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 questions
Follow Shannon and Kyle:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
Connect with Kyle:
LinkedIn: https://www.linkedin.com/in/kyle-rose-rook
Website: 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 questions
Follow Shannon and Oleg:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
Connect with Oleg:
LinkedIn: https://www.linkedin.com/in/olegyusim
Website: 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 questions
Follow Shannon and Omar:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: 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 learned
The invention and evolution of STRIDE methodology for systematic threat analysis
How FDA adopted threat modeling for medical device cybersecurity regulation
The fundamental difference between threat modeling and risk management
Why current approaches to software understanding and composition analysis fall short
Practical advice for scaling threat modeling across organizations
The future of threat modeling with AI assistance
Timestamps:
[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 integration
Connect 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 sensitivity
Connect 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 engineering
Follow Shannon and Lane:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect 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 way
How evidence-based personalization can replace decades of fad diets and miracle cures
Why “pizza night” matters: the importance of designing care that fits real lives
The role of employers, health plans, and policy in making equitable obesity treatment available to all
Timestamps:
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 goals
Follow Shannon and Elina:
Shannon Lantzy
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Elina Onitskansky
LinkedIn: https://www.linkedin.com/in/elinaonitskansky
Website: 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 jurisdiction
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 risk
03:00 – Ed’s background and founding Censinet
05:45 – Why risk assessments in healthcare are so fragmented
08:00 – What hospitals evaluate in third-party vendors
12:00 – When clinical urgency overrides risk protocols
14:00 – Ransomware’s impact on care delivery
16:45 – Managing risk across the vendor lifecycle
18:00 – Shifting from IT risk to business risk
20:00 – Change Healthcare as a case study
21:30 – How Ed built credibility with hospital partners
24:00 – Research linking ransomware to patient outcomes
28:00 – Creating a managed service to test Censinet internally
31:00 – Real-world results: 5X output, fewer staff
34:00 – Transparency as a business practice
37:00 – Overcoming resistance to better risk management
39:00 – What AI is (and isn’t) doing in risk ops today
41:00 – Peer benchmarking and open access to data
44:00 – Three changes Ed would make in markets and policy
47:00 – Leading a mission-driven business
53:00 – Final thoughts and personal drivers
Connect with Shannon:LinkedIn – Shannon LantzyWebsite
Connect with Ed:LinkedIn – Ed Gaudet Website – Censinet
FOLLOW 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 revealed
02:00 – Meet Ryan Torvik: From cybersecurity offense to medical emulation
05:00 – What “embedded” really means—and why these devices remain vulnerable
10:00 – Why firmware updates in MedTech aren’t like consumer tech
14:00 – Building Barnhill: A digital twin for real-time debugging
17:00 – How Barnhill differs from other emulators and digital twins
21:00 – A glucose monitor case study: translating voltage into clinical meaning
25:00 – MedTech’s friction points: regulation, reimbursement, and risk
30:00 – Why cybersecurity lessons aren’t translating to healthcare
34:00 – DevSecOps and SPDF: A new framework for firmware confidence
40:00 – The real barrier: MedTech’s “never touch it again” mindset
45:00 – Can AI help accelerate testing without adding new risks?
49:00 – How Barnhill aims to reduce false confidence and unknown vulnerabilities
52:00 – Ryan’s journey: from hacker to healthtech founder
55:00 – What he learned building large-scale emulation in defense
58:00 – Final thoughts: why trust, transparency, and humility matter most
Follow Shannon and Ryan:
Ryan Torvik
LinkedIn | Ryan Torvik
Company | Tulip Tree Technology
Shannon 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 Holt
04:30 – British boarding schools, Marxism, and clueless career starts
11:45 – From London to Stanford: a detour that changed everything
17:30 – Discovering health tech through Japanese health systems
24:00 – From EMRs to Health 2.0: how a contrarian became a convenor
30:50 – SMACK vs. digital health: what the terminology misses
35:20 – The rise (and crash) of EHR adoption in the U.S.
42:00 – Patient portals, “MyChart,” and why consumer tech still lags
49:40 – Epic vs. Particle: a legal battle over who owns health data
56:00 – Should AI tools access all patient data—or be limited by design?
