Design Control & Rapid Prototyping - Medical Device Software

J

jahabba613

#1
Hi ... Extremely new to this forum but have found it very useful from the outside looking in.

I'm a relatively new employee that works for a very small 12 person company that produces a software only medical device. We are honestly playing catch up after our last audit so being the documentation guru I've been tasked on getting us up to speed and have been recently focusing my efforts on design control procedures and deliverables.

The design method that closely fits out development teams model is called rapid prototyping which in general runs thru the following steps:

1. Define high-level user needs
2. Develop a prototype
3. Prototype acceptance testing
3. Review the prototype with the stakeholder
4. Rework it if necessary

The prototype is not discarded, but rather becomes the unit that eventually goes into production after alpha and beta testing is complete. Being a small company this methodology works well and my intent is not to change how they do it but to assure they meet the design control requirements outlined in CFR part 820.

My issue is that, since the concept and design phases are kinda meshed into one when dealing with rapid prototyping, there is no finalized user requirements for us to do a traceability matrix design verification since it is technically still in a draft mode until the prototype is actually done too. Can anyone offer any advice on how to perform design verification for such a scenario?
 
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RA Guy

Involved In Discussions
#2
Hi jahabba613 and welcome:

Here are my suggestions:

A) document the requirements collected for step 1
B) capture (not necessarily in written docs) what you do in step 2 (this is your first design spec)
C) perform and capture results of whatever basic test you use before user demo (code reviews, units tests, etc.)
D) capture user feedback
E) up-issue user requirements per user feedback
F) repeat B through E until you get user approval
G) validate release candidate to final iteration resulting from the cycles of step E
Iterating your user/product requirements with each prototype cycle is possible and can be done in harmony with Part 820 and/or ISO13485. You obviously have to get user feedback to rework the device, per your steps 3 & 4 above, so you may just need a little more "formailty" in the process.

Sounds like you are describing some type of Agile/XP development cycle.

If that's the case, Dean @ Scaling of Software Agility has been running some blog posts on this over the last few months.

http://scalingsoftwareagility.wordpress.com/

SoftwareCPR has a decent slide deck on Agile development in medical device companies somewhere on their website:
http://www.softwarecpr.com/

A working group @ AAMI recently issued guidance on the use of Agile development for medical software:
http://www.aami.org/applications/search/details.cfm?WebID=P1541_D6110

Hope you find some of this helpful.

RA Guy
 
J

jahabba613

#3
RA Guy ... Thanks for validating (or is it verifying :) my thoughts on how this should work. You are correct in that we are running some hybrid of the Agile dev process so the additional information will be useful I'm sure.

You've been a great help already so thanks!

jahabba613
 

RA Guy

Involved In Discussions
#4
You're welcome.

I spent some time mapping an Agile devlopment cycle to FDA design controls. I found it to be a very interesting project, so if you have any other questions, I'm always happy to share.
 

sagai

Quite Involved in Discussions
#5
I advise to use IEC62304 as a de facto standard to comply with for your development cycle.
It is recognized by FDA, harmonized under MDD and actually contains the requirement for auditors in this subject.
I only would warn you not to mixture project management and software development lifecycle elements, keep them separated and your life will be easier.
br
Sz.
 
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