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Agile Development for FDA Regulated Medical Software
 

Agile Development for FDA Regulated Medical Software

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The FDA regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical ...

The FDA regulates software for medical devices, and may in future regulate mobile medical software as well. Can you speed up time to market with Agile development in an FDA regulated medical environment?

Pathfinder Software shares their experience developing software using lean ux and agile software development best practices for medical devices and mobile medical software.

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Agile Development for FDA Regulated Medical Software Agile Development for FDA Regulated Medical Software Presentation Transcript

  • 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 Agile for Medical Software
  • Its not what you wear... Its how you wear it Agile for Medical Software
  • Very Formal Agile for Medical Software
  • Very Formal Very Casual Agile for Medical Software
  • Formal Process: Inception Agile for Medical Software
  • Formal Process: Step 01 Agile for Medical Software
  • Formal Process: Step 02 Agile for Medical Software
  • Formal Process: Step 03 Agile for Medical Software
  • Formal Process: Step 04 Agile for Medical Software
  • Formal Process: Step 05 Agile for Medical Software
  • Formal Process: Step 06 Agile for Medical Software
  • Formal Process: Step 07 Agile for Medical Software
  • Formal Process: Step 08 Agile for Medical Software
  • Formal Process: Step 09 Agile for Medical Software
  • Formal Process: Step 10 Agile for Medical Software
  • Formal Process: Step 11 - Done Agile for Medical Software
  • Formal Process: Final VerdictDear FDA, We will perform these ‘11’ Formal stepseach and everyday to ensure that nothing is left to chance. -The Formal Group Agile for Medical Software
  • Formal Process: The ResponseDear Formal Group,Great!You have defined your 11 Formalsteps now go forth and DO IT! -FDA Agile for Medical Software
  • Casual Process: Inception Agile for Medical Software
  • Casual Process: Step 01 Agile for Medical Software
  • Casual Process: Step 02 Agile for Medical Software
  • Casual Process: Step 03 Agile for Medical Software
  • Casual Process: Step 04 Agile for Medical Software
  • Casual Process: Step 05 Agile for Medical Software
  • Casual Process: Step 06 Agile for Medical Software
  • Casual Process: Step 07 - Done Agile for Medical Software
  • Casual Process: Final VerdictDear FDA,We will perform these ‘7’ Casual steps eachand everyday to ensure that nothing is left to chance. -Casual Collab Agile for Medical Software
  • Formal Process: The ResponseDear Casual Collab,Great!You have defined your 7 Casualsteps now go forth and DO IT! -FDA Agile for Medical Software
  • ConclusionVery Formal Very Casual Agile for Medical Software
  • Conclusion Mash-up ofVery Formal Very Casual Both? Agile for Medical Software
  • So don’t cut corners and change your process once you define itjust to save time and money! Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 01 Step: 01 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 02 Step: 02 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 03 Step: 03 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 04 Step: 04 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 05 Step: 05 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 06 Step: 06 Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 07 Step: 07 - done Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 08 Step: 07 - Done Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 09 Step: 07 - Done! Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 10 Step: 07 - DONE Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 11 - DONE! Step: 07 - DONE! Agile for Medical Software
  • Formal Process: Steps 1-11 Formal Process: 7 steps Step: 11 - DONE! Step: 07 - DONE! Agile for Medical Software
  • In the end it’s not the product but theprocess that is the concern! Agile for Medical Software
  • • 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 Agile for Medical Software
  • FDA’s Role Agile for Medical Software
  • • Medical device: • Act mechanically or chemically• Pharmaceuticals: • Uses the body’s metabolism Agile for Medical Software
  • • Medical device: • Act mechanically or chemically• Pharmaceuticals: • Uses the body’s metabolism Agile for Medical Software
  • Classes of FDA Devices Agile for Medical Software
  • 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 Agile for Medical Software
  • 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 Agile for Medical Software
  • 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 for Medical Software
  • Agile 101 Agile for Medical Software
  • • In general agile is not new. It is collection of good software practices evolved over years of experience. Agile for Medical Software
  • • 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 for Medical Software
  • Agile Myths• Agile is Working • Simply iterations Without Documentation• One specific methodology • “Glorified hacking”• A “One Size Fits All” • Working without a plan cookbook Agile for Medical Software
  • • Focus on activities that add value• Collaborative• Transparent• Adaptable• Simple• User engagement• Continuous Improvement Agile for Medical Software
  • What to expect Agile for Medical Software
  • • 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 Agile for Medical Software
  • Audit: Plan on it Agile for Medical Software
  • What we know works (Pathfinder’s Process) Agile for Medical Software
  • 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 Agile for Medical Software
  • Know Your Product -> Process -> Production User Needs + Business Goals User Stories (Maser Story List) Software Project Schedule SoftwareDevelopment Checklist Agile for Medical Software
  • Know Your Product -> Process -> Production SoftwareRequirementsSpecification Software Verification & Validation Plan (code review, unit testing, functional testing) SoftwareArchitecture Document Inception Agile for Medical Software
  • Know Your Product -> Process -> Production !" Test Cases Fully Authored User Stories Dev. Code (code review) SVV Protocol Testing Final SVV Test Report SVV Test Report Development Agile for Medical Software
  • Know Your Product -> Process -> Production Design History File (DHF) Agile for Medical Software
  • 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 Agile for Medical Software
  • After Release Agile for Medical Software
  • • Change management strategy• 501K Updates• Bugs/defects• Labeling Agile for Medical Software
  • Questions? Agile for Medical Software