 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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 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.
 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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About the AuthorTravis 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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