Design a medical device to replace manual user operation compatible with ISO Class 5 100 clean room standards. Provide FDA documentation support for user instruction, fabrication, and assembly instructions.
Concept design exploration for mechanical systems to achieve an identified and consistent compression force.
Solution / Success:
Designed and engineered fully pneumatic drive squeeze system that included robustness, safety, serviceability and clean room compliance. The new device increased product throughput and reduced inconsistencies across multiple users.