In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man.

Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt.

Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape.

Key Timestamps:

00:00 – Introduction and Greenlight Guru sponsor message
02:45 – Welcoming Justin Bushko; background in MedTech and engineering
07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing
10:45 – Prototyping with a purpose: Ensuring design iterations target risks
16:00 – Balancing innovation, user needs, and cost-effectiveness
20:30 – Defining essential versus “nice-to-have” features in MedTech
26:45 – Strategic pivots in MedTech: When and why to change course
32:50 – The critical role of design freeze and usability studies
39:10 – Lessons from competitive benchmarking and reverse engineering
46:25 – Handling unique challenges in regulated industries like MedTech
52:15 – Opportunities for MedTech innovation and faster regulatory approvals
58:45 – Advice for founders and importance of building the right team

Standout Quotes:

"Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko
"MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko

3 Key Takeaways:

Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.
Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability.
MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.

References:

MedTech 101:

Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements.

Audience Engagement:

Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!"

Feedback:

We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

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