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:

1. "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko
2. "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:

1. Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages.
2. 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.
3. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration.

References:

• Connect with Justin Bushko on LinkedIn
• Greenlight Guru’s QMS Software
• Etienne Nichols’ LinkedIn

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:

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