Podcasts about Medtech

Medtech is a $900 billion industry transforming how we treat, diagnose, and prevent disease—but its innovation engine is slowing. Vikram Aggarwal, global leader of BCG's medical technology work, explains what's behind the slowdown and how leaders can rethink regulation, software, and talent to re-accelerate breakthroughs. Learn More: Vikram Aggarwal: https://on.bcg.com/4osjpc6 BCG on Medtech: https://on.bcg.com/3LlJ6MC How Medtech Leaders Are Revving Up Their Innovation Engines: https://on.bcg.com/4op2Rl8 Chapters 00:00-01:25 Introduction/Vikram's ‘So What' 01:26-02:10 What is medtech? 02:11-03:46 Where are some of the most exciting innovations happening in medtech? 03:47-05:36 What areas get the most attention? 05:37-07:33 What are the barriers to innovation? 07:34-08:36 How do software and hardware innovation compare? 08:37-09:58 Software in a medical device vs software as a medical device 09:59-11:40 Is there a lag between innovation in software vs hardware? 11:41-13:41 What is the ideal innovation environment for medtech? 13:42-15:13 How do we fix the STEM skills shortage? 15:14-17:46 What will bring the most value over the next decade? 17:47-19:04 What is happening at startups vs established companies? 19:05 – 20:01 Vikram's ‘Now What' 20:02-20:15 Outro This podcast uses the following third-party services for analysis: Podtrac - https://analytics.podtrac.com/privacy-policy-gdrp

Health drives our lives, from our personal well-being to the health of our planet and economy. On the road to UN Climate Change Conference COP30 in Belém (Brazil), taking place from 10-21 November 2025, we shine a critical spotlight on harnessing medical technology innovation for healthcare decarbonisation.   In this episode of MedTech ON AIR, we are joined by Sigrid Linher, MedTech Europe's Director for Sustainability and Environment, to discuss the recent MedTech Europe study report commissioned to Boston Consulting Group on “Decarbonising Healthcare: How a Competitive MedTech Industry Can Contribute”.   The episode looks into what inspired MedTech Europe to launch this milestone project, highlighting the key findings from the study. More importantly, it explains why collaboration turns out to be the game-changer for building more sustainable and resilient healthcare systems.   Listen in as we discuss where MedTech Europe heads from here and why staying the course is essential to fulfilling MedTech Europe's core mission to make innovative medical technology available to more people, while helping healthcare systems move towards a more sustainable path.

Liz is joined on the podcast by Becky Lai, Chief Strategist and VP of Marketing, to talk about the true North Star of commercialization: standard of care. Their discussion reframes success as more than building a product—it's about building a market where the product is trusted, adopted, and indispensable. Together, they explore how purposeful training, meaningful KOL engagement, and a clear strategic vision accelerate adoption and move technologies from launch to lasting impact.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:Rebecca Lai is the Chief Strategist and Marketing Executive at Rebecca Lai Consulting. She is a strategy and commercial executive with over 20 years of experience in medical and health technology companies, ranging from venture-backed startups to Fortune 200 corporations. As a dynamic strategic operator specializing in go-to-market, commercialization, and innovative business strategies, she has consistently driven double-digit growth and scaled new businesses with global impact. With a strong background in devices, diagnostics, and the digital transformation of healthcare, Rebecca has a proven track record of pioneering disruptive solutions across the continuum of care. Most recently, she was VP of Corporate Development and Strategy at iRhythm Technologies (NASDAQ:IRTC), a digital healthcare provider of cardiac monitoring services. She began her career at Medtronic (NYSE:MDT), where she held progressive global leadership roles in sales and marketing. Rebecca is recognized for her ability to navigate complexity and her data-driven, customer-centric approach to creating value and delivering cutting-edge products and services to patients worldwide. She holds a BSE and MSE in Bioengineering from the University of Pennsylvania and serves on the advisory board for Diversity by Doing Healthtech.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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Rebecca Lai⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Cumby 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.

What does Star Trek have to do with medical device safety? More than you think.

This panel was recorded September 18, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠RQMplus.com⁠.Manufacturers often focus on MDR or IVDR and miss cross-cutting EU laws that impact CE marking, technical documentation, quality systems, and reporting. As a result, devices may be delayed, blocked from the market, or recalled, and manufacturers may suffer legal penalties and reputational harm.In this RQM+ Live! panel discussion, experts from BSI, Brabners, and RQM+ map how sectoral, horizontal, and national requirements fit together, how notified bodies assess them, and how to build an evidence-based path to EU market access.We cover practical implications of recent and emerging regulations, including:Batteries Regulation (EU) 2023/1542AI Act (EU) 2024/1689Packaging and Packaging Waste Regulation (EU) 2025/40European Health Data Space Regulation (EU) 2025/327You'll learn:About the market surveillance regulation (EU) 2019/1020 and EU Blue Guide.How to identify all applicable legislation for your product and verify coverage.What notified bodies expect to see and the typical level of scrutiny.How to structure your compliance register, QMS updates, and regulatory reporting.Transition timelines and planning tactics to avoid last-minute surprises.Who should listen: Regulatory, quality, clinical, legal, and product leaders responsible for EU market access for medical devices and IVDs.Panelists and moderator:Greg Griffin, PhD, MRSE – Technical Specialist, BSIClaire Burrows – Regulatory Partner, BrabnersChris Parr, PMP – Principal, RQM+Jaishankar Kutty, PhD – Vice President of Regulatory Affairs, Reimbursement, & Market Access, RQM+ (Moderator)--

This panel was recorded October 2, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at ⁠⁠RQMplus.com⁠⁠.PMCF surveys can strengthen your CER and PSUR or create rework. In this 60-minute panel with live audience Q&A, RQM+ leaders from regulatory, clinical, and scientific writing share what MDR reviewers look for and how to design surveys that generate decision-grade evidence. The session is intended for regulatory affairs, post-market surveillance, clinical evidence, and medical writing leaders at MedTech manufacturers.Listen to learn how to: Define clear objectives, endpoints, and target population so the survey maps to your PMCF plan and CER. Improve response rates without bias and capture higher-quality data, including adverse events and usability feedback. Learn how to position your physician level survey as a chart review. Document methods, rationales, and traceability so notified bodies can follow the logic. Avoid the top reasons reviewers push back on PMCF surveys and how to correct them. Walk away with a practical checklist to pressure test your next PMCF survey and reduce review risk. Who should attend: Regulatory affairs leaders and PMS managers. Clinical evidence and clinical operations leads. Scientific and medical writing leaders, including CER and PSUR authors. Quality leaders responsible for post market surveillance programs. Panelists and moderator: Torrie DeGennaro – Vice President, Scientific & Medical Writing Bethany Chung, Ph.D., RAC – Director, Technical Solutions & Innovation Garrett Jeffries, Ph.D. – Principal Jon Gimbel, Ph.D. – Vice President, Regulatory Affairs--

Audacity is defined as the willingness to take bold risks. It's also a mantra for Lishan Aklog, MD, a co-founder and CEO PavMed, the parent company of Lucid Diagnostics. Aklog makes his second appearance on Let's Talk Medtech to give updates on both companies and to discuss his philosophy on why audacity breeds innovation.