01:04:00 – Remote monitoring, real-world evidence, and research at scale
01:13:20 – Advice for founders: simplify, specify, and clarify
01:21:15 – Future gazing: what MedTech should fix next
Matthew Holt: LinkedIn | The Health Care Blog
Shannon 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 transformation
The difference between adult and pediatric cardiology, and why so many babies go undiagnosed
What it takes to build a hardware + software + AI company in MedTech
The Total Product Lifecycle Advisory Program (TAP) at FDA and how early regulatory collaboration is helping Bloom scale faster
How Annamarie’s earlier policy work led to universal pulse oximetry screening in newborns, a change that reshaped care nationwide
00:03:00 – The story of Eve: when a murmur saved a life
00:07:00 – Why pediatric ultrasound isn’t standard—yet
00:13:00 – What makes pediatric cardiology uniquely complex
00:21:00 – Hardware, software, AI—and the hard path to MedTech
00:30:00 – The public health victory behind CCHD screening
00:39:00 – The trauma and cost of medical transport
00:42:00 – Building ethical, safe, clinically relevant AI
00:46:00 – How regulatory policy (TAP) is shaping Bloom’s future
Follow Shannon and Annamarie:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect 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 Overview
01:29 Meet the Expert: Andrew Hendela
02:30 The SolarWinds Attack and Its Implications
04:01 Challenges in Software Assurance
04:46 The Role of Software Bill of Materials
06:48 Andrew's Background and Career
09:07 Applying Cybersecurity to MedTech
12:56 Behavior Analysis in Software
19:00 Third-Party Software and Compliance
21:08 Understanding Third-Party Software Risks
21:25 Challenges of Hospital Software Updates
21:53 Patient Monitor Vulnerabilities
22:55 Proving the Technology's Value
24:34 Navigating Compliance and Legal Hurdles
25:52 Collaborations and Research Opportunities
27:43 Regulatory Challenges and Solutions
36:47 The Importance of Tangible Impact
39:20 Final Thoughts and Contact Information
Follow 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-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 Innovation
00:44 Meet Dennis Lenard of Creative Navy
00:57 The Importance of User Interface Design
01:41 Introducing Compass: Measuring UI Complexity
02:31 The Role of Evidence-Based Design
04:08 Challenges in User Experience Design
06:11 Real-World Examples and Lessons Learned
08:26 Understanding Complexity in Clinical Settings
12:46 Compass in Action: Success Stories
17:50 The Future of Design in MedTech
20:16 Overcoming Industry Challenges
22:08 The Value of High-Quality Design
26:31 Challenges in MedTech Adoption
27:22 Working with Startups vs. Larger Companies
30:32 Regulatory Approval and Design Process
34:51 Sales Cycle and Acquisition Process
44:14 FDA's Medical Device Development Tools (MDDT) Program
49:24 Final Thoughts and Advice
Follow Shannon and Dennis:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect with Dennis:
LinkedIn: https://www.linkedin.com/in/dennislenard/?originalSubdomain=uk
Website: 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 Records
00:20 Introduction to Inside Med Tech Innovation
01:14 Guest Introduction: Jodi Daniel
02:25 Jodi's Early Interests and Education
04:13 Transition to Health Policy and Law
07:59 Joining HHS and Working on HIPAA
08:43 The Push for Electronic Health Records
17:15 Challenges in Implementing Health IT
20:00 Developing Meaningful Use Regulations
27:36 Balancing Technology and Policy
29:48 Reflections and Lessons Learned
33:39 Debating Policy and Patient Data Integration
34:30 Challenges in Achieving Interoperability
38:13 21st Century Cures Act and Information Blocking
40:25 Current State of Data Sharing and Patient Access
48:09 HIPAA 2.0 and Cybersecurity Concerns
57:09 Innovations in AI and Digital Health
01:02:34 Reflections and Future Directions
01:06:30 Conclusion and Final Thoughts
Follow Shannon and Jodi:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect 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 Hubbard
01:25 The Importance of Data-Driven Decision Science
03:01 Challenges in Risk Management
04:44 Doug Hubbard's Journey and Career
22:53 Applied Information Economics Explained
44:59 Understanding Clinical Trial Evidence
45:18 The Analysis Placebo Effect
47:21 The Psychology of Risk Scoring
48:47 Partition Dependence and Illusion of Agreement
52:30 Quantitative Methods in Risk Management
59:04 Practical Steps to Improve Risk Assessment
01:13:34 Addressing Third-Party Risks
01:21:57 Regulating Medical AI
01:27:07 Conclusion and Final Thoughts
Follow Shannon and Doug:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com
Connect 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 Innovation
00:49 Meet Dr. Katharine Barnard-Kelly
02:46 Early Career and Academic Journey
06:30 Discovering Diabetes and Quality of Life Research
08:57 Challenges in Diabetes Management
14:36 Advancements in Insulin Pump Therapy
19:35 The Importance of Psychosocial Outcomes
26:28 Developing the Inspire Measurement Tool
36:22 INSPIRE Measures and FDA Interest
37:44 Standardizing Person-Reported Outcomes
39:50 Spotlight-AQ: Revolutionizing Routine Care
41:49 AI-Driven Pre-Clinic Assessments
43:39 Expanding Spotlight-AQ to Other Conditions
51:15 Addressing Clinician Burnout
55:56 Future of Spotlight-AQ and Healthcare
01:07:39 Personal and Professional Next Steps
01:11:11 Conclusion and Final Thoughts
Follow Shannon and Katharine:
Connect with Shannon:
LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
Connect with Katharine:
LinkedIn: https://www.linkedin.com/in/katharine-barnard-kelly-phd-0a14b032/
Website: https://www.spotlight-aq.com/
In this episode, Dr. Terry Adirim—a pediatric emergency physician turned federal healthcare policymaker—shares insider perspectives on digital health transformation, AI in medicine, and the future of healthcare leadership.Dr. Adirim has been at the helm of some of the most complex, high-stakes health initiatives in U.S. government, including leading the Department of Defense’s EHR modernization and shaping pandemic preparedness strategies. She brings an unparalleled behind-the-scenes view on how healthcare decisions are made—and what needs to change for clinicians, innovators, and policymakers to build a better system.
00:00 Introduction to MedTech Innovation
00:24 Meet Dr. Terry: A Distinguished Healthcare Leader
01:54 Journey into Medicine: From Childhood to Medical School
03:58 Choosing Pediatric Emergency Medicine
07:01 From Residency to Research: Early Career Highlights
09:12 Transforming Emergency Medical Services for Children
16:15 Policy and Leadership: From Local Impact to National Influence
16:33 Navigating Federal Healthcare Policy
25:23 Military Health System vs. Civilian Healthcare
28:07 Optimizing Health: Military vs. Civilian Approaches
32:39 The Importance of Practicing Medicine in Policy Making
36:43 The Importance of Clinician Involvement in Health Tech
38:27 Challenges and Innovations in MedTech
39:50 The Evolution and Impact of Electronic Health Records
43:47 Addressing Physician Burnout with Technology
45:28 The Role of AI in Healthcare
52:11 Balancing Innovation and Regulation in MedTech
57:30 Rapid Fire Questions and Career Reflections
01:06:37 Personalized and Preventive Care: The Future of Healthcare
01:11:40 Final Thoughts and Predictions
01:13:33 Conclusion and Farewell
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LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
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LinkedIn: https://www.linkedin.com/in/terryadirim/
In this episode of Inside MedTech Innovation, I sit down with Howard Look, CEO of Tidepool, to explore how open-source software, patient-led innovation, and regulatory transformation are reshaping diabetes care.
Howard shares his unexpected journey from Silicon Valley to MedTech, discussing how his background at Pixar, TiVo, and Amazon led him to found a nonprofit that revolutionized diabetes technology. Tidepool became the first-ever open-source, FDA-cleared diabetes management system—a groundbreaking achievement in the digital health space.
00:00 Introduction
02:37 Howard Look's High School Days
06:15 Howard’s College Life and Early Career
10:32 Joining Silicon Graphics
15:48 The TiVo Revolution
23:49 Transition to Med Tech
39:20 FDA Collaboration and Regulatory Decisions
40:15 Innovative Approaches to Software Development
42:17 The Pre-Cert Program and Digital Health
46:44 The Rise of OpenAPS and DIY Diabetes Solutions
57:34 Tidepool's Evolution and Impact
01:08:23 Future Directions and Personal Insights
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LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
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LinkedIn: https://www.linkedin.com/in/howardlook
Website: https://www.tidepool.org/
In today’s episode, we’re discussing the world of obstructive sleep apnea (OSA)—a condition that impacts millions of lives by disrupting sleep, affecting overall health, and increasing the risk of cardiovascular diseases.
Joining me is Kirk Huntsman, CEO of Vivos Therapeutics, a healthcare leader with over 40 years of experience. Vivos has pioneered innovative, non-invasive solutions to OSA, including technologies that address its root causes rather than just its symptoms. We’ll explore what it took to develop and commercialize Vivos’ breakthrough treatments, and what it takes to challenge the status quo in healthcare.
00:00 Introduction
00:46 Meet Kirk Huntsman: Revolutionizing OSA Treatment
04:25 The Intersection of Business and Healthcare
06:48 The Importance of Integrated Healthcare
10:04 Diagnosing Obstructive Sleep Apnea
27:06 The Impact of Sleep Apnea on Health
32:44 Innovative Treatments for Sleep Apnea
36:54 Vivos: A New Approach to Treating Sleep Apnea
47:06 Challenges in the Medical Device Market
49:59 Navigating FDA Regulations
01:10:25 Advice for Entrepreneurs and Future Outlook
01:20:19 Final Thoughts and Closing Remarks
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LinkedIn: https://www.linkedin.com/in/shannonlantzy
Website: https://www.shannonlantzy.com/
Connect with Kirk:
LinkedIn: https://www.linkedin.com/in/kirkhuntsman
Website: https://vivos.com/