Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List," and Mark Duval, President and CEO of DuVal & Associates.

The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.

Interested in sponsoring an episode? Click here to learn more!

Listen now:

Love this episode? Leave a review on iTunes!

Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Key Timestamps

• [00:00:15] - Introduction by Etienne Nichols.
• [00:01:30] - Howard Root's background and the origins of Vascular Solutions.
• [00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.
• [00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.
• [00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.
• [00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.
• [01:10:00] - Closing remarks and takeaways.

Key Takeaways

Latest MedTech Trends:

1. Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.
2. Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.
3. The role of ethical practices in sustaining innovation within the MedTech industry.

Practical Tips for MedTech Professionals:

1. Ensure thorough understanding and compliance with FDA guidelines and local regulations.
2. Implement robust training and compliance programs for all staff, particularly in sales and marketing.
3. Engage experienced legal counsel to navigate complex regulatory landscapes.

Future Predictions in MedTech:

1. Enhanced regulatory frameworks to better define and manage off-label use.
2. Greater use of AI and data analytics to monitor compliance and ethical practices.
3. Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.

Links:

• Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed’s Hit List"
• Mark DuVal on LinkedIn
• DuVal & Associates Client Alerts
• FDA guidelines on off-label promotions
• Etienne Nichols on LinkedIn

Memorable quotes:

• "We're not imposing rules at the bare legal minimum...we want to have a gray area. It’s why you drive 55 in a 60 zone." - Howard Root
• "Always be truthful, fairly balanced, and not misleading when discussing device applications." - Mark DuVal

Feedback:

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or Spotify.