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

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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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 podcast@greenlight.guru — 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.