Sarah Ptach, President and CEO of Canyon Labs, discusses her journey from professional sports and advertising to leading Canyon Labs, a company specializing in medical device and pharmaceutical testing. Inspired by her father's Parkinson's diagnosis, Sarah transitioned to healthcare to make a meaningful impact. She delves into her leadership philosophy, emphasizing the importance of trust, transparency, and collaboration in building a strong company culture. Sarah also highlights Canyon Labs' dedication to elevating industry standards and ensuring patient safety.    Guest links: https://canyonlabs.com/ | https://www.linkedin.com/in/sarahptach/  Charity supported: The Michael J. Fox Foundation for Parkinson's Research Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 067: Sarah Ptach [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 to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I am super excited to introduce you to my guest, Sarah Ptach. Sarah is the President and CEO of Canyon Labs, a leading provider of medical device and pharmaceutical testing, consulting, and sterilization services. She joined the company during a critical ownership transition with a clear goal in mind: to raise the standard of service in the industry and build a true end-to-end solutions partner. Drawing on her background in packaging engineering and testing, Sarah focused on expanding beyond packaging alone to create a more integrated, accessible, and expert driven experience for clients. Sarah began her career in professional sports and advertising, but a desire to create more meaningful impact led her to the healthcare space after her father was diagnosed with Parkinson's disease. She went on to help grow and successfully exit a packaging firm before bringing her vision and leadership to Canyon Labs. In addition to her role at Canyon, she co-leads Kilmer Innovations and serves on the board of the Medical Device Packaging Technical Committee of the Institute of Packaging Professionals. She remains deeply committed to advancing healthcare through innovation, expertise, and strong partnerships. All right. Well, thank you so much for being here, Sarah. I'm so excited to welcome you to the show. [00:02:05] Sarah Ptach: Likewise. Thank you, Lindsey. I appreciate you having me. [00:02:08] Lindsey Dinneen: Of course. Well, I'd love if you would start off by telling us just a little bit about yourself, your background, and what led you to MedTech. [00:02:16] Sarah Ptach: Yeah. Thank you. So I'm Sarah Ptach. I'm the president of Canyon Labs. I have kind of an interesting story of getting into to medtech. I originally started my career actually in professional baseball. I was a contract negotiation person mainly for closing pitchers. And I ran track in college. I thought like, "oh, I wanna be in sports." And I like to say that's the most fun I never wanna have again. It was, it was a great start of a career. It teaches you a lot about negotiation, teaches you a lot about high stakes opportunities. But, you know, in the end it, it felt very kind of un unfulfilling in that perspective. And so I had kind of then taken that into to marketing for a pretty big ad agency in Chicago and hit the same thing. I felt like I was-- you know, now I was just selling people stuff that they didn't need instead of promoting people that, you know, that make a ton of money in the sports industry. And at the time my dad was diagnosed with Parkinson's disease and I wanted to feel like I was making a difference. So I, I went back and got my MBA and my whole goal of that was really to, to use my skills to, to do something that makes a difference in people's lives. So, I had reached out to a really small medical device company and it's " I'm willing to make no money as long as we, we have a difference in a change we can make in the world." And at the time that company couldn't hire me but I ended up getting introduced to another company through that that was in medical device packaging validation. And that was the first dip of medical device that I had. And that company's Packaging Compliance Labs. I was one of the first employees there and we grew that company until it sold a couple years ago. And through that, learned a ton about the medical device space. I kind of made it my personal mission beyond just my job to, to go try to participate in the industry as much as possible, push the status quo of things as much as possible, and really kind of learn where the testing realm or validation realm can make a difference in, in medical devices. And so after that, I was given the opportunity to step in and run and grow Canyon Labs. And Canyon is a whole platform. So for me, it was taking the packaging knowledge that, that I love so much and making that a full service offering. You know, I had always dabbled in sterilization or heard about Biocom, but never really gotten my hands on it. And to be able to be that full service solution with Canyon has not only been a awesome offering to, to give to our clients to really be able to go A to Z, everything from your regulatory to your microbiology, chemistry, packaging, bio comp, and toxicology. But also a good learning challenge for me. I thought that I was, you know, a pretty good packaging engineer and now learning chemistry and microbiology and toxicology, I'm like, "oh, wow. I'm definitely not as smart as I maybe thought I was originally," and I luckily have some amazingly intelligent individuals that, that work on our team, but it's, it's an awesome opportunity to, to not only get to help bring some life-changing medical solutions to market but also have a really good technical brain challenge every single day. [00:05:26] Lindsey Dinneen: Wow. Oh my goodness. I love that. And yes, I mean, sometimes I feel like actually, you know, not being the smartest person in the room is such a gift because then you get to talk to all these really cool people with really amazing experiences and learn. And I'm just one of those people who's constantly-- well, I'm curious all the time, so if I don't understand something, I'm like, "can you tell me more?" [00:05:48] Sarah Ptach: Yeah. No I love that. I completely agree. I think that the better that you can be at facilitating conversations, the, you know, the more successful your organization will be. And it, I really think as the leader of a company it's less about being the, you know, smartest person in the room and more about being the facilitator of that collaboration. [00:06:10] Lindsey Dinneen: Yeah. Yeah, absolutely. I love that. So, okay, so going back in time a little bit-- so, so I know you started off with professional sports, which is really cool. Like what a, what an interesting, unique opportunity and experience and you know, you'll maybe never want that particular brand of fun again, but. I still love that you got to do it. And so I'm curious though, was that always the sort of planning goal for you? Or when you were trying to think about career paths and all of that, younger, what were you envisioning? [00:06:39] Sarah Ptach: Yeah. I think I, I always envisioned myself as a leader. The packaging side of things became my kind of technical passion. But I mean, from a young age, I've always been the captain of the track team or the, you know, the head of any school organization I was a part of. So I always knew I, I wanted to be a leader. I think now, you know, being in that role, you, you learn so much about what different styles and brands of leadership is. I think, you know, to go back to your question about being the smartest in the room, I actually think that, you know, the CEO's job isn't to have all the answers. It's to create the culture where the answers emerge. And, you know, I've always wanted to be a leader. I've been passionate on that side, but I really think that the more, you know, more so than just having leadership pieces to you. It's about having that power to bring people together in that way. [00:07:31] Lindsey Dinneen: Yeah. That's a beautiful way to put it. And I actually would love to dive into this more because I know creating a really positive, good company culture is really important to you, and it's frankly, easy to get wrong, unintentionally-- sometimes maybe it just is what it is, but like sometimes it's not a desire to create it, but it happens. So I'm curious, how have you really intentionally cultivated your current company culture, and where did those lessons come from? [00:08:00] Sarah Ptach: Yeah. Deep question. You could answer that in a bunch of different ways and I could talk your ear off about lessons learned on that side. But I, I think the, you know, the most overlooked competitive advantage, both internally and externally is trust. Like the trust in your team to make decisions, the trust in your clients and even the FDA and your labs work. There's trust across it all. I think internally, from culture standpoint, it's have that trust in people and build, you know, people in a way that, that helps them feel most confident to, to make the decisions that they need to succeed. You know, when we first started talking you, you asked if I have any kind of lesson learned stories and some, I dunno, harsh realities per se. I think one of the more difficult kind of lessons that, that I learned in the course of just being a leader, is knowing when you have a passion for someone and what passions they might have. And I stayed that in the standpoint that I'm a huge believer in people. I want them to be like the greatest version of themselves, and I want them to dream big and go big and, you know, sometimes that's not always what people want for themselves too. And it's, it's a tough reality somewhat to to come to at times. But, you know, really finding what is the growth that people truly want. What is the environment that they want to live in, and how do you help foster something that, that meets the plethora of those ideals that you'll have across an organization is really important. But I think the, the culture I've worked really hard to foster at Canyon and frankly, my, my team fosters alongside me every day. This is by no means just a Sarah show on that piece. But it's a culture of trust, like I said, and it's a culture of transparency. I always like to tell my team, "you know, when I ask questions or probe I'm not trying to get an answer or I'm not trying to, you know, question your way of thinking. I'm trying to understand so that I can be at the same table that you're at and we're not, you know, talking oranges and apples and not realizing it." And so I really try to make sure we foster an environment where there's collaboration, there's trust to have that collaboration. There's trust to have challenges made of each other without it being an inflection of, you know, disliking someone. And then creating that opportunity to ask questions and always stay inquisitive in a way that's meant to greater raise everyone up together. [00:10:28] Lindsey Dinneen: Yeah, that's a wonderful culture that you're cultivating and I love that. But I think you hit on something really key amongst all of the really great points you made, but one of them that really stood out to me was, you talked about how it's not just the Sarah show in this way. It's a whole group effort. And I think that is a critical component that sometimes is forgotten. Like we sometimes think, you know, it's the leader's sort of job or role or just is. It is their leadership. That sort of filters down into the rest of the company and we think it's like a top down way of doing culture, but culture is about absolutely everybody involved in the company. So I'm curious, how do you empower your team members or, and, or when a new team member comes in, how do you communicate, "Hey, this is who we are, these are our values," and make sure that it is a good cultural fit too. [00:11:23] Sarah Ptach: Yeah. You know, we really at Canyon do a lot of things that are just small to, to reinforce and drive culture. We have these bracelets that you can earn, and what they mean is they're all of our company values and you can honor a fellow coworker for, for going above and beyond, or embodying teamwork or really showing integrity. And they get that read out in front of their whole department, and then they get a bracelet to wear proudly. So we do little things to to enhance our culture. And then there's the more macro level pieces, and I think having a baseline understanding of why we all show up to work every single day. You know, it really is to empower life changing medical innovation, and it's to ensure that all the products on the market are not gonna hurt somebody and they are going to, you know, do what they're meant to do in a positive way. You know, if we can all show up with the basis of "everything I do every day is for patient safety," then I think the getting on board with the culture is a lot easier if we all have that base, like regardless of how your day goes, regardless of your email inbox going crazy, we all agree that, you know, patient safety is what we're here to do. And you know, how we can have fun along the way, support each other, do teamwork is just gravy on top of that. So I'd say it's starting with culture that gets that base level item. And once you get that, everything else is just working better together. [00:12:48] Lindsey Dinneen: Yeah. Yes. And honestly, that's a great segue to my next question, but I was really-- I think you, again, honed in on something really critical and having everybody around a shared mission is so cool because that passion and that excitement and that " we're all in this together" and when disagreements or issues come up, which --we're human, they do-- then you can always go back to that shared mission and values of the work we're doing matters. We are all on the same side to provide value to our clients to ensure safety for our patients. So, I think that's a really key thing that you touched on there. Yeah. [00:13:33] Sarah Ptach: Don't get me wrong. I mean, it's a difficult thing to, you know, to keep going on teams. We, Canyon, we did two acquisitions this year. And with that comes a lot of combining cultures, changing culture together, all getting on the same page. And it's not easy, bumps along the road, you know, I think showing that we're all on the same page and working and rowing in the same direction is a conversation I have every single week. And so it's something you can keep reinforcing. And I think it's stacking bricks. You don't just have a house, you gotta continually stack bricks on it. And everyone needs to be involved in saying, "yeah, I wanna be a part of this team and I wanna be a part of this shared mission." And it doesn't build itself overnight. [00:14:19] Lindsey Dinneen: Yeah, absolutely. So speaking and then mentioning back to that segue, 'cause I just didn't ask the question, but can you share more about Canyon Labs and the incredible work that your company is doing for this industry? [00:14:34] Sarah Ptach: Yeah. Yeah. So like I said we're a full service contract testing and consulting firm within the medical device and pharmaceutical space. You know, a lot of the work we're doing is to help a lot of medical devices and drugs in their validation stage. So, you know, we're working through anything from, you know, designing your package to helping your sterilization strategy. You know, sterilization has been something I talked to, I've spoken on a lot this year. You know, it's a hot topic item in the industry. It's something that a lot of people are dealing with 'cause it has EPA implications as well as now tariffs affecting it as well as supply chain issues within it. So I'd say that's a division I talk to a lot and we help a lot of people navigate those. But the underlying whole piece of Canyon is being that trusted lab partner and we're really trying to raise the standard of service in this industry. You know, I came into Canyon being on the other side of the table and sending samples off to get biocom tested or to go through their sterilization validation. And, you know, for me it was this baby I was sending off to be tested and I don't think I was always met with the best customer service or the best accessible expertise when I needed it. And so we, when we built Canyon, we really built it to, to change that. You know, I want our clients to feel like we're one phone call away for any question that they have. You know, we're not just gonna send them their samples back, say, "sorry, it failed. Let us know when you're ready to give us another PO." That, that transactional relationship is, it's a currency that I don't wanna participate in. And so we really saw it after changing that in the industry. [00:16:16] Lindsey Dinneen: Yeah. Excellent. Well, yeah and I love the fact that you were on that flip side and it could bring such a valuable perspective to the company and go, "okay, here's some lessons learned." You know, and you're always gonna get a mix of it, right? You're gonna get like, "Ooh, I don't know if this is how it should be or needs to be," and you're gonna go, "oh, but here's something that they did excellently." So to bring that very valuable perspective is really cool. [00:16:40] Sarah Ptach: Yeah it's been fun. It's you know, in Canyon's infancy a couple years ago, we had the opportunity to come together with a lot of people from different experiences on our leadership team, and so it's-- as long as we all have the baseline humility to say "the way I did it in the past is not necessarily correct," you know, we could all come together and say, "here's what I did, here's what I did, here's what I did. Okay, let's pick the best of all worlds." So it it was a cool opportunity to have a lot of people with a lot of past experience come to a table that was completely, even in that standpoint. [00:17:18] Lindsey Dinneen: Yeah. Excellent. So I know that you are-- well, okay, so I took a look at your LinkedIn profile and had a wonderful time learning a little bit more about you, but I know you are involved so much. Like you are just, I don't know if you sleep because... [00:17:35] Sarah Ptach: Sometimes. [00:17:36] Lindsey Dinneen: Yeah. But the, I especially noticed, you know, you're a founding board member for thePACKout and you've done you're involved in a lot of different boards and groups and you're, it seems like you're just, you know, volunteering as kind of your heart and soul and serving in that way. And so I was wondering if you could speak a little bit about those opportunities that you're with too. [00:17:55] Sarah Ptach: Yeah. I think, first and foremost, before any job or role or position I've ever held, I am baseline, a huge proponent of this industry. And, you know, going back to my original reason to be here, it was my dad having Parkinson's and Parkinson's doesn't have a lot of treatment at this point. And it was like, I hate that. So how do I participate in solving that? And I think being involved in the industry, the super cool part, especially about packaging, is there's so much room for improvement at this point. You know, a lot of the standards that we function off of, they are being improved on a yearly basis, but they weren't made that long ago. So the, you know, the baseline ground zero is not that long ago. And I mean, there's people in the industry that are still in the industry that were there when they made ISO 11607. So it's, you know, it's, it's got a lot of room for improvement. I love how much the industry is trying to go back to patients now, and, you know, we're not just trying to design packages or devices that work well for, you know, me, the manufacturer, or me, the physician, but instead it, you know, really does consider patient comfort, patient safety. So the, a lot of what you'll see of my involvement in the industry is related to patient facing parts of of standards. I'm part of the Kilmer Renovations and Packaging Group and specifically I lead the aseptic presentation group, which is meant to evaluate the way that healthcare technicians interact with packaging in a way to help reduce hospital acquired infections. You know, we used to only design packages as an engineer because it's the perfectly engineered package. And, you know, we didn't think about the nurse that's trying to open it and your perfectly engineered package is just way too hard for a nurse to open and the device goes flying across the room. So it you know, we, we weren't considering those things. So our group is trying to correlate opening methods with types of packages and designs of packages. And we're trying to prove that with the different opening techniques that they teach in school for your surgical techs, your nurses, what is the best way for these different packages so that we can make that training and that design fit in the best way possible for positive patient outcomes. So, it's, a lot of my industry involvement is passion based, but I'd also say that a lot of the industry problems they, they can't be solved by just one company and they can't be solved in a silo. So, you know, the only opportunity you get to get all these stakeholders at the same table are these industry groups. And it's unique, I think, to the medical device industry in general that a lot of us care beyond our day jobs. You know, it's like, "cool, this is my day job, but I genuinely, passionately care about the development of my industry. And so I'm willing to, you know, volunteer my personal time." And I see that across the board every day. And it's really cool. I mean, you have people who have huge jobs at, you know, Johnson and Bausch & Lomb and Medtronic, and they're, you know, they're still willing to put their personal time on the table to advance the industry. So, yeah, all my industry involvement's pretty passion based, but it's the medical device industry and medtech industry is one that's super unique. A lot of people feel that personal passion. [00:21:20] Lindsey Dinneen: Yeah, I couldn't agree more. And thank you for sharing a little bit more about your involvement and your passion for the industry. And I feel so similarly, I, you know, when I joined the industry now a few years ago, I remember having this just moment of getting to meet all these super cool, intelligent innovators that are just literally changing the world and thinking "how lucky am I to be here and play a small part in this big changing thing," and then getting to see exactly to your point, how passionate the people are in the industry and how it's not just a job, it's like a calling. [00:21:59] Sarah Ptach: Well, I think the difference is, you know, in, in medtech, the origin or margin for error is not just financial, it's human. So where you have, you know, maybe your traditional job, you know, the margin of error is a financial impact. You know, the margin of error for people in our industry is human impacts, and that can be positive and negative. So it's hopefully the passion to make those more positively. So. [00:22:24] Lindsey Dinneen: Yes, indeed. Yeah, so, you know, I love the impact your company is making and the industry itself, like you said, is just such a cool place to be, and I think it really does invite those kinds of passionate people who are willing to just kind of be evangelists in a way for the rest of the industry in some fashion and really moving things forward. But because of the impact that's made, I'm wondering are there any moments that really stand out to you as affirming that, "hey, I am in the right place at the right time, in the right industry." [00:22:57] Sarah Ptach: Yeah. I mean, I definitely have some stories where you've-- without disclosing the details of a client-- but you know, you've been part of a launch that you watched that device go change the industry. I was a part of a company that was launching a, it's basically a, an organ transplant way of improving on how organs make it from, you know, the donor to the recipient. And it has improved patient outcomes tenfold to what they used to be. It's made it so that you could take, say, subpar lungs that used to not be able to be donated. And because of this technology, now it can, 'cause it, it has a way of it staying more intact while being transported. And you know, you get involved in those projects and, you know, you might just be helping at a small portion of it, like the sterilization or the packaging or just the biocom testing. But, you know, you watch the outcomes of that and it's like, "wow. Like I, I did that." You know, I've talked to people that work in consumer product goods and, you know, their Super Bowl is seeing their package on the grocery store aisle. And, you know, my, my Super Bowl is seeing the product that you played a part in, reach the market and change the world. Like that's, it's so cool. And to your point before you, you get to be in the room with such cool, innovative, smart people that came up with that product. I am, I'm honored to be the lab testing that is that silent backbone of medical innovation. But to be, you know, that trusted partner to, to get them to the finish line is a, it's a unique feeling, but it's really cool when you get to see a product that you played part of either touch a family member. I've been in an operating room before where I was the one being operated on 'cause I tore my ACL or did something and all I'm doing is looking at all the packaging, like, "Ooh, I did that. I tested that." Such a cool experience. It's sometimes it can be concerning 'cause you're sitting there while your doctor's trying to tell you to just get ready for surgery and you're staring at all the packaging. But it's, it's an awesome round to be in. [00:25:02] Lindsey Dinneen: Oh my goodness. I love that story so much. Yes. I mean, I could see that I, and I've talked to other folks who have similar experiences where they're, you know, they're kind of going along, something happens, they end up needing medical attention, or a family member does, and they go into the, to the hospital and they're like, "oh. I worked on that device" or "Oh, I did the cybersecurity for this one" or whatever, and just like how cool of a just full circle moment is that, and getting to watch in real time and in real life the impact that your work does. That is a huge honor and gift. [00:25:34] Sarah Ptach: Yeah, I I really did tear my ACL and my, and I also broke my back at one point in time, but my back surgeon and I have a really cool relationship and I think it's half because I was probably the biggest pain in the butt patient, 'cause leading up to that surgery it was like, "what device is it? What's the sterilization modality? Tell me what testing they did on it." And I got very lucky. My, my surgeon, his name's Dr. Michael Glisi, he has played actually a big role in getting some better improved medical devices to market both with Globus and with Arthrex. And now he plays a role in training other surgeons on how to best use those medical devices and technology. But it was such a unique relationship to get with him 'cause he's uniquely involved in the industry. So I think he, he maybe tolerates my 9 billion questions better than the average surgeon that just wants to operate on you and see you off. But it was a cool experience to get to, to have that relationship with him now after surgery and watch the impact that, that he's making on the industry as a surgeon too. So I think all stakeholders in this industry hold different areas of importance too. [00:26:49] Lindsey Dinneen: Yeah, absolutely. Oh my goodness. Yes. And, yeah, I could talk about all of this for days and I'm loving this conversation, but I am gonna pivot it, just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want, could be within your industry, but it doesn't have to be at all. What would you choose to teach? [00:27:13] Sarah Ptach: Ooh, that's a good question. I do think I would teach it on people leadership. You know, I, i've been in a lot of different roles and scenarios of people, leadership, especially through acquisitions, seeing, you know, the good, bad and ugly of what other folks do. And I've been really fortunate to have a lot of different mentors in my career that took very different leadership strategies. And I'm by no means saying that I'm the perfect people leader, but I think-- I can tell you a lot of different options and why they do and don't work. So if I was to teach a masterclass it'd probably be in that and I'd be heavy on the transparent leadership side. I'd be heavy on fostering a culture of people that are comfortable talking about issues. And it's not a easy thing to balance, I think with also driving, you know, the work product of the business and the financial success of the business. But being able to marry that, to marry, you know, having a great people culture and having, you know, people that, that love being a part of your company. It, to me, it is the most important part of actually driving your financial success of your company too. And I don't think a lot of people correlate that. You know, they think "I'm the ultimate financial driven CEO. I am the gross margin king." And, you know, " I'm driving my shareholder value." But I really think that, while all that is important, it starts with the people and the more you can get people to care about what they're doing beyond just their job, the more that the natural effect is improved gross margin and better financials. So the masterclass I'd probably teach is how to combine positive people, environment, and culture with good company financial success. [00:29:07] Lindsey Dinneen: Ooh, okay. That's a very powerful masterclass I wanna go take so, so sign me up for that, for sure. That's incredible. Yeah. And you have so much advice and insight and I could just tell, like, again, we could probably talk about this for hours and be very happy, so, yeah, I love that. Okay, and then how do you wish to be remembered after you leave this world? [00:29:30] Sarah Ptach: Yeah. Someone that, that cared deeply about the industry and was willing to to give it my all. You know, you, you jokingly said, "when do you sleep?" I'd argue not a lot, but it's because I love it. Like it's 'cause I love what I'm doing and if that means I'm gonna sacrifice some sleep to make sure the thePACKout is an awesome conference or the, you know, KIPP aseptic presentation team has what we need to change a standard or Canyon, you know, do something better and greater, I'll do it all day long. So yeah, I'd like to be remembered as, at the end of the day, she just really cared. And she was in it 110% at all times. [00:30:12] Lindsey Dinneen: I love that. That's a beautiful legacy. Yes, absolutely. Okay, and then final question, what is one thing that makes you smile every time you see or think about it? [00:30:23] Sarah Ptach: Oh, I love that one. I think someone realizing that the solution to the problem that they came up with was truly right and the solution. And it's like you worked through it yourself. You made it through maybe the hard parts of that decision making, but then you executed and hot dang, it worked. Like that is such a cool experience, especially when it's someone's first time ever having like the leadership role of solving a problem or, you know, the project manager role of solving that problem. It's super cool 'cause you get to watch someone's thought process play out. You get to watch where they see the pros and cons of their decision or the faults that could occur. And then you get to watch 'em navigate that, and then it succeeds and it's like, "hot dang, you did it." It's great. I love that. So that's probably something that makes me smile the most is when someone sees, their true potential being achieved, and they get to see it in the form of something as tangible as solving a problem. [00:31:22] Lindsey Dinneen: That is awesome. I love that so much. Oh my goodness. Well, this has been such an amazing conversation. I'm so thankful for you and for you being willing to share some of your time with me and with our listeners. So thank you so much for all the work you do, and thank you for being in the industry, being passionate about this industry and for being a change maker too, in the way that, you know, companies can operate and be successful. And we don't have to think about it just in terms of financial success, but we talk about it in terms of cultural success too. And so, I just really appreciate your perspective, so thank you for all the hard work you're doing to change lives for a better world. [00:32:02] Sarah Ptach: Thank you. Yeah, thank you, Lindsey. And likewise what you do. It's awesome to see you highlighting some of the stories in the industry and bringing together really good conversations like this. So thank you. [00:32:11] Lindsey Dinneen: Awesome. And we are so honored to be making a donation as a thank you for your time today to the Michael J. Fox Foundation, which is dedicated to finding a cure for Parkinson's disease through an aggressively funded research agenda and to ensuring the development of improved therapies for those living with Parkinson's today. So thank you for choosing that organization to support. Again, thank you so much and thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:32:49] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.  

