When is a Design Input Good Enough?

Q

QACen

#1
Hello,

Can anyone share with me on how you determine if a design input is good enough (this is for a medical device)?

More specifically, how much information do you document as a design input without restricting the design process? Is there a set of criteria that anyone uses when they review the design inputs?

NOTE: I'm not asking what goes into a design input document.

Thanks!
QACen
 
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yodon

Staff member
Super Moderator
#2
Tough one to answer concisely - pretty big topic.

As with any design artifact (or group), you need to consider completeness, consistency, correctness, cohesive, verifiable, etc. Any review should include all stakeholders to ensure that all the aspects are considered. For example, someone from marketing should be able to confirm that the DI will meet the user's needs / desires. Someone from test will be able to determine if the DI is verifiable. Someone from Quality could assess consistency & cohesion. Representatives from the subsystems that elaborate the DI can look at correctness and completeness.
 

harry

Super Moderator
#3
Posting from my experience in design of non medical devices, one has to understand that design is a dynamic process undergoing constant review and during which some new inputs or requirements may come in and at times creating a need for an entirely new approach thus obsoleting the earlier work done.

I believe it is the same for medical devices and I agree with Yodon that this is a tough one to answer concisely.
 

somashekar

Staff member
Super Moderator
#4
When is a Design Input Good Enough?
Well, the proof of the pudding is in the eating.
When your realized product does not come back quickly for changes, and if it comes, you do not say ... Ouch, this must have been considered ...
then the design inputs have been good enough
 

John Broomfield

Staff member
Super Moderator
#5
Design is iterative.

The completeness of the design inputs is improved continually by the design process itself including the cycles of multidisciplinary reviews and the repeated analysis of potential (and actual) failure modes.

Then having verified conformity of the design (to the potentially incomplete inputs) the design process validates the design with prototypes or trials operating under specified service conditions.

Flying machines were invented this way. After competing the assessments and treatments of risk, someone in authority must be convinced enough to make the decision to fly.

...but design is never complete.
 
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