Podcasts about Medtronic

In today's episode Eoin chats with Jason Ziobrowski (Chef Jay Z).Today's guest brings flavor, passion, and purpose to everything he does. Jason Ziobrowski — or as many know him, Chef Jay-Z — has spent nearly two decades as a corporate R&D chef, creating recipes and nutrition programs for hospitals, patients, and communities. His mission? To influence people positively through food and to help change the American palate, one dish at a time.But behind the chef's coat is a deeply personal journey. After years of being told he was simply ‘pre-diabetic,' Jason was finally diagnosed in 2020 with type 1.5 diabetes. At the time, his fasting sugars were nearly 22.2mmol/L (400mg/dL), and his A1C hit 14.Instead of giving up, Jason took charge. He overhauled his lifestyle cold turkey, dropping his fasting sugars down into a healthy range and transforming not just his health, but his outlook on life.Today, Chef Jay-Z is thriving with type 1, using technology like the Medtronic pump, leaning on his family, and continuing to inspire others through food, education, and his own story of resilience. From hospital kitchens to his own blood sugar battles, Jason has learned that lifestyle change isn't just necessary — it can be one of the best things to ever happen to you.As always, be sure to rate, comment, subscribe and share. Your interaction and feedback really helps the podcast. The more Diabetics that we reach, the bigger impact we can make!Questions & Stories for the Podcast?:theinsuleoinpodcast@gmail.comConnect, Learn & Work with Eoin:https://linktr.ee/insuleoin Hosted on Acast. See acast.com/privacy for more information.

R Blank is the founder of Healthier Tech and the host of “The Healthier Tech Podcast”, available on iTunes, Spotify, and all major podcasting platforms.R has a long background in technology. Previously, R ran a software engineering firm in Los Angeles, producing enterprise-level solutions for blue-chip clients, including Medtronic, Apple, NBC, Toyota, Disney, Microsoft, the NFL, Ford, IKEA, and Mattel.In the past, he served on the faculty at the University of Southern California Viterbi School of Engineering, where he taught software engineering, as well as at the University of California, Santa Cruz.He has spoken at technology conferences around the world, including in the US, Canada, New Zealand, and the Netherlands, and he is the co-author of “AdvancED Flex Development” from Apress.He has an MBA from the UCLA Anderson School of Management and received his bachelor's degree, with honors, from Columbia University. He has also studied at Cambridge University in the UK, the University of Salamanca in Spain, and the Institute of Foreign Languages in Nizhny Novgorod, Russia.Shield Your Family from Hidden EMF Risks, check out R Blank's free guide by clicking on this link: https://shieldyourbody.com/empowered Connect with R Blank:Website: https://shieldyourbody.com/empowered Social Media: @shieldyourbody TurnKey Podcast Productions Important Links:Guest to Gold Video Series: www.TurnkeyPodcast.com/gold The Ultimate Podcast Launch Formula- www.TurnkeyPodcast.com/UPLFplusFREE workshop on how to "Be A Great Guest."Free E-Book 5 Ways to Make Money Podcasting at www.Turnkeypodcast.com/gift Ready to earn 6-figures with your podcast? See if you've got what it takes at TurnkeyPodcast.com/quizSales Training for Podcasters: https://podcasts.apple.com/us/podcast/sales-training-for-podcasters/id1540644376Nice Guys on Business: http://www.niceguysonbusiness.com/subscribe/The Turnkey Podcast: https://podcasts.apple.com/us/podcast/turnkey-podcast/id1485077152

In this episode, Kevin Kelleher (Director of Medical Affairs at Medtronic & founder of the Rural Health Technology Consortium) shares his journey from nurse to sales leader, and why passion, and not just money, must drive your career.Kevin's story really stuck with me. He went from nursing into sales, but what makes his perspective different is how he ties everything back to passion and purpose. He also opens up about what it's like serving rural communities, the push for more diversity in clinical research, and even how he balances leadership with family life. Honestly, it's one of those conversations that leaves you rethinking your life. From breaking into medical sales, building trust in rural healthcare, and tackling diversity in clinical research, to leadership, productivity, and family balance... Kevin brings powerful lessons you can apply today.

Join Hannah Campbell, program manager for AORN's Surgical Safety Award Programs, in this episode of Periop Talk. Hannah interviews Marci Kling, a perioperative nurse educator at Emerson Health, who spearheaded the hospital's successful initiative to earn the Go Clear Award for smoke evacuation. Discover how Emerson Health transitioned to a smoke-free environment through grassroots efforts, leadership support, and staff education, leading to significant improvements in patient and staff safety. Learn More about how you can leverage AORN's Center of Excellence in Surgical Safety: Smoke Evacuation in your facility: https://www.aorn.org/education/education-for-facilities/surgical-safety-center-of-excellence/go-clear-awardsThis evidence-based program is made possible by Medtronic through the AORN Foundation.Support the showWelcome to the Periop Talk—your go-to podcast series where we examine the world of perioperative nursing.Episode after episode, we're bringing you professional tips, clinical wisdom, and personal stories that'll make you feel like you're chatting with your work BFFs. Curious about the latest surgical techniques? We got you. Wondering how to navigate the challenges of the periop journey? We're here for that too.Our podcast series isn't just about sharing information; it's about building a community. Meet the people behind the masks, hear their journeys, and join the rotation of periop professionals making a difference. From students and new nurses to seasoned pros, we've got content for every stage of your perioperative practice.Periop Talk is your peek behind the red line to the world of perioperative nursing. It's not just about the OR – it's about the heart and soul of healthcare. Let's scrub in and start making surgery safer, one podcast at a time.Want us at: (1) Periop Talk vlog - YouTube

Morgan Evans is a biomechanical engineer, serial medtech entrepreneur, and angel investor. She shares her journey from aspirations of becoming a doctor, to working in mergers and acquisitions at Medtronic, to co-founding/founding six companies, including Agitated Solutions and Avio Medtech Consulting. Morgan discusses the importance of supporting startups in accelerating market entry, the challenges and opportunities with innovative medtech development, and the value of servant leadership.   Guest links: www.aviomedtech.com Charity supported: Polaris Project 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   EPISODE TRANSCRIPT Episode 063 - Morgan Evans [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Morgan Evans. Morgan is a serial medtech entrepreneur and investor, which means her passion is launching new businesses. She's a biomechanical engineer by training, went to business school and worked for Medtronic in corporate development before jumping fully into the world of startups. Over the past 10 years, she has founded or co-founded six companies: two medical device companies, two medtech accelerators, and two venture investing vehicles. She spends most of her time with Agitated Solutions, which is developing several innovations related to contrast and ultrasound, and Avio Medtech Consulting, which helps lower the barriers to entry for new ideas and new medtech companies. All right. Well thank you so much for joining us today, Morgan. I'm so excited to speak with you. [00:01:42] Morgan Evans: Thank you again for having me. Pleasure to be here. [00:01:45] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind starting off by sharing just a little bit about yourself, your background, and maybe what led you to medtech. [00:01:53] Morgan Evans: Sure, of course. Originally from Houston, I went to school in the Bay Area and studied to be a biomechanical engineer. I originally thought that I was gonna be a doctor, and wanted to start in heart lung transplant of all things. Did an internship between my freshman and sophomore year and quickly learned two things. One is that I love people a bit too much to distance myself emotionally, so it would've really been a hard career for me, I think being on the front lines with that. But the second important thing I learned as well was there was a lot of technologies that existed in the medtech side of the world, just trying to buy people time and give options. And so I fell in love with medtech as a career relatively early. Started working for my first startup in the neuromodulation space before I even graduated undergrad, and loved that. Wore a ton of hats ranging from engineering, clinical commercial. I did some vertical line integrations in there and I started before we were even at 10 employees, left at 55. Thought it was massive 'cause we had middle management. Then toward the tail end of that, started studying to go to business school 'cause I realized I was getting further and further away from my engineering degree. And then I went to Kellogg at Northwestern and when I was there, co-founded my first startup with a clinician that had a great idea, didn't really know how to navigate the regulatory side of the world, and we co-founded that company together. And toward the tail end of that, was recruiting for formal kind of post-business school. Where am I gonna land? What am I gonna do? And decided to go to Medtronic and do mergers and acquisitions within the corporate development team. Did that for about two years. Loved it, learned a lot. The team was great. But big company was a huge change, especially as I just mentioned, you know, I thought 55 was large with middle management. And then you go to 90,000 at the time and deal teams of that. And kind of felt like my calling was going back to startups, so left in 2016 and have been innovating and building companies ever since. [00:03:53] Lindsey Dinneen: Wow. Okay. Well, thank you for sharing a little bit about your background and everything that's led you to where you are today. I really appreciate it, and so I am so intrigued. Okay, so you were on track in, in theory, initially to be a doctor and to go that route and then decided, "Okay, well, maybe this isn't for me," which is so great that you learned earlier rather than later, of course. But so as you were processing through making this transition into medtech and going, "Oh my goodness, there's actually a whole lot here." Were there any particular things that really stood out as being the most intriguing? Were you just kind of interested in the industry as a whole, or were there specific things where you thought, "Oh gosh, I really wanna learn about X, Y, and Z." [00:04:37] Morgan Evans: Yeah. Two things happened in relatively short order that I think landed me in my love, right? The first is, when I was doing this internship, they actually had some preclinical research going on in the basement of the hospital. And I, it's a long story, but I randomly ended up wandering into this place and figuring out it existed, and saw some of the early preclinical research happening live where they actually had a pig that they were trying to induce a heart attack in to then do a treatment for. And this pig actually coded in the middle of the procedure and they literally come out with paddles. And I'm just like, "This is the coolest thing in the world, this is actually how innovation is done and people learn." So that kind of, "Oh, cardiovascular sounds really interesting," was where I originally started. And then, at the time when I was at Stanford, I was playing on the basketball team as well, and I went to a event with some supporters of the program. And the person at my table was Chairman of the Board of a neuromodulation startup, autonomic technologies. And the one thing I at least love that I'm not afraid to ask questions. And so I just was like peppering him with like, "What is this? How does that work?" And that actually led to my first job. And it's kind of fortuitous that you're in the right place at the right time, but then just get exposure, and that was in pain and pain's a hard space. The type of treatment we were doing was treating condition that was known as a suicide headache. And so I think that was helpful to see the impact of the work we can do so early on. And then I, like I said, I've been hooked ever since. [00:06:05] Lindsey Dinneen: Yeah. Yeah, that's great. And those are great stories. I love the synchronicity and how those moments sometimes just play out perfectly and lead you to your next right step. So now you are in a position where you are advising startups, but you have lots of things going on. I feel like when I was looking at your LinkedIn, there were multiple different organizations you're a part of and participating in. So could you share just a little bit about all the wonderful things you're up to these days? [00:06:31] Morgan Evans: Yeah, for sure. So my day job, as I call it, but where I spend by far majority of my time is I am co-founder and CEO of a company called Agitated Solutions. And we say that we're unlocking the potential of diagnostic ultrasound. So we have multiple products that include a contrast agent that's revolutionary and that it has a temporary micro bubble, looking for holes or flaps known as a patent foramen ovale in the heart that's highly associated with cryptogenic stroke. So we have contrast side, and then we also have some software as a way to have better prediction of what our high risk shunts and what could cause stroke. That had a company spin out of it called Moonshot Medical that is more of a traditional incubator where we put all of the IP and ideas that weren't quite ready to be full-blown companies, but we knew there were some things there that I also technically lead. So those are the two that I'm CEO of. I founded a company called Avio, that I'm very passionate about, that is really focused on trying to help get these medical technologies to market faster. The work we do is on the backend of medtech, so quality systems, regulatory, R&D project management. But just in the theory that there's so much paperwork that is behind any innovation, like how do we get better at that paperwork so that we can keep innovators doing what they do best. And then we're just really that helping hand alongside. I joke, all of the things I'm involved in, this was my happy accident. I felt like I was building what I needed for my own startups. Literally no intent of anyone else ever seeing this or offering that as a service. And I just remember distinctly, I woke up one day shortly before my son was born and I was like, "Oh, I think there's actually a business here. Maybe I should run it like one." So that's another one. And then passionate about angel investing in early stage as well. When I fundraised for the first time, I was 29. I'm now 37. I get asked that a lot, although you're not supposed to ask a woman her age. When I fundraised for the first time, especially in these early stage rounds, no one looked like me, both in gender or age. And so I'm one of those believers, "Put your own money where your mouth is," even if they were baby checks to start, they were something. And that's been another area that I also spend some time. [00:08:48] Lindsey Dinneen: Yeah. Wow. Okay. So you've got a lot going on to, put it mildly, which is fantastic. You mentioned something that really stood out to me. You're trying to help these startups bring their medical technology to market faster. And I'm curious, are there maybe one or two things that you see a lot of startup companies perhaps either accidentally overlook, or delay too long, or something like that, where, at the beginning, if they had done X, Y, and Z, they could have gotten their technology to market faster. [00:09:21] Morgan Evans: Yeah, a couple thoughts. One is I think people underestimate the amount of time that it takes to formally document all of the things that go into getting your device compliant and on the market. For example, I've had a client before that came to us that had a product that was working. He had tested it, he'd done all these things and it was a software, and ready to go, and submit to the FDA. And then you're like, "Well, we need user needs and product requirements, and your design schema," which, you know, there is a reason that these processes exist and I think they can make you have a better product at the end of it. But I think, you know, people assume, "Let's build the right product first and then worry how to document it." And then you forget sometimes why certain decisions were made or you know, is this actual requirement or was that done because it was an off the shelf thing? And so there is a lot of learning that I think can be lost by waiting. Now all that said, the other part of it would be that if people kind of shore up too fast, so you overbuild the team, you have a quality person, a regulatory person day one that feel like they need to be doing all of the things and justify their full-time job, then you end up documenting and revising. So there is some healthy balance and tension between the two. So it's not easy to get it perfect. But I would say those are the two areas that come to mind. [00:10:37] Lindsey Dinneen: Yeah, that makes a lot of sense. And I can see where the polar opposites could be challenging. So staying happily in the middle, working with an expert such as yourself, is a really wonderful way to go about that. You mentioned angel investing and being passionate about helping. It sounded like based on your own experience, you're very passionate about helping the next generation of leaders and entrepreneurs in this space create the products and bring what they envision to market. As you've gone about this, and even as you learned for yourself how to fundraise, maybe feeling like, "Hey, nobody else looks like me, is my age," or whatever, what are some learning lessons that you've experienced that you would suggest for somebody who's maybe in a similar situation that you were in? [00:11:28] Morgan Evans: Yeah. Some of it is just to be a little bit fearless, I would say. There's a lot of people that have told me over the years, "Pick one. I don't understand how you do all these things." My least favorite question I've ever gotten is, "Do you ever see your kids?" Yeah. But people ask you that, you know? And I think it's easy to let other people tell you what you should be or what your product should look like or your path should be. And I think I have been fortunate to find some wonderful mentors that empowered me to be my own version. I didn't have an example of someone that had built the things in the way that I had built them or that had a couple of them at one time. But I also knew very confidently that I wasn't dropping a ball and I was doing the right thing by the companies I was building and supporting. And it was helpful to have the army behind me that just loved me for me and supported me in that, in developing it. And I think that next generation of entrepreneur, if you can find the same, that's willing to lean in just for you and there's no ulterior motive other than just to see you be successful, hold on with both hands and then pay it forward to the next one. [00:12:38] Lindsey Dinneen: Yeah. Yes. That's great advice and insight. So when you're thinking about your own career and the companies you're leading, what are some things that you're looking forward to in the future as you yourself continue to evolve and develop your own skill sets and whatnot, and also for your companies that you're leading? What are you excited about? [00:12:59] Morgan Evans: Yeah, I think for me, I'm excited about building that next generation of entrepreneur, which we've talked about a little bit. And how do I influence and build and develop those things without me being the one actively leading them? That's been a new learning that I'm continuing to kind of dabble in and grow personally, which is leading through the art of board work or questions or advising, which is different than leading a company by physically being the head of that company. And thinking about how to train and develop and give people enough of a leash to go and run and be them, but yet have that support system that you're still within their appropriate guardrails that-- I'm kind of mixing metaphors, but I think you get it. You know, it's an art, not a science, and one that I'm enjoying learning and growing and developing in this next phase too. [00:13:53] Lindsey Dinneen: Yeah. Well, and speaking to that in general, so I'm sure you've had a mixture as most of us have had, of good experiences with leadership and poor experiences with leadership, and I'm curious how that has shaped your own leadership style now, especially as you're in this new phase of further developing your leadership skills to look a little different than perhaps they have in the past. But what do you draw from and what's your inspiration when you've developed your own leadership style? [00:14:23] Morgan Evans: Yeah. As I mentioned earlier, I've had a wonderful network of mentors that I think have really leaned in and and done it in the right way for the right reason. And I hope to emulate that myself, of being there to grow people and the technologies and the businesses that you're doing and giving them those chances to shine. As a leader, I believe very much in servant leadership. I never want someone to work a weekend that I'm not working as well. But then you kind of realize that isn't always feasible and can feel uncomfortable sometimes. And how I've evolved to give other people those opportunities, but recognize I'm not gonna be in the weeds enough to help them in the same way, it's a journey. I'd love to say I'm at the destination. I'm one of those, I love iterative improvement. I don't think I'm ever at a destination. But just really trying to lead through the art of question, for example, as opposed to coming with thoughts and opinions, has been a big one for me in the last couple months in particular. [00:15:20] Lindsey Dinneen: Yeah. So approaching with curiosity, it sounds like in an effort to understand and or provoke even perhaps that person taking additional ownership or responsibility in their own creative solutions to perhaps what they're coming up with. Are there particular questions you've found that are really helpful as you're shaping these conversations, helping people understand their next right step? [00:15:46] Morgan Evans: Yeah, I, it's funny because one of my mentors that's been coaching me on this is, she's kind of had that progression of learning to shift from, in the absence of leadership, lead, to leading someone else through that. I actually text her periodically and ask her for guidance of, "Hey, they came to me with... This is what I would normally say. How do I frame this in a question such that I'm giving them enough direction, but not leading the horse to water." So it the art of the question is in, in fact, itself an art. In general, I would think about asking something in the framework of, "Have you thought about the ramifications of?" or, " What is the key thing that we should focus on this week?" It's almost trying to pick out what I would focus as being the main thematic issue or next step, and giving them enough of a carrot that they can get there, but not quite telling them exactly how it should be done. [00:16:44] Lindsey Dinneen: Okay. Yeah. So in general those sort of probing questions that might suggest, "Hey, have you thought about X, Y, and Z? Or, what are your thoughts about X, Y, and Z related to this?" And letting them continue to take ownership and responsibility for that. That's really great. One thing I noticed, and I don't know if this is something you currently still do or not, but I was noticing on your LinkedIn that at least at one point you had a Medtech Startup CEO Bootcamp, which just sounds awesome and I would love, if you don't mind, sharing a little bit more about that and what that looks like. [00:17:17] Morgan Evans: Well, the good news is we are doing it, we're doing another one, I think in June. I'm happy to say I don't know the exact date 'cause that means I'm not in it enough to know exactly the dates. So in the spirit of me trying to take myself up a level -- success. But no, it's interesting because I had worked in medtech for five years before business school, went and got a traditional, you know, learning in all things business, right? Graduated, went to Medtronic, did M&A, and then came and did my first startup. And I remember day one it was like, "Do I form an LLC or C corp?" No one had taught me that. And it's funny because, now you can understand the nuance of the question, but I can't imagine how much money I spent on the first attorney. And yes, there's pass through income, but you know, is that appropriate for investors for me to take a disproportionate loss or there's 1202 tax code and all these other nuance. So I started realizing that a lot of just taking the first step where things that you have to learn on your own or find a really awesome board member, advisor, et cetera, to lean in and help you too. Other examples would be, you know, "How much stock options do you normally give your board?" Or, " Should I do a convertible note or a safe? What is a quality system," right? I knew entrepreneurs that had no idea what those things were. So the thought was, "How do I give enough detail to these other entrepreneurs, so where they at least feel that they can ask the right question?" Because to think that I can teach someone the nuance of verification, of validation strategy in an hour or four, versus someone that has done nothing but R&D for 15 years, right? That's not gonna happen. But if you could teach them enough to then say, "Hey, my CTO or contract design partner, should we dry run this test first? Or what test should we dry run?" Right? If we can give those people just enough there to phone a friend, that was the goal of the program. So just giving people that lay of the land and enough of a roadmap. And a lot of this too, like we literally have an acronym sheet because medtech is full of acronyms, and it's funny that like our acronyms can mean something completely different in other people's spaces. And so just even learning the lingo day one, like what's an SOP or CMO or CDO? [00:19:40] Lindsey Dinneen: That's incredible. I love that. That's so great that you have a cheat sheet because I remember that being such a learning curve when I first got into the industry of, " You just said an entire paragraph worth of acronyms and I would love to understand what you're talking about, but I don't yet." so learning how to decipher all of that was great. I'm thankful for it, but yeah, that's wonderful. A cheat sheet sounds fantastic. You know, it's interesting 'cause you mentioned, with this bootcamp, first of all, I'd love that you offer that. What a fantastic offering for anyone in that position who's just needing that support and that extra guidance, and having something that's so specific to the industry is great. Do we just go to your website for details if anyone's interested in that? [00:20:24] Morgan Evans: Yeah, it would be on the aviomedtech.com website. And then I believe there's a tab that is regard to the bootcamp. And yeah, like I said, it's all the stuff that I wish I would have learned or I learned. It took me way too much time and money, that I just want people to know where the landmines are that I had to step on. And if we can just accelerate that learning and that s-curve for the next entrepreneur, we can get these products to market a lot faster. [00:20:50] Lindsey Dinneen: Yes. I love that you offer that. You've gotten to have an amazing career where you've been diving into the industry itself and working for other people, and then of course being a leader in your own companies now as well. I'm wondering if there are any stories that stand out to you as really just affirming, "You know, I really am in the right place at the right time in the right industry"? [00:21:12] Morgan Evans: Yeah, it's funny. I don't get to reflect on this very often, but I co-founded Agitated Solutions and I founded Avio within one week of each other. I didn't know, again, that I was building what I was building on Avio's side. But what's been so much fun is that as I build and grow this awesome company, that's being an entrepreneur myself, being able to take learnings where I see them and try to pull them thematically into Avio so that you kind of have that flywheel effect. So I'm learning that I enjoy both operating within these technology companies, but also trying to figure out what of the system, or the process, doesn't make sense. Like I know other people might do it this way, but why? And, being able to innovate on the system and the output at the same time has been super fulfilling for me. And like I said, it's kind of a little bit of coincidence that it was within one week of each other, but that's part of where I've learned for myself that I don't think I'm fulfilled by just being in one company or one thing fully, and in fact, me being in something else is part of what makes me better at the other thing. So I feel really fortunate to have found that and to know where my passion lies. [00:22:41] Lindsey Dinneen: Yes. That's very cool. And definitely a gift. And you know how things sort of translate into each other-- I was thinking about this earlier because-- I noticed, and you also mentioned that basketball was, and is as my understanding, a core part of your life. And so you've been both a player, you've been a coach. How has basketball played a role in either life lessons, life skills that you've drawn from it, and or how does it just incorporate into your life? [00:23:11] Morgan Evans: You know, it's actually a really fitting question. So first of all, as an athlete, it taught me I cannot stand to be the weakest link on a team. And when you think about that servant leadership, or that hustle or that grit, I was tall, but I was not the most naturally gifted athlete. And so a lot of where I excelled in basketball was on fundamentals, just solid, putting in the time and doing it. And then I got to the point in my career where I could not outwork other people. I could put all the time in the world in there and I was not going-- like I played behind All American Centers when I was at Stanford, and everybody was an All American coming in to play basketball. And it was a good evolution for me to learn a little bit of "How else can I then play a role if I'm not the most gifted athlete?" and to recognize that a team can function well with all those pieces regardless, right? So I don't need to be the leading score to still have an impact on the team was kind of a good mental awareness of how talent gets pulled together to make effective teams. The other thing on the coaching side, so I actually had career ending surgeries between my junior and senior year. And basketball was, and still is, a big love of my life. And to then have my playing days over unexpectedly was a big transition, and I got to see basketball from the sidelines my senior year. And my job then was to make the other players more effective, to study scouting report, to teach, to try to do what I could to get the team ready, knowing I would never step foot on the court. And if you think about some of the parallels we've already just talked about, which is leading through the art of question or being able to lead and guide, but not being able to be out there, running around with everybody else in and of, in itself is a very similar transition to what I'm going through and continue to go through. I coach young women. I did except for this last year. It's been hard with two kiddos, in particular on my husband, especially, you know, we would do travel tournaments and things like that. But coaching young women too, and realizing it's the end result, but it's also wanting them to be good people and life lessons and skills through it. And how do you have them help respond in adversity? All of that, I think, makes me a better leader, and there's a lot of parallels to the working place, for sure. [00:25:35] Lindsey Dinneen: Yeah. Yeah, that's wonderful. And having a gift like that, even when it looks different and morphs over time, I love that you've been able to draw from it such inspiration and application to other areas of life. I think that's really special. Such a cool aspect of being an athlete. So yeah, thank you for sharing about that. [00:25:51] Morgan Evans: Of course. [00:25:53] Lindsey Dinneen: So, pivoting the conversation a little bit just for fun. Imagine that you are to be offered a million dollars to teach a masterclass on anything you want-- could be within your industry, doesn't have to be-- what would you choose to teach? [00:26:07] Morgan Evans: I would teach something on scrappiness. From my experience, I think there's a lot of people that would know the industry really well, but the how to get things done atypically for less money faster. And that's some of the thematic elements that I hope I'm-- not for a million dollars-- but, you know, starting to teach in our bootcamp. Some of the belief that I think sometimes you get these companies in medtech in particular that are kind of overbuilt, too much too soon. And now they have a really high burn rate and everybody has to leave, essentially a unicorn exit or bust. And how can you burn down and mitigate risk with little dollars and making sure you're spending your dollars in the right places early on? I continue to learn from others in that too, I should mention, but I think it's an area with a lot of impact. [00:26:59] Lindsey Dinneen: Yeah, absolutely. And so relevant and helpful for startups that have no choice but to be scrappy and learn how to be creative on a dime. I think that's fantastic. Great. And then how do you wish to be remembered after you leave this world? [00:27:16] Morgan Evans: Yeah. I hope it's something to do with innovating on technologies that improve and help patients, but also innovating with people and process, that hopefully on all of this, that we're leaving the world a little better than we found it. [00:27:33] Lindsey Dinneen: Yeah. Yeah, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:42] Morgan Evans: Definitely my family. I have two kiddos, Marley and Mason. So my daughter's three months, my son is three. And then my husband Matt. It's hard to do all the things that I do without having an amazing support system. And, you know, you can have the hardest, most stressful day and you come home and my son's like, "Do you wanna play with me?" Or, "Let's play hide and seek" or something. And it's just funny how instantly all that stress kind of melts away. Very grateful for my family. [00:28:10] Lindsey Dinneen: Yeah, family is such a gift. Wonderful. Well, this has been such a great conversation, Morgan. I really appreciate you spending some time with us today, and thank you for sharing about your life and your story and your advice. I am excited to see how you could just continue to grow and thrive. I love the fact that you are just a total boss with all the things that you're doing. So thank you for contributing your gifts to the world, and gosh, I just wish you the most continued success as you work to change lives for a better world. [00:28:42] Morgan Evans: Thank you again for having me. I appreciate you. [00:28:45] Lindsey Dinneen: Of course, and we are so honored to be making a donation on your behalf as a thank you for your time today to the Polaris Project, which is a non governmental organization that works to combat and prevent sex and labor trafficking in North America. So thank you for choosing that organization to support. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you'd share this with a colleague or two, and we'll catch you next time. [00:29:16] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

