Occam Design

Occam Design is a full-service medical device design and contract manufacturing firm based in Louisville, Kentucky, with over 30 years of industry experience. ISO 13485:2016 certified, GMP compliant, and FDA registered, the company operates five Class VII Clean Rooms and holds 55+ patents with $3+ billion in marketplace sales across client projects. Occam Design provides comprehensive services spanning the entire product lifecycle: industrial design and engineering (SolidWorks, solid modeling, process development), rapid prototyping, custom manufacturing at pilot and production volumes, and regulatory guidance through FDA and ISO compliance. The firm specializes in smart devices, wearables, and precision instruments including catheters, cervical devices, and minimally invasive tools. With a Design for Manufacturability-First (DFM) approach and proprietary QMS (QT9), Occam Design serves as a technical extension for medical device innovators seeking cost-effective, on-time product development and manufacturing support.