Podcasts about Medtech

On this episode of the SPOT Radio podcast, Charlie Webb CPPL speaks with Jeff Devich BSME, MBA about the Sterile Start™ program, together they break down why so many medical device manufacturers struggle with the complexity of the ISO 11607 framework and how gaps in understanding can lead to costly delays, failed validations, and audit findings. They share real world insights, practical strategies, and clear explanations that help teams strengthen their sterile packaging programs and avoid common pitfalls.About Jeff Devich BSME, MBAJeff's background includes serving as Director of Operations for a combination of device contract manufacturers. He has extensive experience in equipment and process validation within the MedTech industry. Jeff applies his mathematic and engineering expertise to for the Sterile Start™ program creating Design of Experiments and characterization reports for Van der Stähl Scientific sealers, helping customers understand how process parameters affect their specific products. Email me: jeffrey.devich@gmail.comLinkedIn: https://www.linkedin.com/in/jeffrey-devich-1b6b2788

Are you focusing on growth while ignoring the operational decisions that could quietly derail your MedTech business?Scaling internationally isn't just about entering new markets or adopting the latest AI tools. It requires operational discipline, strong leadership, and the ability to make difficult decisions consistently. In this episode, Hakeem shares the five biggest lessons from his conversation with Joshua Gould, CEO of The Big Word, and explains how MedTech companies can avoid the mistakes that often emerge during periods of rapid growth.You'll Discover:Why operational discipline matters more than speed when scaling internationallyHow to use AI as a commercial advantage rather than a marketing buzzwordThe leadership, compliance, and infrastructure decisions that support sustainable international growthPlay this episode now to discover five international growth lessons that can help you build a stronger, more scalable MedTech business and avoid costly expansion mistakes.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn't a box to check after FDA—it's the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline. Mark Domyahn LinkedInJD Lymon Group WebsiteRAPID Coverage Pathway InformationDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

In this episode of Medsider Radio, we sat down with Karthik Ganesh, CEO of OnMed.OnMed is the healthcare technology company behind OnMed CareStation, a “Clinic-in-a-Box” designed to expand access to primary and urgent care. Before OnMed, Karthik served as CEO of EmpiRx Health, leading the company through rapid growth and a successful private equity transaction in 2021. Throughout his career, he's held leadership roles at QualCare, CareAllies, and Aetna, and advised healthcare organizations through Deloitte and EY.In this interview, Karthik discusses why hybrid care models still require a human touch, how enterprise healthcare buyers evaluate value propositions differently, why brand and culture should shape execution early, and how operating under constraints can sharpen innovation.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Karthik Ganesh, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - Karthik's obsession with healthcare access, and the “broken doorway” problem behind OnMed (05:51) - How OnMed combines telemedicine and brick-and-mortar care into a “Clinic in a Box” (09:04) - The OnMed metrics that surprised Karthik most, including a 37% patient return rate, and the reasons behind the company's success (09:22) - What OnMed designed differently after realizing that patients approach healthcare with their guard up (15:27) - The pitfalls of B2C healthcare and how OnMed was built as a B2B company by intention (22:01) - How Karthik reshaped OnMed around clarity, structure, and high performers (30:23) - What “brand” actually means to Karthik (39:37) - How OnMed tailored its value proposition for payers, providers, employers, and universities (45:45) - Karthik's fundraising philosophy: constraints keep companies inventive

Great medtech innovations win because patients actually use them. In this episode, Ken Nelson, Partner and Founder at Nelson Jennings Ventures, shares his journey from cardiac device sales at Boston Scientific to helping commercialize major players in cardiac monitoring, including iRhythm, BioTelemetry, and Bardy Diagnostics. He highlights how innovations such as wearable cardiac patches have transformed patient adoption and reshaped the monitoring market. Ken reflects on Medtech Innovator's impact in accelerating commercialization, partnerships, and investor readiness. He advises early-stage companies to leverage accelerators and industry events like Life Science Intelligence to strengthen their path to market and fundraising success. Tune in to hear how decades of experience in cardiac monitoring and startup scaling translate into practical advice for founders navigating commercialization and growth! Resources: Connect with and follow Ken Nelson on LinkedIn.

Are you expanding your MedTech business internationally too fast without realizing the operational risks you're creating?Many clinicians assume international growth means entering as many markets as possible as quickly as possible. But in reality, aggressive expansion often destroys operational focus, stretches infrastructure too thin, and exposes weaknesses inside the business. In this episode, Hakeem breaks down why controlled scaling beats reckless expansion and how smart MedTech companies use strategic market entry to reduce risk instead of increasing it.Listeners will discover:Why entering multiple international markets at once can quietly damage business growthHow strong domestic execution creates a competitive advantage when exporting internationallyThe difference between scaling strategically versus scaling emotionally through excitement and FOMOPlay this episode now to learn how to expand your MedTech business internationally without losing operational control, focus, or profitability.Source transcript:Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Why do so many MedTech innovations fail to gain traction—even when the technology works exactly as designed? In this episode of Med Tech Gurus, we're joined by Erin Rollenhagen, Founder and CEO of People-Friendly Tech, UX strategist, and author of Love at First Launch. With experience leading over 200 successful technology launches across healthcare and other regulated industries, Erin brings a unique perspective on what truly drives product adoption. Erin explains why usability and emotional connection often matter more than features alone—and why success depends on how both clinicians and patients feel when interacting with new technology. We explore how companies can preserve the original vision behind their innovations while navigating compliance, scaling challenges, and evolving market demands. From designing onboarding experiences that build trust to using AI thoughtfully without overwhelming users, Erin shares how MedTech leaders can create solutions that align with real-world workflows and deliver meaningful outcomes. If you're a founder, executive, or investor looking to improve clinical adoption and scale innovation without losing the magic of your original idea, this episode offers practical insights into building technology people actually want to use.

Most medtech startups fail before market. The ones that succeed? They plan for it from day one. In this episode, Amanda Helgeson, Business Development Manager at Forj Medical, discusses her work at the CDMO, which helps medtech startups navigate the critical transition from development to manufacturing. She notes that standout companies at Medtech Innovator pair meaningful clinical innovation with the passion and persistence needed to reach the market. Forj differentiates itself by integrating design and manufacturing early, helping companies avoid costly downstream issues. Her core message is to take a holistic, long-term approach, aligning product design, regulatory pathways, and reimbursement strategies from the outset while staying flexible to adapt. Tune in to learn how a holistic, future-focused approach can turn promising ideas into scalable medical devices! Resources: Connect with and follow Amanda Helgeson on LinkedIn. Follow Forj Medical on LinkedIn and explore their website!

Are hidden operational mistakes putting your MedTech export strategy at risk before you even enter a new market?Exporting a MedTech business internationally is far more complex than simply finding distributors or translating documents. In this episode, Joshua Gould explains the operational, compliance, AI, and scaling mistakes that cause companies to lose momentum when entering global markets — and what leaders need to do differently to scale successfully.Listen to discover:The operational mistakes that cause international expansion to break downHow AI can become a real commercial advantage instead of just another buzzwordWhat MedTech companies must understand about compliance, infrastructure, and market-entry strategy before scaling globallyPlay this episode now to discover the costly mistakes MedTech companies make when exporting internationally — and how to scale globally without losing control of your business.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Dr. Connie Lehman, founder and CEO of Clairity.Clairity is the first FDA-authorized AI platform that predicts a woman's five-year risk of developing breast cancer using only a routine screening mammogram.A physician scientist with over 300 peer-reviewed publications, Connie is a Professor of Radiology at Harvard Medical School and Breast Imaging Specialist at Massachusetts General Brigham (on leave). She holds an MD and PhD from Yale and was named to Forbes' 50 Over 50 Innovators and TIME 100 World's Most Influential Leaders in Health.In this interview, Connie discusses her experience translating academic research into a commercially viable startup, the massive undertaking of generating clinical evidence when you're creating a new category, and how Clairity is approaching adoption on two fronts: fitting into physician workflows and building access pathways for patients.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Connie Lehman, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:04) - The broken screening paradigm Connie saw in clinic — and the gap that became Clairity (05:09) - How Clairity rolls the clock back from detection to predicting risk in healthy women (07:31) - Why "more data is better" turned out to be wrong and how that shaped Clairity's product scope (21:57) - How physicians can translate grant-generating discipline into building a company (24:56) - What 18 months of pre-sub meetings revealed about navigating a de novo pathway (26:49) - Why Clairity validated its technology in over 250,000 mammograms when FDA required far less (34:43) - How Connie flipped the natural question from "how can doctors offer this?" to "how can women access it?" (43:47) - How relationships, not pitches, drove Clairity's $43M Series B

In this episode, pulmonologist, intensivist, and advanced bronchoscopist Huzaifah Salat joins Duane Manicini to unpack what's changing in lung cancer care, and why the biggest constraint in MedTech isn't the FDA, funding, or clinician adoption, but founders building for clinicians instead of with them. Huzaifah shares how robotic bronchoscopy, advanced imaging, and better CT quality are enabling diagnosis of tiny, moving lung nodules, and why the next wave may be non-invasive diagnostics like blood-based, saliva, or bronchial secretion testing. He offers an inside look at serving as a regional medical director and physician voice to the C-suite, where “no margin, no mission” meets patient-first priorities, and explains how diverse frontline perspectives, beyond physicians alone, shape products that truly fit real clinical workflows.Huzaifah Salat LinkedInDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedInThank you to our sponsors: Ward Law and JumpStart Inc.

Transformational medtech innovation needs more than a great idea. It needs the right engineering, clinical evidence, reimbursement strategy, and commercialization support to reach patients. In this episode, Peter Lewis, Executive Vice President of Business Development at Hydrix, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss what it takes to bring complex, safety-critical medical devices to market. Peter shares Hydrix's evolution from its origins in Australia to becoming a global medical product development company supporting cardiac, surgical robotics, imaging, neurostimulation, and other advanced technologies. He highlights why clinician-led innovation is especially powerful, what distinguishes today's most promising medtech startups, and why AI, reimbursement, and human clinical evidence are now essential pillars for growth. Tune in to learn what medtech innovators need to consider early if they want to build solutions that truly change care. Resources: Connect with and follow Peter Lewis on LinkedIn or reach out via email. Explore the Hydrix website here!

Are you frustrated that your clinically sound medical devices aren't gaining traction in healthcare?In this episode, we challenge the notion that clinician agreement equates to adoption. You'll learn that adoption is a complex behavioral change that requires understanding multiple roles and barriers.By listening, you'll discover:The key barriers to adoption and how to address them effectively.The importance of tailoring your evidence story for different audiences.Actionable steps to create a behavior change plan for your medical device.Tune in now to transform your medical device strategy and enhance clinician adoption!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

A medical device's intended use is not just a regulatory formality — it is the foundation of the entire product strategy.In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples where unclear intended use created challenges during certification and compliance activities.The episode also provides practical guidance for manufacturers on:Defining a robust intended use statementAligning intended use with clinical evidence and risk managementAvoiding “labeling tricks” that may trigger regulatory scrutinyBuilding internal collaboration between regulatory, clinical, and product teamsThis is an essential discussion for MedTech startups, QA/RA professionals, and manufacturers navigating MDR, IVDR, FDA, or global regulatory pathways.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Linkkarandeepbadwal linkedin: https://www.linkedin.com/in/karandeepbadwal/qra-medical linkedin: https://www.linkedin.com/company/qra-medical/Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

Ireland's growing reputation as a global leader in digital healthtech innovation was highlighted at a major industry event which took place at Trinity Business School. Scaling Digital Healthtech in Ireland, hosted by the four Irish European Digital Innovation Hubs (EDIH),in collaboration with Enterprise Europe Network and Ibec, saw over 400 stakeholders from across the health and life sciences sector come together to hear from leading experts across government, industry and academia, alongside panel discussions and case studies showcasing real-world innovation and impact. Digital Healthtech represents the combination of smart connected devices and AI-powered digital health tools which are transforming the delivery of healthcare and creating opportunities for new disruptive products and services by Irish companies. The event marks the first in a series of national engagements designed to support Irish SMEs and public sector organisations in accelerating the development and adoption of digitisation and to increase the awareness of supports which are already available. Ireland has established itself as a hub for cutting-edge healthtech innovation, supported by a thriving ecosystem of technology companies, researchers and policymakers. The event explored both the opportunities and challenges associated with scaling digital healthtech solutions, including artificial intelligence integration, regulatory compliance, cyber resilience, and access to funding and European markets. Speaking at the event, Minister of State for Trade Promotion, Artificial Intelligence and Digital Transformation Niamh Smyth TD underlined the Government's commitment to advancing Ireland's digital health ecosystem. "Today highlights the strength of Ireland's digital transformation and its growing, innovative healthtech ecosystem. The Government recognises the importance of maintaining and building on this momentum. At the end of 2025, €23 million was announced through my Department and the Digital Europe Programme to extend the European Digital Innovation Hubs (EDIH) Programme to 2029. This investment will enable our hubs to significantly accelerate digitalisation among SMEs and public sector organisations, delivering over 3,000 engagements, 1,100 "Test Before Invest" projects, and more than 200 training courses nationwide. "As work progresses on the National Life Sciences Strategy, Ireland is well positioned to lead the future development of this sector. Bringing together industry, innovation, and expertise is essential to achieving our shared ambition: supporting Irish companies to scale globally while delivering meaningful benefits for patients and healthcare systems. "These efforts are reinforced by a wide range of supports designed to help SMEs grow and internationalise their digital health solutions. These include Enterprise Ireland, the National Enterprise Hub, Local Enterprise Offices, Ibec, Health Innovation Hub Ireland, the European Enterprise Network, and the network of European Digital Innovation Hubs operating across Ireland." Joe Healy, Head of Research and Innovation at Enterprise Ireland said: "Through the European Digital Innovation Hubs, we are supporting Irish enterprises of all sizes and stages to harness advanced technologies, build capability, and compete internationally. This event demonstrates the importance of connecting the network to drive uptake of the supports on offer and strengthening collaboration across industry, government and academia." Ciara Finlay, Ibec Senior Executive said, "Demographic shifts accompanied by the rise of chronic diseases, coupled with the recent impact of the greatest global health emergency in over a century have highlighted the importance of fostering better health system resilience across the world. Digital Health is a solution that can unlock some of the challenges ahead. The digital health segment is estimated to grow at over 17.4% between 2021 and 2027 to €426 billion. "The Medtech, digital health...

Successful medtech commercialization requires founders to know what only they can do best, then bring in the right partners to help scale the rest. In this episode, Dan Purvis, Chairman and Co-Founder of Velentium Medical, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss the evolution of complex medical device development. Dan explains how Velentium was designed to integrate engineering, firmware, mechanical design, cybersecurity, testing, and manufacturing under one roof to better support OEMs from development through production. He also reflects on how medtech innovation has matured, with more companies arriving at events with working technology, animal data, and clearer paths to human use. Finally, Dan emphasizes that successful commercialization requires founders to focus on their strengths, build expert teams, and delegate specialized work. Tune in and learn how medtech companies can move from promising technology to scalable, secure, and patient-impacting solutions. Resources: Follow Velentium Medical on LinkedIn and visit their website here. Connect with Dan Purvis on LinkedIn.

Are you frustrated that clinically approved medical devices aren't gaining traction in healthcare?This episode dives deep into the gap between evidence and execution, revealing that it's often not the product, but the behavioral changes required for adoption that are overlooked. We challenge the common assumption that education alone will drive change.By listening, you'll discover:The key barriers to the adoption of medical devices in healthcare.How to approach behavior change for successful implementation.Strategies for improving clinician engagement.Tune in to discover how to turn your medical device into a success story in the healthcare market.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

On this episode of the Medical Alley Podcast, host Ben Wagner sits down with the leaders of Mobius Medical — co-founder Stefan Czyniewski and VP of clinical operations David Pomfret — for a behind-the-scenes look at the regulatory and clinical strategies shaping the future of medtech innovation. From early feasibility studies in Australia, to scaling operating in the United States, the conversation explores the realities of clinical research, the biggest mistakes founders make when building regulatory strategies, and why bringing medical technology to market is "not just hard — it's really, really, hard." Send us a message! Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram. 