At ESC 2025, a pair of presentations highlighted the ongoing debate over cardiovascular risk reduction with semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound), yielding conflicting signals that clinicians will need to interpret carefully. In this special edition episode, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, explore these studies: SURMOUNT-5 and STEER. A post hoc analysis of SURMOUNT-5 compared the 10-year predicted CV risk reduction between the 2 agents. Using the Framingham Risk Calculator in 751 patients with obesity, tirzepatide was associated with greater benefit than semaglutide. From baseline risks of ~9%, tirzepatide was projected to lower absolute 10-year CV risk by 2.4% (23% relative reduction) compared with 1.4% (13% relative reduction) for semaglutide. Investigators attributed the advantage largely to greater weight and glycemic reductions. In contrast, the STEER study, a real-world analysis of more than 21,000 patients with a mean follow-up of 8.5 months, suggested semaglutide was associated with lower rates of major adverse cardiovascular events (MACE) than tirzepatide. Semaglutide users had a 29% risk reduction in nonfatal MI, nonfatal stroke, or CV death compared with tirzepatide. Limitations included short follow-up, relatively few CV events, and the inherent confounding of observational data. Both Isaacs and Bellini emphasized that while weight and glycemic improvements with tirzepatide appear robust, CV benefits may be molecule-specific. The ongoing SURPASS-CVOT, comparing tirzepatide with dulaglutide, should provide more clarity when full data are released at EASD. In the interim, the hosts advised prescribing based on labeled indications supported by randomized outcomes data—semaglutide for CV and kidney risk reduction, tirzepatide for obesity and sleep apnea—while awaiting definitive trial results. Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others. References: Mamas M. SURMOUNT-5: Tirzepatide compared to Semaglutide in obesity for 10-year CVD risk reduction .Presented at the European Society of Cardiology (ESC) Congress 2025. Madrid, Spain. August 29- September 1, 2025. Novo Nordisk. Novo Nordisk's Wegovy® cuts risk of heart attack, stroke or death by 57% compared to tirzepatide in real-world study of people with obesity and cardiovascular disease. Novo Nordisk. Published August 31, 2025. Accessed September 5, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916422

Ohne Aktien-Zugang ist's schwer? Starte jetzt bei unserem Partner Scalable Capital. Alle weiteren Infos gibt's hier: scalable.capital/oaws. Aktien + Whatsapp = Hier anmelden. Lieber als Newsletter? Geht auch. Das Buch zum Podcast? Jetzt lesen. Der Kalender zum Podcast? Jetzt kaufen. SK Hynix und Samsung haben China-US-Stress. BYD hat Wachstumsstress. Xpeng ist auch Schuld. Analyst pusht TeamViewer. Rüstungsdeals pushen Rheinmetall, BAE & Co. Formel 1 macht krassen Deal. Stada macht riesen Deal ohne Börse. Nestlé feuert CEO. Bei 120 Milliarden Dollar Börsenwert einen Turnaround zu schaffen, ist nicht einfach. Elliott drängt darauf, dass Medtronic (WKN: A14M2J) die richtigen Schritte macht. Übers neue iPhone oder die neue Nintendo Switch spricht jeder. Wir sprechen über die neue Box von Tonies (WKN: A3CM2W). Diesen Podcast vom 02.09.2025, 3:00 Uhr stellt dir die Podstars GmbH (Noah Leidinger) zur Verfügung.

Send us a textWe've got a great one! Joined by Elizabeth Diley, Anna and Paul discuss Gen Z in the workplace and tips on early career success.Elizabeth is an expert having served in global leadership roles at both General Mills and currently Medtronic. Her passion and knowledge are on display?  Connect with her:https://www.linkedin.com/in/elizabeth-dileyMusic in this episode is Pelicans by Joe Cooney. Check him out on instagram @cooney.tunes !!Follow us on Instagram! @work_dad_podcast

Jennifer Chavez joins the show to share her unique path through medical sales — from breaking in as a remote sales rep at Medtronic, to driving strategy as a vascular account executive at Cook Medical, to now leading her own consulting firm helping medtech companies build sales teams and win hard-to-access accounts. She pulls back the curtain on what it's really like to succeed in roles that go beyond the OR. You'll hear how remote sales reps add value, why key account roles require a different skill set, and what it takes to balance strategic storytelling with on-the-ground sales execution. Jennifer also opens up about life as a single mom building a career in this demanding industry, the mindset shifts that fueled her success, and why betting on herself to launch a business was the natural next step. If you've ever wondered how to climb the ladder in medical sales without following the traditional rep-to-manager path, or what it takes to thrive in high-level strategic roles, this conversation is packed with insights you won't want to miss.   Connect with Jennifer: 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!

In this episode, Duane Mancini welcomes to the show Jessica Richter, a seasoned medtech executive and board member of MedtechWOMEN. With over 20 years in the industry, Jessica shares her extensive career journey from a medical device sales rep, through various leadership roles at companies like Medtronic, to her current independent consulting role. The discussion covers vital topics such as navigating the US healthcare market, effective sales strategies, the importance of stakeholder alignment, and tips for early-stage entrepreneurs transitioning into leadership roles. Jessica also highlights the critical role of diversity in medtech and shares insights on the mission and initiatives of MedtechWOMEN, a nonprofit organization dedicated to empowering female leaders in the field.Jessica Richter LinkedInMedtechWOMEN LinkedInMedtechWOMEN WebsiteMedtechVISION Conference WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn

Derek interviews NY Times best selling author, Brian Moran. Brian Moran has over thirty years of expertise as a CEO, corporate executive, entrepreneur, consultant and coach. His background as a corporate executive combined with his experience as an entrepreneur positions him with a unique skill set to help individuals and organizations grow and prosper.Brian's corporate experience includes management and executive positions with UPS, PepsiCo, and Northern Automotive. As an entrepreneur he has personally launched and led successful businesses and been instrumental in the success of many others. In addition, he has consulted for dozens of world-class companies including Coldwell Banker, Mass Mutual, Medtronic, New York Life, and Tiffany & Co.Brian is a recognized expert in the field of leadership and execution. His realization that most people don't lack ideas but struggle with effective implementation led him to the development of The 12 Week Year. In addition to his books, Brian has been published in many of the leading business journals and magazines. He is a sought after speaker, educating and inspiring thousands each year.He is a visionary with a passion for helping others go beyond what they think they are capable of and achieve more than they ever thought possible. His greatest strength might be his ability to take success principles and strategies and help others apply them in a way that is powerful and effective, and gets results.Learn more at: https://12weekyear.com/Business Leadership Series Intro and Outro music provided by Just Off Turner: https://music.apple.com/za/album/the-long-walk-back/268386576

“If you can drive the brain’s naturally occurring activity, what you can get is the biologic expression that is important for brains to maintain and protect themselves,” Cognito Therapeutics’ CEO Christian Howell tells Bloomberg Intelligence in this episode of the Vanguards of Health Care podcast. Howell sits down with BI analyst Matt Henriksson to discuss the company and its Spectris device — a non-invasive therapeutic intervention designed to use gamma waves to preserve brain structure and function, starting with Alzheimer’s patients. He also highlights the promise of Cognito’s Hope study and reflects on how his time in the Navy and at Medtronic under former CEO Omar Ishrak shaped his “fidelity to the mission” leadership mantra.See omnystudio.com/listener for privacy information.

