Podcasts about Medtech

In this episode, Duane Mancini welcomes Brian Morley, CMO of Native Orthopaedics, and returning guest Tino Chow, CEO and Founder at Giant Shoulders, to discuss the critical aspects of building and growing a medtech brand. The conversation explores Brian's journey into Native Orthopaedics, the importance of a clear, operationalized vision for startups, and how to effectively balance creative ideation with execution. They delve into practical strategies for achieving brand alignment, identifying when a rebrand is necessary, and leveraging the digital age for reach. The episode also introduces the valuable concept of visionary and integrator roles, highlighting how a strong brand can serve as an integrator to connect a company's vision with its team and partners.Brian Morley LinkedInNative Orthopaedics WebsiteTino Chow LinkedInGiant Shoulders WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

MedTech graveyards are full of clever devices that never made it past the demo. Dr. Tori O'Daniel (OB/GYN, Medical Director, Oklahoma City) walks us through the five adoption pillars that separate shelf-ware from standard-of-care.In This Episode• The “ease-of-use” litmus test every new device must pass• Why education is a FOREVER activity, not a launch event• How to spot (and empower) your Champion-for-Change• Talking cost: shifting the conversation from unit price to total value• Template-driven VAC submissions that save months of back-and-forth

Ryan Phelan is a partner and patent attorney at Marshall Gerstein. He discusses his journey from a background in computer science and fintech to becoming a prominent IP attorney serving clients in the MedTech industry and beyond. He shares insights on the importance of protecting intellectual property, especially for startups, and the burgeoning role of AI in medical technology. This succinct yet fascinating conversation highlights the critical intersection of law, technology, and medical innovation. Guest links: https://www.marshallip.com | https://www.patentnext.com/  Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 058 - 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 I am so looking forward to my conversation today with Ryan Phelan. Ryan is a partner and patent attorney at the Chicago based intellectual property law firm, Marshall Gerstein, where he counsels medtech companies on protecting their valuable IP. Ryan ultimately believes that AI is an important technology to embrace, but cautions medical device and related companies to approach it pragmatically, developing a policy to govern and protect intangible assets and innovation. All right. Well, thank you so much for being here, Ryan. I'm so excited to speak with you today. [00:01:29] Ryan Phelan: Yeah. Thank you for having me. Thank you, Lindsey. [00:01:31] Lindsey Dinneen: Of course. Well, I'd love if you'd start off by sharing a little bit about your background and what led you to medtech. [00:01:39] Ryan Phelan: Sure, absolutely. So I'm an attorney by trade. And I started off in probably a different place than most people in MedTech, but I have a computer science degree and I worked in industry first for Accenture, doing a lot of programming and consulting in the FinTech world. So, high frequency trading and programming some pretty complicated data algorithms in order to trade stocks and bonds and securities, and things like this. That let me see aspects of intellectual property that people were doing with respect to the code I was writing. So I got curious with IP and law, and that led me to law school, Northwestern Law, in pursuing a joint JD, MBA program, which I finished in 2010. And I went into IP law with a passion for technology, pretty much in the computing space. And then in the last decade or so, IP practitioners, not unlike doctors, like to practice in specific areas and one of the ones that I focused on is software medical devices. And so that, that kind of led me into the realm of medtech. [00:02:48] Lindsey Dinneen: Very nice. Okay. So you have had such an interesting career trajectory and I'm wondering, back in the day, say you're a six year old Ryan, could six year old Ryan have predicted that you would be a lawyer and particularly intellectual property? [00:03:04] Ryan Phelan: Absolutely not. I mean, first of all nobody in my family, at least immediate family, was a lawyer. And so going to law school was not on the radar. I grew up in Louisiana in a small town, basically farm life, so certainly technology and stuff like that wasn't available in the city. But I did have a passion for things that were tech. I was certainly a kid that loved to take things apart and put them back together and build all kinds of Legos and stuff like that. So that basic kind of STEM acumen or desire was always there from the beginning. And so, as I, I grew up and got exposed to more things, certainly in college, it became kind of a passion. And so, I ended up doing that. We did have some medical issues in my family, including cardiac and cancer and stuff like that. So, those types of things always hit home with me and you're getting to a chance to kind of lean into medtech, at least on the software side, with medtech devices that include or incorporate medical technology became very interesting to me personally. [00:04:07] Lindsey Dinneen: Yeah, of course. And so going back just a smidgen when you decided to go into law and you know, you've come from this background that was the software engineering and you've got this fintech background and you have all of these amazing skill sets already, what led you specifically to say, "Okay, I want to focus on intellectual property, and so this is going to be my, my sweet spot." [00:04:33] Ryan Phelan: Yeah. So when you go to law school, you get exposed to a lot of different classes. In fact, in your first year law school, you're required to take a bunch of baseline courses like criminal law and all these things. And so you quickly figure out what you like and what you don't like. And so for me, a computer science degree is always kind of the beating heart of what I loved. And so I wanted to, I tended to like, classes that were up that alley, so to speak. And the IP course that I took was definitely there because it was all about technology, inventions, people making things, and how those inventions played out in court. So I found my greatest joy in law school to be in those classes. So I spoke up the most in class and did the best. There's common saying that "you should do things that you love because you never have to work a day in your life" kind of thing. So I always try to think about that, and certainly fun today because I practice in IP and picked that direction. [00:05:27] Lindsey Dinneen: Yeah, absolutely. So, in addition to all of the other credentials you have, you are also a published author and you are a speaker. And I would love if you would share maybe a little bit more about how you got into being a thought leader as well in your industry and how that path has taken you. [00:05:51] Ryan Phelan: Yeah, for sure. It's the same kind of thing. I've always liked to write as well. And I feel that when I write about something, I really get to understand it. And so in my field, there's a lot of stuff happening all the time. Like a court will come out with a new case, an IP and medtech or AI or something like this, and I really like to dig into it to figure out how can I use this court decision as a tool for clients, or how does this change things up? What will clients ask me questions going forward, or how can this be an interesting topic to either write about or to speak about? And so, I try to learn when I'm reading, and then I write it, and that teaches me, and I think and hope that others get a benefit from that too when I publish, so. [00:06:34] Lindsey Dinneen: Yes, of course. Of course. And you are also, if I'm not mistaken, an adjunct professor. So, first of all, do you sleep? And second of all, tell me more about this as well, please. [00:06:47] Ryan Phelan: Yeah, so I'm an adjunct professor at Northwestern Law. I teach a course on patenting software inventions. I do sleep because it's only once a year for a power week. You know, I think it's like three days out of the year. There's the long classes, they're like a few hours each, but we pack in several 30 minute core sessions into a day. So one day, maybe we'll go for three hours or two hours. And, you know, we will get the benefit of several weeks of coursework by doing all of that at once in those three days. And so, I teach on that. We teach fundamentals of patenting softwares and inventions, which includes medtech software devices. For example, the FDA classifies software, medical inventions in, in, in certain ways, like their software as a medical device where you have the software only such as, you have database with medical data and you're either formatting it or storing it or processing in some unique way, or you have software in a medical device where you actually have a physical device. It's a cardiac device where the software is running or at least partially running that device. And so we talk about ways to, to patent those inventions primarily with US law. So. [00:07:59] Lindsey Dinneen: Very nice. So specifically thinking about your medtech clients, because I know you probably have clients in many industries, but specifically in medtech, what are some of the common mistakes you see medtech companies making? Especially say, you know, an earlier startup or something like that, when maybe they haven't thought through an aspect that really should be thought through a little bit earlier in the process. What are some common things that you see that people should be aware of? [00:08:27] Ryan Phelan: Yeah, I mean, easily one of them is not filing a patent application early. And if they are a startup company and they have their biggest selling product, or what they think will be their biggest selling product, and they don't file a patent application on it, that could be bad because you have one year to get to the patent office with that, at least in the U. S. to file something once it's been publicly disclosed. And if you miss that deadline, then effectively you're allowing your competitors to copy it. And if you're a startup company, the last thing you want is for your product to become extremely successful and then a big Fortune 500 company gets wind of it, figures out you don't have a patent, and then just starts making it themselves and it takes away your market share. So that would be, you know, I think that's every inventor of startups like worst nightmare, right? So, getting that patent on file before the deadline is pretty important. [00:09:22] Lindsey Dinneen: Yeah, of course. Now, I noticed you had recently written an article on LinkedIn about when to file this patent. And I know part of maybe some concerns that might arise are, "Well, we don't necessarily want this to be in public awareness yet." So how do you walk that line between "This is our IP, we're really trying to keep it very tight," versus, "But I also need this protection, this legal protection." So how do you navigate things like that? [00:09:54] Ryan Phelan: Yeah, so the point at which you need to make your invention publicly available or to disclose it because you need to, you know, maybe you're going to pitch competition and you need to show your invention on like a PowerPoint deck in front of hundreds of people. Then that's probably a good point to start thinking about filing a patent application if you're still developing it, and it's like in your basement, so to speak, and nobody's seen it. It's still secret then. You don't need to necessarily file a patent application at that point. Although, there's a funny thing in patent law where, if you have an idea, sometimes there's somebody else thinking about it too, and the first one to get the patent office, wins, and so, you certainly don't want to wait around too long and find out years later that you filed your patent application the day after somebody else. This actually happened with Thomas Edison and the light bulb and he had lots of fights about the other person that was claiming the same thing that lost, and we don't remember his name today because of that. So anyway, so that's one thing to keep in mind when you're starting out. [00:10:54] Lindsey Dinneen: Yeah. Well, and speaking of those kinds of stories, are there any that particularly stand out to you as you've worked with all of these incredible clients who have seriously life changing products they're creating. Are there any that really stand out to you in your memory as affirming, "Oh my goodness, this is why I'm here. This is why I'm doing what I'm doing." [00:11:17] Ryan Phelan: Yeah, for sure. One that stands out is one in the opioid or the narcotics market. In my family, we have an individual who is unfortunately affected by this. And so, I had a client that reached out to me to create a VR program that helps to eliminate or to reduce cravings in this field. And that one was really impactful because using technology and non pharmaceutical way in order to reduce cravings for people that are struggling with addiction of some type, I felt to be very important. So I thoroughly enjoyed working with that inventor and helping to, to create that patent application for that invention. [00:11:59] Lindsey Dinneen: Yeah, of course. Yeah. Thank you for sharing about that. I think sometimes those really personal connection kinds of stories are the ones that really stick in your mind because it, it helps to have this moment of realization, like you know that what you do matters, of course, but then having that extra layer of confirmation that "Yes, this is helping somebody who could literally be a family member or a close friend or relative" is really impactful. [00:12:25] Ryan Phelan: Exactly. [00:12:26] Lindsey Dinneen: Yeah. So considering all of the industries that you currently serve, and of course, you have this incredibly varied background, which can only be wonderful to draw on from this rich history and experience of yours. What are some interesting crossovers you see between industries that can be useful in terms of, maybe one industry approaches something in a way that you've seen could actually really benefit folks in medtech or vice versa. Are you seeing trends like that? [00:12:59] Ryan Phelan: Yeah, absolutely. I mean, one of the biggest ones that I can think of now is artificial intelligence coming into play with medtech. I mean, certainly, medtech kind of runs the gamut of, you know, like, like we mentioned before software only to physical devices that incorporate software. And so AI is interesting because you can load it and AI model onto one of these physical devices, or you can have an AI model that's medtech based sitting on a server somewhere that can help doctors look or find particular cause or whatnot like that, based on symptoms that a patient may walk into, or maybe there's a device, like a needle, that allows that has an AI model on it that helps with injection or something like this. And so, these AI tools are becoming smarter. And I think that they help in the field of medtech and they require a different level of expertise with these inventions to not only create them because they're complex, but also to bring them to market because they require specific FDA regulations. Even the FDA right now is trying to figure out AI. They have approved several AI devices, but it usually comes down to, you know, is your AI device going to change in the near future because you're going to update the model? And if so, does that change it enough to require like a new submission? So the fact that AI moves so rapidly doesn't really mix well with the FDA's process of approving the device and having it set in stone at that approval state. [00:14:30] Lindsey Dinneen: Yeah. So where do you anticipate that this will take medical devices? Do you think it'll become so naturally ingrained in many of them that it's just sort of part of our reality, or do you think we'll still have those --what do we want to call them-- not AI functionality devices? [00:14:48] Ryan Phelan: Yeah, I think both will exist. You know, certainly a spectrum of these devices, right? Certainly there's surgical tools that exist now that have hundreds of years, or a hundred years, just in different, maybe better forms. So, those will stay, stick around. The AI assisted ones, I'm sure will find their niche, and live alongside the the existing tools. [00:15:10] Lindsey Dinneen: Yeah, absolutely. If you could narrow it down, what would be maybe your top piece of advice for a MedTech startup founder from your perspective, in your role? [00:15:23] Ryan Phelan: Yeah, I guess the number one would be again to, you know, make sure you're not giving away your crown jewels. Have your patent filed before you step out. If you're trying to raise money, just be careful that you're not sharing information publicly. You have to share with a potential investor, consider an NDA or if they won't sign an NDA, you can file a provisional patent application with the patent office. That shows that you have something on file before you talk to others. And as long as you describe the invention sufficiently in the four corners of your provisional application, then that's often the best way to protect yourself going out. So I think, as an IP attorney, that, that would be the number one advice that I would give a startup company in the medtech space. [00:16:10] Lindsey Dinneen: That's incredible. Thank you for that. That's really appreciated advice. So, it's so interesting because when I was looking at your LinkedIn profile, of course you have all of this incredible experience, and one thing actually really stood out to me, and that was that at least at some point you have been a and --I'm sure you've done this throughout your career multiple times-- but a pro bono lawyer for Lawyers for the Creative Arts. And I was curious about that and how you got involved, and can you share a little bit about that journey? [00:16:40] Ryan Phelan: Yeah. So LCA or Lawyers for the Creative Arts is an organization here in Chicago that deals with artists of limited means. You know, usually they have some type of basic issue that they want handled and it mainly deals with IP. Typically, I work on a different capacity for these because I see them as like kind of fun learning opportunities. I usually work in the copyright space and the clients that I work with need help either filing a copyright for maybe a piece of art that they've created, or maybe have a question about how their IP is being used or sold in some way, and they need to figure out if their IP has been infringed. And so, we'll work with them in a pro bono capacity to help write a letter to a company or to file a copyright registration and things like that. [00:17:28] Lindsey Dinneen: Well, as a, as my side thing as also an artist, I just want to say thank you because it is so great that you're doing things like that for the artist community. It is not always easy. So, oh, that's great, appreciate it. Yeah. So as you look towards your own future, what are you excited about say in the next year or two? [00:17:50] Ryan Phelan: Very excited to see how, I guess, AI is playing out with medtech. You're seeing regulations and guidelines coming out that The United States Patent and Trademark Office and also the Copyright Office about how these laws will impact artists. I've sat on a panel with the Copyright Office and the United States Patent and Trademark Office as they're thinking through these decisions and putting out these guidelines. There is questions about, is the new administration going to change things up with respect to guidance and guidelines that have come out. So, you know, artists are looking at AI is like a tool, like a paintbrush. And the law is kind of looking at it, obviously from the legal perspective and it doesn't seem like those two things are aligned yet. There's common in, in history that the law typically lags the technology by, you know, a decade or two or more. And so that's certainly the case with AI. For example, there is a famous -- I wouldn't call it a case-- but a denial of a copyright registration at the copyright office for a gentleman that had created an AI piece of artwork, won the Colorado state fair, I think in 2022, and tried to file a copyright registration, but was denied. And he told the copyright office, basically he had entered in 500 plus prompts in order to generate, or at least partially generate, this work of art, but was still denied . Not because of his effort, just because of the way the law is written under current copyright statutes. And so, things like that seem to be, at least from a policy perspective, incorrect. And so it'd be great to see exciting how this plays out. Will Congress care enough to change it or how will artists be impacted under these types of laws and policy considerations going forward? [00:19:35] Lindsey Dinneen: Yeah, absolutely. So pivoting the conversation a little bit just for fun, imagine that you were to be offered a million dollars masterclass on anything you want. It can be within your industry or part of your amazing background, or it could be about something entirely different. What would you choose to teach? [00:19:55] Ryan Phelan: Yeah. Wow. You know, I guess I would teach what I'm currently teaching. Cause I, I do enjoy the class I teach now. I'm at Northwestern, my alma mater, which I love. It's down the street from the office, get to go in same place where I went to school and teach the law and things that I do every day, which is patenting software inventions, including the medtech space. If I could get a million dollars to teach what I do now, that would be wonderful, in this hypothetical, so. [00:20:22] Lindsey Dinneen: Right. I love it. Excellent. And how do you wish to be remembered after you leave this world? [00:20:30] Ryan Phelan: Wow. I hope people remember me as someone who was fun loving and enjoyed tech and hopefully brought some information to the world that helped them in some way. [00:20:42] Lindsey Dinneen: Yeah, of course. And final question, what is one thing that makes you smile every time you see or think about it? [00:20:51] Ryan Phelan: Oh, wow. I guess there's a lot of stuff. I also like to do some type of sports. Currently, the ski season is ending, so I certainly enjoy skiing, so when I see or think about that's one of those things, and now coming is the golf season, so I transitioned into that. We're looking forward to some good weather here, finally, in Chicago. It was 80 degrees last week, and it snowed yesterday, so things are changing from golf to ski season, but one of those is always fun, so. [00:21:17] Lindsey Dinneen: That's awesome. That's fantastic. Yeah. If folks who are listening are in a position, would there be a way for them to get in contact with you and then how early should they do that actually? [00:21:31] Ryan Phelan: Yeah. There's multiple stages. They can get in touch with me anytime they want. You can always find me at our firm's website, Marshall Gerstein. Or if you want to, you can go to patentnext.com, just patent and the word next. com. That's my blog that I write on typically, and it has my contact information there, including my email address. [00:21:51] Lindsey Dinneen: Perfect. Well, thank you so much. Well, Ryan, it has been a joy to speak with you today. I really appreciate you sharing a little bit about your career and your insights, your advice, especially appreciate that for MedTech founders who might, you know, not quite know where to start with this whole legal element that they really need to consider. So I really appreciate you sharing kind of when and how to do that. And we're excited to be making a donation on your behalf, as a thank you for your time today, to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that charity to support. And thank you again so much for being here. This has been a wonderful conversation, and I just wish you the most continued success as you work to change lives for a better world. [00:22:41] Ryan Phelan: Thank you, Lindsey. My pleasure. Happy to be here too. Thank you for having me. [00:22:44] Lindsey Dinneen: Of course. And for our listeners, thank you so much for tuning in. If you're feeling as inspired as I am, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:22:56] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

