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Agile Software Development and the FDA

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Presentation by Pathfinder Software to the Agile Project Management Group and Health 2.0 group on how to get the benefits of agile development in an FDA regulated environment, based on Pathfinder's experience developing software for medical devices

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Agile Software Development and the FDA

  1. 1. Agile for Medical Software:Better Results Faster in FDA Regulated Environments April 26, 2011 Michael Walkden Tavi Scandiff-Pirvu Agile for Medical Software
  2. 2. • 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
  3. 3. Its not what you wear... Its how you wear it Agile for Medical Software
  4. 4. Very Formal Agile for Medical Software
  5. 5. Very Formal Very Casual Agile for Medical Software
  6. 6. Formal Process: Inception Agile for Medical Software
  7. 7. Formal Process: Step 01 Agile for Medical Software
  8. 8. Formal Process: Step 02 Agile for Medical Software
  9. 9. Formal Process: Step 03 Agile for Medical Software
  10. 10. Formal Process: Step 04 Agile for Medical Software
  11. 11. Formal Process: Step 05 Agile for Medical Software
  12. 12. Formal Process: Step 06 Agile for Medical Software
  13. 13. Formal Process: Step 07 Agile for Medical Software
  14. 14. Formal Process: Step 08 Agile for Medical Software
  15. 15. Formal Process: Step 09 Agile for Medical Software
  16. 16. Formal Process: Step 10 Agile for Medical Software
  17. 17. Formal Process: Step 11 - Done Agile for Medical Software
  18. 18. 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
  19. 19. Formal Process: The ResponseDear Formal Group,Great!You have defined your 11 Formalsteps now go forth and DO IT! -FDA Agile for Medical Software
  20. 20. Casual Process: Inception Agile for Medical Software
  21. 21. Casual Process: Step 01 Agile for Medical Software
  22. 22. Casual Process: Step 02 Agile for Medical Software
  23. 23. Casual Process: Step 03 Agile for Medical Software
  24. 24. Casual Process: Step 04 Agile for Medical Software
  25. 25. Casual Process: Step 05 Agile for Medical Software
  26. 26. Casual Process: Step 06 Agile for Medical Software
  27. 27. Casual Process: Step 07 - Done Agile for Medical Software
  28. 28. 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
  29. 29. Formal Process: The ResponseDear Casual Collab,Great!You have defined your 7 Casualsteps now go forth and DO IT! -FDA Agile for Medical Software
  30. 30. ConclusionVery Formal Very Casual Agile for Medical Software
  31. 31. Conclusion Mash-up ofVery Formal Very Casual Both? Agile for Medical Software
  32. 32. So don’t cut corners and change your process once you define itjust to save time and money! Agile for Medical Software
  33. 33. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 01 Step: 01 Agile for Medical Software
  34. 34. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 02 Step: 02 Agile for Medical Software
  35. 35. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 03 Step: 03 Agile for Medical Software
  36. 36. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 04 Step: 04 Agile for Medical Software
  37. 37. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 05 Step: 05 Agile for Medical Software
  38. 38. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 06 Step: 06 Agile for Medical Software
  39. 39. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 07 Step: 07 - done Agile for Medical Software
  40. 40. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 08 Step: 07 - Done Agile for Medical Software
  41. 41. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 09 Step: 07 - Done! Agile for Medical Software
  42. 42. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 10 Step: 07 - DONE Agile for Medical Software
  43. 43. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 11 - DONE! Step: 07 - DONE! Agile for Medical Software
  44. 44. Formal Process: Steps 1-11 Formal Process: 7 steps Step: 11 - DONE! Step: 07 - DONE! Agile for Medical Software
  45. 45. In the end it’s not the product but theprocess that is the concern! Agile for Medical Software
  46. 46. • 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
  47. 47. FDA’s Role Agile for Medical Software
  48. 48. • Medical device: • Act mechanically or chemically• Pharmaceuticals: • Uses the body’s metabolism Agile for Medical Software
  49. 49. • Medical device: • Act mechanically or chemically• Pharmaceuticals: • Uses the body’s metabolism Agile for Medical Software
  50. 50. Classes of FDA Devices Agile for Medical Software
  51. 51. 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
  52. 52. 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
  53. 53. 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
  54. 54. Agile 101 Agile for Medical Software
  55. 55. • In general agile is not new. It is collection of good software practices evolved over years of experience. Agile for Medical Software
  56. 56. • 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
  57. 57. 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
  58. 58. • Focus on activities that add value• Collaborative• Transparent• Adaptable• Simple• User engagement• Continuous Improvement Agile for Medical Software
  59. 59. What to expect Agile for Medical Software
  60. 60. • 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
  61. 61. Audit: Plan on it Agile for Medical Software
  62. 62. What we know works (Pathfinder’s Process) Agile for Medical Software
  63. 63. 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
  64. 64. Know Your Product -> Process -> Production User Needs + Business Goals User Stories (Maser Story List) Software Project Schedule SoftwareDevelopment Checklist Agile for Medical Software
  65. 65. Know Your Product -> Process -> Production SoftwareRequirementsSpecification Software Verification & Validation Plan (code review, unit testing, functional testing) SoftwareArchitecture Document Inception Agile for Medical Software
  66. 66. 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
  67. 67. Know Your Product -> Process -> Production Agile for Medical Software
  68. 68. 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
  69. 69. After Release Agile for Medical Software
  70. 70. • Change management strategy• 501K Updates• Bugs/defects• Labeling Agile for Medical Software
  71. 71. Questions? Agile for Medical Software

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