Welcome back to Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives! In this episode, Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, shared highlights on several major insulin delivery updates making waves at recent meetings. 00:00:00 Introduction 00:00:20 Pivot by Modular Medical 00:07:13 Medtronic's Partnership with Abbott - the Instinct Sensor 00:09:04 Tandem's One-Handed Insert 00:10:14 Tandem's Mobi Patch Pump

Voting in the 2025 Coolest Thing Made in Connecticut challenge is underway! The challenge celebrates the successes of the vital manufacturing industry and highlights the wide range of products produced by our world-class, highly skilled workforce. Featuring 16 Connecticut-made products, the single-elimination, bracket-style competition allows the public to vote on their favorite product.  This special episode of the CBIA BizCast shines a spotlight on these amazing companies, the cool things they make, and their incredible workforces. The companies in this year's challenge are: • American Woolen Company American Blazer : https://americanwoolen.com/ • Amodex Stain Remover: https://amodexusa.com/ • Beekley Medical Elequil Aromatabs Aromatherapy : https://beekley.com/ • Bic Consumer Products Lighter: https://us.bic.com/en_us • Element 119 System X Max G+ Ceramic Coating : https://www.element119.com/ • Ensign-Bickford Aerospace & Defense Frangible Joint : https://ebad.com/ • Fascia's Chocolates Chocolate Lava Cake: https://faschoc.com/ • Horst Engineering & Manufacturing Co. Horst Dreidel: https://horstengineering.com/   • Munson's Chocolates Pecan Caramel Patties: https://www.munsonschocolates.com/ • Naiad Dynamics Fin Stabilizer : https://www.naiad.com/ • Oma's Pride Woof Compete Recipes Dog Food : https://omaspride.com/ • Owl's BrewOwl's Brew Boozy Beverage : https://www.theowlsbrew.com/ • Rose Sisters Chips Baked Flour Tortilla Chips: https://www.rosesisterschips.com/ • Thule ReVert Bike Rack: https://www.thule.com/en-us/ • Urban Mining Pozzotive Glass Concrete: https://pozzotive.com/ • ZANEEZ HealthAnkleStone: https://anklestone.com/ The Coolest Thing Made in Connecticut is produced by the CBIA Foundation in partnership with CONNSTEP and made possible through the generous support of CliftonLarsonAllen LLP, Image Marketing, Blue Back Square, Medtronic, the Connecticut Office of Manufacturing, and Forge. The winner will be announced at the Oct. 2 Made in Connecticut: 2025 Manufacturing Summit. After the competition, the Connecticut Science Center will open an exhibit Oct. 10 celebrating the 2025 Coolest Things Made in Connecticut.

The latest guest on The PR Week podcast is Torod Neptune, a veteran of prominent in-house and agency roles from Medtronic to Waggener Edstrom. Neptune is also a member of the 2025 PRWeek Hall of Fame class, announced just this morning, alongside other industry heavyweights. Now a member of the faculty of the University of North Carolina, Neptune talks about PR and communications in academia, as well as the biggest marketing and communications news of the week, including PRWeek's profile of OpenAI communications leader Hannah Wong.  Plus, remembering longtime Southwest Airlines head of PR and culture Ginger Hardage, who passed away last Saturday.    AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Follow us: @PRWeekUSReceive the latest industry news, insights, and special reports. Start Your Free 1-Month Trial Subscription To PRWeek

William H. Sauer, MD, FHRS, Brigham and Women's Hospital is joined by Wendy S. Tzou, MD, FHRS, University of Colorado Anschutz Medical Campus and Kishan Padalia, MD, University of Colorado, to discuss the results of ablation of sustained monomorphic ventricular tachycardia (SMVT) are suboptimal. For many patients with implantable cardioverter-defibrillators (ICDs), ICD electrograms (ICD-EGs) provide the only available information on SMVT. ICD-EGs have the ability to distinguish morphologically distinct SMVT and can be used for pace mapping.  https://www.hrsonline.org/education/TheLead https://www.jacc.org/doi/10.1016/j.jacc.2024.10.104 Host Disclosure(s): W. Sauer:  Honoraria/Speaking/Consulting: Biotronik, Biosense Webster, Inc., Abbott, Boston Scientific, Research: Medtronic  Contributor Disclosure(s): W. Tzou: Honoraria/Speaking/Consulting: Medtronic, Biotronik, Biosense Webster, Inc., Mediasphere Medical, Kardium, American Heart Association, Medtronic, Abbott, BioTelemetry, Boston Scientific, Kardium Research: Abbott Medical K. Padalia: Nothing to disclose.

Carl Quintanilla, David Faber and Mike Santoli led off the show with developments regarding Intel: Softbank investing $2 billion in the company, as the Trump Administration reportedly weighs taking a 10% stake in the chipmaker. Commerce Secretary Howard Lutnick joined the program and discussed a potential government investment in Intel. Also in focus: Home Depot's quarterly miss, Palo Alto Networks sharesjump on earnings, Nexstar to buy rival TV stations operator Tegna, the "SPAC king," Medtronic and activism, why one particular stock is plummeting 40%. Squawk on the Street Disclaimer

Wall Street recorded a negative session as Tech dragged the broader market down, falling ahead of the Jackson Hole summit which begins on Thursday in the US. S&P 500 down 0.59%, Nasdaq fell 1.46%. Dow rose at the open but fell after the first hour, briefly dropping into the red before recovering to finish flat. Closed near the low, up 10 points.  Primarily strong sector performance with Tech the main drag. Tech fell a little over 1.5% with Nvidia leading the sell-off, down 3.5%, its biggest drop in nearly four months. Cyclicals also saw some weakness while Energy and Financials were flat. Every other sector up. REITs the biggest beneficiary after showing weakness in the previous session, easing yields a boost, as was better-than-expected housing data. Staples also recorded gains of over 1%.In corporate news, Home Depot climbed 3.2% despite missing earnings estimates, while rival Lowe's added 2.2% ahead of its own results. Focus will shift to Walmart and Target, with upcoming reports expected to shed light on consumer resilience. Intel jumped 7.0% after securing a $2Bn capital lifeline from Japanese SoftBank. Palo Alto Networks rose 3.1% on upbeat long-term guidance, while Medtronic fell 3.1% as Elliott Management's stake prompted board changes.Resources down. Oil down as Russian sanctions are expected to ease soon after talks. Copper, nickel and aluminium all down.ASX to rise. SPI futures up 17 points (+0.19%). Results in focus. TCL TLC BRG CWY APAWant to invest with Marcus Today? The Managed Strategy Portfolio is designed for investors seeking exposure to our strategy while we do the hard work for you. If you're looking for personal financial advice, our friends at Clime Investment Management can help. Their team of licensed advisers operates across most states, offering tailored financial planning services.  Why not sign up for a free trial? Gain access to expert insights, research, and analysis to become a better investor.

In this thought-provoking episode of SPOT Radio, host Charlie Webb, CPPL, sits down with sustainability advocate Samantha Smith to explore the critical intersection of healthcare and environmental responsibility. Together, they unpack the growing urgency to make hospitals and clinics more sustainable—without compromising patient care or regulatory compliance. They also dive into the cultural and institutional hurdles that often slow progress, and how a possible shift towards a data-driven decision-making can open new possibilities for long-term impact.If you've ever wondered how medical facilities can reduce their environmental footprint while maintaining safety and sterility, this episode will leave you inspired—and armed with insights to make a difference.About Samantha Smith: DIRECTOR, SUSTAINABILITY AND PRODUCT STEWARDSHIPSenior MedTech leader in Sustainability, ESG, and Product Stewardship, shaping corporate strategy, securing executive alignment, and delivering measurable business and environmental impact. Selected by Medtronic's Executive Leadership Team to build and scale the first R&D function focused on Sustainability, securing $4M+ in funding. Defined and reported to investors Medtronic's first external-facing Sustainability Product and Packaging goals. Trusted voice in MedTech Sustainability, representing the company in key industry and customer forums.CAREER HIGHLIGHTSSustainability Strategy & External Reporting: Secured $4M+ in executive-approved funding to build Medtronic's first R&D function focused on Sustainability and defined external product and packaging ESG goals reported to investors, embedding ESG into product innovation and driving investor confidence.Cost Savings & Risk Mitigation: Negotiated $100M+ in Master Supply Agreements for packaging, delivering 5% year-over-year cost savings and protecting Medtronic from COVID-related supply chain price surges, saving $10M+.Operational Excellence & Circularity:Integrated circularity and eco-design criteria into Medtronic's New Product Development process, advancing FY30 sustainability commitmentsSamantha Smith Email: samanthakeeneysmith@gmail.comLinkedin:  linkedin.com/in/samanthakeeneysmith

In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über Börsen-Non-Event Alaska, eine hoffnungsvolle Softwarestudie mit 6 Top Picks und einen neuen Chart of Doom. Außerdem geht es um CoreWeave, Salesforce, Siemens Energy, Cisco Systems, Palo Alto Networks, ProSiebenSat.1, Novo Nordisk, AstraZeneca, AbbVie, Siemens Healthineers, Sonova, Medtronic, Haleon, iShares Aging Population ETF (WKN: A2ANH1), Boston Scientific, Glaukos, Exelixis, Sarepta, Swisscanto Healthy Longevity Fund (WKN: A40L0T), Eli Lilly, Abbott, UnitedHealth, Microsoft, Amazon, Nvidia, Meta, Netflix, Coreweave, Oracle, Carvana, TSMC, Roblox, Crowdstrike, Opendoor Technologies, Alibaba, PDD, Petroleo Brasileiro, Teva Pharmaceutical, Robinhood, Northrop Grumman, RTX, Lululemon, Mercadolibre, Talen Energy, GE Vernova, Broadcom, Vistra, Micron, Alphabet, Somnigroup International, Flutter Entertainment. Und hier gibt es die Tickets zum Finance Summit am 17. September! https://veranstaltung.businessinsider.de/FinanceSummit Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Der Börsen-Podcast Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

The FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don't).Use KPIs and OKRs to diagnose execution gaps.Build stronger trust and culture through connectedness, from “gemba” walks to multi-channel communication.Sean also shares real-world stories—from transforming an underperforming ultrasound launch to shifting a company's culture from “play not to lose” to “play to win.” Whether you're leading in medtech, life sciences, or beyond, this episode delivers actionable insights you can bring straight back to your team.About the Guest:Sean Gallimore, MBA is an executive consultant with 30 years of leadership across Fortune 500, mid-cap, and private equity–backed companies in medical devices, life sciences, and industrial technology. He has held senior roles at Medtronic, Smith & Nephew, Philips, Parexel, PDI Healthcare, and Dynisco, driving growth through strategy execution, turnarounds, innovation, and building high-performing teams. Today, he advises early-stage medtech companies on scaling operations, commercial strategy, and organizational development.About The FDA Group:The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

 It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: cancer reserach may lead to T1D treatment, GLP-1 oral pill moves forward, Tandem pharmacy moves, Medtronic-Abbott sensor unveield, parents of kids with T1D see income drop, Mannkind submits Afrezza for pediatrics, diabetes scholarships and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Cornell researchers have developed an implant system that can treat type 1 diabetes by supplying extra oxygen to densely packed insulin-secreting cells, without the need for immunosuppression. The system could also potentially provide long-term treatment for a range of chronic diseases. This lab has produced previous implantable devices that have proved effective in controlling blood sugar in diabetic mice, but they can only last so long. "It's the proof of concept. We really proved that oxygenation is important, and oxygenation will support high cell-density capsules," Tempelman said. "The capsules are immune protective and last for a long time without having some kind of fouling of the membrane. The body never likes it when you put a foreign substance in. So that's the engineering in the Ma Lab, to look for materials and coatings for the materials that are immune protective, but also don't invoke excess response from the body because of the material." The next step will be to implant the system in a pig model, and also test it with human stem cells. The researchers are interested in eventually trying to use the system for implanting different cell types in humans for long-term treatment of chronic diseases, according to Tempelman, who is CEO of Persista Bio Inc., a new startup she founded with Ma and Flanders that is licensing these technologies. https://medicalxpress.com/news/2025-08-implant-diabetes-oxygenating-insulin-cells.html XX Mayo Clinic cancer research may be big news for T1D. After identifying a sugar molecule that cancer cells use on their surfaces to hide from the immune system, the researchers have found the same molecule may eventually help in the treatment of type 1. Cancer cells use a variety of methods to evade immune response, including coating themselves in a sugar molecule known as sialic acid. The researchers found in a preclinical model of type 1 diabetes that it's possible to dress up beta cells with the same sugar molecule, enabling the immune system to tolerate the cells. The findings show that it's possible to engineer beta cells that do not prompt an immune response   In the preclinical models, the team found that the engineered cells were 90% effective in preventing the development of type 1 diabetes. The beta cells that are typically destroyed by the immune system in type 1 diabetes were preserved.     https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-researchers-find-sugar-coating-cells-can-protect-those-typically-destroyed-in-type-1-diabetes/ XX A daily pill may be as effective in lowering blood sugar and aiding weight loss in people with Type 2 diabetes as the popular injectable drugs Mounjaro and Ozempic, according to results of a clinical trial announced by Eli Lilly on Thursday morning.   The drug, orforglipron, is a GLP-1, a class of drugs that have become blockbusters because of their weight-loss effects. But the GLP-1s on the market now are expensive, must be kept refrigerated and must be injected. A pill that produces similar results has the potential to become far more widely used, though it is also expected to be expensive.   Lilly said it would seek approval from the Food and Drug Administration later this year to market orforglipron for obesity and early in 2026 for diabetes. https://www.nytimes.com/2025/04/17/health/pill-glp-1-eli-lilly.html XX Use of diabetes technology has dramatically increased and glycemic control has improved among people with type 1 diabetes (T1D) in the US over the past 15 years, but at the same time, overall achievement of an A1c level < 7% remains low and socioeconomic and racial disparities have widened. These findings came from an analysis of national electronic health records of nearly 200,000 children and adults with T1D by Michael Fang, PhD, of the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. The study was published online on August 11, 2025, in JAMA Network Open. Use of continuous glucose monitors (CGMs) increased substantially from 2009-2011 to 2021-2023, from less than 5% in both children and adults to more than 80% and over half, respectively. While A1c levels did drop over the 15 years, just 1 in 5 children and slightly over a quarter of adults achieved a level < 7%. The average A1c level stayed above 8%, with ethnic minorities and low-income patients seeing the smallest gains.       https://www.medscape.com/viewarticle/diabetes-tech-use-rise-a1c-reductions-still-lag-2025a1000lc9 XX Inflammation may predict how well people with diabetes respond to depression treatment, and the effects differ dramatically between type 1 and type 2 diabetes. Diabetes and depression often appear together. Indeed, depression is more than three times more prevalent in people with type 1 diabetes (T1D) and nearly twice as prevalent in people with type 2 diabetes (T2D). When they appear together, treatment for depression can vary widely. In a new study, researchers from the German Diabetes Center (DDZ), the Research Institute of the Diabetes Academy Mergentheim (FIDAM), and the German Center for Diabetes Research (DZD) investigated how inflammation in the body relates to improvement in depression symptoms in people with T1D and T2D. The researchers combined data from three previous German randomized clinical trials that aimed to reduce elevated depressive symptoms and diabetes distress in people with type 1 or type 2 diabetes. Diabetes distress is characterized by feelings of overwhelm, frustration, guilt and worry about diabetes management and its potential complications. A total of 332 participants with T1D and 189 with T2D who had completed both a baseline and 12-month follow-up examination were included in the present study. Measures included depression using the Center for Epidemiological Studies Depression scale (CES-D), blood tests for 76 inflammatory biomarkers, and symptoms broken down into cognitive-affective (e.g., feeling hopeless), somatic (e.g., poor sleep, fatigue), and anhedonia (loss of pleasure) clusters.   After adjusting for factors like age, body mass index (BMI), diabetes duration, cholesterol, and co-existing illnesses, the researchers found that in patients with T1D, higher baseline inflammation was linked to smaller improvements in depression. Inflammation seemed to be more connected to physical/somatic symptoms in T1D patients. In those with T2D, higher baseline inflammation was linked to greater improvements in depression. For these patients, the effect was strongest for cognitive-affective and anhedonia – so, emotional and motivational – symptoms.   The researchers weren't sure what caused the difference between T1D and T2D, but they suggest it might be due to the different forms of immune activation seen in each condition. That is, autoimmune processes in type 1 and metabolic inflammation in type 2. https://newatlas.com/health-wellbeing/inflammation-diabetes-depression-treatment/ XX Parents of children diagnosed with type 1 diabetes suffer an income drop in the years following the diagnosis. The impact is more pronounced in mothers, especially mothers of children diagnosed in preschool years. And these findings come from a European study.. not the US. Previous research has shown that parents of children with type 1 diabetes are at increased risk of stress-related symptoms and may need to reduce their working hours. "In our study, we observed reduced parental work-related incomes in the years following the child's type 1 diabetes diagnosis. The drop was larger in mothers than in fathers. Since mothers earned significantly less than fathers in absolute terms, even before the child fell ill, the relative drop in mothers was 6.6% the year following diagnosis compared to 1.5% in fathers. We further note the greatest impact on work-related incomes in mothers of children diagnosed at preschool age," says Beatrice Kennedy, physician at the Endocrine and Diabetes unit at Uppsala University Hospital and Associate Professor of Medical Epidemiology at Uppsala University, who led the study. This is a huge study, builds on data from national population and health registers and the Swedish Child Diabetes Register (Swediabkids). The study includes the parents of more than 13,000 children diagnosed with type 1 diabetes in Sweden in 1993−2014, as well as more than half a million parents in the general population who have children not diagnosed with diabetes.   The researchers observed that the maternal pension-qualifying incomes (a composite outcome including work-related income and societal benefits) initially increased after the child's diagnosis. This was attributable to mothers applying for the parental care allowance from the Swedish Social Insurance Agency. The parental care allowance was intended to compensate for disease-related loss of work-related income and contribute toward disease-specific costs.   When the research team investigated long-term effects in mothers, they found that the pension-qualifying incomes gradually decreased after eight years, and had not recovered by the end of follow-up − 17 years after the children were diagnosed. https://www.news-medical.net/news/20250811/Mothers-face-greater-financial-impact-following-childe28099s-type-1-diabetes-diagnosis.aspx XX The U.S. Department of Justice has reached a settlement with Metro Nashville Public Schools after allegations that the district violated the Americans with Disabilities Act.   The parents of a student at the Ross Early Learning Center requested that the school monitor their child's glucose monitor. Investigators found the school refused to do so, despite the child's Type 1 Diabetes diagnosis.   As part of the settlement, MNPS agreed to change its policies to allow the use of these devices, ensure trained staff can monitor them throughout the entire school day and at school activities, and improve communication with parents. https://www.wsmv.com/2025/08/12/metro-nashville-public-schools-settles-allegations-it-discriminated-against-students-with-diabetes/ XX Modular Medical has unveiled Pivot, its next-generation insulin patch pump technology aimed at simplifying diabetes care. The company announced its new pump for “almost-pumpers” at the Association of Diabetes Care & Education Specialists (“ADCES”) Conference in Phoenix, Arizona this weekend. It aims for Pivot to target adults with a user-friendly, affordable design.   Modular Medical's current pump, the MODD1, won FDA clearance nearly a year ago. It features new microfluidics technology to allow for the low-cost pumping of insulin. The system has a reservoir size of 300 units/3mL. Users can monitor the pump activity with their cell phone and do not require an external controller. The pump uses a provided, single-use, disposable battery.   The company announced recently that it validated its insulin pump cartridge line for human-use production in the U.S. Days later, it reported the first human use of the MODD1 pump.   Now, it has taken the next steps with the debut of a next-gen pump, set for FDA submission in October.   Modular Medical also gamifies diabetes care The company also said ADCES is the place where it will showcase the first playable level of its new Pivot pump gamified trainin module. Level Ex, a developer of medical games, develops the module.   Modular Medical said gamification offers a way to make medical training more effective and efficient while improving information retention. Given the complexity in pump uptake, the company hopes to provide an easy way to bring its technology to clinicians and patients.   The company expects to have training modules available at the same time as the pump's planned launch in 2026.   “Level One is free because diabetes mastery shouldn't come with a price tag,” Sam Glassenberg, CEO of Level Ex, said. “Modular Medical is breaking barriers too – bringing pump therapy to more people through smart, accessible design. Together, we intend to make diabetes management simpler and more inclusive.   “People learn best through play – and we believe they want to learn about insulin pumps the same way. In Level One, players aren't just mastering diabetes management through gameplay – they're asking to ‘play' with pumps: to explore how they work, understand their benefits, and build confidence before using them in real life. Our partnership with Modular Medical helps make that possible.” https://www.drugdeliverybusiness.com/modular-medical-unveils-next-gen-insulin-pump/ XX On Tuesday, 12 August 2025, Tandem Diabetes Care (NASDAQ:TNDM) presented at the Canaccord Genuity's 45th Annual Growth Conference, outlining strategic shifts and market focus. The company highlighted its plans for commercial transformation in the U.S. and expansion in international markets, alongside addressing competitive challenges and regulatory impacts. While optimistic about growth in Outside the U.S. (OUS) markets, Tandem is navigating a more competitive landscape domestically. We have entered into the pharmacy channel with Mobi only. And so as Mobi's been building up volume, we're getting experience and we're really learning and understanding what pharmacy offers to us. And the proof points have proved out the thesis I said earlier, which is it can really reduce that barrier for patients, is the out of pocket cost. And so we've decided to accelerate our strategy and where we were starting just with Mobi, we are now moving t slim supplies into the pharmacy channel, and that will kick into gear in the fourth quarter. So as people are looking at the cadence of sales for the remainder of the year with this reframing, many folks are seeing what looks like a a might be an outsized fourth quarter and and having trouble understanding those dynamics. We'll be adding the tSIM supplies to those contracts. We also have more coverage. We will have it in the coming weeks effective this year, so we will be increasing that 30% rate before the end of the year. And then, obviously, everyone's in the same cycle right now already negotiating and discussing their 2026 coverage. And so 30% is the floor.   We do expect to continue to grow that coverage in the coming years, and ultimately have a much broader access. Absolutely. It's an exciting technology that allows for us to have an infusion set that extends the wear time from three days to up to seven days. So we're able to use that as part of an independent infusion set, which would then be used with the t slim and with the mobi pump today. But we're also using that same technology as part of the site that's used for mobi when you use it with a tubeless cartridge. So next year, we will launch Mobi in a patch configuration.   It uses the same pump that's available today, but by using a modified cartridge, you're able to wear it as a patch pump. So one of the things we announced on the call is that we're using this extended wear technology as part of that site. So what it allows you to do is to change the portion that you wear in your skin separate from the timing of when you change the insulin cartridge. So it allows for that extended wear time, reduction of burden to the patient, which is especially important for higher volume insulin users as we expand into type two. So from here, we will launch the extended wear site next year along with we'll do a separate regulatory filing for the cartridge portion for Mobi that includes this extended wear technology as a predicate device. So that's another filing that we'll need to do, but we have the clearance today for the independent infusion set, but we'll file another five ten k for use of the extended wear technology as part of the tubeless Mobi feature. https://za.investing.com/news/transcripts/tandem-diabetes-at-canaccord-conference-strategic-shifts-and-market-focus-93CH-3834464 XX MannKind today announced a significant regulatory submission and a large financing agreement with Blackstone. The company submitted its lead inhaled insulin product for expanded FDA approval and secured $500 million in funding, it said.   First, the Danbury, Connecticut-based company announced that it submitted a supplemental Biologics License Application (sBLA) for Afrezza, its inhaled insulin product, in the pediatric population.   MannKind Director of Medical and Scientific Engagement Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, told Drug Delivery Business News at ADA 2025 that a submission was on the way for children and adolescents aged 4-17 years old. Further data shared at ADA found Afrezza both safe and effective in that age range.   Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.   The company expects a review acceptance decision early in the fourth quarter of 2025.   “The submission of our supplemental Biologics License Application (sBLA) for Afrezza in pediatric patients is a meaningful milestone for MannKind and people living with diabetes,” said Michael Castagna, CEO of MannKind Corporation.   Additional funding provides a significant boost for MannKind MannKind also announced a strategic financing agreement with funds managed by Blackstone worth up to $500 million. The financing provides MannKind with non-dilutive capital to advance its short- and long-term growth strategies.   This senior secured credit facility includes a $75 million initial term loan funded at closing. It then has a $125 million delayed draw term loan available for the next 24 months. Finally, it features an additional $300 million uncommitted delayed draw term loan available at the mutual consent of MannKind and Blackstone.   The facility bears interest at a calculated SOFR variable rate plus 4.75% and matures in August 2030.   “This strategic financing significantly increases our operating flexibility and provides us substantial access to non-dilutive capital on favorable terms, complementing our strong cash position,” said Castagna. “The funding will support the expansion of our commercial team in preparation for the anticipated launch of the pediatric indication for Afrezza, if approved, continued pipeline advancement, potential business development opportunities, and general corporate purposes. Partnering with the Blackstone team on this transaction positions us to accelerate our next phase of growth and innovation.” https://www.drugdeliverybusiness.com/mannkind-fda-submission-pediatrics-500m-blackstone/ XX   Medtronic MiniMed Abbott Instinct Sensor [Image from Medtronic Diabetes on LinkedIn] The Medtronic Diabetes business today took to social media to share an early preview of a new integrated Abbott sensor for its insulin delivery systems. Medtronic Diabetes — soon to be MiniMed after its planned separation from the medtech giant – said in the post that the new sensor specifically designed for its own systems is called “Instinct.”   “Get a sneak peek at what's coming next: the Instinct sensor,” the business unit's account wrote. “Made by Abbott, the Instinct sensor is designed exclusively for MiniMed systems. We'll share more details about the Instinct sensor when it's commercially available.”   The sensor, built on the Abbott FreeStyle Libre platform, reflects “the power of the partnership,” Abbott EVP, Diabetes Care, Chris Scoggins, told Drug Delivery Business News earlier this year.   Medtronic and Abbott — two of the largest diabetes tech companies in the world — announced a year ago that they entered into a global partnership pairing Abbott continuous glucose monitors (CGMs) with Medtronic insulin delivery systems.   The partnership aims to collaborate on a system based on Abbott's FreeStyle Libre CGMs with Medtronic's automated insulin delivery technology (the latest generation being the MiniMed 780G) and smart insulin pen systems, such as the InPen system.   Read more about Medtronic, Abbott and the rest of the diabetes tech industry in our free Diabetes Technology Special Report. Medtronic's systems previously used its own CGMs, such as the Guardian 4 and the Simplera platform, and the company intends to continue using those systems as part of a comprehensive CGM portfolio. Under the companies' agreement, the systems would be sold exclusively by Medtronic — including the Abbott CGM.   The companies brought the partnership a step further in April when Medtronic announced the submission of an interoperable pump with the Abbott sensor technology to the FDA. They plan to share more details following the expected FDA clearance, which remains pending.   Management also recently emphasized the multi-year nature of the partnership, meaning Medtronic could pair current and future pumps with other Abbott sensors in the future. That could hint at integration with the company's future dual glucose-ketone monitor, as a number of pump makers have already announced collaborations to pair their systems with the sensor once it hits the market. https://www.drugdeliverybusiness.com/medtronic-diabetes-previews-abbott-sensor-minimed/ XX Governor Glenn Youngkin joined Civica officials at the company's Petersburg manufacturing facility to announce a $3 million grant from the Commonwealth of Virginia to accelerate Civica's efforts to develop and produce affordable insulin for Americans living with diabetes.   CivicaRx Logo   "We are proud to partner with Civica in their mission to make essential medicines more accessible," said Governor Youngkin. "This investment reflects our belief in the power of public-private collaboration to improve lives and strengthen communities."   These funds will support the production of insulin aspart, a rapid-acting human insulin analog used to regulate blood sugar in adults and children with diabetes. Civica plans to produce both rapid- and long-acting insulins at its state-of-the-art manufacturing facility in Petersburg, Va., where the company now employs more than 200 skilled workers.1 Over 8 million people living with diabetes need rapid-acting and/or long-acting insulin.   The Governor also announced that he had officially proclaimed August 7 – 14 2025 'Life Sciences Week' demonstrating the Commonwealth's commitment to "accelerating the advancement of the life sciences through public-private partnerships, STEM education, workforce development, and sustained investment in research and development."   "We are grateful for the Commonwealth's support," said Ned McCoy, Civica's President and CEO. "This funding will help us move closer toward our goal of ensuring that no one has to choose between insulin and other basic needs."   Civica and Virginia officials were joined by Lynn Starr, Chief Global Advocacy Officer of Breakthrough T1D, the leading global type 1 diabetes research and advocacy organization.   "More than one million American adults live with type 1 diabetes, and many still, sadly, ration their insulin, due to the prohibitively high cost of this necessary medication," said Starr.  "Civica's work will help to make insulin more affordable for people across the country."   Breakthrough T1D is among more than two dozen organizations and philanthropists, along with the states of Virginia and California, that have partnered with Civica to support the development of affordable insulins.   Civica's insulin initiative aims to provide patients with predictable, transparent pricing — no more than $30 per vial or $55 for a box of five pens — regardless of insurance status.   About Civica Civica is a nonprofit pharmaceutical company established to address drug shortages. It was founded by a group of U.S. health systems and philanthropies who, after more than a decade of chronic shortages, recognized that the market was not self-correcting and that a different approach is required. Civica works to deliver a safe, stable, and affordable supply of essential medicines to U.S. patients.   Media Contact: Liz Power liz.power@civicarx.org +1 860 501 3849 https://cbs4indy.com/business/press-releases/cision/20250807NY46213/governor-glenn-youngkin-announces-3-million-grant-to-support-civicas-affordable-insulin-programs/ XX If you or someone you love is living with diabetes, you already know the fight isn't just medical—it's financial, too. Between daily supplies, doctor visits, and long-term care, the cost of managing type 1 or type 2 diabetes can be overwhelming. Add college or trade school into the equation, and suddenly staying healthy competes with building a future. That's where scholarships for students with diabetes—like Beyond Scholars and others listed here—step in.   Whether you're headed to a university, a two-year college, or a hands-on trade program, these opportunities were created to ease the load.   Scholarships for students with diabetes Beyond Scholars (from Beyond Type 1): $10,000 for recently graduated high school seniors with type 1 diabetes or type 2 diabetes entering college or trade school. This is one of the largest needs-based diabetes scholarships in the United States. This year, awardees will also receive 6 months of wellness coaching through Risely Health.   Applications open: July 25, 2025 Deadline: August 29, 2025 Winners announced: October 2025 https://beyondtype1.org/beyond-scholars-diabetes-scholarships-college-trade-school/ XX Nick Jonas and Kyle Rudolph are using their platforms for a good cause.   On Tuesday, Aug. 12, the singer and the former NFL tight end (via his professional fundraising platform Alltroo) announced they're teaming up to launch a rally featuring a fan-coveted prize: a custom 2025 Volkswagen ID. Buzz electric bus that the Jonas Brothers have brought along for their 20th anniversary tour.   “Ten years ago, we hit the road with a goal to change what it means to live with diabetes. Since then, Beyond Type 1 has grown into the world's largest digital diabetes community, offering the tools, education, and peer support needed to not only survive but thrive with diabetes,” Jonas, who co-founded Beyond Type 1 (a nonprofit that advocates for those living with diabetes), says in a statement.     “We've challenged stigma, built community, provided life-saving resources, and collectively driven global innovation toward prevention and cure. This milestone is a moment to rally even more support for our mission, and partnering with Alltroo helps us do that in a powerful, engaging way.”   Related Stories Nick Jonas on Managing His Diabetes: 'The Mental and Emotional Health Aspect Is Really Important' nick jonas Nick Jonas Says He Was Diagnosed with Diabetes After Joe Told Their Parents: 'Something's Really Wrong' Joe Jonas and Nick Jonas attend the amfAR Cannes Gala 30th edition at Hotel du Cap-Eden-Roc on May 23, 2024 For Rudolph, the campaign is about "celebrating Beyond Type 1's incredible work over the past decade, and standing behind their vision of a world where everyone with diabetes — or at risk of it — has access to the knowledge, care and support needed for early diagnosis and lifelong health."   While the rally is live on Alltroo.com, fans can also scan QR codes available at all 36 Jonas Brothers concert stops to enter for a chance to win the electric bus. (A winner will be selected on November 14, which is World Diabetes Day.)   Jonas, 32, has long been open about his Type 1 diabetes diagnosis at 13 years old. "I had this kind of wrench thrown into things when I was diagnosed and it took a while to figure out how to count carbs to properly dose for insulin and what things would affect me in different ways," he previously told PEOPLE.   "When I was first diagnosed, I was sitting in the hospital and was scared to death, honestly, while I was learning about how to manage this new thing I was dealing with," Jonas recalled. "It would have been amazing to have someone to look at at that time to say, oh, this is a person living with it and they're following their dreams. They're doing what they want to do with their lives and not letting it slow them down."           https://people.com/nick-jonas-kyle-rudolph-launch-fan-rally-diabetes-awareness-11788684

Send us a textJoin us for an in-depth conversation with Bryant Foster, a human factors expert who's worked with industry giants like Google to make complex products simpler and safer. With a background in cognitive psychology, Bryant shares insights on designing user-friendly products, from surgical systems to smart thermostats, all while keeping the end user at the center of the design process.Main Topics:What drew Bryant into human factors and user experience designHow to define and achieve simplicity in product designAdvanced usability testing tools: eye tracking, pupilometry, and facial emotion analysisWhy users don't always give honest feedback and how to work around itProviding critical design feedback without demoralizing teamsCost-effective approaches to human factors testingSafety considerations in medical device designUse-related risk analysis and task analysis methodologiesLessons learned from working at Google XBuilding successful human factors consulting teamsAbout the guest: Bryant Foster is the Vice President of Human Factors and User Experience at Research Collective, a user-centered research consultancy serving clients from startups to major companies like GE Healthcare, Microsoft, and Medtronic. With over a decade of experience in applied psychology and usability research, he specializes in ensuring products are safe, intuitive, and user-focused.He holds a Master's in Applied Psychology (Human Factors) from Arizona State University and began his career at the Cognitive Engineering Research Institute, later working at Google X as a UX researcher. At Research Collective in Tempe, Arizona, he leads a team that uses methods like ethnography, eye tracking, and biometric analysis.In addition to his consulting work, Bryant mentors students and supports local entrepreneurs through programs like LEAP, blending scientific rigor with empathy in fields from medical devices to consumer tech.Links:Bryant Foster LinkedInResearch Collective WebsiteClick here to learn more about simulation solutions from Simutech Group.

Melissa E. Middeldorp, MPH, PhD is joined by Martin K. Stiles, MBChB, PhD, FHRS, University of Auckland and Waikato Hospital and Eloi Marijon, MD, PhD, Paris University & European Georges Pompidou Hospital, to discuss this Danish nationwide study examines the relationship between socioeconomic position (SEP) and sudden cardiac death (SCD) as well as all-cause mortality (ACM). Analyzing all deaths in Denmark from 2010, researchers found a strong inverse association between both income and education level and the risk of SCD and ACM. Individuals in the lowest income and education groups had significantly higher rates of SCD, even after adjusting for age, sex, and comorbidities. The study highlights that despite Denmark's universal healthcare system, socioeconomic disparities in health outcomes persist, suggesting that factors beyond healthcare access—such as health literacy, lifestyle, and systemic inequalities—play a crucial role. The findings call for further research into the mechanisms driving these disparities and the development of targeted prevention strategies.  https://www.hrsonline.org/education/TheLead https://academic.oup.com/europace/article/27/4/euaf001/7958953?login=false Host Disclosure(s): M. Middeldorp: Nothing to disclose. Contributor Disclosure(s): E. Marijon: Honoraria/Speaking/Consulting: Zoll Medical Corporation, Boston Scientific  Research: Biotronik, Boston Scientific, MicroPort Scientific Corporation, Medtronic, Zoll Medical Corporation, Abbott  M. Stiles: Honoraria/Speaking/Consulting: Abbott Medical, Medtronic, Inc., Boston Scientific

In this episode of UNSCRIPTED, host Sarah Nicastro welcomes Mark Florio, Senior Director of Global Robotics Service and Support at Medtronic's Robotic Surgical Technologies division, to explore 10 success factors for complex global service operations. From centering around customers and building service as a business to managing internal relationships and maintaining team motivation, Mark shares invaluable insights drawn from decades of medical device industry experience. 

