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The Transformation Ground Control podcast covers a number of topics important to digital and business transformation. This episode covers the following topics and interviews: A MedTech Firm Warns of Their Impact from Their Software Switch, Q&A (Darian Chwialkowski, Third Stage Consulting) What do the EU's Antitrust Allegations against SAP Really Mean? (Scott Hays – Vice President at Rimini Street, Marcus Harris – Partner at Taft Law) The #1 Software Proposal Mistake That's Costing Companies Millions We also cover a number of other relevant topics related to digital and business transformation throughout the show.
In this episode of Tank Talks, Matt Cohen is joined by James Baskin, Founder and CEO of ZeroStone AI, to explore how businesses can transition from AI experimentation to real-world impact. James, a three-time founder with multiple successful exits, shares his journey from engineering at the University of Toronto to building and selling telecom ventures alongside Globalive's Anthony Lacavera. He offers valuable insights into leadership, resilience, and overcoming imposter syndrome.Drawing from over 300 conversations with CEOs and AI leaders, James discusses why many companies are “AI-aware but not AI-ready.” He reveals how ZeroStone helps mid-market firms turn failed pilots into scalable, impactful AI systems. James also highlights the differences between generative and agentic AI, the dual transformation of technology and people, and the importance of fostering a culture of curiosity and continuous learning for long-term success. This episode offers practical advice for founders and executives navigating the AI revolution.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.The Founder's Journey & Imposter Syndrome (00:09:41)* “Scaling Your Everest”: the emotional toll of leadership* Facing imposter syndrome in boardrooms* Anthony Lacavera's hard advice: “You don't know what you're doing.”* How that painful truth became a turning pointFrom Go-To-Market to AI Strategy (00:16:00)* Consulting with Series A/B startups on GTM and sales* Transition to AI after dozens of founder conversations* Why most OKRs fail: objectives must tie directly to long-term strategy* Introducing a new framework rooted in “Seven Powers” by Hamilton HelmerBuilding ZeroStone AI (00:22:22)* Founding mission: help mid-market firms (>$50M revenue) unlock real AI value* Observing 300+ executive discussions on AI, awareness high, action low* Why cultural and digital transformations must happen together* Moving beyond “copilots” to autonomous, agentic AI systemsThe AI Leadership Gap (00:24:27)* Boards push for AI results, but internal teams lack clarity* “You need both a data transformation and a human capital transformation.”* The rise of self-selecting teams, who adapts, who opts out* Building cultures of learning, not fearWhy 95% of GenAI Pilots Fail (00:31:16)* Most projects don't touch core business processes* Generative AI ≠ Agentic AI: only the latter changes workflows* AI agents as “digital workers” vs. human productivity tools* How CEOs can start small, measure impact, and scale over three yearsOvercoming the Pilot Trap (00:36:30)* Scaling beyond sandboxes by fixing data architecture* The critical role of clean data lakes, enrichment, and governance* Why early-stage companies move faster than legacy enterprisesAbout James BaskinFounder & CEO of Zero Stone AIA three-time founder with successful exits, James is a seasoned expert in go-to-market strategy, OKRs, and sales leadership. Through ZeroStone AI, he is now guiding mid-market companies to unlock true, measurable value from agentic AI, moving beyond failed pilots to autonomous systems that transform businesses.Connect with James Baskin on LinkedIn: https://www.linkedin.com/in/jamesbaskin/Visit the ZeroStone AI Website: https://www.zerostone.ai/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Seine Branche sei am legitimiertesten, sich zu den EU-Verträgen zu äussern, sagt Adrian Hunn, Direktor von Swiss Medtech. Der Verlust des Marktzugangs bedeute Kosten und weniger Investitionen. Nun treffen auch die US-Zölle die Firmen hart. 20 Prozent wollen Produktionen ins Ausland verlagern. Der Druck auf die Medtechbranche steigt weiter. Nach dem Scheitern der Verhandlungen über das Rahmenabkommen aktualisierte die EU das Abkommen für den Marktzugang für Schweizer Medtechprodukte nicht mehr. Die Branche musste mit Bürokratie und hohen Kosten neue Vertriebswege finden. Wie viel an Investitionen durch dieses Handelshemmnis verloren gingen, ist nicht zu beziffern. Nun treffen zudem die 39 Prozent Zölle die Firmen hart. Eine aktuelle Umfrage zeigt, 30 Prozent der Unternehmen suchen neue Absatzmärkte. 20 Prozent prüfen eine Verlagerung von Teilen der Produktion ins Ausland. Kommt die Wachstumsindustrie Medtech in der Schweiz zum Stillstand? Welche Perspektiven bietet die Schweiz für diese Branche? Warum könnte die Anerkennung der US-Zulassung allenfalls etwas Abhilfe schaffen? Adrian Hunn, Direktor des Branchenverbands Swiss Medtech ist zu Gast im Tagesgespräch bei Karoline Arn.
On this episode of The Medical Alley Podcast, we welcome Informa Markets Senior Editor Amanda Pedersen. Amanda has been covering the medical device industry since 2006, examining trends and innovations with a deep understanding of the medtech landscape. We also discuss MD&M Midwest 2025 taking place in Minneapolis on October 21 and 22. If you're planning to attend, register with the promo code MED to receive a complimentary expo pass.Send us a message!Follow Medical Alley on social media on LinkedIn, Facebook, X and Instagram.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Young Juhn, CEO of Wellysis.Wellysis is the Samsung spinout behind S-Patch, a lightweight wearable that enables long-term ECG monitoring without the discomfort of established cardiac monitoring devices.Young has spent more than two decades bridging hospital and home-based care — from his early career at Johnson & Johnson, to more than a decade at Kaiser Permanente, to leading healthcare innovation at Samsung before spinning out Wellysis in 2019.In this interview, Young shares why patient interviews should shape product design, how regulatory clearance is just the starting point for global commercialization, and why building a medical foundation before branching into consumer markets is critical for lasting adoption.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Young Juhn.
In this episode, Duane Mancini sits down with Amy Rinaldo, Partner at Ward Law Office, to discuss the strategic intricacies of intellectual property in the medtech industry. Amy shares her extensive experience in patent and trademark law, exploring the intersection of IP strategy with regulatory compliance and commercialization. The conversation covers the importance of comprehensive IP planning, the nuances of patents, trademarks, copyrights, and trade secrets, as well as global IP considerations for medtech startups. Amy Rinaldo LinkedInWard Law Office WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
This episode of the Global Medical Device Podcast, hosted by Etienne Nichols with guest Shannon Decker, CEO of VBC1 and an expert in healthcare transformation, dives deep into the science of how adults learn, contrasting pedagogy (child-centered learning) with andragogy (adult-centered learning). The discussion reveals why traditional training methods, like handing new hires 40 SOPs to read, are often ineffective for experienced professionals in the MedTech industry.Shannon explains the core principles of andragogy: adults are self-directed, problem-centered, and bring a vast reservoir of experience to the table (schema theory). They are less motivated by sequential, externally guided learning and more by what is relevant, timely, and what is in it for them. This self-directed approach means successful training in MedTech requires catering to intrinsic motivation and providing tactile, real-world practice rather than just videos or documentation.The conversation pivots to practical applications across the medical device lifecycle. Shannon shares compelling examples, like improving physician adoption of a medical device by shifting the focus from extrinsic financial rewards and regulatory compliance to the intrinsic motivation of improving patient health outcomes. By making users part of the development process and using performance feedback to tap into a professional's competitive spirit, organizations can achieve significantly higher engagement and successful adoption of new technologies.Key Timestamps[03:20] What is Andragogy? How adults learn differently than children.[04:45] The role of schema theory and existing experience in adult learning.[05:40] Why the traditional "drop 40 SOPs" on a new hire's desk fails adults.[07:15] Case Study: The challenge of low medical device adoption and the missing education piece.[08:50] The power of tactile practice and addressing user confidence (e.g., misusing the device).[11:00] Contrasting Andragogy (self-directed) vs. Pedagogy (directed/sequential).[14:10] Applying adult learning to device development: solving the user's problem.[16:45] How to boost adoption: Intrinsic motivation and making users part of the process.[18:20] The key physician motivator: Desire to help people over money or administrative requirements.[21:10] Behavior science: Focusing on influential champions and mid/top performers for diffusion.[22:45] The "Gold Star" effect: Using competitive spirit and relevant KPIs for motivation.Quotes"The way we come to learning with adults is different... The best way that they learn is coming up with things that are relevant to them, things that are timely, things that they need. They want to be interested." - Shannon Decker"I don't talk about the money that they're going to make... What I talk to them about is by paying attention and doing these screening exams, you're going to have an impact on the overall health of your patient." - Shannon DeckerTakeawaysStop Relying on Documentation for Training: Adult learners need tactile input and practice. Replace or supplement large volumes of SOP reading with project team involvement, practical exercises, and hands-on use to build confidence and retention.Focus on the "What's In It For Me" (WIIFM): When designing a medical device or a training program, identify the user's intrinsic motivations. For clinicians, this is often the desire to improve patient outcomes—lead with this message rather than revenue or regulatory burden.Build Champions, Not Just Compliance: Instead of solely focusing energy on low performers or the loudest voices, identify respected, influential leaders (champions) to pilot and advocate for new technology. Their positive experience drives the Law of Respect and encourages wider...
Join us for an insightful episode of Let's Talk Medtech, featuring EY's experts John Babitt and Arda Ural. Our guests delve into EY's latest Pulse of the Medtech Industry Report. They take a deep dive into the state of the medtech industry, examining whether the sector is thriving and assessing the real-world impact of tariffs on medical device companies.Discover which medtech segment is experiencing explosive growth right now and learn why mid-tier companies are gaining unprecedented momentum in the marketplace. From industry health assessments to emerging market trends, this episode delivers essential insights for anyone invested in the future of medical technology.Don't miss this comprehensive discussion that addresses the most pressing questions shaping today's medtech landscape.
In this episode, medtech marketer and MarketCraft founder Omar M. Khateeb joins Samuel to break down how early-stage and growth companies can engineer markets, not just chase attention. From mastering LinkedIn and expanding to X, Meta, and YouTube, to using storytelling that actually drives adoption, Omar shares how the best brands—like Zimmer Biomet and Intuitive—create influence through consistent, authentic leadership content. He reveals the psychology behind attention, the balance between value and unpredictability, and why depth beats surface-level posts every time. You'll also hear how AI is reshaping content strategy, how to refine your voice without losing authenticity, and why strategic pauses can reignite engagement. Whether you're a founder, marketer, or rep in medtech, this episode is your roadmap to building authority, trust, and momentum in a noisy digital world. Connect with Omar M. Khateeb: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!
What if the key to fixing pharma's toughest challenges wasn't more complexity—but more clarity? In this episode of Med Tech Gurus, Shetal Vyas, SVP of Commercial Strategy & Development at Ardelyx, joins us to explore how digital-first strategies are reshaping how we bring therapies to patients. Shetal unpacks how to overcome the $200 billion patent cliff, reframe customer engagement, and build scalable, data-driven commercial models that don't just add tech—but center patients. With practical insights into digital ecosystems, commercialization frameworks, and change management, this episode is packed with takeaways for MedTech innovators navigating the intersection of healthcare, pharma, and digital transformation.
