Inside MedTech Innovation

Shannon Lantzy

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches the people who need it most.

  1. Mission-Driven MedTech w. Mike Monovoukas

    14 MAY

    Mission-Driven MedTech w. Mike Monovoukas

    Mike Monovoukas is the co-founder and CEO of AcuityMD, a platform that helps medical device manufacturers accelerate commercial adoption. Before founding AcuityMD, Mike started his career as a management consultant, then co-founded a medical device startup with his brother, where he first experienced firsthand how much time and effort it took just to prepare for a single sales call. That experience became the foundation for AcuityMD. In this conversation with Shannon Lantzy, Mike walks through how AcuityMD combines publicly available market data with internal commercial data to surface highly personalized opportunities for medical device sales teams. He shares the customer story that defined the company's mission, why the physics of a business model matter as much as the mission statement, and what he believes regulators can do to unlock innovation. He also reflects on building culture at scale, why he hires missionaries not mercenaries, and the spidey sense every founder needs to keep. Timestamps: [00:00:00] Introduction and AcuityMD overview [00:01:00] Competitive swimming, discipline, and early mornings [00:02:04] From athlete to founder: the origin story [00:03:36] First medical device startup with his brother [00:05:08] The research problem that became AcuityMD [00:06:28] The aha moment: combining market data with internal data [00:08:28] What customers measure AcuityMD on [00:09:16] Paul Graham, COVID, and the things that did not scale [00:14:28] Walking through the Synchron use case [00:17:24] What pre-commercial use looks like in practice [00:19:12] Switching between business language and medtech language [00:20:04] Hiring missionaries not mercenaries [00:21:04] Why the physics of the business model matter [00:22:28] The problem with business models that restrict care [00:23:52] Prior auth, AI, and creating bottlenecks [00:25:32] Using FDA's MAUDE database for competitive intelligence [00:27:24] How sales data can feed back into product development [00:30:52] Most gratifying customer story: the rural hospital [00:35:40] Open payments, over-prescription, and the hard questions [00:38:52] AcuityMD's mission: making healthcare abundant [00:42:32] Pre-reimbursement use cases [00:43:44] What is hardest right now: scaling culture [00:45:08] Culture is how people make decisions when you are not in the room [00:46:24] Rapid fire questions Follow Shannon and Mike: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Mike:  LinkedIn: https://www.linkedin.com/in/michael-monovoukas-0786a52b/ Website: https://www.acuitymd.com/

    53 min
  2. Uncommon Sense w. Dr. William Brody

    30 APR

    Uncommon Sense w. Dr. William Brody

    Dr. William Brody has had at least four careers: foundational researcher in CT and MRI, co-founder of three medical device companies, 13-year president of Johns Hopkins University, and leader of the Salk Institute. Now he's codified a lifetime of lessons in his new book, Uncommon Sense, released April 28, 2026. In this conversation with Shannon Lantzy, Dr. Brody shares the decision-making framework that shaped his career: from a course at MIT that changed how he approached hard problems, to the three snake rules of management he still lives by. He discusses the economics of quality in healthcare, why curiosity and focus are both essential to discovery, and what AI-native companies consistently get wrong about breaking into medicine. He also reflects on kindness, risk, survivorship bias, and what it really means to succeed. Uncommon Sense is available through Johns Hopkins Press. Timestamps:  [00:00:00] Introduction and Dr. Brody's four careers [00:01:36] Welcome back and the book overview [00:02:56] Goals of Uncommon Sense and learning to think [00:05:08] What students give back and a note from a former student [00:06:00] Uncertainty, suffering, and the Buddhist parallel [00:07:24] Amar Bose and learning to tackle hard problems [00:08:44] Rob Wallace: from ballet to Stanford's CIO [00:10:36] Career planning is an oxymoron [00:13:56] Bloomberg, kindness, and the mayor who shouldn't have run [00:15:44] The economics of quality at Johns Hopkins and the Toyota system [00:19:44] Treating patients, research, or inventing devices [00:21:32] Turtle on a post: spotting uncommon signals [00:23:24] Curiosity vs. confirmatory research [00:25:16] The MRI contrarian and what it cost him [00:29:36] Kindness as strategy: does it correlate with success? [00:31:04] What is enough? [00:33:08] The book's philosophical tone [00:35:04] Does this advice apply to the common person? [00:38:28] AI in healthcare and what founders get wrong [00:40:30] How Epic actually started [00:41:44] Where the most exciting healthcare innovation is happening [00:43:00] Risk management, uncertainty, and the over-lawyered world [00:47:48] The three snake rules of management [00:50:04] Norman Shumway and "the bleeding always stops" [00:52:28] Rapid fire questions Follow Shannon and William: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with William:  LinkedIn: https://www.linkedin.com/in/william-brody-138920106/

    58 min
  3. Behind FDA’s Heroes w. Dr. Robert Califf

    16 APR

    Behind FDA’s Heroes w. Dr. Robert Califf

    FDA commissioners come and go, but career civil servants are always there, applying the rules without financial conflicts of interest. Dr. Robert Califf served as FDA Commissioner twice, making him one of the most experienced regulatory leaders in healthcare history. Before FDA, he built the world's largest clinical research institute at Duke and spent time in Silicon Valley with Google's Verily. Now he writes weekly on Substack, sharing opinions on controversial topics with specific evidence and nuance. In this episode, Shannon Lantzy talks with Dr. Califf about the referee role of the FDA, why political appointees shouldn't make decisions about individual products, and what delighted him most during his terms. They discuss the history of why we regulate medical products differently than consumer goods, how AI could transform regulatory review, and why studying failures teaches more than studying successes. Timestamps: 00:00 – Regulators as referees who apply rules made by politicians 02:00 – Why the man in the arena is also the referee 04:00 – How honest referees keep societies and sports functioning 06:00 – Commissioner vs. center directors: political vs. career civil servants 08:00 – When rules reflect cultural beliefs vs. scientific evidence 11:00 – Why middle schoolers need to understand FDA's mission 13:00 – Health is different from consumer products: we don't experiment on expendable humans 15:00 – Regulatory innovation before the boom: unsung but vital 17:00 – The hardest thing: keeping hands off individual product decisions 19:00 – Everything delightful: teams working together under imperfect information 21:00 – When ICDs showed 40% reduction in sudden death 23:00 – AI for automated detection and its impact on clinical decisions 26:00 – Why we need regulatory systems to channel activity toward benefit 27:00 – Evidence-based decision making and controversial approvals 30:00 – The iceberg: most FDA impact happens in decisions you never see 32:00 – Moving toward public knowledge of early studies and failures 34:00 – How AI can summarize decisions in minutes for good or harm 35:00 – Rapid fire: Keep your compass on being a good referee Follow Shannon and Robert: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com Connect with Robert:  Substack: https://robcaliff272993.substack.com/ LinkedIn: https://www.linkedin.com/in/robert-califf-69040016/

    37 min
  4. Biodesign for MedTech w. Josh Makower

    26 MAR

    Biodesign for MedTech w. Josh Makower

    The Stanford Mussallem Center for Biodesign has trained innovators whose inventions have touched over 18 million lives while they were still in training. Most people think breakthrough innovation is magic or unpredictable. Dr. Josh Makower proved otherwise. As co-founder of the Stanford Mussallem Center for Biodesign, he created a systematic methodology that breaks innovation into learnable steps: identify who you're serving, understand their needs through direct observation, define the problem without embedding a solution, then invent against clear criteria. The result is a repeatable process that dramatically increases the probability of success. In this episode, Shannon Lantzy talks with Dr. Makower about his journey from mechanical engineering and medical school to founding ExploraMed, an incubator that launched companies like NeoTract and Willow. They discuss how two men created the first wearable breast pump by studying how babies actually feed, why regulatory reform requires empathy on both sides, and what it takes to sustain the innovation ecosystem through capital returns while serving patients. Timestamps: 00:00 – You must return capital to investors to keep the ecosystem going 03:00 – From The Bionic Man to biomedical engineering 06:00 – Learning the language of business to stay in the room 09:00 – Why sustainable businesses, not charity, solve medical problems 12:00 – ExploraMed and the biodesign process in action 14:00 – The hardest part: keeping engineers from racing to solutions 16:00 – Creating the first wearable breast pump 19:00 – How two men learned to solve a problem they don't have 23:00 – Why outsiders can see what insiders miss 26:00 – The golden era of medical devices and what changed in 2008 28:00 – Getting FDASIA passed: fighting for regulatory reform 32:00 – Breaking innovation into learnable steps 35:00 – When needs statements should (and shouldn't) change 37:00 – Disease burden as an invisible, unmeasured problem 40:00 – How to prioritize: outcome severity multiplied by people impacted 44:00 – Who biodesign serves and why the ecosystem matters 47:00 – Measuring impact: 18 million lives and counting 52:00 – Are we over-engineering healthcare? 56:00 – What FDA still needs to improve: consistency across reviewers 01:00:00 – Empathy on both sides of regulation Follow Shannon and Josh: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com Connect with Josh:  LinkedIn: https://www.linkedin.com/in/josh-makower/ Website: https://biodesign.stanford.edu

    1hr 3min
  5. Bridging Diabetes Tech w. Dr. Bob Gabbay

    12 MAR

    Bridging Diabetes Tech w. Dr. Bob Gabbay

    Dr. Bob Gabbay has spent decades at the intersection of diabetes research, clinical care, and technology innovation. From leading the Joslin Diabetes Center to serving as Chief Scientific and Medical Officer at the American Diabetes Association, he witnessed the field transform from sharpening needles on stones to closed-loop insulin systems. Yet despite incredible technological advances, a critical problem persists: the tools that could help people with diabetes simply aren't reaching them or being used effectively. In this conversation, Dr. Bob shares how the DIY diabetes community's "We Are Not Waiting" movement pushed both industry and regulators forward, why A1C and time in range tell complementary stories about glucose management, and how his year of "semi-retirement" turned into mentoring startups and crystallizing decades of knowledge. He discusses the holy grail features still missing from automated insulin delivery, from exercise mode to meal-snap AI, and makes the case for why patient-reported outcomes deserve equal billing with clinical measures. Dr. Bob also reflects on moonshot thinking, the tension between individualizing treatment and population-level safety, and why the last mile problem matters more than the next breakthrough. [00:00:00] Introduction and Dr. Bob's journey from chemistry sets to diabetes care [00:06:00] Creating opportunities through cold calling and community building [00:10:00] Med school without planning to see patients [00:12:00] Leading the American Diabetes Association [00:15:00] Seven turns in diabetes management [00:17:00] A1C versus time in range as outcome measures [00:21:00] Semi-retirement as a digital nomad [00:23:00] Fluid knowledge versus crystallized knowledge [00:26:00] The "We Are Not Waiting" movement's impact [00:30:00] What's still not solved in automated insulin delivery [00:34:00] The mascara metaphor and spoon theory [00:39:00] Sotagliflozin and weighing DKA risk versus benefits [00:46:00] Making emotional outcomes measurable [00:51:00] Moonshots and the Startup Health approach [00:55:00] Non-invasive glucose monitoring lessons [00:58:00] Rapid fire questions Follow Shannon and Dr Bob: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Dr Bob:  LinkedIn: https://www.linkedin.com/in/drbobgabbay/

    1hr 2min
  6. Tech For MedTech: Automated Compliance w. Michael Edenzon

    26 FEB

    Tech For MedTech: Automated Compliance w. Michael Edenzon

    One medical device company cut their software recall response time from 180 days to under 30 by automating compliance evidence collection. In regulated industries like MedTech, shipping software takes weeks not because the code isn't ready, but because proving compliance requires manual evidence gathering. Automated governance captures proof continuously as developers work. When it's time to ship, compliance happens automatically or developers get blocked. The result: 85% faster time to market and developers who become collaborators instead of adversaries. In this episode, Shannon Lantzy talks with Michael Edenzon, CEO of Fianu, about turning cyclical compliance work into continuous automation, why transparency changes developer behavior, and why objective, reproducible evidence should be the new regulatory standard. Timestamps: 00:00 – Why automated governance is the missing piece in DevOps 04:00 – How Michael went from constitutional law student to software governance innovator 06:00 – What automated governance is (and why it's not just another tool) 09:00 – The screenshot problem: When developers game manual compliance systems 12:00 – Do developers hate automated governance or does it free them? 15:00 – What happens when requirements are incomplete or wrong 18:00 – The flywheel effect: How continuous feedback improves control effectiveness 20:00 – Creating a shared language: Pass, fail, in progress, or not found 24:00 – Case study: How a CGM company cut recall response from 180 to 30 days 30:00 – Why you should never automate to a higher standard than you're currently at 33:00 – Simulating the impact of policy changes before enforcing them 37:00 – The power of annotations: Accepting risk while maintaining auditability 40:00 – Why transparency turns developers into your best collaborators 42:00 – Who should (and shouldn't) adopt automated governance 48:00 – What Michael would change about FDA regulation if he could wave a wand 52:00 – Tracking software from Jira story to production runtime and back to adverse events 54:00 – What's next for Fianu: Statistics, reporting, and compliance incentive structures Follow Shannon and Michael: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Michael:  LinkedIn: https://www.linkedin.com/in/michaeledenzon/ Website: https://www.fianu.io/

    58 min
  7. Marketing MedTech w. Joy Duemke

    12 FEB

    Marketing MedTech w. Joy Duemke

    Only 2% of sickle cell patients who could benefit from blood therapy actually receive it, despite it being first-line treatment. Marketing in medical devices isn't about jingles or promotions. It's about looking at data, drawing hypotheses, testing them, and ensuring every claim you make is scientifically relevant. It's closer to research than advertising, requiring the ability to translate between what physicians know, what devices do, and what patients need. In this episode, Shannon Lantzy talks with Joy Duemke, Director of Marketing at Terumo Blood and Cell Technologies, about her 15-year journey across six different roles at one company. They discuss why learning agility matters more than subject matter expertise, how to navigate the overlap between clinical knowledge and product understanding, and what it takes to launch the Bet on Blood program, a partnership addressing systemic gaps in sickle cell care. Timestamps: 00:00 – Why marketing in medical devices is closer to science 03:00 – Joy's path from software to MedTech and the art of cat herding 06:00 – Learning agility: Getting B-pluses in everything from jazz to business law 08:00 – What Terumo does: Unlocking the potential of blood 11:00 – Blood supply chain resilience and the Blood Emergency Readiness Corps 14:00 – The Bet on Blood campaign for sickle cell patients 17:00 – Strategic vs. clinical vs. tactical marketing 20:00 – Getting humble pie from physicians and learning not to guess 23:00 – Creating business cases for new device applications 26:00 – Why marketing is a translator for science 28:00 – Managing claims with precision across legal, regulatory, and clinical teams 32:00 – The art of translation: Making apheresis "an oil change" 35:00 – When you want to make claims but can't support them yet 37:00 – Patient stories and the importance of peripheral vascular access 40:00 – Navigating tariffs and AI in MedTech today 44:00 – Rapid fire: Bet on Blood, heroes, and listening to patients Follow Shannon and Joy: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Joy:  LinkedIn: https://www.linkedin.com/in/joy-duemke-339a922/ Website: https://www.terumobct.com

    47 min
  8. Diagnostic Innovations w. Resa Lewiss MD

    29 JAN

    Diagnostic Innovations w. Resa Lewiss MD

    What if you could see inside a patient's body instantly, without moving them from their bed in the emergency department? Dr. Resa Lewiss spent 25 years in emergency medicine, pioneering the integration of point-of-care ultrasound into clinical practice. As the founding head of ultrasound at Mount Sinai St. Luke's Roosevelt, she built education curricula, established quality improvement processes, and trained the next generation of emergency physicians to use this life-saving technology at the bedside. Her work helped transform ultrasound from a specialty radiologist's tool into a standard part of emergency medicine training—so much so that no emergency medicine resident can now graduate without being deemed competent in bedside ultrasound. In this conversation, Resa reveals how ultrasound changed emergency procedures from blind needle sticks to guided visualization, why she thinks emergency doctors are like assembly line cooks, and how she's democratizing medical education through free, open-access platforms. Plus, she shares a decades-later validation of a life-saving diagnosis that she thought no one had witnessed. TIME STAMPS:  00:00 Introduction to Emergency Medicine and Guest Speaker 00:40 Meet Dr. Risa Lewiss: Career Highlights and Achievements 02:05 Dr. Lewiss' Journey into Medicine 05:16 Choosing Emergency Medicine 08:10 The Reality of Emergency Medicine 10:41 Founding an Ultrasound Program 13:33 The Importance of Point of Care Ultrasound 17:06 Challenges and Future of Ultrasound in Emergency Medicine 22:39 Balancing Administrative and Clinical Roles 23:43 The Role of Ultrasound in Trauma Care 27:14 Challenges and Misuses of Ultrasound 30:07 Med Tech Innovations and Middleware 36:10 The Future of Medical Education 39:44 Rapid Fire Questions and Personal Insights 42:09 Concluding Thoughts and Reflections Follow Shannon and Resa: Connect with Shannon:  LinkedIn: https://www.linkedin.com/in/shannonlantzy Website: https://www.shannonlantzy.com/ Connect with Resa:  LinkedIn: linkedin.com/in/resa-Lewisss-md Website: https://www.resaLewiss.com/

    46 min
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About

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches the people who need it most.

Information

  • Creator
    Shannon Lantzy
  • Years Active
    2024 - 2026
  • Episodes
    44
  • Rating
    Clean
  • Copyright
    © Shannon Lantzy
  • Show Website
    Inside MedTech Innovation