Agile Development And Medtech

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Lean and Agile development in agile environment

Lean and Agile development in agile environment

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  • 1. Agile software development for Medical Devices Robert.Ginsberg@qadvis.se Tel: +46 760 199 469
  • 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. Short survey Who has worked hands on with agile methods for software? Enter Yes No
  • 4. Lean
  • 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. Why Lean – challenges to conquer? To meet challenges such as: • Ever increasing innovation pace • Managing increasing complexity • Being an attractive employer
  • 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. ”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. People, how do we attract the best?
  • 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. The Lean tool box for Sw Scrum TDD (& refacto-ring) Integration Centric Development Continuous integration Visuali-sation
  • 12. Very short introduction to SCRUM
  • 13. SCRUM Product owner Team Customer 24 h Daily SCRUM Sprint 30 days Product Backlog Increment of functionality Sprint Backlog
  • 14. Scrum (7 ± 2)
  • 15. TDD, Test Driven Development Think Write a test case Write code that pass the test Improve the structure
  • 16. Continuous integration Code is • Delivered • Built • Tested • Deployed over and over again, thanks to tool support
  • 17. Visualization
  • 18. Integration Centric Development Focus on early integration to: • Mitigate risks • Keep focus on the product • Get early customer feedback
  • 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. 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. 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. 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. 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. 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. Agile - hands on, where to start? • Cross functional teams • Visualization, sprints, backlog • Pair programming • Test Driven Development • Continuous Integration • Integration Centric Development
  • 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. Summary Agile sw develop-ment 62304 Efficient and compliant Sw process
  • 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