Most medtech startups don't fail because of bad technology; they fail because no one built the market for it. In this episode, Ken Nelson, Partner and Founder at Nelson Jennings Ventures, and Omar Khateeb, CEO of MarketCraft, share how judging at MedTech Innovator sharpens their perspectives as investors, operators, and mentors by exposing them to diverse expert insights across regulatory, reimbursement, and commercialization. They emphasize that medtech success today requires far more than a great product; founders must actively build market demand and prioritize commercialization early. A major mistake many startups make is assuming acquisition will come easily after FDA approval without demonstrating real market pull and adoption. Ultimately, the best founders balance conviction with coachability while leveraging ecosystems like MedTech Innovator to accelerate growth and de-risk their path. If you're building, investing in, or advising medtech companies, this conversation will challenge how you think about commercialization, growth, and what actually drives valuation! Resources: Connect with and follow Ken Nelson on LinkedIn. Connect with and follow Omar Khateeb on LinkedIn. Follow MarketCraft on LinkedIn and explore their website! Check out the State of Medtech podcast!

In this episode of Medsider Radio, we sat down with Antony Odell, co-founder and CEO of Echopoint Medical.Echopoint is a London-based UCL spinout developing iKOr, an optical microcatheter for coronary diagnostics.Antony brings over 30 years of medtech experience across Johnson & Johnson, Fresenius, and Stryker, before transitioning into startups as CEO of Tayside Flow Technologies and Tissue Regenix. He holds a BSc in Physiology and Biochemistry.In this interview, Antony discusses translating academic IP into a commercial device, choosing early clinical sites to balance speed and learning, managing non-dilutive funding as a long-term discipline, and outlines the most important responsibilities of an early-stage medtech CEO.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Antony Odell, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:06) - How Antony's career centered on translating clinical insights into commercial reality (05:54) - What Echopoint's iKOr does, and why 40% of cath lab patients leave without a diagnosis (12:13) - How Echopoint landed its first U.S. clinical site, and what that means for the company (13:48) - What to assess before spinning out an academic idea, and why clinician input is the first real test (20:14) - Why Echopoint chose Barts over typical sites for its first-in-human study (22:58) - How getting too close to one clinical site can lead to dangerous groupthink (30:54) - Why non-dilutive funding belongs on the board agenda permanently (39:54) - How CEOs should manage boards, control information flow, and avoid becoming a “glorified note-taker”

