Medical Device Development

Bring safe, usable Class I and Class II medical devices to market with a development partner that pairs user-centered design with disciplined engineering and documentation. We develop handheld and wearable devices, diagnostic and point-of-care equipment, clinical and laboratory equipment, and home healthcare products. Medical products succeed when they solve a real clinical problem in a way users can adopt. Our work starts with the use environment, the clinicians, caregivers, and patients in it, and the workflows your device has to fit into. Human factors thinking runs through every iteration, from early mockups to formative evaluations, so usability findings shape the design instead of arriving as surprises late in the program. Our engineers integrate mechanical, electrical, and embedded systems with an eye on reliability, cleanability, and manufacturability. We work within your quality system to produce the requirements, risk analysis inputs, drawings, and test documentation your regulatory pathway depends on, keeping the design history file in step with the design. When the design is ready, we prepare specifications and supplier documentation and support transfer to regulated manufacturing, so your device moves from prototype to production with fewer surprises.