Summary

“You can’t walk away from risk. If people did, no one would ever develop a product this complex. The key is learning how to manage risk intelligently through data and a structured process.”

In this episode of the Let's Talk Risk Podcast, host Dr. Naveen Agarwal sits down with Viral Thakkar, Chief Operating Officer of Lungpacer Medical, Inc., to explore the inspiring story of a device that helps patients on mechanical ventilators recover their natural breathing ability. Viral recounts how the idea to stimulate the phrenic nerves trans-venously evolved from a university lab concept into a first-in-kind, FDA-approved technology. He explains how early investment in quality and risk management systems enabled Lungpacer to navigate three clinical trials, to achieve Breakthrough Device Designation, Emergency Use Authorization during COVID-19, and ultimately PMA approval.

The conversation dives into how risk-based decision-making shaped each phase of development - from material selection trade-offs to parallel-path prototyping - and how transparent communication with regulators and investors built confidence in a novel approach to respiratory care. Viral also reflects on leadership lessons from his transition from engineer to executive: balancing innovation with safety, thinking strategically as a QA/RA professional, and having the courage to stay the course through uncertainty. The episode closes with a glimpse into Lungpacer’s future - preventing diaphragm atrophy before it begins through next-generation technology.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:42 Introducing Viral Thakkar01:30 Origins of Lungpacer and early development hurdles04:30 Understanding ventilator-induced diaphragm atrophy06:30 Clinical results and patient impact08:00 How the device works and when it’s used10:15 The EUA experience during COVID-1912:00 Making risk-based trade-offs in materials and design15:15 Communicating risk strategy to management17:37 Strategic role of QA/RA professionals in startups21:13 Career evolution from engineer to executive24:00 Personal story and lessons learned25:00 Future direction and closing comments

Suggested links:

* LTR - Collaboration that drives innovation, not delays.

* LTR: Understanding risk-based thinking.

* LTR: Leadership in the age of AI.

Key Takeaways

* Mechanical ventilation saves lives but causes rapid diaphragm atrophy and lung injury.

* Lungpacer helps recover diaphragm strength to activate the natural breathing pathway via phrenic-nerve stimulation.

* Early implementation of quality and risk systems accelerates innovation safely.

* FDA granted Breakthrough Device Designation in 2016 and PMA approval in 2024.

* COVID-19 EUA demonstrated safety and efficacy under crisis conditions.

* Parallel development reduced risk while maintaining speed to clinic.

* Data-driven, structured decision-making earns management and regulatory trust.

* Cross-functional teamwork and communication are vital for success.

* Courage, patience, and strategic thinking define MedTech leadership.

* The next frontier: using stimulation proactively to prevent ventilator-induced injury.

Keywords

MedTech innovation, breakthrough device, risk-based decision making, regulatory strategy, leadership in startups, quality, risk management, patient safety, strategic decision making, medical device development, transformative healthcare technology

About Viral Thakkar

Viral Thakkar PEng, is Chief Operating Officer at Lungpacer Medical Inc., a company dedicated to developing therapeutic solutions for patients requiring mechanical ventilation.

He has over 20 years of experience in the medical device industry, specializing in the design and development of innovative medical technologies. Viral has led the development of critical care, cardiovascular, robotic surgery, respiratory, and neurostimulation devices. He has been instrumental in bringing to market first-of-their-kind products, including power-actuated surgical stapling devices, cardiovascular and peripheral stents, stent delivery systems, embolic protection devices, and catheter-based intra-vascular temperature management devices. He has successfully led the concept-to-commercialization of seven regulated Class II and III medical devices.

With over 100 global patents his extensive experience includes leadership roles at ZOLL Medical Corporation, Boston Scientific Corporation, Radiant Medical, SMTPL, and Power Medical Interventions.

Viral’s commitment to innovation has contributed to the advancement of the medical device industry, helping improve patient outcomes.

Disclaimer

Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

Let's Talk Risk! is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe