Inside MedTech Innovation

In this episode of Inside MedTech Innovation, I dive deep with Christopher Gates, a pioneer in medical device cybersecurity and engineering. Christopher shares insights from over five decades of experience in medical technology, including his transition from assembly code programming to safeguarding life-critical devices from cyber threats.

From lessons learned at DEFCON to advising the FDA, Christopher explains why blending engineering fundamentals with cybersecurity expertise is essential in today’s medtech landscape. Tune in to learn about the evolving regulatory environment, proactive defense strategies, and why security is more than just a technical challenge—it’s an ethical imperative.

00:33 Meet the Expert: Chris's Journey in Cybersecurity

01:23 The Importance of Engineering in Cybersecurity

03:18 Hacker Culture and DEF CON

07:28 Real-World Cybersecurity Incidents

14:47 Understanding Embedded Systems and Operational Technology

18:45 Regulatory Changes and Their Impact

32:17 The Future of Cybersecurity in Medical Devices

35:12 The Next Stage of Human Capability Amplifiers

35:29 Regulatory Guidance and Its Impact

36:25 Technical Dive: SBOM and Cybersecurity Testing

39:27 Challenges in FDA Submissions

43:17 The Business of Cybersecurity

48:19 Cost and Pricing in Cybersecurity

52:39 Volunteer Work and Industry Standards

55:51 Patching and Updating Medical Devices

01:04:02 Rapid Fire Questions and Conclusion

Follow Shannon and Chris:

Connect with Shannon: 

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

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

Connect with Chris: 

LinkedIn: https://www.linkedin.com/in/christopher-gates-8912a81a/

Website: https://www.velentium.com/

Email: [email protected]

In this episode of Inside MedTech Innovation, I had the privilege of speaking with Dr. Alyssa Abo, a trailblazer in pediatric emergency medicine and point-of-care ultrasound. Dr. Abo’s career is a testament to the power of curiosity, adaptability, and a relentless drive to improve patient care through technology.In this episode, we explore:

00:17 Introducing Dr. Alyssa: A Pioneer in Pediatric Ultrasound

03:53 The Intersection of Technology and Medicine

15:14 The Rise of Point-of-Care Ultrasound in Pediatrics

29:34 The Importance of Training and Competency in Ultrasound

31:45 AI in Ultrasound: The Future of Medical Imaging

34:56 Bridging Technology and Healthcare

39:15 Bloom Standard: Revolutionizing Pediatric Heart Disease Detection

43:38 Addressing Healthcare Gaps with Technology

47:31 Challenges in Pediatric Device Development

58:25 Advice for Physicians, Innovators, and Policymakers

01:02:49 Personal Inspirations and Closing Thoughts

Follow Shannon and Dr. Abo:

Connect with Shannon: 

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

Web: https://www.shannonlantzy.com/ 

Connect with Dr. Alyssa Abo:

LinkedIn: https://www.linkedin.com/in/alyssa-abo-md-mba 

In this episode of Inside MedTech Innovation, I sit down with Dr. William R. Brody—a distinguished physician, engineer, entrepreneur, and leader who has significantly shaped the landscape of medical technology and higher education. Dr. Brody shares his remarkable journey from witnessing the installation of one of the first CT scanners at the NIH to pioneering minimally invasive biopsy technology.

His leadership roles as president of Johns Hopkins University and the Salk Institute guided some of the world’s most prominent researchers. 

02:16 The Role of Technology in Medicine

05:14 Dr. Brody's Early Career and Innovations

21:30 Medical Device Innovations

32:08 Cross-Disciplinary Innovation

34:57 AI and Data Science in Healthcare

39:26 Mentorship and Leadership in Science

44:33 The Role of Boards and the FDA

50:13 Future Challenges and Opportunities

Connect with Shannon: 

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

Web: https://www.shannonlantzy.com/ 

Connect with Bill: 

LinkedIn: https://www.linkedin.com/in/william-brody-138920106/ 

On this episode of Inside MedTech Innovation, I’m thrilled to chat with JC Herz, a true force in software risk management and open source security. From her start as a teenage rock critic sneaking into concerts, to influencing policy at the Department of Defense, JC has carved a unique path to becoming MedTech’s very own cybersecurity superhero. Together, we dive into her journey co-founding Ion Channel and tackling some of the biggest challenges in MedTech today—open-source software risks, supply chain vulnerabilities, and the need for proactive cybersecurity. JC’s insights reveal not only the complexities of this landscape but also what it takes to protect medical technology in an ever-evolving digital world.