Spencer Jones, Founder of XO Medtech and MedtechVendors.com, shares how frontline nursing experiences led him to patent vascular access innovations and ultimately take devices from idea to FDA clearance and product launch. Spencer walks through learning business fundamentals through accelerators, raising early funding, and building sales and distribution networks, then explains why launching a digital-first, AI-native ecosystem has enabled faster, leaner execution than traditional medtech pathways. Spencer also discusses leadership, clear communication, and why AI adoption is essential to accelerate and de-risk early-stage medtech.  Guest links: https://www.linkedin.com/in/medtech-innovation/ | www.xomedtech.com | https://medtechvendors.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 Medical   EPISODE TRANSCRIPT Episode 080 - Spencer Jones [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and today I'm delighted to welcome to the show Spencer Jones. Spencer is the founder at XO Medtech and MedTechvendors.com. He is an RN, MedTech entrepreneur with 12 years of med device leadership. He's a two time med device CEO with 10 plus patents under his belt and has taken devices from idea to FDA clearance and product launch. Spencer has built sales and distribution networks, led product development teams, and raised over 10 million in VC and Angel Capital. Spencer founded XO MedTech in 2024 to create a digital first medtech ecosystem, deploy AI native tools for medtech operators through medtechvendors.com and cultivate the next generation of medtech innovators. All right, Spencer, welcome to the podcast. Thanks for being here. [00:01:43] Spencer Jones: Thank you for having me, Lindsey. I'm very, very excited to be here. Like it's, it's always more fun to be a guest than it is to host the pod, so absolutely thrilled to be a guest on the pod. Thank you for having me. [00:01:54] Lindsey Dinneen: Of course. Absolutely. Well, yeah, let's just, if you won't, don't mind just sharing a little bit about yourself, your background and what led you to medtech. [00:02:04] Spencer Jones: Yeah. Born and raised in Arkansas. I've lived, I traveled a ton and lived in Memphis and whatnot, but grew up in a healthcare household. Dad did anesthesia for, what was it, 36 years or something at the same place. So I thought I was gonna be a CRNA, like actually started pre-med. Took chemistry my freshman year while I was, you know, it was just, I got a C and I was like, maybe, maybe med school's not for me. But but anyways, did the nursing school thing, got out, started working, pretty quickly, knew if you've ever spent any amount of time in frontline healthcare, you just kind of get, it's like a barrage of things that suck. It's just, especially nursing, the devices you're using are commoditized. Like just the workflows are bad. You know, people, it's, healthcare is very broken. Every, it's no secret. Everybody says that. Everybody knows that. So anyways, I noticed pretty quickly that hey, like why isn't this better? Why can't this be like this? And, you know, kind of had that mindset. And before I could even go through like critical care enough to apply to a CRNA school, ended up patenting some devices in the vascular access space. Really leveraged accelerator programs and the entrepreneurial support organizations that were in my area, in my region to, I call it that get that dirt money, which is like the before the seed, you know, your pre kind of, your pre-seed /seed you know, before the pre-seed money. And, and also like the business training, right? Like I wasn't formally trained on business stuff like that. So did that. Did the venture capital hamster wheel a little bit, took a, you know, device through class two de novo clearance. Was doing ride-alongs training, sales reps, doing marketing stuff, you know, managing our ip, managing clinical you know, 300 patient RCT that we had to do in the middle of COVID, launched the product and then past couple years, I left, left that company in 2022. Products still on the market and they got, you know, clearance in, in Europe now and et cetera, et cetera. But just been working more in laparoscopic spine or laparoscopic surgery orthopedic spine and then doing some like consulting projects and, and things like that. And then yeah, XO Medtech and Medtech Vendors that's been. You know, for the past two years, like a big focus. And I know we're gonna talk more about that, but yeah. So it's just been, it's been a great journey. Medtech is one of my --I love it and hate it at the same time, but I wouldn't wanna be doing anything else, frankly. So. [00:04:17] Lindsey Dinneen: Awesome. That's a great intro. Okay. You were, I really, I enjoyed how you sort of went straight from okay, so, so "I, you know, started the career, started in the industry, and then I, I, you know, got a bunch of patents." What were the ideas for the patents? Where did those come from? If we could just go back, how did that, what was that inspiration like? [00:04:39] Spencer Jones: Yeah. So I was night shift, med-surg, big, pretty big hospital in Little Rock. It was like one of the, one of the bigger ones in Little Rock, St. Vincent's, which is like CHI, St. Vincent, et cetera. And like one of my patients --well the, the very first one was a dual lumen peripheral IV. A patient has a peripheral IV in, I need to get a blood draw. They're like, "Go stick his other arm." I'm like, "Why can't we get it out of his, you know, IV that's in his, that's in his forearm?" And, and they were like, "Well, you, you know, you don't want to contaminate, you know, the thing." And I was like, "Oh, okay. That kind of makes sense." And I was like, well, PICC lines have two lumens. So you know, I was like, why couldn't, you know, why couldn't we just have a second lumen on, you know? And I was like, do those exist? And they didn't really exist. There was kind of one that existed, but it was more of like a longer extended dwell peripheral and you know, you kind of needed ultrasound to place it. You didn't really place, you know, normal nurses on the floor weren't gonna place it. And so I kind of, that one was just sheer-- I experienced something that I was like, "Dude, you're kidding me. There's gotta be a better way to do this." You know what I mean? And you know, kind of similar approach in that one. We, you know, that was the very first one so I was like doing these drawings on note cards and then like meeting with a patent attorney and I was like, did that provisional filing and wrote the patent myself and the claims and all this stuff. And the guy thought I was like, just " Okay, yeah, I'll, I'll file the provisional for you, bro, whatever." Filed the provisional, you know, ended up like going to a different attorney 'cause that guy was kind of just not taking me seriously. And so, ended up going to a different person, filed a non-pro provisional, started raising all this money, and that original attorney reached out later, was like, "Oh, so glad, glad to see blah, blah, blah." I was like, "Yeah, yeah, whatever." But then the second one, I, which was Safe Break Vascular, had the, it's kind of similar. Patient was like, had patients pulling out their IVs, pulling out lines, you know, and it's a million things. It's, it's walkie talkie, so like Alzheimer's, dementia, memory care type stuff. You, it's TBIs, it's agitation, sundowners. It's, you're coming off medication, you're drowsy, you forget, you're hooked up. You need to go to the bathroom. You trip on it. The nurse trips on the tubing. There's like a million reasons how, you know. Where mechanical force can get applied to an IV line. And same thing, I was just like, man, like this, it, it feels holding on for dear life is like the wrong approach because skin is only so strong. You get skin tears. Adhesives, you only want them to be so, you know, so, so strong. And it just, you know, it, wrapping it up, then you can't assess the site, you can get infiltration. So it didn't feel like any of the options we had were great. That one, I started to do patent research literally on the floor at the hospital. Like that night. I was like, I, 'cause I knew enough then found someone that had patented it. Like same exact concept. It was a nurse. And design was bad. Like the design, it had springs in it and it was just like not manufacturable and not a good design, but there were like conceptually it was like spot on. And then there were some elements of it that I was like, this would be very useful to have if I was gonna like actually do this. So me and somebody I'd met, and in accelerator program, we bought the patent from 'em for 20 grand which was a steal of a deal. It was like 10K up front, 10K after 18 months. And yeah. And then we turned around and raised a, you know, million dollar seed round within like, within nine months after acquiring the patent, got into an accelerator, ZeroTo510, shout out to them. But acquired the patent in February. Got it, or March, got into ZeroTo510, April. Went there in May, closed our seed round of a million in December, so it was like a nine month, yeah, ordeal. [00:08:03] Lindsey Dinneen: Wow. That's okay. That's awesome. I love the story. I love the fact that it was from boots on the ground going, "Okay, I see this problem. There's gotta be a better solution." That's super cool. So. All right, so you have these patents, you're going and you're working with accelerators. Can you tell us a little bit about what that experience was like, especially since you mentioned, you know, you didn't necessarily have the business background, so there was, there was probably a bit of a learning curve to that whole, you know, how do you get your idea from your, your note card drawing to commercialization. So I'd just love to hear about your experience. [00:08:35] Spencer Jones: Yeah. The, so I did one accelerator before ZeroTo510. It, I basically did two within about a year, a year of each other. It was like back to back to back. But the first one I did, it was industry agnostic. So it was just a lot of like mentorship and lean canvas startup methodology kind of business practice stuff like accounting 101, you know, building financial forecasts and models and like all of that stuff. So I really learned a ton about kind of just non device specific stuff there. Obviously I was learning a ton about device stuff along the way, but then once I got to ZeroTo510, that's when things kind of like really, you know-- and I had, I had won, I won that first accelerator. It was like a competition, and so I had 150K. And I was like, "Oh wow. So maybe, maybe this is gonna be a career path," 'cause I was still working full-time as a nurse and then I got into the second one. ZeroTo510 was amazing. Allan Daisley was running it. James Bell was like the co-director, I think, and it was like bootcamp. It was like, you know, 8:00 AM to 5:00 PM. It was like sessions and mentor hours and office hours and " Alright, we're done with that. You guys work on this for an hour and a half, we're gonna come back and talk about like the finished product and you better have it done." You know what I mean? And it was every day. I lived up at this building. It was amazing sponge mode. You know, it was one of those environments where you're just like constantly soaking it in and learning and learning and like you can feel your brain expanding like every day. You know, you wake up excited. And that one was amazing. Met a ton of people that I still work with today. You know, met my co-founder at XO Medtech. Met him at that accelerator. But yeah, it was just, that one was amazing. I was like, life changing. Came back from that and I was like, "This is what I was meant to do." I felt like I you know, found my calling. And so, yeah, shout out to the people there that you know, we're a part of that. [00:10:20] Lindsey Dinneen: Love it. Excellent. So, okay, so you found your co-founder for XO Medtech, and this is great because I wanted to dive into that. So, so you've, you've now successfully taken like several products to market and of course you have a lot of other great industry experience. What was, how was it different starting XO Medtech and Medtech Vendors than perhaps other things that you'd done in the past? [00:10:47] Spencer Jones: Yeah. You know, I'm gonna say it was way easier just to be honest. I mean, I mean, you know, I think we, we were doing a lot. We started building XO Medtech in 2022, 2023, and at that time a lot of it was like, it was really focused on the community and the training platform and the resources and kind of all the videos and things that we put in there. Which I still like to this day, will stand on it, that like there, if you're an early stage innovator and you're, you wanna like kind of internally like level yourself up, right? There's no better place than like XO Medtech and the training and inside there to do that, right? But, but yeah, it was we started doing it at a time when AI was starting to become, like Chat GBT, what was it, four was coming out or whatever. So we started it kind of before the wave and then as we were continuing to build it in like 2023 which was like the meat of us building it. It was like kind of starting to become more of a thing, but we still weren't really using it that much. But then as we really went into kind of like launch and growth mode in 2024, it was just like a huge tailwind and like being able and, and it continues to be. But like not having to raise, you know, three, four, $5 million to get a business off the ground and to get to a point where you can start selling something is just incredible. I mean, like we are, we are so agile and can move so quickly and, you know, we don't have any investors. We don't want any investors. So like our speed at which we can move is unbelievable. And coming from somewhere where it's " Oh, you wanna put out something for marketing? Route it through the quality management system and like maybe it goes out in two weeks." You know, we can go from like idea to feature in a week. You know what I mean, you know, let alone like idea to like press release, right? That's 10 minutes if we want to be, right? So really it's just, it's a lot easier and this takes nothing away. There's some incredibly rewarding parts of kind of my, like my medtech journey and stuff like that, like the day we got FDA clearance and, and X, Y, and z whatever date, you know, first sale and getting our first GPO contract. But it's, it's definitely more I would say day to day, just like the exhilarating agility, excitement type stuff that you like, don't really get with with me. And I'm not, I'm not taking anything away from, I'm still a medtech person through and through and I'm sure at some at some point I'll you know, do another device. We're developing another device at Lapovations, so, in combo spine. So my hands are still in it, but I love, love, love what we do at XO Medtech. It's so much fun. [00:13:11] Lindsey Dinneen: Awesome. Well, I love hearing that. So tell us a little bit about both XO Medtech and Medtech Vendors and yeah, their, their focuses. [00:13:21] Spencer Jones: Yeah. So I think, you know, like I said, we started XO Medtech and it's, it's a online community. So think like Skool, like S-K-O-O-L School or Circle, or there's some other Mighty Networks, like one of the-- we use Circle-- but you know, it's whether you're ideation or just like curious about medtech all the way through like series A really, you know, we've got, you know, there's community feed, people are posting. I mean, we posted you know, Project Medtech, you know, event stuff, discounts a lot of exclusive stuff where, I think we added, it was like three or $4,000 worth of discounts. Like just for being like once you join XO Medtech. But then there's that primary feed people, it's like a massive exchange of value and it's it's not like LinkedIn. There's no promotion. Like we base, we will take your post down if you're like nakedly promoting your own stuff or your services, whatever. The whole point of it is to be massive exchange of value. So you know, "Hey, we did some like really cool testing, ETO sterilization testing on coil tubing to see how it retained its memory. Here's what we found, your pictures," you know what I mean? Just stuff like that where it's like kind of giving people behind the, behind the curtain peaks at your own organizations or that kind of, those, those moments of alpha, those nuggets that you've found and just sharing it so you can have you know, and they're doing the same and everybody's better for it. But then we have a training course and then some other like mini courses, probably a couple dozen downloadable resources. So these are like, you know, prebuilt, proformas, budget forecasts, you know, IP stuff, due diligence type stuff, like stuff to help you with, get your data room beef, you know, beefed up and looking good. And we do videos. There's some live events every now and then. So, so that was very focused on the founder side, you know what I mean, like the entrepreneur side. We, you know, my co-founder used to run a med device, venture studio, so like doing like business engineering, business development, engineering, you know, kind of market related stuff for like early stage, largely like clinician and inventors and stuff like that. He used to run a, a, a group that did that. And we knew we wanted to kind of start to do more offerings that kind of for that side of the table, like the CDMO contract manufacturer design and development group side of the table. So we launched, we started building MedTechVendors.com and launched it in 2025, February, 2025. And then did kinda a relaunch with adding some like agentic AI features in I think at the end of the summer last year. But it, but at its core, I always say this analogy, it's like Angie's List, right? You know, Angie's List, what do they do? Well, it connects people with local pros. Allows them to like, evaluate, engage them really easily, you know, get, get their stuff done quickly from trusted people. You know what I mean? So we have the same approach. We help device teams, and that could be device teams at large, medium, small, or startup organizations or tech transfer offices, whoever we help those device teams find, evaluate, and engage contract manufacturers, CDMOs testing facilities, design and development groups, one man band engineers, whatever through the platform. We have an an ag agentic AI chat. So like it'll ask you questions about your device. It'll start recommending, "Hey, do you need this? Do you need these types of services? Are you looking for this type of vendor? This type of vendor?" It pre-populates forms. It generates matches for you. You can review each vendor's profile, one click get email intros or request quotes, and we're adding some some really cool additional features around some different like skills that you can run. So, think like a reimbursement skill or market a, you know, different predicate device selection skill, whatever. And so those are all gonna be like linked up to the to this kind of AI agent. I don't wanna say too much 'cause we're still building it. I'm like really excited about, but there's other things that we're adding to it. The ability to do quote, visualization you know, and trying to make it kind of a, you know, a home away from home, a hub where you can track execution, get things done, engage vendors, and kind of evolve it more laterally in kind of the lifecycle journey. Not just " Hey, I'm looking for a vendor," 'cause that's a very acute point in time in a, you know, in a person's journey. But trying to expand it out to say the period of time when you're doing X and Y and Z and looking for a vendor so we can get some really was sticky, more sticky use and add more value. So, that was that. And we've started really focusing on some more like intimate, I would say, engagements with CDMOs contract manufacturers focused on giving their sales and marketing teams massive, massive leverage using AI and ai, AI native tools. [00:17:35] Lindsey Dinneen: Awesome. That's really cool. Yeah. Okay, so going back a little bit to the, to XO Medtech, I know you know you, you mentioned that there's a lot of resources available, but one of the things that I think is super cool, and I would love if you just share a little bit more about this, is you have a course that-- i don't remember the name off the top of my head-- but it's basically sort of Medtech Innovation 101. It's, I think... [00:18:00] Spencer Jones: Yeah, The Playbook. [00:18:00] Lindsey Dinneen: Call it like-- The Playbook! And you call it like the MBA for somebody who needs to learn. So can you just share the value of that and sort of what, what made you go, "Okay. I have, you know, the expertise in all these different areas enough to be able to share the journey from start to finish." [00:18:19] Spencer Jones: Yeah, absolutely. I think like the, the value there partially comes-- I mean, I think speaking about the value, you gotta speak about kind of like why there was a gap there, like how it, why it didn't exist, whatever. There's just a lot of really bad content in medtech. You know, there's a lot of stuff that reads I mean, there's guidance documents, you know, ISO and this and that. Like those are tough reads, right? And then, you know, the, the content around " "here's how you really fundamentally apply these guidance documents and here's how all this fits together." And it just felt like everything was I don't know what the opposite of like inside baseball is, right? Like that kind of " Hey, here's what you really need to know." Whatever the opposite of that is, is how medtech content felt like to me everywhere. It was just like polished press releases, really, like consulting speak. You know, "You gotta be strategic with your analysis." It's okay "You know, you know, you gotta find your champions." "How do I find them? What do I tell them? You know, how do I engage them?" So it was just, that was the big gap. So I think the value, what we tried to do with The Playbook was, you know, give, like I said, pre-seed all the way through Series A, the right information, like the right depth, on the right topics in the right order with the right assets, so resources, downloads, all that stuff along the way so that you can go cradle to grave on this, basically be a novice, or we've had people that have launched products and gone through it and they were like, "Holy crap, I wish I would've had this five years ago." But the whole idea is to basically not make you a supreme expert on any one of those topics. There's 46 different lessons, 47, and like you can get through each one in probably 20 minutes, right, 15 minutes. But not to make you an expert on each individual topic, but to give you like a dangerous level of information on any one, and then make you able to dive deeper on any of them, you know, very quickly and easily. So like when you meet with your, you know, a regulatory consultant or an IP attorney, or go down the list, you are not, they're not saying words you don't know for the most part. You're not paying them $300 an hour or $500 an hour to educate you on definitions and concepts. Right? You're, you're applying principles and evaluating strategy versus " What's that again? Like, how does this, what's the timeline for that?" 'Cause that you know, that's just not good for anybody. You know, so, so that, that's kinda the main, the main value prop thrust of it. And I just, I frankly didn't think it existed, but proof's in the pudding. Like we've sold it to accelerator programs, we've sold it to hospital, you know, innovation departments. We've sold it to incubators, like trade associations that have like their like kind of innovation arms. It works. Like when people do it, it works. It's funny-- we can talk about this too-- but like the, you can lead a horse to water thing. It's funny how many people say they want to be entrepreneurs and say they wanna be innovators and really they just want to just yap. And they don't actually wanna put the time in. I'm telling you, it's like crazy how many, you know, fake entrepreneurs there are out there. But it's okay. It's okay. You know, like there has to be, I think there needs to be some cleaving or weaning or calving of the herd to some degree because we've got, I don't know, and maybe we need to develop 'em more, but it's, it is frustrating seeing it firsthand when it's like "You have a really cool device, but you are so uninvestible and you have no interest in being coachable that it just hurts me." [00:21:30] Lindsey Dinneen: Oh yeah, absolutely. No, I love that you've done that resource and yes, super excited to see hopefully a lot of innovation actually happen and be successful as a result of that. So with, you know, okay, so you have, you have this community now and I'm wondering if there are any moments that kind of stand out to you, maybe as you've built the company, also Medtech Vendors that kind of enforce, "Wow, I am, I am in the right place at the right time." [00:22:00] Spencer Jones: You know, I definitely-- you know, it's, it's, it's really, there's not, I would say, any huge singular moments. I mean, we've had people like get business from coming on the XO Medtech podcast. You know, we've had people meet new clients, new strategic partners type stuff, like in the XO Medtech community. I mean, I've made a ton of friends in the XO Medtech community, people that I talk to you know, every, every week or two you know, Brad Shirley, I'll mention him. He's fantastic. And like I've learned from him, he's learned from me. We've both learned stuff from the community. I, I, I really do think it's though, it's like it's, you know, those-- whether it's a LinkedIn DM or you know, somebody messaging me in XO and they're like, "Hey, I just went through this lesson. It was like, so good. You know, blah, blah, blah." And I think those little things honestly like power me, power me up, give me juice, give me energy. You know, and, and like reading, we, we did a ton of, I mean we probably got 30 people that did kind of like a pre- and post- assessment and they gave their feedback on The Playbook so we could refine it like as we were, you know, after launch and all that stuff 'cause we're constantly trying to improve it. And have reading the testimonials and people just being like, yeah, like "This is, this is killer." People that are brand new, people that have been in the industry for 20 years that went through it. I think so, I think, I think it's kinda like a myriad of those things. I would say some of the stuff on-- and that's on the XO Medtech -- I think some of the stuff on the Medtech Vendor side and what we're doing with, you know, kind of campaigns and the tools that we're developing and the work that we're doing there, like we are fully an AI native organization. Like it, like we, it there is just not at all like a significant amount of people in medtech using AI to like actually do not in their products. I don't care about that. Like I'm talking about like in their day-to-day operations and, and whatnot and like we're trying to change that. And so like in that respect, like we will come out with things, you know, release features, release products, build custom tools for CDMOs and you know, the looks on their faces and like how amazed that they are at X, Y, and Z. And sometimes it's like stuff where it's hey, I'm like building them a just showing them how to do something with not even a tool that we built and like they're blown away. And anyways, all of that stuff, I feel like, man, like this is where I'm supposed to be because like. We, we've gotta make MedTech a more attractive investment opportunity. We've gotta compress the development cycles and the cost to develop and the time to develop and get things to market. You know, and I look at AI drug discovery for the pharma world as like a huge way that that's happening. But we have to have that similar type of like, when you to engage with this, it will be good for our ecosystem and industry as a whole, becoming more investible, becoming more cash efficient and all that stuff because you've seen other sectors, you know, software is taking money from early stage medtech, like nobody's business. You know, people are investing AI and you know, I just looked at the annual report from like HSBC, the Venture Report, and like me, early stage medtech funding continues to be down. You know what I mean? So we just gotta do something like, I, I feel like it's an existential, it's an existential issue for early stage medtech to get better at being scrappy and using AI. [00:25:03] Lindsey Dinneen: And there's so much opportunity there. Yeah, I love that you're helping to promote that. So you've gotten to lead a number of different companies now and through very challenging milestones. And so I'm curious, how has your own leadership philosophy developed over the course of your career so far? [00:25:24] Spencer Jones: Oh, what a good question. You know, I, I hate to say this, but I've almost gotten more cynical, you know. [00:25:30] Lindsey Dinneen: Okay. [00:25:31] Spencer Jones: Well, and it, it's, it's like I try to be very protective of my time and like protective of the time of the people that I work with, right. You know, and that doesn't mean I'm not willing to like go the extra mile and whatnot, but I think it's about respecting people's time. Right? And, and you know, I think honestly my leadership philosophy, I think a lot of it revolves around just like incredibly clear communication and like staying above the fray. No riff-raff, just just executing and moving fast and like keeping expectations really high, because I feel like when you've got complacency, you know, at the top, it just, it like doubles every rung of the ladder lower that you go in the org chart or whatever. You know, so I think like pace, you know, pace and hyper clear communication, like no subversive or passive aggressive or anything. It's just like straight up, like I'll just exactly tell you if I wasn't happy with something or whatever, but I just, I don't know, like I feel, I feel like you know, leadership style too, like I think, I think it, so much of it boils down to communication for me. It's just like really, really clearly communicating and like making sure that people understand what good work looks like and what a, them doing a good job looks like, and where... Yeah, I think, I think being clear about expectations, really clearly communicating those expectations around like work product, what it should look like, how fast it should get done, how many updates I need, or how many questions I expect to get as you're doing this, what resources I expect you to expend and explore before you come to me with something you could Google. Like all of that stuff, but honestly, I, it, it's kind of a tough question thinking in like the more immediate past, just because I feel like there's been such like, almost like a flattening of org charts, frankly, with the way that we're using technology and AI these days where I feel like in the companies I'm operating in right now, like it's mainly just principles and like lower level stuff, like we're either delegating to AI agents or delegating to like VAs that are in a different country or something, you know what I mean? And, and so there's just been a big flattening. You know, seven years ago, six years ago, I was managing, you know, new grads outta college, two or three at a time, and, you know, having to like, have these kind of like, you know, like brotherly, you know, like talks with, you know, these types of things, " Hey, like you really gotta do this" and like coaching and stuff like that, i, you know, there's a, we have to have that stuff. I'm just not in, in organization and honestly, the organizations I'm in right now in startup world I just feel I don't know. Like I, I feel like we're, I haven't seen that and I, I know a lot of organizations that are small and nimble and whatever, and I feel like the org charts are getting real flat in terms of like people that are getting managed, you know, it's a lot of agents getting managed, frankly. [00:28:21] Lindsey Dinneen: Yeah. Yeah, yeah. Interesting. Yeah, that, that's a really interesting insight too. But I really do think that to your point of coaching and mentorship and how much of a difference that makes, but especially, I was just on this conversation earlier today of the critical importance I feel that there is about establishing expectations across the board, whether it's your clients, your employees, your coworkers, just making sure that everybody's on the same page is such a critical aspect of, of setting yourself up for success. So yeah, I love that you touched on that 'cause like I said, literally earlier today. [00:29:00] Spencer Jones: Yeah. And, and can I, can I, quick aside here. It's, it's on topic, but before we move on, I mean, I, I'm not the first person to think this or say this, but I'll, I'll die on this hill. The more you use AI when, when you're using it the right way, right, the better leader and better specifically, the better communicator you'll become, right? Why? So much of interpersonal office drama, bad management, bad leadership is like what we talked about, right? It's poor communication. It's expecting people assumed something or had knowledge they didn't, right? It's not letting them know what you really wanted, what good work looks like, all that stuff. This is all context engineering, right, which is just a similar to prompt engineering, but context engineering is kind of the other more important piece these days with AI. What do I mean by that? Like I'm gonna give a prompt to a chat. Is it in just like a virgin chat or is it in a project? What context, what documents, skills, reference templates, et cetera, access to code bases does that project have, right? What am I telling it to do? How am I breaking that down? How am I, you know, big, high level goal? What do I want it to do? What does the output need to look like? How deep do I want it to go? Right? Like, how many questions I say, "Ask me like five or six questions" when I'm prompting, right, if I want that, right? Give, so giving the other person right in that space to say " What questions do you have?" Right? The, the, the best people at context engineering and leveraging AI in that way end up becoming more, better and better and better communicators because it's-- I mean, yes, you're talking to a machine, but at the same way, like those principles a hundred percent apply to good professional communication. So I'll die on that hill. There's a lot of people that are like brain rott using AI. It's " what's the weather today?" And you know, "how many calories does mayonnaise have?" And those people are not, you know, they're, they're not improving their leadership communication by using app, but the people actually doing it right a hundred percent are, [00:30:52] Lindsey Dinneen: Yes, I could not agree more. I think that is one of the coolest things that AI has taught me personally is-- to your point, to be a better communicator, to be clearer with the way that I communicate, to avoid assumptions that the other person, say, knows what I'm talking about or, or does have the context behind why I asked the question the way I did, or all those kinds of things. So I, I could not agree with you more. Yeah. And it's exciting to see how it continues to evolve. Okay. [00:31:22] Spencer Jones: Yeah. And why, real quick, why, like the AI models, especially with the reasoning models and stuff, Opus 4.6, all this stuff, telling them why they're doing something and why doing it, doing a certain task within that project flow is important is proving to be more effective than telling them how. And I think that's something where, you know, you tell someone what to do, they may do it, but if you tell them and make them believe why it's important, they do it that way, they're really gonna do it that way. [00:31:49] Lindsey Dinneen: Yeah. Love that so much. Okay. All right, 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, could be within your industry, but doesn't have to be. What would you choose to teach? [00:32:05] Spencer Jones: Does this, assume-- I have a question. Does this assume that I'm already I'm already capable and you know, have enough expertise to actually teach this class? Or is it like I choose this topic, I'm now an expert in that and I get to teach it? [00:32:19] Lindsey Dinneen: I like, I like I like both options, but I'm gonna go with option B because you have a million dollars to play with, right, so you could build up the expertise. Yeah. [00:32:29] Spencer Jones: You know, I would still say like building AI tools, AI agent systems, you know, skills and subagents and these flows and, and really tactically executing that for medtech. And that that goes from founder, you know, innovator to service provider, reg, quality ,reimbursement, like all the way up through sales and marketing and then like CDMO teams, you know, doing contract manufacturing, doing this. Like I, I just, I'm so passionate about it and I, I just see that there's so much untapped opportunity that that is the thing I think, and, and like we, we are doing that not a masterclass, but like we are working with groups to do some of that. But, I just, it's just so, so, so, so much opportunity to do it. And I think there's like weird structural reasons why it's not being adopted the same, you know, at the same clip it is in other industries. But you know, medtech's very rules-based game. You know, you've got your guidance docs, you've got your predicate devices, you've got your clinical trial protocols, you've got your stats analysis. You got your, you know, X, Y, Z hospitals get paid a certain way. Like lots of formulas, lots of reference material, lots of guidance docs. You know, it's very kind of rules and order based system in a lot of ways. And biology has its own kind of, prescriptive way that things happen, right? So I just feel like it's so primed for it. And anyways, I, I just, I wanna see it adopted more so we can see like what's happening with software now, where, you know, the cost to build and, you know, produce and get software to market has com has almost collapsed, but compressed to, you know, from like months, maybe years to, you know, days and weeks and, you know, you got a $200, 250 bucks worth of like software subscriptions, Claude this, that, the other, you can get it done in a week if you, you know, two weeks if you put your mind to [00:34:21] Lindsey Dinneen: Yeah. Yeah. No, that would be an incredible masterclass. I like it. All right. And then how do you wish to be remembered after you leave this world? [00:34:30] Spencer Jones: Oof. God, what a good question, Lindsey. You know, I hope to be remembered at all. [00:34:35] Lindsey Dinneen: Yeah. [00:34:36] Spencer Jones: You know, 'cause I, I'm definitely one of those people that's " nobody cares, nobody's thinking about you." You know, you may have, I, I mean, I think there's like some healthy main character syndrome that people can have that gives 'em confidence, but at the end of the day, no one cares. They're just, everyone's thinking about themselves. But if I am remembered, which I hope to be I wanna be viewed as like someone that was, I'd say, loved their family was a good dad, good husband. I would say brought people joy, was like fun to be around, but like from a interested in other people sense, you know, you know, genuinely cared about people. But I would say that on the professional side, like somebody that you know, would like consistently just delivered an absurd amount of value whether it was, you know, running a business or coaching and developing people at a company or working on behalf of clients or trying to make a positive change. I would say impactful and valuable, you know, with the work that I'm doing. That's, that's, that's how I wanna be remembered. I mean, we don't have big, I don't wanna be a unicorn billion dollar company. No, we have no desire to do that. We don't even have a, a desire to get acquired at any point. We're not raising money, you know, we've, we've deliberately chosen to bootstrap it. You know, we frankly just wanna employ really awesome smart people that we work with, you know, pay everybody well. And like I said, add a absurd amount of value you know, and joy to the people and the clients that we work with and like work at the company with, you know what I mean? [00:36:05] Lindsey Dinneen: Yeah. Yeah, that's a absolutely wonderful legacy to aspire to. I love it. All right. And then final question. What is one thing that makes you smile every time you see or think about it? [00:36:19] Spencer Jones: Oh, I gotta be, I've got a 1-year-old kid. Banks. Banks Austin Jones. So it's gotta be him, and my wife of course. One thing that makes me smile though, every time I see it, oh... you know, I am, I'll cry at a good TikTok, so I'm so I guess that's like a form of smiling, you know? But I'm a pretty big softie, honestly. You know, this is gonna sound weird, but it's kind of those moments where you know, people usually strangers and usually people that don't look like each other, just show humanity to each other. And that could be like holding a door open for somebody. It could be small things, you know what I mean? But I really love seeing those moments and capturing them like candidly, you know? Just you know, oh, I was in a restaurant, I saw this thing happen. You know? I really love that these days. [00:37:09] Lindsey Dinneen: Yeah. Yeah. We all need more of that these days too, so, yeah. Love it. Alright, well, Spencer, this has been a, a fantastic conversation. I really appreciate you and your time today. I love what you're building in the medtech industry and cultivating community and resources and providing value. So just thank you for everything you're doing to change lives for a better world. [00:37:34] Spencer Jones: Thank you. Can I ask you a question? I feel like you were so good, like with the questions and kind coming on the back of like my responses, but I have a question for you like what? You know, what about the medtech space, like most excites you? It can be a specific technology, it can be a specific, you know, company doing something. It can be anything, but what's most exciting to you, kind of looking at 2026 and, you know, kind of in the realm of medtech broadly. [00:38:00] Lindsey Dinneen: Yeah. Oh, I love that question. So I love this industry in general, but there, there's something really special about the energy of being around people who truly care about making a difference. Part of the reason I started The Leading Difference was because I, when I first joined, had sort of noticed this sort stigma from people from the outside who weren't very familiar with the innovation, what it takes to get from, you know, drawing to commercialization. Just didn't, just didn't know. And there was this stigma that people were here just for the money. And then I started meeting all of these incredible change makers who they had personal stories of what they were seeing, or a family member was impacted. And I just loved the fact that there were so many cool people doing such cool things and getting to play a small role in that was the coolest thing in the world. So, you know, I, I say I happily stumbled into medtech five years ago and found my people and my happy place, haven't looked back. I love it. I love being around people who are genuinely trying to do good things in the world. And I hear about new and you know, new ideas every day, and I get excited probably almost equally about most of them because it's just cool to see. So I don't know. Does that answer your question? [00:39:29] Spencer Jones: No, it, it does. I mean, it, it really the, it all comes back to the patient at the end of the day. And I definitely, I, I feel like when people think of like medical device stuff, like their minds immediately go to like Stryker sales reps or something, you know what I'm saying? And there's just so much more to it than that. And there's one of my favorite things about medtech is like the personalities, you know, like you got your wacky, you got your wacky inventors and you know, you got your straight laced regulatory people. But when you get to know 'em, they're, they're absolutely hilarious. You know, you got your attorneys, you got your like, and I, every industry, every industry has their personalities. But I think medtech, you know, you got your beef head sales reps that are like posting " What's up guys? I'm here in the locker room in my scrubs" and like "Motivation Monday." You're like, "Oh my God." But it's just like all these personalities and you go to these conferences and you just see 50 of the same person, but they're each different, they have their own dreams and conflicts and ideas and whatever, but they're still like so in the same box in some ways. I think that's one of the funnier, like funnier things about medtech that just makes it quirky, you know? [00:40:30] Lindsey Dinneen: I love it. And I also love the amount of respect that I see shared amongst people of very, very different backgrounds and areas of expertise. And that was one of the things that made me fall in love with the industry too. I was like, I, for instance, you know, I'm in, I'm in marketing and business development, so I play a very small role in, in sharing about these devices. But people, the engineers that I work with and the consultants that I work with, and everybody in the ecosystem is always just " Wow, well, I can't do what you're doing. And so I think what you're doing is fantastic." And so there's just, there's this mutual respect that I think is super cool about being here too. So yeah, I'm a fan. [00:41:08] Spencer Jones: Yeah, I agree. I agree. We could, we could keep going for, for days... [00:41:12] Lindsey Dinneen: I know. [00:41:13] Spencer Jones: ...On this. I really, I know, I know we have to wrap it, but but yeah. Well, Lindsey, thank you for having me. Seriously, this was a blast. And you know, I'll just maybe like quick sign off plug or something here. If anybody that's listening to this is like interested in, leveraging AI, leveraging AI in medtech or for you personally or whatever, follow me on LinkedIn and post a lot of content about it. You know, talk about it a lot on the podcast. But then if you're, if you're on the founder side, if you're an innovator, like join XO Medtech. If you're on the CDMO side, if you're, you know, on a sales and marketing team, contract manufacturer, CDMO, even like signed development groups, that kind of stuff like, you are like, "We know we need to be using AI to better leverage X, Y, Z, or do this thing. We have all these, we have HubSpot and this thing and that thing, and none of it works together well and we've got too many tools." Whatever. Just hit me up. Let's have a conversation. We're doing some absolutely incredible things leveraging AI, giving these sales and marketing teams like crazy leverage. So yeah, just drop a dm. I'd love to talk to you. [00:42:08] Lindsey Dinneen: Awesome. Sounds good. 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, and we wish you continued success as you work to change lives for a better world. Looking forward to seeing the future of all the good things that you're doing. All right. Bye. [00:42:41] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Don Chigazola is back with Chigazola Merchants French wines on California Wine Country with Dan Berger and Daedalus Howell. Don Chigazola receives the first Golden Corkscrew with a fanfare for brass orchestra, for being a guest ten times on CWC. The last time Don Chigazola was on CWC was this episode last January, with a selection of wines he imports from Italy. Today, we will taste Chigazola Merchants French wines, which Don has just begun to import. These wines come from a vineyard and winery called Domaine Tour Campanets, located about an hour north of Aix en Provence in a village called Les Puys. Don has brought five bottles, two whites, two Rosés and one red blend. The winemaker is Emanuelle Baude, the daughter of the family that bought the property decades ago. The first is a Rosé, made of 70% Grenache and 30% Syrah. We’ll hear a lot of those varietals today, since they make up a lot of the production in Provence. California Wine Country is brought to you by Deodora Estate Vineyards. Visit Deodora to discover 72 acres in the Petaluma Gap that produce exceptional Chardonnay, Pinot Noir and Riesling. Sip the difference! Chigazola Merchants French Wines Don Chigazola opened Chigazola Merchants 14 years ago after retiring from Med Tech. The regulatory process took 6 months, but he finally got federal and state licenses to import, distribute and retail wines from Europe. They have been importing wines from Italy for 13 years, including most of the well-known Italian varietals, from 12 of the 20 regions covered. They developed an interest in French wines when his wife Debbie tasted some French Roses. Now, Chigazola Merchants French wines are coming in through the same process they have for importing Italian wines. Dan says that this Rosé wine carries so much more of that tropical fruit plus spice component from the Grenache. The Syrah is there for flavor but not or intensity. Dan says that Grenache makes the best Rosé in Provence. It’s delicate but dry, loaded with flavor. Domaine Tour de Campanets There is a centuries-old tower on the property, Tour de Campanets means bell tower in Provençale French. The wines labeled Bois des Fées are their top quality production. Along with his wife and son, Don travels to meet the producers and visit the wineries. The don’t import from a producer unless they walk the vineyards and get to know the family. The other Rosé is under the Bois de Fées label. This one is made with Cabernet Sauvignon, it has more acidity and more weight. Dan observes that American wine buyers think that if a wine is inexpensive, it can’t be any good, even if they are. People didn’t trust inexpensive wines from Provence because the price was low. On the east coast, these were the bargain hunters’ paradise. People knew about them. But on the west coast they didn’t sell. All these wines cost under $30 but Dan says they are comparable to wines that cost over $40. Don says to his clients who may resist Rosé, if you taste this Rosé it will change what you think about Rosé. A Vermentino by any other name The Tour de Campanets Cuvée is a blend of 50% Rolle (which is another name for Vermentino), 35% Sauvignon Blanc and 15% Ungi Blanc. Rolle, or Vermentino, has taken hold in France. The Italians claimed the name and so the French renamed it. This grape has a trace of pineapple in the aromatics that you don’t get anywhere else. This wine is completely dry. Daedalus suggests marketing it as “Rolle in the hay,” Marketing department, work on that. Ungi Blanc is the same as Trebbiano. It is another renaming. In Sardengna, Cannonau is Grenache, but the French wouldn’t let the Italians use the name Grenache. It’s the same grape. It’s global politics in a bottle. There is an annual wine show in Paris that the Chigazolas have attended for the last 3 years. This is how they started making contacts in France. The last tasting is a 2024 red blend. Dan says that Don is doing a service to his customers These wines are different than his Italian wines. Don has the experience to know how to find these wines, that are unique, delicious and priced at $30 and below. These wines and these bargains are unique. 

