Boyd Allin

Staged Medical Device Development

Staged Medical Device Design "the handoff"Developing a complex medical device spans a significant period of time and a significant expertise spectrum. Early ideation and technology development through transfer to volume manufacturing covers a tremendous range of skill sets. Staged product development as employed by StarFish has some unique benefits for dealing with the changing skill sets required throughout the development cycle. Staged development is essentially the partitioning of the development into finite work efforts.

A non-exhaustive list includes:

  • product definition”,
  • User interface/experience
  • alpha” design
  • beta development”
  • Pilot production and transfer to full manufacturing

Product definition is broadly the identification of high risk areas and then risk reduction by way of “bench top” technology proof of concept experiments and initial mechanism proof of concept prototypes. A sub stage can include aesthetic industrial design and brand language. User interface/experience design is receiving significant attention and emphasis from the FDA with edition 3 of IEC 60601. Alpha prototype is the first attempt at a reasonably complete system, albeit usually without complete aesthetics. Beta development is the first true embodiment of the design utilizing high volume processes and materials. Pilot production and transfer to full manufacturing is a multi-staged set of work that takes a Beta prototype through DFMA reviews and generally moves the design to high volume production readiness.

Staged development prevents moving to the next stage without team and client agreement that the risks have been appropriately addressed and the stage completion criteria are satisfactorily met to warrant progression.

I have found that this staged approach has a beneficial repercussion perhaps not anticipated when the process was initiated. Stage transitions give rise to natural and logical places to change the team content. Generally most designers naturally have an area of expertise and interest meshing well somewhere in the design cycle but not spanning the entire cycle. Some designers and engineers are adept at ideation, architecture and system design while others excel at mechanism design and plastics design. Still others are most efficient at the detail oriented aspects associated with the transfer to manufacturing. At stage transitions, early developers can be pulled into other projects allowing more appropriate and effective staff to replace them as the development progresses. It is critical to have continuity in the development; the project manager is the source of this continuity and they should be diligent about including the early team members in critical gate reviews, brainstorms and stage transition meetings so that knowledge is not left behind. The transition between team members is often most effective with some overlap to help facilitate knowledge transfer.

I would advocate that product development companies identify the areas of interest and expertise of their designers and when possible, move them onto projects at the appropriate project stage to maximize the utilization of those skill sets. Keeping a designer engaged in the stages of the development cycle they are strongest in may result in increased efficacy, higher employee satisfaction and superior products.


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