Naming Convention

Milas

Registered
#1
I have a couple of questions in relation to the current NPI process which is being deployed by the Medical device Manufacturer I work for and would appreciate your comments/feedback on the below:

The naming convention for the 4 stage NPI process, which is currently deployed, is as follows: Conception -Trial Run - Pilot Run and Mass Production. Can I ask whether this naming convention for the phases is correct or, is there an alternative naming convention which is used to identify the different phases of the NPI process for medical devices ?

We also assists with the development of the customers products. Can I ask whether development comes under the conception phase or should it have its own different phase ? and the second part of this question is that regardless of whether it's included in the conception phase or has its own phase, can the overall process be still referred to NPI or does the inclusion of development mean its needs to be referred to as NPID or something else, i.e. product Realisation process ?
 
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yodon

Staff member
Super Moderator
#2
I'm not aware of anything that drives a specific NPI process / stages so it's up to your company as to how they name them.

Where development falls would be difficult to say without seeing what your company's definition of the stages are. I would expect, though, that development will be prior to your (presumably manufacturing) conception. The standards / regulations drive a "Design [and development] Transfer" activity prior to manufacturing and I would suppose that would be the kickoff point for your Conception stage. Product Realization (based on ISO 13485 - the US QSR has similar activities but doesn't use that specific term) spans design and development through production.
 
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