In this episode of Tank Talks, Matt Cohen and John Ruffolo break down the latest developments in U.S.-Canada trade negotiations, particularly around tariffs and energy, with insights into how these pressures could shape future relationships.The conversation shifts to the growing energy demands of AI, as Matt and John explore how both the U.S. and China are navigating energy needs, and whether Canada could play a more significant role. They also analyze NVIDIA's $110 billion vendor financing strategy, drawing comparisons to the telecom bubble, and discuss the growing risks in data center financing. With the IPO of Fair Me America, they examine how the market is reacting to tech companies with no assets but huge valuations. A packed episode full of fresh insights on the intersection of tech, politics, and business.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.US-Canada Relations & Trump's Tariff Strategy (04:28)Matt and John discuss the ongoing negotiations between Mark Carney and President Trump regarding trade policies, tariffs, and key sectors like steel, aluminum, and energy. Can Canada withstand the pressure, or will it need to change its approach?The Energy Battle Between the US and China (09:03)What role does energy play in geopolitics? Matt and John explore how both the US and China are navigating their energy needs, and why Canada has lost some of its leverage as the world's energy supply game changes.NVIDIA's Vendor Financing Playbook: Lessons from Lucent & Nortel (11:18)John shares a deep dive into how NVIDIA's vendor financing strategy mirrors the mistakes made during the telecom bubble, drawing parallels to the strategies employed by Lucent and Nortel. What's the risk when revenues are tied to customers who may never pay?AI, Data Centers, and the Future of Technology (17:20)From the massive energy demands of AI to the rise of private equity-backed data centers, Matt and John dissect the latest AI and GPU investments and how the industry's future could be shaped by companies like Meta and OpenAI.The “Yellowstone Club” of Hyperscalers (20:26)The two discuss the bizarre world of hyperscalers and REITs, looking at how some data center startups are getting massive valuations without any real assets or revenue, and what this means for the future of tech investments.Bezos Weighs In on the AI Bubble (25:12)Jeff Bezos surprises everyone with his thoughts on the AI industry, calling it an “industrial bubble” rather than a financial one, and analyzing the disconnect between massive investments and real-world returns.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
When is it time to move from a training consultant to a full time hire? In this episode, Liz sits down with Heather Ramsey, Director of Client Learning and Development for OneDigital, to discuss just that. In their conversation, they explore when to hire, who to hire, and how to align that hire with the business strategy. Along the way, they define what makes a good trainer and some of the common mistakes they see in hiring for an in-house role. In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Heather Ramsey is the Director of Client Learning and Development for OneDigital Company. She oversees the OneDigital Leadership Coaching Services, Client Learning Development and Strategic Offsite Facilitators.She believes that empowered, engaged leaders and employees will help the organization reach its business objectives faster. She enjoys partnering with client leaders to build a learning and development culture with the client to support their business, increase retention and drive higher employee engagement. She and her team are seasoned professionals in the areas of training and development, leadership coaching, and facilitating leadership and company retreats.With over 20 years of learning and development experience, Heather uses innovative techniques to deepen each learning development program designed, or training class delivered. Virtually or in-person, she is a high-energy facilitator who captures her audiences immediately and keeps them engaged and on target throughout the training or facilitation.As a leadership and team building facilitator, she is an expert with working through difficult situations with ease and grace. As an Executive-level coach she connects with her clients and helps them to find new ways of working to help them be most successful. She infuses these same principles in her team as they work with clients.Heather is a subject matter expert and certified Predictive Index Partner. She is an avid learner and reader of business and leadership books, articles, and seminars. She holds a bachelor's degree from U.C. Davis in Managerial Economics, and a master's degree from Cornell University in Executive Human Resource Management.Here is a link to her website: https://launch.onedigital.com/learning-and-developmentSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: Heather RamseyCumby ConsultingRachel MedeirosLiz CumbyAbout Cumby Consulting:Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.
In this episode, Duane Mancini sits downs with Leo Eisner, a seasoned expert in medical device safety and compliance, as he shares his extensive experience and knowledge on the IEC 60601 standards. With a career spanning over 40 years, Leo talks about his beginnings at NASA, his role in the development of medical safety standards, and the intricacies of compliance testing. Discover the complexities of the IEC 60601 updates, the importance of staying informed, and practical advice for medical device manufacturers.Leo Eisner LinkedInEisner Safety Consultants WebsiteImpacts on IEC 60601-1 WebinarDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
Gina Catalano went from leading sales teams in medical devices to coaching surgeon leaders and healthcare executives. In this conversation, she shares how emotional intelligence (EQ), communication, and team strength drive real results in the operating room, the boardroom, and beyond.RESOURCESwww.centroforzagroup.com
In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to dive deep into the rapidly evolving AI landscape, its economic ramifications, and Canada's growing potential as a global tech leader. They discuss pivotal topics, such as energy challenges in AI infrastructure, the rise of AI tokenization, and the impact of government policies on the sector. With a focus on the future of tech, investments, and the role of Canada, this episode offers an insightful look at where the industry is headed.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.AI Energy Demands & Canada's Opportunity (00:04:39)John and Matt discuss the massive demand for compute power in AI and Canada's potential to lead by meeting these energy needs. They highlight the importance of matching energy capacity with data center development to become a global tech leader.The AI CapEx Boom and the Trillion-Dollar Question (00:07:05)The discussion shifts to the booming capital expenditures in AI, with a particular focus on the rising costs of building AI infrastructure and whether this growth is sustainable in the long term.Canada's AI Strategy and Sovereign Identity (00:14:21)The conversation turns to Canada's AI strategy, with a task force focusing on innovation, research, and talent retention. John shares his thoughts on the potential challenges and opportunities for Canada in becoming a key player in the AI space.The SEC's Push for Tokenization in the U.S. (00:19:33)The episode also delves into the SEC's efforts to allow the tokenization of stocks and what this could mean for the financial industry and blockchain adoption.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Today's guest is Faithe Toomy, Director of Voice of the Customer and Insights at Insulet. Insulet is a medical device company specializing in wearable drug delivery systems for diabetes care, combining engineering, clinical research, and digital health capabilities to develop automated therapeutic solutions. Faithe joins Emerj Editorial Director Matthew DeMello to discuss how data and AI are transforming call center operations while maintaining compliance and customer trust. Faithe also shares practical strategies for training agents, leveraging conversational analytics, and implementing AI tools that enhance workflow efficiency, improve first-contact resolution, and support a more confident, human-centered customer experience. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on the ‘AI in Business' podcast!
Rosemary Coates has spent three decades inside the hardest questions in manufacturing… where to build, what to move, and how to survive the politics around it. On this episode of The Manufacturing Culture Podcast, she walks through the real story behind offshoring, why reshoring is more trickle than tidal wave, and how companies can make smarter location calls without blowing up cost or capacity.We go back to her origin story… blue collar roots, a transportation management elective that lit the fuse, and a career that ran through Solar Turbines, defense work, Hewlett Packard, Big Four consulting, and finally her own firm. When the 2012 election turned China into a punching bag, Rosemary pivoted from moving factories out to helping leaders bring work back in a way that actually pencils. She founded the nonprofit, nonpartisan Reshoring Institute and now advises with data instead of slogans.We dig into what really changed. Labor in China is no longer cheap. Geopolitics now sits beside cost on the decision tree. Carbon footprint matters when your supply chain stretches across oceans. The grid cannot power a sudden factory boom even if you build it. And the workforce of today is not lining up for low skill, mind numbing assembly. The path forward looks like automation where it fits, contract manufacturing for flexibility, and a cold look at labor mix and total landed cost before anyone signs a lease.Mexico's rise gets a clear-eyed review… proximity, lower carbon, easier logistics, and a young workforce make Central Mexico compelling. Vietnam is full. India brings time and inventory penalties on the water. Demographics matter. So do hurricanes, wildfires, and the ability to shift production when the world throws a brick through your window.We also talk wages, the hole blown in the middle class, and why the new middle class is built on writing, computing, and mechatronics rather than grease and punch presses. Rosemary explains her expert witness work inside global supply chain disputes and leaves us with a simple truth… strategy beats sentiment, and the best decisions use both spreadsheets and context.Sponsor note:Med Device Boston is your go-to Med Tech sourcing and education expo, September 30 through October 1 at Boston's BCEC. 200 plus suppliers. 1500 plus attending professionals and OEM decision makers. Explore 3D printing, AI, materials, regulatory tech, and contract manufacturing under one roof. Visit meddeviceboston.com to register and plan your visit. Links in the show notes.Guest:Rosemary Coates, Executive Director of the Reshoring Institute, global supply chain strategist, expert witness, and author of five books on sourcing and manufacturing.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Josh Vose, CEO of Tulavi Therapeutics.Tulavi is advancing hydrogel-based implants like the allay Hydrogel Cap, which is designed to optimize nerve injury recovery and reduce the risk of neuroma formation.Josh is a physician, engineer, and entrepreneur with more than 20 years of experience in medical devices. He has held leadership roles at Medtronic following its acquisition of PEAK Surgical and drove growth at startups including SIA Health, which he led through commercialization and acquisition by Integra LifeSciences.In this interview, Josh shares why defining the clinical problem with absolute clarity is the foundation of medtech success, and how leaning into the harder regulatory path can create lasting moats.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Josh Vose.
This week on Taking The Pulse, Heather and Seth record at the NCLifeSci 2025 Annual Meeting with Bobby Patrick, Senior Vice President of Government Affairs at AdvaMed. Bobby shares how the world's largest medical technology association is advocating for expanded Medicare coverage of breakthrough devices, navigating the evolving role of AI in diagnostics, and addressing supply chain and tariff challenges. We also explore how AI is enhancing physician decision-making and how patient trust and data security remain central to innovation. Tune in now for a timely look at the policy and technology shaping the future of medtech.