Are you frustrated with stagnant growth despite having an experienced distributor?This episode uncovers the common misconceptions surrounding long-term distributor relationships and highlights how reliance on these partnerships can lead to hidden underperformance. You'll learn why it's essential to reassess your distribution strategy for optimal success.By listening, you'll discover:The key criteria for selecting effective distributors in your marketHow to evaluate if your current distributor is truly the right fitActionable steps to boost underperformance and increase market growthTune in to transform your medical device strategy and unlock growth potential.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're discussing the FDA's third-party review program. This option is available for certain 510k reviews. It is performed through an independent organization that is not part of the agency. As such, there are additional costs involved but the time savings could potential make up for that added expense. Other factors and considerations are also reviewed. During this conversation, the following questions are addressed:If I need to get a 510k clearance on my new medical device, is going through the FDA my only option?Under what circumstances should a sponsor consider using the third-party review program?Under what circumstances should a sponsor not consider using the third-party review program?How popular is the third-party review program, i.e., why are many people not familiar with it?Can you provide some examples of devices that have gone through the third-party review program.What advice would you provide in choosing which third-party review organization to work with?What are the key steps when considering using the third-party review program?When evaluating potential third-party review organizations, do you have recommendations on what questions to ask?Is there anything like the third-party review program outside the US, i.e. is there any regulatory precedent?What else is important, and what are today's takeaways?Listen to this discussion and see if you may have interest in the third-party review program. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if your ideas/inquiries/suggestions align with a future episode.Send us Fan Mail For more medtech news and information, visit https://www.mpomag.com. 

The future of medtech is built by the people who keep moving ideas from concept to care. In this episode, Tom Salemi, editorial leader, podcast host, and longtime medtech community builder behind DeviceTalks, shares how his path from community journalism eventually led him into healthcare reporting, medical devices, conferences, and podcasting. He reflects on discovering purpose in serving industry communities and launching DeviceTalks Weekly during the pandemic to keep conversations going when in-person events stopped. Tom also discusses the importance of continuing to move forward during career pivots and uncertain moments that require people to bet on themselves. He explains why DeviceTalks focuses on the people behind medical innovation and shares his excitement about advances in neuromodulation, stroke care, clot removal, and surgical robotics. Tune in to hear how community, persistence, and purposeful storytelling continue to move medtech forward. Resources: Connect with and follow Tom Salemi on LinkedIn. Explore the Device Talks website!

Why do so many breakthrough MedTech products fail — even when the technology works? In this episode of Med Tech Gurus, we're joined by Holley Miller, Founder and President of Grey Matter Marketing and one of the most direct, no-nonsense voices in healthcare commercialization today. With nearly three decades in life sciences — from the early days of surgical robotics to advising CEOs, boards, and investors — Holley has helped create more than $4.5 billion in enterprise value by doing one thing differently: designing adoption before launch. Holley is the architect of what she calls the Product Adoption Lie — the dangerous belief that better products automatically win. In this conversation, she explains why most launches fail not because the product is weak, but because the market was never taught to change its beliefs or behavior. We explore why adoption must be engineered, how category design replaces traditional go-to-market playbooks, and why alignment across clinical, regulatory, and commercial teams is essential to changing the standard of care. If you're a founder, executive, or investor trying to scale innovation — not just launch a product — this episode delivers a hard truth and a clear roadmap for building something the market can't ignore.

Strong medtech innovation is not just about building great technology. It is about solving a real market problem, proving product-market fit, and creating a path to sustainable growth. In this episode, Darcy Bachert, CEO at Prolucid Technologies, joins Saul Marquez at the MedTech Innovator Radar Forum to discuss how medtech companies can bring promising technologies to market. Darcy shares how Prolucid supports organizations across the medical and nuclear sectors, with a strong emphasis on imaging and diagnostics. He reflects on the strength of the MedTech Innovator ecosystem and the momentum of companies progressing through the program with impactful innovations. Darcy also explains that today's funding environment demands more than IP and regulatory progress; investors want real-world, market-ready, and monetizable solutions. Tune in and learn why medtech companies need to stay close to customers while building technologies that can truly succeed. Resources: Connect with and follow Darcy Bachert on LinkedIn. Follow Prolucid Technologies on LinkedIn and explore their website here.

