MedTech Vulnerability Response w. Ken Hoyme

Vulnerability disclosures are speeding up, and the tools built to defend medical devices haven't caught up to that pace. Ken Hoyme spent his career building the safety-critical systems behind the Boeing 777 and Boston Scientific's cardiac devices, then wrote the paper that became the industry's playbook for streamlining post-market security patching. He joins Shannon Lantzy to break down why the gap between finding a vulnerability and fixing it matters more than ever, what code signing has to do with who controls a patch, and why automated insulin delivery could become the proving ground for how medical devices get updated in the future.Timestamps:[00:00] Introduction to Ken Hoyme and his paper on post-market security[01:00] Ken's path from Honeywell to Guidant to Boston Scientific[04:00] What draws Ken to life-critical systems[06:00] Ken's high school years and family background[07:00] What AAMI is and how Ken got pulled into committee work[09:00] The origin of AAMI TIR57 and its purpose[10:00] Why cybersecurity risk doesn't behave like historical safety risk[12:00] The CIA triad and why medical devices need to think beyond confidentiality[14:00] Real-world cases: MRI outages and stroke misdiagnosis risk[16:00] Why patching everything immediately isn't as simple as it sounds[17:00] The "sneaker net" era of deploying software updates[19:00] Ken's core thesis for vertically integrated devices like CGMs and insulin pumps[20:00] The parallel between hardware sustaining engineering and software patching[23:00] Why platform and application testing get tangled together[25:00] Making the case for separating verification from validation[26:00] Why it's hard to predict how a patch changes system behavior[27:00] The case for a dedicated, separately funded post-market patch team[30:00] AI as a red teamer and the coming vulnerability flood[32:00] The Linux bug that sat undetected for 27 years[33:00] Could open-source patches be trusted for medical devices[36:00] What it would take to "validate the validation"[58:00] The worst advice Ken's heard about post-market security[1:00:00] What Ken would fix about how FDA regulates devices[1:03:00] Ken's heroes and where to find him onlineConnect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Ken: LinkedIn: https://www.linkedin.com/in/kenhoyme/

Generative AI doesn't act like a medical device. It acts like a form of intelligence, and Dr. David Blumenthal thinks it should be overseen like one. Blumenthal, the Harvard-trained physician and policy expert who ran the $25 billion federal rollout of electronic health records under Obama, joins Shannon Lantzy to lay out a new framework for regulating AI as a practitioner rather than a tool. They trace the parallel between physician training and AI development, debate whether FDA is even the right agency for the job, and dig into why nobody actually measures doctor error rates. The conversation moves through Operation Warp Speed, the economics of EHR adoption, and a look ahead at fully automated hospital wings.Timestamps: [00:00:00] Introduction and AI's promise and peril in healthcare[00:03:00] David's path from Capitol Hill to primary care to the Commonwealth Fund [00:12:00] Operation Warp Speed as a model for fast, safe innovation [00:20:00] Why FDA safety review protects the market as much as patients [00:25:00] Meaningful use and the human side of EHR adoption [00:32:00] Defining generative AI: intelligence, not medical device [00:36:00] Borrowing physician licensing to oversee AI [00:44:00] Comparing human training to AI accreditation [00:52:00] Who should regulate agentic AI in the clinic [00:56:00] Measuring error rates: doctors versus algorithms [01:04:00] Economic incentives and how AI adoption differs by system [01:08:00] Science fiction, robotic surgery, and rapid fireFollow Shannon and David:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with David: Website: https://www.hks.harvard.edu/about/david-blumenthal

The technology to secure healthcare already exists. Getting it adopted by the people building medical devices is a different problem entirely. Andrew Carney spent a decade in classified offensive cyber operations, defended one of the world's largest banks through the Log4j crisis, and now runs cybersecurity programs at ARPA-H and DARPA. Shannon and Andrew get into what it actually means to run a "locked down" med device that isn't as safe as it looks, how digital twins and cyber ranges let hospitals stress-test systems without touching a live patient environment, and why a tool that automatically finds and fixes software vulnerabilities is landing a 95% acceptance rate from human developers. They also cover how medtech companies can plug directly into ARPA-H's research pipeline, and what it takes to pitch a federally funded research program from scratch.Timestamps: 00:00 – ARPA-H and the case that the tech already exists, it's just not distributed 03:15 – From classified offensive cyber to reverse engineering without source code 10:00 – Inside HSBC during the Log4j crisis 17:30 – What a "locked down" legacy device can still get away with 25:00 – Thinking like the attacker: foothold, ransom, and silent data exfiltration 32:00 – DigiHeals: adapting defense-grade tools for healthcare 39:00 – Digital twins, cyber ranges, and testing at scale 45:30 – What UPGRADE actually does (and the limits ARPA-H won't cross) 51:30 – Karambit's "software bill of behaviors" 59:30 – The SBIR lineage path from proven tech to commercial product 69:00 – What it takes to become an ARPA-H program manager 75:00 – Rapid fireFollow Shannon and Andrew:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Andrew: LinkedIn: https://www.linkedin.com/in/andrew-carney-945458a6/Website: https://arpa-h.gov/

Software problems cause 20 medical device recalls a month. 82% of those are classified as software design failures. Dr. Robert Charette has spent five decades documenting why large-scale technology systems fail and why organizations keep repeating the same mistakes.In this conversation with Shannon Lantzy, Bob brings a perspective rarely heard in medtech: one shaped not by the device industry, but by NASA, the Department of Defense, Fortune 100 companies, and the national rollout of electronic health records. He introduces the distinction between software failures and software blunders, explains why testing is impossible to perfect but impossible to skip, and walks through the risk ecology framework that looks at technical, financial, political, and organizational forces together. He also addresses the Change Healthcare ransomware attack as a case study in systemic interface risk, the red-yellow-green project management inversion, and what AI-generated code means for regulated software.Timestamps:[00:00:00] Introduction and the 20 recalls a month statistic [00:02:44] Why Bob's outsider perspective is the point [00:03:16] NASA Challenger and the software review panel [00:08:44] Why you can never test everything but can never stop testing [00:11:56] Failures vs. blunders: a critical distinction [00:13:12] What is a risk ecologist? [00:15:16] When FDA regulation is the only incentive that works [00:16:08] The case for market-driven standards and tort law [00:22:24] Bob's role in the EHR meaningful use panel [00:25:44] Why the national EHR rollout was not well thought through [00:29:00] Change Healthcare as a systemic interface failure [00:30:16] How to map interfaces and assume failure [00:33:36] Efficiency vs. single point of failure [00:34:44] International regulatory reliance and the turtles all the way down problem [00:39:24] Designing software to be verified and validated from the start [00:43:00] Applying V&V to automated insulin delivery systems [00:48:00] Flipping the risk dashboard: start at red, prove your way to green [00:51:20] Why no one wants to be the naysayer [00:53:08] How executives actually tolerate risk [00:55:04] The Hubble Effect and knowing when to kill a project [00:56:28] AI and regulated software: the gray beard's take [01:01:04] AI is perfect for experts and dangerous for everyone else [01:03:16] Cardinal rule: your system will be evaluated outside the criteria you set [01:04:12] Rapid fire questionsFollow Shannon and Robert:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Robert: LinkedIn: https://www.linkedin.com/in/robert-charette-500309/Website: https://www.ieee.org/

Randy Horton is Chief Solutions Officer at Orthogonal, a firm that specializes in accelerating software as a medical device, digital therapeutics, and connected device ecosystems. He has spent his career at the intersection of product management, digital transformation, and regulatory compliance, and co-chairs the cloud computing standards committee at AAMI with Pat Baird from Philips.In this conversation with Shannon Lantzy, Randy breaks down why medtech companies are either too cautious about cloud or not cautious enough, and what good cloud design for medical devices actually looks like. He explains the concept of indirect control, why the medical device you had at 8am may not be the same one you have at 8pm, and how modern software practices from Netflix, Amazon, and other tech giants are more compatible with medtech's safety requirements than most people realize. He also addresses the language gap between tech and medtech, the role of the quality systems engineer, and why the FDA is no longer the biggest barrier to innovation.Timestamps:[00:00:00] Introduction and the cloud computing challenge in medtech[00:02:36] Randy's origin story and the early commercial web[00:03:28] How healthcare ran through his career before medtech[00:05:44] Lessons from an $80 million IT transformation[00:07:00] Why established companies struggle to separate why from how[00:09:56] The all-nighter on Mosaic that started everything[00:11:00] Retail tech, hardware is hard, and the limits of the physical world[00:13:20] Sensors, foundational models, and the promise vs. reality of platforms[00:15:08] History as systems thinking[00:17:24] Safe, effective, and commercially successful: what that means in cloud[00:19:52] How cloud providers change constantly and why that matters[00:21:44] Indirect control: the crux of cloud in medtech[00:23:36] Conservative cloud architecture as good medical device design[00:24:00] Post-market surveillance vs. revalidation: the naming debate[00:25:44] Two scenarios: too conservative and not conservative enough[00:27:32] Risk matrices and why Shannon hates them[00:29:40] Deming, total quality management, and the real conversation[00:31:08] What medtech can learn from unregulated industries[00:33:52] Why medtech still builds custom[00:34:16] The language gap between tech and medtech[00:37:20] Wrapping risk-based thinking around AI development[00:42:44] The quality systems engineer role[00:45:00] Evidence and traceability as the real difference[00:46:00] Cost, documentation, and tools like GitHub and Jira[00:48:52] Sales conversations at Orthogonal[00:51:36] What is next: neurostimulation, home diagnostics, new business models[00:53:48] CMS is now the bigger barrier than FDA[00:54:24] Rapid fire questionsFollow Shannon and Randy:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Randy: LinkedIn: https://www.linkedin.com/in/randyhorton/Website: https://orthogonal.io/

Dr. Adam Cifu is a general internist and professor at the University of Chicago, co-author of Medical Reversal, and co-founder of Sensible Medicine, one of the most widely read independent medical publications in the country. He sees patients daily, teaches the next generation of physicians, and writes about the gap between medical consensus and medical evidence.In this conversation with Shannon Lantzy, Dr. Cifu breaks down what medical reversal actually means and why hormone replacement therapy is one of the most instructive examples of how medicine gets things wrong. He shares his nuanced take on CGMs, AFib detection, wearables, and blood pressure monitoring, and explains why the same device can be genuinely helpful for one patient and harmful for another. He also reflects on what evidence-based regulation should look like, what he hopes changes at FDA, and why primary care is still the most important relationship in medicine.Timestamps: [00:00:00] Introduction and Dr. Cifu's background[00:01:44] Deciding to become a doctor[00:03:08] What other career he might have had[00:04:40] Writing, publishing, and the piece that changed everything[00:05:40] What his practice actually looks like[00:07:32] Why Sensible Medicine is a group publication[00:10:16] Finding Sensible Medicine through Marty Makary's book[00:11:28] What medical reversal means[00:12:40] Hormone replacement therapy as the defining case[00:15:40] Shannon's personal experience and the gap in clinical practice[00:17:00] When turning healthy people into patients goes wrong[00:20:20] The Oura ring and what biofeedback actually teaches[00:22:04] Should daily burden be measured? Dr. Cifu pushes back[00:24:08] When data doesn't help[00:26:44] N of one trials and personalized medicine[00:32:48] Technology in primary care: entering with trepidation[00:34:28] Stenting and the cautionary tale of extrapolation[00:38:28] Early adopters as beta testers[00:39:16] What a clinic day actually looks like[00:43:12] The Whoop blood pressure controversy[00:46:32] AFib detection: who it helps and who it harms[00:49:40] A hypothetical 82-year-old, Apple Watch data, and a caregiver's anxiety[00:51:32] When information helps patients and when it makes things worse[00:53:24] Adam Cifu AI: the case for and against[00:57:24] When a test won't change management[01:00:44] Hopes for FDA and evidence-based regulation[01:04:00] Medical devices and the surgical reversal risk[01:07:04] Rapid fire questionsFollow Shannon and Adam:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Adam: LinkedIn: https://www.linkedin.com/in/adam-cifu-bbb8ba206/Website: https://www.sensible-med.com/

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 questionsFollow 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/

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 questionsFollow 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/

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 refereeFollow Shannon and Robert:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Robert: Substack: https://robcaliff272993.substack.com/LinkedIn: https://www.linkedin.com/in/robert-califf-69040016/

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 going03:00 – From The Bionic Man to biomedical engineering06:00 – Learning the language of business to stay in the room09:00 – Why sustainable businesses, not charity, solve medical problems12:00 – ExploraMed and the biodesign process in action14:00 – The hardest part: keeping engineers from racing to solutions16:00 – Creating the first wearable breast pump19:00 – How two men learned to solve a problem they don't have23:00 – Why outsiders can see what insiders miss26:00 – The golden era of medical devices and what changed in 200828:00 – Getting FDASIA passed: fighting for regulatory reform32:00 – Breaking innovation into learnable steps35:00 – When needs statements should (and shouldn't) change37:00 – Disease burden as an invisible, unmeasured problem40:00 – How to prioritize: outcome severity multiplied by people impacted44:00 – Who biodesign serves and why the ecosystem matters47:00 – Measuring impact: 18 million lives and counting52:00 – Are we over-engineering healthcare?56:00 – What FDA still needs to improve: consistency across reviewers01:00:00 – Empathy on both sides of regulationFollow Shannon and Josh:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Josh: LinkedIn: https://www.linkedin.com/in/josh-makower/Website: https://biodesign.stanford.edu