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:Tony Recupero is President, Commercial Operations of SI-BONE. Tony leads SI-BONE's commercial operations, including sales, market access, reimbursement, professional education and international. He is a proven commercial leader, responsible for the company's go to market strategy that has led to exponential revenue growth. Prior to SI-BONE, Tony was formerly the President of Catalyst Performance Advisors where he advised several medical device companies on commercial strategy. Tony was previously President and CEO of Baxano, Inc. Tony was also the Vice President of Sales for Kyphon from startup in 1999 through the end of 2004. Kyphon was acquired by Medtronic for $4.2 billion dollars. Early in his career, Tony progressed to senior sales management roles at United States Surgical Corporation and Sulzer Spine-Tech, Inc. Tony earned a B.A. in Communications from State University of New York at Albany and attended The General Management program at Harvard Business School.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: ⁠⁠⁠⁠⁠⁠⁠⁠⁠Tony Recupero⁠⁠⁠⁠Cumby 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.

Melissa E. Middeldorp, MPH, PhD is joined by Thomas F. Deering, BS, MBA, MD, FHRS, CCDS, and T. Jared Bunch, MD, FHRS to discuss a 31-item questionnaire was developed and distributed among healthcare professionals via the EHRA network and social media between 23 September and 21 October 2024. https://www.hrsonline.org/education/TheLead https://academic.oup.com/europace/article/27/4/euaf075/8099191?login=false Host Disclosure(s): M. Middeldorp: Nothing to disclose. Contributor Disclosure(s):   T. Deering: Honoraria/Speaking/Consulting: Sanofi, Pacemate, Pfizer, Inc., Omny Health, Preventice Research: Abbott, Boston Scientific, Medtronic, Biotronik, Biosense Webster, Inc.,  Stock Options - Privately Held: HeartBeam Officer, Trustee, Director, Committee Chair: Board Membership T. Bunch: Honoraria/Speaking/Consulting: Pfizer, Inc. Heart Rhythm Society

In this episode of The Atrium, host Dr. Alice Copperwheat speaks with Professor Pieter Kappetein, Professor of Cardiothoracic Surgery at Erasmus Medical Center and Vice President and Chief Medical Officer of Medtronic, about the future of revascularization. Chapters 00:00 Introduction 00:47 Dr. Kappetein Background 04:19 Getting Into Research 05:36 Work Balance 06:35 Industry Role in Career 09:30 Status of Revascularization 12:20 SYNTAX Trial 13:40 EXCEL Trial 15:54 AHA Guidelines & Heart Teams 18:59 Heart Teams 21:15 Future of Revascularization 24:10 Hybrid Approaches 25:55 Advice for Surgery Training They discuss the history of revascularization, the SYNTAX trial, the EXCEL trial, and the new American Heart Association (AHA) guidelines. They also explore the Heart Team approach and what's on the horizon in this important surgery specialty.    The Atrium is a monthly podcast presenting clinical and career-focused topics for residents and early career professionals across all cardiothoracic surgery subspecialties. Watch for next month's episode on segmentectomy with thoracic surgeon Dr. Agathe Seguin-Givelet. Disclaimer The information and views presented on CTSNet.org represent the views of the authors and contributors of the material and not of CTSNet. Please review our full disclaimer page here.

Dexcom generates more than $4 billion in annual revenue and has a market cap north of $30 billion, making it one of the biggest digital health companies in the world. And it all started with a better way to measure blood sugar.In this episode, Halle is joined by Kevin Sayer, CEO of Dexcom, the company that pioneered continuous glucose monitoring (CGM). Under Kevin's leadership, Dexcom scaled from $40 million to $4 billion in revenue, became the standard of care for people with diabetes, and is now expanding into consumer wellness with its direct-to-consumer product, Stelo.We cover:

Nidhi Oberoi is a dedicated medtech executive with over 17 years of experience and currently serves as Business Leader, Imaging Franchise at Terumo Medical Corporation. She discusses her journey from India to the heart of the medtech industry, her impactful work on innovative heart valve treatments while at Medtronic, and her advocacy for women's health. Nidhi shares her leadership philosophy centered on empowerment, the importance of mindfulness in business, and her vision for a future in cardiology and women's health.   Guest links: https://www.linkedin.com/in/nidhi-oberoi-278a111/ 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: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 060 - Nidhi Oberoi [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Nidhi Oberoi. Nidhi is a seasoned MedTech executive dedicated to the mission of serving clinicians and patients. With over 17 years of experience working on commercialization of innovative technologies, She has led various strategic and operational initiatives that have transformed standard of care. Her bold, collaborative, and empathetic leadership style allows her to push boundaries and inspire teams to create durable value. She currently leads business initiatives for the structural heart business in Medtronic, which serves patients with heart valve disease. She's also an advocate for evidence based care for women's health. Nidhi has an undergraduate degree in economics from India and an MBA in marketing and entrepreneurship from Syracuse University. Thank you so much for being here, Nidhi, I'm so excited to speak with you. [00:01:44] Nidhi Oberoi: Yeah, thanks for having me. [00:01:46] Lindsey Dinneen: Of course. Well, I would love, if you don't mind just starting off by sharing a little bit about yourself and your background and what led you to MedTech. [00:01:56] Nidhi Oberoi: Yeah, absolutely. I was born and raised in India, and just like any typical Asian Indian household in those days, if you were a bright student, you were generally expected to pursue a track in sciences, medicine or engineering, or maybe a second option in accounting and finance. Predictably, after I completed my high school, I was on my path to pursue a career in sciences. But then I changed courses and ended up pursuing an undergraduate degree in economics, and eventually an MBA in marketing and entrepreneurship from upstate New York. Now, as I reflect back and realize that what attracted me to business eventually, it was this realization that it's both in art and a science. The science aspect helps to ensure that the business can financially run smoothly with a strong P&L, while the art side of the business is the ability to set the vision, the direction, inspiring people, innovating, connecting with people. So what I really was interested was in a career in marketing and general management. You asked me what led me to medtech, I'd say my entry into the healthcare industry was by chance. I got recruited into this industry through a summer internship when I was doing my MBA with a company called Conva Tech, which was part of Bristol Myers Squibb then. And by the time I had completed my internship, I already knew I wanted to be in the healthcare industry given the impact you have on the patient's lives. I did have opportunities to interview with other companies like Philip Morris and others, and I just decided that this is what I wanted to do. And after I graduated, I started working for a company called Covidian, which was then a spinoff from TCO International. And Covidian was eventually acquired by Medtronic. It's been 16, 17 years since I've been working for this company and it has a really strong mission of elevating pain, restoring health, and extending life of patients around the world. So that's that's my story there. [00:04:07] Lindsey Dinneen: Excellent. Thank you so much for sharing that. I'm curious. Of course your career trajectory has been really interesting and you've had a lot of different experiences along the way. So what are some of the key things that say maybe your schooling or your early career really set you up for success for what you're doing now? [00:04:29] Nidhi Oberoi: Yeah, so there's just so many different experiences that either have shaped my interest, where I wanna go, or has shaped my leadership style. Now, as I mentioned, I decided to move away from sciences to a more kind of social sciences field, economics and then business, and that was due to the fact that I was not the person who could just crunch numbers sitting on the table. I liked connecting with people. So I think some of those personality traits helped me decide what I wanted to do. And I would say one of my core value is impact, purpose. And so healthcare, it was just natural for me to gravitate towards healthcare because you are truly impacting people with different technologies. And I'd also say, as I grew further along in my career, early on when I joined Covidian, I had some great leaders who gave me a lot of ownership, and that shaped my leadership style as well. And that's how I operate. I empower my teams. I coach them along, but give them a lot of accountability. So there's so many different experiences, but these are some of the experiences that come to mind as. As as I reflect back now what that has shaped my career and also my leadership style. [00:05:55] Lindsey Dinneen: Yeah, absolutely. And speaking maybe more into your leadership style, I'm really curious if you could tell us a little bit more about that philosophy of yours. I love that ownership mentality. It sounds very counter to what a lot of folks don't appreciate, and that's micromanagement. And so I'm curious, how do you bridge the gap yourself as a leader between making sure that, your team stays on track and the goals and really key, important performance indicators are met, while also giving them that ownership and that empowerment to make decisions and do things in a way that best aligns. [00:06:35] Nidhi Oberoi: Yeah. So I think there's so many different facets of leadership, and let me highlight some of the others that feeds into the third aspect, which is the empowering team. So I think as a leader, first thing first, you need to provide clarity, direction, focus. I've been part of so many different teams where if people can relate to what they're doing, why they're doing, they can get lost, right? So I think that's the first thing. You need to have the ability to cut through the noise, provide direction to the team, organization you're leading. And then the second part is inspiring and bringing people together to execute on that vision. So this is the culture piece. You are listening to others, you're hearing others' perspectives and being inclusive. And the last thing, which I mentioned early on, is empowering your teams and making them accountable. So to your question of how you bridge the gap, I think you have to give clear direction. And when you empower teams doesn't mean that you don't coach them, right? You are just telling them that you trust them to do the job and you are here to help them. And one of the technique that I use is I ask questions, so I don't give answers. When you ask someone in your team to lead the project, they come to you. Then you ask questions. And I've seen, based on my experiences, that gives them a sense of ownership that this is something they're thought through. And oftentimes I've heard from people that they feel like they become a better version of themselves because I ask a lot of questions. I make them think. So that's my approach on how I kind of bridge the gap, but also make sure along the way that you're supporting them in the right direction. [00:08:24] Lindsey Dinneen: Absolutely. Yeah, and you mentioned as you were speaking a little bit towards how your past experiences shape who you are and how you kind of relate to the world now, you mentioned core values, and I would love, if you don't mind, if you would share a little bit more about your core values. I noticed that on your LinkedIn profile, that was something that was very highlighted as being extremely important to you, which I love. I'd love if you would share a little bit about maybe how you developed your core values and how those play out for you. [00:08:57] Nidhi Oberoi: Yeah, absolutely. I think core values is something that you always have, but you just sometimes need a little bit of handholding to unfold those, right? And so in my case, a few years back, I had an opportunity to work with a coach, and she really helped me understanding what I'm good at. These are things that you already have, but you may not realize or you may not know how to articulate. So for me, the number one thing that came out was purpose. And I'm like, "No wonder I'm in the healthcare industry. I'm big on impact. I like building things." And so that's where it's coming from. The other core value of mine is excellence. I like to do things with excellence. I put my heart and soul into things. I'm a very passionate person. But also you gotta have an eye on quality versus decision making, right? Over time, I've learned excellence is my core value, but it's a journey, it's a process. It's not a destination. So you don't have to dwell on things. Sometimes things go wrong and you just have to keep moving on and have a growth mindset. So there's a good aspect of the value, but there could be a blind spot, like in this case for excellence and I've learned to manage that as well. And yeah, so I think these are some of the core values, which is, I think, also part of being a leader. You have to have self-reflection. You need to dig deeper and understand what you stand for. And, this has just guided me along the way. And yeah, so those are some of the things that I'd say has really helped me all along in my career. [00:10:41] Lindsey Dinneen: Yeah, of course. So, tell me a little bit more about your current position and what are you looking forward to as you move forward in your own career as well? [00:10:53] Nidhi Oberoi: Yeah, currently I'm in the structural heart space, and these are really old and sick patients. And it's just amazing to see these patients getting impacted by our technology, getting back to their day-to-day life. And as part of structural heart, also, most recently I've been able to work on therapies. I've been focusing on the congenital portfolio, which is, these are devices that are used to treat patients that have congenital disease, and it's very impact driven because you're dealing with children here who tend to get multiple surgeries throughout their lifetime. So my role right now is to focus on business initiatives. Some of it is expansion across geographies. Some of it is increasing supply for these products. I mean, there's not a big business case for these kind of products, but the impact is huge. So that's my current focus. And, moving forward, in my career, I'm looking to grow into a general management track, and that's what attracted me to marketing because I consider marketing as running a business within the organization. So for me, running a business would be something that I would be looking forward to. And that's why I have spent time in so many different kind of roles, whether it's marketing, it's commercial transformation, whether it's global roles. So that's how I've been building my skillset so that I can one day lead a business. [00:12:25] Lindsey Dinneen: Yeah, that's very exciting. Okay, so you're building all of these skill sets. You're working towards this incredible goal. Do you have an idea of what kind of business you would want to get into? Or is this, " We'll see," and I'll interview you again when that happens? [00:12:38] Nidhi Oberoi: Yeah, I think cardiology, there's so much opportunity in cardiology. There are so many people getting impacted by cardiovascular disease around the world, and there's so much innovation too happening, not just on the treatment side, but also on the diagnostic side. So I would say either something in the cardiology space would be very attractive because it's innovative. There's such a huge population that gets impacted by it. Or the other area of interest for me is women's health, and I think it just makes me smile how there's progress being made. I know there's so much work that needs to be done. We know there's not enough evidence, it's underfunded, but I think the work is starting there, and better evidence generation will lead to better decision making, which will lead to better outcomes. So I would say either in the cardiology space or the women's health space, these are the two areas of interest to me. [00:13:38] Lindsey Dinneen: Yeah. And I noticed again, with LinkedIn, you are very passionate about women's health and I love that. And I am wondering if you could speak a little bit towards some of themes that I kind of picked up on, things like stigma with women's health, medical gaslighting and self-diagnosis. And I know there's a lot to that and it's probably too much for one conversation today, but can you highlight a couple of the areas that you particularly find concerning, that are things that we can all do better? [00:14:11] Nidhi Oberoi: Yeah. Yeah. I think first of all there's such lack of education and awareness. As women transition through different stages of life, I feel like a lot of it is taken for granted. We don't question it. And as someone who's been following this for a little bit of a time, I almost feel like it's my duty and being in the healthcare industry, to raise awareness about this or encourage them to be more educated patients. When they go to a doctor, if they don't get answers, they should ask more questions. So I think, so that's that lack of education and awareness piece. There's a lot of work happening. There's so many advocacy groups. Women are coming together, supporting each other, so I think that's happening as well. The other thing that really bothers me is on the diagnostic side. I wrote an article around women get mammograms. Just because there's not enough evidence out there, sometimes you just have to go through a number of tests to have a diagnosis, either a positive or a negative. So I also feel like maybe the advent of technologies like AI in the diagnostic field can help improve that, because it starts with the diagnostic side, and we just don't have enough right now. And like I said, it can either be a good thing or bad thing. I've also heard of women going through a number of tests to find out that they don't have anything, which is fine, but it's just a lot of money along the way getting to the diagnosis. And then, the third thing I'd say is as we get more intelligent with evidence, it will lead to better awareness among the physician community too. And that's what gaslighting comes because there's not a lot of evidence, there's not a lot of awareness. Even physicians sometimes can't guide you in the right direction. But if you have more studies coming out, it will make them more aware and guide their patients in the right direction. So there's just so many different things, but I feel like you could start being a self-aware patient and not just assume as you go through different stages of your life that this is what it comes being with a woman. Be more proactive, ask questions, research, talk to other people and get help. [00:16:32] Lindsey Dinneen: Yeah. Yeah, that's really great advice, and I appreciate your perspective in sharing with us a little bit about maybe even some of the things that we all can do as we're trying to hopefully push the quality of women's healthcare forward and make it more widely available and whatnot. So thank you for sharing. As you have been going throughout your career-- and you obviously care so much about purpose and you have a lot of passion for helping people and for the healthcare industry in general-- are there any moments that really stand out to you as affirming, "Hey, I am in the right industry at the right time?" [00:17:11] Nidhi Oberoi: Yeah, there's been so many moments and I would say most of these moments are when I've interacted with patients. When I started with Covidian, I was leading an initiative which would help a lot of women who were having open hysterectomies-- this is like 10, 15 years back-- to have a minimally invasive hysterectomy through a new procedure technique. So it was called single incision surgery. And I happened to talk to some patients, and it was just amazing to hear those stories where they were telling me how they could get back on their feet, travel, within just a week after the procedure. So that's the defining moment. And then, when I was working on one of the businesses where patients have very varicose veins, I met a patient who was a mom of four. So she had four kids within a span of six, seven years, and she had very visible varicose veins on her legs. And that impacted her quality of life. And when she got the procedure done with our technology, she was just so happy. It was not just cosmetic, but also less painful, and being more present with her kids because of that. And then I'd say most recently in the cardiology space, these are really sick patients, older patients with multiple conditions, and just hearing their stories of getting a new heart valve, it's amazing to see how, again it's getting back to life. So it's always, when you meet these patients, those are the defining moments, and it just reaffirms why you're in healthcare and why you need to continue to work in the healthcare space. [00:18:58] Lindsey Dinneen: Yes. I love that so much. Yeah, so pivoting the conversation a little bit just for fun. Imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry. It could be related to anything your background, your experience, but it doesn't have to be. What would you choose to teach? [00:19:19] Nidhi Oberoi: Yeah, that's a great question. I don't think I have an expertise right now, but maybe something on mindfulness and yoga. One of my goals is to do a yoga teacher training, but the importance of mindfulness in business. There's so many things you can do: power walks, taking a break, journaling. These are so underrated, but I think these things are necessary. It's more important than ever now, given the fast change. There's so much, so many changes happening at such a fast pace. So I would say that would be my topic, but I don't think I'm ready yet to have that masterclass. [00:20:03] Lindsey Dinneen: Fair enough. Fair enough. So I'm curious, how long have you been incorporating these kinds of really important mindfulness practices into your own life and your own routine. Is this something that you've had for years and years or is it a more recent development? [00:20:19] Nidhi Oberoi: Yeah, I think it's more recent. I would say three to four years, although I wonder why I did not do that. I think within the organization, as you are managing multiple things, it just forced me at that point of time when I was juggling a lot of things in my life and I wanted some pause and clarity. And I actually, years back, I had take a yoga class and then I started doing core barre yoga as well. So I realized that it really has a big impact on me. And then I just try to be more disciplined and try to take out time, if not every day, maybe every two days, but I would say it's more of a recent phenomena. It does require a lot of discipline. Earlier you start, the better it is because you're not going to get it right away. It takes a lot of discipline and commitment to incorporate these. And you won't be able to do it all the time, but at least starting that and trying to incorporate day to day life is a good start. [00:21:26] Lindsey Dinneen: Yeah, absolutely. I found personally that starting my day with a much more intentional routine that includes things like meditation and those kinds of mindfulness practices makes a huge difference in how I feel throughout the whole day and the week in general. So, and that's a more recent development for me too. So it's one of those interesting things about how that evolves over time. So I love that. Thank you for sharing about your own journey. All right, and then how do you wish to be remembered after you leave this world? [00:21:59] Nidhi Oberoi: As I said purpose is my core value, big on impact. So I just want to leave the world a little bit better and do my bit. And whether it's working on things, like working on technologies and providing access to health care to patients, probably globally. So it's just continuing to make an impact in the healthcare space and leaving the world a little bit better than I inherited it. [00:22:27] Lindsey Dinneen: Yes. Excellent. And final question, what is one thing that makes you smile every time you see or think about it? [00:22:37] Nidhi Oberoi: Yeah. There are so many different things. As you start meditating or focusing on mindfulness, it's the small things in life that you start enjoying. Being in Minnesota, the good weather is difficult to come by. So sunshine really makes me happy. But yeah, I think being present makes you more joyful. You just start enjoying everything in life. The other thing I would say is just simple acts of kindness. People helping other people is also something that just moves me and touches me. [00:23:11] Lindsey Dinneen: Yeah, of course. I'm really curious. Okay, so I said final question, but then I have a follow up. So when you said being present helps bring you joy, could you share a little bit more about what you mean by that? [00:23:24] Nidhi Oberoi: Yeah. So I think being present means that you are not thinking about your past and you're not thinking about your future. And so what that means is all you're focusing is what's in the now, and I'm going to start speaking the language of someone who teaches yoga or meditation, but being present really is you're not in the past. You're not in the future. You're just enjoying your day, the moment, as it comes by, it's as simple as that. You're centered. You're aligned with yourself and you just focus on what's in your control. You don't dwell on things either of the past or in the future. So I think that's a very, that's a beautiful moment to be in. [00:24:11] Lindsey Dinneen: Yes, I couldn't agree more. Well, thank you for sharing a little bit more about that. I really appreciate it. And thank you so much for your time today. This has been such a great conversation. I've loved learning about you, and I'm so excited about your career future, especially with your goal of starting your own company at some point. So I will be cheering you on for that whole process. I know that's no small undertaking. But in the meantime, I just want to say thanks again for your time, and thank you so much for working hard to change lives for a better world. [00:24:45] Nidhi Oberoi: Well, thank you so much. Thank you for the opportunity. It's been so fun chatting with you. You're joyful. [00:24:52] Lindsey Dinneen: Thank you. Well, excellent. 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. Thank you also so much to our listeners for tuning in. And if you're feeling as inspired as I am right now, I'd love it if you'd share this episode with a colleague or two. And we'll catch you next time. [00:25:30] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