The National Standards Authority of Ireland (NSAI) has published its 2024 Year in Review, highlighting a transformative year of progress in areas critical to Ireland's future, including housing innovation, digital resilience, and sustainability. In a year of global uncertainty and rapid advances in areas like cybersecurity, NSAI played a pivotal role in supporting business competitiveness and advancing Ireland's strategic ambitions under Housing for All, the Climate Action Plan, and the Digital Europe Programme. Minister of State with responsibility for Employment, Small Business and Retail, Alan Dillon TD said: "The NSAI plays a vital role in strengthening Ireland's business ecosystem. From enabling housing innovation through Modern Methods of Construction (MMC) and Building Information Modelling (BIM) to advancing cybersecurity and sustainability, NSAI's Year in Review displays how the organisation supports our industries to grow safely, smartly, and compete internationally. The Year in Review reflects the important role NSAI plays in supporting Irish businesses and setting and maintaining world-class standards, measurement services and certification systems." In 2024, NSAI advanced key pillars of its Strategic Plan 2022-2026 in the areas of housing, digital transformation, climate and MedTech through standards, metrology and certification that directly support Ireland's Programme for Government and economic growth. Geraldine Larkin, NSAI CEO, said: "NSAI is committed to supporting businesses to enable growth, competitiveness and long-term success. We're proud to act as a bridge between innovation and assurance, empowering Irish businesses of all sizes to operate with confidence, integrity, and international credibility. Whether it's bringing a new MMC housing system to market or achieving ISO certification in information security, we ensure companies can move faster, meet expectations, and lead by example." Key highlights from the report include: Supporting housing innovation: With 80 new MMC enquiries and 48 new applications received in 2024, NSAI's MMC department is supporting faster, safer and more efficient construction outcomes. NSAI's Sustainability and Built Environment department approved 1,132 construction products last year and NSAI established a dedicated Building Information Modelling department before Christmas. Agrément certification is specifically aimed at products or systems that are new or innovative. The KORE group in Cavan, for example, achieved MMC Agrément certification through NSAI for its insulated concrete formwork system and its insulated foundation system. Caroline Ashe Brady, Commercial Director with the Kore Group said: "NSAI's rigorous assessment process has been crucial in enabling us to bring next-generation construction solutions to market with confidence. MMC Agrément certification helps manufacturers in the construction industry, like ours, to meet both compliance requirements and sustainability goals." Cybersecurity at the forefront: In September 2024, NSAI was appointed lead co-ordinator for the EU TrustBoost programme, aimed at strengthening cybersecurity certification across the EU. With threats to data privacy and digital infrastructure on the rise, this initiative under the Digital Europe Programme is helping to develop new technologies and tools to create a more secure digital ecosystem for Europe. Separately, NSAI developed a new certification readiness tool for Irish SMEs around information security. Innovation and excellence through standards: As Ireland prepares to take over the presidency of the Council of the EU in July 2026, NSAI continues to take a leading on the role of standards in support of the single market. This is a vital role at national and European level. In 2024: 1,467 standards were published 286,209 standards were accessed 200 new members joined technical committees (there are now over 2,400 national committee members) Precise measuring for trade: NSAI's Nati...

As drug abuse rises globally, organizations and governments are turning to preventive solutions. With over 450 active accounts across 24 countries, Intelligent Bio Solutions (Nasdaq: INBS) is making a significant impact through its Intelligent Fingerprinting Drug Screening System.In this interview, Doug Heath, VP of Global Sales, and Anna Turkington, VP of Marketing, discuss how the company is advancing portable, rapid, and pain-free drug testing using its fingerprint-based screening technology.They also share insights into Intelligent Bio Solutions' business model, growth outlook, market opportunity, and global expansion strategy.Find out more: https://ibs.inc/Watch the full YouTube interview here: https://youtu.be/qHeVoWcBU_U And follow us to stay updated: https://www.youtube.com/@GlobalOneMedia?sub_confirmation=1

In this episode of Medsider Radio, we had a really engaging conversation with James (Jim) Corbett, CEO of AVITA Medical.AVITA Medical's RECELL system uses Spray-On Skin Cell technology to accelerate healing for patients with severe burns and wounds.  Jim brings nearly 40 years of medical device leadership experience to AVITA Medical. His career spans global commercial and operational roles, including President of Boston Scientific and General Manager of Scimed Life Systems. Jim has served as CEO of six companies, including three publicly traded entities — Microtherapeutics, ev3, and Alphatec Spine — as well as CathWorks, Home Diagnostics, and Vertos Medical.In this interview, Jim shares lessons from a career spanning global medtech leadership positions — including the importance of hands-on fundraising, adapting sales strategies as products mature, and how generating clinical evidence beyond FDA requirements serves commercial adoption.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Jim Corbett.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're highlighting comments made by FDA representatives at an event about the most common premarket review issues they see in submissions. First, there is some discussion regarding whether the issues are truly premarket or postmarket concerns. Then, we look at what these are, why they are likely so common, examples of them, and how to avoid running into these issues yourself. During this conversation, the following questions are addressed:Recently, three medical device senior operations officers from FDA's Office of Inspections and Investigations spoke at a conference about the most common “issues” FDA encounters during the premarketing review of medical devices. Can you give a recap of what they said?In your 30+ years of experience working in the medical device industry, would you agree with FDA that these are the three most common issues?Before discussing the three specific common problems individually, what do you think is the “root cause” of these problems?Can you provide some examples?How can design change and design creep get companies in trouble with FDA?What does “marketing beyond authorized intended use” mean?Do you have suggestions and/or best practices to avoid running into problems around these issues?What else is important?What are today's takeaways?Listen to this discussion and see if you've run into these issues yourself. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com andSend us a textFor more medtech news and information, visit https://www.mpomag.com.

Irish Manufacturing Research (IMR) and AMBER, the Research Ireland Centre for Advanced Materials and BioEngineering Research, have officially launched the European Space Agency (ESA) Phi-Lab Ireland - a pioneering six-year programme designed to drive innovation in space technologies within companies in Ireland. Ireland, as a global leader in advanced manufacturing and materials science, will address the thematic area of space-optimised hardware. Phi-Lab Ireland will fund cutting-edge research across the entire life-cycle from materials discovery and testing, to the scaled production of components optimised for the unique and challenging environment of space. Benefiting from the combined capabilities of two of Ireland's leading research organisations, Phi-Lab Ireland will also offer access to expert mentorship and training programmes, state-of-the-art research infrastructure, comprehensive networking opportunities, and significant seed funding for projects up to 24-months. Welcoming the expansion of the European Space Agency's Phi-Lab network to Ireland, Minister for Enterprise, Tourism and Employment, Peter Burke, said "the launch of ESA's Phi-Lab Ireland offers Irish companies a great opportunity to further develop in the areas of advanced manufacturing and materials innovation. Available to space active companies and to companies who up to now haven't considering entering into this market, Phi-Lab Ireland will offer expert mentoring and training programmes, access to state of the art research infrastructure and critical seed funding up to €400k. Working in partnership with ESA, IMR and AMBER, two of Ireland's leading research organisations, will strengthen the capability of the growing Irish space eco-system and I look forward to Irish companies taking their place in the globally competitive space sector. I am particularly pleased to see this degree of endeavour and innovation taking place here in Mullingar in my own constituency". "The establishment of ESA's Phi-Lab in Ireland marks a pivotal moment in our journey to position Ireland at the forefront of space innovation. The initiative reflects our continuing partnership with the European Space Agency and our shared ambition to harness cutting-edge technologies for economic growth and global impact. Phi-Lab Ireland will empower Irish companies to lead in the development of transformative advanced manufacturing technologies, unlocking new markets and creating high-value opportunities for the future" said Minister of State for Small Businesses and Retail, Alan Dillon, on the launch of Phi-Lab Ireland as part of the expanding ESA Phi-Lab network. Phi-Lab Ireland's first funding call for research project proposals from Irish companies seeking to grow in Ireland's developing space ecosystem is now open. Unique to Phi-Lab Ireland, projects are welcome from companies who in the past may have never considered their products for the space sector, and also current space-active companies seeking to advance their position in this market and/or bring their innovations to larger terrestrial markets. Commenting on the launch of Phi-Lab Ireland's first funding call, Dr. Ken Horan, Director of Technology Innovation and Entrepreneurship at IMR and Head of ESA Phi-Lab Ireland said "ESA Phi-Lab Ireland is a unique opportunity for Irish SMEs, start-ups, and researchers to become leaders in space-focused innovation. Today the Space sector offers opportunities akin to those presented by the MedTech sector a few decades ago and before that, ICT manufacturing. These have become cornerstones of the Irish economy. We want to see Ireland equivalently recognised as a global leader in the Space sector and are building a national competence centre to advance this ambition". Prof. Mick Morris, Director of the AMBER Centre added "AMBER are delighted to partner with IMR to support Irish industry and researchers in exploring new commercial opportunities in the space sector. This activity will build on our...

In dieser Folge von MedTalk ON AIR sprechen wir mit dem geschäftsführenden Direktor und Inhaber der KLS Martin Group – einem der führenden Medizintechnikunternehmen mit Sitz in Tuttlingen. Wir werfen einen Blick hinter die Kulissen eines Hidden Champions, der weltweit Maßstäbe in der Chirurgie setzt. Was bedeutet Innovation im Spannungsfeld von Regularien, Digitalisierung und globalem Wettbewerb? Und wie gelingt es, den Spagat zwischen internationalem Wachstum und regionaler Verwurzelung zu meistern? Ein Gespräch über Zukunftsstrategien, globale Herausforderungen, regulatorische Realitäten, Vernetzung – und über die persönliche Motivation, individualisierte Medizintechnik weltweit möglich zu machen.

This week's episode features a fascinating interview with Nazmus Tareque and Raoul Peltier, co-founders of AnthroTek, a startup that is pushing the boundaries of material science in medical and robotics applications.Nazmus and Raoul come from very different worlds - law and VC on one side, drug delivery and materials science on the other - but together they're building hyper-realistic silicone solutions for real world impact.A few standout moments from the conversation:

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.Key Timestamps00:02 – Introduction to Greenlight Guru and medtech process integration01:15 – QMS evolution from startup to commercialization03:00 – Phase-based product development overview (Phases 0–6)06:35 – Why QMS should follow product needs, not just regulatory triggers09:10 – Agile vs. proceduralism in quality systems11:50 – Building a quality culture during the feasibility phase15:25 – When to implement QMS controls and how to prepare for “enforcement points”18:40 – Investor-driven and regulatory QMS triggers21:10 – How early QMS planning saves time and reduces future remediation26:20 – Ashkon's final advice for startups: start small and stay proactiveStandout Quotes"You've got to take the BS—being burdensome—out of QMS."Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development."Start small and do a little bit at a time—it won't seem like a burden."A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.Top TakeawaysUse the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.Don't Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech's safety responsibilities, rather than formal procedures.Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.ReferencesAshkon Rasooli on LinkedInGreenlight Guru – Quality management software for medical devicesEtienne Nichols on LinkedIn – Connect with the hostISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standardsISO 14155 Overview – Relevant for clinical validation proceduresMedTech 101: What Are “Enforcement Points”?In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver's license checkpoint—you may be cruising just fine, but at that moment, you must prove you're compliant. The earlier you prep for them, the smoother your...

Listen in as four outstanding MedTech leaders dive into the real-life challenges and mindset shifts that come with working in startup environments. In this special Future Leader Sessions episode of Career Diaries, our panel shares insights on:Speaking the CEO's languageBalancing long-term vision with day-to-day executionLeading through uncertaintyHear honest stories and practical advice on: ✔️ Getting CEO buy-in on quality and regulatory priorities ✔️ Communicating risk to non-technical executives ✔️ Maintaining strategic focus amid daily fires ✔️ Building a strong quality culture in fast-moving startups ✔️ Making the leap from technical expert to strategic leaderOur expert panel features: 

Listen & subscribe on Apple, Spotify, YouTube, and other platforms.   Welcome everyone to the weekly San Diego Tech News!    I'm Neal Bloom from Fresh Brewed Tech, the Tacos and Tech Podcast, and Interlock Capital. My co-host in this episode is Fred Grier, journalist and author of The Business of San Diego substack. He covers the ins-and-outs of the startup world including breaking news, IPOs, fundraising rounds, and M&A through his newsletter.  Before we dive in, we wanted to thank and ask our listeners to help us grow the show, leave a review and share with one other person who should be more plugged in with the SD Tech Scene. Thank you for the support and for helping us build the San Diego Startup Community!   June 20 Recent events debrief: MedTech, AI, GP/LP  BIO in Boston Startup activity in SD Recent Carta funding data in relation to San Diego and by stage Fundings Retrorate - podcast & Seaside Equity raises $723M for two funds   Cadre AI coming out of stealth Qualcomm acquisition of AlphaWave Semi for $2.4B   Curated Events List – For full list – check The Social Coyote July 1 - SD Tech Founders with Andy Ballester, GoFundMe and Eyepop AI co-founder July 4 - Founders Hike  July 8 - Afternoon Founders Hike July 29 - Dev & Data x CTO Talks: Healthtech Night  

The show starts unpacking the latest results from equipment hire company Ashtead (AHT). Mark Robinson analyses the outlook for US construction spending, the company's sensitivity to tariffs and its valuation. It's then on to Ashtead's smaller rival Speedy Hire (SDY), which is closing some of its depots due to rising staff costs. Listen to find out everything investors need to know. Next up is one of the IC's Ideas of the Year, which are putting in a strong performance again in 2025. Pensions consultancy XPS Pensions (XPS) reported full-year figures earlier this week – Julian Hofmann asks if its booming business can continue.Lastly, our Big Read on the medical technology sector. Mark Robinson covers the issues facing the industry, the options for investors and a potential tariff winner.Timestamps 1:50 Ashtead9:20 Speedy Hire18:29 XPS Pensions27:36 MedtechRead more on these topics:Ashtead stymied by falling used equipment salesSpeedy Hire attempts to boost efficiencies as HMRC loads costsThe cutting-edge medtech stocks worth owningListen to more podcasts from Investors' Chronicle on Apple, Spotify and YouTube Hosted on Acast. See acast.com/privacy for more information.

In this episode, Liz and Rachel discuss Liz's interview with Sandy Waugh Ruggles on the importance of developing a go-to market strategy with specific physician targets. They share best practices for getting specific on who to target first, and how that information impacts the training process. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Sandy's interviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting:   Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

Julio Martinez-Clark, Co-Founder and CEO of Bioaccess, a Latin American MedTech CRO that works with US-based medtech and biopharma startups to conduct their first-in-human trials outside the US to accelerate development and recruitment. Data from overseas clinical trials conducted to international standards is considered valid and can support conversations with investors, strategic partners, and the FDA. Drawing on resources in the Balkans, Latin America, and Australia, clinical trials can get faster approvals, more easily recruit patients, and benefit those living in the communities where clinical trials are conducted.   Julio explains, "The mission is to accelerate global clinical trials, and the type of clients is mostly us. Occasionally, we have European clients, but they're mostly San Francisco-based, Boston-based, San Diego-based, Minnesota-based, or Boston-based companies that are looking to execute a first-in-human clinical study outside of the United States. And for many reasons, Latin America is an obvious choice, at least for the exploratory phase. When they're looking for different countries, they usually explore Eastern Europe, Australia, and Latin America. And we help these companies, which have been predominantly US-based MedTech startups. More recently, we have expanded to biopharma as well. But let's talk with the conversation on MedTech startups, and their struggle to conduct these first inhuman trials in the United States. They seek help when they want to go overseas, and they call for us to help them find investigators and to recruit patients and to get past approvals, etc." "There is one single thing, which is that these companies are startups. Getting this type of trial approved is really, really difficult and expensive. And the timeline to get them approved is really uncertain. So when you have a startup that has investors backing the company and they have a business plan, they have some milestones, it is difficult to predict when you're going to hit these milestones, and you need to keep the investors happy. So if you don't have a solid business plan, then you are not going to be able to raise more funds to continue your operation and development."  #BioAccess #GlobalTrialAccelerators #DigitalHealth #PrecisionMedicine #LATAMTrials #BalkansClinicalResearch #AustraliaCTN #AANVISA #ALIMS #MINSA #TrialAcceleration #FirstinHumanTrials #ClinicalTrials #MedTechInnovation #Biopharma #MedTech #PatientRecruitment #CRO bioaccessla.com Download the transcript here

Julio Martinez-Clark, Co-Founder and CEO of Bioaccess, a Latin American MedTech CRO that works with US-based medtech and biopharma startups to conduct their first-in-human trials outside the US to accelerate development and recruitment. Data from overseas clinical trials conducted to international standards is considered valid and can support conversations with investors, strategic partners, and the FDA. Drawing on resources in the Balkans, Latin America, and Australia, clinical trials can get faster approvals, more easily recruit patients, and benefit those living in the communities where clinical trials are conducted.   Julio explains, "The mission is to accelerate global clinical trials, and the type of clients is mostly us. Occasionally, we have European clients, but they're mostly San Francisco-based, Boston-based, San Diego-based, Minnesota-based, or Boston-based companies that are looking to execute a first-in-human clinical study outside of the United States. And for many reasons, Latin America is an obvious choice, at least for the exploratory phase. When they're looking for different countries, they usually explore Eastern Europe, Australia, and Latin America. And we help these companies, which have been predominantly US-based MedTech startups. More recently, we have expanded to biopharma as well. But let's talk with the conversation on MedTech startups, and their struggle to conduct these first inhuman trials in the United States. They seek help when they want to go overseas, and they call for us to help them find investigators and to recruit patients and to get past approvals, etc." "There is one single thing, which is that these companies are startups. Getting this type of trial approved is really, really difficult and expensive. And the timeline to get them approved is really uncertain. So when you have a startup that has investors backing the company and they have a business plan, they have some milestones, it is difficult to predict when you're going to hit these milestones, and you need to keep the investors happy. So if you don't have a solid business plan, then you are not going to be able to raise more funds to continue your operation and development."   #BioAccess #GlobalTrialAccelerators #DigitalHealth #PrecisionMedicine #LATAMTrials #BalkansClinicalResearch #AustraliaCTN #AANVISA #ALIMS #MINSA #TrialAcceleration #FirstinHumanTrials #ClinicalTrials #MedTechInnovation #Biopharma #MedTech #PatientRecruitment #CRO bioaccessla.com Listen to the podcast here  

Julio Martinez-Clark, co-founder and CEO of contract research organization (CRO) bioaccess®️, joins hosts Michael Roberts and Scott Zeitzer to discuss why Latin America is a great place for clinical trials for medical devices. Julio explains how both the startup and the patients benefit from studies conducted in Latin America, and what startups should be thinking about as they get ready to begin first-in-human studies. Hosted on Acast. See acast.com/privacy for more information.

Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval. From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-based strategies, Adam shares hard-earned insights for avoiding the "second valley of death" post-clearance. Whether you're a domestic startup or an international company entering the U.S., this episode arms you with a tactical understanding of compliance landmines and scalable go-to-market strategies.Key Timestamps00:02 – Intro: The real MedTech “valley of death” after FDA clearance04:45 – Why U.S. state-level registration is misunderstood and overlooked08:15 – State-level definitions of medical devices and why they differ11:20 – Strategic go-to-market options: Distribution vs. Direct17:00 – How regulations vary drastically by state (CA, TX, etc.)21:50 – The real risks of noncompliance: lawsuits, bad PR, and due diligence failures26:15 – Why distribution agreements can stall your growth (and how to avoid it)34:30 – Sales tax & use tax: The hidden compliance trap39:10 – Logistics, warehousing, and long-term liabilities in contracts44:55 – Overlooked pitfalls: Secretary of State filings and income tax in 36+ states51:15 – Software as a Medical Device (SaMD): U.S. compliance still applies55:30 – Selling to the U.S. government vs. private sector buyers59:20 – Veterinary devices and why they still need regulatory controls1:03:10 – What a winning go-to-market strategy actually looks like1:10:25 – Adam's final advice to MedTech startups (foreign and domestic)Standout Quotes"You're not entering one country—you're entering 50 states and D.C. Each with its own rules, definitions, and tax laws."—Adam Steadman explains why U.S. MedTech entry requires a state-by-state strategy, especially for international companies."None of the strategics want your warehouse management system—they want your product, your sales, and your proof of market fit."—Steadman on why building non-core infrastructure slows down commercialization and valuation.Top 5 TakeawaysFDA Clearance ≠ Market Readiness – State-level registrations, sales tax laws, and pharmacy board definitions often delay or block commercialization.Distribution Isn't Always a Shortcut – National distributors may have misaligned incentives and can lock you into exclusivity that hinders growth.Sales Tax is a Regulatory Minefield – 46 states require separate sales tax registration, exemptions tracking, and monthly filings—even if you're tax-exempt.Beware of Long-Term Contracts – Logistics and distribution contracts often lock companies into rigid terms that prevent pivots or acquisitions.Speed to Market Is Strategic – Getting to market fast is often the difference between becoming #1 or #3—and #3 often gets nothing.MedTech 101What Is “Nexus” and Why It Matters for Sales Tax?“Nexus” refers to the minimum level of economic activity that triggers tax obligations in a given state. For example, selling $100,000 of devices or 200 transactions may establish nexus, requiring you to register for sales tax. Unlike VAT in Europe, U.S. sales tax laws are state-specific, making this a major compliance hurdle for MedTech companies.References & Resources

Jill Ellul has over 30 years of experience in the pharmaceutical industry and is the Founder & Managing Director of Mojoco, a business consultancy that offers innovation-led solutions to the Pharma, MedTech, and Biopharma sectors. Hear how to boost innovation & creativity in your organisation, how to dissolve groupthink, whether generative AI helps or hurts innovation, how to keep innovation the priority in your organisation, and whether all industries have room to be innovative. Connect with Shirley at ShirleyKavanagh.com and on LinkedIn, and Jill at MeetMojoco.com and on LinkedIn

In this thoughtful conversation, we explore the transformative role of AI in healthcare. From over a thousand FDA-approved AI-enabled medical devices to breakthroughs in medical imaging, the discussion highlights the importance of trust, transparency, and bias mitigation. Join Tracy Ring, Chief Data Officer and Global Generative AI Lead for Life Sciences; Tom Kawalec, Managing Director for Life Sciences Practice at Accenture; and Shaye Mandle, Executive Director of Digital Health Tech at AdvaMed, as they delve into AI's future in personalized care and its potential to reduce healthcare costs.

Every year, the Fierce Medtech team highlights 15 standout companies that are pushing the boundaries of innovation in medical technology. From reinventing diagnostics and surgical tools to advancing AI and biological research, this year’s Fierce 15 is full of startups rethinking what care should look like—and improving on what came before. In this episode of "The Top Line," Fierce Medtech Senior Editor Conor Hale breaks down the themes and standout trends from this year’s list, offering a closer look at the ideas and technologies reshaping the healthcare landscape. To learn more about the topics in this episode: Introducing Fierce Medtech's Fierce 15 This episode is sponsored by Cencora. See omnystudio.com/listener for privacy information.

Maria Artunduaga is the founder & CEO of Samay, the winner of the 2024 MedTech Innovator accelerator, as well as a groundbreaking physician, scientist, and inventor. Maria discusses her inspiring journey from a small town in Columbia to leading a top MedTech company in the US. After pivoting away from plastic surgery training, she channeled her efforts into creating Sylvee, an AI wearable sensor for COPD patients. Maria shares her relentless determination, innovative problem-solving strategies, and the creation of a company culture that emphasizes learning and diversity.    Guest links: https://www.samayhealth.com/home | https://www.linkedin.com/in/drartunduaga/  Charity supported: ASPCA Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 057 - Maria Artunduaga [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 I am delighted to welcome as my guest today, Maria Artunduaga. Maria is a physician, scientist, and inventor with 60 plus prizes, including becoming the first woman to lead a US LATAM company to win MedTech Innovator, the world's most competitive accelerator for medical technology surpassing over 1300 global companies. A top 1% student in Columbia, her country of birth, she relocated to the US to pursue plastic surgery training, but abandoned it to dedicate herself to solve the problem that killed her grandmother-- a lack of home technologies that can detect COPD exasperations early. Maria has raised 5.2 million, almost 60% in non-dilutive capital from NSF and NIH to build Sylvee, an AI wearable sensor that can provide COPD patients with continuous data on pulmonary functions similar to what continuous glucose monitoring sensors do for diabetic patients. Her invention has been featured by a hundred plus media outlets, including Forbes, TechCrunch, Bloomberg, Fierce Healthcare, and more. Before Samay, Maria completed postdoctoral studies in human genetics at Harvard Medical School, started a plastic surgery residency at the University of Chicago, and completed two master's degrees, one in global public health at the University of Washington, and another in translational medicine at the University of California at Berkeley and San Francisco. She lives in Mountain View, California with her husband, 2-year-old daughter, and four pets. In her free time, she enjoys flamenco dancing, bolero singing, traveling the world, and fostering diversity in and outside the workplace by mentoring underrepresented scientists and entrepreneurs. All right. Well, thank you so much for being here, Maria. I'm so excited to finally get a chance to speak with you. I'd love if you would share a little bit about your background and your career trajectory. What led you to MedTech? [00:02:40] Maria Artunduaga: Sure. So it's gonna be a little long and I'm gonna tell you everything about my life because the personal history is very important to me and for my company too. So, as you have noticed, I have an accent. So, I grew up in Columbia in a very small town in the southern part of the country. My parents were both doctors and I'm the oldest of four kids and two of us followed their lead. So my life in my city was pretty chill. Everyone knew everyone. I spent most of my days at a Catholic school studying very hard on weekends where I usually spent tagging along my parents to doctor events. One of the things that I really like to tell, it's how my parents work as entrepreneurs really shaped my life. They were real pioneers. They built in my hometown the first big clinic back in the eighties and the nineties. And my mom was the only woman in that group, and she actually was the CEO for a while, which was a big deal. She was the only woman in a partnership of 10 people. And watching them build that clinic, that hospital really taught me a lot about dealing with uncertainty and finding solutions. Every day we'll have supper or lunch and I'll just hear all of these challenges and stories, their struggles and how they solve things. Something that was, that is definitely super helpful in what I do now, right? So, and then I was 16 and after high school I moved to Bogota, the capital, which is up in the mountains, it's very cold. I got a scholarship 'cause I was always a very good student. You know, career I spent my last year, I spent nine months in the US. Honestly, coming to the US blew my mind. The technology that I got to see, the speed, effects on science, it was nothing like I've ever seen before, and that was true inspiration for me. So I knew that I had to come to the US. I needed to come back to learn from the best, of course. And it's interesting because my parents didn't want me to relocate to the US. I was the oldest. I was supposed to follow into their footsteps and obviously, like inherited that clinic, right? That hospital, we call it clinic, it's actually a hospital. And I was a very contrarian. I didn't listen to them. I told them, you know, I really wanna be where the best people are. And what I did was that I, it took me three years to save the money to come to the US, to get Harvard to actually sponsor me my visa because they wouldn't pay me for the first year. So I remember I had to save $30,000, which in pesos is significant. So back in 2007, so many years ago, I made it to Boston, and the original idea was that I wanted to become a pediatric plastic surgeon and bring that level of care back to Columbia. I spent four years of researching a genetic ear condition that's called microtia. And with that work, I was able to land a plastic surgery residency spot or position at the University of Chicago. And I shared this with a lot of people. I actually had a really negative experience. Things didn't go as planned. I actually faced discrimination. I eventually, you know, had to leave and I made the top choice to never ever go back into clinical practice. And I changed paths. I was 32 years old and yeah I decided to switch gears. I retrained into public health and tech. And then in 2016, I moved to the Bay Area where I am right now. And I got another scholarship to finish master's in translational medicine at UC Berkeley and UCSF. And during the courses that I took, some of them with business class etc., etc., I decided to found Samay in 2018. I really wanted to build something that would really make a difference in respiratory medicine. And this is where my grandmother comes. So my, the grandmother, my abuela, her name was Sylvia and she had Chronic Obstruct Pulmonary Disease or COPD and she's the reason behind my company. So, she often couldn't tell when her symptoms were getting worse. That's a huge problem. Catching the respiratory attacks, exacerbations is definitely key to keeping people outside of the hospitals, and obviously feeling their best to have a better quality of life. So, that's what we are trying to solve with a company, right? If we are able to catch those exacerbations even with a day or two notice in advance, right, that we can all make a difference. And so by missing these exacerbations, we are having really high expenses in hospitalizations and ER visits and the problem we trying to solve is that today technologies that are adequate enough to be used outside of the hospital because the ones that are considered to be the gold standard, they are very expensive. They are confined to their hospitals and they are very difficult to complete for the patient, especially when they're exacerbating. They need to blow out forcefully for about 10 seconds, 21 times. So what we are doing is, we are developing a sensor that makes it super simple for people to use it at home to track their lung function without doing those forceful maneuvers and ideally in the future to warm them, right? Like to let them know when things are starting to go south or obviously, you know, not going very well, and that's what it's all about. I mean, that's what we do with Sylvee right here. And it's wearable sensor and we have done significantly well over the past couple of years. We actually just won MedTech Innovator. [00:08:04] Lindsey Dinneen: Yeah. Significantly well over the last few years. Yes. So congratulations on that, and I want to dive into all of those exciting milestones in just a second. But I am, first of all, so inspired by your story. Thank you for just sharing that your resilience and your grit and your determination are really admirable. So thank you for sticking with something that was not easy, not an easy path. [00:08:29] Maria Artunduaga: I know. I know. [00:08:31] Lindsey Dinneen: It continues not to be, ironically, as we've kind of touched on before, but just going backward a little bit in your story. So I, it sounds to me like getting the opportunity to watch your parents have this incredible impact on their community and the healthcare and the opportunity is just so valuable for you. And even just learning about how your mom was the CEO and those kinds of things, did that help shape the idea for you that not only is entrepreneurship possible, is innovation and healthcare possible, but you can also be this in incredible leader as a woman in whatever capacity? I would just love to dive into that. [00:09:13] Maria Artunduaga: Yeah, it's super interesting, right? My mom really taught me a lot about leadership. She's a surgeon, so you can imagine how good of a leader she is in the operating room at home, everywhere, right? I mean, she's definitely the general, that's how I call her. And I honestly, I try to replicate, so my leadership and styles pretty much shaped by her. So I always call her my best role model whenever somebody asks me about the question, right? So I'm just like her. I lead from the front. I like setting the pace by working the hardest. So I really like to lead by example and I also, just like she did, and obviously because of her surgical training, I hold myself to a really high standard, and I expect everyone on my team to do the same. So people in my company know that I'm very strict, I'm very disciplined, and they know that from the beginning. It's so funny because when I interview all of them, at the final interviews with me, and I actually do the anti sale to join Samay. It's like, this is, these are all the reasons why you shouldn't join. I start describing myself as a very intense, obsessed CEO with insomnia, which I still have, because I really wanna make this work, right? So, yeah, I, ask them, and most of them say yes. I really like, I attract people that like challenges, especially intellectual challenges. So, yeah, to this point, most of them say yes. Some of them have obviously, you know, because probably too much. But at the same time, I tell them, "Look, this is going to be very hard in terms of the deliverables, the things that we're expecting from you." But at the same time, my goal is to not only help people with respiratory problems, I try to sell the company as a company where everyone that gets hired can be themselves and thrive. So, so for example, I tell them," Look, I'm trying to be the boss that I never had." And this goes obviously very tied to the very negative experience that I had during my surgical residency and even before, right? So, I never had a boss that really supported me, who recognize my true self and those characteristics as good things, right? So they always try to tone me down. I'm very energetic, as you can notice, and I'm also super ambitious. I'm really ambitious. I wanna do all of these great things. And they always thought that I was aiming for too much, especially for a woman. It's like, " You need to lean in, Maria. You need to behave." So I remember my residency, they were criticizing like, "Why are you behaving like this, Maria? Why are you asking so many questions? You're asking too many questions. You look more as an internal medicine doctor. Why are you always smiling, Maria? Why are you so happy?" So now, with everyone that I hire, what I try to do is that I focus on understanding their dreams and I try to figure out how this job is gonna help them get there. So if they wanna become a top engineer, maybe they wanna learn managerial skills, or they wanna run operations, or they eventually wanna become a founder themselves. So I try to create a partnership with them where they obviously help me succeed with the company, build Samay, but at the same time they get to do this personal growth. So it's extremely important that they get to place where they wanna be. [00:12:32] Lindsey Dinneen: Yeah, that's wonderful. And such a gift to your employees. And I also honestly, that sort of anti interview or whatever technique is brilliant because you do want it to be a fit for everyone, and it's so much better to have aligned expectations from the start. So, oh my goodness, that's so interesting. So, okay, so then. Speaking into that, how do you develop a company culture for yourself? You've learned from some pretty negative experiences, so obviously that's what not to do, but you know, as you're crafting your own company culture now, what kinds of things are sort of your core values, other than of course, your hard work and your excellence and holding yourself and others to high standards, but what kinds of things do have you developed that make it special to be where you are? [00:13:19] Maria Artunduaga: Yeah, I mean, that's a really good question. I'm very true to myself, and one of the things that I wanna do with Samay, it's I wanna create legacy. If you go to my WhatsApp, that's exactly the little logo or the slogan that's below my name: I'm creating or building my life's legacy. That's how I pitch myself. So I really wanna be remembered as someone that made healthcare more accessible, especially for the people that get left behind. So growing up in Columbia, I saw firsthand how unfair things will be and I wanted to change that. So that's how the values of Samay go, people first. I think legacy, it's extremely important, right? It's about getting those life changing tools and opportunities into the hands of people who really need them. And again, it's not necessarily, the group that we're building. It's the own experience of building a company with me, learning from the company, from the people that are working with. I really wanna make it accessible for people. And I wanna also be obviously a source of inspiration. You don't necessarily need to be this perfect person to be a CEO. You know, life is a struggle and that's totally fine. Just be very passionate about building legacy, right, your work and how you're impacting other people. And especially for me, I do a lot of work with women and minorities. I really wanna empower them to chase their dreams in science and technology. I really care about people. I don't know, I'm selfless about me. It's all about the others and creating legacy and being remembered. So, yeah, that's how I, that's how I roll. [00:14:59] Lindsey Dinneen: I love that. I love that. So speaking of you embracing the CEO role, when you first started your company, did you feel ready to step into this kind of position? Or was it something where you just were like, "You know what? I see the need. I know I can make a difference in this field. I'm gonna do it and I'll learn along the way." [00:15:19] Maria Artunduaga: No, not at all. And let, so there's a very good anecdote that I'm sharing. Again, back to all of these life changing experiences. I got into medtech because of, I don't know, somehow the planets got aligned, right? So I was doing a master's in public health because I thought that was going to be my real call, working for Gates in Seattle, because that's where I actually lived for about two years. Then I came to realize that it was very bureaucratic. It's very, was very slow. I have a type A personality. I really like to fix things very quick. I like to implement stuff. So I decided to do a second master's degree, and as I mentioned, here in Berkeley, I decided to join one of Atma METs minority programs for students, right? It's called SMDP. And I remember that was back in 2016, and they sent me to Minneapolis for the big conference. And that's where I got my first real taste of MedTech. And I remember watching the MedTech Innovator finals with Paul Grand. He was introducing the program, the finalist. I remember clearly seeing all of his pitches and how Green Sun Medical CEO won, and it was a game changer to me because when I saw them pitch, it was very exciting. You know, all these technologies, the many millions of people they could definitely impact, I saw that, and it clicked. I could turn the scientific ideas into something that helps millions in a way, the way how I would practice medicine, but in a more impactful way. So interesting story though. So the other thing that was very inspiring or at least that motivated me, I was the only person in the room who looked like me and spoke with an accent from South America, from Latin America. So it was like two reasons behind it. For me, it was I wanna be a medtech entrepreneur, but at the same time I wanna be able to break the glass ceiling, right? The first Latina physician CEO building a company that has hardware, software, and AI, this is what we actually do. And yeah, so it, it's mainly that. I really like challenges and I'm very motivated to show people that I can do things that might seem impossible or too difficult. So I really like showing people that anything is possible with a lot of hard work and determination. So yeah, that's mainly it. [00:17:47] Lindsey Dinneen: I love that. Embracing those challenges, running full steam at them and having that, I don't know, that gumption is fantastic too. And the desire, like... [00:17:57] Maria Artunduaga: Thank you. [00:17:57] Lindsey Dinneen: ...you said, to break through those ceilings and to represent and say, "No, it is possible." It is, and I love that. So, excellent. Okay, so can you share a little bit about the journey that the company has gone under recently and some of the really exciting milestones? I know there have been bumps and whatnot, but maybe some of the exciting things that have been developing and what you're looking forward to as you continue down the road. [00:18:24] Maria Artunduaga: Sure. I mean, whew. There are so many things that have been happening for the last couple of months. So it's been a long journey. It's been six years so far. Initially, you know, I wanted to build a company with an idea that was inspired, obviously, by the fact that I lost my grandmother to exacerbation and also because, at the time, I didn't know what I wanted to build. When I was doing an interview with a pulmonologist, what I realized was that I could actually build a technology that could be inspired by consumer devices, so hearing aids for example. And funny story is that my husband who is also Columbian, and went to MIT, he's been working at Google for over a decade and he's an auto engineer. He does a lot of things. He's very smart and he's one of the main architects. What I decided to do back then was, let's repurpose hearing aid technology by sending signals through the chest, and let's use the physical principle of acoustic resonance to understand what's going on inside of the lungs. And that's exactly what we are doing. We have 10 granted patents so far. We have 20 more pending on pulmonary so far. So we've done a lot of things. So we've tested that device on 450 people almost. All of our numbers of accuracy are over 90. Sensitivities and specificities are also between 82 to 98. Right now we are starting to see changes a few days before an exacerbation is actually diagnosed by a physician, which is extremely exciting. We have data from two people. Obviously it's a small sample size. We are following eight of them, and we're aiming to finish at 60 to hundred people in the next year or so. So that's our main goal. We've raised 5.2 million, 60% of that money is coming from grants, federal grants, and we just submitted a breakthrough designation to the FDA about a week ago, so fingers crossed, though, we get it right? There are a lot of things in the pipeline, things that are very exciting. Right now I'm super excited 'cause those six years were very hard. I was running a science project with my nails, getting money from grants, help from people who have known me forever. It was very hard for me to recruit a full-time CTO. So my husband has been helping me with some hours here and there. And we have right now 12 people in Columbia. So for developers, designers, clinical researchers, we are running most of our operations in Latin America because it's extremely, well, obviously cost efficient, and more importantly, we have access to people that are patients especially that are, that exacerbate more often. So we are to leverage all the different angles that we can get. [00:21:04] Lindsey Dinneen: Yeah. Wow. So lots of exciting things in the works and in the future, and oh my goodness, I'm so excited, can't wait to continue to celebrate all those wonderful accomplishments. So I'm curious, as you've taken this journey and even before with your other health experiences and finding this path, are there any moments all along the journey that really stand out to you as affirming, "Yes, I am in the right place at the right time, in the right industry." [00:21:31] Maria Artunduaga: Yeah, beyond the MedTech Innovator, the experience eight years ago, I mean, every day I find that this is the perfect fit for me. I always tell people, "Look, entrepreneurship is not for everyone. It really needs to be a fit of personality." So when I talked to my parents, because at the beginning they weren't very agreeable with the idea of me becoming an entrepreneur 'cause physicians don't do this, right? I was sort of like a black sheep of a family, 'cause my sister, she's successful and she's a pediatric radiologist as she's working for an academic center in, in Dallas. So, my personality, I'm Type A. I'm very anxious. I really like doing things super fast. I really like to get things done, right? So, I dunno if I picked the wrong career, probably could have done a better job as an engineer, as a scientist myself. So at heart, I'm a true scientist. That's what I really enjoy. I like practicing medicine, sort of miss it a little bit, but I'm more in the quest of solving questions and discovering, right? That's what really excites me. And then, every day is a new day when you're building a company. And the challenges that I have every day, all of the problems I have to solve, I really enjoy the process of solving them. And this is a little crazy. Who gets excited with problems, right? So, I don't know, that's probably me. So I guess every day, the moment I go home or that I go to sleep, I say, "This is perfect. I don't think I'll be as happy as I am right now if I had stayed medicine. I don't think so." [00:23:10] Lindsey Dinneen: Wow. And that says a lot. And that just affirms to you on a daily basis, "Yeah. I am doing what I'm supposed to be doing. That's wonderful. [00:23:17] Maria Artunduaga: Exactly. Right. It's like, yeah, I'm good at this thing. You know? I like solving problems. I got, I really enjoy the fires. I really like them. I's like, I don't know. I'm, yeah. I'm addicted to them. [00:23:30] Lindsey Dinneen: I love that. Well, and that is unusual, and I'm curious, do you? But it's a great thing. No, it's a wonderful thing. Yeah, no, absolutely. I love that. So, so when you're at finding yourself up against a problem, do you start with any particular kind of established framework? Do you like to just brainstorm solutions? How do you approach problem solving? [00:23:53] Maria Artunduaga: Gosh, this is a really good question. It's like, you know, if I had to teach something, right? So I'm very good at solving problems, at connecting different disciplines, right, to solve those issues. So for example, the way how I go about them, first of all, I don't get frustrated or too anxious about it. I always try to think first, right? And then, yeah, I start brainstorming. I'm very quick at thinking, my mind goes super quick. I have a whiteboard right behind me. I do a lot brainstorming on my own. I ask a lot of questions too. So I rely on a lot of people, and I get a lot of feedback on the way, how I think a problem needs to be solved. And obviously with time and experience, the older that you get, the better you become, right? So yeah, honestly, every problem is different. I just like seeing it from different angles, right? I'm very good with social stuff. I'm very good with arts too. I really like doing science, learning a about engineering. I really like different ways of solving problems. For example, I remember that I we had this NIH grant and we were working collaboration with a big, famous academic center right here. And things weren't working very well. That was through during a pandemic and I was getting charged things that we actually didn't approve. So things were getting a little awkward. I decided to finalize that agreement. But then I got through this situation that I had no access to patients here in the States, and at the time, I didn't have my clinical site in Columbia opened up. So what I did was the craziest thing, which is what I did, was that I bought an $80,000 machine and I came into an agreement with a friend from medical school who has a pulmonary practice in South Florida, one of the largest pulmonary practices. He's a partner with nine other guys, and they see probably a hundred patients every day. Can you imagine that? So respiratory patients, and I told him, "Look, I don't have any money to pay your rent, but I'm gonna give you equity for that rent, and you're gonna use this machine from Monday through Thursday, and I'm going to test your patients from Friday to Saturday. And I'm going to bring people, I'm going to become my own CRO, right? So I'm gonna bring people, doctors, from Columbia on a J1 visa as a research scholar visa. I'm gonna train them and I'm gonna get them to do the recruitment, review everything, test the patients. We are going to become our own CROs, and we are going to do as many people as we can every single week." So we were able to do 430 people in a span of a probably a year and a half. Something that usually would cost us thousands of dollars. I dunno how much money I spend, probably just 300,000 to do everything. Can you imagine? I mean, that's significantly cheap compared to any other quote that I've been getting from an academic center. So, I sometimes go for the crazy idea, right? Like, what's the craziest thing that I could think of? I literally, I write it down, right? And then I just try to double check with my lawyer. "Am I doing something illegal here?" And I, yeah, I cross reference with other founders. " I'm thinking of doing this, how that's that sound?" And they're like, "This is pretty non-traditional, Maria, but I mean, if you can get it done..." I'm like, "Yeah, of course I can get it done." And I just get it done. I just don't take a no for an answer. I'm very good at also finding, convincing people to jump on board with the vision, the mission. This excitement, this energy, people really get very engaged with Samay and with me as a founder, and they love it. Most of these people either have invested in the company, they are helping me many more hours, pro bono, literally free, and we are building together. [00:27:43] Lindsey Dinneen: Wow, that is so cool. And what a fantastic story. Thank you for sharing that one as well. Oh my word. [00:27:50] Maria Artunduaga: I have way too many stories to share. This is the one I really like to, to tell people. [00:27:55] Lindsey Dinneen: I love that, and I love the willingness to come up with those crazy ideas. And it might be just so crazy that it works. So, hey, you never know until you try, and that's fantastic. Oh my gosh, I love that approach. Alright, so pivoting the conversation a little bit just for fun. Imagine you are to be offered a million dollars to teach a masterclass... I know! ...to teach a masterclass on anything you want. What would you choose to teach? [00:28:22] Maria Artunduaga: Yeah. So, good question. So, gosh, I, I tackle problem. So my, my brain again is very good at figuring stuff out. That plus the fact that I'm very stubborn. So if I'm into something, I don't give up easily. And now I'm gonna tell the story about our winning MedTech Innovator. We beat 65 companies globally, right? And I still like, sort of, I cannot process that we won. So the story goes like this, but a year ago, I tried to raise five millions, my very first institutional round, and I totally flopped. [00:28:55] Lindsey Dinneen: Oh. [00:28:56] Maria Artunduaga: I only got $200,000 because multiple funds that I was talking to, they wanted me to feel half of the round before weighing any money or signing anything. So you can imagine. So do I got, you know, chicken or the egg problem? I failed. And instead of crying or mopping, I thought, "Okay, wait. I got into Medtech Innovator. You know what? I'm just gonna win that competition, still $350,000." And why not? So obviously people, my advisors, my best friend, "Like, you're crazy. It's the most competitive thing ever. You're not established in the field. People know who you are, but it's not like you have exited a company or anything, right? You're not even an engineer, Maria." So what I did was, again I went back to my whiteboard. Again, I probably should have become an engineer before, I dunno. I'm really good at solving problems. So I was like, "You know, this is a problem. These are the different ways how I can tackle this." And more importantly, I'm very good at the studying stuff. I really like, again, knowing, wisdom, information. I just love that. I really love that. So what I did was, I treat it like a big project, and I talked to the past winners, anyone who had done or won any sort of like prize with MedTech Innovator, and I figure out their secret sauce. So I either talk to them, I studied every single video, every single pitch. I spend many hours studying everyone who had one or had done significantly well throughout the accelerator. So what I discovered was the accelerator was kind of a school, like a school. So the harder you work, the better you do. And one of the things that I realized was that mentors and reviewers were key players. So I focused on building those connections. I met with many of them. I probably spent about, I don't know, probably four to five hours meeting with mentors, anyone who I thought could help me somehow, obviously, for free, because a lot of the help that they give used for free. And I also spent a lot of time doing homework, the webinars, et cetera, et cetera. I ask a lot of people for advice. I really got people excited about Samay. I recruited my mentors and they got on board from day one. Because of that, I started building those relationships and it was authentic. I mean, don't get me wrong, this wasn't like, you know, I'm trying to play anybody. I really care about what they had to say, and I incorporate all that feedback into my company to this day. So the other thing is, I make sure to go to everywhere, every webinar, every event, everything. My camera was always on, because most people, when they do their webinars, they don't even turn on their cameras, right? So I was very engaged. I was asking questions, I was getting involved with everything. Same thing with the Slack channel that we have for MedTech Innovator. I was helping people, I was sharing stuff. I was even offering to make introductions. I really made sure that people knew who I was. And I obviously also asked the MedTech Innovator people, the staff, for help, feedback, right? Am I doing this right? What do you think I should do? Anything that you can share with me that you think. I was very clear with them. I wanna go to the, I wanna get to the finals. I told them, and I remember they telling me, "Oh, Maria, about getting to the finals, it's so hard. It depends on the strategics and the sponsors." And I was like, " I'm gonna get there. What do you think I should do?" So I literally ask a lot of people how I needed to get there. And with the finals, the way how they pick the finalist, it's actually the mentors who go in front of the strategics, and they sort of champion your company. And they really went to bat for us. They told them how committed I was, the many people that from my team were actually going for participating to the winner because I brought people from my team... [00:32:45] Lindsey Dinneen: Yeah. [00:32:46] Maria Artunduaga: You know, very few founders did that. I brought people from Colombia, obviously online, people who barely could understand English. But, I made them prepare questions. "You need to do this and that we need to be super engaged. We need to help other people." And they saw it was hard work. And at the end, we got into the finals and what I realized was, okay, so after the finals, I understood that the game was, obviously it changed. The way how the winner is chosen is that the audience votes, right, during The MedTech Conference. So what I did was, I went all in on social media. We made an awesome video for the best video competition. I remember that that was the first thing that I did back in June. I scheduled two weeks. I flew to Columbia. I hired right people. I made sure that I was perfect, so I was part of the creative team. I designed everything. Again, I really like arts, right? That's why, one of the reasons why I didn't, I was in pleasantry and that's why I really like dancing too, right? So I'm obsessive with everything that we do. I really am into the details and I supervise everything. And we also got into the finals for the best video competition. So I was going to this problem from every single angle. I didn't let anything up to chance. I, yeah, I'm a freak. I'm a control freak. That's what I did. I remember that even for the pitch, the four and a half minute pitch, I practiced, I don't know how many hours, but every single thing that I say that was obviously memorized, needed to be perfect. The way how I, let's go back to dancing since you're a dancer yourself, the way how I moved my hands, right? The way, how I walked on that stage, everything was rehearsed. So, yeah, I mean, I just I worked my ass off. I mean, everything was the way it needed to be and that's how we won. [00:34:39] Lindsey Dinneen: Yeah. Wow. That's great. What a fantastic story. Yeah. Amazing. Yes. I love how it's so choreographed. Yeah, that's [00:34:48] Maria Artunduaga: great. It was choreographed, [00:34:50] Lindsey Dinneen: I love that. Excellent. Well, I know you have touched on the importance of legacy and how much that means to you, but how do you wish to be remembered after you leave this world? [00:35:03] Maria Artunduaga: Oh gosh. Yeah. I mean, so I have a little daughter, I want to some somehow replicate the same experience that I had with my mom. Maybe she doesn't even realize how much of the inspiration and the impact that she had on me. And again, leading by example, I don't spend a lot of hours with my daughter, right? I have a nanny for 12 hours. So my salary goes to her payment, right? Yeah, I wanna be remembered as somebody who tried very hard, who literally, instead of saying things, I walked the talk. The things that I said I was going to say. For example, I'm very opinionated with anything diversity and inclusion because, as I've said, I've experienced discrimination myself. So I walk the talk, I build a product, I build the change. I worked really hard. I impacted a lot of people. And more importantly, the world has changed somehow because I existed. So that's that. It's as simple as that. I wanna help other people get to fulfillment of their lives and their dreams. And yeah, and I obviously wanna be happy while I do all of these things. And more importantly, I wanna feel that I learned a lot. I really like learning. The process of learning every single day, learning a new thing makes me super happy. So if I don't learn something new, I consider day as, you know, as like a flop or something. So yeah, it's very simple. I'm actually a very simple person, I'm not that complicated. [00:36:30] Lindsey Dinneen: Yeah. Okay. And then final question. What is one thing that makes you smile every time you see or think about it? [00:36:39] Maria Artunduaga: Oh, cute. I mean, obviously my daughter. So I'm a mom. I'm 44, well, almost 45, and I had her at 42. So just thinking about her makes me smile every single time. She's a miracle baby. She's, you know, after four years of IVF, eight retrievals, it finally happened. I finally had her, and having her in my life has turned my world upside down in the best way. She's determined, and she's only three. She's diving into doing all sorts of things. She's doing gymnastics, she's building Legos, she's doing engineering stuff. I really like that "I can do anything attitude" and obviously I'm sort of like reinforcing her to do anything she wants to try. So seeing her try all these new things, all this confidence that I, that she has. It's like, I don't know. I mean, that inspires me. That motivates me to be a better mom, a better CEO, and to do exactly the same thing with the people that I work with. So everyone in my company, I I tell them I'm a mom, right? So, remember that, and I try to do the same with them. It's like I tell them, what do you wanna do? What do you wanna learn this month? What do you need? Right? My work as a CEO is getting the resources and put out the fires. Just tell me, and this is your playground, so I'm trying to do exactly the same with my daughter too. But yeah, I'm very happy with her. [00:38:07] Lindsey Dinneen: Aw, that's wonderful. I'm so glad. Well, oh my goodness, this conversation has been amazing. I kind of wish it didn't have to end, but I also wanna respect your time 'cause obviously you have so much going on. But thank you so much for sharing about your story, your advice. You're so inspiring, and I know this is gonna inspire so many people to go for it, and not to have the fear, to have that problem solving mentality, and growth mindset and learning and, hey, look where curiosity got you. [00:38:37] Maria Artunduaga: Yeah, exactly. That's a perfect slogan. It's all about that curiosity and it gets you places. Look at me. [00:38:43] Lindsey Dinneen: Yeah, exactly. Yeah. And this is just the start. [00:38:47] Maria Artunduaga: Yes, of course. [00:38:48] Lindsey Dinneen: Indeed. So I just wanna say thank you again for your time today, and we just wish you the most continued success as you work to change lives for a better world. [00:38:58] Maria Artunduaga: Thank you so much and thank you again for invitation. I really enjoyed it. [00:39:02] Lindsey Dinneen: Yeah, absolutely. Me too. And we are honored to be making a donation on your behalf as a thank you for your time today to the American Society for the Prevention of Cruelty to Animals, which is dedicated to preventing animal cruelty in the United States. We really appreciate you choosing that organization to support and thank you just again, so very much for your time here today. Yeah, and holy cannoli, thank you so much to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we'll catch you next time. [00:39:44] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

