Able Medical Devices

Able Medical Devices is a private, revenue-generating contract development and manufacturing organization (CDMO) headquartered in Gwinn/Marquette, Michigan, founded in 2010. The company provides end-to-end outsourced services for medical device companies, including design, development, prototyping, and manufacturing of Class I, II, and III implants and instruments. With an FDA-registered, ISO 13485:2016 certified facility and a leadership team boasting decades of industry experience from firms like RTI Surgical and Pioneer Surgical, Able positions itself as a scalable, quality-focused strategic partner. Its business model is entirely service-based, catering primarily to orthopedic and cardiovascular device innovators.

Integrated contract development and manufacturing (CDMO) platform offering design control, risk management, project engineering, and precision manufacturing (CNC machining, laser welding, EDM) for Class I-III medical devices within an ISO 13485:2016 certified, FDA-registered facility.

Able competes in the fragmented medical device contract manufacturing space against large global CDMOs (like Flex, Jabil), specialized orthopedic manufacturers, and smaller machine shops. Its differentiation lies in its senior team's deep industry experience, full-service capabilities from design to production, and focus on complex, precision-machined implants and instruments for strategic partnerships.