Episode 87

The Hardest Part Was Making It Manufacturable

Why Solving a 30-Year Surgical Gown Problem Required Redesigning The Product Around Manufacturing Constraints.

Bill Kimball·Senior Vice President Operations·Maine-Lee Technology Group

About This Episode

Most surgical gowns still leak at the glove-gown interface — a problem surgeons have dealt with for decades.

In this episode, Bill Kimball explains how his company developed Tough Cuff, a surgical gown technology designed to eliminate fluid leakage. But the real challenge wasn’t inventing the solution — it was figuring out how to manufacture it reliably at scale.

Bill walks through the failed first prototype, the manufacturing constraints that forced a redesign, and how the team ultimately developed a production method that could pass FDA 510(k) approval while remaining cost-competitive with existing gowns.

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