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How To Avoid Founder Fallout: 10 Steps for Strong MedTech Startup Partnerships

5/14/2025

 
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Starting a medical device company can be one of the most rewarding paths for an entrepreneur. It’s a chance to innovate, solve real clinical problems, and build something with lasting patient impact. Many successful startups in the MedTech space begin not with a single founder, but with a partnership—a shared vision between two or more individuals eager to carve out a slice of the $500B+ global MedTech market.

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Case Study: Validation Strategy for Global Production Expansion

4/28/2025

 
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Scaling from early-stage commercial operations to global medical device manufacturing demands precise execution. Our client, a Class III OEM, faced an urgent need to expand production capacity across multiple international facilities while meeting the strict regulatory requirements of the medical device industry. Square-1 Engineering partnered with the client to drive this transformation, with a focus on validation excellence, operational scalability, and long-term compliance.

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Case Study: Product Development & Prototyping

4/23/2025

 
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​Breaking through a crowded market: A Class II biopsy systems OEM partnered with SQR1 to develop a universal delivery system. The goal: outperform competitors with a smarter, more cost-effective design. Our team delivered a solution that earned clinician approval, reduced costs, and gave the client first-mover advantage.

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Case Study: Manufacturing Process Improvements

4/22/2025

 
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Learn about how we helped an angioplasty treatment developer overcome challenges with their pilot manufacturing process, streamlining their extensive process. With implementations for scalable manufacturing, we were also able to reduce their new employee training time by 83% and ultimately help them produce better quality and yield. 

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Case Study: Quality System Remediation

4/22/2025

 
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Dive into this case study to learn how we helped a Class III medical device company to navigate remediation, guiding them through system-wide nonconformances across QMS, Operations, and R&D Sustaining. Ultimately, we quickly helped them get back on track and even shortened the project timeline by 6 months.

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    About the Author

    Travis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services.  He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA.

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