Going for Growth - the business development programme for female entrepreneurs - will host an Inspiring Roadshow event at Dublin City University (DCU) next month. The Going for Growth: Inspiring Roadshow will take place at the Polaris Building at DCU's Glasnevin Campus on November 6. Doors open at 6 pm. The event will run from 6.30 pm to 9 pm and includes time for networking and refreshments. Registration is free and can be booked on the home page of the www.goingforgrowth.com website under 'News Updates'. The Inspiring Roadshow is one of a series planned in Dublin and Galway, which are designed to provide information and encouragement to businesswomen at any stage of their entrepreneurial journey. Alongside an array of special guest speakers, there will also be information on supports, like Going for Growth, designed for those who wish to increase revenue, create employment, and explore new market opportunities. The DCU event will feature contributions from Dr Sheelagh Brady, founder of the AI-powered personalised travel risk management application Kowroo; Emily Brick, founder and Managing Director of Athena Analytics, an EdTech company that tracks academic performance using machine learning and AI tools; and Dr Anne Cusack, founder and formally of Critical Healthcare, a leader in the Emergency Services market providing healthcare solutions at the frontline. Dr Sheelagh Brady will offer insight into her journey from academic research in the areas of Criminal Justice and Crime Science to working in high-risk environments with the United Nations and European Union missions in countries such as Nigeria, Libya and Bosnia and Herzegovina. She co-founded Kowroo to provide travellers with real-time personalised risk insights, enabling them to make smarter decisions while abroad. Emily Brick will discuss how she combined her academic background in statistics and data analytics with a passion for mathematics and education to create Athena Analytics in 2017. The EdTech company now works with 350 schools to enable more data-driven academic tracking and support. Dr Anne Cusack, meanwhile, will give an outline of her experience co-founding Critical Healthcare, a contribution which is sure to showcase her strong background in MedTech and digital technology, as well as her experience in scaling a business. These Inspiring Roadshows are taking place while the call for applications for a new cycle of Going for Growth is open, so enterprising women, at various stages of their entrepreneurial journey, can learn what is possible from the experience of other women. Going for Growth is supported by Enterprise Ireland and KPMG. The closing date for receipt of completed applications for participation in the next cycle of Going for Growth is midnight, November 21. Those interested in getting an application form sent to them should register on the website www.GoingforGrowth.com. Sixty places are available for the free programme, which is due to begin with a one-day Launch Forum in January and will run until June. National Director of Going for Growth, Paula Fitzsimons, said: "We're delighted to bring our Going for Growth: Inspiring Roadshows to Galway and Dublin in November. We hope the information provided at these evenings, along with the contributions from our guest speakers, will encourage female entrepreneurs to be more ambitious in their business development goals. We also hope that it will demonstrate the support available, including Going for Growth, designed to support ambitious women to realise their growth aspirations. The deadline for applications for the 18th cycle of Going for Growth is midnight on Friday, November 21, so Inspiring Roadshows come at just the right time for anyone who may be considering applying." Visit www.goingforgrowth.com for more details and to request an application form. More about Irish Tech News Irish Tech News are Ireland's No. 1 Online Tech Publication and often Ireland's No.1 Tech Podcast too. You can find ...

One of the challenges we face in Australia is getting more homegrown medtech products purchased and used by local hospitals and health services. MTPConnect's Pathway to Market – Medtech Capability Uplift Program has been supporting ten market-ready Victorian medtech manufacturers to position themselves competitively for local health procurement opportunities. The recent Australian Medtech Manufacturing Alliance (AMMA) Medtech Showcase profiled Victorian-made products and innovations from 25 local manufacturers spanning surgical care and diagnostics to hospital consumables and equipment. From a new nasal swab designed for children to smart bedding systems for aged care and healthcare sectors, the lineup was impressive.The Showcase highlighted ‘Better Health Made Here' – and the MTPConnect Podcast was on the ground talking to companies involved, including those taking part in the Pathway to Market program - Ventora Medical's Edward Buijs,  Rhinomed's Michael Johnson, Dentalife's Tom Stray, Sleeptite's Cameron van den Dungen and Certius Medical's Tim Stewart - as well as local leaders Care Essentials' Helen Skazas and Lindo's Robert Gangi. The Pathway to Market program is an initiative of the Australian Medtech Manufacturing Alliance (AMMA), delivered by MTPConnect in partnership with BioMelbourne Network and supported by the Victorian Government. Applications for the 2026 Pathway to Market program will open towards the end of 2025. 

