What happens when a digital health pioneer becomes a cancer patient and discovers his own doctors missed a life-threatening diagnosis? Steve Brown, founder and CEO of CureWise, shares his remarkable journey from building one of the first remote patient monitoring companies to nearly losing his life to a rare blood cancer that went undetected until the Palisades Fire displaced him to new doctors with fresh eyes.In this episode of Inside MedTech Innovation, Steve joins Shannon Lantzy to discuss how he built AI agents that diagnosed his own cancer using the same data his original doctors had reviewed, then used those same tools to advocate for off-label precision treatments that saved his life. Now, he's building CureWise to give every patient access to the same level of personalized treatment insights.Steve and Shannon explore:Why the standard of care often represents what we knew years ago, not what's possible todayHow AI can synthesize all of medical knowledge to enable truly personalized medicineThe critical difference between building healthcare solutions for others versus being patient zeroWhy precision oncology requires new regulatory paradigms beyond randomized controlled trialsHow patient advocacy powered by AI can level the playing field in cancer treatmentThe role of FDA innovation in accelerating life-saving treatments without compromising safetyTimestamps00:00 The Promise and Perils of AI in Healthcare00:08 Introducing Steve Brown: A Digital Health Pioneer01:30 Steve's Journey from Video Games to Healthcare Innovation03:52 The Impact of Remote Patient Monitoring06:15 A Personal Health Crisis: Steve's Cancer Diagnosis14:10 The Role of AI in Steve's Diagnosis and Treatment23:00 The Vision for Cure Wise: Precision Medicine for All25:04 The Future of Personalized Medicine27:21 Navigating Medical Scenarios and Doctor Conversations28:54 The Role of AI in Personalized Medicine29:20 Business Model and Future Vision30:36 Challenges and Opportunities in AI and Healthcare32:20 Focus on Cancer and Personalized Medicine35:22 Patient Education and Advocacy37:54 Regulatory Innovation and AI47:02 The Paradigm Shift in Medical Knowledge49:30 Rapid Fire Questions and Final ThoughtsFollow Shannon and Steve:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Steve: LinkedIn: https://www.linkedin.com/in/brown2020/ Website: curewise.com
When your insulin pump connects to your phone or your glucose monitor shares data with the cloud, is it secure? And what does "secure" even mean?In this episode of Inside MedTech Innovation, Shannon Lantzy sits down with Jacob Combs, Chief Information Security Officer and VP of Cybersecurity at Tandem Diabetes Care. Jacob brings deep expertise from across telecom, defense, financial services, and healthcare—and now protects connected devices that deliver life-sustaining insulin therapy to people with diabetes.This conversation explores the unique challenges of medical device cybersecurity: the tension between usability and security, the reality of legacy systems and security debt, how to scale security by design across engineering teams, and why regulatory requirements can actually be a competitive advantage.Jacob and Shannon discuss:Why medical device security is fundamentally different from enterprise IT securityThe critical balance between safety risk and security risk in insulin delivery systemsHow threat modeling becomes a verb that transforms engineering cultureThe challenge of maintaining security across interoperable diabetes management ecosystemsWhy "secure enough" requires sophisticated risk management, not just risk assessmentHow compensating controls and lifecycle management address security debt in fielded devicesThe role of FDA guidance in driving security programs forwardWhat it takes to push software updates quickly while maintaining quality and regulatory complianceTimestamps00:00 Introduction to Medical Device Cybersecurity01:03 Meet Jacob Combs: Expert in Medical Device Cybersecurity02:12 The Mission-Driven Approach to Cybersecurity03:16 Balancing Safety and Security in Medical Devices05:18 Challenges in Medical Device Cybersecurity09:57 The Role of a CISO in Medical Device Companies13:55 Risk Management and Cybersecurity in Medical Devices17:17 Interoperability and Complexity in Medical Devices26:55 Future of Cybersecurity in Medical Devices36:08 Cybersecurity in Med Tech: A Non-Competitive Necessity36:30 The Ethical Dilemma of Charging for Security37:25 Product Security as a Growth Engine38:50 Marketing Security: A Competitive Edge39:32 Quality and Security: A Symbiotic Relationship41:08 Regulatory Challenges and Operational Efficiency42:36 Measuring Cybersecurity Quality43:57 Navigating Regulatory Requirements51:23 Innovating with AI in Security Documentation55:25 Threat Modeling: A Cultural Shift59:23 Legacy Devices and Security Debt01:06:03 Balancing Security and Innovation01:09:08 Rapid Fire Questions and Closing ThoughtsFollow Shannon and Jacob:Connect with Shannon : LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/ Connect with Jacob: LinkedIn: https://www.linkedin.com/in/jacobcombs/ Website: Left to Our Own Devices Podcast
When Justin Eastzer was misdiagnosed with type 2 diabetes at 30, he turned to TikTok to share his experience with a new glucose meter. The community's response changed everything: he actually had type 1 diabetes, and his doctor had missed it. That moment launched Diabetic Tech, now one of the most trusted patient education platforms in the diabetes space with over a million downloads. In this conversation with Shannon Lantzy, Justin breaks down the disconnect between what medtech companies think users want and what actually matters. He shares why the DIY diabetes community has been building their own automated insulin delivery systems since 2016, how AI meal-snap features could transform daily management, and why companies announcing problems matters more than the problems themselves. Justin also discusses the regulatory tension between innovating for advanced users versus protecting the broader population, and offers a compelling vision for how continuous software updates could bring diabetes tech to the speed of consumer technology.Timestamps:[00:00:00] Introduction and Justin's misdiagnosis journey[00:04:15] What makes Diabetech's approach unique[00:08:25] Balancing entertainment, education, and technical accuracy[00:12:10] Language matters: "diabetic" vs "person living with diabetes"[00:14:30] Creative bursts during low blood sugars[00:18:35] Interviewing executives and asking hard questions[00:21:50] The Dexcom G7 sensor issues and transparency problems[00:25:10] Real-time discussion of Tandem pump safety alert[00:29:30] Why transparency matters more than the problem itself[00:33:20] Justin's business model and team structure[00:37:45] The innovation speed problem in diabetes tech[00:40:30] AI meal-snap features: the holy grail that's already here in DIY[00:46:35] What it's like to calculate carbs for every meal[00:49:05] Exercise management and the temp basal feature gap[00:51:25] A1C vs time in range vs lived experience[00:56:00] CGMs for wellness: opportunity or distraction?[01:02:20] Balancing innovation for advanced users vs general safety[01:05:10] Shannon's moonshot proposal for trustworthy software updates[01:13:25] Cybersecurity, safety testing, and the path to faster features[01:14:50] Rapid fire questionsFollow Shannon and Justin:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.com/Connect with Justin: LinkedIn: https://www.linkedin.com/in/justin-eastzer-70402034Website: https://www.tiktok.com/@diabe_tech
Most medical device companies think quality systems slow them down. Kyle Rose proves the opposite is true.Kyle Rose is the founder and president of Rook Quality Systems, a consulting firm that helps early-stage medical device companies build efficient, compliant quality management systems. With 13 years of experience and nearly 40 employees, Rook has guided companies through FDA submissions, acquisitions, and their first audits by focusing on lean processes over bureaucracy.In this conversation, Kyle shares stories from the trenches: the software company that accidentally logged thousands of "complaints" in Zendesk, the smart pill dispenser that failed to block light properly, and the COVID diagnostics work that helped get critical products to market fast. He explains why quality systems actually help companies catch problems before they become catastrophic, how AI is changing regulatory submissions, and why more over-the-counter medical devices could transform healthcare access.Timestamps:[00:01:30] Introduction to Rook Quality Systems[00:02:10] Kyle's journey from industry to consulting[00:05:20] Professional lessons and standout moments[00:08:05] When software companies realize they're medical devices[00:09:15] The Zendesk complaint story[00:13:05] Success story: acquisition and first FDA audit[00:15:20] When companies don't buy into quality systems[00:16:40] The FDA warning letter discussion[00:19:00] How quality systems catch device failures[00:19:50] The smart pill dispenser light-blocking failure[00:24:30] How tech is changing consulting and compliance[00:28:45] MDSAP and international standards[00:31:15] FDA's Medical Device Development Tools program[00:34:00] Regulatory pathways that need improvement[00:37:10] What would help FDA reviewers most[00:42:05] Verifying hyperscalers like AWS and Google[00:44:35] Rapid-fire questionsFollow Shannon and Kyle:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.com/Connect with Kyle: LinkedIn: https://www.linkedin.com/in/kyle-rose-rookWebsite: https://rookqs.com/
When Oleg Yusim joined Baxter in 2016 as one of the first dedicated medical device security architects, the industry was just beginning to understand that shared PINs like "4444" across entire product fleets weren't acceptable security. Ten years later, as Chief Product Security Officer at Illumina, he's mastered something far more difficult than technical security: translating cybersecurity risks into language that CEOs, CFOs, and boards actually understand and act on.In this conversation with Shannon Lantzy, Oleg breaks down why medical device cybersecurity fundamentally differs from enterprise IT (hint: confidentiality takes a backseat to integrity and availability when lives are at stake), how to use data-driven benchmarks to show executives where they stand against competitors, and why the question isn't "can we afford this security investment" but rather "does this help us survive and do good in the world, or does it push us toward failure?" He also shares pointed advice for cybersecurity startups trying to break into medtech: elegant technical solutions mean nothing if they don't solve the industry's actual pain points, and coming from a DoD environment often raises red flags because commercial companies won't accept the productivity hits that military mandates require.Timestamps:[00:00:00] Introduction and Oleg's recent AI hackathon success[00:03:40] How coincidence and life-critical systems shaped his career path[00:06:25] The jump from military communications to medical devices at Baxter[00:09:30] What it was like being a security architect when the field barely existed[00:11:05] Why medical devices had rudimentary security before 2014[00:13:00] CIA triad differences: why confidentiality isn't king in medtech[00:16:00] Integrity attacks on infusion pumps and why "nobody would do that" isn't valid[00:18:25] Medical devices as perfect attack footholds for hospital networks[00:20:40] HIMSS data: 5-10% of hospital attacks start from compromised devices[00:22:20] Building product security teams and changing company culture[00:26:10] The CEO presentation: three slides with data, thirty slides in your pocket[00:28:15] How to quantify cybersecurity posture as percentage of requirements met[00:30:55] Using benchmarks: FDA guidance, customer requirements, and competitor analysis[00:33:20] Why better security means faster sales and integration[00:36:50] Headcount vs vendor costs in security budgets[00:40:20] Risk acceptance conversations when budgets get cut[00:42:20] The critical importance of data-driven decision making[00:44:25] Framing security investments as business survival, not just cost[00:47:30] Advice for cybersecurity startups targeting medtech[00:49:30] Why DoD-derived solutions often miss commercial pain points[00:52:20] Rapid fire questionsFollow Shannon and Oleg:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.com/Connect with Oleg: LinkedIn: https://www.linkedin.com/in/olegyusimWebsite: https://www.illumina.com/
Remote surgery across continents exists today, so why isn't it widespread in the United States?Dr. Omar Al-Kalaa spent 15 years at FDA's Office of Science, Engineering and Laboratories, where he became the bridge between telecom operators, medical device manufacturers, and regulators. His work on wireless coexistence and 5G connectivity shaped how next-generation networks intersect with medical device safety. He convened 70+ stakeholders to create the Landscape Analysis of 5G in Healthcare and developed new evaluation methods for connected medical systems.In this conversation, Omar reveals why your continuous glucose monitor competes with Netflix for wireless spectrum, what's actually preventing telesurgery in the U.S., and how he's continuing to advance connectivity innovation through his company Inovectrum.Timestamps:[00:00:30] Introduction to Dr. Omar Al-Kalaa[00:02:50] Remote surgery: Science fiction or reality?[00:08:10] The Lindbergh Operation: First transatlantic telesurgery[00:15:25] How Omar convened the 5G healthcare working group[00:16:15] FDA's Office of Science, Engineering and Laboratories: Future-proofing the agency[00:22:30] Building the Medical Device Innovation Consortium working group[00:26:10] The Landscape Analysis of 5G in Healthcare[00:34:30] Wireless coexistence: Why your glucose monitor competes with Netflix[00:42:55] Omar's journey from PhD to FDA to entrepreneurship[00:45:30] Launching ECTRA and the future of connectivity innovation[00:49:35] Rapid-fire questionsFollow Shannon and Omar:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.com/Connect with Omar: LinkedIn: https://www.linkedin.com/in/omar-al-kalaa/Website: https://www.linkedin.com/company/inovectrum/
What does it take to transform cybersecurity from reactive patch management to proactive secure design? Adam Shostack, the world's leading expert on threat modeling, takes us inside Microsoft during its pivotal security transformation in the early 2000s and reveals how those lessons shaped FDA's approach to medical device cybersecurity today.From the auto-run vulnerability that infected millions of computers monthly to creating the STRIDE methodology now used worldwide, Adam shares the origin stories behind fundamental cybersecurity practices. He explains how threat modeling evolved from expert-driven whiteboard sessions to systematic, scalable processes that any engineering team can implement.Shannon and Adam explore the critical difference between risk management and threat modeling in design, why "pouring concrete and then wondering about properties" fails in cybersecurity, and how FDA's pre-market guidance ensures patient safety while fostering innovation. They dive deep into the four key questions every threat modeler must answer and why starting threat modeling with a simple napkin sketch can prevent costly architectural changes later.Key Topics:Microsoft's trustworthy computing transformation and lessons learnedThe invention and evolution of STRIDE methodology for systematic threat analysisHow FDA adopted threat modeling for medical device cybersecurity regulationThe fundamental difference between threat modeling and risk managementWhy current approaches to software understanding and composition analysis fall shortPractical advice for scaling threat modeling across organizationsThe future of threat modeling with AI assistanceTimestamps: [00:00] Microsoft's security crisis and transformation [07:03] The auto-run story and data-driven decision making [14:10] Birth of scalable threat modeling and STRIDE methodology [23:43] FDA's systematic approach to adopting threat modeling [32:41] Engineering fundamentals vs. risk management in cybersecurity [42:49] The software understanding problem and why it's so hard [55:20] Innovation vs. regulation balance in different industries [57:21] Rapid fire: Current projects, heroes, and startup advice [1:02:05] Scaling threat modeling and AI integrationConnect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzy/ Website: https://www.shannonlantzy.com/Connect with Adam: Website: shostack.org Books: "Threat Modeling: Designing for Security" and "Threats: What Every Engineer Should Learn from Star Wars"
What if the LED lights and screens we rely on daily are causing neurological injuries we can't see? Dr. Jennifer Hackett, a molecular biologist who discovered her own sensitivity to LED flicker in 2018, takes us deep into the science and silence surrounding this invisible health threat. From her research background at Johns Hopkins and Harvard to becoming a patient advocate, Jenny shares how she used scientific methodology to investigate her own injury and what she discovered could change how we think about modern lighting. Shannon and Jenny explore the difference between visible and invisible flicker, why current safety standards may be inadequate, and what this means for public health as LED adoption accelerates worldwide.Timestamps: [00:00] Personal injury from LED workplace lighting [05:20] Jenny's scientific background and career transition [14:45] The moment of LED injury recognition [28:30] Testing the flicker hypothesis with scientific rigor [42:15] Professional flicker measurement and data collection [54:10] Current lighting industry standards and their limitations [1:03:30] Population-level health correlations and research gaps [1:21:00] Support resources and next steps for research [1:34:00] Accessing medical care and basic needs with LED sensitivityConnect with Shannon:LinkedIn: https://www.linkedin.com/in/shannonlantzy/Website: https://www.shannonlantzy.com/Connect with Jenny: LinkedIn: https://www.linkedin.com/in/jennifer-hackett-molbio/Website: flickersense.org & ledstrain.org
When Lane Desborough's 10-year-old son was diagnosed with type 1 diabetes in 2010, this chemical engineer did what came naturally: he applied industrial-scale automation principles to save his child's life. What followed sparked a movement that continues reshaping medical device innovation today. Lane's journey from creating Nightscout (one of GitHub's most-forked repositories) to founding the revolutionary "We Are Not Waiting" movement reveals how patient-driven innovation can outpace traditional development. Now, with support from the Helmsley Charitable Trust, Lane is building the Automated Insulin Delivery Interoperability Framework (AIDIF), an FAA-level simulator designed to accelerate innovation and expand access to life-saving diabetes technology for millions who can't "crawl through broken glass" to build their own solutions.Timestamps: [00:00] Opening: Personal hero who sparked a movement [04:25] Why Lane entered medical technology [08:20] Cross-disciplinary innovation and "exclusionary language" [10:25] The "We Are Not Waiting" origin story [14:00] The burden of being your child's pancreas [21:40] From remote monitoring to open source revolution [24:35] Scaling beyond the most engaged 10,000 users [32:25] The Automated Insulin Delivery Interoperability Framework [38:45] Why clinical trials aren't enough: recruitment bias [41:20] Building FAA-level simulation for medical devices [46:15] Medical Device Development Tools and regulatory innovation [49:00] Heroes, help needed, and ecosystem engineeringFollow Shannon and Lane:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Lane: LinkedIn: https://www.linkedin.com/in/lanedesborough/Website: http://www.nudgebg.com/
Obesity is one of the most complex and misunderstood chronic conditions in the world, affecting more than 60% of adults globally and 75% in the U.S. Yet, despite its prevalence, care systems continue to underdeliver, relying on one-size-fits-all advice, outdated stigma, and underutilized data.In this episode of Inside MedTech Innovation, Elina Onitskansky, founder and CEO of Ilant Health, joins Shannon Lantzy to challenge the status quo. Ilant’s model integrates behavioral science, AI, human coaching, and comprehensive care pathways, from bariatric surgery to anti-obesity medications, to deliver truly personalized obesity care at scale.Elina shares:Why obesity care has been treated differently from other chronic conditions and how stigma, bias, and lack of physician training keep it that wayHow evidence-based personalization can replace decades of fad diets and miracle curesWhy “pizza night” matters: the importance of designing care that fits real livesThe role of employers, health plans, and policy in making equitable obesity treatment available to allTimestamps: 00:00 – Should we treat all patients with obesity the same? 01:00 – Shannon’s personal connection to the topic 02:46 – How Ilant Health blends AI, behavioral science, and human coaching 04:36 – Why personalization matters in obesity treatment 06:00 – The impact of stigma and bias in clinical care 07:22 – Elina’s personal and professional journey into obesity care 10:42 – From fad diets to evidence-based solutions 13:50 – Designing treatment that fits patients’ real lives 17:00 – Rethinking how medications are labeled and prescribed 20:18 – The role of patient preferences in regulatory decisions 22:25 – Why obesity should be coded with greater granularity 24:50 – Why Ilant partners only with employers and health plans 27:00 – What a patient’s journey with Ilant looks like 31:00 – Building trust through peer navigators and empathy 33:00 – The power of longitudinal care and evolving goalsFollow Shannon and Elina:Shannon LantzyLinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comElina OnitskanskyLinkedIn: https://www.linkedin.com/in/elinaonitskanskyWebsite: https://www.ilanthealth.com
Shannon Lantzy sits down with Dr. Richard O'Neill, a regulatory innovator who spent 40 years working in energy markets at FERC and ARPA-E. Dr. O'Neill shares the development and implementation of market optimization software that now generates billions in annual cost savings for American consumers through more efficient electricity markets. The conversation covers the 18-year timeline from algorithm development to full adoption across Independent System Operators, the institutional challenges of innovation in critical infrastructure, and Dr. O'Neill's current work on next-generation market algorithms as AI drives increased energy demand. This discussion provides insights into how regulatory innovation happens, why proven technologies face adoption barriers, and the intersection of academic research with real-world policy implementation.Key Timestamps:[00:01:00] Dr. O'Neill's background at FERC and ARPA-E[00:03:00] Development of market optimization algorithms[00:05:00] PJM's beta test results and cost savings[00:07:00] Market efficiency and participant benefits[00:11:00] 18-year adoption timeline across ISOs[00:15:00] AI energy demand and infrastructure challenges[00:16:00] Current work on algorithm improvements[00:18:00] Expected impact on power generation markets[00:21:00] Risk management in critical infrastructure[00:23:00] Resource allocation and implementation barriers[00:27:00] Case study of completed but unadopted beta test[00:29:00] Federal and state regulatory jurisdictionRichard O’Neill: LinkedIn | WebsiteShannon Lantzy: LinkedIn | Website
In this episode of Inside MedTech Innovation, Ed Gaudet, CEO and founder of Censinet, joins host Shannon Lantzy to examine how cybersecurity risk is becoming a direct factor in patient care.Ed shares what he learned selling into hospitals where every deal required a different security assessment, and how those fragmented processes prompted him to build Censinet. The conversation explores why healthcare environments are particularly complex, how ransomware is affecting hospital operations, and what leaders can do to make better decisions across the vendor lifecycle.For innovators, policymakers, and clinicians, this discussion offers a practical look at how health systems are starting to treat cybersecurity not just as an IT concern, but as part of their core clinical and operational strategy.Timestamps:00:00 – What’s at stake in cybersecurity risk03:00 – Ed’s background and founding Censinet05:45 – Why risk assessments in healthcare are so fragmented08:00 – What hospitals evaluate in third-party vendors12:00 – When clinical urgency overrides risk protocols14:00 – Ransomware’s impact on care delivery16:45 – Managing risk across the vendor lifecycle18:00 – Shifting from IT risk to business risk20:00 – Change Healthcare as a case study21:30 – How Ed built credibility with hospital partners24:00 – Research linking ransomware to patient outcomes28:00 – Creating a managed service to test Censinet internally31:00 – Real-world results: 5X output, fewer staff34:00 – Transparency as a business practice37:00 – Overcoming resistance to better risk management39:00 – What AI is (and isn’t) doing in risk ops today41:00 – Peer benchmarking and open access to data44:00 – Three changes Ed would make in markets and policy47:00 – Leading a mission-driven business53:00 – Final thoughts and personal driversConnect with Shannon:LinkedIn – Shannon LantzyWebsiteConnect with Ed:LinkedIn – Ed Gaudet Website – CensinetFOLLOW SHANNON & ED:
What happens when a firmware bug brings a ventilator offline during a pandemic? For Ryan Torvik, it raised a question: Why are embedded medical systems still so fragile, and so hard to test?In this episode of Inside MedTech Innovation, host Shannon Lantzy talks with Ryan Torvik, founder of Tulip Tree Tech and a former offensive cybersecurity engineer, about how decades-old assumptions about embedded software are colliding with modern needs for safety, speed, and resilience. With funding from ARPA-H, Ryan is now building Barnhill, an emulation framework that lets manufacturers test firmware in a virtual environment before it ever hits the device.Together, they explore how digital twins, DevSecOps, and real-time behavioral testing can radically improve embedded medical systems, without breaking them in the process. Plus: what MedTech needs to learn from the automotive and defense industries, and why debugging a glucose monitor might have more in common with securing a microwave than you think.00:00 – The Stakes: Firmware bugs during COVID and what they revealed02:00 – Meet Ryan Torvik: From cybersecurity offense to medical emulation05:00 – What “embedded” really means—and why these devices remain vulnerable10:00 – Why firmware updates in MedTech aren’t like consumer tech14:00 – Building Barnhill: A digital twin for real-time debugging17:00 – How Barnhill differs from other emulators and digital twins21:00 – A glucose monitor case study: translating voltage into clinical meaning25:00 – MedTech’s friction points: regulation, reimbursement, and risk30:00 – Why cybersecurity lessons aren’t translating to healthcare34:00 – DevSecOps and SPDF: A new framework for firmware confidence40:00 – The real barrier: MedTech’s “never touch it again” mindset45:00 – Can AI help accelerate testing without adding new risks?49:00 – How Barnhill aims to reduce false confidence and unknown vulnerabilities52:00 – Ryan’s journey: from hacker to healthtech founder55:00 – What he learned building large-scale emulation in defense58:00 – Final thoughts: why trust, transparency, and humility matter mostFollow Shannon and Ryan:Ryan TorvikLinkedIn | Ryan TorvikCompany | Tulip Tree TechnologyShannon Lantzy LinkedIn | Shannon Lantzy Website | shannonlantzy.com
Health tech legend Matthew Holt joins host Shannon Lantzy to unpack the tangled evolution of healthcare technology, from paper records to AI, patient activism to regulatory standoffs.Known for launching The Health Care Blog and co-founding the Health 2.0 conference, Matthew has spent over two decades critiquing, convening, and catalyzing the digital health ecosystem. He’s not here to sugarcoat progress, or the lack of it.From the early days of medical computing to today’s explosive debate over data access and AI regulation, Matthew offers rare behind-the-scenes stories and no-BS takes on where we’ve been, and where we’re headed.00:00 – Introduction to Matthew Holt04:30 – British boarding schools, Marxism, and clueless career starts11:45 – From London to Stanford: a detour that changed everything17:30 – Discovering health tech through Japanese health systems24:00 – From EMRs to Health 2.0: how a contrarian became a convenor30:50 – SMACK vs. digital health: what the terminology misses35:20 – The rise (and crash) of EHR adoption in the U.S.42:00 – Patient portals, “MyChart,” and why consumer tech still lags49:40 – Epic vs. Particle: a legal battle over who owns health data56:00 – Should AI tools access all patient data—or be limited by design?01:04:00 – Remote monitoring, real-world evidence, and research at scale01:13:20 – Advice for founders: simplify, specify, and clarify01:21:15 – Future gazing: what MedTech should fix nextMatthew Holt: LinkedIn | The Health Care BlogShannon Lantzy: LinkedIn | Website
What if a single moment of intuition could save a newborn’s life? In this episode of Inside MedTech Innovation, I sit down with Annamarie Saarinen, co-founder and CEO of Bloom Standard, to explore how a deeply personal medical emergency turned into a global mission to revolutionize pediatric diagnostics.Annamarie shares the remarkable story of her daughter’s near-missed heart defect, and how a chance encounter with a visiting echo tech led to a lifesaving diagnosis. That experience revealed a massive gap in pediatric care: access to ultrasound, particularly in the hands of providers who aren’t trained specialists.Bloom Standard is tackling that gap by developing the world’s first self-driving ultrasound system designed for babies and young children. Using AI and automation, their device brings diagnostic-grade imaging to the frontlines of care, empowering clinicians anywhere in the world to detect critical conditions early, accurately, and affordably.We talk about:The birth of Bloom Standard, and how trauma became transformationThe difference between adult and pediatric cardiology, and why so many babies go undiagnosedWhat it takes to build a hardware + software + AI company in MedTechThe Total Product Lifecycle Advisory Program (TAP) at FDA and how early regulatory collaboration is helping Bloom scale fasterHow Annamarie’s earlier policy work led to universal pulse oximetry screening in newborns, a change that reshaped care nationwide00:03:00 – The story of Eve: when a murmur saved a life00:07:00 – Why pediatric ultrasound isn’t standard—yet00:13:00 – What makes pediatric cardiology uniquely complex00:21:00 – Hardware, software, AI—and the hard path to MedTech00:30:00 – The public health victory behind CCHD screening00:39:00 – The trauma and cost of medical transport00:42:00 – Building ethical, safe, clinically relevant AI00:46:00 – How regulatory policy (TAP) is shaping Bloom’s futureFollow Shannon and Annamarie:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Annamarie: LinkedIn: https://www.linkedin.com/in/annamariesaarinen/Website: https://www.bloomstandard.com/
In this Tech for MedTech episode of Inside MedTech Innovation, I talk with Andrew Hendela, co-founder and CEO of cybersecurity company Karambit.AI, focused on software behavior analysis, about how software updates are quietly redefining safety and risk in connected medical devices.Andrew shares the real-world implications of software supply chain vulnerabilities, including insights from the SolarWinds cyberattack, and how traditional testing methods often fail to catch malicious changes. We dig into why static software bills of materials aren’t enough, and how observing behavior, not just ingredients, can reveal hidden risks.We also explore what the FDA’s evolving regulatory stance means for MedTech teams deploying AI and software-driven features, and how Andrew’s work is making it possible to validate safety at speed. For developers, regulators, and clinical leaders, this episode sheds light on a critical, but often overlooked, pillar of digital health: ensuring that every software update is safe, explainable, and ready for patient-facing use.0:00 Introduction and Overview01:29 Meet the Expert: Andrew Hendela02:30 The SolarWinds Attack and Its Implications04:01 Challenges in Software Assurance04:46 The Role of Software Bill of Materials06:48 Andrew's Background and Career09:07 Applying Cybersecurity to MedTech12:56 Behavior Analysis in Software19:00 Third-Party Software and Compliance21:08 Understanding Third-Party Software Risks21:25 Challenges of Hospital Software Updates21:53 Patient Monitor Vulnerabilities22:55 Proving the Technology's Value24:34 Navigating Compliance and Legal Hurdles25:52 Collaborations and Research Opportunities27:43 Regulatory Challenges and Solutions36:47 The Importance of Tangible Impact39:20 Final Thoughts and Contact InformationFollow Shannon and Andrew:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Andrew: LinkedIn: https://www.linkedin.com/in/andrew-hendela/Website: https://karambit.ai/
In this Tech for MedTech episode of Inside MedTech Innovation, I talk with Dennis Lenard, CEO of Creative Navy, about how user interface complexity affects the real-world performance of medical devices.Dennis shares the story behind Compass, a tool his team developed to measure and reduce visual complexity in device interfaces. We explore why reducing cognitive load is critical for clinicians, how evidence—not intuition—should guide design decisions, and where regulatory thinking is starting to evolve.We also talk about the persistent gaps in how MedTech companies prioritize usability, and why simplifying a device’s interface is often a financial advantage—not just a user experience improvement.00:00 Introduction to MedTech Innovation00:44 Meet Dennis Lenard of Creative Navy00:57 The Importance of User Interface Design01:41 Introducing Compass: Measuring UI Complexity02:31 The Role of Evidence-Based Design04:08 Challenges in User Experience Design06:11 Real-World Examples and Lessons Learned08:26 Understanding Complexity in Clinical Settings12:46 Compass in Action: Success Stories17:50 The Future of Design in MedTech20:16 Overcoming Industry Challenges22:08 The Value of High-Quality Design26:31 Challenges in MedTech Adoption27:22 Working with Startups vs. Larger Companies30:32 Regulatory Approval and Design Process34:51 Sales Cycle and Acquisition Process44:14 FDA's Medical Device Development Tools (MDDT) Program49:24 Final Thoughts and AdviceFollow Shannon and Dennis:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Dennis: LinkedIn: https://www.linkedin.com/in/dennislenard/?originalSubdomain=ukWebsite: https://creativenavy.com/
Before 2005, your health records were probably sitting in a filing cabinet. Today, they’re digital—but that doesn’t mean they’re accessible, interoperable, or secure. In this episode, I sat down with Jodi Daniel, the legal strategist and former federal policymaker who helped shape how we got here.Jodi was the first Director of Policy at the Office of the National Coordinator for Health IT (ONC). She played a leading role in drafting the HIPAA privacy rules, designing meaningful use policy, and writing the early standards that defined what electronic health records should be. If you’ve ever wondered why health data doesn’t flow the way your banking or travel data does—Jodi explains exactly why.We talk about why $34 billion in EHR incentives didn’t solve interoperability, the hidden business incentives behind information blocking, and the real reasons your provider still makes you fill out a clipboard. Jodi also shares how new technologies—especially AI—are testing the limits of our current regulatory frameworks.00:00 The State of Electronic Health Records00:20 Introduction to Inside Med Tech Innovation01:14 Guest Introduction: Jodi Daniel02:25 Jodi's Early Interests and Education04:13 Transition to Health Policy and Law07:59 Joining HHS and Working on HIPAA08:43 The Push for Electronic Health Records17:15 Challenges in Implementing Health IT20:00 Developing Meaningful Use Regulations27:36 Balancing Technology and Policy29:48 Reflections and Lessons Learned33:39 Debating Policy and Patient Data Integration34:30 Challenges in Achieving Interoperability38:13 21st Century Cures Act and Information Blocking40:25 Current State of Data Sharing and Patient Access48:09 HIPAA 2.0 and Cybersecurity Concerns57:09 Innovations in AI and Digital Health01:02:34 Reflections and Future Directions01:06:30 Conclusion and Final ThoughtsFollow Shannon and Jodi:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Jodi: LinkedIn: https://www.linkedin.com/in/jodidaniel/
In this episode of Inside MedTech Innovation, I sit down with Doug Hubbard, the decision science expert behind How to Measure Anything and The Failure of Risk Management. Together, we unpack the hidden flaws in how MedTech organizations assess uncertainty—and how to fix them with data-driven models.00:22 Meet the Expert: Doug Hubbard01:25 The Importance of Data-Driven Decision Science03:01 Challenges in Risk Management04:44 Doug Hubbard's Journey and Career22:53 Applied Information Economics Explained44:59 Understanding Clinical Trial Evidence45:18 The Analysis Placebo Effect47:21 The Psychology of Risk Scoring48:47 Partition Dependence and Illusion of Agreement52:30 Quantitative Methods in Risk Management59:04 Practical Steps to Improve Risk Assessment01:13:34 Addressing Third-Party Risks01:21:57 Regulating Medical AI01:27:07 Conclusion and Final ThoughtsFollow Shannon and Doug:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.comConnect with Doug: LinkedIn: https://www.linkedin.com/in/dwhubbard/Website: https://hubbardresearch.com/
In this episode, Katharine Barnard-Kelly, PhD, Chartered Health Psychologist, joins me to discuss the critical intersection of mental health, chronic disease management, and medtech innovation. Dr. Barnard-Kelly has spent her career measuring the psychosocial impact of disease and translating that research into tangible tools for clinicians and regulators alike.As the co-founder and CEO of Spotlight-AQ, an AI-driven patient engagement platform, she shares how her technology is revolutionizing healthcare—reducing clinician burnout, improving diabetes management, and ensuring that patient voices are truly heard in medical decision-making.00:00 Introduction to MedTech Innovation00:49 Meet Dr. Katharine Barnard-Kelly02:46 Early Career and Academic Journey06:30 Discovering Diabetes and Quality of Life Research08:57 Challenges in Diabetes Management14:36 Advancements in Insulin Pump Therapy19:35 The Importance of Psychosocial Outcomes26:28 Developing the Inspire Measurement Tool36:22 INSPIRE Measures and FDA Interest37:44 Standardizing Person-Reported Outcomes39:50 Spotlight-AQ: Revolutionizing Routine Care41:49 AI-Driven Pre-Clinic Assessments43:39 Expanding Spotlight-AQ to Other Conditions51:15 Addressing Clinician Burnout55:56 Future of Spotlight-AQ and Healthcare01:07:39 Personal and Professional Next Steps01:11:11 Conclusion and Final ThoughtsFollow Shannon and Katharine:Connect with Shannon: LinkedIn: https://www.linkedin.com/in/shannonlantzyWebsite: https://www.shannonlantzy.com/Connect with Katharine: LinkedIn: https://www.linkedin.com/in/katharine-barnard-kelly-phd-0a14b032/Website: https://www.spotlight-aq.com/