The new product introduction (NPI) process for medical devices is often arduous, with manufacturers needing to balance device specifications with the shifting requirements of the healthcare system and FDA. The NPI process involves evaluating not only the device, but also its design history, production parameters and the tools and methods that affect its performance in clinical use. Medical device manufacturers are subject to increasing regulatory scrutiny, ambiguity surrounding reimbursement levels and the need to produce substantially differentiated clinical offerings. The increasing pressure of this evolving environment has elevated the need to bring new devices to market as fast as possible (without sacrificing quality, compliance or design).
The turmoil of this changing environment has led a number of organizations to turn to the expertise of companies like Sanmina to ensure the successful introduction of a new medical device. Sanmina is a leading electronics contract manufacturer serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market; providing end-to-end design, manufacturing and logistics solutions, delivering superior quality and support.
I recently came across this case-study and wanted to share it as an example of how medical device NPI can be fast-tracked through the use of an EMS company like Sanmina. The case study outlines how Sanmina helped the device go from design to market in only 10 months.