Are you struggling to grow your medical device business while juggling the pressures of visibility and adoption?In this episode, we challenge common assumptions about growth strategies in healthcare. Many companies mistakenly believe that chasing patients through marketing is the fastest path to success, but this often leads to stalled growth and missed opportunities.By listening, you'll:Understand why meaningful partnerships outperform visibility in driving adoptionLearn how to assess the true value of your offering and its impact on customer retentionDiscover strategies to recalibrate your growth approach for sustainable successTune in now to uncover the secrets to building a thriving healthcare business by prioritizing value over noise.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In this episode of Medsider Radio, we sat down with Kurt Jacobus, co-founder and CEO of restor3d.restor3d provides patient-specific orthopedic implants using 3D printing and advanced software.Kurt has over two decades of experience in medtech entrepreneurship, including successful exits to Enovis and NuVasive. Prior to his career in medical devices, Kurt was a consultant at McKinsey & Company. He holds a PhD in Mechanical Engineering and is an Adjunct Professor at Georgia Tech. In this interview, Kurt discusses how restor3d used the FDA's 520(b) pathway to generate revenue and regulatory proof simultaneously, why self-regulating beyond FDA requirements makes submissions a competitive barrier, and how to approach investor relationships and board construction with long-term thinking.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Kurt Jacobus.KEY MOMENTS FROM THE INTERVIEW(03:21) - How Kurt went from wanting to build race cars to 20 years of orthopedic entrepreneurship (06:03) - How restor3d's patient-specific implants challenge the “8 sizes fit 8 billion people” model (15:36) - Why early-stage companies should “ring the cash register” as soon as possible (17:16) - How a 520(b) pathway helped restor3d generate revenue before full FDA clearance (31:48) - How restor3d treats every FDA submission like a PhD thesis and holds itself to standards beyond what regulators ask for (35:24) - What Kurt learned from restor3d's limited market release (40:03) - How Kurt raised is last$100M+ round, and why fundraising is really a networking game (45:13) - What makes a great board, and how the wrong one can quietly derail a company

Some of the most meaningful healthcare innovations start with a deeply personal problem and the determination to make care more dignified. In this episode, Alli Truttmann, founder and CEO of Wicked Technologies, shares how a personal caregiving experience led her to pivot from lifestyle products into medical device innovation. Inspired by her grandmother's end-of-life journey, she identified critical gaps in incontinence care and set out to create solutions that improve dignity, sleep quality, and caregiver awareness. She discusses the company's evolution into healthcare, highlighting the Wicked Smart Pad, which detects small amounts of moisture and alerts caregivers in senior living environments. Alli also reflects on her experience with MedTech Innovator and how its network and support have helped shape her journey as a first-time device founder. Tune in to learn how personal experience, smart product design, and the right medtech network can help bring more dignity and innovation to care. Resources: Connect with and follow Alli Truttmann on LinkedIn. Follow Wicked Technologies on LinkedIn and explore their website here.

Are you losing out on revenue simply because you undervalue convenience in healthcare?In this episode, we challenge common assumptions about patient convenience and its impact on medical device adoption. You'll learn how prioritizing ease of use can bridge care gaps and boost revenue.By listening, you'll:Understand the real impact of patient convenience on compliance ratesLearn how to improve your go to market strategy with actionable insightsDiscover why good medicine is essential for good businessTune in now to transform your approach and enhance the adoption of your medical device!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

In just the past two months, Stryker, Intuitive Surgical, and Medtronic – three of the world's Top 100 Medical Device companies – have faced cyberattacks. Why are medtech companies becoming prime targets for hackers? What makes medical devices so vulnerable? And how is the FDA responding? In this episode of Let's Talk Medtech, Naomi Schwartz, VP of Regulatory Strategy at Medcrypt, breaks down: ✅ The anatomy of recent cyberattacks on leading medtech firms ✅ Why hackers are targeting the medical device industry ✅ What these breaches mean for patient safety and data security ✅ FDA's new cybersecurity requirements and what companies must do now

Investors, what if one of Asia’s biggest ageing-investment opportunities is a healthcare problem few people even talk about? Asia’s ageing population is quietly fueling a surge in demand for urology care - and investors may be underestimating the scale of the opportunity In Money and Me we meet the largest medical device company in Southeast Asia Michelle Martin speaks with Wong Yau Chung, CEO of Temasek-backed Advanced MedTech Holdings, about a possible listing, how the Singapore-grown MedTech is using acquisitions and its strategy to compete globally and a key question. Could urology become one of the next major long-term investment themes tied to ageing demographics?See omnystudio.com/listener for privacy information.

It's In The News - where we bring you the top diabetes stories and headlines happening now. This week, Tzield approved down to age one and over, Omnipod trials for fully closed loop, Tandem approved for pregnancy, Eversense 365 launches in Europe, generic Ozempic in Canada, an award for the T1D Barbie and more.  Announcing Community Commericals! Learn how to get your message on the show here. Don't miss our in-person events: www.diabetes-connections.com/events  Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom  All about 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  Okay.. our top story this week: XX The U.S. Food and Drug Administration (FDA) approved Tzield (teplizumab-mzwv) for use in children in stage 2 type 1 diabetes (T1D) ages one and older. The approval expands the previous indication from those aged eight and above and was granted under a priority review process. This decision is supported by one-year data from the PETITE-T1D Phase IV study, which evaluated the safety and pharmacokinetics of Tzield in children under eight years old. Tzield was approved for use in individuals 8+ in stage 2 T1D in 2022. Since then, we have been working to expand the eligible population. This expansion effort includes individuals in stage 3 T1D, who can preserve endogenous insulin production for longer when they take Tzield and, most notably today, children in stage 2. https://www.breakthrought1d.org/news-and-updates/tzield-approved-for-children-ages-one-and-older-in-stage-2-t1d/   XX Big write up in the journal Pediatrics about screening for type 1. Citing the 2025 ADA Standards of Care in Diabetes, the opinion piece talks about how to engage the greater healthcare community.  It says: We aim to encourage the development of strategies to emphasize the importance of T1D early detection, integrate screening into routine health care encounters, and support implementation of T1D screening. Pediatricians and other primary care clinicians are well positioned for greater collaboration with the multidisciplinary team, ensuring early detection, timely intervention, and improved outcomes. https://publications.aap.org/pediatricsopenscience/article/2/2/1/207272/Type-1-Diabetes-Screening-in-Pediatrics-Putting?autologincheck=redirected   XX More info about GLP-1 drugs and people with type 1. New study shows off label use did not lead to DKA or pancreatitis in a large 1-year single-center study. Moreover, GLP-1 agonist use in people with T1D was associated with lower overall rates of hospitalization, as has occurred in type 2 diabetes Although GLP-1 agonists are not approved by the FDA for T1D management, off-label adjunctive use has risen for those with obesity. Semaglutide was the most commonly-used GLP-1 (65.5% of GLP-1 users) followed by tirzepatide (23.5%). The rest were using the older-generation drugs: liraglutide or dulaglutide. Lots more information to come on type 1 and glp 1-s in upcoming studies. https://www.medscape.com/viewarticle/use-glp-1s-type-1-diabetes-not-linked-increased-dka-2026a1000d56 XX Health Canada ‌​has approved the first generic ​version of ​Danish ⁠drugmaker ⁠Novo ‌Nordisk's Ozempic drug. In January 2026, the Canadian patent for Ozempic will expire, paving the way for cheap generic versions of the semaglutide injections that help regulate blood sugar levels and appetite. Health Canada said this generic, like existing products, is indicated to be used for the "once-weekly treatment of adult patients with Type 2 diabetes to manage blood sugar levels." With three generics on the market, Tadrous said the price could drop to about $100 or less, depending on their dose. Health Canada said it's currently reviewing eight other generic submissions by different companies and expects to make a decision on these in the next few weeks and months. https://www.cbc.ca/news/health/ozempic-generic-health-canada-9.7180566 XX  Insulet has enrolled the first participant in a pivotal study for its fully closed-loop (FCL)A automated insulin delivery (AID) system for type 2 diabetes (T2D  The participants are between 18 – 75 years of age, living with T2D and using insulin (basal-bolus or basal-only). The Company received Investigational Device Exemption (IDE) approval in March 2026 from the U.S. Food and Drug Administration (FDA). The Company plans to submit a 510(k) filing to the FDA in 2027 and launch its FCL AID system for T2D in 2028.   XX insulet Corporation (PODD) has initiated a voluntary recall of certain lots of its Omnipod 5 insulin delivery Pods in the U.S. after detecting that some devices had a manufacturing defect that causes insulin leakage.   Patients using the affected devices could risk experiencing high blood glucose levels due to insufficient insulin delivery, the Acton, Massachusetts-based MedTech disclosed in a statement late Thursday. The company has already notified the FDA about the recall, which it said will affect nearly 1.5% of Omnipod 5 pod units it manufactures annually. The customers were advised to immediately seek a product replacement at no cost if a Pod from a defective lot is currently in use. https://www.msn.com/en-us/money/companies/insulet-recalling-certain-defective-omnipod-insulin-delivery-devices/ar-AA1YyslT?apiversion=v2&domshim=1&noservercache=1&noservertelemetry=1&batchservertelemetry=1&renderwebcomponents=1&wcseo=1&bundles=feat-es2020-c XX Tandem Diabetes Care (Nasdaq:TNDM) gets FDA clearance for its automated insulin delivery (AID) technology for use in pregnancy. The FDA cleared the company's Control-IQ AID technology for use in what they call: pregnancy complicated by type 1 diabetes mellitus. Tandem says t:slim X2 and Mobi are the first and only commercially available AID systems cleared for use during pregnancy in the U.S. https://www.drugdeliverybusiness.com/tandem-fda-clearance-aid-pregnancy-t1d/ XX Tandem also issued an urgent medical device correction for a software problem with its Mobi insulin pumps. The malfunction may cause insulin delivery to stop, causing high blood sugar if not addressed, the Food and Drug Administration said in a Wednesday recall notice. We told you about this back in October when Tandem sent a letter to customers notifying them of the fault and instructing them to update their pump software as soon as possible. The FDA now issued a class one recall, the most serious type. We just released a bonus episode all about Tanem – tubeless mobi and what else is in the pipeline. You can listen to that wherever you are listening to this.. it's the episode just before this one. https://www.medtechdive.com/news/tandem-recalls-mobi-insulin-pumps-over-software-malfunction/818260/   XX Switching CGMs didn't make a measurable difference for adults using MiniMed's pump system. In a real-world analysis presented at the International Conference on Advanced Technologies & Treatments for Diabetes, researchers found that CGM metrics for patients who switched from the Guardian 4 sensor (MiniMed) to Instinct by Abbott were able to maintain a time in range of greater than 75%. "When it comes to the automated insulin delivery system ... I think the sensor matters less and the system matters more," Viral N. Shah, MD, professor of medicine in the division of endocrinology and metabolism and director of diabetes clinical research at Indiana University Center for Diabetes and Metabolic Diseases, said during a presentation. "Having a different sensor with the system, I think the [glycemic] outcomes will still be what you want." I'm including this because the headline here seemed to indicate no CGM makes a difference, but this study only looked at two. https://www.healio.com/news/endocrinology/20260401/switching-cgm-sensors-does-not-impact-glycemic-outcomes-with-automated-insulin-delivery   XX Vitamin D supplementation may help delay or prevent disease progression in people with prediabetes.. in people who have specific variants in their vitamin D receptor gene. This was found after a second look at large study where researchers found vitamin d really did make a difference.. a second look with people who had a specific gene variation had much better results. "More research is needed to see if there are other factors that are associated with risk reduction." https://www.medicalnewstoday.com/articles/vitamin-d-supplements-help-prevent-type-2-diabetes-right-gene-variants   XX Senseonics (Nasdaq:SENS) announced today that it initiated the first European launch of its Eversense 365 continuous glucose monitor (CGM). The launch comes a few months after the company picked up CE mark for the long-term, implantable CGM in January. Eversense 365 is the world's first 365-day CGM system. It also holds clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems, like the Sequel Med Tech twiist system. The company said it made Eversense 365 available to the first patients in Sweden. It plans to bring the sensor to Germany, Spain and Italy in the coming weeks https://www.drugdeliverybusiness.com/senseonics-launches-eversense-365-europe/ XX A machine learning model can improve genetic prediction of type 1 diabetes by as much as 10%, show results from a University of California, San Diego study.   The researchers used the machine‑learning model T1GRS to improve on a gold standard polygenic genetic risk score used to predict who is likely to develop the condition called GRS2. The GRS2 polygenic risk score has been widely tested and can be used to predict newborns who are at high risk of developing type 1 diabetes. While early prediction can't necessarily stop the disease it can help to prevent emergencies like diabetic ketoacidosis at diagnosis, allow families time to prepare and could allow use of therapies to delay onset of the condition. In this study, Gaulton and colleagues carried out a genome‑wide association study in 20,355 people with type 1 diabetes and 797,363 non‑diabetic Europeans, as well as a further analysis around the MHC region in 10,107 diabetic and 19,639 nondiabetic individuals. https://www.insideprecisionmedicine.com/topics/molecular-dx/machine-learning-tool-helps-improve-type-1-diabetes-prediction/ XX Sen. Mark Warner (D-Va.) said Monday that he will return to the upper chamber this week after taking time off for the death of his daughter, Madison.   The Virginia senator wrote on the social platform X, "As we remember our incredible daughter, Maddy, my family has been deeply touched by the outpouring of support we've received. Thank you to everyone for your kind words." Madison Warner, 36, died earlier this month after a decades-long battle with juvenile diabetes and other health issues. Mark Warner and his wife, Lisa Collis, wrote in a statement last Monday that they were "heartbroken beyond words" by their daughter's passing.   On Monday, the former Virginia governor said his daughter "was a deeply empathetic and engaged person" and that "as recently as the day she passed, she was full of ideas and suggestions" for him, including how he could improve his social media presence.   "She used to say to me: 'Dad, you have the power — you have to use it.' She pushed me to make the most of my position, to use my seat in the Senate to help people in meaningful ways," he added.       "If I can find any solace during this time, it's that I have the enormous privilege to serve Virginians and the responsibility to keep working for a better, more just world in Maddy's name."   Warner concluded, "I look forward to returning to the Senate this week and continuing that essential work."   Madison Warner is survived by two younger sisters.     An estimated than 2.1 million Americans, including about 314,000 children and adolescents younger than age 20, have diagnosed type 1 diabetes as of March — which is what juvenile diabetes is commonly called — according to the CDC's National Diabetes Statistics Report.   An estimated 11 million U.S. adults have undiagnosed diabetes, the report notes.   Symptoms of type 1 diabetes include feeling more thirsty than usual, urinating a lot, bed-wetting in children who have never done so, feeling very hungry and losing weight without trying, according to the Mayo Clinic. https://thehill.com/homenews/senate/5851605-mark-warner-diabetes-death/ XX Mattel, Inc. and Breakthrough T1D just won a Gold Halo Award for Best Cause Product Initiative for the launch of the first Barbie with T1D.  The Halo Awards recognize the most outstanding corporate social impact efforts over the past year.

A breakthrough idea isn't enough in medtech; it takes the right technical partner to navigate software, regulation, and the path to market. In this episode, Chris Kennedy, Vice President of Partnerships at Prolucid Technologies, explains how the company helps medtech innovators transform complex ideas into market-ready products through specialized software engineering. He outlines Prolucid's work across device software, software-as-a-medical-device, cloud applications, and FDA-regulated development. Chris highlights how they support founders in navigating challenges like design controls, cybersecurity, quality systems, and regulatory readiness. He also shares insights from MedTech Innovator, emphasizing the value of coachability and the growing role of AI as a force multiplier to help small teams scale efficiently. Tune in to learn how medtech companies can build smarter, move faster, and use the right partnerships and tools to scale innovation more effectively. Resources:Connect with and follow Chris Kennedy on LinkedIn.Follow Prolucid Technologies on LinkedIn and explore their website here.