What if the most affordable and effective treatment for autoimmune diseases isn't a pill—but light? In this episode, Adi Soozin interviews John McMahon, the medtech veteran behind over $500 million in exits and now co-founder of Cytoind, a company harnessing narrowband UVB phototherapy to retrain the immune system—safely, affordably, and with stunning early results.Recently featured on the cover of Scientific American, Cytoind's tech mimics sunlight to reduce MS fatigue and may hold the key to treating other autoimmune diseases. With existing insurance coverage, FDA engagement, and a $4M raise underway for their pivotal trial, this episode dives into one of the most exciting biotech frontiers—and a rare investment opportunity.From the biology of light to billion-dollar potential, this is a must-listen for founders, investors, and futurists alike.

Dans cet épisode spécial de La France Bouge, direction Vivatech, le grand salon de l'innovation, pour découvrir les startups qui transforment la santé.Nous rencontrons Pierre Guillocheau (Crédit Agricole Santé et Territoire), qui défend des solutions de proximité pour l'accès aux soins.Focus aussi sur Okomera, qui développe des jumeaux numériques de tumeurs pour accélérer la recherche contre le cancer, et sur Reflect, une alerte intelligente pour les personnes sourdes.Un condensé d'innovations au service des patients et des territoires.Notre équipe a utilisé un outil d'Intelligence artificielle via les technologies d'Audiomeans© pour accompagner la création de ce contenu écrit.Distribué par Audiomeans. Visitez audiomeans.fr/politique-de-confidentialite pour plus d'informations.

Mention légales : Vos données de connexion, dont votre adresse IP, sont traités par Radio Classique, responsable de traitement, sur la base de son intérêt légitime, par l'intermédiaire de son sous-traitant Ausha, à des fins de réalisation de statistiques agréées et de lutte contre la fraude. Ces données sont supprimées en temps réel pour la finalité statistique et sous cinq mois à compter de la collecte à des fins de lutte contre la fraude. Pour plus d'informations sur les traitements réalisés par Radio Classique et exercer vos droits, consultez notre Politique de confidentialité.Hébergé par Ausha. Visitez ausha.co/politique-de-confidentialite pour plus d'informations.

In this episode of Medsider Radio, we sat down with Todd Usen, CEO of Adagio Medical.Adagio specializes in catheter-based ablation technologies for the treatment of cardiac arrhythmias, with a focus on ventricular tachycardia (VT).  Todd has over three decades of leadership experience in the medical technology industry, with particular expertise in commercial strategy, operational performance, and business transformation. Before joining Adagio, Todd served as CEO of Minerva Surgical, a women's health company, and as CEO of Activ Surgical, a digital surgery startup. Todd has also served in executive positions at Olympus, United States Orthopedics, Smith and Nephew, and Boston Scientific.In this interview, Todd shares insights on making usability central to commercialization strategy, leveraging breakthrough designation beyond regulatory validation, and assembling effective boards by carefully selecting both investor and independent members who bring operational expertise.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Todd Usen.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing MAUDE safety reports and taking a look at what the issues are with them. More specifically, we're digging in to find out why almost a third of the reports are delayed or incomplete. We'll get insight on what these reports are, if they are important, and what should be done to improve that 30% figure. During this conversation, the following questions are addressed:First, Mike, if you would, please explain what the Manufacturer and User Facility Device Experience (MAUDE) Database is.What are the MAUDE reporting requirements?How well does the MAUDE reporting system work?Are there consequences for a delayed or incomplete report?Given the statistics, is the MAUDE database a reliable source of information for medical device manufactures? for clinicians? for patients? for anyone?What should manufacturers do?What should the FDA do?What else is important?What are today's takeaways?Listen to this discussion and see if your company might have an issue with submitting a correct MAUDE report. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

With over 20 years of cross-functional experience, Maarten ter Mors is a MedTech leader known for his curiosity, adaptability, and people-first approach. His career spans engineering, product management, marketing, sales, and general management. Today, he's Senior VP and Head of Brachytherapy Solutions at Elekta, where he brings people, technology, and strategy together to make a real-world impact.Maarten believes that no matter how advanced technology becomes, people remain at the heart of progress-especially when working with AI, not against it.With a career shaped by adaptability and cross-functional moves, Maarten offers a unique lens on how to grow in a fast-evolving industry.Tune in for:Moving across functions (before you're “ready”)Why sales skills matter in every roleWhat AI will really change in MedTech careersHow to build cognitively diverse, high-performing teamsWhy curiosity is your ultimate growth engineAnd much more!Career inspiration, medtech opportunities, hiring solutions, and market insights, all in one place. Find them here - linktr.ee/elemedCareer inspiration, medtech opportunities, hiring solutions and market insights, all in one place. Find them here.

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who's responsible, and what industry and regulators can do to fix it.Key Timestamps[02:30] What is the MAUDE database, and why does it matter?[06:10] The critical difference between reportable and non-reportable adverse events[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons[17:45] Underreporting, late submissions, and missing data: The disturbing stats[25:00] High-profile companies dominating late reporting violations[32:10] Legal consequences: What expert witnesses look for in MAUDE data[38:50] Is it poor systems or lack of regulatory understanding causing failures?[46:00] Recommendations for manufacturers: What responsible reporting looks like[53:20] How FDA could modernize the MAUDE database to better serve patients[1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance[1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill itStandout Quotes"A report in the MAUDE database is just a historical record. It doesn't say why it happened or who's at fault—just that it happened."— Mike DruesThis quote underscores the limited utility of MAUDE reports and why interpretation requires caution."If you're not a medical device professional without your tools, then you're not really a medical device professional."— Etienne NicholsA poignant reminder that compliance and quality are human-led, not software-enabled by default.Top TakeawaysLate Reporting is Widespread and RiskyNearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.MAUDE Is Misused—Despite FDA WarningsManufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.Three Companies Account for Over Half of Late ReportsLarge, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.Electronic Tools Help, but Culture Matters MoreSoftware can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.FDA and Industry Both Need to EvolveSuggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.ReferencesFDA MAUDE Database21 CFR 803.16 – MDR Reporting RequirementsEtienne Nichols on LinkedInMedTech 101: What Is MAUDE and Why Should You Care?Think of the MAUDE database as a public logbook of adverse events involving medical

Julio G. Martinez-Clark CEO of Bioaccess and President of IAOCR/GCSA Americas is a MedTech trailblazer helping startups accelerate First-in-Human (FIH) clinical trials across Latin America, with over 20 years of experience spanning healthcare, telecom and venture capitalIn this episode, we unpack why more MedTech companies are turning to LATAM for faster, more cost-effective trial execution. Julio shares how his Miami-based CRO helps deliver 58-day CE mark approvals, his experience supporting 100+ device startups and why time, not money, is the most precious currency for early-stage founders. We also touch on trial quality, regulatory strategy and why he believes Latin America will play a defining role in the next era of global MedTech innovationTimestamps:[00:00:47] Why LATAM Is the Next MedTech Trial Hub[00:02:21] The Problem with FIH Trials in the U.S.[00:04:42] How bioaccess® Reduces Approval Timelines by 70%[00:06:01] Strategic Sites, Patient Retention & CRO Infrastructure[00:08:17] Do LATAM Trials Hold Up to FDA & EU Scrutiny?[00:10:43] The Fundraising Pressure Behind Faster Clinical Results[00:12:22] Founder Mistakes in In-House Trial Management[00:14:11] Why LATAM May Overtake Eastern Europe in FIH Volume[00:17:26] Regulatory Standards, UNESCO, and Regional Quality[00:20:10] Julio Outside the Office: Family, Fitness & PodcastingGet in touch with Julio - https://www.linkedin.com/in/juliomartinezclark/Learn more about Bioaccess - https://www.bioaccessla.com/ Get in touch with Karandeep Badwal - https://www.linkedin.com/in/karandeepbadwal/ Follow Karandeep on YouTube - https://www.youtube.com/@KarandeepBadwalSubscribe to the Podcast

Nicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP, country-specific rules, and audit requirements.David breaks down where companies most often go wrong—managing rules in Excel, underestimating the operational burden, and lacking traceability across contracts, SKUs, and sales data. He discusses how automation not only reduces risk and effort but also preserves trust with licensors by ensuring accuracy and transparency.The conversation also covers how organizations can recognize when it's time to move beyond spreadsheets, what a successful royalty system implementation looks like, and why experience matters in such a niche space.Whether you're paying or receiving royalties, this episode offers valuable insight into a critical but often misunderstood area of life sciences operations._____The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. For project or resource needs, visit ⁠https://www.thefdagroup.com/

David Levin, Interim Global Head of Healthcare Investment Banking and Co-Head of U.S. M&A, Ahmed Attia, Managing Director, Healthcare M&A and Jason Levitz, Head of Healthcare Equity Capital Markets, convened at RBC's Global Healthcare Conference in New York, to share insights on the latest M&A trends in life sciences, MedTech, and equity financing.

In this insightful podcast episode, Dr. Martha Morrell, CMO of NeuroPace, shares her transformative journey from academia to pioneering a revolutionary treatment for epilepsy. The RNS System, inspired by cardiac devices, offers targeted stimulation to the brain, tailoring interventions to each patient's needs. Dr. Morrell discusses the challenges and triumphs of steering such an innovation to FDA approval. Her story highlights the intersection of expertise, perseverance, and multi-disciplinary collaboration in MedTech, setting a new precedent for epilepsy treatment.

Credibility isn't what you think it is — it's not what you believe, it's what your customers and colleagues experience. And in today's high-stakes MedTech environment, skipping the small details or ignoring key feedback can quietly erode trust, stall deals, and block innovation. In this episode, sponsored by Physician Growth Accelerator, we talk with Bill Facteau, President and CEO of Earlens, about how credibility shapes every level of success, from individual sales calls to boardroom pivots. Bill shares lessons from leading multiple MedTech startups, why great products still fail without the right strategy, and how Earlens' creation of Virsono Hearing Centers offers a new model for delivering better hearing care. What we discuss in the episode: Why credibility depends on how others perceive you, not how you see yourself The overlooked role of preparation and discipline in winning (or losing) sales trust How feedback loops between sales and leadership drive better pivots and strategies Why even world-class MedTech products fail without the right business model and market fit Lessons from Earlens' creation of Virsono Hearing Centers and how they reshaped hearing care delivery Resources from this episode:  Get the free MedTech Talk Tracks for Action Physician Growth Accelerator Earlens Social Media:  Connect with Bill on LinkedIn Connect with Zed on LinkedIn

In this episode of Medsider Radio, we sat down with Stuart Long, CEO of InfoBionic. InfoBionic's virtual cardiac telemetry platform, MoMe ARC®, brings together a tiered hospital-grade monitoring capability powered by advanced AI-enabled analysis for cardiac interventions.Stuart has over two decades of experience in the medical device and healthcare technology sectors, with a focus on driving rapid commercial growth. His leadership spans roles including CEO of Monarch Medical Systems, global chief marketing and sales officer at CapsuleTech, and executive positions at Philips Healthcare, Agfa HealthCare, AMICAS, and FUJIFILM USA. At CapsuleTech, he developed strategic initiatives that led to the company's acquisition by Qualcomm Life. In this interview, Stuart shares insights on combining debt and equity financing, hybrid commercial approaches, and positioning startups for acquisitions through adjacent market development — all while maintaining the persistence needed to survive the long game.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Stuart Long.

Julio Martinez-Clark teamed up with his cardiologist brother and other doctors to help speed up the clinical trials part of the process. Julio's team at bioaccess® is moving medicine forward quicker by helping startups and researchers get the data from clinical trials in other countries. Advancements can now come to market quicker while also helping suffering people in countries that do not have the means to afford the proper medical care. This saves time, money, and people.Julio Martinez-Clark is the co-founder and CEO of bioaccess®. Julio believes Latin America is an untapped destination for Medtech clinical research. Since 2010, Julio has supported +100 Medtech in operationalizing successful clinical trials in several countries in Latin America. Julio was the chairman of the board of the Association for the Advancement of Clinical Research in Colombia (AVANZAR). Julio writes a column at Med Device Online, where his articles have been "Featured Editorials" on several occasions. Julio hosts the LATAM Medtech Leaders podcast, interviewing Medtech leaders who have succeeded in Latin America.Julio has a wealth of experience in various fields, including serving as an advisor to the CEO of Amavita Heart and Vascular Health™, the most extensive cardiovascular practice in South Florida, an advisor to government agencies in Colombia looking to position the country as a clinical trial destination, and a mentor to startups at Macondo Labs, a top incubator in Colombia.Learn more at www.bioaccessla.com and connect with Julio on Linkedin @juliomartinezclark Visit ConfidenceThroughHealth.com to find discounts to some of our favorite products.Follow me via All In Health and Wellness on Facebook or Instagram.Find my books on Amazon: No More Sugar Coating: Finding Your Happiness in a Crowded World and Confidence Through Health: Live the Healthy Lifestyle God DesignedProduction credit: Social Media Cowboys

Are you ready to launch? This week, Liz is joined by Sandy Waugh Ruggles to discuss go-to market strategy. In their conversation, they discuss the importance of identifying targets early and training commercial reps on those targets so that they can best sell the product. Sandy shares why she recommends utilizing psychographic descriptors for targeting and the importance of gaining alignment on these targets prior to launch.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Sandra is the President of Summit Rock Strategy Consulting, where she specializes in leading medtech development teams through strategic decisions, assessing opportunities, defining product and portfolio plans, and preparing for commercial launch. She also serves as director for policy research in the Stanford Biodesign Policy Program. Sandra is both an inventor and an innovator. She holds over 20 patents in various domains, from consumer medical devices to therapeutic proteins, and has led multiple US product launches. Sandra co-founded Catalyst Biosciences and was named a Top Innovator Under 35 by MIT Technology Review. Sandra earned a PhD from the University of California, San Francisco in biophysics and was a Stanford Biodesign Innovation Fellow.Subscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe!Connect with us on LinkedIn: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Sandy Waugh RugglesCumby Consulting⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Rachel Medeiros⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Liz Cumby⁠⁠⁠⁠⁠About Cumby Consulting: Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research. With real-world analogies, like orchestras and dashboards, Muzio explains how leaders can create alignment, drive faster decisions, and unlock collaborative problem-solving by focusing on the future instead of the past. Whether you're part of a startup or an established MedTech firm, this episode delivers actionable strategies to help your team iterate with purpose.Key Timestamps[00:01] Introduction and sponsor message from Greenlight Guru[01:13] Meet Ed Muzio and the premise of Iterate[03:15] Why most management meetings don't drive real action[06:40] The “Alice” video case study and how it exemplifies iterative management[11:50] Common objections and barriers to implementing iterative processes[17:00] Using forward-looking data instead of status updates[22:08] MedTech example: anticipating 510(k) review delays[29:15] Making decisions early to gain planning time[34:20] How to get started if you're a small or early-stage company[37:40] Cultural barriers in iterative team models[41:20] Handling matrixed environments and CEO-level priorities[47:10] Why clarity of decision-makers matters in early teams[51:45] The biggest mistake mature companies make in team meetings[55:05] Final advice: focus on behavior, not buzzwordsStandout Quotes“If you walk into a meeting and it's 26 minutes in and you haven't made a decision yet—and that's normal—you're probably not solving anything.”—Ed Muzio on the inefficiency of status-only meetings in traditional management culture.“We don't need to forecast history. We need to plan around the future.”—Ed Muzio explaining why forward-looking metrics are the only actionable data in iterative teams.These quotes challenge conventional meeting norms and emphasize a proactive mindset crucial to success in fast-moving MedTech environments.Top TakeawaysBackward-looking metrics kill momentum. Most leadership teams spend meetings reviewing past progress. Instead, focus on forecasting future outcomes and addressing variances before they become problems.Accountability must be systemic, not personal. A team can only normalize issue-raising if the entire culture shifts to expect it—making it safe and standard to surface concerns early.“Succeed or fail together” breaks silos. When departments align to shared goals, cross-functional collaboration becomes natural. Incentives that isolate progress undermine execution speed.Don't vote—decide. In small teams, designate a clear decision-maker and avoid democratic processes that lead to politicking instead of clarity.Adopt flexible systems over rigid charts. Org charts don't reflect reality. Iterative management embraces the messiness of matrixed teams and adapts meetings and collaboration structures fluidly.References

Dr. John Sweetenham shares highlights from Day 4 of the 2025 ASCO Annual Meeting, including new research on maintenance therapy in small cell lung cancer and a virtual reality psychosocial intervention for patients undergoing hematopoietic stem cell transplantation. Transcript Hello, I'm Dr. John Sweetenham, the host of the ASCO Daily News Podcast, with my takeaways on selected abstracts from Day 4 of the 2025 ASCO Annual Meeting. My disclosures are available in the transcript of this episode. Today's selection features reports of 3 randomized trials in very different clinical settings: maintenance therapy in extensive small cell lung cancer (SCLC), upfront surgery in advanced ovarian cancer, and a supportive care intervention for patients undergoing hematopoietic stem cell transplantation. The first of these studies, Abstract 8006, was presented by Dr. Luis Paz-Ares from the University Hospital [October 12] in Madrid, Spain, and reports the primary results of the IMforte trial. This was a phase 3 trial evaluating the combination of lurbinectedin and atezolizumab as first-line maintenance therapy in patients with extensive small cell lung cancer. Despite some improvements in the first-line treatment of extensive small cell lung cancer with the use of checkpoint inhibitors in combination with platinum-based chemotherapy, most of the patients experience early disease progression and long-term survival remains very limited. This provides a rationale for considering a maintenance intervention. Lurbinectedin is an alkylating agent and transcription inhibitor [that is] already approved in the United States for patients with relapsed/refractory metastatic SCLC following platinum-based chemotherapy. It has been shown to synergize with immune checkpoint inhibitors in pre-clinical studies and has also been evaluated in early-phase clinical trials. The IMforte trial is a global, randomized trial in which patients are initially treated with atezolizumab, and those patients who do not progress on induction therapy are then randomized to maintenance therapy with atezolizumab alone or atezolizumab with lurbinectedin. The primary endpoints of the study were progression-free and overall survival. Four hundred and eighty-three patients were randomized and at a median follow-up of 15 months, the median progression-free survival for patients who received the combination was 5.4 months and the median overall survival was 13.2 months. This compares with 2.1 and 10.6 months, respectively, in patients who received atezolizumab only. The lurbinectedin and atezolizumab combination was generally well-tolerated, with no new or unexpected safety signals. The benefit was consistent in magnitude across all the relevant patient subgroups. This is the first phase 3 study to show a progression-free and overall survivial improvement with first-line maintenance in extensive stage SCLC and the result is likely to be practice-changing, establishing a new standard of care in this tough-to-treat disease. Next up is LBA5500, presented by Dr. Sven Mahner from LMU University in Munich, Germany. This describes the results of the TRUST study, a randomized trial of upfront surgical therapy in advanced ovarian cancer. As background, total macroscopic tumor resection with maximal effort cytoreductive surgery is the cornerstone of treatment in patients with advanced ovarian cancer. The optimal timing of such surgery remains controversial, whether it's more beneficial as a primary cytoreductive surgery before chemotherapy or in the form of interval cytoreductive surgery after 3 cycles of neoadjuvant chemotherapy. Previous studies have addressed this issue, but results have been confounded by issues of patient and center selection. The TRUST study is a randomized, international, multicenter phase 3 trial that compares the outcomes of the timing of surgery in surgically fit patients with seemingly resectable FIGO stage IIIB/IVB ovarian, tubal, and peritoneal carcinoma. To ensure consistent and adequate surgical quality, participating centers in the trial were required to obtain accreditation and undergo an onsite quality assurance review. This included assessment of infrastructure, surgical proficiency, complete resection rates, and surgical volume. Seven hundred and ninety-seven patients with advanced ovarian cancer were randomized to undergo surgery prior to therapy with 6 cycles of carboplatin and paclitaxel along with bevacizumab and a PARP inhibitor, or to have the surgery between the third and fourth cycle of the same systemic therapy. Of the initial 797 patients, 688 comprised the intent-to-treat population, of whom 345 received primary cytoreductive surgery and 343 received neoadjuvant chemotherapy followed by interval cytoreductive surgery.  The results show that patients undergoing primary surgery had significantly improved progression-free survival compared with those who had interval cytoreductive surgery (median progression-free survival was 22.1 months versus 19.7 months). No difference in overall survival was observed between the 2 arms of the study.  This is the first study to show a benefit for primary cytoreductive surgery, although the progression-free survival improvement was not reflected in an overall survival difference. A subgroup analysis for patients who underwent complete cytoreduction suggests a progression-free survival and survival benefit, although it isn't clear to me that the study was powered for this endpoint. Nevertheless, these are very difficult studies to perform, and the investigators should be congratulated for this robustly conducted clinical trial. Today's final abstract is 1504, presented by Dr. Hermioni Amonoo from Harvard Medical School. The trial evaluated BMT-VR, a virtual reality psychosocial intervention for patients undergoing bone marrow transplantation. This randomized trial included adult patients undergoing autologous and allogeneic transplantation. The BMT-VR platform included, among others, modules addressing psychoeducation, coping, acceptance, and gratitude. BMT-VR patients were provided with VR headsets and completed all modules during their hospitalization. Patient-reported outcomes were then assessed at 2, 4, 12, and 24 weeks post-BMT. Use of the VR tool was tracked during hospitalization. Control patients received usual care during their hospital stay and were then assessed at the same intervals post-BMT.  Eighty evaluable patients were randomized, 39 to BMT-VR and 41 to usual care. Completion rates for the BMT-VR modules were high [at] around 70-75%.  Patients who received the BMT-VR intervention experienced significantly improved anxiety, quality of life, and coping at 4 weeks post-BMT. In the longer term, sustained benefits were seen at 24 weeks for some endpoints including quality of life, with some benefits, including for depression and PTSD symptoms, improving longitudinally over the study period. These data are preliminary and will need to be confirmed in larger multicenter studies, but this trial demonstrates the feasibility of using virtual interventions in our patients and also provides intriguing preliminary data that they may be effective. Thanks for listening to today's report and I hope you will join me again tomorrow to hear more top takeaways from the final day of ASCO25. If you value the insights that you hear on the ASCO Daily News Podcast, please remember to rate, review, and subscribe wherever you get your podcasts.   Disclaimer:   The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.     Find out more about today's speaker:     Dr. John Sweetenham       Follow ASCO on social media:      @ASCO on Twitter     @ASCO on Bluesky     ASCO on Facebook     ASCO on LinkedIn       Disclosures:    Dr. John Sweetenham:     No relationships to disclose 

What if clinical trials could save lives and launch your global medtech career? What happens when you combine cutting-edge medical devices, international clinical trials, and a relentless drive to create real-world impact? Meet Julio M. Clark — CEO of bioaccess® and host of the LatAm MedTech Leaders podcast — who turned a one-man regulatory operation into a pioneering contract research organization transforming healthcare across Latin America. In this episode of Neurocareers: Doing the Impossible!, we explore: How Latin America became a hub for first-in-human clinical trials The unique challenges and opportunities of medical device research in global markets Why AI is revolutionizing everything from informed consent to trial proposals Career pathways for biomedical engineers and clinicians in medtech startups The mindset needed to build impactful ventures from scratch — even after failure Julio shares the entrepreneurial journey behind bioaccess®, the future of medtech clinical trials, and how YOU can contribute to life-saving innovation—even if you're just starting out. Whether you're a neurotech enthusiast, aspiring clinical researcher, or global health innovator—this episode will inspire you to think bigger, act bolder, and, most importantly, choose the right table.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about off-label communication. More specifically, we're reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed:Can you first please provide an explanation of what “off-label” is in terms of the FDA?Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?What's new in this “final” guidance?What is meant by firm-initiated communication containing scientific information on unapproved uses?If you communicate with an organization about unapproved (or off-label) uses, what will happen?If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?Does FDA need to know about the communication?What else is important?What are the most important takeaways?Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this discussion. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're continuing our conversation on off-label communication. In this part, we're examining the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed:Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.Now getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what's potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?Do you have any examples you can share?Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don't need to be?What happens when a company makes unsupported, deceptive, or completely false claims about a product?In your professional opinion, should we allow a company to advertise unapproved claims that haven't gone through a formal review process? Is it a good thing or a bad thing?What else is important?What are the most important takeaways?Listen to this discussion after you've heard Part 1 and see what you think of off-label communication and the guidance. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

Dr. Shalabh Gupta, founder and CEO of Unicycive Therapeutics, shares his inspiring journey from practicing medicine to leading groundbreaking innovations in kidney disease treatment. Dr. Gupta discusses his comprehensive framework for identifying and developing medical solutions, his vision for Unicycive's future, and the importance of focus and execution in medical startups. He reveals the challenges and triumphs of bringing life-changing products to market and offers profound advice for new entrepreneurs in the industry.   Guest links: https://unicycive.com/  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: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 056 - Dr. Shalabh Gupta [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 am so excited to introduce you to my guest, Dr. Shalabh Gupta. Dr. Gupta is the founder and CEO of Unicycive Therapeutics. He is a visionary in healthcare, leading groundbreaking efforts to design innovative therapies and reimagine how we approach unmet medical needs. His work goes beyond the lab as he's driving a healthcare revolution by developing innovative therapies addressing critical gaps in treatment. His perspective combines decades of experience and expertise in drug design with a deep commitment to equity in health care. Well, welcome to the show, Shalabh. I'm so excited that you're here with me today. [00:01:35] Dr. Shalabh Gupta: Thank you. Thank you for hosting me. [00:01:36] Lindsey Dinneen: Of course. I'd love if you wouldn't mind just telling us a little bit about yourself, your background, and what led you to MedTech. [00:01:45] Dr. Shalabh Gupta: By way of background, I'm a physician, trained, practiced, did my medical training in internal medicine, residency in physical medicine and rehab, research fellowship in cardiac and pulmonary rehabilitation, board certified physician, practice in New York at NYU hospital, NYU Medical Center. This is where I did my medical training for roughly decade after finishing medical school. I also have a graduate degree in finance management from NYU. While I was doing my residency training, I realized that I wanted to find a way to have a broader impact on society as well as what we were working on in learning medicine. So, I started my career working initially with a biotechnology company at the time to help them get their drug with FDA through a regulatory approval process. The beginning of the process is called IND following a investigation new drug application, IND application. I actually visited FDA on their behalf, met with FDA back in the time when everything used to be in person. Built from there onward, joined Wall Street from working as a stock analyst. So I covered biotech companies as a stock analyst, and the weekend and holidays that were available, I worked to continue to practice the medicine at NYU as an attending physician, and then joined another bank and covered pharmaceutical stocks and worked covering six of the largest pharma companies that include Pfizer, Merck, Viacom, Selling Power, Eli Lilly, Bristol Myers Squibb. From there, I moved to California. I worked for Genentech in corporate strategy. Genentech, at the time, and continues to be, one of the largest biotechnology companies. And from working at Genentech, I got my inspiration to start my own companies. So I founded two companies prior to finding starting Unicycive. All my companies are focused on aesthetic therapeutic area. Unicycive is focused on nephrology, treatment of kidney diseases, and we have two drugs in development. We have a lead drug that is pending approval from the US FDA in June of 2025 this year. And the second, I guess, finish phase 1 clinical trial in the UK. And we are in discussion with the agency to proceed with the next stage of clinical trial in the US. So that's a quick background. [00:04:14] Lindsey Dinneen: Wow. That's incredible. Thank you for sharing your story. Yeah. So let's talk about your company now. You've become CEO of this company. You're developing these products that are going to change lives. What first made you realize that there was a gap that needed to be filled in the market for this? And then, what prompted you to go, "You know what? Hey, I think I can have the solution for this or I can have the answer to this." [00:04:38] Dr. Shalabh Gupta: The first question that you ask, understanding the unmet need in medicine, there are a lot of problems that you can address. So, to give you a framework, if I am thinking about a problem, I want to understand if a couple of things, and in order of priorities, these are: can I find a solution that with my resources-- resources is time, energy, and money-- can I create a product that will truly make it to the market? Number two is that I also feel that one can get very blindsided that "I have a solution," but not understand what other solutions exist in the market. So understanding the competitive landscape. If I create this drug, this device, this product, and it is going to take three to four years in the market to come to the market-- which, by the way, in medical word is a still very fast track because it takes much longer-- what will the competitive landscape look like for 5 years down the road? So that's the second part. And third is that what is the solution that I'm developing? Is it unique in terms of having a novel, either as a drug device or drug device combination, or as a patented drug, patented device, because in our industry, it's not really possible to scale up something until unless you have an IP or intellectual property protection. And then from there onward, the last thing is also, who's going to fund me, how I think about funding, not for next six months a year, but also a continuum of the product development. If I think about all these 4-5 problems, then you start to narrow it down. There are some problems that are very much worthy of exploration. For example, treatment of Alzheimer's, we all know it's a big unmet need, we all know there's a big market opportunity. But I realized that was something we couldn't do it with the products or the development candidates that I had seen. So, being able to define where is the end point and goal. Being able to understand, can I make an impact? And when I say I, I speak for myself, but each one of us, I always remind entrepreneurs, we each one of us have our own deck of cards. We have to play with our cards, we can't compare ourselves with somebody else, or we can compare some other cases study. So understanding more about what is so unique that I can bring to table that can I make a difference and then making a business around this where the thesis lies. Once you identify that, then there's a question about continuing to execute and keep changing your plan as you go along. [00:07:11] Lindsey Dinneen: Yeah, absolutely. Well, I love your framework for thinking through all of those things. And so of course you use that when you thought, "Hey, here's this issue. I could potentially have a solution," and you went through this process. And then can you tell us about your innovation now and how that is helping and how you expect it to help change all these wonderful lives? [00:07:33] Dr. Shalabh Gupta: So, so for treatment of kidney diseases, first of all, it has been one area of development that has not had that much of innovation. And, and I think that is where the initial part of the thesis was that focusing on nephrology of kidney diseases is not same as developing a drug for cancer treatment. Cancer treatment changes every six months a year. The standard of care continues to evolve. Is there an unmet need in cancer treatment? A hundred percent, but the part is that the pace of innovation is very rapid. Is it same in nephrology? It's getting there, but it's still the development of a new products in nephrology still is not at the same pace. So I thought there was something we could make a difference by a small company. The drug that I acquired from another company was a drug that had finished a clinical trial. So it had shown that the drug is safe. It had also shown some signal of it working in healthy volunteers. That's a phase one trial. And the innovation came from a car battery company that had figured out how to make a big, large size pill to make it smaller. And sometimes greatest innovation, greatest insight come from the fact that when I talk to the kidney doctors, the physicians who take care of these patients there with the treatment of kidney diseases, they said the problem for these patients are the patients have to take 12 to 15 pills per day. And this innovation allowed us to be able to make that number of pills go down from 13 to 12 or 15 to three pills per day, one pill with each meal. And then the regulatory pathway became a bit more clear that if I can show that our drug is similar to the drug that was in the market, maybe there was an opportunity to go through expedited pathway, which is what we did. And I acquired the drug in 2018, went to FDA right after acquiring the drug to expedite the pathway again, thinking about de risking the development pathway. And as I mentioned in 2025, we are expecting the approval. So that is the process about it. And that's the story behind the lead drug. [00:09:51] Lindsey Dinneen: Great. Excellent. So that is really exciting. And as you continue to go forward with this company and the innovations that you're creating, what is your ultimate goal or dream that you're really striving for? [00:10:06] Dr. Shalabh Gupta: So, the focus for Unicycive is building new novel treatment for kidney diseases. Our lead drug is expecting approval in June 2025. But we have a second drug in development, and we continue to think about what will be something that we as a small company can bring to market. There are other areas of unmet need in kidney treatment. But instead of doing too many things at the same time, we continue to think, "How do we grow our company? What will be the vision for the company three years down the road, five years down the road?" And what we want to continue doing is to develop the drug candidates, advance them. Right now, after the first drug we get through approval, it will be the second drug. There is a thought process behind it. One of the biggest challenges that I've seen for smaller companies and startups is that they end up in doing too many things at the same time, which is difficult to do, even for big companies. You know, big companies, they have a one product that is a marquee product, they launch that and then they develop other things. So, being able to stay focused is also key because you can have a lot of energy, you can have a lot of ideas, but you have to focus on which one you can do first. [00:11:22] Lindsey Dinneen: Yeah, that is so true. It's such great advice, a good reminder. Yes, focus is so important. You know, honestly, that's probably one of the tricky things that startups in this particular field might struggle with is that focus. So I'm wondering what kind of advice do you have for say a brand new entrepreneur in the industry who has these great ideas, but you know, maybe has so many that they're a little too scattered. [00:11:52] Dr. Shalabh Gupta: Right. So, I think you may start with 10 ideas but the framework I gave you that: can this idea in this given timeframe with my resources and the funds that I can raise, can it make a difference? So you start to narrow it down. You start with a big funnel, narrow it down. And then maybe you have two or three ideas. Instead of thinking to yourself that "No, I'm not going to tell my idea to anyone because somebody else can take it away," find people who will be willing to pressure test those ideas. Then you will have identified something, maybe one Idea that is worth the pursuit. So then you focus on that. So that's one part of how to triage it because we all have ideas, but those ideas may not be worth developing once you go and talk to the marketplace. And marketplace is your investors, the physicians, and the patients. I keep saying about these three stakeholders, because if physicians cannot prescribe what you are developing, then it's of no use. If patients don't necessarily benefit, then it's of no use. And if you cannot get insurance companies a reimbursement for that means the product will never get here. So it's a process, but nobody can come up with an idea. And there is no great idea. There are ideas that you have to, and then once you find that one idea that resonates with all the stakeholders, physicians are excited about it. If you talk to patients, and you want to do that early on, you don't want to develop an idea and then go, you know, that is the greatest idea but nobody really perceives it that way that except you and a couple of your friends and people who work with you. I don't mean in a bad way. I mean, that you want to be able to test this idea very quickly. So once you get that idea, once you identify what is that the company should be focused on, then the question about is actually building an execution plan. And the only advice I can give is that at any given day for a company, startup, especially whether you're a founder or you're a founding team member, the list of priorities is 50, 5, 0, or maybe 100. It takes time to figure out of those 50, which are the top three that are most important and then being able to focus on those three. You know, the reason I say that no one can work on 50 priorities at the same time. But we all can take two or three priorities and say, "These are the three things that I'm going to work on today. That is this week. Those are the things I'm going to do this month." And therefore you start to develop identifying priorities. The right ones takes time. Sometimes it is a fundraising. Sometimes it's a building a team. Sometimes it's a product development. Sometimes it's all three of them, but being able to allocate your time and energy and focus is a key. People say it's the question of money. I don't think it's a question of money. Money is one of the resources, but the biggest resource we all have is a time and energy and focus. In a company of our size, we are a publicly listed company, and we now have grown from where we used to be, and it's still small. Even today, there are a lot of things we choose not to do. We choose not to go to conferences. We choose not to publish papers. If something is a priority to us, we say, "This is the only thing we're going to focus on. This is the next three months, this is our main goal." And every team meeting I have, I always remind people, three priorities. More than three, way too many. One may not be enough. But because if you can't remind people, what is the priority for the company, then you will not succeed. It is a very challenging environment to think about a startup company or companies in general. And when you have too many priorities, you tend to lose focus on. By building priorities, having priorities, executing them. You create momentum, you create confidence. They create success and you keep climbing the ladder. But truly the biggest challenge for us in the beginning of the career is that identifying which are those three priorities that matter. And once you have had some experience, then the challenge is to keep those priorities and change them as you go along, right? As you go along, you have to continue to grow. For example, in the beginning, it may be the five people you have and that may be enough. But as where we are in the company, it's a question about growth of the organization, right size, not too many people, not too little, hiring enough people so we can continue to execute on our vision and the promises that we made to ourself and to our investors. [00:16:27] Lindsey Dinneen: Thank you for that advice. That was fantastic. And such a great way to narrow it down and help people understand how to narrow down so that they can actually focus and succeed before moving on. I love that. Thank you. So, you know, looking back over your life, and of course, you've had such an incredible career that has really taken you in a lot of different directions. Could 10 year old you have ever anticipated where you'd be today? [00:16:54] Dr. Shalabh Gupta: I don't think so. I think I think we all have a what I call a true north compass. What I did think at the 10 years of age, if I can go back, maybe 10 is too early but maybe 15 or 16 or 17, that hasn't changed. Let me tell you 2 things that I always felt most inspired and excited about. Number one was that I wanted to be in healthcare because, intellectually, I like biological sciences. I felt, "My gosh, what could I do with that if I could make a difference?" And number two was that I, from very early on, I wanted to be something which could help people directly. As you know, there are many ways you can help people, but being in medicine or healthcare, I felt there was a direct impact. Now, looking back after several decades, I feel that part of the influence was my dad. My dad is a physician, continues to see patients and do pro bono work. So that had a very lasting influence on me. That helped me to think about, okay, this is what I want to do. Then being trained as a physician, then going to work on Wall Street, then there was a question about understanding how the impact can be broadened, if you will. The way to think about what I do today versus what I did, say, as a physician, physicians see, say, 10 patients, maybe 12 patients if you're seeing an outpatient basis per day. And if you're in an ICU or ICU doctor, an ER doctor, you could see more number of patients, but then smaller time. And you multiply that impact that many patients, let's just say 10 patients per day, and you work at 300, 350 days, 360 days, 365 days, don't take any break, but that is that many patients a year. What we do today has a potential to impact hundreds and thousands and millions of patients and not just in the U S, globally. So from one vantage point is just magnifying the impact. And the other vantage point is doing what I would have done before. I still love sciences every day. My job is to not just talk about business, but also think about, "How do we fundamentally solve the problem?" And having had those experiences you know, it helps you to keep yourself grounded. One part, I know this wasn't your question, but one advice I can give people who are thinking about developing their careers as an entrepreneur, if you are a founder and CEO, especially think about your career or skill set as I spoke, a wheel, a circle. Every skill that you have, some of us start with more technical background, like me and MD. Then you have to develop their finance and business skills and the business development skills. So sometimes people say, "Well, you know, ABC went to grad school and they dropped out of grad school and they started a company." That's wonderful, but think about much longer beyond a two-year, three-year, five-year time horizon. And that's what helped me to think about my career. So I worked on the Wall Street, but that gave me a finance and understanding about how public companies are valued, not just by the company, but how stock analysts value the company, how investors value the company, what moves the stock, what did Genentech to understood. That gave me the chance to understand how a big biopharma company thinks about their product development. And at Genentech, in some interactions we have had, we were looking at the products from other smaller companies, either to collaborate with them or to acquire those products. So that's a different skill set. I went very early on, as I said, in my career, I went to FDA. So even though I'm not regulatory expert, but I understand how agencies think about the product approval so that helps you to make a more of a holistic viewpoint because the business has become more complex, and you cannot just have a only business degree and you say, "Well, I'm going to succeed." Some people have rounded that up by years and years of experiences. And then there is also innate desire to learn. I learned from not just doing the work I do every day, but my, my, you know, talked a lot about it. I read anytime I get I read books that are not related to medicine, that are not necessarily related to health care, because you have to understand how to grow a revolution. You have to understand leadership skills that are not necessarily taught in schools. So, you have to find a way to continue to refine yourself, because the only way you can create a great company is to become a better version of yourself. [00:21:31] Lindsey Dinneen: Thank you so much for talking about that and for sharing your advice. And I love that image of the wheel. It's a good reminder that sometimes life takes you on very interesting tangents, but sometimes they all do merge at some point. You've got this little sliver of this knowledge that you're working on, and then this experience, and then they start building and I really love that, that, that way of thinking about it and also remembering that It's very useful. So, so like even earlier, I was struck, you talked about how there was inspiration from car batteries, right? And so how interesting is that to go from, what you might expect within your industry, here's how to solve a problem. But then you guys went outside and said, how do other people solve problems? Like maybe we can borrow from that. And I think that's really cool. [00:22:21] Dr. Shalabh Gupta: And I also think that if you stop focusing on only in your industry, learn from anywhere. Some of the best learnings that I have personally, that felt inspirational to me, did not come from biotech companies. They come from tech companies, truly. When you think about the worst, most successful tech companies like Amazon, Apple. I can go on and on, but there are things that you can learn from them. There are things you can learn from the founder of Amazon, Jeff Bezos. He talks about building Amazon and he talks about doing many experiments at a smaller scale that fail at Amazon in order for them to succeed at a few that really work. And this is where I was saying that culling the ideas, you may start with 10 ideas, but no one can develop 10 ideas, no one. And it's not because of money. People say, "Well, that if I had money." There have been numerous examples where companies have been funded with lots of money and the companies fail. Part of the problem is that when you get too much money, I think you may not realize that you still have to deliver. Because focus and execution takes really knowing what the target is, and then hitting the target and not one time and time again. Targets may change, but the companies cannot focus in 20 different things. In the beginning, you have to start with a very key thesis. [00:23:39] Lindsey Dinneen: Yeah. Absolutely. Absolutely. And yeah, so learning from other industries, and that actually kind of also brings up a thought. So as you've gone along in your career and you've had many different iterations of who you are and what you bring to the world, now, are there any moments that really stand out to you as affirming, "Yes, I am in the right place at the right time?" [00:24:04] Dr. Shalabh Gupta: Yeah, that's a very good question. And I have had a chance to think about it every now and then. So there are there, there are certain observations I'll make. You know, people always say, " What will be your dream job?" And I think the dream job for someone is the job that which you will do any given day, and you will feel a joy that you're doing it and you're not doing for remuneration. You're not doing because you're going to get paid. And we all have those different moments in time. People talk about "flow" where the time stops because you're doing something so deeply engaging that you lost track of time. You forgot where you are. You're not feeling tired. For me building of this company and the team that we have assembled at Unicycive is that flow. Any day that I'm not traveling, I am in my office. I don't work from home. I am every single day in my office. And sure we have a small team, but when we work with the team, these are motivated, driven people with decades of experiences. We feel that we are in a common mission, like we are solving the world's greatest problem. And I know that may be exaggeration, but that's how it feels. And being with them in a room and thinking about a complex problem-- and not just thinking of a problem like how big companies think about it-- but thinking of the problem in a scientific way, but delivering it a solution that only a small company can do that to me is a joy. Number two part is that as I've gone further on my career, I, I am a mentor to a number of startups from Stanford and UCSF, and many Stanford companies, many of them come with a very different problem than purely a biotech company. Since the pro bono work, I do this because I find by telling other people from their problem, I get to reflect on my own problem, and I do that on every quarter. There's one or two companies and I've been really privileged. I feel one of the greatest joys to meet with these great CEOs and Stanford has been a great collaborator. They have a program called Start X in which they have these companies that are participating in a accelerator program. And Stanford's accelerator is different and unique that they don't take any equity. They provide you the opportunity for mentorship. I was part of that program many years ago. So I meet with the CEOs and many of these CEOs will come very different problem. As an example, there is a company that's focused on artificial intelligence using interaction between a physician or healthcare provider and patient, and being able to use AI to streamline that interaction. That is a point that I saw of 10 years of clinical practice, how that communication is broken, literally is broken. Patients go to doctors, not because doctors are the world's greatest knowledge source, but patients at the end of day, they need someone to help them feel better, help them understand the problem that the physician can solve it. What ended up in being in today's healthcare system in the U. S. is that doctors have become mechanical and not because doctors are bad, because we are given these many things to document these many things to chart. If you talk to a physician, a primary care physician, many times the physician is sitting behind the computer screen. Those bedside manners are gone, like literally they are not there until you go into concierge medicine because the physician has to fill up this chart. I practice medicine. So understanding how this company and this CEO, this entrepreneur is trying to solve that problem, I lean back to the years of clinical practice. Then I lean back to the building the company. They're prioritizing it, having three priorities, having five priorities, and then being able to understand. And every company has some things which are similar, growth of your product development, continuing to advance the company, continuing to tell the story, attracting the right team members. It just gets magnified at a broader level. But the problems start similar, very similar. You know, think about when we talk about tech companies, Apple, the first thing they had to do, develop a product, then build a team, then sell the product, tell the, sell the vision, you know, and then continue to raise money. And that part is seems sometime very lonely. It also seems that I am uniquely burdened with these problems. And I always remind people, "You know, as much as you would like to think that you are unique. I assure you, it is not a problem that we are gifted with. We all have to face the same set of problems, sometimes more, sometimes less." So then you start to take them less personally. You start to say, "Okay, I'm not the first one to face this problem. These problems have happened to people like me before and they will overcome. How can I do it?" Then you'd become safe, a solution based thinking versus a place where you get overwhelmed with the problem because problems exist. And if anyone is listening to this podcast and if they've developed a started a company, I can assure you the problems come with a flood. They are not going to end ever. So it is disappointing. Sometime it feels that, "Oh my gosh, it is me versus the world," but it is not so. If you have good set of mentors, people who are not directly involved in day to day in your business, there are people who can help you think through it. And that is something that I find a great joy in talking to these CEOs, being able to help them understand the problem. And I say, you know, a couple of hours a month, but then when I go back to my own work, one that I realized this was the same problem I faced a few years ago. Two, it's a similar version of the problem I face at a slightly larger scale today. And three, being able to step out of from your own narrow zone, it gives you perspective. Then what I said to you about that problems are not, these are not personal problems. These are the problems we all face developing a product. It doesn't matter whether you healthcare. People tell me health care or product development is really hard. You talk to my colleagues, our CEOs who are running tech companies. Products in development and tech companies may seem easier, but to create a great product that truly solves customers problem, it's not easy. [00:30:30] Lindsey Dinneen: Yeah, and well, I love that mentorship and sort of teaching and guiding, giving advice to the next generation is something is of a core value of yours and something you really care about. And it actually is a great segue into my next question, which is just pivoting the conversation for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, what you're doing right now, but it doesn't have to be. What would you choose to teach? [00:31:02] Dr. Shalabh Gupta: I think as much as we all feel that entrepreneurship is an external game, I think it's a lot of internal mindset, being able to understand yourself better. Being able to understand who you are, what are your true core values, what really drives you. It takes time and it requires a continuous interrogation, asking yourself, "Is this really what I enjoy?" Some of us feel it's a glamour that we feel like we want to be CEO. Some of us would be better off as a CTO, Chief Technology Officer. Some of us would not want to do startups. It's not for everybody. And it's okay because you can work in a bigger company and can be, you know, people talk about entrepreneurial pursued within a large organization. Maybe that's what for you. But being able to understand yourself, it's a very important part. And I think unfortunately, formal education does not help us no matter what degrees and which schools. And it really doesn't matter whether you a science degree, MD, PhD, or your business school degree like MBA, we're all very uniquely different, and we have different values. What one person sees inspired by, for somebody else, it may be a nightmare, you know. It's a thing that people think that startups are so much fun. I read a joke. It says, "People leave 9 to 5 job to work from 5 to 9, which is 5 a. m. to 9 p. m." So I think that's because this is some truth to it. And I've said to people again and again that if making money is your objective, please don't go as to run a startup. It is probably the worst way to think about pursuing the financial part. You do something because you have a faith and belief in something. And it doesn't have to be the faith about changing humanity. It's about something that you have a unique skill set or unique product idea that you believe you can bring to the marketplace. The biggest focus we all can have is making an impact. If I can serve a large number of patients, I can serve a large physician, I will have a product that will make money, therefore, that will make money for enterprise that will make money for investors. And therefore, as a company, we will make money. It's a very simple truth, but we like to make it complicated. I really mean it. The more I got to understand this part of the process better, which goes back to the basic thing that I said to you, if you said that you have a master class, the one thing I will say to you, it's spend time to understand yourself. And it's okay to realize that what I thought I like, I don't like it. The part that I talked to you about flow, it takes efforts. I've had many careers, but when I work in my company, the time can stop for four or five hours, literally we can be working on something. And I have a team and it's not just me alone. I have a team that when we think about a problem, these are people who have spent three decades in working in different companies, large, small, many size companies, we could work cohesively, collectively, think about a problem. And that to me, it's a joy. For me, that is a creation, right? You know, we're thinking about the problem, which may be a design of a clinical trial, because we have to think we have to use brains. And I always say, "God gave us a gift, which is a neuron. So use it, let's use them." And challenge yourself, right? And the challenge in a good way, not be a condescending ending jerk and say "No, how could you do it?" I try to say to people, "Look, I understand this is how it is done, but I want to do two things. Number one, please believe me that we can do better, faster, cheaper. And number two, I promise you that whatever I'm telling you, I'm not going to tell you and walk out of the conference room. I will work hand to hand." We call it a hand to hand combat is essentially that I'm not just telling you I'm going to work with you. I want to find the solution, but we can't do that thing that are you used to. Every trial, people tell me it's going to take 18 months, 12 months, it's going to cost as much. We shrink that thing timeline cost by not 10, 20%. We talking 50%. And these are people have done this before. So, so I need the courage to be honest and say, "No, we can't do it. We have to do it faster, better, cheaper, but how?" And then asking them. So, I say, "It's okay that we walk away and we don't have a clue. It's okay. Today's Thursday. Let's come back. Take three days to think about it." But the reason is that because when you ask yourself from a place that I can't do it, the mind is start to find solution versus when you say, no, I can't do it. Because in that case, it's a subconscious mind that keeps on giving you 15 reasons why you can't do it. People talk about growth mindset. I've always said to people, "We may not be able to do this thing today, but the understanding that with a little bit of help, a little bit of patience, a little bit of it, making ourself better, we can become that company, we can become that organization." And that really requires challenging ourself. And that's where I went back to. I want to go back to this question you asked earlier. People talk a lot about entrepreneurship as if it is some very specific skill set. I think because if you know yourself, you know what is your true zone is, then you want to surround yourself places that you are either not good at, or you don't enjoy doing it, right? In the beginning, it is just you and a vast amount of problems to face. Then you start to build your team. Then you start to see yourself, "You know, maybe Bob can do this work. I really, I'm not that good at it. I don't like doing it." Then you start to rely and surround yourself with not same skill set, but the people who are complementary skill set. And that's how you build a team. That's the foundation of team. Then you build trust and you say to Bob, "Whatever you do, it's not your fault. I'm here to protect you." You don't point fingers at each other. We always remind the example of Navy SEAL. You know, I've never worked in the US Army. I was not an Army veteran, but the ethos that Navy SEAL uses where the team wins, I always tell people we are a winning team. We are not looking for MVPs, you know, because the teams win. Teams create products, teams create value. Individual glories is not useful and this is something you have to keep reminding us that we keep drilling it down and say " No, it's not Bob. It's not John. It's not James. It's us. It's as a team." Again, as you grow through the company stages, your skill set has to continue to evolve and people always say, "Well, how do you lead a team?" The first thing that I always said, "Every single person in my team, you are a leader. Why? You wake up in the morning, brush your teeth. You're leading yourself." Really! Like, what do you do with your day? If you happen to be a parent or partner, a spouse or somebody, you have people you influence around yourself, right? So instead of worrying about, "Oh, you know, I want to lead a company." First, you have to lead yourself and you have to lead with courage. It's starting a company, building a company, right? Yeah. No matter what the media tells you, it is hard. It's hard to develop a product. It's hard because the challenges are not one or two. There are many. Being able to drill down, saying "These are the three things I'll focus on. These are the only things that matter." And then if something new comes up, you have to face that challenge and put the third in your list. It comes in a different page. You know, I use this basic exercise. I have a notebook, a physical notebook and not electronic one, and a piece of paper. What are the top three priorities? And then the other part is that I've asked people to do this exercise when startup companies, CEOs come and tell me all their problems, all the things they want to do. I said, "Humor me if you will. This is the end of the year. And let's say today is we are in 2025. What would you like to tell yourself a year from now? If everything happened the best you could imagine, how many customers, how many products, what will be the stage of product, who would have funded you? Who are the people behind you?" And I asked him to write in a whiteboard. And I say, imagine, no, this is the five thing. If they write 25 things, I say, "No, this is down to five things. What are those five things you would like?" And again, everything has just gone and you can't believe you're sitting there. What will it take? Is it this? And then you start to have a goalpost, right? It's a target. Then you work backward. [00:39:37] Lindsey Dinneen: Yeah. Yeah. Well, that's great. That is such great advice. So thank you, first of all, for sharing, but I think in general, your masterclass would be so much-- you'd have to have a full day or more. That's great though. I love that. How would you wish to be remembered after you leave this world? [00:39:57] Dr. Shalabh Gupta: That's a very good question. That's one that I ask myself every day. The most important thing for me is to be who I am to make a difference for people who are around me. For me, my family is very important. I have kids and I always think about it. What will my children remember? Then it comes down to people who work with me. We want to give an experience to people. I've had people who have worked for I keep saying it two or three decades. My true wish is that I always say for whatever time they work at Unicycive, I want them to be remembering this is the best time they work for a company and that is the best hope we can do it. Because as a entrepreneur, if I can make our company the best experience, best environment, then that creates the best products. And a company like us, we realize that we are going to face challenges and it's not a question of this, the question is how many challenges. The question is not going to be, "Will the challenge defeat us?" The question is, "How do we overcome the challenges?" So it's about growth mindset, having a very distinct, clear vision and empowering people. And last thing is that what we do in healthcare affects millions of people people. Our drug is not going to be just in the U. S. We have partnerships outside U. S. We think about patients in China, South Korea, Southeast Asia. We are talking to companies in Europe. It's an opportunity to make a difference globally. And that is what keeps us going. That's what, you know, when that's when I talk with flow, that is what makes you want to work, whether it's a weekend or whether it's a late evening. And I think that is something which we all need to do to find something that is meaningful. And meaning means different things to different people in different phases of life. So it doesn't have to be, you know, I tell even my own team member, " Unicycive does not have to be the purpose of your life, but let me help you to manifest your best version so you can work well, because you are working here, you are spending your time, might as well make it meaningful for you and for the company." So finding that balance is key and it's a constant challenge. I never take anything for granted. It's a constant to my own team members. How can we make it better? You know, people always say the company grows and we started with the company. We went to IPO with one person. That was just me as an employee, which is not a common thing. I frankly don't know any other company that I've ever seen that went to a straight IPO with one employee. But that wasn't about me. It was about building the company, building the team. Today, we have 25 or so more, but it's still a small team. And people always ask me, "How do we go from 25 to 50 and it still remain the same." I said "Exactly how we became 5 to 10 to 15, 15 to 20." Because if you keep the culture same, focus same, and you remind people that it's not about who we are individually, but it's what we could be collectively. And you have it going and you know, something you're passionate about, you will give all that you got and then some more or else there is not worth fighting for because life is hard and building a product developing a technology or running a company is hard. So, either you are a full believer or else you can't do it. I mean, if you can do it, it's going to be miserable on both front. You want to do a good job and you will find it very difficult. So. [00:43:24] Lindsey Dinneen: Yeah. Indeed. Yeah. Excellent. Well, and then final question. What is one thing that makes you smile every time you see or think about it? [00:43:36] Dr. Shalabh Gupta: I think when you look back on the challenges that you once thought were unsurmountable, and then you say to yourself, "Huh, that was just a curve in the road, not a roadblock." Then you start to smile because of not because how smart you are, but how much together a team can accomplish. And you start to find, if you're working in a company setting, you start to feel that people start to feel empowered. My team says that you did it. I said, "No, we did it. I just showed you a judicious path, but you did it. I didn't do it. All I said to you is to change your framework." Because it's a framework. It's a mindset. And I keep saying about mindset because if you come with the idea that " No, I only, I need this much money, this much time, these many resources," you'll find you the subconscious mind keeps on validating those challenges. But if you say, "No, people like us have done it before I can do it, we can do it." And give them the time and space and say, "Look, you don't have to have an answer right now, but please go back and just think about it." Then they come back with the answer and they themselves surprised. But it truly requires a authenticity, a vulnerability, and being absolutely willing to fall on your face and get up and just fight again. And that's part people don't realize. People think about that every company is a smooth road up, but the companies go through the cycle. It's not when you're going up, it's what happens when you fall down. Can you pick yourself up? And it's not just with your team, but with your investors too. You know, we thought that we're going to file an NDA in 2020. You know, 2024, we had planned for everything and the whole thing was there, but we ended up in having to run an additional trial and then you have to communicate with integrity through transparency. This is what happened. This is what is there, but we can accomplish that. So then that all of all that helps you to look back a smile, laugh and say, "Okay, I accomplished that. We can do the next one." And that keeps the growth happening. And at the end of the day, we are not happy because we accomplished small things by doing small effort. Most of us as human beings want to be challenged in the right way and we feel joy in doing hard things that take a lot of efforts and once seemed just impossible to do it. And the question is, can you do it with your entire team, not just personally? And that's what inspires people. We want to be that company that people want to work for not because they need a job, not because we can take care of their 401k. I mean, those are a wonderful thing and I'm blessed that we can do all of that, because once upon a time, we didn't have any of that. So I don't take it for granted, it is something. But the fact is that what was the mission hasn't changed ever. And you know, that that is something which is worth pursuing it. And I think if people start to see that they can accomplish that, these challenges are not personal, that they are bound to come. And then they have a support group, you know, we all need somebody other than ourselves and people whom we are surrounded with somebody to hold our hand and say no, you fell down, but it's okay. You can get up. I think it's that support system, right? The more you can have it, the more different types of people you can relate to and call them friends, mentors, that helps. And I have tons and tons of them because my gosh, I mean, there are days seems like, how would I ever get out of this? As much as you may think that I have all the source of inspiration, but then if somebody else holds your hand, they say, no, you can do it. That is what gets you going to the next step. [00:47:25] Lindsey Dinneen: Absolutely. Well, goodness, this has been an amazing conversation, just packed full of incredible, helpful advice, and just very practical down to earth sharing. So thank you so much for your time today. I really appreciate everything you're doing to, to make an impact. So thanks again for your time. [00:47:44] Dr. Shalabh Gupta: Thank you very much. Thank you for hosting me and thank you for your time and interest. Really appreciate it. [00:47:49] Lindsey Dinneen: Of course. We are so honored to be making a donation on your behalf 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 also they advocate for policies that create long term solutions to hunger. So thank you so much for choosing that charity to support, and we just wish you the most continued success as you work to change lives for a better world. And thank you also to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two, and we will catch you next time. [00:48:31] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this episode of Medsider Radio, we sat down with Shreya Mehta, co-founder and CEO of Zenflow.Zenflow is a medical device company focused on treating benign prostatic hyperplasia (BPH). A biomedical engineer, Shreya brings over 15 years of experience in medtech, including serving as a lead reviewer at the FDA, where she specialized in cardiovascular devices. Shreya co-founded Zenflow in 2014 out of the Stanford Biodesign Innovation Fellowship. The company was one of the first medical device startups backed by Y Combinator and also received early support from StartX and the UCSF Rosenman Institute at QB3.Shreya's experience at Zenflow reveals strategies for grounding innovation in patient needs, building productive FDA relationships, and leveraging accelerator programs to transform academic concepts into viable businesses.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Shreya Mehta.

