Pathway Medtech, LLC

Pathway Medtech is a US-based contract manufacturer and medical device development partner founded in 2013. The company specializes in end-to-end services for medtech innovators, including design and engineering, product development, regulatory strategy, and manufacturing. Pathway Medtech operates an FDA-registered and ISO 13485-certified facility capable of handling short-run, high-precision assembly through high-volume manufacturing. The firm positions itself as a single-source solution for companies at any stage of the product lifecycle—from concept and prototype development through preclinical, clinical, regulatory submission, and commercialization. Core competencies include mechanical engineering, concept development, functional and regulatory-focused design, quality assurance and quality control (leveraging cloud-based systems), and FDA/regulatory clearance strategy. Recent project examples include work with Cohero Health, exoskeleton devices, grasping forceps, and surgical bed clamps, indicating capabilities across orthopedic, surgical, and diagnostic device categories. The company was founded by experienced mechanical engineers and positions itself as accessible to small businesses, startups, and venture-backed firms navigating funding and regulatory pathways. All manufacturing, design, and regulatory services are performed in-house at their Santee, California facility.