In this episode, Etienne Nichols and Matt Stratton, Director and Principal Consultant at Coalition, delve into the dynamic and complex world of neurotechnology.

They discuss the expansive definition of neurotech, the significant challenges in accelerating innovation—particularly concerning regulatory frameworks and cross-functional collaboration—and how a united industry voice can overcome these hurdles to bring life-changing devic...

As global clinical trials become more competitive and data-driven, Latin America is stepping up with a new global standard in clinical trial quality. In this episode, Etienne Nichols speaks with Julio Martinez-Clark, CEO of BioAccess and a key advocate for clinical site certification in Latin America.

They discuss the launch of the GCSA certification and IAOCR accreditation now available in the Americas, exploring how these standar...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “c...

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale.

Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of ...

Many MedTech companies focus heavily on FDA clearance but overlook a critical layer of U.S. market entry: state-level compliance. In this episode, Etienne Nichols speaks with Adam Steadman, CEO of MDD Options, to unpack the real-world challenges that derail commercialization after regulatory approval.

From navigating state-specific registration, sales tax laws, and distribution logistics to choosing between direct and distributor-b...

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment.

Mike challenges MedTech professionals to rethink how...

In this episode recorded live at LSI Dana Point, Etienne Nichols sits down with Ed Muzio, author of Iterate, to explore how iterative management helps MedTech companies move faster as they scale. Muzio breaks down the pitfalls of traditional management—including siloed execution and backward-looking metrics—and offers a proven alternative grounded in over 70 years of research.

With real-world analogies, like orchestras and dashboar...

In this live episode from the LSI conference, Etienne Nichols sits down with Justin Bushko—known as the "MedTech Man" and author of Medical Device Fireside Chats—to dive into what separates thriving medical device companies from those that fail.

From costly engineering missteps like ignoring tolerance stack-ups to the human factors issues that derail usability in the OR, Justin shares battle-tested advice based on his experience re...

Christian Espinosa, founder of Blue Goat Cyber and leading voice in medical device cybersecurity, joins Etienne Nichols to unpack the urgent and often misunderstood topic of cybersecurity in MedTech. From FDA’s 2023 regulatory overhaul to real-world hacking scenarios that could harm patients, Christian provides practical advice for innovators, RA/QA professionals, and software teams. He also shares why waiting until the last minute...

In part 2 of a critical two-part series, Etienne Nichols and regulatory affairs expert Mike Drues explore the nuanced pathway of switching a medical device from prescription (Rx) to over-the-counter (OTC).

This episode dives deep into what triggers a new submission, how usability testing and human factors play an expanded role for lay users, and the regulatory logic that guides these transitions. The conversation highlights the imp...

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs).

This episode unpacks how...

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass.

They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigat...

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets.

From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market stra...

Episode Summary:

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kirk Petyo, Managing Partner at Talent Factory Recruiting, to explore the art and science of hiring in MedTech.

Kirk shares strategies for building magnetic employer brands, explains the difference between competencies and capabilities in candidates, and warns about the hidden costs of bad hires or delayed recruitment....

In this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development.

They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in ...

In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru’s Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry ...

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Olga Chashchina, a MedTech startup founder with extensive international experience. They explore how cultural differences affect communication in the medical device industry and the importance of understanding intercultural nuances.

Drawing from the book The Culture Map by Erin Meyer, Olga shares practical insights on managing global teams, th...

In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Scott Pantel, CEO and founder of Life Science Intelligence (LSI), to explore how LSI bridges the gap between medtech innovation and commercialization.

Scott shares LSI’s origin story, the evolution of its events, and the importance of cultivating meaningful relationships within the medtech ecosystem. Learn how LSI’s global meetings—from Dana P...

In this episode, Etienne Nichols sits down with Tiffany Ryder—healthcare advocate, physician assistant, and founder of Red Flag Hero—to discuss the complexities of product adoption in healthcare. Tiffany shares her journey from rural Louisiana to the NFL cheerleading squad and into emergency medicine, highlighting how personal experience shapes her patient advocacy.

The conversation dives deep into why healthcare professionals are s...