Inside MedTech Innovation

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

Follow Shannon and Terry:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Terry: 

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

Follow Shannon and Howard:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Howard: 

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

Follow Shannon and Kirk:

Connect with Shannon: 

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/

Welcome back to Inside MedTech Innovation, the podcast where we explore the intersection of technology, leadership, and patient-centered care. In this episode, we’re honored to feature Dr. Deborah Kilpatrick, a visionary leader driving the transformation of medtech and digital health through innovation and collaboration.

Deb’s career is a masterclass in bridging complex engineering challenges with the practical needs of patient care.

00:00 Introduction

00:24 Meet Dr. Deb Kilpatrick

03:22 Journey to Engineering and MedTech

13:18 Impact of Computational Mechanics in MedTech

27:02 Patient-Generated Health Data and Evidation

42:55 MedTech vs. Pharma

43:36 Navigating Regulatory Paths in MedTech

45:42 Balancing Stakeholder Interests in MedTech

49:41 The Role of Venture Capital 

51:32 Changing the Standard of Care in Medicine

01:02:45 MedTech Women: Founding and Impact

01:21:42 Advice for Regulators and Future Predictions

01:23:48 Conclusion and Final Thoughts

Follow Shannon and Deborah:

Connect with Shannon: 

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com/

Connect with Deborah: 

LinkedIn: https://www.linkedin.com/in/deborahlkilpatrick/

Website: https://evidation.com/