Agile for Medical Software:Better Results Faster in FDA  Regulated Environments             April 26, 2011           Micha...
• FDA is not the bad guy• FDA is not your customer• FDA is about ensuring safety and sustaining  life• Protects us from fo...
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...
Formal Process: The ResponseDear Formal Group,Great!You have defined your 11 Formalsteps now go forth and DO IT!           ...
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 le...
Formal Process: The ResponseDear Casual Collab,Great!You have defined your 7 Casualsteps now go forth and DO IT!           ...
ConclusionVery Formal                Very Casual                            Agile for Medical Software
Conclusion              Mash-up ofVery Formal                Very Casual                Both?                            A...
So don’t cut   corners and change your  process once you define itjust to save time and money!                      Agile f...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 01                    Step: 01                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 02                    Step: 02                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 03                    Step: 03                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 04                    Step: 04                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 05                    Step: 05                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 06                    Step: 06                          ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 07                Step: 07 - done                       ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 08                Step: 07 - Done                       ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 09                Step: 07 - Done!                      ...
Formal Process: Steps 1-11   Formal Process: 7 steps        Step: 10               Step: 07 - DONE                        ...
Formal Process: Steps 1-11   Formal Process: 7 steps   Step: 11 - DONE!            Step: 07 - DONE!                       ...
Formal Process: Steps 1-11   Formal Process: 7 steps   Step: 11 - DONE!            Step: 07 - DONE!                       ...
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 t...
FDA’s Role             Agile for Medical Software
• Medical device:       • Act mechanically or chemically• Pharmaceuticals:       • Uses the body’s metabolism             ...
• Medical device:       • Act mechanically or chemically• Pharmaceuticals:       • Uses the body’s metabolism             ...
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• Of...
Class II• General commercial quality control and  manufacturing practices alone may not be  sufficient to assure safety• Ex...
Class III• General commercial quality control and  manufacturing practices alone may not be  sufficient to assure safety• P...
Agile 101            Agile for Medical Software
• 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 col...
Agile Myths•   Agile is Working        •   Simply iterations    Without Documentation•   One specific    methodology       ...
•   Focus on activities that add value•   Collaborative•   Transparent•   Adaptable•   Simple•   User engagement•   Contin...
What to expect             Agile for Medical Software
•   FDA isn’t necessarily interested in waterfall•   Longer Project Inception due to documentation    of project history• ...
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                                          U...
Know Your Product -> Process -> Production  User Needs  + Business     Goals                            User Stories      ...
Know Your Product -> Process -> Production  SoftwareRequirementsSpecification                          Software Verification...
Know Your Product -> Process -> Production               !"                                          Test Cases  Fully Aut...
Know Your Product -> Process -> Production               Design History                File (DHF)                         ...
Know Your Product -> Process -> Production   User Needs   + Business      Goals                                          U...
After Release                Agile for Medical Software
• Change management strategy• 501K Updates• Bugs/defects• Labeling                               Agile for Medical Software
Questions?             Agile for Medical Software
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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 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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  • Transcript of "Agile Development for FDA Regulated Medical Software"

    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 Design History File (DHF) 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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