Agile Development for FDA Regulated Medical Software

Agile for Medical Software:
Better Results Faster in FDA
Regulated Environments
April 26, 2011
Michael Walkden
Tavi Scandiff-Pirvu

Agile for Medical Software

• FDA is not the bad guy
• FDA is not your customer
• FDA is about ensuring safety and sustaining
life

• Protects us from focusing only on proﬁts


Its not what you wear...
Its how you wear it


Very Formal


Very Formal Very Casual


Formal Process: Inception


Formal Process: Step 01


Formal Process: Step 11 - Done


Formal Process: Final Verdict

Dear FDA,

We will perform these ‘11’ Formal steps
each and everyday to ensure that nothing is
left to chance.

-The Formal Group


Formal Process: The Response

Dear Formal Group,

Great!
You have deﬁned your 11 Formal
steps now go forth and DO IT!

-FDA


Casual Process: Inception


Casual Process: Step 01


Casual Process: Step 07 - Done


Casual Process: Final Verdict

Dear FDA,

We will perform these ‘7’ Casual steps each
and everyday to ensure that nothing is left
to chance.

-Casual Collab


Formal Process: The Response

Dear Casual Collab,

Great!
You have deﬁned your 7 Casual
steps now go forth and DO IT!

-FDA


Conclusion


Conclusion
Mash-up of
Both?


So don’t cut
corners and change your
process once you deﬁne it
just to save time and money!


Formal Process: Steps 1-11 Formal Process: 7 steps
Step: 01 Step: 01


Step: 02 Step: 02


Step: 03 Step: 03


Step: 04 Step: 04


Step: 05 Step: 05


Step: 06 Step: 06


Step: 07 Step: 07 - done


Step: 08 Step: 07 - Done


Step: 09 Step: 07 - Done!


Step: 10 Step: 07 - DONE


Step: 11 - DONE! Step: 07 - DONE!


In the end it’s
not the product but the
process that is the concern!


• FDA = Authoritative QA
• They are interested in sticking to a plan
• FDA lets you set rules to follow
• Need to know your team/client/
environment/product


FDA’s Role


• Medical device:
• Act mechanically or chemically
• Pharmaceuticals:
• Uses the body’s metabolism


Classes of FDA Devices


Class I
• Not intended to support life
• Least regulatory controls
• 74% of devices are exempt from pre-
market approval
• Often a few pages of documentation will
sufﬁce to pass pre-market approval


Class II
• General commercial quality control and
manufacturing practices alone may not be
sufﬁcient to assure safety
• Existing methods are in place to prove safety
• Project is characterized by signiﬁcant
documentation and process compared to a
“normal” Agile project


Class III

• General commercial quality control and
manufacturing practices alone may not be
sufﬁcient to assure safety
• Project is possibly R&D, but will still require
signiﬁcant documentation and process
compared to a “normal” Agile project


Agile 101


• In general agile is not new. It is collection
of good software practices evolved over
years of experience.


• Individuals and interactions over
processes and tools

• Working software over comprehensive
documentation

• Customer collaboration over
contract negotiation

• Responding to change over following
a plan


Agile Myths
• Agile is Working • Simply iterations
Without Documentation

• One speciﬁc
methodology • “Gloriﬁed hacking”

• A “One Size Fits All” • Working without a plan
cookbook


• Focus on activities that add value

• Collaborative

• Transparent

• Adaptable

• Simple

• User engagement

• Continuous Improvement


What to expect


• FDA isn’t necessarily interested in waterfall

• Longer Project Inception due to documentation
of project history

• Longer ramp-up time than a traditional Agile
project

• team must understand more process and
bigger picture early on

• Faster software delivery than a traditional FDA
project


Audit: Plan on it


What we know works
(Pathﬁnder’s Process)


Know Your Product -> Process -> Production
User Needs
+ Business
Goals
User Stories
(Maser Story
List)

Software
Software
Requirements
Project
Speciﬁcation
Schedule
Software Veriﬁcation &
Validation Plan
(code review, unit testing,
functional testing)
Software
Design History
Development Software File (DHF)
Checklist Architecture
Document
Inception

!"
Test Cases
Fully Authored
User Stories

Dev. Code
(code review)
SVV Protocol

Testing

Final SVV Test
Report
SVV Test
Report
Development



User Needs
+ Business
Goals
User Stories
(Maser Story
List)

Software
Project
Schedule

Software
Development
Checklist



Software
Requirements
Speciﬁcation
Software Veriﬁcation &
Validation Plan
(code review, unit testing,
functional testing)

Software
Architecture
Document
Inception



!"
Test Cases
Fully Authored
User Stories

Dev. Code
(code review)
SVV Protocol

Testing

Final SVV Test
Report
SVV Test
Report
Development



Design History
File (DHF)


After Release


• Change management strategy
• 501K Updates
• Bugs/defects
• Labeling


Questions?


Agile Development for FDA Regulated Medical Software

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