Development of a Medical Product – Transition to Production

We keep in mind throughout the development of a medical product process that the first rule of design for any medical device, like the physician’s creed, is to “first, do no harm”. At critical design review points along the way we perform detailed analysis of the sequence of usability for this device, and identification of any opportunities for misuse or failure, for example, with handheld surgical tools a set of safety interlocks and inspection procedures can be designed and specified that are required to assure the device is always safe in the user’s hands, and safe for the patient.

We employ a convergent medical product development process. And as we move the design toward production Bresslergroup’s engineers and designers bring a broad and deep experience base in design for an extremely wide range of manufacturing techniques, including rapid prototyping, casting, NC machining, injection molding, blow and rotomolding, pressure forming, metal injection molding, powder metal, stamping and sheet metal forming.

Bresslergroup stays involved to assure success at every step of the way in bringing the development of a medical product to market, including first article inspection and vendor management, both domestic and overseas. Bresslergroup team members remain active through final documentation and through production. This interaction ensures that design intent is maintained even as tradeoffs are made when selecting final components, tweaking the final part design for maximum production efficiency during the development of your medical product.


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