In this episode of Tank Talks, host Matt Cohen sits down with Sameer Dhar, Co-Founder and CEO of NiaHealth, to explore how proactive healthcare is reshaping the future of medicine.Sameer shares his remarkable journey from living in nursing homes for a year while building his first startup (Sensassure) to launching NiaHealth, a Canadian health-tech company empowering people to take ownership of their longevity through AI-driven diagnostics and personalized insights.With over $8 million in funding and a 12,000-person waitlist, NiaHealth is building a clinician-first model that complements Canada's public system, helping users prevent disease decades before it develops. Sameer also discusses why prevention, not treatment, must drive the next wave of healthcare innovation, how AI will augment rather than replace clinicians, and what it takes to build a mission-driven company in a regulated industry.Whether you're a founder, investor, or health enthusiast, this conversation reveals how the next generation of health tech startups can blend AI, clinical integrity, and human empathy to create lasting impact.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.The Entrepreneurial Spark (05:52)* How the Next 36 program transformed Sameer from a finance student into a founder* The power of founder-focused education in shaping Canada's startup ecosystem* Lessons from learning to “think like a builder” instead of an employeeFrom Customer Discovery to Conviction (10:46)* How customer discovery can turn into “analysis paralysis” if you never act* Why true innovation means taking bold bets, not just collecting insights* The importance of timing when moving from research to executionBuilding NiaHealth (13:26)* The personal mission to keep people healthy long before disease develops* How the pandemic revealed gaps in personal healthcare ownership* The evolution of NiaHealth into a platform offering advanced diagnostics, clinician reviews, and personalized longevity plansIntegrating with the System (17:12)* Why NiaHealth chose a “clinician-first” model rather than going fully digital* How nurse practitioners bridge the gap between data and diagnosis* The importance of integrating with Canada's public system to maintain trustTrust and Transparency (22:51)* Addressing criticism about private healthcare models in Canada* Why NiaHealth avoids affiliate sales to maintain clinical integrity* The company's research-led approach to responsible, evidence-based testingFilling the System's Blind Spots (26:13)* Canada's biggest blind spot: a reactive healthcare model built around disease* How prevention and early diagnostics reduce system strain and save lives* The mission to empower users to act on health risks decades in advanceAI as an Enhancer, Not a Replacement (29:16)* Why Sameer believes AI should support, not replace, clinicians* How AI enhances diagnostic accuracy and clinician productivity* The role of empathy and human connection in patient outcomesScaling Impact (33:11)* NiaHealth's vision to reach 100,000 Canadians by the end of next year* Partnering with insurers and governments to expand preventative care* Why a “built in Canada, for Canada” strategy is key to long-term successAbout Sameer DharSameer Dhar is the Co-Founder and CEO of Nia Health, a serial entrepreneur and health-tech innovator recognized among Canada's Top 20 Under 20 and Edmonton's Top 40 Under 40. He previously founded Sensassure, an elder-care technology startup acquired by global health leader Essity.Connect with Sameer Dhar on LinkedIn: https://www.linkedin.com/in/sameerdhar/Visit the NiaHealth website: https://www.niahealth.co/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

In-utero procedures can yield better long-term outcomes for the baby. However, fetal surgery relies on instruments developed for other disciplines. An early-stage startup in Maryland is developing in-utero instruments to improve outcomes for both fetus and mother.Fetal Therapy Technologies CEO Selena Shirkin joins Key Tech's Andy Rogers for Episode 42 of the MedTech Speed to Data podcast to discuss startup innovation in fetal surgery.Need to knowFetal surgeries carry risks — In addition to uterine damage complicating future pregnancies, 40% of surgeries have a risk of preterm birth.Few specialized tools are used — In the field's forty-year history, the FDA has only approved the Karl Storz Fetoscope for use in fetal surgeries.Off-label device use is widespread — Equipment borrowed from adjacent fields like laparoscopy and neurosurgery weren't indicated for use in the uterus.The nitty-grittyShirkin and Chief Technology Officer Eric McAlexander founded Fetal Therapy Technologies as students in Johns Hopkins University's biomedical engineering graduate program. While shadowing surgeons, they saw how off-label instruments complicated procedures.“I watched a surgeon using a grasper and suture,” Shirkin recalled. “The suture was falling out of the grasper because they didn't fit. It took time in the surgery to make sure that didn't occur.”Observations like these led the team to wonder why the field lacked optimized tools. “As biomedical engineers,” Shirkin says, “we asked ourselves what if we created those purpose-built instruments that actually make these procedures safer?”They quickly ran into the commercial limits of a market as small as fetal surgery. With only one device FDA-approved for in-uterine procedures, surgeons have no choice but to use devices off-label. So Fetal Therapy Technologies is flipping the script by leveraging the broader applications of an instrument designed for fetal surgeries.“In a way, our company solves two problems at once,” Shirkin says. “A company that creates a fetal innovation [that] also raises a much broader market of general microsurgery.”Their first product is a uterine port. “Similar to laparoscopic surgeries,” Shirkin explains, “that involves inserting a port through the abdomen into the uterus. [The new] port is designed to leverage the elastic properties of the uterine environment to make entry safer than the current clinical standard.”For broader commercialization, they aim to demonstrate equivalence to predicate devices and qualify as a 510(k) Class II device following benchtop and animal studies. Approval for fetal surgeries is a longer journey, but the company can build on its data before entering human trials.Data that made the difference:Shirkin offered insights for other students considering an entrepreneurial future in MedTech.Leverage university resources. “We work incredibly closely with the Johns Hopkins Center for Fetal Therapy,” Shirkin says. We've also gotten opportunities from Johns Hopkins Technology Ventures.”Build a network of advisors. “We are supported by a very broad variety of clinical, technical, and business mentors across the Johns Hopkins ecosystem and beyond.”Tap into local funding sources. “There's a lot of collegiate business plan competitions that we've been very successful [raising] non-dilutive funds that way. There are also state-level grants. We just received a Baltimore Innovation Initiative grant.”

Sydney Mrowczynski didn't plan to end up under a welding hood. As a teenager she dreamed of fashion design — until a boyfriend told her she couldn't weld. Challenge accepted. A few years later, she's worked across multiple shops, learned how things really get built, and is now studying industrial management and applied engineering at Southern Illinois University to bridge the gap between the floor and the front office.This episode of the Manufacturing Culture Podcast is a crash course in what real culture looks like from someone living it. Sydney's take is simple: great culture means communication, teamwork, and quality. Most shops have one or two of those — rarely all three. She shares what it's like being the only woman on the floor, the extra proof she's had to carry into every new job, and why too many people get comfortable doing things “almost right” for 20 years.We get into failure as a teacher — how welding forces you to face mistakes and learn faster than any classroom. Sydney talks about integrity, leadership, and the shops that cover bad welds instead of fixing them. She lays out the difference between a leader who checks in, listens, and teaches versus one who just points and barks orders.If you run a team, hire apprentices, or manage training programs, you'll want to hear her take on trade schools too — how they teach to plate instead of teaching to reality. She argues that students should weld on rusted, greasy, and painted metal, not perfect coupons, if they're expected to survive their first week on the job.Sydney is now balancing school with work at Tenco Hydro in Sugar Grove, Illinois, helping bring metal fabrication in house and ship their first stainless wastewater tank. She's seen the gaps firsthand — and she's building the bridge from within.It's an honest, sharp conversation about what manufacturing culture really needs: leaders who communicate clearly, care about quality, and build environments where new talent wants to stay.SponsorMed Device Boston is your go-to Med Tech sourcing and education expo, September 30 through October 1 at Boston's BCEC. With 200+ suppliers, 1,500+ attending professionals, and expert-led workshops on 3D printing, AI, materials, regulatory tech, and contract manufacturing, it's built to advance the next generation of medical device innovation. Visit meddeviceboston.com to register.ConnectFind Sydney Mrowczynski on LinkedInSubscribe to the Manufacturing Culture Podcast on YouTube and your favorite platform.

In this episode of Medsider Radio, we sat down with Tim Gleeson, CEO of BRIJ Medical, a company rethinking one of the oldest procedures in medicine — surgical wound closure.BRIJ's Brijjit Force Modulating Tissue Bridge is a small, non-invasive clip designed to redistribute tension across incisions, helping wounds heal with fewer complications and smaller scars.An accomplished entrepreneur and investor, Tim also founded and led Novasyte Health through its acquisition by IQVIA and later launched VIDANT Capital. A former Medtronic executive, Tim brings global experience and a lifelong passion for building impactful medtech ventures.In this interview, Tim shares why the biggest opportunities often hide in “boring” markets, how focusing on physician champions and patient psychology drives commercial traction, and why the best fundraisers plan for twice the time and four times the cost.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 Tim Gleeson.

In this episode, host Etienne Nichols and guest Dr. Allison Komiyama, CEO and Founder of Blue Stocking Health, dive into a fascinating dialogue about the language used in healthcare and MedTech, particularly the terms patient, customer, and user. They explore how these words influence the perception of care, service, and the entire medical device development process. The conversation touches on the friction and inefficiencies that arise when the relationship dynamic is unclear, highlighting the different nuances between passively receiving treatment and being an active consumer of health services.The discussion delves into the historical context of the word "patient," which is rooted in the Latin patior, meaning 'to suffer.' Dr. Komiyama shares insights from industry conferences, noting that many individuals prefer to be called a "person" or an "empowered patient" rather than a passive sufferer. This ties directly into the growing movement of individuals seeking to own their health and be active participants in their care, fueled by readily available information and a focus on health span over just disease treatment.Ultimately, the key takeaway for MedTech innovators is the importance of understanding their end-user and tailoring their language—in labeling, clinical studies, and human factors testing—to align with the user's preferred terminology. The shift from "caregiver" to "care partner" is highlighted as a prime example of evolving language that acknowledges a collaborative, mutual relationship, moving away from a hierarchical structure to one of shared purpose.Key Timestamps[0:01:25] - Introduction to Dr. Allison Komiyama and Blue Stocking Health's mission to amplify the good of MedTech.[0:04:14] - Discussion begins: Patient vs. Customer vs. User in MedTech.[0:06:05] - The etymology of "patient" (patior, to suffer) and the push for "person" or "empowered patient."[0:08:22] - Historical context: Passivity of the patient role and the doctor's assumed knowledge.[0:09:50] - The impact of consumerism, AI, and the "health span" movement on patient empowerment.[0:12:35] - The value of seeking multiple opinions and the role of patient priorities in customizing care.[0:15:30] - Shifting terminology: Why "caregiver" is moving toward "care partner."[0:18:22] - How language diversity enriches the conversation and enhances communication.[0:21:00] - Tying diverse language use to MedTech innovation and product development.[0:22:15] - The importance of understanding end-user biases and assumptions in MedTech.[0:24:25] - Impactful personal stories: How specific interactions define a positive care experience.[0:29:10] - Concluding thoughts: Why plurality and qualifiers (e.g., "empowered patient") may be the ideal goal.Quotes"I think there's a lot of folks at FDA even that we're like, we don't want to use the word patient. We want to use the word person. And patient actually comes from the term patior, which means to suffer." - Dr. Allison KomiyamaTakeawaysRegulatory & Clinical Strategy: When defining the target population for your device—in 510k, IDE, or PMA submissions—be mindful of the terminology. Consider using terms like "end-user," "person living with [condition]," or "care partner" alongside "patient" to reflect a modern, inclusive understanding of...

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing the government shutdown and its potential impact on medical device manufacturers and their submissions. This shutdown is almost one month in, and its conclusion does not seem to be in the near future. So, what do you do if you have a device being submitted to the FDA, already under review, or some other scenario involving the agency? During this conversation, the following questions are addressed:First, can you please explain what is out-of-bounds? (i.e., What will we NOT talk about?)What can FDA do during the shutdown?If a company currently has a submission under review, pending communications (e.g., emails, questions, pre-submission meetings), or other activities currently pending with the Agency, what would you advise the company to do? How should they proceed?If a company plans to make a submission, request a pre-submission meeting, or engage with FDA about other activities in the near future (but has not done so yet), what would you advise the company to do? How should they proceed?Can a company submit a pre-sub request during this shutdown?From a public policy perspective, how could situations like these be mitigated or possibly prevented in the future?What additional thoughts/questions/comments/concerns/recommendations/etc. do you think are important to share regarding the shutdown and its implications on medical device companies in particular and regulatory affairs in general?What else is important?What are today's takeaways?Listen to this discussion and see if you can take action during the shutdown. 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 text For more medtech news and information, visit https://www.mpomag.com.

In this episode of Tank Talks, host Matt Cohen and John Ruffolo break down the most important stories shaping Canada's innovation economy, from the upcoming federal budget and its impact on founders and investors, to Canada's fintech shake-up as open banking finally gains momentum.The duo dives into AI's growing legal minefield, including the mounting lawsuits against Perplexity and Sora, and discusses what this means for startups training models on licensed versus unlicensed data. They also unpack Cohere's rumored IPO, Canada's AI partnership with the UAE, and what it reveals about the country's global strategy for data centers and sovereign capital.From Blue Jays playoff economics to AI data sovereignty, this Rundown is packed with sharp insights, timely analysis, and the kind of candid commentary you won't hear anywhere else.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Canada's Make-or-Break Federal Budget (08:46)With the federal budget weeks away, John calls this the Liberal government's credibility test, a defining moment for innovation, R&D reform, and fiscal discipline.* The state of Canada's finances and investor sentiment* Expectations for R&D tax credit and AI policy reform* Why “good ideas” might not matter if the fiscal hole is too deepOpen Banking Finally Gets Real (12:55)The Bank of Canada registers 300 new payment service providers, marking a major milestone for Canada's fintech ecosystem.* How this could shake up the Big 5 banks' oligopoly* Why Wealthsimple, Shopify, and Koho stand to gain* John's take on trust, liquidity, and the future of financial competitionCanada-UAE AI Investment Deal (15:34)AI Minister Evan Solomon signs a non-binding MOU with the UAE on data center investment. Is this a real opportunity or political theater?* What “non-binding” really means for Canada's capital strategy* Mark Carney's push to diversify trade away from the U.S.* Why every major country is chasing sovereign data capitalCohere's IPO Tease and the AI Hype Cycle (18:11)Cohere's CEO Aidan Gomez hints at “going public soon.” Matt and John weigh the risks and timing of an AI IPO in a frothy market.* Lessons from the Faire America IPO and $16B valuations with no assets* The pressure of capital requirements in AI infrastructure* Why timing the public markets almost never worksAI Lawsuits, IP Infringement, and Data Licensing Wars (20:48)From Reddit vs Perplexity to Hollywood vs. Sora, Matt and John break down the growing AI legal battles over content rights.* The global IP divide: what happens when China ignores licensing rules* Why only the biggest players can afford compliance* The coming “Rule of Three” in the AI data economyConnect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