Morrilton Chamber taking nominations for annual awards; Baby Box installation begins at Med-Tech; Calhoun Scholarship established at UACCM; Atkins Heritage Fest is Saturday; Model T club to visit Morrilton Depot Museum; Dogs fall out of top five; We visit with Michelle Jones and Holly Tramel with the MHS Homecoming Parade Committee
In this episode, Duane Mancini chats with Logan McKnight, a seasoned professional with a vast background in medtech. Logan shares her journey from starting in medical services and neuromonitoring to leadership roles, culminating in the establishment of her consulting firm, Goodnight Consulting. The conversation dives into the nuances of managing corporate and field leaders, the importance of transparency, communication, and trust in leadership, and the complexities of managing people. Logan also highlights the benefits of feedback mechanisms like 360 reviews and underscores the significance of self-awareness and mindset in effective leadership.Logan McKnight LinkedInGoodnight Consulting Website“Mindset: The New Psychology of Success” by Carol Dweck “The Culture Code: The Secrets of Highly Successful Groups” by Daniel CoyleDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
In this episode, host Etienne Nichols sits down with Jose Bohorquez and Mohamad Foustok from CyberMed to dissect the complex world of Software as a Medical Device (SaMD) and cybersecurity. They emphasize that SaMD is first and foremost a medical device and should be treated as such from the very beginning of the development process. The conversation highlights the most common mistakes companies make, like treating security as an afterthought and jumping straight into coding without a solid architectural plan.Mohamad Foustok introduces the concept of "zero trust" and the critical importance of designing for security across the entire product lifecycle, from initial concept to post-market surveillance. The discussion clarifies that cybersecurity is not limited to network-connected devices but applies to any medical device with a software function, regardless of its connectivity. They also touch on the historical context of FDA guidance, noting a significant shift in recent years that has raised the regulatory bar and put a greater emphasis on robust cybersecurity documentation.The guests provide actionable advice for MedTech professionals, stressing the value of a balanced approach that integrates security and functionality from day one. They explain that a well-thought-out process, though seemingly slower at the outset, ultimately saves time and resources by preventing costly and time-consuming redesigns later on. This episode serves as a vital guide for anyone looking to build a secure and compliant medical device in today's evolving regulatory landscape.Key Timestamps[01:50] Common pitfalls in developing SaMD, including overlooking regulatory guidance like IEC 62304.[03:20] The critical mistake of treating cybersecurity as an afterthought in product development.[05:00] Who cybersecurity applies to beyond software, including patients, manufacturers, and supply chains.[06:30] The FDA's stance on cybersecurity for any device with a software function, even if not network-connected.[08:00] A discussion on "reasonable assurance of cybersecurity" and what it means for manufacturers.[10:00] The "zero trust" principle and why you should never assume a network is secure.[14:00] How hospitals and other stakeholders are demanding more rigorous cybersecurity standards.[15:40] The ideal process for a "security-first" development lifecycle.[21:00] Why rushing development without a proper architecture can lead to significant delays and cost overruns.[23:00] A brief history of FDA's cybersecurity guidance and the major shift in 2023.Quotes"Software as a medical device ultimately is a medical device, and so you want to be developing it from the get-go with that mindset." — Jose Bohorquez"Security can't be an afterthought. You have to consider security at the inception of your approach to a product." — Mohamed FustokTakeawaysA "Security-First" Mindset is Essential: Integrate cybersecurity from the initial architectural phase of your project. This proactive approach saves significant time and money by avoiding costly redesigns and delays later in the development process or after an FDA submission.Cybersecurity is for All Software-Driven Devices: Don't assume that only cloud-connected devices need cybersecurity documentation. The FDA requires documentation for any device with a software function, including embedded systems and programmable logic, even if it's not connected to a network.Regulatory Compliance is a Process, Not a...
Ofer Shalev is the CEO and founder of Newphase, a MedTech company that has developed a new treatment for advanced cancer patients. Their technology uses tiny particles that target and destroy cancer cells while leaving healthy cells unharmed, offering hope for patients when other treatments have stopped working. Avraham and sat down with Ofer to discuss how their technology works, how he came up with the idea, how he got funded, the challenges he's faced, tips for startup founders and much more. Do you have a great innovation? We'd love to hear from you. Contact us by going to https://jmbdavis.com/startup/contact. Learn more at https://jmbdavis.com and https://jmbdavis.com/startup. Also available at https://soundcloud.com/jmbdavis/ ofer-shalev-of-newphase. Listen to all of the episodes at https://jmbdavis.com/podcast.
In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to discuss pivotal developments shaping Canada's economy and tech industry. They cover a range of topics, from Canada's immigration policies in light of changes to the U.S. H1-B visa program to the evolving AI landscape and its economic implications. John provides insights on how Canada could leverage these immigration shifts to attract global talent, while exploring the risks of inflated AI valuations and the potential for an AI bubble.The conversation also delves into the rising vendor financing model in AI, which could contribute to market instability, and examines whether the massive investments in AI infrastructure are sustainable. John reflects on the challenges facing Canadian companies, including the latest news from Constellation Software and its founder, Mark Leonard's resignation. Together, they explore how AI and its financial impact may create headwinds for established companies while offering opportunities for the Canadian tech sector to emerge as a global leader.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.AI CapEx Bubble: A Growing Concern (07:30)The conversation shifts to the massive capital expenditures in AI, with John analyzing the risks associated with overbuilding data center infrastructure and the possibility of a tech bubble.Vendor Financing in AI: A Dot-Com Repeat? (09:52)John draws parallels between current AI financing models and the early 2000s dot-com bubble, exploring whether companies are overexposed in the AI sector.The Future of AI Valuations (15:04)An in-depth discussion on the risks of inflated AI company valuations and the potential economic fallout.Canada's Immigration Advantage: H1-B Visa Adjustments (18:12)John and Matt discuss the implications of recent changes to the U.S. H1-B visa program and how Canada could use this shift to attract top talent.Constellation Software: A Transition and the Role of AI (27:09)John reflects on the recent news of Mark Leonard's resignation from Constellation Software and what this means for the company, especially in light of AI-driven changes.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
In this episode of Tank Talks, host Matt Cohen sits down with Nejeed Kassam, a serial founder, investor, and advocate for positive change. With a journey that spans from launching his first business as a teenager to scaling and selling Keela, a CRM for nonprofits, Nejeed's experience offers valuable insights for entrepreneurs, especially those navigating the challenges of building tech-driven impact companies.Nejeed shares his entrepreneurial beginnings, the lessons he learned growing Keela, and the challenges he faced when taking on external funding. He also discusses his new venture, Rewire Digital Therapeutics, an AI-powered mental health company using gamification to help users manage depression and anxiety.From scaling Keela to navigating a successful exit, Nejeed dives into his journey and the key principles he follows in his entrepreneurial endeavors. Whether you're interested in nonprofit tech, mental health, or financial literacy, Nejeed's story provides inspiration and practical wisdom.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Nejeed's Early Entrepreneurial Beginnings (08:12)* Starting a business at 14 with his brothers in Vancouver* Learning from early failures and the importance of sales in businessScaling Keela and the Path to Acquisition (15:17)* The journey from building Keela as a side hustle to scaling it into a successful company* The decision-making process behind bringing in external capital and navigating an exit* Insights on the acquisition process and private equity rollupsRewire Digital Therapeutics: Tackling Mental Health with AI (25:34)* How Nejeed's personal experiences with mental health drove him to create Rewire* Leveraging AI and gamification to address mental health issues like depression and anxiety* The future of digital therapeutics and its potential to impact millionsFinancial Literacy: Teaching Kids Money Management (35:11)* How Nejeed teaches his kids about financial literacy* Building the financial literacy platform, Snowball 72, and its impact on Gen Z and Gen Alpha* The importance of creating safe, accessible financial learning environmentsNejeed's Lessons on Building Impactful Businesses (45:23)* The importance of staying committed to solving meaningful problems* Building businesses that balance profit with positive societal impact* The role of resilience and discomfort in entrepreneurshipAbout Nejeed KassamNejeed Kassam is a serial entrepreneur, author, and advocate for positive change. He co-founded Keela, a CRM for nonprofits, which he successfully scaled and sold in 2024. He is now co-founder of Rewire Digital Therapeutics, a company focused on using AI and gamification to help people manage mental health issues like depression and anxiety. In addition to his work in tech, Nejeed is passionate about financial literacy and has launched Snowball 72, a platform aimed at teaching the next generation about money management. Nejeed's entrepreneurial spirit is driven by his desire to solve real-world problems and make a meaningful impact on society.Connect with Nejeed Kassam on LinkedIn: https://www.linkedin.com/in/nejeed/Visit the Keela website: https://www.keela.co/Visit the Rewire Digital Therapeutics website: https://rewiredigitaltherapeutics.com/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
A candid conversation with high school engineer and FIRST Robotics alum Natalie Macias about curiosity, consistency, and carving out room for young makers inside a sometimes closed-off industry. We talk early exposure to CAD and flight sims, why manufacturing is the first mile of everything, the lemon tree lesson on failure, and how leaders can be firm yet flexible. Natalie wants more hands-on opportunities before college and a more welcoming on-ramp for students who are ready to show up.Guest:Natalie Macias, student engineer from Los Angeles, senior capstone lead, robotics team veteran, and Future Faces of Manufacturing feature with AMT. She's using LinkedIn to learn directly from practitioners and find mentors across the industry.What you'll hear:How a DOD Starbase program quietly introduced CAD, chemistry, and flight simulation to a curious kid from South CentralWhy FIRST Robotics felt like a real company under deadline, with design, programming, assembly, and manufacturing all moving togetherThe jump from loving law to choosing engineering, then finding home in manufacturingA classroom set up like DARPA, complete with two “companies” competing for a contract under a mentor who worked at Northrop GrummanWhy opportunity before college is the missing bridge and how dual-enrollment and apprenticeships could fix itLeadership as knowing your people, staying open to feedback, and bending for the needs of the group without becoming a people-pleaserCreating space in schools so students can actually grow rather than learn inside a boxFailure as pruning a lemon tree so the next season grows strongerUsing LinkedIn for mentorship and perspective, not just job huntingThe ask to our audience for college experience stories from programs that truly delivered hands-on engineeringKey quotes:“If you keep showing up, even if you didn't do well, you're showing that you want to be there. That goes a long way.”“Manufacturing is phase one. Piece by piece, chip by chip, you're contributing to something bigger.”“Failure isn't to stop us. It's pruning the dead branches so the tree can grow.”“Be firm where it matters and flexible where it helps the group.”“Create space for growth. Don't keep students in a box, then act surprised when they don't grow.”Topics covered:Early STEM ignition through Starbase and school projectsFIRST Robotics as a training ground for teamwork and urgencyHands-on access for high schoolers versus the current college-first gateHow industry perceptions can intimidate newcomers and how to fix that welcomeLeadership habits students will actually followNatalie's college search and what she's looking for in an engineering programThe pace of automation and why that excites herNatalie's ask to listeners:If you studied engineering or work in manufacturing, message Natalie on LinkedIn with what your university actually did to prepare you. What labs, co-ops, shops, or professors made the difference. Short stories beat brochures.Sponsor note:Med Device Boston is the go-to Med Tech sourcing and education expo on September 30 through October 1 at Boston's VCEC. 200 plus suppliers. 1500 plus attending professionals and OEM decision makers. Explore 3D printing, AI, materials, regulatory tech, and contract manufacturing under one roof. Register and plan your visit at meddeviceboston.com.Resources mentioned:Starbase STEM programFIRST Robotics CompetitionProject-based capstone with a Northrop Grumman mentorDual-enrollment and apprenticeship models for high school studentsHow to support Natalie:Share a warm intro to mentors who welcome high school talent into labs, job shops, and build teamsInvite her to tour your facility or shadow an engineer for a daySend those honest college experience notes she asked forAbout the Manufacturing Connector Network:We help brands and builders turn trade shows, plant tours, and expert interviews into a steady pipeline of video, audio, and social content. On-site capture, mobile studio, short-form editing, podcast production, and distribution that stays consistent week after week. If you're heading to a show or launching a product, we'll bring the cameras and do the heavy lifting.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Ahmed Elmouelhi, CEO of TRiCares. TRiCares is developing Topaz, the first purpose-built transcatheter tricuspid valve replacement system — a technology designed specifically for the right side of the heart, where complex anatomy has made durable solutions elusive.Ahmed is a 20-year medtech veteran with leadership experience across electrophysiology, men's health, neuromodulation, and structural heart. Before joining TRiCares, he helped build multiple businesses at AtriCure and held key roles at Medtronic during the early days of TAVR. He also serves as Chairman of the American Heart Association in Minnesota.In this interview, Ahmed shares why adoption — not added complexity — is the ultimate measure of medtech innovation, how a small group of physician champions can accelerate clinical studies faster than internal resources alone, and why treating your board like collaborators in the “sandbox” leads to stronger partnerships and better outcomes.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ahmed Elmouelhi.