In this live conversation from UNLEASH Las Vegas, Mark Smith, VP of Talent Acquisition at Medtronic shares how a serious injury - and the recovery that followed - reshaped his approach to leadership, time, and focus. He reflects on the shift from overextension to intentionality, what it means to truly prioritize, and how the experience has made him a more present and effective TA leader.

In this week's Digital Health Roundup, MedTech Insight's Marion Webb discusses her interview with Johns Hopkins researcher Axel Krieger who published study findings on autonomous surgery. Brian Bossetta highlights new FDA cybersecurity guidance and Medtronic's partnership with IRCAD to train surgeons on robots. Shubham Singh highlights his interviews with OpenWater on stroke and EnsoData on sleep. Natasha Barrow discusses FDA approval challenges with Flow Neuroscience's CEO. Tags: robotics, robotic surgery, FDA, cybersecurity, cardiology, neurology, leadership interviews, neurostimulation, commercial, medtech.

Jessica Richter is a medtech executive and a board member with MedtechWOMEN. Jessica shares her inspiring journey from B2B sales to becoming a leader in the medtech industry, including overseeing a wide range of vital functions such as clinical trial strategy, regulatory affairs, and market access. Jessica provides insightful advice on overcoming common industry challenges, and underscores the value of quality systems, expert team-building, and fostering a supportive network for women through MedtechWOMEN.   Guest links: https://www.linkedin.com/in/jessica-richter-5aa43517/ | https://medtechwomen.org/ 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: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 059 - Jessica Richter  [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Jessica Richter. Jessica is the Executive Vice President and General Manager at Veranex, a global provider of end-to-end solutions that accelerate MedTech innovation through deep expertise and integrated resources. As the leader of Veranex's contract research organization and consulting services business unit, she oversees clinical trial strategy and execution, clinical data services, regulatory affairs, quality and compliance, market access and reimbursement. She also manages operations, client engagement, business development and performance tracking. A seasoned leader in medical devices and diagnostics, Jessica has extensive experience in software as a medical device, surgical innovation, oncology, aesthetics, cardiology and gastroenterology. Her tenure at Medtronic and Becton Dickinson shaped her expertise in commercialization, sales strategy, physician education, patient advocacy, and change management. Beyond her current role, Jessica serves on the boards of medtech, women and UCLA's technology development group. She actively advises startups, accelerators, and universities, including medtech innovator UC Berkeley's Master of Translational Medicine Program, the Mayo Clinic's Executive Steering Committee for the Surgical Innovation Summit, and UCLA BioDesign.   Thank you so much for being here, Jessica. I'm so excited to speak with you. [00:02:15] Jessica Richter: Likewise, Lindsey, thank you so much for having me. [00:02:18] Lindsey Dinneen: Of course. Well, I'd love if you wouldn't mind sharing a little bit about yourself and your background and what led you to medtech. [00:02:26] Jessica Richter: Awesome. Yeah, happy to. So, I was born and raised in California. I am the youngest of three girls and my entire family is really in the healthcare delivery field. So both my grandfathers were surgeons. My mother is a nurse. Both my sisters are clinical psychologists. And so when I went to school, I had aspirations at one point to get into medicine, and then through a really challenging organic chemistry class, kind of started to realize that maybe the practice of medicine wasn't where I belonged. And so I initially graduated from Berkeley, had my sights set on potentially doing something in communications, and started off in business to business sales in the telecom industry. So as far from medtech as maybe one could think. Had some experience with software, this is when Blackberries were a thing, if you remember those. And then a friend of mine was a recruiter and reached out and said, "Hey, I, I know that you're into medical and into medicine, and that was something you were interested in. Have you ever considered a career in medical device sales?" And frankly I didn't even know that that existed. I mean, this was 20 years ago, so this was before, you know, internet and all of those things existed, obviously, but it wasn't as pervasive as it is now. And so I wasn't even aware that these jobs existed. The fact that you could be working on the delivery of care but not be a healthcare provider was an eyeopening moment. And so I got in and started actually working at a surgical company called Deval. It's part of CR Bard, which is now part of Becton Dickinson, and I cut my teeth in medical device sales. And then I went on to work in a commercial role within other companies Given Imaging, Covidian, Medtronic. I ascended to sales leadership, working with key opinion leaders, working on the patient advocacy side. And then about eight years ago, I had the opportunity through an organization that we'll talk a little bit more about, called MedtechWOMEN, that I was involved in to learn about a consultancy that was looking for a head of business development marketing. It was a small group called Experian Group. I joined them and then within nine months was promoted to Chief Operating Officer, which was a position that I absolutely loved because we were working on the pre-commercial side of things and regulatory quality systems, clinical trials. And I had always had experience in the post commercial side. So eyes open to what happens, everything leading up to commercial. And I got a masterclass from my colleagues there, learning so much about what happens again, pre-commercial. But then one of the other things that came out very quickly is I've always been someone who loves operational efficiency. And I know that's not sexy or cool, but I just like seeing something that isn't working optimally and get it working optimally is something that brings joy. So I had the opportunity to do that within Experian Group, and then really help the organization, which was already very successful, go from a very successful kind of local consultancy to a much larger, broader group with a broader footprint, more global client base. And then we were acquired by the firm that I currently work with called Veranex, and that really exploded capabilities of what was a 50% consultancy to now over a thousand people with a much broader global reach in the US, in Europe, and in India. [00:05:36] Lindsey Dinneen: Wow. That is incredible. Well, first of all, thank you for sharing your story and your background and all the amazing things that led you to where you are right now. That's incredible. So many questions, in a good way. But let's dive in a little bit about, yeah, so, so tell us a little bit more about your role right now, and what are you excited about as this consultancy continues to grow and new opportunities arise. What's on the future for you? [00:06:02] Jessica Richter: So now I lead one of three business units here at Veranex. So I lead our CRO and Consulting Services Business Unit, and that encompasses regulatory, quality, and clinical, as well as commercial strategy, market access reimbursement, things like coding, coverage, payment. So we help mid-size, early stage, and some of the largest strategic medtech companies, as well as some biopharma as well with companion diagnostics, navigate sometimes the tumultuous waters needed to bring a device from inception all the way through to commercialization. Veranex also has two other business units in preclinical as well as extensive design, development and engineering. So there's leaders in each of those capacities. And what we do on CRO and consulting services is really consultative. So we work with clients to develop strategies in all of these areas, and then we roll up our sleeves and work alongside them to make sure that those strategies are actually executable, so to help them along the way. And some of our clients have teams, so it's strategic and we're advisors. Other clients, if they're early, early, may not have extensive expertise or the ability to build out teams in that way. So we go in, or our team goes in, and really provides them that support along the entire continuum. It's interesting, just today, we have a client we've been working with for two years. They're in Switzerland, but they've been working with our US and global team. They just got news from FDA that they obtained FDA clearance. And I'll tell you, I think our team is as excited as theirs because, when you're in a company, it's all that you're living, breathing, doing. When you're consulting, you're a little bit at an arm's length. So when our clients achieve their results, and it's their work, but in concert with ours, the feeling of accomplishment really is just, it's one of those that's explosive. So we've celebrated that. We ring a bell. We'll share a lot, we'll do some marketing around it with this client. But it's really fun. That's the part that really drives not just me, but members of our team as to "How can we help more companies get more products to patients?" [00:07:58] Lindsey Dinneen: I love that. First of all, congratulations, that's exciting, and I'm thrilled for your clients and for you guys because it matters so much and what a great milestone. So that's wonderful. But yeah, so I'm curious, you've seen a lot of different sides to medtech and to the business side of things, and I'm curious what are some potential stumbling blocks that you have seen that companies, especially when they're perhaps a little bit younger or earlier on in the process, what are maybe one or two stumbling blocks that you see that you think, "You know what, hey, if we put a little bit of thought into this, we can overcome this very easily, but we need to be thinking about this from the start." [00:08:36] Jessica Richter: Okay. There's two things. One of them is gonna be a shameless plug, but I swear it's true, and that's quality. I think companies don't focus enough on quality systems 'cause it's just not the fun or sexy thing, but it's literally where we see companies struggle because they think about it too late. They do just in time. They think an EQMS is the answer, and it's not the only answer, it's a component. So quality would be the short answer. The longer answer is people. So what we see is oftentimes, people, especially in a cost constrained environment, which we are today, where fundraising is tough, people do need to be financially astute as far as what they're spending and how they're spending it. But sometimes you get more by spending a little bit more to get the right advice. So for example, if somebody is expert in engineering or expert in regulatory, excellent. Know where your expertise is not, and then supplement. So either hire a consultant or bring on an employee or have a member of your board that can advise them that way. More often than not, we see people trying to just kind of figure it out as they go, which isn't a bad strategy, but there are critical decisions and inflection points along the way. For example, if you're developing a clinical trial, thinking only about your regulatory strategy and not about your commercial goals or the claims you're going to make, you are gonna have to ultimately spend twice as much when you have to do secondary studies that you could have avoided by including that in endpoints. So there's little things like that along the way where if you don't know what you don't know, it's really difficult to see those hurdles. It's helpful to bring in people, even in an advisory capacity, to help you say, "Okay, these are the hurdles that you're gonna face." You're gonna have new hurdles that maybe that you won't know or people won't know, but it's really making sure that you surround yourself with experts in those key areas. [00:10:25] Lindsey Dinneen: Mm. That's great advice. Experts in those key areas. Well, speaking to the advisory point, I'd actually love to talk about your involvement with MedtechWOMEN, and tell us a little bit about that organization and how it serves women in this industry. [00:10:39] Jessica Richter: Absolutely. Thank you for asking. It's something that I could literally talk about for this entire podcast. So, I alluded to it earlier, but MedtechWOMEN, I got, and I say "roped in" lovingly, but I was introduced to this organization, gosh, maybe a decade ago now when I was at Covidian and then Medtronic, and a mentor of mine, Amy Belt Raimundo, was one of the founders of MedtechWOMEN. And she had mentioned to me, because there weren't a lot of female leaders within that section of my business at the time, so I was paired with her and it feels like kismet because she was this spark of like, this is what badass female leadership looks like. She knew her stuff, she was really focused on the issues. She made time and said yes anytime I had a question or wanted to meet. Our conversations were really meaningful and actionable. Sometimes we just talked as friends. It wasn't always so agenda based, but she introduced me to MedtechWOMEN and shared with me that there's this organization. It's all volunteers. It's kind of membership based and it's literally women getting together talking about the issues in our industry. And it wasn't as focused on things like work-life balance, which quite frankly is a challenge, no matter what your gender is. There are great forums for talking about work-life balance and how you prioritize your health and your mental wellbeing, and that is really, really important. But some of the events that I had gone to as far as women in leadership or women in medtech were really focused on those things and that wasn't what I wanted to talk about. I wanted to see incredible pioneers or trailblazers in our industry talking about the things that mattered in industry and sharing their perspectives. And that's exactly really the thesis of MedtechWOMEN. And so it was an organization founded over a decade ago. It started really as just an annual event, this MedtechVISION event, where we brought women together on a podium talking about the issues impacting healthcare today. It evolved. So after a couple of years and a couple of different topics, what we started to see is that there was a real thirst in the community that we had beyond just that individual or that one time a year we got together for the event. And so we developed a kind of MedtechWOMEN 2.0. We brought on an Executive Director. And we essentially launched a much, much grander vision of what MedtechWOMEN was. So it included membership. It included mentorship, so formal pairings. We created a board of directory, kind of a pathway to get to more women on boards. We also have local events, networking events, virtual events in partnership with our sister organizations like MedTech Color and Diversity by Doing. And then of course we still have our annual event. And then just this past month we actually brought on a new executive director. Her name is Yvonne Bokelman. She is a longtime industry veteran, tremendous leader in medtech, and someone who's really passionate about the organization, the mission, the vision. So we're excited to see what she will do in her role here. [00:13:38] Lindsey Dinneen: Yeah. That's incredible. Thank you so much for sharing a little bit about the organization and its history and who it is serving, and it really resonated because I agree with you that there's wonderful platforms for being able to talk about some of the. Some of the topics that tend to come up quite a bit for women, especially women leaders, and I love the fact that you are fully acknowledging that those things are great as well, but that your focus is a little bit different. And so I'm curious, what are some interesting stories or things that have happened maybe unexpectedly from this network of incredible women supporting each other, learning from each other. Can you share a little bit that? [00:14:17] Jessica Richter: Oh yeah, absolutely. And I'll tell you, many of us that have been members for a long period of time will attest to the fact that job opportunities come via this network, learning opportunities, sales and business opportunities. I mean, we network in the same way that we would in any other conference or any other meeting, but deals certainly have gotten done within and at MedtechWOMEN and MedtechVISION events. But most importantly, and one of the things that I always tout, is that MedtechWOMEN is a sisterhood that will take that call. And what I mean by that is if you have a question, if you need to phone a friend-- going back to what we were talking about earlier of that network of you don't know what you don't know, but somebody probably does-- within MedtechWOMEN, someone definitely does. And so what we encourage our members and our mentors and anyone that's a part of the organization to do is reach forward and reach back. And so when I say take that call, if someone calls-- and I just had literally three conversations in the last three weeks-- with more junior people looking for career advice or wanting to have a question about regulatory or their thinking about a decision point in their job, and what should they do? I always take that call and, you know, we're all busy. We all have things to do, but that 30 minute conversation can have a really big difference. And I know for me, likewise, when I have a question, when I'm coming up against something where it's helpful to have a thought partner, sometimes you want that outside of your own company, or outside of your boss, or outside of your team. And so the MedtechWOMEN Network is incredibly powerful and very supportive. And in my experience, and I've tried it both ways, we will always take that call. [00:15:53] Lindsey Dinneen: Oh wow. That's incredible. So, okay, so mentorship and leadership is obviously a key component of your life, something that you're passionate about. From your own experience as a woman in this industry, are there any things that come to mind that you would say, just pieces of advice-- let's say for other women who might be younger in their career and they're looking to grow, they're looking to become leaders, they're looking to become maybe thought leaders, or own their own company, things like that-- what are some things that you might suggest to them from your own experience would be helpful? [00:16:27] Jessica Richter: Oh yeah. It's, it's a great question, Lindsey, because there's a lot of things. I wish we could just mind share. First and foremost, I would tell women to go for it. I think sometimes we self-sabotage or hold ourselves back if we don't have all of the information or feel like we're a hundred percent qualified. And there's been tons of studies that demonstrate that. So first and foremost, go for it. I had this conversation with one of my mentees who was taking on a new role and I said, "It's okay that you're feeling this way or that way. Do it and do it scared." Like it's okay to not feel like you have all of the confidence, right? And it doesn't mean fake it till you make it, although there's a little bit of that too. But I would say don't let fear hold you back. So that would be the first piece of it. The other piece of it is make sure that you have, really, your own board, meaning advocates, mentors, coaches, thought partners, people that you can reach out to and rely upon. And that has to work both ways. I will tell you, I have learned as much from mentees as I have learned from mentors. And so recognizing that knowledge is shared both ways, no matter what your seniority is. For people that are junior, they have their on the pulse of things that I'm not as privy to, and sometimes I feel, feel that even more strongly. Likewise for people that have been in this industry 40, 50 years, they have institutional knowledge that I only wish that I had. And so, being at this midpoint in my career, I'm sandwiched between both and really appreciate, so I would implore people that are hoping and wanting to pursue leadership, go for it. [00:18:00] Lindsey Dinneen: Yeah. Thank you for that. I, I love that advice. I really appreciate it. So, you have had such an interesting career and going from communication and sales, and then to this new role and Chief Operating Officer, all these cool things. For your own leadership style, what would you say are maybe one or two key things that you have found to be really helpful for you as a leader in the industry in the way that you approach the people that you lead? [00:18:30] Jessica Richter: Another great question, Lindsey. So I would say, well --first maybe I'll share some lessons learned 'cause I've made a ton of mistakes. So I think one of the things that I didn't appreciate early on as a leader that I definitely appreciate now, is that we all have our own lens, our view with which we take on and see the world, and that's the view in which, you know. And so as a leader, initially, my thought was, "Well, everyone kind of sees and feels it this way with their own flavor." That is not true. Everyone has their own view and that's really shaped by their family, their background, their culture, lots of different aspects. And so I think for me, some advice as a leader would be, be humble, take the time to really seek to understand, and then, even if you are heightening your communication, multiply that times three or four and then you're probably scratching the surface, 'cause people need to hear things different ways, multiple times. And it doesn't mean you need to micromanage or drill things down, but when you're leading an organization and bringing people along on a change, especially, it is important that people understand the why, the who, the what, the how come, and that they hear that re repeatedly so that they can understand it, they can buy into it, and that you're creating an environment to make sure that their questions are addressed. So, lesson learned kind of recommendation on the leadership piece. I think the other just piece of advice is that sometimes people aspire to leadership because they think it's glamorous or there's gonna be a lot of money there, or it looks like the leader doesn't have to do that much work, they're just delegating. What I would say is leadership is not glamorous. It's often thankless. It's super hard. I work tons of hours and I love the team that I work with, and so for me the why is that. But if you are not loving that, don't do that. There's plenty of opportunities that you can contribute meaningfully as an individual contributor or a principal or a subject matter expert, and that's great too. So know that if you want to lead people and be involved on that side of leadership, I welcome it. I think it's fantastic. I think there's a lot of people that get into it with a misconception of what it will look like. And I'll tell you it's worthwhile, but it's hard. [00:20:43] Lindsey Dinneen: Yeah, absolutely. Yeah, when you were talking about that it, the glamor side of things, I just remember so vividly and I, I joke about it because I think it's funny-- but very quickly, I used to own my own dance studio and I built that from the ground up. And people would say things to me like, "Oh my goodness. What you're doing, you're living your dream. That's amazing! Oh my gosh, how cool is that?" And inside, I'm like, "Ha, yeah, I mean, I spent the first two hours as the janitor this morning, and then the next two hours as the CEO. And then, you know..." And it's funny, but it's true, you wear a lot of hats as a leader and sometimes your job is literally getting down into the nitty gritty and cleaning up, and that's fine too. So I love that. [00:21:24] Jessica Richter: My quip is always from the janitor to the GM, like, "What needs to get done? There's no task too big or too small." And ultimately, I think that what you described in yourself, and I love that, is servant leadership, right? Like for me, I've always responded well, when a leader isn't above any task and doesn't ask for something that they themselves would not be willing or aren't willing to do along with their team member. And so again, that's, that's not the definition of leadership, but in my eyes, that's a definition of leadership that really resonates with me. [00:21:55] Lindsey Dinneen: Mm-hmm. I agree. Yeah. Well, speaking of stories and those kinds of fun things too, are there any that stand out to you, perhaps along your career or with MedtechWOMEN, or anything really, that just affirm to you that, "Hey, I am in the right industry at the right time, doing what I should be doing?" [00:22:14] Jessica Richter: Oh yes. So there's a couple of different specific examples. So firstly, one of the things that has happened as of late, and I feel like-- not to get too woo or California on you-- but these synchronicities where you'll be thinking about something or remembering something, and suddenly a project and people come together around it-- and again, I think that's part of the power of the network. But there was a friend of mine that I had run into at a conference, we were talking about a specific aspect of their business that was really needing some, some development, and it turned out that after that conversation, literally not a week later, I got a call from a prospective client that was interested in working in this specific space. We were able to connect them with this person that was in need of that exact thing. And it was with software and with AI and so a partnership was forged and now they are literally about to embark in this really explosive and announcement will be forthcoming about it. But there's so many examples of little nuances and synchronicities like that, that again, happen because of staying open, staying curious, that powerful network right place, right time. But I also think it's the magic of our industry. It's really small. People sometimes fail to appreciate because you have these large organizations that are hundreds of thousands of people, but the leaders within the organization are fairly connected and tight. It's really an interconnected ecosystem. So that's just kind of one broad example. There's also other really small examples of the power, I think, of MedtechWOMEN in just how it ignites and how it brings people together, especially across senior and junior roles. So when we do our networking events, we try to do them regionally, just to try to bring different people together. And you can have like the CEO of sometimes a large organization, like Lisa Earnhardt from Abbott is a member and an active participant. She often will come to events talking to someone who's their very first year in medtech. And when you see these examples of sponsors of ours really showing up and demonstrating a commitment to giving back, and you see these people that are junior that may not even know the seniority of the leader that they're speaking to, recognizing that we're all people at the end of the day, trying to really ideally propel healthcare and help patients in their journeys to health and wellness. And so when you see examples of those sparks and those little ignites, it reinforces why we're here, what it is we're doing, and really the power of the organization. [00:24:41] Lindsey Dinneen: Yeah! Well, I think that the more times that you get to see those connection points, and those synergies or whatever we wanna call them, I think that that does impact us in a way that goes, "Yeah, the work that I do matters and it's impacting people's lives and maybe in very different ways." So some of it is, yeah, that end user and that patient, and oh my goodness, what this device can do for them and their quality of life. And sometimes it's the person behind the invention and what does that journey look like for them personally and the impact on their own family and their life. So I love hearing about those connection points. [00:25:16] Jessica Richter: Well, and that's the joy of working also with, I mean, large strategics for sure, but the startup companies, oftentimes it's a physician and engineer. The physician is seeing the unmet need because of the patients coming into their clinic. They're feeling hopeless 'cause they can't address it, but also empowered because they know what to do. So those are the really fun, kind of feel good projects, especially because there is no one better equipped than a clinician, right, to say, "Okay, here's the gap." Engineers can help to design and develop, but oftentimes that's where the teams are sort of left in the lurch to say, "Okay, what do we do from here?" And so it is incredibly powerful to enable these innovators, no matter what their backgrounds are along that journey. And it's not a quick one as you know, being on the manufacturing side. It's not something that's quick or easy. It's not something that is a high success rate. And when it works, there is no better feeling. When you commercialize a device or when you get it through the FDA, that's just the start. When it's actually used in patients and you start to hear those patient advocates and those stories, and you expand indications and are able to help more patients, that's the thing that makes it worthwhile. And when the going gets tough, 'cause it does that, those are the stories, right, that really inspire us to continue. [00:26:33] Lindsey Dinneen: Yes, absolutely. Amen to that. So, okay, so I have so many thoughts swirling around, but I do want to pivot the conversation a little bit just for fun. So imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It can be within your industry, but it doesn't have to be. What would you choose to teach? [00:26:53] Jessica Richter: Oh, I love this question. I'll try to make it not about our industry 'cause it's something I've been working on a lot lately, and it's a testament to patience, which is something that I think we could all use more of, but I could definitely use more of. So we rescued a dog in Covid. She's a Doberman pit mix. Her name is Poppy and she's delightful. And she was severely neglected. So when we got her, we knew she was really shut down and that we would have to do work to bring her out of her shell. My husband and I don't have kids. We have a quiet home. I knew that we could take that on. And so while I won't say I am the expert, what I have done in the four years we've now had her, is extensively worked with her on the, what I would call the "Art of the Dog Walk." So we have learned how to really master exercise, training, and discipline as a way to show affection, 'cause for a dog that shut down like that, that's really what she needed to thrive. It was humbling and very educational for me. I've always been a huge animal lover. I used to volunteer when I had a lot more time with an animal rescue. And so I was able to parlay that and work with a trainer really on honing those skills so that Poppy could not just be social in the world, but be less shut down. So it would be so fun to share a masterclass on that 'cause I had so many reflections and learnings on patience. The art of going slow, the art of taking in the world, of just slowing that down, not being on my phone, right, being really present with her. And I sort of joke with my husband, I feel like now when I walk her-- I dunno if you've seen the movie "Avatar"-- but like we connect our avatars and we like go on into this world, and it's meditative. It's our morning practice and it's something that for me has been incredibly rewarding, and challenging, and a huge learning experience that, that I would love to share. [00:28:50] Lindsey Dinneen: Oh, that's wonderful. Oh my goodness. Yes. I am a huge dog lover, so anytime someone's telling me about their dog, it's just instant happiness. [00:28:59] Jessica Richter: Likewise. And for my, my favorite thing that it will always bring a smile to my face is the unlikely animal friends, like if you see like a squirrel a dog or a kookaburra or something, you're like, "Ahh!" [00:29:10] Lindsey Dinneen: It's so cute. It's precious. Yes. I love it. And to me it reinforces, "Hey, we can actually all get along if we try." I mean, I know it's a little different in the animal kingdom, but still, I still love that. Oh my goodness. Great. Well then, how do you wish to be remembered after you leave this world? [00:29:32] Jessica Richter: You know, legacy is something, that I think is important. It's funny, I've been working with my niece on her college essays and college admittance, and reflecting back to my views when I was 18 versus my views today in the world now. And even speaking to my mom about legacy, 'cause it's something, you know, she's approaching her eighties that she thinks more and more about. So it's conversations that we have a lot. I really would love to be remembered as an enabler, as someone who really enables those around me to be successful, to achieve more, to obtain what they want right to, to drive forward. I love being around creative people and innovators and people with really expansive imaginations, and I think my superpower is kind of capturing and enabling those things. So it would be great to be able to enable more people around me. And that's true with patients and healthcare and the clients that we support as well. You know, one of the things that has always been pointed out to me-- and again, my grandfather was a huge proponent of this-- is when things aren't going well in the world, you can focus on what's going wrong or you can look for the helpers. And so, as a surgeon, he was one of those helpers. And so I think he ingrained that in me very early on. And so I'd love to be remembered as someone who is a helpful enabler. [00:30:51] Lindsey Dinneen: Hmm. Yes. That's a beautiful legacy. I love that. [00:30:54] Jessica Richter: I am curious, Lindsey, I know this is like, you're the, you're the interviewer, but how would you like to be remembered? [00:31:02] Lindsey Dinneen: Oh, thank you for asking. First time! You know, there are so many things, so many things that I love doing for other people. But I really actually resonated with your idea of enabling. And I would say mine is very similar. And that is that I love helping people achieve their dreams. And that can look like lots of different things to lots of different people. So it's when I'm working with a company, it always started with one person's idea, right? All these big companies started off as this tiny little one person's idea that became something. And I think just helping that, those sparks, especially when maybe they're eager, but they're not quite ready. They're scared, they're nervous, they're whatever, and helping them see a clear path to achieving those dreams and goals is one of my favorite things. And whether that's just a personal, I wanna run a marathon, I don't even how to know how to get started, or whether it's, I have this great idea for a book, but I am concerned about, like, "Nobody will read it, no one will care." Well, that's not the point. Let's start somewhere. And so I think for me, it's about empowering people to live the life that they want to live and hope that they can live. That's what I would love to be remembered for. [00:32:16] Jessica Richter: Well, that's beautiful. I hope that via this and the other things that you're doing, it seems like you're already on that track. [00:32:22] Lindsey Dinneen: Well, thank you. I appreciate that. I really appreciate you asking me too. Thank you. Well, and then final question, and you've sort of perhaps alluded to this-- I'll see if it's different than your first time-- what is one thing that makes you smile every time you see or think about it? [00:32:37] Jessica Richter: Oh, well, definitely the unlikely animal pairings for sure. [00:32:41] Lindsey Dinneen: Yes. [00:32:42] Jessica Richter: Anytime with family. Family is super important to me. So anytime I can spend time with our family, that is for me, a smile doesn't go off of my face. And also kind of what you said, celebrating other people's wins. And I celebrate my own as well-- I think it's important that we do that-- but there is nothing like, it's a grin, like when someone on our team has an accomplishment, the grin is twice as big, right? Because you just, to see that reflected, that success, that attainment, that win reflected for the people that you work alongside, that brings a smile to my face every time. [00:33:20] Lindsey Dinneen: Yeah, nothing quite like it, and it's so powerful. Yeah, huh. Oh my goodness. Well, this has been an amazing conversation. I don't really want it to end, but I know we have other things we have to get to today, so I just wanna take some time to say thank you so very much for being here with me, Jessica. Thank you for sharing all about your incredible career so far and all the exciting things that are to come, and speaking to MedtechWOMEN and that incredible organization. So I'm really excited for our listeners who might not have been familiar with it to go check it out, lots of opportunity there. And gosh, I just wish you the most continued success as you work to change lives for a better world. [00:34:01] Jessica Richter: Thank you, Lindsey, for hosting and I would encourage anybody who's unfamiliar with MedtechWOMEN, if you're new to industry or if you've been here a while, there is a place for you within MedtechWOMEN. Membership is super low cost. It's $150 for standard membership a year, $75 for junior members. You can follow us on LinkedIn, but highly, highly encourage everyone to join the network. And thank you for the opportunity to share a little bit more about MedtechWOMEN today. [00:34:26] Lindsey Dinneen: Of course. 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. Thank you also to our listeners for tuning in, and if you're feeling as inspired as I am right now, I'd love it if you share this episode with a colleague or two, and we'll catch you next time. [00:34:57] Jessica Richter: Thanks, Lindsey. [00:34:59] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Geoff Martha, MBP and Chairman and CEO of Medtronic joins Vineeta to talk about the strength of Minnesota business and the impact big and small companies have around the world.

In this episode of the Diabetes Innovators Series, Scott Hebl, Vice President for Program Management at Medtronic, discusses the exciting innovations and future of the MiniMed brand following its separation from Medtronic. He highlights the importance of simplifying diabetes management through advanced technology, including artificial intelligence and user-friendly devices. Scott shares his personal journey with medical devices and his passion for improving patient care. Chapters 00:00 The Excitement of Innovation in Diabetes Care 02:05 Future Innovations and Technology in Diabetes Management 06:03 Insights from the Scientific Sessions 08:19 Personal Journey and Passion for Medical Devices Resources: Medtronic Scott Hebl LinkedIn

Scaling AI across a healthcare system takes more than just good technology—it requires effective governance, operational focus, and the right data foundation. In Part 2 of our conversation with Kiran Mysore, Chief Data & Analytics Officer at Sutter Health, he explores how Sutter is operationalizing AI across its 24 hospitals and hundreds of care sites. You'll hear: How the AI Council—a cross-functional governance body—ensures alignment, safety, and momentum What makes the “Sutter Navigator” platform a game-changer for operational visibility Why “speed of business” and “speed of foundation” must be balanced to move fast and responsibly How Sutter is applying lessons from finance and retail to transform healthcare This episode is a masterclass in AI implementation at scale—perfect for health system leaders, innovators, and data executives alike.       About Kiran Kiran is the Chief Data Analytics Officer at Sutter Health, a leading not-for-profit healthcare network in America. With over 25 years of experience, Kiran has been instrumental in driving digital transformation and leveraging data and AI to generate business value across various sectors, including healthcare, technology, and consulting.    Before joining Sutter Health in September 2023, Kiran held significant roles at prestigious organizations such as Medtronic, GE, Apple, and St. Jude Medical. His expertise includes optimizing operations, developing real-time insights, and modernizing technology infrastructures. Known for his commitment to fostering data-driven cultures and championing diversity and ethical practices in data, Kiran's leadership at Sutter Health focuses on making data and insights meaningful to improve healthcare outcomes, operational efficiency, and patient care. His work exemplifies the transformative power of technology in advancing healthcare. About Bright Spots Ventures Bright Spots Ventures is a healthcare strategy and engagement company that creates content, communities, and connections to accelerate innovation. We help healthcare leaders discover what's working, and how to scale it. By bringing together health plan, hospital, and solution leaders, we facilitate the exchange of ideas that lead to measurable impact. Through our podcast, executive councils, private events, and go-to-market strategy work, we surface and amplify the “bright spots” in healthcare, proven innovations others can learn from and replicate. At our core, we exist to create trusted relationships that make real progress possible. Visit our website at www.brightspotsinhealthcare.com.  

Marty, Eric, and Dave talk about the flood of stories from one rumor post about future Vision Pro devices and new video about editing immersive video.Product Prediction Kuo: Apple working on 7 head-mounted products, roadmap starts in 2025https://9to5mac.com/2025/06/29/apple-working-on-7-head-mounted-products/ After Vision Pro's Flop, Apple Doubles Down on Headsetshttps://www.androidheadlines.com/2025/06/after-vision-pros-flop-apple-doubles-down-on-headsets.html Samsung Headset PredictionsSamsung's Upcoming XR Headset Could Beat Apple Vision Pro With Sharper 3,800 PP| OLEDoS Displays, But A Smaller Field Of View Might Be Its Biggest Drawbackhttps://wccftech.com/samsung-headset-display-better-than-vision-pro/ Samsung's Project Moohan XR headset could be similar to Vision Pro in more ways than onehttps://www.androidauthority.com/samsung-xr-headset-project-moohan-display-suppliers-3571210/Samsung's Project Moohan to have more Pixel Density than Apple Vision Prohttps://samlover.com/2025/06/26/project-moohan-to-have-more-pixel-density/ Inside BonoInside the First Feature-Length Immersive Film for Apple Vision Pro: Bono - Stories of Surrenderhttps://www.cined.com/inside-the-first-feature-length-immersive-film-for-apple-vision-pro-bono-stories-of-surrender/ Behind the Work: How The Artery Brought Bono: Stories of Surrender to Apple Vision ProHow The-Artery Brought Bono: Stories of Surrender to Apple Vision Pro | LBBOnline Vision Pro Colonoscopy Apple Vision Pro will help get to the bottom of colonoscopy cancer detectionhttps://appleinsider.com/articles/25/06/25/apple-vision-pro-will-help-get-to-the-bottom-of-colonoscopy-cancer-detection Medtronic, Cosmo to conduct GI Genius trial on Apple Visionhttps://www.massdevice.com/medtronic-cosmo-gi-genius-apple-vision-pro-study/ Rush University to Host Colonoscopy Study Using Apple Vision Prohttps://hitconsultant.net/2025/06/25/apple-vision-pro-and-medtronics-gi-genius-to-be-used-in-live-colonoscopies/Mantel Group review for enterpriseThe Vision Pro, and how to unlock its potential: a tech consultant's perspectivehttps://mantelgroup.com.au/the-vision-pro-how-to-unlock-its-potential-a-tech-consultancy-perspective/ Spatial NPC released  We released an open source "spatially intelligent NPC" app for VisionPro!https://www.reddit.com/r/augmentedreality/comments/1lkmxlb/we_released_an_open_source_spatially_intelligent/ BlackMagic camerasFilmmaking for the Vision Pro Era: Apple and Blackmagic's Immersive Video Workflowhttps://www.cined.com/filmmaking-for-the-vision-pro-era-apple-and-blackmagics-immersive-video-workflow/ CANAL+ BRINGS MOTOGP TO VISION PRO WITH BLACKMAGIC URSA CINE IMMERSIVEhttps://www.mactech.com/2025/06/27/canal-brings-motogp-to-vision-pro-with-blackmagic-ursa-cine-immersive/Blackmagic URSA Cine IMMERSIVE Tech Explainer - Shooting Apple Immersive Video for the Vision Prohttps://www.youtube.com/watch?v=QpkIEncCOfw HTML Model element A step into the spatial web: The HTML model element in Apple Vision Prohttps://www.webkit.org/blog/17118/a-step-into-the-spatial-web-the-html-model-element-in-apple-vision-pro/ New smart glassesXiaomi Unveils China's Answer to Ray-Ban Meta Smart Glasses with a Few Killer Featureshttps://www.roadtovr.com/xiaomi-ai-glasses-meta-smart-glasses-features/ Image editors2 Cool Image Editors for Vision Prohttps://www.iphoneness.com/apple-vision-pro-apps/cool-image-editors-for-vision-pro/ APPS BezelBezel app - Show your iPhone inside Apple Vision Prohttps://www.reddit.com/r/VisionPro/comments/1agdon5/bezel_app_show_your_iphone_inside_apple_vision_pro/ Show your iPhone inside Apple Vision Prohttps://nonstrict.eu/bezel/vision/ Bezel: Spatial Phone Mirroringhttps://apps.apple.com/us/app/bezel-spatial-phone-mirroring/id6476657945 MacStockMacstockconferenceandexpo.com  50$ off with code “PODTALK50”

Join clinical experts Cheryl Rosenfeld, DO, FACE, FACP, FSVM, ECNU, Madhuri M. Vasudevan, MD, MPH, FACE, and Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP, to learn how the AACE Patient Journey of Diabetes Technology supports people with diabetes in navigating their treatment options with confidence. This patient-friendly resource, developed from AACE clinical guidelines and reviewed by Diabetes Sisters, a leading patient advocacy organization, provides clear and accurate information on diabetes technologies, from glucose monitors to insulin delivery devices. The experts also highlight how members of the endocrine care team are using this tool to empower people with diabetes to manage their journey. This episode is brought to you with the support of Abbott, Novo Nordisk, Medtronic, and Vertex.

I'm thrilled to share some incredible insights from our latest podcast episode featuring the one and only Scott Brown, managing partner of Velora Capital. Scott's journey is nothing short of inspiring, and I can't wait for you to dive into our conversation. Here's a sneak peek of what you can expect:

Navigating Clinical Trials for Medical Device Startups: Insights from Julio Martinez-Clark of bioaccess®In this episode of The Thoughtful Entrepreneur, host Josh Elledge sits down with Julio Martinez-Clark, Founder and CEO of bioaccess®, to explore the challenges medical device startups face in navigating early-phase clinical trials. Julio draws on his extensive experience to explain how bioaccess® is helping companies conduct trials in Latin America as a strategic alternative to the U.S., offering startups an efficient and cost-effective way to progress. The conversation dives into the intricacies of regulatory compliance, data quality, and patient recruitment, offering critical insights for innovators looking to accelerate their time to market.Overcoming the Challenges of Medical Device Clinical TrialsJulio Martinez-Clark explains the complex journey from medical device innovation to market. He highlights that medical device development is often capital-intensive and time-consuming, with startups typically relying on grants in the early stages before needing millions to fund animal studies, human trials, and regulatory submissions. One of the biggest challenges that startups face is meeting investor expectations for rapid progress and clear milestones, particularly with the ultimate goal of acquisition by large players such as Medtronic or Johnson & Johnson.The U.S. clinical trial process, while rigorous, is also costly, and the lengthy approval timelines add pressure for startups already constrained by limited resources. Julio stresses that many medical device innovators underestimate the amount of time it takes to secure funding, develop products, and get approval from the FDA. He also shares how crucial it is for companies to factor in the regulatory strategies and financial resources needed to navigate these challenges without facing setbacks.To overcome these challenges, startups should build long-term financial plans and strategies, preparing for what can be a long and resource-heavy journey. This proactive approach, combined with a solid regulatory strategy, ensures that startups remain on track and avoid costly delays.About Julio Martinez-ClarkJulio Martinez-Clark is the Founder and CEO of bioaccess®, a company dedicated to helping medical device startups navigate the early stages of clinical trials and regulatory approval. With years of experience in the medical device and healthcare innovation sectors, Julio provides strategic insights into accelerating time to market and achieving regulatory compliance for cutting-edge medical technologies.About bioaccess®bioaccess® is a leading contract research organization (CRO) focused on supporting medical device startups through early-phase clinical trials, particularly in Latin America. Offering a more affordable and faster approach to clinical trials, bioaccess® helps startups overcome high costs and lengthy timelines associated with U.S.-based trials while ensuring adherence to global regulatory standards and high data quality.Links Mentioned in This Episodebioaccess® WebsiteJulio Martinez-Clark on LinkedInKey Episode HighlightsThe Fractional Legal Team...

In this wide-ranging and direct conversation, Bill George, former Medtronic CEO and Harvard Business School professor, offers a disciplined framework for leading in conditions of persistent volatility. Drawing from decades of leadership experience and research, George emphasizes that leadership today is no longer about managing processes, it is about confronting ambiguity, enabling experimentation, and sustaining purpose across shifting conditions.   Five themes stand out: Opportunity Must Be Created, Not Awaited. George argues that emerging leaders should not wait for promotions or formal permission. Instead, they should identify unaddressed problems, volunteer to lead, and deliver results without demanding titles. Career growth, he suggests, is a function of action, not seniority. Innovation Begins at the Front Lines. Whether referencing his early decision to cancel a Medtronic pacemaker program that lacked patient benefit, or urging leaders to spend less time in conference rooms and more with customers and staff, George insists that enduring breakthroughs stem from direct observation and empathy, not from internal data analysis alone. Risk Tolerance Determines Strategic Renewal. George contrasts firms that institutionalize risk such as Medtronic's venture incubation model, with those that allow internal resistance to block change. Innovation, he asserts, must be structurally protected from corporate inertia, and leaders should be judged on the courage to champion unpopular ideas that later prove transformative. Culture Must Reward Learning Over Defensiveness. Drawing parallels between U.S., European, and Japanese innovation cultures, George critiques over-regulated, failure-averse systems that suppress experimentation. True progress, he says, requires the willingness to learn through trial, adaptation, and even initial failure. AI Is a Strategic Imperative, Not a Cost Play. Rather than using AI to drive out labor costs, George advocates for using it to rethink business models entirely, supporting frontline autonomy, enabling new services, and unlocking unmet needs. He cautions leaders against adopting a defensive posture and urges them to fund experiments that explore the true potential of the technology. Throughout, George offers a leadership mindset anchored in authenticity, courage, and customer-centric design. His advice is clear: future leaders must raise their hands, operate at the edge, and move fast before the window of relevance closes.   Get Bill's book here: https://shorturl.at/3iHRb True North, Emerging Leader Edition: Leading Authentically in Today's Workplace   Here are some free gifts for you:   Overall Approach Used in Well-Managed Strategy Studies free download: www.firmsconsulting.com/OverallApproach   McKinsey & BCG winning resume free download: www.firmsconsulting.com/resumepdf   Enjoying this episode? Get access to sample advanced training episodes here: www.firmsconsulting.com/promo  

生醫工程是近年來熱門的專業，由於生醫工程是一個較新的專業，很多人對於生醫工程的職涯和出路並不熟悉。 這一集我們特別邀請到目前在腦機介面領頭羊公司 Synchron 擔任 Principal System Engineer 的張耀銓博士和我們分享他一路以來的職涯：如何從電機/電控學士轉到生醫工程博班，從學界如何透過與業界密切合作的機構進入業界、如何進到醫療器材大廠 Medtronic 和現在的 Synchron，以及在學習和求職上遇到各種挑戰與心得。 張耀銓博士也在上一集中，和我們分享了侵入式腦機介面目前的進展和 Synchron 的獨特優勢，對腦機介面發展有興趣的朋友歡迎到上一集收聽。  

Join HRS Board Member Prashanthan Sanders, MBBS, PhD, FHRS (University of Adelaide) as he discusses this exciting paper, presented at Heart Rhythm 2025. He is joined in the Heart Rhythm Tv Studio in San Diego, California by Louise Segan, MBBS, MPH (Alfred Health), and Takanori Yamaguchi, MD, PhD (Saga University). This discussion took place on-site at Heart Rhythm 2025.   https://www.hrsonline.org/education/TheLead https://www.heartrhythmjournal.com/article/S1547-5271(25)01245-7/fulltext Host Disclosure(s): P. Sanders: Honoraria/Speaking/Consulting: Boston Scientific, Abbott Medical, Research: Boston Scientific, Abbott, Medtronic, Becton Dickinson, CathRx, Pacemate, Kalyan Technologies, Ceryx Medical, Biosense Webster, Inc., Hello Alfred, Abbott Medical Membership on Advisory Committees: Pacemate, Medtronic PLC, Boston Scientific, CathRx, Abbott Medical Contributor Disclosure(s): T. Yamaguchi: Honoraria/Speaking/Consulting: Abbott Japan, Biotronik, Boston Scientific, Abbott Medical, Japan Medtronic, Inc., Daiichi Sankyo, Novartis, Japan Lifeline, Nihon Kohden, Bayer Healthcare Pharmaceuticals Japan, Boehringer Ingelheim L. Segan: Nothing to disclose.

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

Ann Latham is the Founder of Uncommon Clarity, a consulting firm helping professionals gain cognitive clarity. As a clarity consultant, she has worked with notable businesses, including Hitachi, Boeing, and Medtronic. Ann is also the author of The Power of Clarity, The Disconnect Principle, The Clarity Papers, and Uncommon Meetings. Her insights have appeared in The New York Times, Bloomberg, and Management Today. In this episode… The word “clarity” is used frequently in business contexts, but what does it mean? For entrepreneurs and leaders, clarity involves identifying your goals and methods for achieving them. How can you gain clarity in all aspects of your professional life? Widely recognized “Clarity Queen,” Ann Latham has discovered the common roadblocks to goal progression, including a lack of specificity and clear communication. She maintains the importance of gathering enough information to make informed decisions about the next steps. This involves identifying specific decisions and action steps and developing detailed plans to execute them. In this episode of the Lead Like a Woman Show, Andrea Heuston sits down with Ann Latham, the Founder of Uncommon Clarity, to discuss how to gain clarity in your professional life. Ann explains how to accelerate results and optimize communication in meetings, the takeaways from her TEDx talk, and insights from her books.

Minnesota has the highest rate of people working remotely in the Midwest, according to the Minneapolis Federal Reserve. More than a third of workers in the state worked at home at least part time in 2023. But now, five years after the pandemic, the great experiment of remote work is shaking out. More employers are calling workers back to the office. On Monday, tens of thousands of state employees who had been working remotely are required to return to work in person at least 50 percent of the time, complying with a return-to-office order from Gov. Tim Walz. Some private companies, such as 3M and Medtronic, also are dialing back their work-from-home policies and President Donald Trump has sought to end remote work for federal workers.MPR News host Angela Davis discusses what we've learned about remote work — when it works and when it doesn't — and what its future might be. Guests: Chris Farrell is a senior economics contributor for MPR News and Marketplace.  Colleen Flaherty Manchester is a professor and faculty director of the Center for Human Resources and Labor Studies in the Carlson School of Management at the University of Minnesota. She studies flexible work and other benefits and programs offered by employers. Subscribe to the MPR News with Angela Davis podcast on: Apple Podcasts, Spotify or RSS.   Use the audio player above to listen to the full conversation.     

#293: Today I'm sitting down for a casual solo episode spilling the tea on how things are going post-rebrand, and sharing my favorite new hack for getting things done when I feel like crashing out.Resources:Follow Marina Girgis on IG to learn more about her retreatsEpisode 225: How Reading Fiction Makes Us Raise Our Standards and Practice Self-Care with Kennedy RyanEpisode 271: How to Rebrand Your Life in 2025Episode 281: Gabrielle Union on Moving Through Creative Blocks, Embracing Vulnerability and No Longer Going 50/50Episode 283: The Business of Rebranding and Owning Your Success with WeezyEpisode 289: Choosing Alignment Over Ambition with Daria BurkeCan't Get Enough by Kennedy RyanOf My Own Making: A Memoir by Daria BurkeSubscribe to my Substack, Balance with LesSponsors:Simply Pop is a new fruit-forward bevy of prebiotic sodas with 6 grams of fiber. Go to cokeurl.com/simplyPOP to find out where you can try it.Nuuly Subscription Clothing Rental is a must-have for switching up your style. Visit nuuly.com and use the code BALANCEDLES to get $28 off your first month.Medtronic is spreading awareness about the importance of talking about women's heart health. Visit alettertomymother.com to learn more.IM8's Daily Ultimate Essentials is my go-to drink for getting all the nutrients I need. Go to IM8health.com/lucky and use code LUCKY for a free welcome kit, five free travel packs, and 10% off your order.Keep in touch:Follow on IG: @shessoluckypod @lesalfredFollow on TikTok: @shessoluckypod @lesalfredVisit our website at balancedblackgirl.comPlease note that this episode may contain paid endorsements and advertisements for products and services. Individuals on the show may have a direct or indirect financial interest in products or services referred to in this episode.Produced by Dear Media.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

A conversation with a Medtronic engineer who's been with the company since the beginning of the Artificial Pancreas project. Lou Lintereur is now Chief Engineer for AID systems at Medtronic.. we talk about the recently approved Simplera Sync Sensor, changes coming to Medtronic pumps, he answers your questions about AI use, patch pumps, and the idea of a pump that needs zero user interaction. Note: this episode was recorded before Medtronic's announcement that they will spin off the Diabetes division. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Join us at an upcoming Moms' Night Out event! Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom  Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.

Do you want to get into Medical Device Sales?? If so →  https://www.newtomedicaldevicesales.com/podcastFrom filing for bankruptcy to working with the top medical device companies, Roxy Tirado shares her full journey. Topics include grit and perseverance, what it's really like being a female in medical device sales, landing multiple job offers in six weeks, surviving and thriving at Medtronic and Intuitive, the pressure of big-name companies, building confidence, preparing like a pro, investing in mentorship, and staying grounded in gratitude and humility.Key Takeaways:Don't wait for rock bottom.If you're feeling stuck or beat down in your current role, don't wait for a breaking point—make the move now.You don't need sales experience.Roxy broke into top companies like Medtronic with zero B2B sales experience. Hard work and coachability mattered more.Ask for help.Utilize mentors and community. Roxy leaned on others when she doubted herself, and it made all the difference.Be human first, sales rep second.Build relationships with honesty and authenticity. People buy from reps they trust, not robots with brochures.Play the long game.It's not about a quick sale—it's about becoming someone your clients can count on for the long haul.00:00:00 - Start00:02:04 - Who Is Roxy Tirado00:08:01 - What Was Your Experience, First 6 Months With Medtronic00:16:11 - Finding Motivation While Being Told You Will Fail Every Day00:21:09 - Accepting Failure To Succeed00:26:44 - Keep Relationships When You Move On00:39:13 - Changing Companies00:46:09 - Reflecting On From Being Bankrupt To Successful00:55:58 - Biggest Takeaways From The Last 3 Years In My Career01:04:15 - Future Plans

Terresa Zimmerman is an entrepreneur, author, advisor, and mentor to business owners. Terresa traveled the world for decades working on business and brand strategy challenges with the world's largest organizations, cross-industry, rooted in B2B, including Fiserv, QUALCOMM, NVIDIA, Brocade, Gerdau, Teck, Medtronic, and more. We can only guess how that led her to become the only female founder of a men's underwear brand, Wood Underwear®. With Wood, she quickly discovered her love for Main Street and all the small businesses that fuel our communities and neighborhoods. She is a 3X award-winning author of the best-selling Oh, Lords! She is an investor and co-founder of an enterprise software company and has been recognized for her advocacy of women founders and aspiring entrepreneurs.Terresa is forever training for another big run and trying to improve her golf game. She and husband, David, live in North Carolina, with Aussies, Whizkey, and Tequila. You can find Terresa on LinkedIn.Connect with Terresa here:https://www.linkedin.com/in/terresachristensonzimmerman/www.woodunderwearwoodunderwear.com and mainstreetmatters.coClick below to download our free template for 3 high-impact posts for LinkedIn:https://www.thetimetogrow.com/ecsposttemplates