Early detection saves lives, but today's tools are often invasive, slow, or used too late. In this episode, Breath Diagnostics CEO Ivan Lo explains how a non-invasive breath test can detect volatile organic compounds (VOCs) associated with disease—positioning breath as a first-line screen for early-stage lung cancer and potentially pneumonia and TB. We cover the science (why breath can capture near real-time biological change), sensitivity/specificity signals from 800+ patients, and a go-to-market/regulatory plan that prioritizes post-op pneumonia (shorter trials, no entrenched standard of care) before lung cancer screening. We also discuss platform economics (low-cost disposables, existing LC-MS infrastructure), trial scale and cost, and how breath could support ongoing monitoring after treatment. Investors get a clear view of timelines, risks, and upside; founders get lessons on platform positioning, capital efficiency, and sequencing indications. Highlights include...Why breath (VOCs) can surface disease signals minutes–hours after biological changeFirst-line screening thesis vs. liquid biopsy and CT workflowsEarly data: ~94% sensitivity / 85% specificity across 800+ patients (lung cancer context)Regulatory path: post-op pneumonia first (faster FDA route), lung cancer nextUnit economics: low-cost cartridge + existing LC-MS labs (hub-and-spoke)Clinical design: trial scale, costs, and companion-diagnostic “cocktail” potentialPlatform beyond oncology: pneumonia, TB, inflammation, RUO for pharmaChapters00:00 Intro & why early detection needs a rethink00:47 What Breath Diagnostics does (the “breath bag”)03:34 VOCs 101: why breath can be earlier than blood06:41 First-line screen vs. confirmatory tests08:19 Will this be ubiquitous at annual visits?11:53 Commercialization path & funding realities12:37 Pneumonia first: faster FDA route14:09 Lung cancer timeline & business model15:34 Hospital economics & pneumonia savings18:24 Trial scale/costs; disposable chip economics20:34 Team, funding strategy, and sequencing22:08 Early data and a “false negative” biopsy case24:12 TAM & eligibility (20M Americans qualify)25:06 What success looks like (2–3 years)27:00 Investor closing thoughts

The Transformation Ground Control podcast covers a number of topics important to digital and business transformation. This episode covers the following topics and interviews:   A MedTech Firm Warns of Their Impact from Their Software Switch, Q&A (Darian Chwialkowski, Third Stage Consulting) What do the EU's Antitrust Allegations against SAP Really Mean? (Scott Hays – Vice President at Rimini Street, Marcus Harris – Partner at Taft Law) The #1 Software Proposal Mistake That's Costing Companies Millions   We also cover a number of other relevant topics related to digital and business transformation throughout the show.  

What if a discreet sensor could quietly prevent one of healthcare's most common—and dangerous—IV injuries? In this episode of Med Tech Gurus, Jaclyn Lautz Ph.D., COO of IV Watch, takes us inside the journey of building a global standard of care. Jaclyn shares how her team navigated the EU MDR maze, achieved regulatory approvals across 16 countries, and proved their technology's impact through powerful clinical studies. From mentoring moments that shaped her career to the operational discipline driving IV Watch's innovation, this conversation delivers invaluable insights for MedTech leaders aiming to scale globally while keeping patient safety at the core.

In this episode of Medsider Radio, we sat down with Kate Dilligan, CEO of Cooler Heads.Cooler Heads is a commercial-stage company addressing a problem affecting many chemotherapy patients undergoing treatment for solid tumors: hair loss and the loss of privacy that comes with it. The company's FDA-cleared medical device, Amma, makes scalp cooling accessible by fitting into infusion center workflows rather than disrupting them.Kate brings an unconventional background to medtech — from political fundraising to developing classified software for the U.S. government. As a solo female founder who had never worked in hardware, she started Cooler Heads in 2018 after her own experience with breast cancer. By mid-2025, the company had raised $11 million in Series A funding and placed devices across 27 states, with most accounts having never offered scalp cooling before.In this interview, Kate shares how to design for health system adoption by solving workflow problems first, why saying “no” to scope creep protects your first-generation product, and how political fundraising tactics translate directly to building investor relationships in medtech.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 Kate Dilligan.

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What's Regulatory Affairs? How does R&D fit in?In this video, I walk through eight of the most common roles you'll find in pharma, medtech, biotech, and diagnostics companies. We'll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.If you're trying to figure out where you belong in industry, this one's for you.Please like, share, and subscribe if you find it helpful!Timestamps00:00 Introduction and Background01:07 Overview of Industry Roles02:43 Quality Assurance06:14 Regulatory Affairs08:22 Research & Development09:46 Clinical Affairs11:07 Manufacturing & Operations12:09 Quality Control / Analytical Testing14:05 Supply Chain & Procurement15:13 Validation & Technical Services16:39 Career Path Insights and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

As you grow and scale out of early start-up mode, there will come a time to hire an internal training department. But when? And who? This week, Liz and Rachel break down the interview with Heather Ramsey diving into what to look for in an internal training team. They cover key qualities to prioritize, the differences between hiring from MedDevice vs. L&D, and how consultants can help bridge the gap and get your internal team up and running. 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:Heather Ramsey Interview 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:   ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠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.

Ralph Keiser, CEO of ArcheHealth, highlights the severe financial pressures that hospitals are confronting as a result of rising costs and declining reimbursements. Reductions in reimbursements are threatening hospitals that serve underinsured populations. Costs are increasing due to tariffs on medical device components and the general price inflation on medical supplies and drugs.  ArcheHealth is focused on helping hospitals improve operational efficiency to lower the expense of delivering care. Ralph explains, "The tariff index is going to come mostly around medical devices and device components. So plastics, metals, packaging, things that the device manufacturers use to deliver their products to hospitals and health systems, those will likely get passed through. It won't be huge incremental costs, so there will be additional costs due to tariffs. It depends on a couple of things. Do you have a strong contract that sort of embargoes your current price? Then maybe in the next contract term you'll see that pass through or the contract so the supplier to pass through, you'll see them. We're monitoring month by month the current or last month's spend was on these items, and do we see a chart impact by manufacturer by line." "One thing that I want to make sure we talk about, too, isn't just shared impact. So the cost to a hospital for devices and drugs averaged 8.9% more in 2024. So just by nature of the market raising its prices for goods that hospitals use to cover patient care, those moved up without tariffs 8.9% last year. We think we're tracking increases that are happening despite the tariff overlay or on top of the tariffs. We still think that the pressure on hospitals is due to the price of therapeutics, and is going to continue to go up, tariff or not. And so I want to mention that because this is the ongoing impact of the cost of MedTech and drugs that gets passed through to the consumer." #ArcheHealth #AIinHealthcare #HealthTech #HealthcareOperations archehealth.ai Listen to the podcast here

Ralph Keiser, CEO of ArcheHealth, highlights the severe financial pressures that hospitals are confronting as a result of rising costs and declining reimbursements. Reductions in reimbursements are threatening hospitals that serve underinsured populations. Costs are increasing due to tariffs on medical device components and the general price inflation on medical supplies and drugs.  ArcheHealth is focused on helping hospitals improve operational efficiency to lower the expense of delivering care. Ralph explains, "The tariff index is going to come mostly around medical devices and device components. So plastics, metals, packaging, things that the device manufacturers use to deliver their products to hospitals and health systems, those will likely get passed through. It won't be huge incremental costs, so there will be additional costs due to tariffs. It depends on a couple of things. Do you have a strong contract that sort of embargoes your current price? Then maybe in the next contract term you'll see that pass through or the contract so the supplier to pass through, you'll see them. We're monitoring month by month the current or last month's spend was on these items, and do we see a chart impact by manufacturer by line." "One thing that I want to make sure we talk about, too, isn't just shared impact. So the cost to a hospital for devices and drugs averaged 8.9% more in 2024. So just by nature of the market raising its prices for goods that hospitals use to cover patient care, those moved up without tariffs 8.9% last year. We think we're tracking increases that are happening despite the tariff overlay or on top of the tariffs. We still think that the pressure on hospitals is due to the price of therapeutics, and is going to continue to go up, tariff or not. And so I want to mention that because this is the ongoing impact of the cost of MedTech and drugs that gets passed through to the consumer." #ArcheHealth #AIinHealthcare #HealthTech #HealthcareOperations archehealth.ai Download the transcript here

This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration (FDA). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported marketing applications like PMAs and 510(k)s typically stops, essential activities like active review of already-filed submissions, post-market safety surveillance, enforcement of recalls, and Investigational Device Exemption (IDE) reviews continue, drawing on existing user fee reserves.The discussion pivots to the significant slowdowns that occur, notably the suspension of non-MDUFA-goal-tied interactions, such as Q-submissions (Pre-Submissions) and most interactive reviews. For startups and small manufacturers, the halting of the crucial small business designation processing can be particularly detrimental, leading to astronomically higher user fees once the government reopens. Michael emphasizes that the industry should anticipate this political risk and plan submission timelines strategically, positioning a government shutdown as an "uncontrollable natural disaster" that requires proactive risk mitigation.Michael provides actionable advice for MedTech leaders to pivot during a shutdown. He recommends using the enforced delay to significantly improve the quality of submissions—making them easier to navigate and review once the FDA is fully operational—to gain a crucial advantage over the backlog of queued submissions. Furthermore, companies should utilize the time to focus on parallel activities such as process validation, refining quality systems, and strengthening commercial and reimbursement strategies. Michael stresses the importance of remembering the core mission: getting life-improving technologies to patients, and using any delay as an opportunity to emerge stronger and more prepared for commercial launch.Key Timestamps1:45 - The initial effects of a shutdown: What truly stops at the FDA (new submissions) versus what keeps running (existing reviews, IDEs, post-market surveillance).3:50 - Why active review of filed submissions continues—the role of the user fee "reserve."5:58 - Critical functions that stop or slow down: Pre-submissions (Q-subs), interactive reviews, new policy guidance, and routine inspections.7:25 - The major impact of halting the small business designation process on user fees for new manufacturers.8:36 - MDUFA (Medical Device User Fee Amendments) explained: How user fees fund the FDA and maintain operations during a lapse.11:51 - Direct effects on a MedTech company's runway and the loss of interactive review.13:17 - Actionable advice: Improving submission quality for easier review to mitigate the post-shutdown backlog.15:00 - Strategic pivot: Focusing on parallel work like process validation and quality system refinement.16:03 - Communicating with investors and partners: Positioning the shutdown as an uncontrollable event and shortening the commercial launch gap.18:50 - Looking ahead: Planning submissions around budget resolution deadlines to anticipate shutdown risk.20:53 - Final advice: Keeping the patient-focused mission in mind and maximizing internal...

In this episode of The Digital Executive, host Brian Thomas sits down with Nic Aldrich, a seasoned leader in the medical device industry with over a decade of experience spanning Stryker, Johnson & Johnson, and now OrthAlign. Nic shares how his journey from global marketing in large corporations to leading a nimble medtech innovator has reshaped his approach to marketing, technology, and organizational agility.Nic dives into the evolution of surgical navigation—from bulky capital systems to handheld, data-driven precision tools—and how OrthAlign's platform has now surpassed 400,000 surgical procedures worldwide. He reveals the company's mission to make precision accessible to every surgeon, in every setting, while maintaining simplicity, accuracy, and trust.As OrthAlign transitions from a hardware company to a tech-enabled service provider, Nic discusses how data, software, and connectivity are transforming surgery into a smarter, more collaborative ecosystem. Rather than chasing automation, he emphasizes augmentation—using intelligent tools that empower surgeons to perform at their best.Finally, Nic shares how clarity of mission and culture of collaboration drive agility in an industry that traditionally moves slowly. His leadership philosophy: when people are deeply connected to purpose, innovation naturally accelerates.If you liked what you heard today, please leave us a review - Apple or Spotify. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Tyler O'Malley is the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen, Inc. Tyler shares his journey in the MedTech industry and discusses Exagen's innovative approaches to autoimmune testing solutions, including cutting-edge diagnostics for lupus and other diseases. With over a decade of experience, Tyler provides insights into the challenges and breakthroughs in the field, highlighting the significance of early diagnosis and personalized treatment, while also discussing the challenges and opportunities in effective leadership during different stages of company growth.   Guest links: https://exagen.com/ Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 066 - Tyler O'Malley [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 excited to introduce you to my guest today, Tyler O'Malley. Tyler serves as Associate VP of Clinical Affairs and Market Access at Exagen, Inc., a leader in autoimmune testing solutions. In his role, he oversees clinical trials, bioinformatics, and medical policy development for Exagen's current diagnostic portfolio and pipeline of proprietary solutions. With more than a decade of experience, O'Malley has contributed to more than a dozen clinical trials focusing on clinical validity and utility evidence for autoimmune diagnostics. His expertise is widely recognized with numerous publications in esteemed peer reviewed journals, and notably, he's the first author of one of the largest clinical utility studies in lupus diagnostics. O'Malley graduated from Georgia Gwinnett College with a Bachelor of Science in biology, concentrating in biochemistry. His 11 year career in research and development and medical affairs encompass medical science, education, assay development, and clinical research coordination. Well, welcome to the show, Tyler. I'm so excited to have you here today. [00:02:01] Tyler O'Malley: Thanks, glad to be here. [00:02:02] Lindsey Dinneen: Yeah, absolutely. Well, I would love just starting off by telling us a little bit about yourself, your background, and what led you to MedTech. [00:02:11] Tyler O'Malley: Sure. So, I'm the Vice President of Clinical Affairs, Bioinformatics, and Market Access at Exagen. We're a specialty diagnostics company focused on autoimmune rheumatic diseases. So we develop proprietary testing technology for conditions like lupus, rheumatoid arthritis, Sjogren's disease, as well as many others. And yeah, our focus is trying to find solutions for patients who are dealing with what are many times challenging chronic diseases that can present themselves in very mysterious ways oftentimes. And so, these are challenges that patients have that have, for the most part, gone unsolved for many decades, and so there's a lot of opportunity out there. In terms of, myself, my background, I've been with Exagen for the past 11 and a half years. So I've been doing this for a while now, and I've worked in a couple of different areas within the organization, doing work within the lab assay development, as well as outside the lab doing clinical research, statistical analysis, which led to the bioinformatics role. And then as well as doing some work trying to align our clinical evidence with medical policy for our tests which is the market access role. So, a little bit of everything, but there are some through lines that I assure you do make some sense if you really think about it. [00:03:33] Lindsey Dinneen: Excellent. Excellent. Well, thank you for sharing a little bit about that. There's so much to dive into, but going back a little bit in your story, when you were thinking about careers-- you're a eager high school student ready to embrace college, and you're ready for the next step --is this something that you could have imagined yourself doing or has this always been a passion of yours? Or is this something you kind of found yourself in? [00:03:57] Tyler O'Malley: Not at all. So, no I, so I will say I've always been interested in autoimmunity. So that's always been something that has always piqued my interest, whether I was in high school or college. And so I guess in that sense, it's not a surprise. But the laboratory diagnostics component of it was not something that was on my radar when I was in high school or college. And I guess the journey to Exagen was, after graduating from high school, went and got a bachelor's degree in biology with a biochemistry focus. So, that's sort of my background there. And while I was getting the degree and focusing on biochemistry, I had the opportunity through a resource scholarship at Georgia Tech to work in a graduate lab, which was a really interesting experience where, you know, for a little over a year I had the opportunity to work alongside PhD candidates, postdocs, on a research project that was partially funded and get the experience and understand what it's like to work towards a PhD and what it would look like to kind of go down that path of graduate level research. And I think it had the opposite effect that it was intended to have in that it kind of showed me I didn't want to do that. So, I think in a lot of ways I was happy I had that experience 'cause it showed me before I went down that path that it was something I didn't wanna do. Nothing against it, I guess I wanted to do something that maybe had more of a translational impact, a little bit closer to the patient. And so, finished my degree, and at the time I was living in Georgia, so I finished my degree in Georgia, left and moved out to California, and ended up at Exagen by pure chance through a recruiter. And that was back in 2014, and basically just joined Exagen at the time when it was a smaller company, and grew with the company, and was fortunate enough to have the ability to learn a lot of different functions within the company as it grew, and there were a lot of different things that needed to be done a as the company was growing. And so it, it's been kind of a, an interesting ride since then. [00:06:08] Lindsey Dinneen: Yeah, absolutely. And of course all of those different experiences, I'm sure, have woven their way in, like you said. Sometimes you have to kind of look for that line, but there is one that's, apparent when you look back. So, can you talk a little bit more about the company, what it does, especially in regards to its testing technology, and I'd love to hear about some of the innovation that's just coming out of this incredible organization you're a part of. [00:06:35] Tyler O'Malley: Sure. So our our testing, again, primarily focuses on addressing unmet needs in patients who have autoimmune connective tissue diseases. And specifically we have some proprietary technology around biomarkers that help diagnose systemic lupus. And lupus is kind of the prototypical autoimmune disease in that it can manifest in just about any different way. It can show up in your skin, your heart, your lungs, your kidneys, just about any way you can imagine, and sometimes in multiple different ways. And so in that way, it can be challenging to diagnose 'cause it can look like so many different things. And much of the testing that is used for lupus or has been used traditionally is very antiquated. Antibody tests that were developed many decades ago that have been refined to some extent over the years, but for the most part are not overly sophisticated. So, what Exagen has done over the past 15 or so years is brought forward some technology, that was originally licensed from University of Pittsburgh, looking at measuring a form of the complement system, which is a part of our immune system. It's a very ancient form of our immune system. It's a collection of proteins that come together to help fight off pathogens and help clear debris to keep our our immune system healthy. And what we're able to do is measure essentially the buildup of a complement fragment that builds up on your red blood cells and on your B lymphocytes. And what this does is it gives us a unique ability to detect lupus that's much more sensitive than the conventional means. And what that means, when I say sensitivity, is that it's able to pick up more lupus patients than the conventional testing. So, one way of thinking about this is like, if you have a hundred patients in a room that all have lupus, right? Because they've been assessed by a doctor, they've been clinically diagnosed, and you were to test them, and say your conventional test is 50% sensitive, meaning half of the room would test positive on this test and the other half would test negative. This test that we're talking about here, it would pick up two thirds of the room, right, as opposed to conventional testing, which would pick up fewer patients. So, that's the kind of technology that we're trying to develop here, which is trying to be more inclusive, pick up more patients sooner, give better insights to physicians to combine with their clinical assessments such that patients can get earlier treatments and hopefully stave off some of the more kind of disastrous outcomes of the disease that come with not getting treated soon enough and not getting treated appropriately for their symptoms. [00:09:31] Lindsey Dinneen: Yeah, of course. That's incredibly important and I'm so glad that the company is working to create those solutions, like you said, because previous methods while maybe somewhat useful, are more antiquated at this point. And so it's really important to have these new strides in innovation. So as you're dealing with all of this, I'm sure that there are stories that have come up about real people having impacted lives because of the technology that your company is bringing. Do you have any examples that you could share with us about that? [00:10:05] Tyler O'Malley: Sure. Yeah, there's been a number of individuals that we've had the fortune of meeting over the years. And they come and share the story with our team. We like to bring folks in with, for example, when we bring on new sales team members, we try to bring on a patient just to be able to share their story. So, recently we had an individual, who is connected to someone who works in our organization-- again, just pure chance-- who happened to have a very unique story. So first of all, lupus, for those who don't know, is a condition that primarily affects women. Lupus is a disease that affects women at a ratio of nine to one, nine to one female to male or so, in other words, around 90% of lupus patients are women. But that's not to say that it isn't an issue for that subset of of men that do develop lupus. And in fact, the disease tends to be more severe in that 10% of lupus patients that are men. So this individual who we've had the chance to meet and hear his story, really interesting because he's-- you would never know if you met this guy-- because he's a CrossFit guy. He is probably the healthiest guy you can imagine looking at him. But he went a harrowing journey to get to his diagnosis. And it all started with, relatively -- well, I don't wanna downplay it-- but let's call it "less severe symptoms" like alopecia and rashes, things like this that sort of make you think, "Well, gee, that's strange," or "I wonder what that is all about." And then leading up to much, much more severe symptoms like severe edema and pericarditis that was ultimately life threatening. And ultimately, he was able to get the right testing and get to the right doctors, but it was not a short journey from the time that these symptoms initially presented themselves to the time where he was able to get to the test and to get to the right diagnosis and onto the right treatment. The good news is, he's in a much better place now after finding out what's causing his symptoms and getting to a treatment management plan that works for him and he's even back to getting to an exercise routine that works for him. It's maybe not exactly the same as what it was before, but I mean, that's the thing. Now, you can lead a relatively normal life with lupus. It wasn't that long ago, call it several decades ago, where the mortality rate for lupus was as high as 50% in the first year after diagnosis. Treatment advances have greatly improved that and have changed the lives of people who live with Lupus now, but it used to be a very severe diagnosis. It still is, but it's very manageable now. [00:12:54] Lindsey Dinneen: Wow. Yeah. And so catching it and having that answer to, like you said, really difficult health journey where you're just not sure what's going on. And I really appreciate you talking a little bit about how Lupus looks different and manifests itself differently in different circumstances so it can be difficult to initially diagnose. So I love the fact that the company is focusing on things like that, when caught early can maybe make a huge difference in somebody's life like the gentleman you mentioned. Thank you for sharing about that. So now your own career has been really interesting in that you have gotten to do a lot of different things within the company and learn so much. Now as you've continued to grow with the company, you've, I'm sure, developed a lot of different leadership skills along the way, and I'm curious what it's been like in that sense of your journey to embrace leadership and how do you go about it? What have you found works really well, and maybe what advice would you have for somebody who's a little bit earlier in their career? [00:13:58] Tyler O'Malley: Yeah. Really interesting question. And I, I guess, my experience was, I came into an organization that was, I think at the time, maybe in the entire company was maybe 60, 70 people. So, as you can imagine, it was a very flat organization. I reported directly to the Chief Scientific Officer when I first joined the organization as a relatively low level R&D employee. So that afforded me, I think, a unique opportunity because I was often involved with project planning and discussions that I don't know that you get that opportunity in different types of corporate settings. And I think what has proven very useful in terms of my development, and as I look back and reflect on kind of what's led me here is, I can just recall, so, so many times, especially early on in, in a startup-- which can sometimes be chaotic and there's a lot of moving parts and things are moving fast-- there would be times where I would be in meetings where I wasn't necessarily expected to do very much, I think, or contribute much. And I would just sort of observe, right? And I think there's so much you can learn through not just listening to the conversation, but the body language of the people around the table. The way that people present, the way that people take criticism, the way that they respond. It was almost like a, it was a lesson every day just watching that. And I think where I thrived and maybe added value at times was realizing when people were talking past one another and just, at times, trying to find a way to come into that and say, "Well, right, but did you consider maybe what this person was trying to communicate here?" And, you can't always resolve those sorts of situations, but sometimes you can. And that's really valuable when you can help two individuals get past an impasse like that. So, and I think it helps you build credibility doing that too, being a bridge builder in that sense. And, and I think, that was something I don't know-- whether intuitively or purely by accident, I don't know-- I figured out over time was that, maybe as a young person in your career, sometimes it can be easy to get caught up on sort of the X's and O's of your job, whatever it is that you're doing-- if you're a computer programmer, you're doing bioinformatics or whatever the case may be-- you can get really caught up in the technical skills that you're trying to hone and develop. But there's so many soft skills that you have to build as well at the same time. And there's the relationships that you build, as well, that you don't know when you're gonna need them or when they'll pay off. But things change at organizations and you're glad when you have those relationships when it comes time to need them. [00:16:51] Lindsey Dinneen: Yeah. Absolutely. Yeah. I love your discussion on the idea of being a bridge builder, because I've been thinking a lot about that recently where there's so much unintentional missed communication, just literally just passing by where, one person is saying something, the other person's saying something, and as an outsider, you're able to have a little bit of a distance to go, "Oh, you're kind of saying the same thing, but I'm not sure that you guys realize that, and here's how." Yeah, that translating is a really important skillset and a fun one when you can nail it down. So as you look towards the future of your own career and the company's trajectory, what are some things that you're looking forward to? [00:17:35] Tyler O'Malley: Well, we obviously have a number of exciting pipeline initiatives that bring a lot of energy to me as I think about what we're trying to do going forward. I'm excited about where the company is headed in terms of its trajectory. I've described my time at the company as, even though I've been at the same company for 11 and a half years or so, I really feel like I've worked for three different companies in that time, in that, there was a period of time that was a startup up until the point the company went public. And then there was this time from when the company was public, where we raised a lot of money, there were a lot of expectations and didn't exactly kind of work out exactly as we had hoped. And then there was a leadership change. And now we're sort of in this third phase now where the arrow's pointing up and we have realigned our strategy here and we found a way to be sustainable and to be able to continue to build on something where hopefully we can continue to find interesting technology that's out there. We have an ongoing partnership with, as an example, Johns Hopkins University to try to develop a test to help address lupus nephritis. So this is a particular form of organ manifestation of lupus. It's one of the more common manifestations of lupus, and one of the more devastating forms of lupus, in that almost 50% of lupus patients will have kidney involvement at some point in their disease. And as much as 10 to 20% of patients who do have lupus nephritis will go on to unfortunately develop end stage kidney disease and require dialysis or kidney transplant. So it's obviously life altering and can be, very impactful to individuals. So, to be able to work on something like that and be able to potentially alter the trajectory of someone's life in that way is pretty cool to think about. And, not everyone gets to do that. I mean, it's not that other jobs aren't meaningful, it's just not everyone gets the opportunity to do that kind of thing. And if you can also find joy in what you're doing in your job. I think that's also great too. I mean, it's really cliche, the things people say, and so I won't do it. The whole, like, " If you like what you do, you never work." Believe me, it's work. I do feel like I'm working sometimes, for sure, but I can't complain. I do, for the most part, have fun with what I'm doing. I'm fortunate enough, I have a great team of people, well-- three teams of people-- that I really enjoy working with, and being able to work with people and see them grow and develop and be a part of that is also super rewarding as well too. So, yeah, I'm just, I'm having a lot of fun. [00:20:26] Lindsey Dinneen: Yeah. Excellent. Wonderful. Well, gosh, I'm gonna pivot the conversation just for fun a little bit. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. Now, this could be within your industry, but it doesn't have to be. What would you choose to teach? [00:20:45] Tyler O'Malley: I think that-- maybe this is kind of fun, probably not-- but I think that ,I don't know why, and it's funny because it's-- I don't even know if this qualifies because I don't even know how I would teach it-- but I think I'm fairly good at guesstimating numbers and it's really useful in that it helps in a lot of different situations to be able to shortcut math. And to be clear, it's not that I'm doing long division in my head or anything like that, but it's, if you can kind of shortcut and get the approximate number, it can be really useful. And it's a nice kind of party trick too kind of thing. Again, I don't know how I would teach it 'cause it's sort of like it's up here, and I don't know how I would externalize that, but yeah, that's something I feel like would be kind of cool to figure out how I could teach that. [00:21:35] Lindsey Dinneen: Absolutely. Yeah. It's a superpower. So it would be very cool to try to then-- you've got this innate ability-- so then to try to break it down into how does somebody else develop the skill sets that you just sort of possess, and go from there. That would be really entertaining. I love it. Great answer. Okay. And then the next question is, how do you wish to be remembered after you leave this world? [00:21:59] Tyler O'Malley: Yeah. Well, that's a deep question. I think that the most meaningful impact that you can have is the impression you leave on the people that you interacted with, right? And I think, for me, I would just hope that the people that I've had the chance to spend time with-- obviously family, friends, people I worked with, people who worked on my teams-- I would just hope that as they would reflect on the time that we had together, that it would be a memory that was time well spent and that hopefully there are some good shared experiences that we had and that hopefully I left something that was meaningful. But as it relates to the work that we're doing, I hope that the impact that we're having-- some of it has a longer reach than even what we can see today, 'cause I think, truly being selfless is trying to build things that you'll never realize the benefit of: planting trees that you'll never sit under yourself. It's for someone else down the line in the future. [00:23:14] Lindsey Dinneen: Yeah. Yeah. I love thinking about it in those terms too: being willing to do your bits of good and let them go out into the world and not necessarily know the ripple effects and still use that as a worthwhile use of your time. I love that. And then final question, what is one thing that makes you smile every time you see or think about it? [00:23:39] Tyler O'Malley: Yeah, I think the easy answer is probably my kids. So I have two kids, and that's kind of the reprieve from the work life and kind of focusing on all this important stuff that we're trying to do here at work, but being able to kind of break away from that and focus on building them up and watching them grow and develop and become their own person is really cool. It's obviously a unique experience and it's a nice thing to be able to think about when you need something to kind of bring you back up. [00:24:12] Lindsey Dinneen: Yeah, absolutely. Just a different way of looking at the world from such a fun perspective. I love that. [00:24:19] Tyler O'Malley: Yeah. [00:24:20] Lindsey Dinneen: Yeah. Well, Tyler, this has been such a great conversation. I so appreciate your time today telling us a little bit about your story, the company, and all the incredible work that you guys are doing to change lives for a better world. And we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and thank you so much for being here and thank you for doing what you do. [00:24:59] Tyler O'Malley: Thank you. It's it's been a pleasure. [00:25:01] Lindsey Dinneen: Excellent, and thank you also to our listeners for tuning in, and 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. [00:25:14] Dan Purvis:  The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world. 

