#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit

Global Medical Device Podcast powered by Greenlight Guru

Content provided by Greenlight Guru + Medical Device Entrepreneurs. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Greenlight Guru + Medical Device Entrepreneurs or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.

13d ago 9:27

MP3•Episode home

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 reviewing hundreds of device designs. He also delivers a wake-up call to startups overly focused on licensing or acquisition as the endgame. Whether you're an engineer, founder, or CEO, this episode offers critical insights into how to build a product that works—and a company that lasts.

Key Timestamps

00:00 – Introduction & Greenlight Guru Sponsor Message
01:26 – Live from LSI: Introducing Justin Bushko
02:55 – Why Early-Stage Engineering Mistakes Derail Companies
04:12 – The Critical Role of DFM and Tolerance Analysis
06:20 – Real-World Usability Failures: FDA Warning on Cranial Fixation Devices
08:10 – Human Factors Oversights & Surgeon Behavior
10:25 – What CEOs Should Focus On vs. Engineers
12:20 – Economic Buyers, KOLs, and Commercialization Challenges
14:05 – Don’t Chase the Exit: Why Founders Should Build for Longevity
16:00 – Final Thoughts and Takeaways

Standout Quotes

“If your partners can’t explain how and why they did your tolerance analysis, they probably didn’t do it right—and it’ll cost you nine months later.”

—Justin Bushko, on the hidden dangers of relying too heavily on outsourced design partners.

“Founders aiming for a quick exit send the wrong message. Build something sustainable. Acquisition should be a byproduct—not the goal.”

—Justin Bushko, challenging the exit-first mindset common in early-stage MedTech.

Top Takeaways

DFM & Tolerance Analysis Are Non-Negotiable: Skipping detailed design-for-manufacturing and tolerance stack analysis often leads to failure right before tooling and commercialization—when funds are already tight.
Human Factors Must Be Built-In Early: Surgeons may not use your product as intended. Validate with a wide range of KOLs to uncover unintended use or misuse.
Test for High-Risk Use Cases Early: For devices like inserters, test mechanical thresholds that could lead to field failures. Don’t wait until post-market feedback.
Understand Economic Buyers, Not Just KOLs: A surgeon’s support doesn’t guarantee adoption. You need champions who can advocate to hospital boards and procurement teams.
Stop Chasing Exits—Build Real Companies: Investors and acquirers see through the “quick flip” mentality. A sustainable business model attracts more serious interest.

References

Greenlight Guru – Sponsor and end-to-end MedTech quality management platform
Justin Bushko on LinkedIn
Etienne Nichols on LinkedIn
Medical Device Fireside Chats – Justin Bushko’s Book (Amazon) (If mentioned/linked on-site)

MedTech 101: What is Tolerance Stack-Up Analysis?

Imagine building a puzzle where each piece is just slightly off in size—by the time you put it all together, nothing fits. That’s what tolerance stack-up is about. Every part in a device has a manufacturing variation. If those tolerances aren’t analyzed cumulatively, you can end up with a product that doesn’t assemble or fails under stress. Tolerance analysis helps predict and prevent these compounding errors before they happen.

Poll Question:

What’s the biggest product development risk in early-stage MedTech?

Tolerance stack-up issues
Ignoring human factors
Economic misalignment with buyers
Rushing to an early exit

Discussion Prompt:

Have you ever seen a product fail in the field due to a design assumption? Share your story and how it changed your approach.

Feedback

Enjoyed the episode? Want to hear more from product engineers, founders, or regulators? Let us know!

Send your feedback, guest ideas, or questions to [email protected] — we read every email and respond personally.

Sponsor Mention

This episode is brought to you by Greenlight Guru, the only MedTech-specific quality management platform. Whether you’re an engineer working through DFM or a CEO planning your go-to-market strategy, Greenlight Guru helps you manage compliance, risk, and innovation—all in one place.

430 episodes

#Business #Consultants; R #Health Industry #Health and Well-Being #Health Care #Tech #Fitness #Medicine #Medical Device