Have you ever wondered why your medical device fails to gain traction after regulatory approval? You're not alone.In this episode, we explore the critical difference between mere activity and a real commercial strategy. Many MedTech companies mistakenly believe regulatory approval guarantees demand, only to find themselves stalling without solid market plans.By listening, you'll:Learn how to develop a commercial strategy in parallel with regulatory processes.Understand the three key questions to answer before approval to ensure market readiness.Discover why engaging buyers early can facilitate smoother adoption of your medical device.Tune in now to transform your approach to go-to-market strategies and avoid costly missteps!Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Dagens ämnen: 0:00 Intro 4:08 Rapporter - Qualcomm, Cambi m.fl. 13:08 Medtech 14:49 Försvar 18:16 Sivers 22:10 Sandisk 25:53 GameStop 30:45 RTAC 35:32 Makro 37:54 Vätgas och energi 42:33 Veckans Fill or Kill   www.instagram.com/fillorkillpodden   Tack RoboMarkets! https://open.spotify.com/show/7nqoFzFNOZHoQDUnrwKf4L    @RoboMarketsSE Tack @avanzabank! http://avanza.se   Tack Virtune! www.virtune.com  

In this episode of Medsider Radio, we sat down with Alfred Griffin, co-founder and CEO of LightForce.LightForce is the developer of the world's first fully customized 3D-printed bracket system directly personalized for each patient's digital treatment plan.Alfred holds a DMD and PhD in Craniofacial Biology from the Medical University of South Carolina and completed his orthodontic residency at Harvard School of Dental Medicine, where he currently serves as faculty and the Board of Fellows. An ABO-certified practicing orthodontist, he continues to see patients every month while running the company.In this interview, Alfred shares how applying existing technology to an overlooked market can unlock a larger opportunity, how adoption friction is a design problem, and why scaling a new category requires treating operations as a core product investment.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with Alfred Griffin.KEY MOMENTS FROM THE INTERVIEW(02:43) - How growing up in a family of dentists shaped Alfred's path into orthodontics (07:41) - How LightForce uses digital planning and 3D printing to create fully customized braces (08:48) - Why LightForce isn't a brilliant idea, but an obvious fix for the teen braces market that aligners missed (12:19) - How LightForce is like Google Maps for teeth, eliminating detours and removing inefficiencies (17:30) - How Alfred built LightForce around his clinical strengths and hired for experience to round out the gaps (30:56) - The 3-part secret to LightForce adoption by physicians (36:42) - How Alfred approaches fundraising, matching investors to the company's stage and needs (41:51) - About LightForce's digital factories and why they're the company's core moat

Shai Policker, Co-Founder and Managing Partner at Edge Medical Ventures, a medtech venture studio and fund focused on developing and investing in medical devices that address unmet clinical needs. With a BSc in Electrical Engineering from the Technion, an MBA from Columbia Business School and over 25 years building medical device companies, Shai has founded or scaled 18 companies across cardiovascular care, surgery and respiratory health, filing more than 40 patents along the way.In this episode, Shai cuts straight to something most investors won't say out loud: that even a great technology with strong clinical data can still fail. Not because the product is wrong but because the process takes too long and the funding runs out. He breaks down the fragmented decision-making landscape in healthcare, why physicians loving your product means almost nothing if the payer isn't on board and why reimbursement is the real gatekeeper that kills more companies than bad science ever will.We also explore what makes Edge Medical Ventures different from a traditional VC fund. Shai explains how their venture studio model starts from validated unmet needs with a strategic partner already at the table and how their hands-on go-to-market support continues well past the R&D phase. A combination that helped one portfolio company go from zero to FDA approval with distribution agreements and paying customers on just $2.5 million. We also get into the Israeli startup mindset, the right way to think about IP and patents and how to know when a founder should step aside.Timestamps[00:00:17] What Pulled an Electrical Engineer Into MedTech 25 Years Ago[00:01:48] What 18 Companies Taught Shai That One Never Could[00:03:04] How to Know If the Problem Is Painful Enough to Build Around[00:04:56] Why 80% of MedTech Startups Fail Even With Great Technology[00:07:53] What a Venture Studio Actually Is and How It Differs From a VC Fund[00:10:51] The $2.5 Million Company That Got FDA Approval and Started Selling[00:13:54] Why Israeli Startups Move Faster Than Everyone Else[00:17:28] How to Think About Patents Without Becoming Obsessed With Them[00:23:44] Balancing Speed and Discipline Without Creating Expensive Mistakes[00:26:20] Final Advice: What Shai Wishes Every MedTech Founder KnewConnect with Shai - https://www.linkedin.com/in/shai-policker-b8760a3/Learn more about Edge Medical Ventures - https://edgemed.vc/Get in touch with Karandeep Badwal - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.linkedin.com/in/karandeepbadwal/ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow Karandeep on YouTube - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@KarandeepBadwal⁠⁠⁠⁠⁠⁠⁠⁠Medical device training courses delivered by Karandeep through Bywater - ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.bywater.co.uk/

Kat Hurd, executive coach and founder/CEO of Med Tech Collective, shares how nearly two decades in medical device sales and leadership, including at Boston Scientific and Saluda Medical, shaped her mission to help reps and leaders build influence, ownership, and long-term career momentum in complex, high-stakes environments. Kat explains why strong clinical partnership can elevate sales conversations into trusted-advisor relationships that impact outcomes, and outlines how she coaches individuals, trains teams, and supports go-to-market strategy. She also dives into the distinct challenges women face when navigating rooms where they're “the only,” the career accelerant of mentorship versus sponsorship, and practical ways to break into medtech by identifying gaps and learning the industry's language.    Guest links: https://kathurd.com/   Charity supported: Save the Children Interested in being a guest on the show or have feedback to share? Email us at theleadingdifference@velentium.com.  PRODUCTION CREDITS Host & Editor: Lindsey Dinneen Producer: Velentium Medical   EPISODE TRANSCRIPT Episode 079 - Kat Hurd [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host Lindsey, and I am delighted to welcome today Kat Hurd. Kat is an executive coach and the founder of MedTech Collective, where she helps medical device sales reps and leaders build influence, ownership, and long-term career momentum in complex, high stakes environments. With nearly two decades of real world experience in medical device sales and leadership, including senior roles at Boston Scientific and Saluda Medical, Kat brings a rare blend of commercial rigor, strategic insight, and credibility earned in the field based in Arizona. Kat is a speaker, advisor and coach who believes that when sales reps and leaders learn to own their voice, their business and their influence, the ripple effects extend far beyond individual success, shaping teams, cultures, and the future of the industry itself. Kat, welcome. Thank you so much for being here today. I'm super excited to speak with you. [00:01:45] Kat Hurd: Thank you so much for having me, Lindsey. It is an honor. I always love these conversations. [00:01:49] Lindsey Dinneen: Excellent. Well, if you don't mind just starting off by sharing a little bit about who you are, your background, and what led you to medtech. [00:01:58] Kat Hurd: Yeah, absolutely. Well, medtech, I like to say it's always, I was kind of born into it. So my mom is a nurse and she ran a medical clinic when I was in middle school and high school. So truly I would go to the clinic after school and, if, if actually we didn't have school, I remember one of the days sitting in a pharmaceutical rep lunch presentation, so I really got exposed before I even knew what it was. Even in that moment, I wish I'd understood more of what that rep was doing and really dug deep. You know, I thought I was gonna go to school and be a doctor, and then I quickly realized I didn't like freshman bio. And I wanted something where I could have an impact but still have some flexibility. So I actually, my to, to take you back to like how this all started, my background, sports medicine and so my undergrad and graduate degrees are in exercise science. I used to be taping ankles and rehabbing knee injuries and doing all of those things. And then I got exposure through that of being in the operating room when our athletes would have, you know, the injuries that were being surgically repaired, and that was really where I got that secondary introduction into medical device and started having conversations with other people who'd made the transition from athletic training where you have a ton of, you know, in insight into the human body and understanding of the medical world. And moving that into the sales arena. And so I met with someone in Iowa City. I'm a University of Iowa grad, and he was running the western half of the US for Boston Scientific at the time. And one thing led to another, led to me flying to Arizona and interviewing and then moving their site unseen really. I was there for, you know, max of 24 hours total in my interview process. And I just packed two suitcases and said "I wanna break into medical device." And that was in 2010. And I just fell in love with the industry and the therapy. So I was in neuromodulation working directly with spinal cord stimulator patients and started as a clinical specialist, and then I really quickly realized the way to have very clear impact on patients and providers was really actually to be in that sales role and be the one directing the support, directing the resources. And in neuromodulation, because you're in the OR and actually programming the stimulator, you're also kind of supporting the patient's care, which for me was right in my wheelhouse. And then I moved into leadership. And you know what you really wanna know is probably how did I land where I am now? And so I spent 10 years or 11 actually at Boston Scientific. And then moved to Saluda Medical, so to commercialize a small Australian based startup here in the US, which was such a fun and unique opportunity. And I always knew that was gonna be more of a three to five year play, and I just had it on my heart that I wanted to build a business to help reps be better reps, because I believe that the quality of care and the quality of outcomes is also directly tied to the partnerships and the caliber of the industry that supports the therapies. [00:05:00] Lindsey Dinneen: Okay. I love that. And I have so many questions as a result, but okay, let's start a little bit with what you're doing now and then maybe, we'll, we'll get to some of the other stuff as well, but, so you're supporting reps, and I think you said something really impactful about a lot of the patient outcomes kind of goes back to how, how the reps can be the best they can be. So I'm curious what all goes into that for you and what kind of training or coaching do you provide? [00:05:31] Kat Hurd: Absolutely. You know, I really, I saw that squarely and believed it when I was a sales rep myself. So I spent the first six years of my career on the sales side of things, and then moved into being a sales leader. And as a sales leader and then an area Vice President Saluda, it was the thing that I saw of like our teams and our people that excelled the most, weren't just the best salespeople, but they were the people that understood how to, for lack of a better word, leverage that clinical and patient experience into the entirety of the sales process and sales cycle. So good clinical care and driving good sales conversations, levels up the partnership and really creating this layer of, not just being a partner, but being a trusted advisor with the providers that you work with. So how that translates into my business now, 'cause oftentimes, you know, I get the question of like, why did you leave a burgeoning career? I had one physician who was like, "You were gonna be a CEO. Like, why'd you leave medtech?" I'm like, "I didn't leave. I'm just doing it differently," because I saw so strongly and so clearly that having the right resources as a sales rep and at the right time as a sales rep changes your career. I was lucky to have great mentors, but there's things that if I had had the right support and resources at the right time, I could have been even, you know, faster or more impactful in my results. And so that's what I do now. What my business looks like now is really, you know, threefold. So I work directly with sales reps who, not through their companies, but they'll come to me directly and we do sales and leadership coaching. So working on the strategies in their business, how they're, you know, clinically supporting. But, you know, I, I leave the clinical nuts and bolts to the organization because I'm not an expert, and that, unless it's spinal cord stimulation, then we can talk that for days. But you know, really how they're leveraging their clinical prowess into their sales process and building systems for success. And then I work directly with companies helping train and elevate their talent, both on the sales and leadership level. Then I also have an arm of my business where I do, and that's kind of more of the consulting arm of my business. I also help with sales strategy and go to market strategy. And then I also do more of like corporate speaking. So keynotes and workshops and seminars really focused on both how do you build and grow your career in medtech, particularly as a woman, because we know there's just not a lot of us. And you know, part of what I'm so passionate about is helping everyone and raising the caliber of talent everywhere, but also making sure that women have the structure, the resources, and the idea of the systems that they need to create so they can go as far as they want to. Doesn't mean they have to go all the way to the C-suite level if that's not what they want, but to ensure that they have the representation and the pathway in front of them to understand how to get there. [00:08:27] Lindsey Dinneen: Excellent. Okay, so let's dive into that a little bit because I know, I know you're super passionate about helping, you know, in general the industry succeed and, and move forward. But yeah, you have a particular passion for helping women. And I'm curious what's, what are some of the challenges or differences you see in a woman as she's trying to build her career in this versus say, a man who might just have a, a different experience? [00:08:52] Kat Hurd: Yeah, very different lived experiences and a lot of the tools and tactics and strategies that I work with my clients on are pretty universal. But what isn't universal and what we really work on for my female sales leaders and sales executives is that mindset and approach. Because you both have to you, well, you have to understand one thing, how to navigate rooms where you're the only or the lonely. Because most often in medtech, you will find yourself, at some point in your career, and if you haven't, please call me. I wanna know who you are and talk to 'cause that would be amazing if you've never been in a room where you haven't been the only woman. But it, it requires nuance. It requires an understanding of how to position yourself and your insights in a way that they land. And land effectively with the decision makers that you build the right connections. So you have access and visibility, and that's really the internal corporate side of things. And then you have the customer facing where there's of course nuance of, I mean, I had, when I was a sales rep, I had three female physicians as customers over the duration of my career. So I needed to understand how to work closely and collaborate with male physicians and do it in a way that there was a clear and fast line of what that relationship and rapport was. And I was able to do that so successfully that not only did I win a bunch of awards, but many of those individuals have become friends and mentors and sponsors of mine as well. [00:10:22] Lindsey Dinneen: Wow, that's incredible. Yeah. I actually wonder if you could speak a little bit to what you just said, because this is something-- so recently I had an opportunity to host a leadership summit, and one of the things that came up in the keynote was about how there different types of mentorship available. So, so you need, you need people who are kind of in your corner coaching you, but then you also need that kind of next tier, which is that sponsor like you were saying. So I wonder if you could speak a little bit to that. [00:10:54] Kat Hurd: Absolutely. Mentorship and sponsorship is, is some of the best lighter fluid that you can add to your career growth, truly. And I'm so passionate about it, I, some of what I do from a consulting work standpoint is actually help organizations build mentorship programs. That was my very first consulting contract when I started my business. So I, I'm actually very proud of that and I, I don't ever share that, so thank you for asking that question. 'cause I don't think I would've even called that out. But it's so inherently valuable and I, I'll just take us on a quick sidebar of why it's so important especially for women, because women, when it comes to career growth, will wait until they have 100% of the qualifications to apply for a role. When left to our own devices, we oftentimes will look at it and say, "I either don't wanna be rejected, I don't wanna waste anyone else's time or my time, or, well, I don't have all of those qualifications, so I'm not going to apply. I'll wait." Now, our male counterparts are far more brazen and they need three out of five of those qualifications, and they are convinced they are the top candidate, and there's something to be said for that, right? You know, I, I aspire to that level of, of confidence and conviction and I, I, you know, really both, you know, encourage and in some ways push and, and motivate my clients to do, to take that mindset and approach and not just the unbridled confidence. We do need that. But to understand that you don't have to have every single checkbox because when you're looking at career growth, if you're fully qualified and can do everything of the entire job scope on day one, you've actually already entered a role that you're already overqualified for. [00:12:37] Lindsey Dinneen: Ooh. [00:12:39] Kat Hurd: Because where do you grow? [00:12:41] Lindsey Dinneen: Mm-hmm. [00:12:42] Kat Hurd: So, so that's, that's the importance of mentorship and sponsorship is to have others see maybe what you don't, and help you identify where your talents and where your strengths are. Because really career growth, the best thing you can do is lean into those talents and then explore the edges that you need to grow into, and mentorship can help you do that. Now, the difference between mentorship and sponsorship: a mentor is someone who's likely walked the same path or similar, has done much of what you've done or has insight into it, and can provide insight, guidance, resources, and be a sounding board. What you don't want is a mentor that just commiserates or tells you that everything you're doing is right, yeah, because we all have areas to grow. So that's, mentorship is so important to have those people that it's kind of your lifeline, right? Can you, what's your phone a friends? You gotta have some of those phone a friends. And then sponsorship, those are people that can help you open doors. And sometimes a mentor will also be a sponsor. They're not mutually exclusive, but those sponsors are individuals who have influence and access to rooms that you aren't in, as do your mentors oftentimes, but can help open doors create introductions and open pathways that you didn't even know existed. The mentors and sponsors alike will be those people to encourage you to apply for roles when you think, "Oh, I don't know, I'm, I'm not sure if I'm ready." I mean, that actually, as I said, that took me right back to, I was in Atlanta, Georgia when there was an area vice president role that opened up. I was a regional director at Boston Scientific at the time. And I went to my area vice president, who I worked for, and he's like, I was like, I don't know if I'm qualified. He's like, absolutely, you're applying. [00:14:28] Lindsey Dinneen: I love that and "I'm gonna follow up with you." [00:14:32] Kat Hurd: Yeah, yeah, exactly. And I didn't get the role, but that isn't the point. It's the conversations and the growth that even comes from it too. So, so sponsorship is so important because it really is what can create some of the access and avenues and opportunities that you didn't know were possible. I'll share kind of a quick illustration of that 'cause it's very relevant. Dr. Mike Dorsey, he has a, a society called Sierra Spine Society. Not sure if you're familiar it. [00:14:59] Lindsey Dinneen: Little bit. Yeah. [00:15:00] Kat Hurd: It's one of the best conferences out there. I'll just say that. Like you get to ski while you're there and it is wonderful. But when you talk about sponsorships, so I've known Mike through my career, especially as I moved to Saluda Medical, you know, expanded my sales leadership influence and the geographies that I supported. But when I went out and started my own business, he was the first one to come to me and say, Hey, I wanna partner with you. I want you to come to Sierra Spine and run an industry panel. [00:15:30] Lindsey Dinneen: Yeah. Yeah. [00:15:31] Kat Hurd: And there's no conversation like that that exists now. And we were texting about it this morning. It's why it's such a timely example, because now these conversations are, are popping up at other society meetings about the partnership, the collaboration, what is the role of industry and outcomes, all of those important things. And so his sponsorship has led to me now having other opportunities and conversations with different societies and different physician partners about the importance of those collaborations, about the accelerant that they can be in care and in, in outcomes. And so without someone like Mike, like Dr. Dorsey, I wouldn't have had that opportunity. I wouldn't have even had necessarily the proof of concept to go have these conversations. So that's where sponsorship can be so inherently valuable in your growth and creating movements and motions that you just truly didn't know were gonna be possible. [00:16:26] Lindsey Dinneen: Yeah, and I think you said something that I wanted to touch base about. So, you know, you were talking about how oftentimes women don't apply for positions because they don't meet all the qualifications. And I, I know that's a very common thing and something that I've heard from people that I've helped mentor are sometimes when they're young in their career or they're wanting to break into, say, medical device sales, sometimes they have all of these incredible skill sets, but because they're not already part of the industry, they feel that they're not always sure how to connect the dots and get seen. And I'm curious, what are some of the things that you recommend for young professionals who are in this spot trying to break in or trying to keep growing? [00:17:10] Kat Hurd: Yeah. Yeah. It's getting, gaining a clear understanding of your talents, your experiences, and how they translate to the person that's hiring is one of the most challenging and also most transformative things that you can do when you're searching to break into the industry. And so it's really, you know, having conversations with hiring managers before you're in an interview process. The job interview starts, the job application, the job opening, and you know, recruiting starts far before the opening is posted. So, step one, and I know that folks out there know this, but it's really, it's getting clearer on what facet of industry you wanna get into, understanding what those pieces are that you, that are, are critical in that role. Like what does that hiring manager really need? What are the problems they're looking to solve with that hire? And then translating your experience into the solutions that they're ultimately looking for. So what that like in said and simpler language, you have to be able to speak their language and understand their needs so you can position yourself as the solution to those needs. [00:18:31] Lindsey Dinneen: Do you think also there are some good resources out there that you would recommend in terms of, part of what I know the barrier can feel like, and, and it, it can be really daunting when you first get in the medtech industry because, for many reasons, but somebody might say an entire sentence where you're like, I have no clue what you're talking about, based on all of the industry jargon um, and acronyms and things like that. And so I'm wondering, are there resources available that, you know, people that are looking to break into the industry could access? [00:19:04] Kat Hurd: There are a ton of resources out there. The challenge is knowing the right resources. There's also a ton of programs that will support you in your breaking in. This is gonna be an unpopular opinion. I don't think you need big, expensive programs to create results. What you need is a strong belief in your candidacy and an understanding of what your gaps are. [00:19:29] Lindsey Dinneen: Mm-hmm. [00:19:31] Kat Hurd: And then the solutions and strategies of how to fill them. Now you can get there faster with the resources and framework. I mean, I don't have a formal program, but I still help people on a, you know, one-off basis break into the industry. But at a broader level, I think what you're really asking is how does someone, it's kinda like eating an elephant. Like where do you, where do you take the first bite? You have to get started in knowing what you don't know. And so truly, I would encourage people if you're looking to break into the industry, to sit down and make a list of all the things that you don't know about the medical device industry. And that might be what are the different, you know, verticals of the industry? What are even the, you know, the specialties or the therapies and then, okay, so "I don't know even what space I would want to get into." That's, you know, bullet number one to identify. Then, "I don't know the language or terminology." That's an easy one to fix. I used to always tell candidates that go take an online medical terminology class. Learn to speak the language. I feel like they're out there for like 20 bucks or something. You can find really easy ones. I'm sure you could do free ones. You could probably ask chatGBT to create you, you know, a laundry list of acronyms and medical terminology and an understanding. Because when you understand the environment, that's when you can translate your experience into something that's relevant. But when you don't understand the environment the customers work in, what the needs are of the hiring manager and what the positioning is of the company, it becomes really hard to position yourself as the right candidate. So to go back to like, what are those resources? Absolutely. There's, there are folks that do some free programs. I mean, honestly, TikTok, there's a ton of people dropping knowledge on TikTok. There's some YouTube channels out there. I'm actually recording kind of a mini podcast series this week with Jay Pendleton, who's another. You know, big name in the medical device space, but adjacent to medical device from an industry standpoint, where we're gonna be talking about a lot of this because there is such a need, and the most important thing is first you identify the gaps and then you go find those resources. Of course, AI is a great place to go, but also have those human connections, make that outreach because that actually will help you then in your job search as well. [00:21:47] Lindsey Dinneen: Right, exactly. And then making those connections. I always say you never know where that'll lead. You just, you don't, you might think it's just a quick intro and, and that's fine, but then your, your name will come to mind from if somebody's hiring or needs something. It's just, yeah, that, that's great advice. So, one of the things I wanted to ask about is you do a lot outside of, you know, your full-time job, which I'm sure feels more, even more full-time now, uh, running your own business. But tell us a little bit about some of the things that you're passionate about outside of full-time work that you volunteer for. [00:22:25] Kat Hurd: Yeah. It, it's funny you say that, you know, the, the, the full-time job now is definitely like an all-time job, not just a full-time job, but I love it. So I hate to be that person that's like, it doesn't feel like work when you love what you do, but I loved what I did before, you know, this is a new way of me doing it. But I also firmly believe that the, and I've seen it in my business, the best years I had as a sales rep and as a sales leader were the years where I wasn't just giving to my team and to my organization but was also connected and giving to my community as well. So right now, that looks like me spending a ton of time at Ballet Arizona. I'm the Vice Chair of the board of directors, so I have, I committed to a four year leadership, yeah, leadership journey with them. So I have two years as vice chair and then I'll be Board Chair for two years. And it's just really, you know, I've been dancing since I was itty bitty. I had a short stint on the Phoenix Suns for a hot minute, and you know, it's been something that has been creatively my kind of happy place since I was little. And it's been really fun to take my business acumen and my strategic mind and get to apply it to the art form that I love. So that's where, you know, these days where I'm spending a lot of my time, but I also do rescue work and work at our local animal shelter, walking dogs, giving them treats, you know. There's something to be said for walking in after a long day or a long week to, and yes, people often are like, it's so sad. How can you do that? Those dogs are so happy to see you, there is no way, truly no way that you can leave pissed off. Like, it just, it takes the, the weight of the week or whatever the situation is, and shifts your mind and shifts your perspective because truly I think when we, you know, come from a head space of gratitude, because we are all so lucky to be in the medtech world, the opportunities that we have, the, you know, just uncharted territory really that our career can take. That's the best part. I'm sure you didn't imagine that you would have a podcast and you would have, you know, the influence that you do with MD&M and all these other opportunities that are afforded to you. And so, it's good to be reminded of how much we do have, and it never hurts to get some puppy kisses too. [00:24:42] Lindsey Dinneen: Exactly. Well, you're speaking my language on both of them. [00:24:46] Kat Hurd: Love that. [00:24:46] Lindsey Dinneen: When we were, when my husband and I were paused for a little while in Oregon, we would go and do and go walk dogs and, and yeah, it is, it is hard because you kind of fall in love instantly all the time, but it is such a, it's so, it's such a gift. It's a gift for you. [00:25:02] Kat Hurd: Yeah. It, it really is. And we foster failed twice, so, yeah. You know, so we probably just should admit that we aren't good fosters we're good, you know, pet parents, but it is, and even you can't take all of them home with you. So just, you know, having those moments with them is really fun. [00:25:21] Lindsey Dinneen: So you mentioned your business acumen being wonderfully applied to the arts world, which is a, which is so great. I'm also wondering how it's worked on the opposite side of things. Like what do you think dance taught you growing up that you apply? [00:25:37] Kat Hurd: I love this question, and I was just saying this last week. I sat down at dinner with a mentor and sponsor of mine, and I was telling him that I am convinced --you cannot convince me otherwise-- that my dance background-- 'cause I actually, I went as far as to get a degree in dance. So like I live and breathe it for for a long time. And that is what made me such a successful sales rep especially in the OR environment because what do you do as a dancer? You observe patterns of movement and you, you are, you can predict what's going to happen physically before it happens because you can read those cues and so that is exceptionally valuable in the OR when as a sales rep, your job is to be like bright and present when they need you, and blend into the background when they don't. And it is like a dance in the OR, it's absolutely choreographed. And then when that goes into sales conversations, it's reading the nonverbals and understanding what someone's body positioning and posture is telling you without their words. And you really do, especially I, I did a lot of modern dance in college, you learn that improvisation, you have to be able to read someone's movement before it happens. So yes, it's a great question and I, I, you know, strongly believe, I know that athletes often get hired as medical device reps, but I think dancers are just an untapped and really under leveraged subset of talent because their skills can translate so strongly. [00:27:09] Lindsey Dinneen: I love that. Well, shout out to dance is I think many of the listeners know I'm also a dancer, so I of course, feel very strongly about the connection and the power that the arts can provide for any career really. [00:27:23] Kat Hurd: Truly. I'm curious for you, what do you feel like your, if of your background, right, of your maybe it's dance or some of the volunteer work or the travel that you do, how has that positioned you in your current career for success? [00:27:36] Lindsey Dinneen: Oh, that's, that's a fun one. I think so I think all of the skills that I learned as a dancer have been instrumental. Things like learning how to take correction with grace and apply, apply it quickly, apply the feedback quickly, permanently to make a big difference. I think learning teamwork and how you fit into the broader picture as a whole, you're not always gonna be the soloist or kind of the leader in charge necessarily. So sometimes you have to know when you're gonna be to put in dance terms, the corps de ballet. You have to know when to be the main group of dances. But again, not feeling like any role is insignificant. We all work together to success. I also think that resilience is a huge component of it. The grit that is required for dancing translates so well into anything else because this industry can be difficult and like you said, depending on where you're navigating, and what you wanna do, sometimes it takes a lot of sort of persistence and, and resilience and grit. Yeah, I could go on and on, but those are things that come immediately to mind. [00:28:48] Kat Hurd: Yeah, absolutely. It's that resilience. I mean, when you take it back to the conversation about breaking into the industry, you have to be willing to-- and same as in arts or in athletics-- like be willing to let yourself fail, to push yourself to your edges, to understand your limitations, and then blow past them. Because if you just stay at what your limitations are, you're never really gonna get where you wanna go. And as a dancer, you have to live that life all the time. And it is, it's absolutely, those are the hallmarks to breaking in. You have to be agile. You have to be very comfortable with rejection. You have to be very gritty in trying and trying and trying again, and it doesn't matter how many times you don't get a response, you're still gonna send out those messages. You're still gonna ask people for coffee chats. You're still gonna send one question to one person and ask for three minutes of their time. [00:29:39] Lindsey Dinneen: Yep. Yep. I love it. All right, so I'm curious, as you've had a really cool career in this industry, what are, what is a moment maybe that stands out as really solidifying that, "Hey, I'm, I'm in the right place at the right time." [00:29:54] Kat Hurd: Oh man, that's a hard question. I love that because I feel like I've had so many of those moments, and interestingly, it's not the moment that have been, you know, me standing on stage accepting an award. I think it's been in the little moments, like those quiet whispers of like, " Yes, this is it." You know, the, the times where my customers, you know, as a sales rep would come to me and say, "Here's the challenge I'm having. What are your thoughts?" Not about spinal cord stimulation, but because we built this trusted partnership and, you know, and I became an advisor in their world and not just another rep, right? So like those moments as a sales rep really were the moments that were were those kind of inflection points for me. And then I look as a sales leader of seeing my team win as a coach. You know, I, I get the question of like, well, you know, how did you prepare for what you're doing now? I'm like, "Guys, I'm coaching. I was coaching people for the last 10 years as a sales leader. Now I just do it for my own company instead of others." You know, but, and I will say this. The moment I knew that I was on the right path in my, my current role in starting my own company was starting to see the impact that it would have on the reps that I was working with. The sales leader who came to me as she first got promoted and then now is currently ranked first in her company, you know, like the, the reps-- even just this last weekend I got a text message from a rep I hired a few years back and who's at a different company doing big things and they just won a massive onstage award as Rookie of the Year. You know, really cool moments that getting to be a part of their success and their journey because not only is it incredibly fulfilling do you get to make a, a massive impact, but it also financially sets you and your family up for massive opportunity ahead. You know, I just had a client where we negotiated an additional 25K on her offer. Like that's a big deal, right? [00:31:58] Lindsey Dinneen: Wow. Yeah. Yeah. That's huge. [00:31:59] Kat Hurd: So, so I apologize because I didn't give you just one moment because, for me, it's, it's the invisible thread that runs through and that, because that thread has always been present in a different form or fashion, it's given me this in some ways insane courage to do things that people think are, are delusional and know that it's the right thing because of the impact that it's gonna have. [00:32:24] Lindsey Dinneen: Love it. Absolutely love it. Okay, so pivoting the conversation just for fun, imagine that you were to be offered a million dollars to teach a masterclass on anything you want. It could be within the industry or what you're doing now, but it doesn't have to be. What would you choose to teach? [00:32:42] Kat Hurd: Anything I want? Oh my gosh. Can I give two answers? Good. Because the first thing I would absolutely just want to teach one on this industry, and that's the power of influence in building your net, your web, I call it your, your web of, of influence. That changes your career. It's who you, who knows you, what they know of you, and that is what opens doors. So I feel like I would, I would do that. Right. And I, I have to do that because that's really what I'm so passionate about. But if it was like any off the wall topic, it would be traveling to Europe on a budget. I have it on lock. And particularly how to do the long haul flights without jet lag. [00:33:35] Lindsey Dinneen: Oh, excellent. [00:33:37] Kat Hurd: Yeah. [00:33:38] Lindsey Dinneen: Might need to talk more about this offline. [00:33:41] Kat Hurd: I feel like I have such a system and one of my my last boss used to always say, he's like, "You can go," 'cause I international travel is my, like, my passion outside of dance. And he's always like, "You can go, you just have to promise me that you'll come back." He used to joke. He's like, "I'm afraid that one day you just won't come back." So I made good on my word. I always came back, but I did learn a lot of tips and tricks along the way. [00:34:07] Lindsey Dinneen: Awesome. Excellent. Great masterclass topics. How do you wish to be remembered after you leave this world? [00:34:15] Kat Hurd: Oh, I love that. And what it unique question to ask in a podcast about medtech. I, I think we get so stuck in talking about who we are as professionals, that we don't always talk about the bigger pieces. So I wanna be remembered as someone who cared deeply and made an impact on others. Yeah. [00:34:35] Lindsey Dinneen: Yeah. Yeah. I love that. And you're well on your way, so there you go. [00:34:41] Kat Hurd: I like to think so. It's all a work in progress and it's truly a testament to, you know, to take it back to some of the start of our conversation to the mentors and sponsors I've had along the way who have given me-- you know, I, I talk about borrowed belief a lot because there's gonna be times in your career where you don't think you have what it takes. And that's where mentors and sponsors come in. And having people that will loan you their belief in you, so you can believe in yourself, even just for a moment to go do the thing that feels really scary. And because I've had those people, you know, I've I've felt brave enough to take those risks and moments. [00:35:17] Lindsey Dinneen: Love it. Yeah. Excellent. All right. And then final question. What is one thing that makes you smile every time you see or think about it? [00:35:26] Kat Hurd: Oh my gosh. Well, at the risk of sounding like that dog lady, it's a hundred percent our pups. We have, we have two now, and our current foster slash foster fail has this unbridled energy that I always look at her and think, "Gosh, if I could bottle that." Yes. So yeah, it's my family, right? My partner, Matt. I think that those, it's those moments. At the end of the day, I couldn't do what I do without my family, without Matt and yeah, so I'm very lucky to have them. [00:35:55] Lindsey Dinneen: Love that. Excellent. Well, this has been an amazing conversation, Kat, and we are so honored to be making a donation on your behalf as a thank you for your time today to Save the Children, which works to end the cycle of poverty by ensuring communities have the resources to provide children with a healthy, educational, and safe environment. So thank you so much for choosing that charity to support, and also thank you for continuing to work to change lives for a better world. We're grateful, and I wish you the most amazing continued success. [00:36:30] Kat Hurd: Well, Lindsey, thank you for all that you're doing as well. Even hosting these conversations, it's such an important, you know, distinction to talk about how do you make a difference in this space and change things for the better. So thank you for your kind words and the opportunity to have this conversation, get to hang out with you for a little bit. And yeah, I look forward to our next conversation. [00:36:50] Lindsey Dinneen: Awesome. All right. Thank you. [00:36:53] Dan Purvis: The Leading Difference is brought to you by Velentium Medical. Velentium Medical is a full service CDMO, serving medtech clients worldwide to securely design, manufacture, and test class two and class three medical devices. Velentium Medical's four units include research and development-- pairing electronic and mechanical design, embedded firmware, mobile app development, and cloud systems with the human factor studies and systems engineering necessary to streamline medical device regulatory approval; contract manufacturing-- building medical products at the prototype, clinical, and commercial levels in the US, as well as in low cost regions in 1345 certified and FDA registered Class VII clean rooms; cybersecurity-- generating the 12 cybersecurity design artifacts required for FDA submission; and automated test systems, assuring that every device produced is exactly the same as the device that was approved. Visit VelentiumMedical.com to explore how we can work together to change lives for a better world.