In this episode of Tank Talks, Matt Cohen is joined by James Baskin, Founder and CEO of ZeroStone AI, to explore how businesses can transition from AI experimentation to real-world impact. James, a three-time founder with multiple successful exits, shares his journey from engineering at the University of Toronto to building and selling telecom ventures alongside Globalive's Anthony Lacavera. He offers valuable insights into leadership, resilience, and overcoming imposter syndrome.Drawing from over 300 conversations with CEOs and AI leaders, James discusses why many companies are “AI-aware but not AI-ready.” He reveals how ZeroStone helps mid-market firms turn failed pilots into scalable, impactful AI systems. James also highlights the differences between generative and agentic AI, the dual transformation of technology and people, and the importance of fostering a culture of curiosity and continuous learning for long-term success. This episode offers practical advice for founders and executives navigating the AI revolution.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.The Founder's Journey & Imposter Syndrome (00:09:41)* “Scaling Your Everest”: the emotional toll of leadership* Facing imposter syndrome in boardrooms* Anthony Lacavera's hard advice: “You don't know what you're doing.”* How that painful truth became a turning pointFrom Go-To-Market to AI Strategy (00:16:00)* Consulting with Series A/B startups on GTM and sales* Transition to AI after dozens of founder conversations* Why most OKRs fail: objectives must tie directly to long-term strategy* Introducing a new framework rooted in “Seven Powers” by Hamilton HelmerBuilding ZeroStone AI (00:22:22)* Founding mission: help mid-market firms (>$50M revenue) unlock real AI value* Observing 300+ executive discussions on AI, awareness high, action low* Why cultural and digital transformations must happen together* Moving beyond “copilots” to autonomous, agentic AI systemsThe AI Leadership Gap (00:24:27)* Boards push for AI results, but internal teams lack clarity* “You need both a data transformation and a human capital transformation.”* The rise of self-selecting teams, who adapts, who opts out* Building cultures of learning, not fearWhy 95% of GenAI Pilots Fail (00:31:16)* Most projects don't touch core business processes* Generative AI ≠ Agentic AI: only the latter changes workflows* AI agents as “digital workers” vs. human productivity tools* How CEOs can start small, measure impact, and scale over three yearsOvercoming the Pilot Trap (00:36:30)* Scaling beyond sandboxes by fixing data architecture* The critical role of clean data lakes, enrichment, and governance* Why early-stage companies move faster than legacy enterprisesAbout James BaskinFounder & CEO of Zero Stone AIA three-time founder with successful exits, James is a seasoned expert in go-to-market strategy, OKRs, and sales leadership. Through ZeroStone AI, he is now guiding mid-market companies to unlock true, measurable value from agentic AI, moving beyond failed pilots to autonomous systems that transform businesses.Connect with James Baskin on LinkedIn: https://www.linkedin.com/in/jamesbaskin/Visit the ZeroStone AI Website: https://www.zerostone.ai/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

Seine Branche sei am legitimiertesten, sich zu den EU-Verträgen zu äussern, sagt Adrian Hunn, Direktor von Swiss Medtech. Der Verlust des Marktzugangs bedeute Kosten und weniger Investitionen. Nun treffen auch die US-Zölle die Firmen hart. 20 Prozent wollen Produktionen ins Ausland verlagern. Der Druck auf die Medtechbranche steigt weiter. Nach dem Scheitern der Verhandlungen über das Rahmenabkommen aktualisierte die EU das Abkommen für den Marktzugang für Schweizer Medtechprodukte nicht mehr. Die Branche musste mit Bürokratie und hohen Kosten neue Vertriebswege finden. Wie viel an Investitionen durch dieses Handelshemmnis verloren gingen, ist nicht zu beziffern. Nun treffen zudem die 39 Prozent Zölle die Firmen hart. Eine aktuelle Umfrage zeigt, 30 Prozent der Unternehmen suchen neue Absatzmärkte. 20 Prozent prüfen eine Verlagerung von Teilen der Produktion ins Ausland. Kommt die Wachstumsindustrie Medtech in der Schweiz zum Stillstand? Welche Perspektiven bietet die Schweiz für diese Branche? Warum könnte die Anerkennung der US-Zulassung allenfalls etwas Abhilfe schaffen? Adrian Hunn, Direktor des Branchenverbands Swiss Medtech ist zu Gast im Tagesgespräch bei Karoline Arn.

Timestamps:6:51 - Is it possible to protect your mental health as a Founder?20:00 - How to know when you've transitioned from a startup to a scale-up?23:42 - What creates the most pressure for Founders?35:49 - How do we build up resilience?This episode was co-produced with Innovaud, the innovation and investment promotion agency for the canton of Vaud.Episode Summary: Sahar Hosseinian, Co-Founder and former CTO of Novigenix, spent over a decade building AI-powered oncology diagnostics before joining Zurich-based Prevision Medicine as Chief Quality Officer. She holds a PhD in Statistics from EPFL. Charlotte Ducrot is Head of Scaleups & Growth at Innovaud, the innovation and investment promotion agency for the canton of Vaud. She holds an MA in International Affairs from the Geneva Graduate Institute and worked for companies like Swisscontact and the WEF before joining Innovaud in 2022.During their chat with Merle, Sahar and Charlotte dive into why mental health remains one of the biggest unspoken challenges for founders, even in high-performing Swiss startups. Sahar shares the emotional highs and lows of raising CHF 25 million in MedTech, while Charlotte explains how burnout risk spikes after funding success. They discuss how pressure from investors, teams, and personal expectations can compound - and how self-awareness, boundaries, and community can counter it.They also get into the specifics of resilience and building systems that prevent chronic stress, breaking down how founders can recognize early warning signs, create support networks, and align their work with their personal values. Charlotte introduces the “Realize-Regulate-Recover” framework and Sahar reflects on redefining success beyond constant hustle. Together, they remind founders that protecting mental health isn't a weaknes, but a strategic advantage for scaling sustainably.The cover portrait was edited by ⁠⁠⁠⁠Smartportrait. ⁠⁠⁠⁠‍‍‍‍Don't forget to give us a follow on⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Instagram⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Linkedin⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠,⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ TikTok⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, and⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Youtube ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠so you can always stay up to date with our latest initiatives. That way, there's no excuse for missing out on live shows, weekly giveaways or founders' dinners.

On this episode of The Medical Alley Podcast, we welcome Informa Markets Senior Editor Amanda Pedersen. Amanda has been covering the medical device industry since 2006, examining trends and innovations with a deep understanding of the medtech landscape.  We also discuss MD&M Midwest 2025 taking place in Minneapolis on October 21 and 22. If you're planning to attend, register with the promo code MED to receive a complimentary expo pass.Send us a message!Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.

In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting 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 Young Juhn.

In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation covers the importance of comprehensive IP planning, the nuances of patents, trademarks, copyrights, and trade secrets, as well as global IP considerations for medtech startups. Amy Rinaldo LinkedInWard Law Office WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training methods, like handing new hires 40 SOPs to read, are often ineffective for experienced professionals in the MedTech industry.Shannon explains the core principles of andragogy: adults are self-directed, problem-centered, and bring a vast reservoir of experience to the table (schema theory). They are less motivated by sequential, externally guided learning and more by what is relevant, timely, and what is in it for them. This self-directed approach means successful training in MedTech requires catering to intrinsic motivation and providing tactile, real-world practice rather than just videos or documentation.The conversation pivots to practical applications across the medical device lifecycle. Shannon shares compelling examples, like improving physician adoption of a medical device by shifting the focus from extrinsic financial rewards and regulatory compliance to the intrinsic motivation of improving patient health outcomes. By making users part of the development process and using performance feedback to tap into a professional's competitive spirit, organizations can achieve significantly higher engagement and successful adoption of new technologies.Key Timestamps[03:20] What is Andragogy? How adults learn differently than children.[04:45] The role of schema theory and existing experience in adult learning.[05:40] Why the traditional "drop 40 SOPs" on a new hire's desk fails adults.[07:15] Case Study: The challenge of low medical device adoption and the missing education piece.[08:50] The power of tactile practice and addressing user confidence (e.g., misusing the device).[11:00] Contrasting Andragogy (self-directed) vs. Pedagogy (directed/sequential).[14:10] Applying adult learning to device development: solving the user's problem.[16:45] How to boost adoption: Intrinsic motivation and making users part of the process.[18:20] The key physician motivator: Desire to help people over money or administrative requirements.[21:10] Behavior science: Focusing on influential champions and mid/top performers for diffusion.[22:45] The "Gold Star" effect: Using competitive spirit and relevant KPIs for motivation.Quotes"The way we come to learning with adults is different... The best way that they learn is coming up with things that are relevant to them, things that are timely, things that they need. They want to be interested." - Shannon Decker"I don't talk about the money that they're going to make... What I talk to them about is by paying attention and doing these screening exams, you're going to have an impact on the overall health of your patient." - Shannon DeckerTakeawaysStop Relying on Documentation for Training: Adult learners need tactile input and practice. Replace or supplement large volumes of SOP reading with project team involvement, practical exercises, and hands-on use to build confidence and retention.Focus on the "What's In It For Me" (WIIFM): When designing a medical device or a training program, identify the user's intrinsic motivations. For clinicians, this is often the desire to improve patient outcomes—lead with this message rather than revenue or regulatory burden.Build Champions, Not Just Compliance: Instead of solely focusing energy on low performers or the loudest voices, identify respected, influential leaders (champions) to pilot and advocate for new technology. Their positive experience drives the Law of Respect and encourages wider...

