MDDI Article: De-Risk Your Medical Device Project with Targeted Prototypes

Non-form-factor test bench to develop and refine key elements of optics and electronics. (Product Creation Studio)

Effective prototyping can significantly reduce time to market and overall development cost.

It is a struggle, even for a seasoned product development leadership team, to make the appropriate trade-off up front: pre-product de-risking work versus the often-critical need to get the product to market quickly. Targeted prototyping may seem like it adds time to the overall development schedule; however, if the non-vetted portion of the design is later found to have negative impacts on the development schedule downstream, the cost becomes much greater.

Mike Kahn — Product Creation Studio’s Director of Firmware and Electrical Engineering —wrote an article for MDDI (published June 24, 2021) about leveraging prototypes and mock-ups early on in the device design process to minimize development costs and schedule, ensure product performance, and to make sure all user needs are met.

Article excerpt:

A prototype can efficiently answer key questions about a new design, as long as the team considers the appropriate type of prototype and fidelity for the given development cycle. This can significantly reduce time to market and overall development cost. For example, pre-screen testing on an early circuit board prototype that may not be constructed with final materials or processes can streamline the regulatory submittal/approval process later. If the prototype is good enough to assess compliance with relevant regulatory requirements, the data gathered will be hugely valuable in the subsequent design updates.

Read the full article to find out more about how prototyping at various inflection points will help you save time and ensure success later on in development.