Oakley Meta took center stage at Vision Expo West, where the Defocus Media team toured the EssilorLuxottica booth to see how AI, smart eyewear, and next-gen lenses can raise the bar on real-world patient care. Alongside Ray-Ban Meta and Nuance Audio, the team explored how design, fit, battery life, and everyday usability come together to help eye care professionals deliver better conversations in the exam lane and better outcomes in everyday life.
In this episode, Duane Mancini welcomes back Kevin Saem, Managing Director of Zapyrus, for an enlightening discussion on the future of the MedTech industry. The episode delves into the latest trends in medtech funding, highlighting a significant increase in investments outside the U.S., the pivotal role of diagnostic technologies, and the importance of clinical data over revenue for attracting investments. Kevin shares groundbreaking advancements in data analytics and predictive machine learning applications, helping medtech companies and service providers enhance their commercialization strategies and efficiency. Kevin Saem LinkedInZapyrus WebsiteZapyrus H1/Q2 2025 MedTech Financial ReportDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
This episode with Stuart Grant of Archetype MedTech demystifies the "front end of innovation," a critical yet often overlooked phase of medical device development. Stuart, a seasoned MedTech veteran with over two decades of experience at Johnson & Johnson, shares insights from his doctoral research on this topic. He breaks down the process, defining the front end as the crucial period between applied science and new product development, where teams identify unmet clinical needs and shape a product concept. This conversation offers a clear roadmap for balancing creativity with structure, using the Design Council's Double Diamond model and Stuart's 10 key insights for observing user behavior.Stuart Grant's discussion on the front end of innovation highlights the importance of deeply understanding the user and the environment in which a device will be used. He introduces a number of tools and techniques, such as the Pugh Matrix and the NVivo software, to help teams transition from a broad exploration of ideas to a focused, viable product concept. Stuart explains that while the front end may seem "fuzzy," it can be a systematic process that uncovers the true clinical and market needs that will determine a product's success. He emphasizes that the most successful devices aren't just incrementally better, but are born from a deep understanding of customer insights.This episode is an essential guide for anyone involved in MedTech innovation, from academic researchers to seasoned engineers. Stuart's insights challenge the conventional reliance on key opinion leaders and provide a framework for a more holistic, user-centric approach. He outlines how to identify and interpret subtle user behaviors, from workarounds and unconventional uses to unspoken frustrations, all of which are critical for developing a truly impactful and user-friendly medical device. Whether you're at the very beginning of a project or looking to improve your current innovation process, this episode provides actionable strategies to bridge the gap between a great idea and a marketable product.Key Timestamps(2:00) Defining the "Front End": Stuart explains what the front end of innovation is and why its name has evolved from the "fuzzy front end."(8:00) The Double Diamond Model: An explanation of the UK Design Council's Double Diamond, illustrating the divergent and convergent phases of problem-solving.(12:30) Common Pitfalls: Discussing the three critical questions to answer: Is there a market (viability)? Is the technology possible (feasibility)? Do users want it (desirability)?(15:00) Balancing Creativity and Structure: The roles of different team members and how to manage the creative (divergent) and critical (convergent) phases of innovation.(21:00) 10 Ways to Find User Insights: Stuart breaks down the specific techniques and red flags to look for when observing users, including workarounds, affordances, and areas of disjuncture.(26:00) The Problem with KOLs: Why relying solely on key opinion leaders can be a mistake and the importance of observing a wider range of users.(30:00) Triggers of Use: How unconventional uses of a device can reveal new product opportunities.Standout Quotes"A craftsman will build you exactly what you ask for. An artist will build you what you didn't know you need." - Etienne Nichols"You don't just do what the customer says because that could lead to a terrible product." - Stuart GrantTakeawaysObservation is Key: Go beyond interviews. The most valuable insights come from observing users in their natural environment,...
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Welcome back to Let's Talk Medtech, where we're joined by returning guest Paul Grand, CEO of MedTech Innovator, for an essential conversation on securing capital in the medical technology space.In this value-packed episode, Paul reveals why successful fundraising requires a comprehensive, holistic approach rather than a narrow focus. He maps out proven strategies for medtech startups to attract and secure investment at various stages of development, drawing from his extensive experience in the industry.Paul also shares remarkable insights into how MedTech Innovator has successfully connected over 700 promising companies with investors, helping transform innovative ideas into market-ready healthcare solutions.Whether you're a medtech entrepreneur seeking funding, an investor looking for opportunities, or simply interested in the business of medical innovation, this episode delivers actionable wisdom from one of the industry's most respected voices.Subscribe to Let's Talk Medtech for more expert conversations on navigating the complex world of medical technology development and commercialization.
Dr. Adam Power, co-founder and Chief Medical Officer at Front Line Medical Technologies, shares his fascinating journey from a background in vascular surgery to developing COBRA-OS, a groundbreaking device for hemorrhage control. He discusses the challenges and milestones in bringing this life-saving technology to market, the impact of the device in trauma and emergency care, and innovative future applications, including its unexpected use in non-traumatic cardiac arrest. Guest links: https://frontlinemedtech.com/ Charity supported: Canadian Cancer Society 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 064 - Dr. Adam Power [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello, and welcome back to another episode of The Leading Difference podcast. I'm your host, Lindsey, and today I'm excited to introduce you to my guest, Dr. Adam Power. Dr. Power is a leader in innovative medical devices for trauma and emergency care that is committed to lowering the barriers and bleeding control and resuscitation. Dr. Power was instrumental in the development of COBRA-OS, drawing on his unique clinical viewpoint and expertise to ensure utmost patient safety and assist with the company's global expansion. In addition to his current role as co-founder and Chief Medical Officer at Front Line Medical Technologies Incorporated, Dr. Adam Power is a vascular surgeon in the division of vascular surgery at Western University, which he joined in the fall of 2012, and he is involved in all aspects of academics and clinical care. Also, Front Line was just named the 2025 Medical Device Technology Company of the Year, so I definitely wanted to highlight that too. All right. Well, thank you so much for being here today, Adam. I'm so delighted to speak with you. [00:01:55] Dr. Adam Power: Yes, it's a pleasure to be here. Thank you. [00:01:57] Lindsey Dinneen: Of course. Well, I'd love if you would start by sharing a little bit about yourself, your background, and what led you to what you're doing today. [00:02:05] Dr. Adam Power: Sure, I'd love to. So I'm a Canadian. I grew up on the east coast of Canada and was always interested in science and math and those types of things. I think, importantly, I grew up with an identical twin brother as well. So we really didn't know what we wanted to do with our lives, and ultimately we're good in science and math and ended up in medicine. And then both of us, when we got into medicine, we weren't sure exactly what we wanted to do in medicine, and ultimately both of us became surgeons. He became a urology surgeon, and I became a vascular surgeon, where we joke that we're both plumbers. I deal with the red stuff and he's the yellow stuff. But I did my initial medical school out on the east coast of Canada and then I did my general surgery training, which also involved trauma training, and then did a Master's of Bioscience Enterprise, which was basically biotech business from the University of Cambridge in the UK. When I finished my general surgery training, I continued on and did vascular surgery training at Mayo Clinic down in the US, and since that time after graduating from there, I've been at Western University in London, Ontario, Canada, for the past 13 years practicing as a vascular surgeon and an academic vascular surgeon. But when I was here at Western, I was always interested in innovation. I filed my first patent as a resident way back when, and have filed many over the years. But ultimately, if I was ever gonna see anything that came outta my head and was actually used in a patient or I could actually use in a patient, I figured I'd have to do it. I knew that I couldn't do it by myself. And so, I was very fortunate to meet my co-founder Dr. Asha Parekh. She's a PhD, biomedical engineer, extremely smart jack of all trades, and we teamed up now about eight years ago. We met here at Western, teamed up and really took an idea right out of our heads and patented it and raised money for it, prototyped it, brought it all through the regulatory steps to approvals, built a quality system and ultimately got it out onto the market in Canada, US, Europe, now Australia, and more to come. So the commercialization piece is what we've been focusing on over the past three years. And it's been really fun, but very exhausting but very rewarding as well. I think I'll stop there because I've been blathering on, but... [00:04:39] Lindsey Dinneen: No, it's fantastic. I really appreciate it. Plus, it's really fun to hear about your trajectory and so, okay, so you've teased us a little bit about this company of yours and this innovation of yours. Can you now share a little bit more about that and the development of it over time? [00:04:55] Dr. Adam Power: Yes, of course. Well, I mean, thing that we recognized early on is, and I'll just explain how I normally explain it, is if you have bleeding, it's a hemorrhage control device. And so if you have bleeding in your extremities, then you can often either put pressure on it or you can put a tourniquet on it. The problem when you have internal bleeding in the torso is that you can't actually put direct pressure on it, and there's no tourniquet that necessarily works for intraabdominal, intrathoracic bleeding. And when people bleed to death before coming to hospital, I mean, they're bleeding in these areas. You can empty almost your entire blood volume into your chest or into your abdomen. And this does account for a significant number of fatalities in all environments, basically in the trauma environment. That's military, that's pre-hospital, that's any time that that people are bleeding from internal organs. And so, because this is such a problem, the old fashioned way to fix it is to open up someone's chest and put a clamp on the aorta. So what does that do? Is it basically above the clamp, keeps blood flowing. The remaining blood in the body keeps blood flowing to the brain and the heart, keep you alive. And then below the clamp, it stops sort of the hemorrhaging from the spleen or the liver or whatever. So there's two things going on. One above the clamp and two below the clamp. But opening up somebody's chest in, you know, side of the road or in the emergency department really is impossible. You need highly skilled people like vascular surgeons like myself to be able to do this. And even if we were at the side of the road, we don't have the resources available to keep a patient alive. So there is this idea that we could do this minimally invasively, sort of accomplish this through minimally invasive means. And this, the idea of doing REBOA, which is an acronym-- Resuscitative Endovascular Balloon Occlusion of the Aorta-- came into being. This was probably 15, 20 years ago now. It wasn't necessarily a new idea. It had been done since the Korean War. There was somebody actually put a balloon up into someone's aorta to stop bleeding, but it came back again and was starting to be used a little bit more because. And so really the idea is to, through the femoral artery in your groin where you can feel a pulse, you introduce initially a sheath, which is your access point, and then you place the device up through the sheath, up into the aorta and inflate a balloon in the aorta. So instead of an external clamp, it's an internal balloon clamp that keeps blood flowing above the balloon and stops the blood flowing from below the balloon. Initially these devices were as big as my baby finger, like they were massive. And so if you put them in and you took it out, there was a big hole in the artery, had to cut down on the artery and repair the artery. But as it got more and more advanced and technology advanced, they become smaller and smaller. So that's really where we came in. The initial devices were 12 French, about the size of my baby finger. And then it advanced to Seven French and all of a sudden Seven French-- and these are diameter, French sizes are basically diameter-- and so when it went from 12 to seven French, now we could start doing it through the skin without actually cutting down on the artery. But