Agile Development And Medtech

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Lean and Agile development in agile environment

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Agile Development And Medtech

  1. 1. Agile software development for Medical Devices Robert.Ginsberg@qadvis.se Tel: +46 760 199 469
  2. 2. Short presentation of me Robert Ginsberg • 26 years in SW • 17 years in Medical Device SW • Participated in approx 20 audits, FDA, MDD, etc. • Co-author of IEC/ISO 62304 • Lean believer . Implemented agile software methods at two large medical companies
  3. 3. Short survey Who has worked hands on with agile methods for software? Enter Yes No
  4. 4. Lean
  5. 5. Time line 2005 Rup, XP FDD Lean Manufacturing Lean Development Lean Manufacturing Aha …. (Mary Poppendieck, Lean Development) 2003 2004 2005 2006 2007 2008 2002 2009
  6. 6. Why Lean – challenges to conquer? To meet challenges such as: • Ever increasing innovation pace • Managing increasing complexity • Being an attractive employer
  7. 7. Innovation, are we taking care of the knowledge? Explicit knowledge Conscious tacit knowledge Unconcious tacit knowledge individual team Higher value Source: Bartholomew, David. Sharing Knowledge. David Bartholomew Associates, 2005
  8. 8. ”The thorniest problem we have with software is its complexity” Mays, IBM 1994 Chaos Com-plexity Ambiguity Simplicity Com-plexity People Technology Require-ments
  9. 9. People, how do we attract the best?
  10. 10. Why Lean – gains • Higher quality and productivity • Better usage of the total knowledge in your organization • Higher level of innovation • Higher focus on value added activities • Feedback loops and focus on impediments
  11. 11. The Lean tool box for Sw Scrum TDD (& refacto-ring) Integration Centric Development Continuous integration Visuali-sation
  12. 12. Very short introduction to SCRUM
  13. 13. SCRUM Product owner Team Customer 24 h Daily SCRUM Sprint 30 days Product Backlog Increment of functionality Sprint Backlog
  14. 14. Scrum (7 ± 2)
  15. 15. TDD, Test Driven Development Think Write a test case Write code that pass the test Improve the structure
  16. 16. Continuous integration Code is • Delivered • Built • Tested • Deployed over and over again, thanks to tool support
  17. 17. Visualization
  18. 18. Integration Centric Development Focus on early integration to: • Mitigate risks • Keep focus on the product • Get early customer feedback
  19. 19. Going agile, impediments • Affects many key roles in the company and may cause uncertainty and ”turf war” • There is usually an outer framework, that the agile approach has to comply with • Difficult to establish the product owner role • Hard to get requirements, developers and testers to go in the same pace • Sets high expectations on people
  20. 20. Authorities, what do they say? • Wants evidence that we: – Have done our best to make a safe product, ”Risk management” – That we are In-the-state-of-control • Manufacturer decides on processes and tools used • Must be easy and efficient to audit
  21. 21. Can standards help? • FDA has been deeply involved in development of both 14971 and 62304 • Those will affect and in the long run replace several of the current guidelines from FDA No standard can override QSR!
  22. 22. 62304 in relation to other standards ISO/IEC 60601-1-6 (Usability) ISO/IEC 60601-1 issue 3 (Safety & ess performance) ISO 14971 (Risk Management) ISO/IEC 62304 (SW Process Management)
  23. 23. 62304 content • Based on 60601-1-4 and AAMI 68 • Defines minimal levels for process activities • Aligned with FDA´s expectations and terminology • Takes different approach than 61508 – manufacturer best suited to choose best processes, techniques and tools Biggest home work for many companies: Integrated SW risk management
  24. 24. Integrated risk management • Focus of effort and money • Traceability risk measures – reqs – verification is a key issue • Enables efficient documentation • Tool support is critical when combined with agile approach, e.g. configuration management • Several agile techniques are recognized and encouraged by FDA, e.g. Test Driven Development, Design-by-contract, Misra, etc
  25. 25. Agile - hands on, where to start? • Cross functional teams • Visualization, sprints, backlog • Pair programming • Test Driven Development • Continuous Integration • Integration Centric Development
  26. 26. Going agile, recommendations • Start in small scale -> evaluate -> adapt • Create a good mix of Top down and Bottom up implementation • Visualize impediments and progress !!! • Invest in training • Communicate, communicate, communicate …
  27. 27. Summary Agile sw develop-ment 62304 Efficient and compliant Sw process
  28. 28. Qadvis contact details Qadvis is a consultant company for Quality and Global Regulatory for Medical Devices. Contact: www.qadvis.com info@qadvis.com Tel +46 8 601 01 05

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