Are you chasing regulatory approval without a clear commercial strategy? This common mistake could jeopardize your medical device sales.In this episode, we uncover the relationship between regulatory compliance and commercial strategy, challenging the assumption that they are separate processes. Many believe that obtaining approval guarantees market success, but that's far from the truth.By listening, you'll:Understand how to integrate regulatory and commercial strategies effectivelyLearn the importance of speaking to actual customers before seeking approvalDiscover how misaligned features can turn your innovation into a 'me too' deviceTune in now to ensure your regulatory efforts translate into real revenue and market readiness for your medical device.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Why do qualified candidates apply to role after role in clinical research and never hear back? In this episode of the Clinical Trial Podcast, we unpack what's really happening behind the scenes in the hiring process. Getting hired isn't just about your technical skills. It's about how hiring managers assess risk, how recruiters decide who to champion, and who actually gets attention versus who gets ignored. Kunal Sampat is joined by Giovanni Lauricella, Co-Founder and CEO of Lifeblood, an executive search firm specializing in MedTech. With over 15 years of experience placing board members, C-suite leaders, and cross-functional talent globally, Giovanni brings a unique perspective from inside the hiring process. In this episode, you'll learn: Why strong candidates get filtered out before interviews What hiring managers are actually looking for How recruiters decide who to advocate for What it really takes to break into and advance in clinical research If you've ever felt stuck in your job search or wondered why the process feels like a black box, this conversation will give you a clearer understanding of how hiring decisions are actually made.

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.Understanding the UDI StructureTo fully understand Master UDI-DI, it's important to distinguish between the different levels:• UDI-DI → Identifies a specific device• Basic UDI-DI → Groups devices with the same intended purpose and characteristics• Master UDI-DI → Applies to highly individualized devices with specific design parametersThis new layer aims to better manage products with high variability.Why Master UDI-DI Was IntroducedFor certain devices — such as spectacle frames, lenses, and other customizable products — the number of variations can become overwhelming.Master UDI-DI helps:• Reduce the number of identifiers required• Improve traceability• Simplify product grouping• Enhance recall efficiencyKey BenefitsDespite its complexity, Master UDI-DI brings several advantages:✔ Better organization of device data✔ Improved market surveillance✔ Faster identification during recalls✔ Stronger protection against counterfeit productsChallenges for ManufacturersHowever, the implementation is not without challenges:• Increased data requirements• Risk of incorrect UDI assignment• Need for cross-functional coordination• Integration with EUDAMEDAs highlighted in the discussion, errors in UDI can be costly — including recalls and data inconsistencies.Timeline and UrgencyWhile the labeling deadline is set for November 2028, manufacturers should not wait.EUDAMED requirements are already active, and preparation takes time.

Why do so many great MedTech products stall after launch — even when the data is there? In this episode of Med Tech Gurus, we're joined by Amy Brouhle, Vice President of Strategic Business Development at S2N Health. A former emergency department nurse turned commercialization leader, Amy brings more than 20 years of experience spanning clinical care, GPO strategy, national accounts, and MedTech growth. Her career includes senior roles at Vizient, Hillrom, and GE Healthcare, giving her a rare, end-to-end view of how innovation actually gets adopted — or stuck. At S2N Health, Amy helps MedTech companies cut through the noise of fragmented data and turn insight into action. We explore why most organizations don't have a data problem — they have an insight problem — and how aligning sales, marketing, and strategy around the right signals can unlock utilization, accelerate adoption, and improve investor confidence. From GPO dynamics and channel strategy to AI-powered targeting, territory planning, and go-to-market execution, Amy shares practical lessons every founder and commercial leader needs to hear. If you're trying to translate innovation into revenue and scale, this is a conversation you won't want to miss.

Are you letting the fear of failure prevent your medical device from thriving in the market?This episode reveals how the conventional wisdom around failing can actually stifle innovation. Embracing failure is not just an option; it's a necessity for growth in the healthcare sector. By listening, you'll:Learn to view failure as a stepping stone to successUnderstand the role of failure in fostering resilienceDiscover how to encourage your team to innovate without fearTune in to revolutionize your approach to failure and open new paths for success in your medical device journey.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

The transition from a cleared medical device to a commercialized product is one of the most perilous phases for a MedTech startup. While founders frequently anticipate the technical and regulatory hurdles of early-stage development, they often underestimate the "commercial valley of death." Success in the modern healthcare economy requires more than a functional prototype and clinical validation; it requires an exact blueprint to navigate the complex organizational structures of health systems, ambulatory surgery centers, and value analysis committees.A primary pitfall for early-stage innovators is the discrepancy between clinical data expectations and real-world market entry. Founders naturally possess an unwavering belief in their technology to secure funding, yet this can inadvertently lead to an overestimation of rapid adoption and an underestimation of institutional purchasing complexity. Mitigating this pressure requires integrating strategic commercial leadership early in the timeline—often months prior to receiving regulatory clearance—to properly align the market profile and build institutional momentum before the product officially launches.Choosing the right commercial framework depends heavily on the disruptive nature of the device itself. While traditional hiring mechanisms or independent distributors can be effective for incremental or transactional product categories, highly disruptive technologies and high-ticket capital equipment demand a deeper, more execution-focused partnership. Implementing a modern, fractional commercial model provides seed-stage companies with a capital-efficient method to engage veteran industry strategics, reassure investors, establish clear operational ROI for hospital administrators, and build a lasting culture of advocacy within clinical environments.Key Timestamps00:01 – Introduction to the Commercial Valley of Death: Etienne Nichols introduces guest Ryan O'Mahoney and redefines the "valley of death" as the treacherous phase spanning prototyping, global scaling, and institutional market adoption.03:24 – The Underestimation vs. Overestimation Trap: Analysis of why clinical data optimism can lead to inflated forecasting and a failure to anticipate the procedural gauntlet of modern hospital purchasing.04:51 – Optimal Timing for Commercial Integration: When founders should bring on commercial expertise, highlighting why a few months prior to FDA clearance is the ideal window to build momentum.07:41 – Investor and Strategic Benefits: How early commercial positioning signals stability to venture capitalists, enhances company valuations, and opens doors for strategic corporate exits.10:03 – Go-To-Market Frameworks Compared: A breakdown of traditional full-time hiring, utilizing independent consultants, and leveraging distribution networks, alongside the risks and benefits of each.13:16 – The Rise of Modern Fractional Commercial Models: Exploring the hybrid approach as a capital-preserving mechanism designed for maximum impact on initial adoption.15:06 – The Three Non-Negotiable Pillars of Adoption: Introduction of the foundational framework required to pass go: clinical superiority, technical clinician enhancement, and administrative return on investment.18:59 – Escaping Perpetual Pilot Programs: Strategies to convert early clinical interest and hospital trials into concrete, multi-million dollar purchase orders.22:30 – Navigating Value Analysis and Hospital Budgets: How to pivot the conversation from purely clinical superiority to operational and economic ROI for healthcare administration.25:27 – Recruiting and Managing High-Intellect Commercial Teams: Building an organizational culture centered around purpose, passion, and retaining the founding team as an inspirational backbone.Quotes"They underestimate the complexity of introducing the technology and actually getting it through the gauntlet of introduction to whether it's individual hospitals, health systems, ambulatory surgery centers, or even privately owned labs and institutions." — Ryan O'Mahoney"In this modern day, and the economic climate, and the power that administration has... the clinical is not enough." — Ryan O'MahoneyTakeawaysCommercial StrategyEngage Commercial Strategy Pre-Clearance: Begin structuring your commercial roadmap and refining your Ideal Customer Profile (ICP) 2 to 3 months before expected regulatory clearance to ensure your go-to-market execution launches seamlessly.Capital Allocation & FundraisingLeverage Fractional Expertise to De-Risk Valuation: Utilizing fractional commercial executives preserves vital runway while instilling institutional confidence in investors, signaling that the organization is prepared for real-world scaling.R&D & Product AlignmentPass the Three-Pillar Framework Before Scaling: Ensure your technology satisfies all three essential vectors before attempting commercial scale: measurable clinical differences for the patient, procedural advantages over the status quo for the practitioner, and clear economic return on investment for the administration.Market DevelopmentPre-Align Administration to Avoid Broken Pilots: Prevent your device from getting stuck in perpetual, non-revenue-generating clinical trials by engaging hospital administrators in virtual demonstrations early, tying the success metrics of the pilot directly to a formal budget proposal pathway.ReferencesCatalyst Ventures: The commercial acceleration and strategy firm founded by Ryan O'Mahoney, specializing in bringing paradigm-shifting medical technologies to global markets.Etienne Nichols: Connect with the host on LinkedIn via Etienne Nichols' LinkedIn Profile.MedTech 101 SectionThe Valley of Death (Commercialization)In the medical device space, engineers often look at the "valley of death" as the difficult phase of raising money to move from a prototype to regulatory submission. However, there is a second commercial valley of death. This is the period after you get your official clearance from regulatory bodies (like the FDA), where companies frequently run out of money because they cannot figure out how to navigate complex hospital networks, get approved by purchasing committees, and turn clinical interest into consistent sales revenue.Value Analysis Committee (VAC)Think of a hospital's Value Analysis Committee as a strict gatekeeper panel for the hospital's wallet. Years ago, if a doctor liked a medical tool, the hospital bought it. Today, a formal committee made up of administrators, finance staff, and doctors must review every new product. They analyze whether the device is truly better than what they already use, if it reduces hospital stay times, and if the financial cost makes sense against the hospital's annual budget.Feedback Call-to-ActionWe want to hear from you. Have you encountered the commercial valley of death in your own medical device journey? Do you have specific regulatory, commercial, or operational topics you want us to unpack in upcoming episodes?Drop us a line at podcast@greenlight.guru with your thoughts, questions, or guest recommendations. We read every email and look forward to delivering the personalized insights you need to confidently bring your innovations to life.SponsorsThis episode of the Global Medical Device Podcast is brought to you by Greenlight Guru, the only dedicated medical device success platform. Moving successfully from innovation through the commercial gauntlet requires total synchronization across your entire lifecycle. Greenlight Guru's modern Quality Management Software (QMS) ensures your documentation, design controls, and regulatory submittals remain audit-ready and airtight during pre-market development.Once cleared, seamlessly transition your clinical data collection into the real world using Greenlight Guru's Electronic Data Capture (EDC) solutions. Together, their QMS and EDC ecosystem empowers MedTech startups to de-risk their commercialization process, satisfy demanding institutional purchasing committees, and scale safely worldwide. Learn more at www.greenlight.guru.

Are you frustrated by slow adoption rates of your medical device? You're not alone.This episode challenges common assumptions about clinician feedback and market readiness. You'll learn how to dig deeper into feedback to uncover real challenges that hinder adoption.By listening, you'll discover:The true barriers to adoption for your medical deviceThe importance of asking specific questions to gain clarityHow to simplify the introduction of your product for greater clinician acceptanceTune in to discover actionable strategies to enhance your medical device's market presence and adoption rate.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you frustrated by the slow uptake of your medical device in export markets?In this episode, we challenge the common belief that distributors are solely responsible for market uptake. You'll learn why the slow adoption of your product is often not about activity, but rather about how demand is generated and responded to.By listening, you'll discover:The true constraints holding back your medical device's successHow to ask the right question about demand generationInsights on how to rethink your export strategy for better resultsTune in to uncover insights that can help you transform your go to market strategy for your medical device.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you tired of guessing your way through MedTech exporting decisions?This episode shows why many MedTech companies stumble when they don't have a structured approach to diagnose their issues.By listening, you'll discover:A structured framework for confident decision-making in medtech expansionHow to Identify key constraints that hinder your growth and adoption ratesHow to effectively evaluate feedback without making premature changes Tune in to gain the confidence and structure needed for successful exporting in the medical device field.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.

Are you confident in your distributor's transparency? This episode may change that view.In this episode, we're uncovering a critical mistake in medical device distribution that could leave you vulnerable. Many clinicians mistakenly believe regular chats with distributors are enough for a solid partnership, but that's often not the case.By listening, you'll discover:How transparency impacts your distribution strategyThe essential questions to ask during distributor meetingsActionable tips on creating effective contingency plansTune in now to ensure your medical device distribution isn't a risky gamble.Book a 30min Healthcare Export Accelerator discovery callMessage me via DM on LinkedinThis podcast is for clinicians and solo founders feeling stuck in turning their medical devices into real businesses, with practical insight on go to market strategy, sales strategy, product launch, sales plans, business growth, exporting, selling internationally and how to scale up their international sales in MedTech.