In this episode of The Med-Tech Talent Lab, Mitch Robbins sits down with Tom Ross, founder of The Device Doctor and fractional COO at OUI Medical, to explore what separates medical device startups that reach the market from the ones that stall.

With nearly four decades in medical technology, Tom has raised capital, built sales organizations, launched products, and guided companies through acquisitions involving Medtronic, Smith & Nephew, and Orthofix. Drawing on a career spent almost entirely inside startups, sometimes as employee number two, he shares the warning signs he looks for in a young company, why unrealistic projections made during fundraising cause damage long after the round closes, and why founders building what he calls real devices, products that enter the body and do something, face a far harder capital market than their software and AI counterparts.

The conversation also explores the difference between what a CEO does and what an operator does, when a founder should bring in a COO, and why Tom argues the O should stand for outcomes rather than operations. He walks through the case of a surgeon who got his technology back with FDA clearance in hand but no company capable of building or selling it, and he's candid about the evolution of his own consulting practice, including why the message "I can help with anything" never sold.

Whether you're a founder, an investor, a commercial or operations leader, or an experienced professional weighing a move into consulting, this episode offers practical insights on building companies that can actually execute, positioning yourself around a specific problem, and what the next two years may hold for MedTech.

In this episode, you'll learn:

The first warning signs that a medical device startup is headed for trouble

Why projections made to attract investors create problems that surface years later

Why hardware device companies face tougher fundraising than AI and digital health startups

What founders underestimate about supply chain, on both the build side and the customer side

The right time to bring in a COO, and why chief outcomes officer is the better title

Why an FDA-cleared product is not the same thing as having a company

What clinical founders consistently misjudge about what it takes to commercialize

How to evolve a consulting message from "I can do anything" to something that actually sells

...and so much more!

Tom Ross on LinkedIn:

https://www.linkedin.com/in/thomaswross/

The Device Doctor on the web:

www.thedevicedr.com