In this episode of the MedTech Podcast, partner Vinita Kailasanath speaks with Stephanie Toney, Chief Business Officer at Diatiro Health, about the company's mission to transform kidney transplantation. They explore the importance of equity and patient access in MedTech. Stephanie also shares her perspective on emerging trends such as AI, digital health, and precision medicine—and their potential to improve outcomes and expand access for underserved populations.

Join us for an insightful episode of Let's Talk Medtech, featuring EY's experts John Babitt and Arda Ural. Our guests delve into EY's latest Pulse of the Medtech Industry Report. They take a deep dive into the state of the medtech industry, examining whether the sector is thriving and assessing the real-world impact of tariffs on medical device companies.Discover which medtech segment is experiencing explosive growth right now and learn why mid-tier companies are gaining unprecedented momentum in the marketplace. From industry health assessments to emerging market trends, this episode delivers essential insights for anyone invested in the future of medical technology.Don't miss this comprehensive discussion that addresses the most pressing questions shaping today's medtech landscape.

In this episode, medtech marketer and MarketCraft founder Omar M. Khateeb joins Samuel to break down how early-stage and growth companies can engineer markets, not just chase attention. From mastering LinkedIn and expanding to X, Meta, and YouTube, to using storytelling that actually drives adoption, Omar shares how the best brands—like Zimmer Biomet and Intuitive—create influence through consistent, authentic leadership content. He reveals the psychology behind attention, the balance between value and unpredictability, and why depth beats surface-level posts every time. You'll also hear how AI is reshaping content strategy, how to refine your voice without losing authenticity, and why strategic pauses can reignite engagement. Whether you're a founder, marketer, or rep in medtech, this episode is your roadmap to building authority, trust, and momentum in a noisy digital world.   Connect with Omar M. Khateeb: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!

What if the key to fixing pharma's toughest challenges wasn't more complexity—but more clarity? In this episode of Med Tech Gurus, Shetal Vyas, SVP of Commercial Strategy & Development at Ardelyx, joins us to explore how digital-first strategies are reshaping how we bring therapies to patients. Shetal unpacks how to overcome the $200 billion patent cliff, reframe customer engagement, and build scalable, data-driven commercial models that don't just add tech—but center patients. With practical insights into digital ecosystems, commercialization frameworks, and change management, this episode is packed with takeaways for MedTech innovators navigating the intersection of healthcare, pharma, and digital transformation.

In this episode of Tank Talks, Matt Cohen and John Ruffolo break down the latest developments in U.S.-Canada trade negotiations, particularly around tariffs and energy, with insights into how these pressures could shape future relationships.The conversation shifts to the growing energy demands of AI, as Matt and John explore how both the U.S. and China are navigating energy needs, and whether Canada could play a more significant role. They also analyze NVIDIA's $110 billion vendor financing strategy, drawing comparisons to the telecom bubble, and discuss the growing risks in data center financing. With the IPO of Fair Me America, they examine how the market is reacting to tech companies with no assets but huge valuations. A packed episode full of fresh insights on the intersection of tech, politics, and business.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.US-Canada Relations & Trump's Tariff Strategy (04:28)Matt and John discuss the ongoing negotiations between Mark Carney and President Trump regarding trade policies, tariffs, and key sectors like steel, aluminum, and energy. Can Canada withstand the pressure, or will it need to change its approach?The Energy Battle Between the US and China (09:03)What role does energy play in geopolitics? Matt and John explore how both the US and China are navigating their energy needs, and why Canada has lost some of its leverage as the world's energy supply game changes.NVIDIA's Vendor Financing Playbook: Lessons from Lucent & Nortel (11:18)John shares a deep dive into how NVIDIA's vendor financing strategy mirrors the mistakes made during the telecom bubble, drawing parallels to the strategies employed by Lucent and Nortel. What's the risk when revenues are tied to customers who may never pay?AI, Data Centers, and the Future of Technology (17:20)From the massive energy demands of AI to the rise of private equity-backed data centers, Matt and John dissect the latest AI and GPU investments and how the industry's future could be shaped by companies like Meta and OpenAI.The “Yellowstone Club” of Hyperscalers (20:26)The two discuss the bizarre world of hyperscalers and REITs, looking at how some data center startups are getting massive valuations without any real assets or revenue, and what this means for the future of tech investments.Bezos Weighs In on the AI Bubble (25:12)Jeff Bezos surprises everyone with his thoughts on the AI industry, calling it an “industrial bubble” rather than a financial one, and analyzing the disconnect between massive investments and real-world returns.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

When is it time to move from a training consultant to a full time hire? In this episode, Liz sits down with Heather Ramsey, Director of Client Learning and Development for OneDigital, to discuss just that. In their conversation, they explore when to hire, who to hire, and how to align that hire with the business strategy. Along the way, they define what makes a good trainer and some of the common mistakes they see in hiring for an in-house role. 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:Heather Ramsey is the Director of Client Learning and Development for OneDigital Company. She oversees the OneDigital Leadership Coaching Services, Client Learning Development and Strategic Offsite Facilitators.She believes that empowered, engaged leaders and employees will help the organization reach its business objectives faster. She enjoys partnering with client leaders to build a learning and development culture with the client to support their business, increase retention and drive higher employee engagement. She and her team are seasoned professionals in the areas of training and development, leadership coaching, and facilitating leadership and company retreats.With over 20 years of learning and development experience, Heather uses innovative techniques to deepen each learning development program designed, or training class delivered. Virtually or in-person, she is a high-energy facilitator who captures her audiences immediately and keeps them engaged and on target throughout the training or facilitation.As a leadership and team building facilitator, she is an expert with working through difficult situations with ease and grace. As an Executive-level coach she connects with her clients and helps them to find new ways of working to help them be most successful. She infuses these same principles in her team as they work with clients.Heather is a subject matter expert and certified Predictive Index Partner. She is an avid learner and reader of business and leadership books, articles, and seminars. She holds a bachelor's degree from U.C. Davis in Managerial Economics, and a master's degree from Cornell University in Executive Human Resource Management.Here is a link to her website: https://launch.onedigital.com/learning-and-developmentSubscribe 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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Heather Ramsey⁠⁠⁠⁠⁠⁠⁠⁠Cumby 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.

Med-Tech Startup Reality Check: Capital, Competition & Life-Saving Innovation | Top Global StartupsJoin Eric Goslau, President & CEO of Transverse Medical (Series C stage), as he shares unfiltered insights from 30+ years navigating med-tech startup challenges - from competing with Big Corp incentives to defining "good enough" products that save lives.

In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60601 updates, the importance of staying informed, and practical advice for medical device manufacturers.Leo Eisner LinkedInEisner Safety Consultants WebsiteImpacts on IEC 60601-1 WebinarDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

Gina Catalano went from leading sales teams in medical devices to coaching surgeon leaders and healthcare executives. In this conversation, she shares how emotional intelligence (EQ), communication, and team strength drive real results in the operating room, the boardroom, and beyond.RESOURCESwww.centroforzagroup.com

In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to dive deep into the rapidly evolving AI landscape, its economic ramifications, and Canada's growing potential as a global tech leader. They discuss pivotal topics, such as energy challenges in AI infrastructure, the rise of AI tokenization, and the impact of government policies on the sector. With a focus on the future of tech, investments, and the role of Canada, this episode offers an insightful look at where the industry is headed.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.AI Energy Demands & Canada's Opportunity (00:04:39)John and Matt discuss the massive demand for compute power in AI and Canada's potential to lead by meeting these energy needs. They highlight the importance of matching energy capacity with data center development to become a global tech leader.The AI CapEx Boom and the Trillion-Dollar Question (00:07:05)The discussion shifts to the booming capital expenditures in AI, with a particular focus on the rising costs of building AI infrastructure and whether this growth is sustainable in the long term.Canada's AI Strategy and Sovereign Identity (00:14:21)The conversation turns to Canada's AI strategy, with a task force focusing on innovation, research, and talent retention. John shares his thoughts on the potential challenges and opportunities for Canada in becoming a key player in the AI space.The SEC's Push for Tokenization in the U.S. (00:19:33)The episode also delves into the SEC's efforts to allow the tokenization of stocks and what this could mean for the financial industry and blockchain adoption.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com

Today's guest is Faithe Toomy, Director of Voice of the Customer and Insights at Insulet. Insulet is a medical device company specializing in wearable drug delivery systems for diabetes care, combining engineering, clinical research, and digital health capabilities to develop automated therapeutic solutions. Faithe joins Emerj Editorial Director Matthew DeMello to discuss how data and AI are transforming call center operations while maintaining compliance and customer trust. Faithe also shares practical strategies for training agents, leveraging conversational analytics, and implementing AI tools that enhance workflow efficiency, improve first-contact resolution, and support a more confident, human-centered customer experience. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!

Rosemary Coates has spent three decades inside the hardest questions in manufacturing… where to build, what to move, and how to survive the politics around it. On this episode of The Manufacturing Culture Podcast, she walks through the real story behind offshoring, why reshoring is more trickle than tidal wave, and how companies can make smarter location calls without blowing up cost or capacity.We go back to her origin story… blue collar roots, a transportation management elective that lit the fuse, and a career that ran through Solar Turbines, defense work, Hewlett Packard, Big Four consulting, and finally her own firm. When the 2012 election turned China into a punching bag, Rosemary pivoted from moving factories out to helping leaders bring work back in a way that actually pencils. She founded the nonprofit, nonpartisan Reshoring Institute and now advises with data instead of slogans.We dig into what really changed. Labor in China is no longer cheap. Geopolitics now sits beside cost on the decision tree. Carbon footprint matters when your supply chain stretches across oceans. The grid cannot power a sudden factory boom even if you build it. And the workforce of today is not lining up for low skill, mind numbing assembly. The path forward looks like automation where it fits, contract manufacturing for flexibility, and a cold look at labor mix and total landed cost before anyone signs a lease.Mexico's rise gets a clear-eyed review… proximity, lower carbon, easier logistics, and a young workforce make Central Mexico compelling. Vietnam is full. India brings time and inventory penalties on the water. Demographics matter. So do hurricanes, wildfires, and the ability to shift production when the world throws a brick through your window.We also talk wages, the hole blown in the middle class, and why the new middle class is built on writing, computing, and mechatronics rather than grease and punch presses. Rosemary explains her expert witness work inside global supply chain disputes and leaves us with a simple truth… strategy beats sentiment, and the best decisions use both spreadsheets and context.Sponsor note:Med Device Boston is your go-to Med Tech sourcing and education expo, September 30 through October 1 at Boston's BCEC. 200 plus suppliers. 1500 plus attending professionals and OEM decision makers. Explore 3D printing, AI, materials, regulatory tech, and contract manufacturing under one roof. Visit meddeviceboston.com to register and plan your visit. Links in the show notes.Guest:Rosemary Coates, Executive Director of the Reshoring Institute, global supply chain strategist, expert witness, and author of five books on sourcing and manufacturing.

In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.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 Josh Vose.

This week on Taking The Pulse, Heather and Seth record at the NCLifeSci 2025 Annual Meeting with Bobby Patrick, Senior Vice President of Government Affairs at AdvaMed. Bobby shares how the world's largest medical technology association is advocating for expanded Medicare coverage of breakthrough devices, navigating the evolving role of AI in diagnostics, and addressing supply chain and tariff challenges. We also explore how AI is enhancing physician decision-making and how patient trust and data security remain central to innovation. Tune in now for a timely look at the policy and technology shaping the future of medtech.

In this episode, Duane Mancini chats with Logan McKnight, a seasoned professional with a vast background in medtech. Logan shares her journey from starting in medical services and neuromonitoring to leadership roles, culminating in the establishment of her consulting firm, Goodnight Consulting. The conversation dives into the nuances of managing corporate and field leaders, the importance of transparency, communication, and trust in leadership, and the complexities of managing people. Logan also highlights the benefits of feedback mechanisms like 360 reviews and underscores the significance of self-awareness and mindset in effective leadership.Logan McKnight LinkedInGoodnight Consulting Website“Mindset: The New Psychology of Success” by Carol Dweck “The Culture Code: The Secrets of Highly Successful Groups” by Daniel CoyleDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn