen: Mm-hmm. [00:16:17] Ofer Shalev: At the beginning... By the way, even today we have we have, we have twenty-four employees. Six of them are PhD Along the way, since we need people that know how to read articles, how to analyze article, et cetera. So I would say that we have in a, in a, in a company of about six, seven employees, three or four of them were PhD. There was a lot of self-learning to do. Later on, we start to make, "Okay, we have to develop. We have to build a product." So obviously, we, we, we mixed this team with people that came f- with some experience from the industry. Furthermore, experience from the medical device industry. Okay? So I would say along the time the, the, the population in New Phase become to be more heterogeneous. [00:17:08] Lindsey Dinneen: Hmm. Mm-hmm. [00:17:10] Ofer Shalev: Because really we-- you-- I mean, currently we have a product, so we need people about regulation, about quality, people that know very well engineering, people that have a idea about operation and not only researcher. But again, at, at the beginning, all, all our employee came from the... I mean, we, we, we, we re recruit about I think three or four PhD at the beginning to start with, and it will change along the way. Yeah. Now about-- you ask about leadership. So, I would say that I ca- I can see the leadership not only about, about leading people, but also about pushing your vision. Okay? Because again at the beginning, an idea of changing the cancer disease into a manageable disease, it was not so well accepted idea. Anyone ask about curing, but we keep saying, "No, there is no, there's no g- currently, there's not a real good chance of curing. Let's focus about prolonging life." Nowadays, it's common language. You can see from any, any drug company discuss the issue of manage- manageable disease. But when we start with this vision, it was very hard to convince people about it, and obviously many of them said in a very skeptical way, "You will not make it." [00:18:29] Lindsey Dinneen: Mm. [00:18:29] Ofer Shalev: So this part of the leadership as well, "Okay, I heard you. Let's, let's meet at the end of the day and we'll see what hap- who, who is the right one." So, yeah. So I would say that in our case, leadership is, is mainly to, to maintain the vision, to push the vision, to develop the vision. Partially it's about, a- about employees, sure, because at the end you have to recruit employees that will implement this vision into a technology, into a product But I would say that in a company like New Phase, the, the leadership is as more than 50% is about the vision. [00:19:11] Lindsey Dinneen: Yeah. Yeah, pushing the vision forward. I, I really appreciate that. I, you know, you had so many things at the beginning that you were talking about that I really appreciated. You talked about never giving up, overcoming difficulties, and loving challenges, and I think all of those are critical, of course, as an entrepreneur. But I'm also particularly curious about your h- you mentioned that you break down challenges into pieces and then rebuild, and I'm curious, where did that philosophy come from and how do you practically implement it? [00:19:48] Ofer Shalev: Frankly speaking, I don't know from where it came. No, I don't know. I mean, you know, with... Du-during the way, I, I, I had many, many chance to, to, to rethinking about some problem that we solved, and I asked myself, "How the hell we know what to do?" I, I don't know, frank- In, in many times, I would say that main-ma-mainly because we try to simplify the problem to pieces, and then we have a breakthrough id-idea about it. It is not-- I mean, the methodology is about breaking the problem into pieces. How to assemble it again, this is a breakthrough. I don't know how to explain it. [00:20:32] Lindsey Dinneen: Okay. [00:20:33] Ofer Shalev: really. [00:20:33] Lindsey Dinneen: Yeah, but do you find that maybe taking it apart and so probab- maybe part of it is, I wonder, you know, when you've got a challenge, it feels big and insurmountable, and you can't make any progress versus if you break it down and you go, "Okay, yeah, maybe this as a whole feels t- like too much, but what about this one little piece that if I can overcome this, then it will push me forward in overcoming the ultimate challenge?" I wonder if it's partly... [00:21:02] Ofer Shalev: It, it, it might be, it might be the situation. It's simple to, to deal with a, with a simple or with a, with a partial challenge, partial partial problems. And then it says, "Okay, I, I, I solved this issue. Let's try to solve another issue." And all of a sudden, you figure out that, "Hey, I have the full picture. I solve it." [00:21:23] Lindsey Dinneen: Yeah. That's, that's really cool. Okay. So, you know, you've had an amazing career, and not just within this space of course, but before that, and I'm just wondering if maybe especially along this particular journey with New Phase, are there any moments that really stand out to you as affirming, "Wow, I am in the right place at the right time in the right industry"? [00:21:54] Ofer Shalev: Yes. I, I, you know, I, I think that it's... No, it will, it will par-- it will par-- I, I will answer you partially. I mean, once we decided to founder the company and that myself and my partner, Dr. Rafael Hof, we have after another company that we, we had, and we-- And when he came with this idea, I thought to myself, "If there are two entrepreneur worldwide that are able to deal with that problem, it's probably the two of us." Yeah. Ab-absolutely. Yeah. [00:22:31] Lindsey Dinneen: Yeah. [00:22:32] Ofer Shalev: Because the way that we work together, the w- the way that we each one of each one of us cover different area, how to build this kind of a crazy idea. I would say that really just only, you know, two people that are crazy enough and can work so well together can deal and succeed in this task. So this is the kind of, of, of of memory that I have from the beginning of the company. [00:22:57] Lindsey Dinneen: Yeah. I love that. That's, that's really cool. You, you know, you mentioned also at the beginning that some of your experience as a pilot was really critical in helping you learn different skills or disciplines that help you succeed throughout your career and today. Do you mind just talking a little bit more about some of the things that you still hold onto as really important lessons learned? [00:23:24] Ofer Shalev: Okay, know, to be in a, in a cockpit of a fighter i-- of a, of a fighter airplane, I mean, just ones that was there can, can understand what I'm speaking about. But it's a who- the whole way of thinking. So I would say that from time to time, when I have quite, quite a big challenge, I, I, I imagine to myself that I'm in the cockpit, okay? In order to, to think the same way that you used to think fifty years ago. Okay? Now with, wi-with, with regarding with regarding it to to some advice, okay? To to some to some other entrepreneur, let's call it this way. So, I would say that first of all, choose a real breakthrough idea. Not an idea that, okay that probably someone else did before or will do it after-- will, will make it after you. Try to find a real breakthrough idea to... Because, you know, at the end, you, you sacrifice a, a big piece of your life about it. [00:24:24] Lindsey Dinneen: Mm-hmm. [00:24:25] Ofer Shalev: So try to find something which is real, real something. This is one. Then you have to have a very strong backbone and remain committed to your vision. Yes, you might change the technology, that's okay, but you have to be committed to your vision. And furthermore, probably many times along the way, you will hear from people you will not succeed, it's the wrong way, et cetera, et cetera, et cetera. So nowadays, when I hear this kind of a voice, I say, "Why don't you open the startup of yourself? If you know it so well, why don't you open? Because you don't have the courage?" [00:25:06] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:25:08] Ofer Shalev: And yes, courage is, is, is, is another component which is very important to entrepreneur that choose a way how to change the world. [00:25:18] Lindsey Dinneen: Mm. Yeah. I love that. Thank you for sharing. Okay, so pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars to teach a master class on anything you want. Could be within your industry, doesn't have to be. What would you choose to teach? [00:25:40] Ofer Shalev: I don't know how to do it, but I will say it in other ways. I probably to, to, to, to teach people how to avoid or what to do while you are in a dead end. [00:25:52] Lindsey Dinneen: Hmm. Okay. Do you wanna elaborate a little bit? 'Cause I'm curious. [00:26:00] Ofer Shalev: I think that, that, that your ability really to believe in yourself is a key factor. [00:26:05] Lindsey Dinneen: Mm-hmm. Mm-hmm. [00:26:06] Ofer Shalev: Your ability to, to free your mind, not to focus about the current problem, but to free your mind, going outside and try to find some other idea is quite important one. [00:26:18] Lindsey Dinneen: Yeah. [00:26:18] Ofer Shalev: Yeah, those kinds of things. Probably we have to think about this kind of a masterclass. [00:26:23] Lindsey Dinneen: That would be a great masterclass, yeah. Okay. All right. [00:26:27] Ofer Shalev: By the way, I, I truly believe that in order... I mean, at least that's what I'm doing. But I, I besides that I'm working very hard, I try to read many books. It might be biography, it might be historical novel, it might be by... it might be a thriller. I try to be very, very diverse in what I am reading. I believe it's, it's just fruitful my mind, and not to focus about only about some scientific articles. [00:26:56] Lindsey Dinneen: That's... I love that. That's great. All right. And how do you wish to be remembered after you leave this world? [00:27:06] Ofer Shalev: Well, it's not something that I particularly concerned about it, truly. I don't, I, I don't... I, I, I will say fir- I will say something else. I truly believe that true leader are not focused about what people will remember about them. It is important that the vision will stay. It's important that a father and mother, or children that have cancer in the family will be able to live longer life with a better quality of life. It's much more important if people know, "Hey, Ofer Shalev bring this technology to the market." [00:27:45] Lindsey Dinneen: Mm-hmm. [00:27:46] Ofer Shalev: That, that the way I see it. I mean, I don't care too much what will people remember after I leave this world. [00:27:53] Lindsey Dinneen: Yeah. No, that's, that's beautiful. I love that. Okay, and then final question: What is one thing that makes you smile every time you see or think about it? [00:28:04] Ofer Shalev: Well, that is very, that is very easy. You know, when you have so many, so many grandchildren, so, to hear the questions "Why did, why did it happen?" "Why the bird is flying so high?" The, the truth and simplicity of children and the way that they are thinking, that's really something that make, I think, everybody smiling about it. [00:28:28] Lindsey Dinneen: Yeah. That's so fun, and I couldn't agree more. I I have a few nieces and a nephew, and getting to, to sort of see the world again through their eyes and perspective is just really fun. It's just, it's joyful. [00:28:44] Ofer Shalev: Yeah, it's a great chance to hear about a simple way of, of how the world should, should be. [00:28:49] Lindsey Dinneen: Yeah. Curiosity. I love the never-ending curiosity. [00:28:52] Ofer Shalev: And asking many questions. It's very-- I mean, asking question is, is a great, is a great benefit. [00:28:58] Lindsey Dinneen: Yes. [00:28:58] Ofer Shalev: Ask as many questions as you can. [00:29:00] Lindsey Dinneen: Your whole life. [00:29:01] Ofer Shalev: Yeah. [00:29:02] Lindsey Dinneen: Yeah. Excellent. Well, this has been such a great recording. I really appreciate you sharing your your vision especially about New Phase and where you hope that the company will go and, and the lives that it'll impact. And I know you're well on your way, and I just wanna thank you for not listening to the people who said, "This is not gonna happen," or were trying to discourage you. I'm just so thankful that you're doing what you're doing. And we are honored to be making a donation on your behalf as a thank you for your time today to Feeding America, which works to end hunger in the United States by partnering with food banks, food pantries, and local food programs to bring food to people facing hunger, and they also advocate for policies that create long term solutions to hunger. So thank you for choosing that organization to support. So, really appreciate you being here today and just really appreciate everything you're doing to change lives for a better world. [00:30:00] Ofer Shalev: Thank you very much, Lindsey. [00:30:02] Lindsey Dinneen: All right. You too. Bye. [00:30:04] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Thinking about exporting your MedTech product to the GCC? Are you actually ready to build a market there or are you simply looking for a distributor?Successfully exporting a MedTech product to the GCC takes more than appointing a distributor and waiting for sales. You need clear clinical value, the right commercial partner, a plan for creating demand, meaningful measures of early progress, and ongoing manufacturer support. In this episode, Hakeem shares five key lessons from his conversation with experienced GCC distributor Sameh Salama to help you prepare for commercialisation, adoption and sustainable sales across the region.Listen to discover:Why strong clinical value and evidence need to come before approaching GCC distributors.How to choose the right distributor, create demand and measure the activities that lead to adoption and sales.Why successful MedTech export requires ongoing manufacturer support rather than expecting your distributor to build the market alone.ActionListen now to discover the five things you need to get right before exporting your MedTech product to the GCC and give yourself a stronger foundation for adoption and sustainable sales.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence classification, clinical evidence, risk management, labeling, identification, and ultimately the entire market access strategy.In this Easy Medical Device podcast collection, we focus on two important regulatory topics: defining a proper Intended Use and understanding Master UDI-DI.Intended Use: The Foundation of Your Regulatory StrategyIntended Use may look like a simple statement, but it can influence almost every part of a medical device's regulatory pathway.A poorly defined Intended Use can create downstream problems with device classification, clinical evaluation, risk management, and regulatory submissions.Even small changes in wording can have significant consequences, particularly for areas such as Software as a Medical Device (SaMD).The discussion also explores a common misconception: manufacturers cannot simply use a disclaimer or change their labeling to avoid medical device regulation when the actual intended purpose and claims bring the product within the medical device framework.Understanding Master UDI-DIDevice identification is another increasingly important part of regulatory strategy.Master UDI-DI introduces an additional layer that MedTech manufacturers need to understand when managing device identification and regulatory information.Understanding how it fits into the broader UDI framework can help manufacturers prepare their documentation and data strategy while avoiding mistakes that could create additional regulatory or operational work later.Building a Stronger Market Access StrategyAlthough Intended Use and Master UDI-DI address different regulatory challenges, they share an important principle: regulatory strategy should be considered early rather than treated as an administrative task at the end of development.Clearly defining your device, understanding its regulatory implications, and preparing the right identification strategy can help create a more predictable path toward market access.For Regulatory Affairs professionals and medical device manufacturers, these conversations provide practical insights into two topics that can significantly influence the regulatory journey from product development to market.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Is the future of MedTech innovation shifting away from devices—and toward manufacturing? In this episode of Med Tech Gurus, we sit down with Mark Freitas, Managing Director and Life Sciences Leader at Alvarez & Marsal, to explore a major shift happening in MedTech: capital is moving away from traditional device acquisitions and toward advanced manufacturing platforms and CDMOs. As device complexity increases and technologies converge across hardware, software, and biologics, the ability to manufacture at scale is becoming a strategic differentiator—not just an operational function. Mark breaks down why 2026 is shaping up to be a pivotal year for MedTech M&A, with a surge in deal activity driven by private equity exits, OEM carve-outs, and platform roll-ups. He explains why scarcity of specialized capabilities—not revenue—is now driving valuation, and how regulatory infrastructure has emerged as a hidden but powerful competitive moat. We also explore how founders and operators should think about CDMO partnerships, when to own manufacturing versus outsource it, and why many companies get the timing wrong. For MedTech leaders, investors, and innovators, this episode delivers a clear message: the winners in the next wave of MedTech won't just build great products—they'll build (or partner for) the capabilities to make them.

If a great export distributor had four MedTech products to choose from today, why would they choose yours?MedTech manufacturers spend a lot of time asking whether a distributor is capable of selling their product. But there's another question that's just as important: why should a good distributor choose you? Taking on your product means investing their sales time, clinical resources, customer relationships, marketing activity and reputation. In this episode, Hakeem unpacks a real decision with experienced GCC distributor Sameh Salama to reveal what good export distributors actually look for before deciding whether a MedTech product represents a genuine commercial opportunity. Listen to this episode to discover:Why strong clinical evidence matters to export distributors but isn't enough on its own to create a compelling commercial opportunity.What good distributors assess before agreeing to represent your MedTech product—and why a distributor who challenges you can actually be a very positive sign.Why successful MedTech commercialisation and export depends on the manufacturer and distributor working together to create demand, rather than expecting the distributor to build the market alone. Listen now to discover what good export distributors really look for and how to make your MedTech product a commercial opportunity they'll want to invest their time, resources and relationships in.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with we sat down with Murthy Simhambhatla, CEO of SetPoint Medical.SetPoint is commercializing the first FDA-approved neuroimmune modulation implant for rheumatoid arthritis.Previously, Murthy was CEO of Evolus, leading the company through its IPO, and held multiple leadership roles at Abbott, including President of Abbott Medical Optics and head of the company's Ibis Biosciences molecular diagnostics business. Earlier in his career, Murthy led development of Abbott's XIENCE drug-eluting stent platform following Abbott's acquisition of Guidant. Murthy holds a Ph.D. in Polymer Engineering and is a Fellow of the American Institute for Medical and Biological Engineering.In this interview, Murthy discusses building commercial conviction years before launch, how to sequence platform indications around adjacent markets, and why SetPoint built its reimbursement function in-house rather than outsourcing it.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Murthy Simhambhatla, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:18) - Murthy's journey from Guidant, Abbott, and Evolus to leading SetPoint Medical (09:53) - How SetPoint stimulates the vagus nerve to reprogram the immune system (11:32) - Why SetPoint built a reimbursement hub around the entire referral workflow (21:36) - A guide to building technical and commercial conviction for a novel therapy (26:58) - The trifecta Murthy wanted in place before commercial launch (30:56) - Why rheumatoid arthritis became SetPoint's first indication (36:11) - How commercial adjacency shapes platform expansion (42:20) - A business case for handholding patients through reimbursement (48:03) - The two lessons behind every skeptical investor question

In this episode, Joe Tumolo shares why the best medtech companies don't just build innovative products; they build relationships that drive commercialization. Drawing on more than 25 years in healthcare and life sciences, Joe reveals how founders can strengthen fundraising, hire the right sales team, navigate healthcare adoption, and create commercialization strategies that lead to lasting success. Discover why aligning with customers, investors, and partners may be the most valuable competitive advantage a startup can have.Joe Tumolo LinkedInJTSC, LLC LinkedInJTSC, LLC Website“Thinking Fast and Slow” by Daniel Kahneman Revisionist History Podcast with Malcolm Gladwell “The Undoing Project” by Michael Lewis Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

On this episode Jim Tate welcomes Dr. Gary Wietecha, Chief Medical Officer of Med Tech Solutions. Med Tech provides services to align EHR, IT, and AI‑enabled workflows to improve operations, support clinicians, and enhance patient care efficiency. He leads clinical strategy at MTS and helped launch ProviderCare, a one-on-one EHR adoption coaching program for NextGen and eClinicalWorks customers aimed at reducing clinician burnout. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play Healthcare NOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen

Thinking about exporting your MedTech product to the GCC? What if finding a great distributor is only the beginning of what you need to succeed?The GCC can be an attractive export market for MedTech companies, but you can't simply take the strategy that worked in the UK, Europe or US, appoint a distributor and expect the same results. In this episode, Hakeem speaks with GCC MedTech distributor Sameh Salama about what manufacturers need to understand before entering the region, from choosing the right commercial partner and navigating local purchasing dynamics to clinical education, KOL engagement and supporting your distributor after launch. By listening you'll discover:Why the GCC isn't one MedTech market and what manufacturers need to understand before choosing where and how to enter. How to choose a distributor with the right portfolio, relationships and capacity to successfully commercialise your MedTech product. Why successful MedTech export requires an ongoing partnership between manufacturer and distributor, including clinical education, training, market development and clear activity plans that lead to sales. Listen now to learn how to commercialise and export your MedTech product successfully in the GCC by choosing the right partner, supporting them effectively and building the market for long-term adoption and growth.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Dr. Austin Chiang has built one of medicine's most distinctive public platforms. He is a triple board-certified gastroenterologist, Chief Medical Officer for Medtronic's Endoscopy business and Associate Professor of Medicine at Thomas Jefferson University. He is also one of healthcare's most influential physician voices online, with hundreds of thousands of followers across TikTok, Instagram, YouTube and LinkedIn. That makes him an ideal guest for Season 11 of Fixing Healthcare with cohosts Dr. Robert Pearl and Jeremy Corr. This season asks what patients, clinicians and healthcare leaders are saying now that feels meaningfully different from the past. Chiang hears those concerns from several vantage points: as a practicing physician, medical technology leader, educator and public-facing doctor. For Chiang, three issues stand out: Clinician burnout and loss of autonomy Chiang says physicians are struggling with administrative burden, documentation demands, prior authorization, staffing shortages, reimbursement pressure and a growing sense that medical decisions are no longer fully in their hands. Pearl pushes further, asking whether clinicians must take more responsibility for affordability rather than simply objecting to the oversight created in response to rising costs. Chiang agrees that physicians need a better understanding of the broader healthcare ecosystem if they want to help change it. Medical misinformation and social media Chiang has spent more than a decade learning how to communicate across platforms and audiences. He explains that accurate medical information must now compete with sensationalized claims from people who are not held to the same professional standards as clinicians. For doctors, the challenge is to be credible without being boring, engaging without becoming irresponsible and platform-specific without compromising the message. That tension is especially important in areas like gut health, diet, probiotics and the microbiome, where uncertainty creates space for simple but potentially misleading answers. Clinician-led innovation As Medtronic's Chief Medical Officer for Endoscopy, Chiang works at the intersection of clinical practice and medical technology. He explains that innovation in medicine is slow for good reason: new tools must prove safety, clinical value, workflow fit and real-world usefulness before becoming mainstream. But he argues that clinicians need to be more involved in that process because they understand the nuances of patient care, staff experience and adoption better than outsiders can. The conversation also explores colorectal cancer, which is rising among younger adults. Chiang explains why colonoscopy remains the gold standard for prevention, while also noting that lowering screening ages further would create major capacity challenges. He also discusses AI-assisted polyp detection, the future of endoscopy and why fully autonomous colonoscopy remains difficult given the complexity of human anatomy. There's much more in this conversation, including physician career paths beyond traditional practice, how doctors should respond when patients bring AI-generated information to appointments and what people with chronic GI conditions need from clinicians, platforms and online communities. Tune in to hear one of medicine's most visible digital physician leaders explain how doctors can help shape a future where technology, social media and medical innovation better serve patients. * * * Fixing Healthcare is a co-production of Dr. Robert Pearl and Jeremy Corr. Subscribe to the show via Apple, Spotify, Stitcher or wherever you find podcasts. Join the conversation or suggest a guest by following the show on X and LinkedIn. The post FHC #224: Austin Chiang on burnout, misinformation and the future of med-tech appeared first on Fixing Healthcare.

Cybersecurity in healthcare is no longer an IT issue—it's a patient safety issue. In this episode of Med Tech Gurus, we sit down with Skip Sorrels, Field CTO and Chief Information Security Officer at Claroty, to explore how cyber threats are evolving from data breaches into full-scale clinical and operational disruptions. With a unique background as both an ICU nurse and healthcare cybersecurity leader, Skip brings a rare perspective on what actually happens inside a hospital when systems go down. From electronic medical records shutting off to clinicians reverting to paper processes, these events don't just slow operations—they fundamentally impact patient outcomes. We dive into the growing risks tied to connected medical devices and hospital infrastructure, including operational technologies like HVAC systems, water filtration, and building controls—areas increasingly targeted as the "path of least resistance" for attackers. Skip also shares why healthcare organizations must begin treating cybersecurity like disaster preparedness, focusing on operational resilience, recovery planning, and real-world readiness—not just prevention. For MedTech innovators, this episode delivers a critical message: security is no longer a feature—it's a requirement for trust, adoption, and patient safety. If you're interested in healthcare cybersecurity, medical device security, hospital operations, digital health risk, or MedTech commercialization, this episode offers a powerful and timely perspective on one of the most important challenges facing healthcare today.

If your MedTech product isn't selling as quickly as expected, are more salespeople really going to fix the problem?When a MedTech launch underperforms, hiring more salespeople, recruiting another distributor or attending more exhibitions can feel like the obvious answer. But if the market hasn't been prepared and customers don't yet see a compelling reason to change, more sales activity won't solve the underlying problem. In this episode, Hakeem explains why successful MedTech commercialisation and export starts long before launch—and why understanding and preparing your market can save you from trying to force adoption later.In this episode you'll discover:Why MedTech commercialisation should begin months before your product launches, rather than after regulatory approval.Why adding salespeople or export distributors won't fix a market that isn't ready to adopt your product.How understanding what keeps your customers awake at night can help you create demand, prepare the market and accelerate adoption.ActionListen now to learn how to prepare your market before you commercialise or export your MedTech product, so your sales team can convert demand rather than having to create it from scratch.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Medical device leadership becomes deeply personal in this conversation with commercial executive Don Donnelly.For more than two decades, Don has helped build commercial organizations, launch disruptive neuromodulation technologies, and develop high-performing sales teams. But the greatest leadership lesson of his career didn't happen in a boardroom—it happened when his nine-year-old son suddenly became seriously ill.Don shares how his family's two-year search for answers ultimately led to a diagnosis of PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections), and how that experience transformed the way he thinks about leadership, physicians, patients, and advocacy.Jordan and Don also discuss:• Building startup commercial organizations• What separates good sales leaders from great commercial leaders• Why the best leaders listen first• Lessons learned from launching breakthrough neuromodulation technologies• The future of neurotechnology• Patient advocacy and navigating rare diseases• Why "sometimes behavior is biology"Whether you're in medical devices, healthcare leadership, or simply love stories about resilience, this episode is filled with practical wisdom and genuine humanity.Resources:To purchase "Navigating PANDAS: A Family's Journey to Healing and Advocacy" by Don Donnelly, click here: https://bit.ly/4wFklO7To connect with Don: https://bit.ly/3TFzJeT

Move faster without losing focus: why medtech innovation must balance agility, regulation, and patient needs. In this episode, Mike Stuedemann, Co-Founder and Principal Consultant at agilityIRL, discusses how medical device companies can use agile techniques to accelerate product development while maintaining FDA compliance. He explores the regulatory challenges surrounding AI-enabled devices, particularly as technologies continue to learn and evolve after launch. Mike also explains how AI can support quality and regulatory teams by identifying potential risks, flagging requirements for review, and reducing manual work without replacing human expertise. Finally, he shares why personalized medicine, responsible data use, and practical applications of "boring AI" can drive more meaningful innovation while keeping accessibility, affordability, and patient outcomes at the center. Tune in to learn how agile development, human oversight, and patient-centered innovation can help medtech companies navigate a rapidly changing industry! Resources: Connect with and follow Mike Stuedemann on LinkedIn. Follow agilityIRL on LinkedIn and explore their website. Listen to the Take5 IRL podcast here.