that Seven French size was still very large and you're putting this in the hands of people that don't do this all the time. And so, we had the idea to bring it down even further now to Four French. And so this is essentially the size of an IV. And so you put a tiny little IV in somebody's femoral artery. And lots of different people can do that. And then you advance the device up in, inflate the balloon and you can magically occlude the aorta. In our first study that we did, the first inhuman study, we averaged about just over a minute to occlude someone's aorta, which was really fast to be able to get that amount of control that quickly. So that, that was really been the advancement is to decrease the access size, make this whole procedure simpler so that so that we can essentially save more lives. [00:09:08] Lindsey Dinneen: Okay, so thank you so much for sharing a little bit about that. Can you tell me about the beginnings of this innovation and how you brought it to market? Because it's really wonderful to hear all the success, and I'm so excited to hear that it's spreading, you have presence all over the place now. But you know, that's not an easy pathway. And I'm curious if you could walk us through a little bit about that decision to go, "You know what? We have a solution to a known problem, we can make this happen." And then how did you actually go about doing that? [00:09:42] Dr. Adam Power: Yeah. I think, I mean, I make it sound fairly straightforward, like a nice story, but it certainly was not that. I mean, we were very lucky I would say, that we had a lot of great advisors and mentors that we figured that we try not to fail early, fail fast. We wanted to make this one as successful as possible. So before we made any decision, we often would consult our mentors. And I'm a surgeon. I like to shoot first, ask questions later. My partner is not. And so I think we, we strike an excellent balance between not just the engineering and clinical side of things, but also from driving a business forward, getting all the information, but helping to get decisions made and moving forward. You know, starting out, we really had to choose the right sort of fit for what we wanted to pursue. We like to say it checked all the boxes. It checked all the boxes as far as even where we are. We're in Canada, we're not in a tech triangle where there's tons of funding opportunities. We knew we would be limited from a funding perspective, so we couldn't choose something that necessarily required a hundred million dollars to start up. So, you know, we had this device that we knew that we could fundraise for it. And then once it was fundraised, it was simple enough that we could get it manufactured. We chose to go the OEM route for the original equipment manufacturer, so we didn't have to build a manufacturing facilities ourselves. And then really from there, and building a quality system in the regulatory, we did work with a lot of consultants, that was both positive and negative experience. We had great consultants. We had not so great consultants. But really what our our goal was, is to learn the process ourselves. And so there's always manuals for things, even from the FDA perspective. They give out great documentation about what is supposed to go into an FDA application. And we dug into that. We really tried to understand. We did not trust anyone. That's one of my rules in surgery is, "don't trust anyone, not even myself." So we really didn't trust our consultants, and we tried to double check and triple check everything so that we didn't make mistakes. And of course, we did make mistakes and had to go back to the drawing board a few times. But as much as we wanted to get this out there, we really did wanna learn the process and know the process because ultimately we're the ones that are responsible to the patients in the end, and we needed to make sure that we had a handle on each and every step of the way. We, of course, because of that, were maybe not as quick as we could have been but in other places we became more efficient because, as we learned the process, getting feedback back and doing it right the first time, it really made a difference. So. [00:12:39] Lindsey Dinneen: Yeah, absolutely. Of course. Yeah, and I appreciate you going into a little bit more of the nitty gritty details 'cause it is so fun to hear the success stories, but of course, as you go along, there's that pathway to success. And it's helpful to understand that yeah, it's gonna be potentially a long road, sometimes windy, sometimes weird, but at the same time that it is possible. So as you look to the future with your company, what are you thinking of in terms of the future? Are you going to continue down this pathway and continue with iterations of this device? Are you thinking of new devices to introduce as well? Or, what are your thoughts for the future? [00:13:18] Dr. Adam Power: Yeah. And I have to be very careful what I say here, obviously. I can share generically what our thoughts are. We love this. Ultimately there was no better feeling than to use-- I mean, I've used my device to save a patient. And, you know, I would say that Asha, who's my co-founder, she cares. I'm a physician, but she cares about the patients just as much as I do, as does everyone in our company, which is really quite rewarding. But the future, what does the future hold? We really want this to get to everywhere. Yes, we're in lots of different countries ,have commercialized really all around the globe, but we really wanna go deeper into a lot of these geographies and really help as many people as possible. We realize that we can't do it on our own and are gonna need help. And so that's, we're in a growth phase right now of our company and we're looking for strategic collaboration. We're looking for those opportunities to deepen our ties and in all the different geographies. That being said, we are inventors and of course we have an idea every day about what we could improve on. But as far as the pipeline goes for our company, we are focusing on some very specific up and coming applications that we hope to have in the next couple of years. And I also wanna say that, I talked about trauma and bleeding, but the more exciting side of aortic occlusion has really been the applications. And you'd think, okay, it makes sense for trauma to be able to stop blood flow and stop bleeding. But some of our recent successes have been through postpartum hemorrhage. And there is this really, terrible condition called placenta accreta, where the placenta grows into the uterus and when you deliver the baby either by C-section or by delivery, and then the placenta attempts to be delivered, it tears, and you can have torrential bleeding. And, and so our device is being used in these women who are pregnant when inflicted with this condition and helping to decrease blood transfusions, helping to save a mother's life. So that's been really amazing. And then next on the horizon is strangely there's, it's not even a bleeding application. We've done some research and there's research going on globally about using aortic, minimally invasive aortic occlusion for non-traumatic cardiac arrest. And so if, which is really, again, it's like, "Oh my gosh, does this thing do everything? It might make your supper tonight if you're not careful." So it, so what happens there is that if somebody drops dead basically in front of you, and you start CPR, if you start pushing on their chest and pushing on their heart, you're pushing blood to the whole body. And the way you get someone back to life is if you can get the heart muscle oxygenated again. So if you put an aortic occlusion balloon up close to the heart, every time you push, you're directing blood right into the coronary arteries and right into the brain as well. And so what we're seeing is that there's increased return of spontaneous circulation rates when you do this with CPR. And there are different trials around the world that if this shows that there's an increase in survival or in better neurological survival, this will be the first time that we've really changed the script on cardiac arrest since advanced cardiac life support came out many years ago. So this, again, is very exciting for a simple device to be able to make that much impact in all these different areas. So, you know, we have a lot to focus on right now, even growing into the future because some of these, like cardiac arrest, are quite early on. So we don't wanna lose sight of this great original product, but we do think all the time about different pipeline ideas that could help other patients. [00:17:18] Lindsey Dinneen: Yeah, but, and to your point, even the amazing other use cases for this incredible device, like you said-- maybe it's gonna make us dinner next-- but the idea being that, who knows? I mean, there's so much more to discover even now, which makes me excited just to think about how many more use cases you could have for it and how many more people you could save. So, speaking of that, are there any stories that kind of stand out to you, moments that you've had where, you know, either through your day job, so to speak, being a vascular surgeon, but also being the co-founder of this company that really sort of affirmed to you that, "You know what? I am in the right place at the right time, in the right industry." Just those moments that really stick with you. [00:18:05] Dr. Adam Power: Yeah, I mean, it obviously all stems back to the patient and what patients are impacted. And I remember, the first time that the device was used at our hospital, one of the radiologists called me in and said, " We need to use one of these balloon occlusion devices for a patient that's been in an accident." And so I went in and I said, "I actually have the device that my partner and I created. We can use this for the patient." And so we started using it for the lady that was involved in a very serious accident, had a pelvic fracture, and she was a Jane Doe at that particular time. She was anonymous. And anyway, we noticed that she had actually had some vascular surgery done based on her angiograms, and I leaned over and I-- so she was sedated, but she was awake-- I said, "Have you had vascular surgery? Who's your vascular surgeon?" And she said, "It's Dr. Power. He's such a nice man." And so I was actually helping one of my patients. That was pretty crazy. [00:19:04] Lindsey Dinneen: Oh. [00:19:05] Dr. Adam Power: Also from my hospital, when I heard one of my junior residents was able to save someone's life. So, you know, junior residents are often good, but they're not trained surgeons. And so to have a simplistic device that one of my residents could actually place and help someone, that's pretty amazing too. There's also been times where like even the postpartum hemorrhage, we hear the first cases in the States of saving mother and baby. That's pretty incredible. Or that we donated some devices to the Ukraine conflict as well, and we heard that it saved some soldiers' lives as well. And there's different military groups that, that use our device and save soldiers. So it's all back to the patient. And hearing those success stories and hearing about somebody alive because of this particular device, because of all this effort that we've put in. I mean, it's really makes it worthwhile. It sounds kind of corny, but as a surgeon, I can help one person at a time, but as somebody involved in industry and medical device industry, I don't even have to be there. You know, this device can help long after I'm gone. The tricky part of it, being the Chief Medical Officer is, I usually only have to worry about my patients. Now I have to worry about everybody worldwide and the device being used. That was a little hard to wrap my head around initially, but yeah. [00:20:28] Lindsey Dinneen: Yeah, of course. But the ripple, the ripples, the impact that you get to have because of this device and because of your diligence getting it to market, because it isn't an easy path, and that's incredible. So thank you for doing the work that you're doing. That's not easy and it's very appreciated. This is incredible. So, yeah. So, okay. When you were growing up, let's say 8-year-old, Adam-- you know, you're having a good time doing whatever you like to do-- could you possibly have pictured yourself where you are now? [00:21:08] Dr. Adam Power: No, I don't think so. I mean, I, I. I came from a very small, like, small upbringing and, you know, in my family I had absolutely lovely family members, but they really, apart from my aunt, they weren't overly educated. And so I really didn't know what it took to be successful in life, really. I had work ethic from my parents, that's for sure. And so that's what they bred into me. And all I knew is that I was gonna work as hard as I could, and I figured that as long as I keep working-- and I was lucky to have some brains as well-- then I figured things would fall into place. They honestly haven't fallen into place exactly how I pictured them as I grew older and what it would look like. But I'm certainly thankful for where I am right now, and what is the next five years or 10 years gonna look like? I have no idea. And I guess I just don't even picture it. I have goals, but I also know that those goals change depending on circumstances. And you need, as I'm growing into middle age-- I think I'm beyond middle age now-- I'm thinking about midlife crisis and things like that. I get into philosophy and there's like telic and atelic things and so, it's sounds, again, it's about the path and the journey. It's not about the ultimate goal because, having reached a lot of these successes, that good feeling lasts for maybe a day or half a day. And you think you know, I spent all these years coming with the, with our device, getting our device to market and getting FDA approval and like, oh my gosh, like, you'd think, I'd feel so great about that. And it did. It