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail. From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.Key Timestamps00:00 – Introduction & Greenlight Guru Sponsor Message01:26 – Live from LSI: Introducing Justin Bushko02:55 – Why Early-Stage Engineering Mistakes Derail Companies04:12 – The Critical Role of DFM and Tolerance Analysis06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices08:10 – Human Factors Oversights & Surgeon Behavior10:25 – What CEOs Should Focus On vs. Engineers12:20 – Economic Buyers, KOLs, and Commercialization Challenges14:05 – Don't Chase the Exit: Why Founders Should Build for Longevity16:00 – Final Thoughts and TakeawaysStandout Quotes“If your partners can't explain how and why they did your tolerance analysis, they probably didn't do it right—and it'll cost you nine months later.”—Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners.“Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.”—Justin Bushko, challenging the exit-first mindset common in early-stage MedTech.Top TakeawaysDFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don't wait until post-market feedback.Understand Economic Buyers, Not Just KOLs: A surgeon's support doesn't guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.ReferencesGreenlight Guru – Sponsor and end-to-end MedTech quality management platformJustin Bushko on LinkedInEtienne Nichols on LinkedInMedical Device Fireside Chats –

Jacob and Rob dive into the shifting mood in U.S. markets, as post-"Liberation Day" volatility gives way to a more constrained and uncertain fiscal landscape. They unpack the massive implications of the Trump administration's budget bill, surging yields, and declining investor confidence. The conversation then pivots to Chinese biotech, where Jacob raises the alarm about America's declining edge in R&D, regulation, and talent retention. What follows is a sobering look at cultural skepticism, institutional decay, and whether the U.S. still believes in scientific progress. It's glum, sharp, and deeply thoughtful. They promise to be more cheerful next time.--Timestamps:(00:00) - Introduction and Episode Overview(00:38) - Current State of the US Market(02:32) - US Fiscal Policy and Economic Outlook(05:58) - Comparing US and Chinese Economic Strategies(16:41 The Future of US and Chinese Biotech(33:05) - Challenges in Biotech and Med Tech(33:46) - China's Capital Allocation Advantage(34:43) - Impact Capital and Social Investing in the US(36:37) - Historical Context of US Social Welfare(39:31) - US Biotech Industry's Unique Position(41:24) - Immigration and Talent in US Research(45:04) - Public Perception of Science and Progress(50:37) - China's Rise and US Decline: A Balanced View(52:13) - Local Resistance to Tech Development in the US(57:36) - Concluding Thoughts on US-China Relations--Jacob Shapiro Site: jacobshapiro.comJacob Twitter: x.com/JacobShap--The Jacob Shapiro Show is produced and edited by Audiographies LLC. More information at audiographies.com --Jacob Shapiro is a speaker, consultant, author, and researcher covering global politics and affairs, economics, markets, technology, history, and culture. He speaks to audiences of all sizes around the world, helps global multinationals make strategic decisions about political risks and opportunities, and works directly with investors to grow and protect their assets in today's volatile global environment. His insights help audiences across industries like finance, agriculture, and energy make sense of the world.--This podcast uses the following third-party services for analysis: Podtrac - https://analytics.podtrac.com/privacy-policy-gdrp

In this episode of Girls with Grafts, we're joined by Phoenix Society CEO, Amy Acton, to explore the stories behind the data in the 2024 State of the Survivor Report!