00:23 Introduction to MedTech Innovation

00:32 Pen Testing a Medical Device App

01:45 Third-Party Risks in Medical Devices

02:12 Meet JC Herz: Innovator in Risk Protection

02:56 The Birth of Ion Channel

03:46 Challenges and Realizations in Open Source

05:13 Understanding Supply Chain Risks

09:41 From Media to Tech: JC's Journey

13:59 Navigating Startup Challenges

23:39 The Importance of Maintenance in Software

31:09 Introduction to Zlib and Its Importance

31:33 The Single Point of Failure in Infrastructure

31:50 Adversarial Actions and Their Impact

32:57 The Business Problem of Risk Management

35:31 Technical Debt and Operational Risks

36:14 Hospital Systems and Vulnerability Management

37:25 Contractual Terms and Open Source Maintenance

40:47 Automation in Contract Compliance

41:58 Transparency and Trust in Supply Chains

43:45 Advice for Medtech Manufacturers

50:55 Family Principles and Personal Heroes

55:10 The Crisis of Epistemology

57:30 Conclusion and Where to Find More Information

Follow Shannon and JC:

Connect with Shannon: 

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

Connect with JC: 

LinkedIn: https://www.linkedin.com/in/jc-herz-1781/

In this episode, I had the pleasure of sitting down with Dr. Sandra Waugh Ruggles, a true expert in the MedTech space and an absolute powerhouse when it comes to innovation policy. Sandy walks us through the often-overlooked reality of how long it really takes for a medical device to get from FDA clearance to Medicare coverage—a whopping 5.7 years, on average! We dive into why that delay exists, how it impacts both patients and companies, and what can be done to close that gap.

Listen in to hear Sandy’s fascinating stories and her deep expertise on how we can bring life-changing technologies to those who need them faster.

00:25 The Long Road to Medical Device Approval

01:06 Meet Sandy Ruggles: Innovator and Policy Expert

01:48 From Biotech to MedTech: Sandy's Journey

03:45 Family Influence on Career Path

05:10 Regulatory and Policy Innovation

09:57 The Biodesign Process: From Needs to Insights

19:15 Electrophysiology and Emergency Department Innovations

24:26 Prototyping Challenges and Market Opportunities

25:55 The Journey of the Pacing Wire

27:00 Innovation Policy: An Introduction

27:45 Creativity in Policy Making

30:16 Navigating the Path to Medicare Coverage

32:19 The Valley of Death in MedTech

36:31 Challenges in Medical Device Approval

43:41 Bureaucracy and Innovation

46:50 The Heart of Healthcare

48:38 MedTech Heroes and Closing Thoughts

Follow Shannon and Sandra:

Connect with Shannon: 

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

Connect with Sandra: 

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

Cyberattacks in healthcare are more dangerous than ever, but how do we actually protect our most critical infrastructure? In this episode, I sit down with Erik Decker, Chief Information Security Officer at Intermountain Healthcare, to discuss the growing threat of cybercrime in healthcare and what’s being done to fight back. We break down why healthcare is a prime target, how ransomware is disrupting patient care, and the steps needed to build a more secure future. If you’re curious about how cybersecurity is evolving to keep patients safe, this conversation is a must-listen.

What you’ll learn:

00:25 The Rise of Cyber Attacks in Healthcare

00:58 Meet Eric Decker: Leading the Charge in Cybersecurity

01:52 Understanding the Role of a CISO

03:29 Eric Decker's Journey into Cybersecurity

07:45 The Day-to-Day Challenges of a CISO

13:23 Defending Against Live Cyber Attacks

26:18 The Health Sector Coordinating Council

30:39 Strategic Discussions in Critical Infrastructure

31:10 Addressing Medical Device Vulnerabilities

31:33 The Role of CPAC in Free Conversations

32:22 Strategic vs Tactical Approaches

35:06 Collaborative Efforts with the FDA

38:02 Regulatory Perspectives and Challenges

41:21 Cybersecurity Standards and Resilience

49:58 Personal Insights and Leadership

58:26 Advice for Technology Developers

59:14 Mentorship and Career Reflections

01:00:57 Conclusion and Final Thoughts

Follow Shannon and Erik:

Connect with Shannon: 

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

Connect with Erik: 
LinkedIn: https://www.linkedin.com/in/erik-decker/

In this episode of Inside MedTech Innovation, host Shannon Lantzy speaks with Susan Bartlett Foote, a prolific author, lawyer, health policy expert, and Professor Emerita at the University of Minnesota. Susan shares her journey from facing challenges as a woman in law during the seventies and eighties, to shaping health policy and medical technology regulatory environments. Through her work with the FDA, her groundbreaking articles, and her role in establishing the Medical Technology Leadership Forum, Susan offers crucial insights into the evolution of medical devices regulation and innovation. She also discusses the critical interplay between regulation, innovation, and industry dynamics, providing valuable lessons and stories from her extensive career.

00:00 Introduction to Inside MedTech Innovation

00:53 Susan Bartlett Foote's Early Career and Challenges

01:58 The Evolution of Medical Device Regulation

04:27 FDA Committees and Consumer Representation

09:01 Impact of Early Medical Devices and Innovations

18:46 Susan's Work on Capitol Hill

39:09 The Medical Technology Leadership Forum

50:27 Reflections and Advice for Future Innovators

57:26 Conclusion and Final Thoughts

Follow Shannon: https://www.linkedin.com/in/shannonlantzy/

Check out Susans book: https://www.crusadeforforgottensouls.com/

In this episode of Inside MedTech Innovation, host Shannon Lantzy introduces Barry Liden, Managing Advisor of Patient Voice Advisors and Director of Public Policy at USC’s Schaeffer Center. Barry shares his journey into patient preference research within the medical device industry, discussing his role at Edwards Life Sciences and the importance of incorporating patient perspectives into regulatory decision-making. They delve into the practical applications of patient preference studies, showcasing how these methods can influence clinical trial design, regulatory approvals, and market access. Barry emphasizes the economic and patient-centered benefits of this approach, advocating for its broader adoption in healthcare innovation.

00:14 Welcome to Inside MedTech Innovation

00:38 Meet Barry Liden: Patient Voice Advocate

01:29 Barry's Journey into Patient Preferences

01:43 The Fork Story: Early Decision-Making Lessons

02:53 Patient Preference Research in MedTech

05:04 The Role of Preferences in Regulatory Decisions

07:23 Real-World Examples of Patient Preferences

09:27 The HIV/AIDS Crisis and Patient Advocacy

14:06 Obesity and Medical Device Approvals

17:58 The Aortic Valve Replacement Saga

32:01 The Role of Patient Preferences in Medical Device Development

32:53 Patient Preference Study: Stroke Risk vs. Minimally Invasive Procedures

34:02 Impact of Patient Stories on Regulatory Decisions

35:57 Challenges with Incorporating Patient Data in Medicare

36:47 Canada's Approach to Patient Preference Data

39:06 Economic Importance of Patient Preferences for Device Developers

40:14 Early Stage Development: Incorporating Patient Preferences

45:13 Designing Clinical Trials with Patient Preferences

47:05 Cost Savings and Risk Tolerance in Clinical Trials

53:33 Shared Decision Making and Patient Preferences

55:29 The Growing Importance of Patient Preference Studies

58:19 Advice for MedTech Developers and Patient Communities

01:02:14 Conclusion and Final Thoughts

Episode Resources: 

Video on HTA Decision Making: https://www.youtube.com/watch?v=gOPl8hQztsU

Follow Shannon and Barry:

Connect with Shannon:  https://www.linkedin.com/in/shannonlantzy/

Connect with Barry:https://www.linkedin.com/in/barry-liden/
Discover Patient Voice Advisors: https://www.patientvoiceadvisors.com/

In this episode of Inside MedTech Innovation, host Shannon Lantzy explores the intersection of medical technology and regulation with guest Susannah Fox, a health and technology strategist. They discuss the empowering nature of regulation, the ingenuity of patient-led innovations, and the importance of open access to information. Highlights include inspiring stories about the diabetes community's DIY revolution, the creation of a tremor-proof pill dispenser for Parkinson's patients, and the transformative potential of prize competitions and collaborative efforts between regulators and innovators. Susannah shares her journey and insights into the ongoing patient-led revolution in healthcare, emphasizing the power of community and connectivity in driving meaningful change.

00:00 Introduction to the Podcast

00:26 Meet Susannah Fox: Health and Technology Strategist

03:11 The Story Behind Rebel Health

05:52 The Moebius Syndrome Community

12:09 Innovative Solutions for Parkinson's Patients

15:17 The Power of Community and Technology

22:57 Susannah Fox's Origin Story

25:22 Diabetes Technology and Regulatory Challenges

27:15 The Role of the CTO in Government

29:02 Innovative Programs at HHS

30:56 Prize Competitions and FDA Challenges

39:23 The Impact of Continuous Glucose Monitors

45:45 Patient-Led Innovation and Regulatory Challenges

56:54 The Future of Patient-Driven Data

58:33 Conclusion and Final Thoughts

Follow Shannon: https://www.linkedin.com/in/shannonlantzy/

Follow Susannah: https://susannahfox.com/

Get a copy of Rebel Health here: https://mitpress.mit.edu/9780262048897/rebel-health/

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

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