felt great, but you wake up the next day and you gotta keep going. So you have to enjoy the journey and that's really what it's the wisdom that comes with age is trying to enjoy the journey as much as possible and not focus too much beyond that. [00:23:09] Lindsey Dinneen: Yeah. Yeah, and I think that's really good advice too, in that it is because the daily life isn't usually all the celebration and successes. I mean, that does happen and those are good moments, but because the vast majority of our life is spent on the journey component of it, and going through those peaks and valleys, it is important to find something you love and feel that you can make an impact in. So I'm so thankful that this is what you've chosen to do. So pivoting the conversation a little bit just for fun, imagine that you're to be offered a million dollars to teach a masterclass on anything you want. Could be within your industry, but it doesn't have to be. What would you choose to teach? [00:23:55] Dr. Adam Power: And would that mean that I was an expert in it? [00:23:58] Lindsey Dinneen: Well, certainly if you're getting paid a million dollars, somebody has decided you aren't an expert at it. How about that? [00:24:05] Dr. Adam Power: Okay. Well. Can I pretend like I'm an expert in it? There's something that I really love, but I'm not I'm probably not an expert in it. It would be, I would teach a masterclass in DJing. Isn't that strange? I know it's so random. [00:24:21] Lindsey Dinneen: Oh my goodness! Tell me more! [00:24:23] Dr. Adam Power: Well, I mean, I love music. I've, I grew up playing lots of sports and never was involved in music. And, and I've always appreciated music and art, but I was never able to do it. And, you know, growing up I did love sort of all types of music and then even electronic music and it just somehow talked to me. So I started DJing electronic music basically when I was around med school and have always loved it now, and when I was over in England, I DJ'ed on the campus radio and also DJ'd in a club. It was really fun and it sounds pretty silly to be talking about this when I have these other things that are on the go. But honestly, being able to share space with other human beings these days, and actually having a good time and having it not be stressful and having it be only, you know, everybody's wishing others to have a good time. There's not many people that go out sort of dancing into electronic music that are thinking bad things about other people. Really they're just out for a good time. And so being able to steer that whole music and scene is pretty awesome. And I do love it. And I don't DJ as much as I used to, but I still do different events, usually Christmas parties for the operating room. I'll do the typically wedding sort of DJ, but then they always, 'cause they know me, they let me do an hour long electronic set, which is like hardcore electronic. But then I go back to the regular stuff. But I would want to teach a masterclass in DJing. [00:25:56] Lindsey Dinneen: That is awesome. How exciting. Oh my gosh, I love that. And I think you're right. Music brings us together and it's a wonderful way to, to share a little bit of joy. [00:26:07] Dr. Adam Power: Yeah. [00:26:08] Lindsey Dinneen: Yeah. Okay. And then how do you wish to be remembered after you leave this world? [00:26:15] Dr. Adam Power: I, so number one is I don't, again, with my midlife crisis, I've actually been trying to eliminate my ego as much as possible. And so when people talk about legacy, it actually gives me the hives these days to be quite honest, because I don't like that because I think you're focused a lot on yourself. In my opinion, a lot of legacy is all about you. The way that I would wanna be remembered, though, is truly that I was kind and compassionate to everyone that I met, and that I stood for something, and that I left the world a better place. [00:26:57] Lindsey Dinneen: Yeah, those are wonderful things to want to be remembered for, absolutely. And then final question, what is one thing that makes you smile every time you see or think about it? [00:27:09] Dr. Adam Power: My kids. My son Kai and my daughter Saoirse. They are the light of my life. And I, you would think that with how busy I am ,you know, those things would deprioritize, but they truly are the one thing in my life that makes me smile when I get up in the morning. [00:27:30] Lindsey Dinneen: Oh, that's wonderful. Well, that is absolutely incredible. I loved getting to meet you and speak with you a little bit today. Thank you so much for sharing about your journey. Thank you for sharing about your incredible device and your bits of wisdom along the way. The idea of we've gotta enjoy the experience, the path, the journey. And I just really appreciate you spending some time with us. So thank you for everything you're doing to change lives for a better world. [00:27:59] Dr. Adam Power: Oh, well, thank you for giving me the opportunity to speak with you. It was absolutely lovely chatting with you today. [00:28:05] Lindsey Dinneen: Wonderful. Well, thank you again so much. Thank you also to listeners who are tuning in, and if you're as inspired as I am, I would love it if you would share this episode with a colleague or two and we'll catch you next time. [00:28:20] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.
In this episode of Tank Talks, host Matt Cohen is joined by Christian Weedbrook, Founder and CEO of Xanadu, a groundbreaking Canadian company leading the charge in photonic quantum computing. With over $250 million raised, Xanadu is on track to revolutionize industries through its cutting-edge quantum technologies.Christian discusses his transition from academia to entrepreneurship, the challenges of building a quantum company, and the potential for quantum computing to reshape industries like AI, drug discovery, and materials science. He shares his insights on Canada's role in the future of quantum tech, how quantum's “ChatGPT moment” will likely change the game, and why error correction is the key to scalable quantum applications.Christian also dives into Xanadu's ambitious plans for a quantum data center in Toronto, aiming to leverage room-temperature photonic computing to create the world's first fault-tolerant quantum computing environment by 2029. From AI-driven innovation to material science breakthroughs, this episode is packed with insights on how the future of computing is being redefined.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.Christian's Journey from Quantum Physics to Entrepreneurial Vision (08:15)* The transition from academia to founding Xanadu.* Early quantum research and turning theory into a business.Quantum's "ChatGPT Moment" (13:10)* How quantum computing's breakthrough will mirror AI's rise.* The promise of quantum in industries like AI and drug discovery.The Challenges of Quantum Capital and Investment (16:20)* The hurdles of fundraising and dealing with investors unfamiliar with quantum technology.Xanadu's Recent Breakthrough in Photonic Error Correction (18:47)* How solving error correction will pave the way for real-world quantum applications.* Quantum advantage in practical settings.Canada's Advantage in Quantum and Xanadu's Global Impact (22:01)* Why Christian chose to build Xanadu in Toronto.* How Canada can lead the quantum revolution and avoid the pitfalls faced by the AI sector.The Future of Quantum Chemistry and Material Science (39:10)* The role of quantum computing in next-gen battery and solar cell development.* Why quantum chemistry is the next big frontier.About Christian WeedbrookChristian Weedbrook is the Founder and CEO of Xanadu, a leading quantum computing company based in Toronto, specializing in photonic quantum technologies. With a PhD in quantum computing, Christian has held postdoctoral positions at MIT and the University of Toronto, contributing to groundbreaking work in the field. He founded Xanadu in 2016, aiming to make quantum computing scalable and commercially viable. Under his leadership, the company has raised over $250 million and is on track to build the world's first fault-tolerant quantum data center by 2029. Christian is dedicated to positioning Canada as a global leader in quantum computing and helping to unlock its potential across industries like AI, drug discovery, and material science.Connect with Christian Weedbrook on LinkedIn: https://www.linkedin.com/in/christianweedbrook/Visit the Xanadu website: https://www.xanadu.ai/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
From Surgeon to CEO: Prof. Marc Possover's Inspiring Journey in Medical Innovation The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life's mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery. In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education. A Career Built on Medical Breakthroughs Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide. Why a Surgeon Became a CEO Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice. As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career. Patient Education as a Driving Force Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most. By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership. Building a Global Legacy Through Training Prof. Possover's passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach. This dedication reflects a philosophy that medicine's greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations. Lessons for Medical Professionals and Entrepreneurs This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business. Clinical expertise can fuel entrepreneurship when paired with strategic thinking. Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand. Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers. Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover's journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership. In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage. Links INSP Link: https://isnp.possover.com/index neurogyn: https://neurogyn.com/ Possover: https://www.possover.com/en/ Youtube: https://www.youtube.com/results?search_query=marc+possover Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice
What if you could cut your product development time in half—and avoid the regulatory landmines that derail most startups? In this episode of Med Tech Gurus, Marcel Botha, CEO and Founder of 10XBeta, reveals how his Brooklyn-based venture studio helps innovators turn bold ideas into compliant, fundable, and scalable medical technologies. With deep expertise in design, engineering, and regulatory strategy, Marcel shares how 10XBeta supports founders in navigating the critical—and capital-intensive—first mile of MedTech development. From pandemic-driven ventilator designs to launching 50+ products, Marcel delivers powerful lessons on speed, structure, and investor alignment. Gurus, if you're building in the deep end of innovation, this episode is your blueprint.
In this episode of Tank Talks, host Matt Cohen is joined by John Ruffolo to dive into a wide range of topics affecting Canada's economy, from energy and tech to blockchain. They discuss the government's announcement of major projects like LNG Canada's expansion and the critical need for nuclear energy. The conversation also touches on Canada's role in the global energy market, especially with the growing importance of renewables and the challenges of balancing carbon-based energy.The episode shifts to AI and blockchain, exploring how Canada can stay competitive in the tech race. They also dive into the rise of stablecoins in Canada with Tetra Digital Group's new Canadian peg stablecoin aimed at transforming B2B payments. Lastly, the episode examines the increasing presence of Canadian executives in U.S. tech companies and the risks of overvaluation in the AI startup space.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.LNG, Nuclear & Energy Future: Canada's Next Big Steps (00:07:13)Matt and John discuss the announcement of major energy projects in Canada, including LNG Canada's expansion and the importance of investing in nuclear energy for the future.Stablecoin Innovation: The Canadian Peg Stablecoin (00:15:01)Tetra Digital Group in Calgary launches a Canadian peg stablecoin set to revolutionize B2B payments. John and Matt explore how it could impact Canada's financial landscape.Opendoor's New CEO: Canadian Leadership in U.S. Tech (00:18:25)Opendoor appoints a Canadian executive as CEO, sparking a conversation about the growing influence of Canadian tech talent in major U.S. companies.AI Valuations: Are We Heading for a Tech Crash? (00:25:39)With the AI boom in full swing, Matt and John examine the potential for overvaluation and the risks of an AI bubble, echoing insights from Vinod Khosla on market “carnage.”AI's Future: Innovation or Overhype? (00:26:15)Matt and John delve into the power law of investing, discussing how capital is flowing into AI and why only a few companies will win big while many others will fail.Connect with John Ruffolo on LinkedIn: https://ca.linkedin.com/in/joruffoloConnect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Marc Penna, CEO of Voyager Biomedical. Voyager is a clinical-stage company tackling one of the most persistent challenges in dialysis care: reliable vascular access. Marc has more than 20 years of experience leading clinical research and regulatory programs across cardiology, vascular disease, and oncology. Since 2014, he has focused on early-stage ventures, with leadership roles at Intact Vascular and Vesper Medical — both acquired by Philips — as well as senior positions at Edwards Lifesciences, Boston Scientific, and AngioDynamics.In this interview, Marc shares how to pressure-test new medtech ideas, why collaboration with regulators and trial sites builds lasting credibility, and how disciplined fundraising and smart exit planning can set startups apart.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Marc Penna.
Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let's Combinate, Subhi Saadeh sits down with Dominick Romano, founder of Drainpipe.io, to unpack the future of AI in pharma, medtech, and drug/device regulation. The conversation goes deep into how AI could reshape dossier preparation, regulatory submissions, and quality oversight — and what strategies regulators and companies need to make sure speed doesn't come at the cost of trust.We explore:- Why pharma's unique risk profile makes AI regulation different from other industries-How ICH guidelines and process validation can be applied to AI systems-What “combinatorial problem sets” mean for pharma and AI models-The role of AI in regulatory affairs and dossier preparation-How regulators may use AI to accelerate reviews and approvals-The balance between speed, accuracy, and zero hallucinations in regulatory contexts-The future of AI in quality control, biologics, and beyondIf you work in pharma, medtech, or drug/device combination products, this episode will give you a clear look at how AI could change your world and what needs to happen before it earns the regulator's trust.Episode Chapters00:00 Introduction: Regulating AI in Pharma/MedTech01:01 Pharma's Unique Risk Profile02:14 AI in Regulatory Affairs03:44 Combinatorial Problem Sets in Pharma04:24 ICH Guidelines and AI Regulation08:22 Process Validation in AI10:20 AI in Regulatory Submissions15:54 Ensuring Accuracy and Consistency17:02 Regulatory Agencies and AI18:28 Accelerating Drug Approval with AI21:36 Time Savings in Dossier Formation25:44 AI in Quality Control for Biologics27:42 Challenges in AI Integration29:25 The Future of Pharma & MedTech with AI30:40 Where to Find Dominick RomanoDominick Romano is the founder and CEO of Drainpipe.io, focused on building trustworthy AI systems for regulated industries like pharma and medtech. A graduate of Full Sail University in video game development, his career spans game design, programmatic advertising, and voice applications before moving into AI. He was named one of Technology Innovators' Top 50 AI CEOs and has contributed to global initiatives such as the WHO/ITU AI for Health program. Today, he helps organizations explore how AI can be validated and integrated without compromising compliance or trust.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.
This week, Liz and Rachel discuss the interview with Marnie Hamp and the importance of staying relevant post-launch. In their conversation, they focus on the need for training, marketing, and sales to all have ears in the field and strong collaboration among departments so that the needs of the reps and the customers can be met. In addition, they discuss the need to cross-train clinical reps and sales reps while maintaining clear roles and responsibilities.In 2025, we're embarking on a MedDevice Training Journey: From clinical trials to standard of care. Join us all year long as we explore training at each stage of the product life cycle.Need help developing your clinical trial training strategies? Contact us at training@cumbyconsulting.com.Related Resources:Marnie Hamp InterviewSubscribe to our newsletter to hear more about the journey from clinical trials to standard of care! Click here to subscribe! Connect with us on LinkedIn: Cumby ConsultingRachel MedeirosLiz CumbyAbout Cumby Consulting: Cumby Consulting's team of professionals deliver innovative MedTech training services for physicians, sales representatives, teaching faculty, key opinion leaders and clinical development teams. Whether you need a complete training system developed to deliver revenue sooner or a discrete training program for a specific meeting, Cumby Consulting will deliver highly strategic, efficient programs with uncompromising standards of quality.
In this episode, Duane Mancini chats with Lisa Jacobs, US President of eCential Robotics and Founder of STRIPES. With over 20 years of experience in orthopedics, robotics, and spine, Lisa delves into her motivations, challenges, and significant career milestones, including her personal connection to orthopedics through her brother's medical condition. The conversation covers her leadership style, emphasizing hands-on mentorship and the importance of not rushing commercialization efforts in startups. Lisa also discusses her organization, STRIPES, a women-focused networking group in medtech offering mentorship and support to help break industry barriers.Lisa Jacobs LinkedInSTRIPES Network Website eCential Robotics WebsiteDuane Mancini LinkedInProject Medtech WebsiteProject Medtech LinkedIn
In this episode, host Etienne Nichols sits down with seasoned MedTech entrepreneur Steve Bell to discuss the critical lessons for starting and scaling a medical device company. With over 30 years of global experience, Steve shares insights from his work with major corporations like Johnson & Johnson and his role in building Europe's largest MedTech unicorn. He reveals how a conversation with his wife led him to develop an extensive course and a new MedTech AI tool to help founders navigate the complex and often unforgiving startup landscape.Steve emphasizes the importance of moving beyond a great idea to build a viable business. He outlines the foundational mistakes that sink over 75% of startups, from emotional attachment to non-viable concepts to underestimating the time and financial commitment required. He introduces his “greenhouse score” system, an objective, data-driven tool designed to help founders evaluate their business idea against global competition, urging them to "kill their ideas early" if they aren't built for success.The conversation also touches on the unique challenges facing first-time founders, including the critical decision of who should lead the company. Steve advises against a "have-a-go-hero" mentality and highlights the value of bringing in experienced leadership to avoid costly mistakes. He stresses that true success lies in being "needs-based, not product-based," focusing on solving a core problem rather than becoming overly attached to a specific solution. The episode concludes with a warning about protecting intellectual property (IP) and the costly mistake of sharing proprietary information prematurely.Key Timestamps00:02:13 The origin story of Steve's MedTech startup course.00:04:58 The #1 reason MedTech startups fail: A good idea isn't always a good business.00:08:54 The greenhouse score and MedTech AI advisor for objective business idea validation.00:11:09 Why entrepreneurship is a "wide open field" and how to find a path.00:12:00 The importance of "Location, Location, Location" for MedTech startups.00:13:58 The MedTech Survival Guide book and life lessons learned.00:17:02 Should a first-time founder be the CEO?00:18:10 How to find and compensate an experienced CEO.00:20:45 Why you must be needs-based, not product-based.00:22:47 The difference between a business and an orphan or philanthropic project.00:23:53 The risk of destroying your IP before you even get started.Quotes"Every idea is good, but not every idea is a good business... some of them are just really interesting tech that's trying to look for a home." - Steve Bell"Most likely thing for most companies is the idea you go in with is not the idea you come out with... You need to be needs-based, not product-based." - Steve BellTakeawaysValidate Your Idea Objectively: Don't rely on gut feelings. Use data-driven tools to assess your business idea's viability. If your "greenhouse score" is low, don't abandon the need—pivot the solution or fix the weaknesses.Stack the Deck in Your Favor: Simple, logical choices can significantly increase your odds of success. This includes selecting a strategic business location and prioritizing a strong team over a lone "have-a-go-hero" founder.Hire Experienced Leadership: A first-time founder should rarely be the CEO. Bringing in a seasoned professional with C-suite experience can save millions of dollars and years of development, as they bring invaluable scar tissue and a network of investors.Protect Your...
In this episode of Tank Talks, host Matt Cohen sits down with Nikunj Kothari, Partner at FPV Ventures, to explore his journey from product leader at LinkedIn, Opendoor, and Meter to early-stage investor. Nikunj shares candid insights on why the best companies thrive under benevolent dictatorships, how AI is reshaping SaaS pricing models, and what makes founders truly exceptional.From his early years growing up in India to becoming one of the most thoughtful voices in venture, Nikunj opens up about his decision to leave operating roles, his angel investing beginnings, and his transition to VC at storied firm Khosla Ventures before joining FPV. He also dives deep into evaluating founders, navigating hypergrowth, and why outcome-based pricing may define the next decade of SaaS.Whether you're a founder looking to scale, an investor trying to spot the next breakout company, or simply curious about how AI is rewriting business models, this episode is packed with hard-earned lessons and bold ideas.A Quick Word from our Sponsor, FaskenAt Fasken, our clients don't wait for the future. They build it. As the first and largest dedicated emerging tech practice in Canada, our team is composed of founders, ex in-house counsel, developers and business advisors who have guided clients from startup, to scale-up, to exit. The trust of our clients has enabled us to consistently rank at the top of every major Canadian M&A, Capital Markets and Venture Capital league table. With deep industry knowledge and experience across all areas of emerging and high growth technology including ClimateTech, MedTech, Artificial Intelligence, Fintech, and AgTech we're your partners within the innovation ecosystem as you transform the landscape of what's possible.Tomorrow starts here. Own it with us.For more information, visit fasken.com/emergingtech and follow us on LinkedIn.From India to Silicon Valley: Nikunj's Early Journey (00:08:21)How his blend of engineering, design, and business led him to product management at LinkedIn and startups.Learning From Hypergrowth at LinkedIn and Opendoor (00:011:23)Why talent density and ambitious missions drive scaling organizations.The Investor's Lens: Spotting Latitude in Founders (00:013:32)Nikunj's framework for evaluating founder vision and depth at the earliest stages.Why the Best Companies Are Benevolent Dictatorships (00:015:39)How companies like Shopify and Coinbase thrive under strong, opinionated leaders.The Tension for Non-Founders in Dictatorship Environments (00:21:09)Nikunj's personal lessons as a PM executing a founder's vision.The Pivot to Investing: From Angel Checks to Khosla Ventures (00:23:26)Why he left operating roles, and what he had to unlearn as he became a VC.Joining FPV Ventures and Betting on Founder POVs (00:27:18)How FPV approaches concentrated early-stage investing with diligence and conviction.Gross Margins, Kingmaking, and the VC Trap (00:32:09)Why focusing on revenue quality matters more than chasing top-line growth.AI and the Future of SaaS Pricing Models (00:39:31)How outcome-based and usage-based pricing will disrupt per-seat SaaS models.Navigating Enterprise AI Adoption (00:44:22)The role of champions in enterprise sales and lessons from scar tissue in early adoption.Competing in Crowded Markets: The Series A Challenge (00:47:31)Why exceptional founders and market depth matter more than being first.Hot Takes: Solo Founders in the AI Era and the Future of IPOs (00:54:24)Nikunj's contrarian views on solo founders and whether Canva will go public.About Nikunj KothariNikunj Kothari is a Partner at FPV Ventures, where he focuses on early-stage investments with a founder-first approach. Previously, he was a product leader at LinkedIn, Opendoor, and Meter, where he helped scale hypergrowth startups and navigate tough product challenges. Nikunj began angel investing while at Opendoor and later joined Khosla Ventures, before moving to FPV to pursue concentrated, high-conviction seed and Series A investments. Known for his sharp writing on venture and product strategy, Nikunj has become a leading voice on topics ranging from benevolent dictatorships to the future of SaaS pricing.Connect with Nikunj Kothari on LinkedIn: https://www.linkedin.com/in/nikunjkVisit the FPV Ventures website: https://fpvventures.com/Connect with Matt Cohen on LinkedIn: https://ca.linkedin.com/in/matt-cohen1Visit the Ripple Ventures website: https://www.rippleventures.com/ This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit tanktalks.substack.com
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about a recent Editor's Letter I wrote for MPO that gave reasons why placing a warning label on wellness devices about their status as an FDA regulated medical device would be a good idea. Does Mike agree? Do you agree that patients should be provided with an explanation that a wellness product does not get reviewed or approved by the FDA? During this conversation, the following questions are addressed:My editorial is about wellness products. Before discussing further, can you remind us what a wellness product is?Why did you write this column and given wellness devices have been “formally recognized” by FDA since 2016, why did you write it now?In your title, you use Wellness Products vs. Wellness Devices. Why?You point out in your editorial that general wellness devices are low risk devices. In fact, that's part of the title of the guidance. But is it correct to say, “General wellness devices are low-risk devices”?Let's discuss the example from my editorial (SaltAir by Halosense).Should wellness devices be required to have a disclaimer regarding their lack of FDA review, or should it be the consumer's responsibility to research and find out more about the product on their own?If a disclaimer is recommended (maybe not required), what should the disclaimer say?What else is important?What are today's takeaways?Listen to this discussion and see if you think wellness products should get a warning. If you'Send us a textFor more medtech news and information, visit https://www.mpomag.com.