Are you pricing your MedTech product based on evidence and value... or simply making an educated guess?Pricing is one of the most important commercial decisions you'll make, yet many MedTech founders spend years developing their product and only a few hours deciding what it's should cost. In this episode, Hakeem shares a practical five-step framework to help you understand your market, quantify your value, validate your pricing, and develop a pricing strategy that supports successful commercialisation and export.In this episode, you'll discover:Why competitor pricing should inform your thinking, but never determine your pricing strategy.How to assess the value your MedTech product creates and use it to justify your price.A practical framework for validating your pricing with clinicians, procurement teams, distributors, and customers before commercialisation and export.Listen now to learn how to price your MedTech product with confidence, strengthen your commercialisation strategy, and avoid costly pricing mistakes before entering new markets.If you need help with your pricing, message me on linkedin with the words "pricing supportThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn't enough.David Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running the company. This conversation covers the practical realities behind that journey, from quality control to clinical setbacks to investor pitches.Topics discussed:Defining TissueSpan's regulatory path and quality control as a medical device (02:49)The significance of first-in-human studies and what early clinical experience reveals (04:11)Selecting an initial clinical indication and opportunities for technology expansion (05:50)Realistic assessment of where soft tissue repair technologies apply—and where they do not (07:18)The stepwise progression from in vitro to animal models in product development (08:18)Navigating setbacks, including the impact of Covid-19 on clinical trials, and the value of adaptability (10:36)Bridging science and business in biotech fundraising and communication (12:15)Key takeaways from pursuing an executive MBA alongside building a biotech company (13:42)The importance of collaboration, mindset, and meaningful networks in driving biotech innovation (15:19)Smart insight: The transition from scientist to founder brought its own learning curve. Eva-Maria pursued an executive MBA while running Regenosca, and points to financial and business vocabulary as the skill she'd have built earlier if she could. For a technical founder or CMC lead, the lesson isn't to become a business generalist, it's that the moment you're translating a manufacturing process or clinical dataset into an investor pitch, fluency in the language of accounting, market strategy, and cost structure becomes as load-bearing as the science itself.This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery.Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet:LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.comSupport the show

Why do breakthrough medical technologies still fail to get adopted? In this episode of Med Tech Gurus, we sit down with David Neale, Co-Founder and CEO of Argá  MedTech, to explore what it really takes to bring a differentiated cardiac technology from concept to clinical adoption. Argá is advancing next-generation pulsed field ablation (PFA) for the treatment of atrial fibrillation, with early data showing 100% procedural success, strong safety, and high lesion durability. But as David explains, great clinical data alone isn't enough. Drawing on decades of experience in cardiac rhythm management, David shares why so many promising technologies fail—not because of engineering, but because they ignore physician workflow, hospital operations, and real-world usability. From designing a single, multi-configurable catheter platform to simplifying complex EP lab environments, Argá's strategy is built around one principle: innovation must fit the workflow to win adoption. We dive into lessons from first-in-human trials, the importance of disciplined execution, and why companies must design for three critical stakeholders: clinicians, operational teams, and administrators. David also shares practical insights on site selection, physician alignment, and how to move from strong data to real-world adoption. If you're interested in cardiac electrophysiology, pulsed field ablation, MedTech commercialization, clinical trials, or healthcare innovation, this episode delivers a powerful playbook for turning technology into adoption.

Start earlier than you think: why proactive quality and regulatory planning can save medtech companies time, money, and costly remediation. In this episode, Joseph McGonnigal, Account Manager at Rook Quality Systems, discusses how medtech companies can build stronger quality management systems and better prepare for regulatory submissions. He explains how AI can help teams lay the foundation for high-quality documentation, while emphasizing that experienced professionals remain essential to review outputs, address technical details, and ensure compliance. Joseph also explores the growing regulatory complexity surrounding software-as-a-medical-device, AI-enabled technologies, and de novo submissions. Finally, he shares why startups should document decisions early, establish quality processes from the outset, and avoid waiting until regulatory issues become costly problems. Tune in to learn how early documentation, expert guidance, and proactive quality management can help medtech companies move toward regulatory approval with greater confidence! Resources: Connect with and follow Joseph McGonnigal on LinkedIn. Follow Rook Quality Systems on LinkedIn and explore their website!

Is your MedTech product genuinely ready for commercialisation and export, or are you simply working through a checklist?Many MedTech founders believe that regulatory approval, clinical evidence, patents, and distributor interest mean they're ready for commercial success. But commercial readiness is about far more than ticking boxes. In this episode, Hakeem explains why successful commercialisation depends on multiple factors working together and introduces a structured way of assessing whether your MedTech product is truly ready for commercialisation and export before investing significant time and money.In this episode, you'll discover:Why regulatory approval, clinical evidence, and distributor interest don't automatically mean your MedTech product is commercially ready.The key questions that reveal whether your product is ready for commercialisation, adoption, and export.How to identify commercial risks early so you can make better investment, launch, and export decisions with greater confidence.Listen now to learn how to assess your MedTech product's commercial readiness, strengthen your commercialisation strategy, and export with greater confidence.Message me with CPI on Linkedin, to really see if your product is ready for commercialisationThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode, we sat down with David Veino ( https://www.linkedin.com/in/david-veino-a452158/ ), President and CEO of Neuros Medical ( https://www.neurosmedical.com/ ). Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimul...

