Founded in 2014, Alva Prototypes makes custom precision-machined prototypes and parts for medical-device manufacturers, with a particular focus on surgical instruments and orthopedic devices for the spinal market. The Pottstown company helps customers refine designs for easier, less costly production and can carry projects from prototype development into light manufacturing. It is also a specialty partner for secondary machining of 3D-printed, patient-specific implants.
Proto Dev and Fab, LLCFounded in 2020 from James Rogers’s garage machine shop, Proto Dev and Fab develops medical devices and turns difficult design ideas into working prototypes. The company combines product-development and design-for-manufacturing guidance with hands-on fabrication, including prototype work such as the Project Spiritus rescue-ventilation device. Rogers brings experience as a machinist and design engineer, along with multiple granted and pending patents and a master’s degree in engineering.MILFORD, OH
McLean Medical and Scientific, LLCSince 1921, McLean Medical and Scientific has been a family manufacturing partner for surgical instrumentation and medical devices, tailoring products to customers’ exact specifications. Based in Saint Paul, the company combines skilled craftsmanship with prototype development, finishing and assembly, and production runs ranging from small to large quantities. Its work is supported by strict customer confidentiality and an emphasis on regulatory compliance in the U.S. and abroad.PITTSFORD, NY
Avalign Technologies, IncKnown for bringing advanced medical-device manufacturing under one roof, Avalign Technologies supports orthopedic and other surgical-device companies from early design through production. Its Akron operation, Avalign Additive, grew from Slice Manufacturing Studios and occupies a 35,000-square-foot facility with a 22-person team. The broader company also operates manufacturing facilities in Germany and the United States and holds ISO 13485 certifications across several units.AKRON, OH
Axial MedicalJust outside Philadelphia, Axial Medical is a dedicated contract manufacturer that takes medical implants from prototype through production, with a particular focus on complex spine and orthopedic work. Its 40,000-square-foot Warminster headquarters, custom-built in 2014, houses more than 60 five-axis CNC machines alongside in-house finishing and metrology capabilities. Axial Medical is ISO 13485:2016 certified and FDA registered.WARMINSTER, PA