In this episode, host Etienne Nichols sits down with Josh Eckelberry, Principal at Solas BioVentures, for an illuminating conversation about venture capital in the MedTech and life sciences sectors. Josh shares his journey from a medical background to a career in venture capital, driven by a passion for creating "leveraged change" by helping innovative technologies reach a broader patient population. He explains how this approach allows for a greater impact than what's possible in one-on-one clinical care.Josh delves into the unique investment philosophy of Solas BioVentures, which is an operator-led firm that provides hands-on guidance to early-stage startups. He introduces the firm's core "dote, goat, float, and moat" framework, which evaluates a company's therapeutic efficacy, management team, economic viability, and intellectual property. The discussion provides a candid look at how venture capitalists assess risk and make investment decisions, highlighting the importance of building a strong, emotionally intelligent team and demonstrating a clear path to market.The conversation also explores practical strategies for startups to de-risk their investment proposition. Josh offers insights on how companies can use a pre-submission to get crucial feedback from the FDA, and how leveraging the right advisory board can instill confidence in potential investors. He explains the value of bringing in key opinion leaders and how a well-structured clinical trial, with thoughtfully designed inclusion and exclusion criteria, is essential for proving a technology's safety and efficacy.Key Timestamps1:02 - Josh's transition from medicine to venture capital.7:27 - The unique, operator-led investment approach of Solus Bio Ventures.12:47 - The "dote, goat, float, moat" framework for evaluating startups.15:02 - What makes a great management team ("the goat").24:43 - De-risking strategies for early-stage MedTech companies.27:55 - The importance of regulatory discussions with the FDA.30:13 - Building and compensating a strong advisory board.Quotes"I call that leveraged change. I try to change that fulcrum of not just one patient at a time like I felt like in clinical medicine, but advocating and changing the lives of hundreds of people by getting these drugs and devices to market." - Joshua EckelberryTakeawaysFocus on the team: Investors, particularly at the early stage, place significant emphasis on the management team's experience, emotional intelligence, and ability to navigate challenges. Past success and a positive, collaborative culture are key indicators of future performance.De-risk early and strategically: To attract early-stage capital, companies must proactively address key risks. This includes securing strong intellectual property, proving therapeutic efficacy, and engaging with regulatory bodies like the FDA through pre-submissions to gain confidence.Build a knowledgeable advisory board: A well-vetted board of advisors with a strong reputation and deep industry knowledge—particularly in areas like reimbursement and regulatory affairs—can be a major confidence booster for investors.Understand the "Dote, Goat, Float, Moat" framework: Companies should be prepared to address these four pillars: Dote (therapeutic efficacy), Goat (management team), Float (economics/reimbursement), and Moat (intellectual property).Embrace the conversation: Early-stage investors are often more accessible than founders might assume. Reaching out and engaging with...
Josh Cohn, Chief Commercial Officer of EndoSound, joins Test. Optimize. Scale. to share how his team is changing access to GI procedures through innovative medical technology and equity crowdfunding. With 17 years of experience in the medical device industry, Josh has built a track record of leading teams ranked #1 in revenue, percent to plan, and conversion dollars year after year. In this episode, Josh explains why EndoSound is gaining national attention from investors, physicians, and surgical centers. He breaks down how their technology lowers costs for patients, expands access to care in underserved communities, and opens new opportunities for doctors and facilities. Josh also talks about the company's Reg CF campaign on Wefunder, how they attracted hundreds of investors, and why he believes crowdfunding is essential to the future of MedTech. Whether you're a founder, investor, or curious about medical device innovation, you'll hear real insights into testing, optimizing, and scaling a healthcare startup.
Medsider Radio: Learn from Medical Device and Medtech Thought Leaders
In this episode of Medsider Radio, we sat down with Christopher Haig, co-founder and CEO of Efemoral Medical. Efemoral is developing bioresorbable scaffold technology for peripheral arterial disease. Chris has over 25 years of experience in cardiovascular devices, holding leadership roles at strategics including Guidant Corporation and Abbott Vascular, and driving growth at startups such as Calypso Medical and QT Vascular, where he built commercial infrastructure and launched multiple products ahead of its $55 million IPO.In this interview, Chris shares how bioresorbable scaffold technology found new life for peripheral arterial disease — and the lessons on matching tech to significant needs and choosing trial sites for lasting data.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Christopher Haig.
Even the most driven professionals can find themselves stuck working harder but not moving forward. The culprit? Not market conditions, not product fit, but what bestselling author and executive coach Dr. Noah St. John calls head trash. In this episode, sponsored by Physician Growth Accelerator, Dr. St. John joins Zed Williamson to explore how subconscious limitations cap performance, even for top MedTech reps and leaders. With a track record of helping clients add over $3 billion in revenue, he reveals why traditional goal-setting isn't enough, how to identify the “yeah buts” that sabotage progress, and how to replace time-wasting habits with high-leverage actions. What we discuss in the episode: Why head trash is more than negative thinking—it's any limitation keeping you stuck. The hidden cost of doing $10/hour work as a $10K/hour performer Why humans avoid pain more than they pursue pleasure Real-world case studies where removing head trash unlocked exponential growth How MedTech professionals can recognize and address limitations in themselves and their customers Why a system-driven approach to success outperforms personality-driven motivation Resources from this episode: Get the free MedTech Talk Tracks for Action Visit Dr. Noah's Website Subscribe to Dr. Noah's YouTube Channel Social Media: Connect with Dr. Noah on LinkedIn Connect with Zed on LinkedIn Connect with Clark on LinkedIn
It Happened To Me: A Rare Disease and Medical Challenges Podcast
Join us as we delve into the evolving landscape of clinical trials in Latin America with Julio G. Martinez-Clark, CEO of BioAccess. Discover how his company is pioneering pathways for medtech innovators and shaping the future of medical device innovation in emerging markets. Bioaccess® is a trailblazing company that's helped over 100 Medtech innovators navigate global clinical trials, and he currently serves as Ambassador of International Accrediting Organization for Clinical Research in the Americas. With a career that spans healthcare infrastructure, telecommunications, and regulatory strategy, Julio is a leading voice in the field of medical device innovation in emerging markets. From his early days at Johns Hopkins Hospital to his current role in shaping ethical and efficient trial systems across Latin America, Julio's mission is clear: to expand access to high-quality research for patients and sponsors alike. He's also the host of the Global Trial Accelerators™ podcast, where he dives into trends in Medtech, Biopharma, Radiopharma and clinical trial innovation. We unpack what makes Latin America a strategic region for clinical trials, especially for rare diseases, and explore how improving trial access can speed innovation, and change lives. Episode Discussion Topics: Introduction to Julio G. Martinez-Clark and his role at BioAccess. The clinical trial landscape in Latin America and its strategic importance. Julio's career journey from Johns Hopkins Hospital to BioAccess. The impact of cultural competence and community engagement on clinical trials. Challenges and solutions for conducting clinical trials during the pandemic. The role of artificial intelligence and digital tools in clinical trials. The future of clinical research in Latin America, including radiopharmaceuticals and theranostics. The importance of international standards and certifications for clinical research sites. Success stories and innovative approaches in clinical trials. Julio's podcast, Global Trial Innovators, and its focus on industry education. During the episode a blog post on bioaccess' website was referenced that highlights academic papers that talk about the higher recruitment and retention rates in Latin America, here it is: https://www.bioaccessla.com/blog/the-latin-american-advantage-why-clinical-trial-recruitment-and-retention-outpace-the-us-and-europe Connect With Us: Stay tuned for the next new episode of “It Happened To Me”! In the meantime, you can listen to our previous episodes on Apple Podcasts, Spotify, streaming on the website, or any other podcast player by searching, “It Happened To Me”. “It Happened To Me” is created and hosted by Cathy Gildenhorn and Beth Glassman. DNA Today's Kira Dineen is our executive producer and marketing lead. Amanda Andreoli is our associate producer. Ashlyn Enokian is our graphic designer. See what else we are up to on Twitter, Instagram, Facebook, YouTube and our website, ItHappenedToMePod.com. Questions/inquiries can be sent to ItHappenedToMePod@gmail.com.
Send us a textSpencer Jones began his healthcare career as a registered nurse in Little Rock, Arkansas, where he witnessed firsthand the clinical need that sparked his first device: SafeBreak® Vascular, a patented solution to prevent IV line dislodgement. As a nursing alumnus of the University of Arkansas, Spencer led SafeBreak from idea to FDA approval in 2022, drawing on early mentorship from Innovate Arkansas and a successful accelerator experience with ZeroTo510.In 2015 he founded Lineus Medical as co‑founder and CTO, securing multiple U.S. and international patents while raising seed and Series A funding. In 2020 he began consulting with Lapovations, the University of Arkansas‑spawned medtech startup behind AbGrab®, a suction‑based tool enabling safer and more consistent abdominal entry in laparoscopy.Since officially joining Lapovations in October 2022, Spencer has served as CTO, VP of Sales and now CEO, leading efforts like a national sales rollout, Series A financing, SBIR IIB grant, and the Class I FDA launch of AbGrab across 18 states. Beyond product development, he's an active mentor and ecosystem builder through XO Medtech, ComboSpine, and educational partnerships.Spencer is passionate about democratizing clinical innovation—especially for nurses, physicians, and students—and now leverages AI tools to accelerate medtech startup growth. Recognized by Nurse.org as “Nurse Innovator of the Year,” he is a powerhouse blending clinical insight, technical execution, fundraising prowess, and ecosystem leadership. LINKS:Guest LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/Guest website: https://xomedtech.com/ Aaron Moncur, hostClick here to learn more about simulation solutions from Simutech Group.