What does it take to successfully commercialize medical technology in today's rapidly evolving healthcare landscape? In this episode, Mike Monovoukas, CEO and Co-Founder of AcuityMD, shares how a failed startup inspired him to build one of medtech's leading commercialization platforms. From leveraging AI and data to helping companies launch products more effectively, to raising an $80M Series C and building a mission-driven business, Mike offers valuable insights for medtech founders, innovators, and commercial leaders. Tune in to learn why commercialization starts long before product launch and how AI is changing the future of medtech. Mike Monovoukas LinkedInAcuityMD LinkedInAcuityMD WebsiteAcuityMD Press Release Biodesign Book Link Duane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law, Wheelhouse DMG, and JumpStart Inc.

From generic implants to patient-specific solutions: how additive manufacturing is expanding what is possible across medtech. In this episode, Anekant Jain, Manager, Polymer Technologies at EOS, discusses how industrial additive manufacturing is transforming healthcare by enabling the production of customized implants, prosthetics, dental devices, and other patient-specific technologies. He explains why additive manufacturing extends far beyond traditional 3D printing, requiring scalable production, qualified materials, reliability, and repeatable outcomes. Anekant also explores how advances in sensors, materials, and manufacturing are creating more responsive prosthetics with haptic feedback and stronger integration with the human body. Finally, he examines the barriers to broader adoption, including qualification processes, reimbursement, cost, and access, and explains why the industry must rethink what is possible rather than simply reproducing traditional solutions. Tune in to learn how additive manufacturing, customization, and cross-industry collaboration are pushing the boundaries of medical innovation! Resources: Connect with and follow Anekant Jain on LinkedIn.  Follow EOS on LinkedIn and explore their website at eos.info.

What do clinicians actually want before they'll adopt your MedTech product?Many MedTech founders focus on product features, clinical evidence, and regulatory approval, believing these alone will drive adoption. But clinicians evaluate new technologies through a very different lens. In this episode, Hakeem shares the five biggest lessons from his conversation with Dr Tangwan Azorfor, giving you a clinician's perspective on what really influences adoption and how you can better align your commercialisation strategy with the realities of clinical practice.In this episode, you'll discover:Why improving patient care is the first thing clinicians look for when evaluating a new MedTech product.How workflow, training, and real-world clinical experience influence adoption more than many founders realise.Five practical lessons to help you position your MedTech product for stronger clinical adoption from a clinician's perspective.Listen now to understand what clinicians really want before adopting a new MedTech product and learn how to apply these insights to improve adoption and commercial success.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

What separates companies that consistently grow from those that simply launch products? In this episode, Caitlin Mayer, Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business, shares the go-to-market principles that have helped her team build stronger customer partnerships, align cross-functional teams, and accelerate growth through portfolio-based marketing. Drawing on real-world experience leading commercialization strategies in one of healthcare's fastest-growing care settings, Caitlin explains why today's customers expect more than products. They expect solutions that improve workflows, deliver economic value, and solve meaningful operational challenges. She also shares the planning process her team uses to unite marketing, sales, clinical, and product teams around a single business objective, creating the alignment needed to execute consistently and drive measurable results. What you'll learn: 1. Why portfolio selling creates stronger customer partnerships than product-centric selling. 2. How customer insights should shape positioning, segmentation, and go-to-market strategy. 3. How cross-functional alignment creates better execution and measurable business results. 4. A practical framework for moving from product launches to sustainable revenue growth. About Caitlin Mayer: Caitlin Mayer is the Senior Director of U.S. Marketing for Medtronic's Acute Care & Monitoring business. With more than 15 years of experience in healthcare marketing, she specializes in customer-centered go-to-market strategy, cross-functional alignment, and building commercial programs that drive measurable growth. Resources: • Connect with Caitlin Mayer on LinkedIn • Follow Medtronic on LinkedIn • Explore the Medtronic website

What if the next cyberattack didn't just steal data... but endangered someone's life?Every heartbeat monitored. Every infusion pump connected. Every medical device trusted.Now imagine what happens when those systems are compromised.In this eye-opening episode of The Raygacy Show, host Rayson Choo sits down with Christian Espinosa, a leading MedTech cybersecurity executive, to uncover the invisible threats lurking behind modern healthcare technology.This isn't a conversation about passwords and software updates. It's about the human cost of cyber vulnerabilities, the ethical responsibility of innovation, and why leadership—not technology—is the strongest defense against the next crisis.Together, they explore: