Medical Device Prototyping and Pilot Batches

Medical Device Prototyping and Pilot Batches

Prototypes that answer the riskiest question first, then look and behave like the production device. Digital prototypes and simulation, 3D-printed and machined parts, board spins, test stands and robotic test rigs, functional prototypes and a golden sample: the pre-certification unit that fully meets the functional requirements and becomes the reference for production.

We build pilot and clinical batches of up to 200 units in house, supply devices and software for preclinical and clinical studies, and support the study. Examples: 100 pairs of a load-sensing rehabilitation crutch; a 100-unit batch of a glucose monitoring patch that's now in clinical trials; a post-operative cold therapy device taken from concept to clinical trials in 12 months. On one blood-handling device we compared 10 digital prototypes and built the best three.

ISO 13485:2016 certified quality system covering design, development, production and distribution of medical device prototypes; $125 per hour.