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Medical Device Software Development - A Perspective from a Lean Manufacturing Plant

  • Conference paper
Software Process Improvement and Capability Determination (SPICE 2011)

Part of the book series: Communications in Computer and Information Science ((CCIS,volume 155))

Abstract

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

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References

  1. EU, Council Directive 93/42/EEC of the European Parliment and of the Council, Concerning Medical Devices, E. Council, Editor, Official Journal of the European Union (1993)

    Google Scholar 

  2. EU, Directive 2007/47/EC of the European Parliment and of the Council. Official Journal of the European Union (2007)

    Google Scholar 

  3. FDA. U.S. Food and Drugs Administration, http://www.fda.gov (accessed March 10, 2011)

  4. RTCA, DO-178B, Software Considerations in Airborne Systems and Equipment Certification. RTCA (Radio Technical Commission for Aeronautics) (January 1992)

    Google Scholar 

  5. FDA, Code of Federal Regulations 21 CFR Part 820, U.F.a.D. Administration, Editor (April 2009)

    Google Scholar 

  6. CDRH, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA (2002)

    Google Scholar 

  7. IEEE, IEEE Reliability Society - Annual Technical Report (2008)

    Google Scholar 

  8. ANSI/AAMI/IEC, 62304:2006. Medical Device Software-Software life cycle processes, Association for the Advancement of Medical Instrumentation, p. 67 (2006)

    Google Scholar 

  9. Spence, J.W.:There has to be a better way! In: AGILE Conference 2005. Inst. of Elec. and Elec. Eng. Computer Society, Denver, CO, United states, July 24–25 (2005)

    Google Scholar 

  10. Bosch, T.: Medical Device Software Development—Going Agile, http://www.mddionline.com/article/medical-device-software-developmentmdashgoing-agile (accessed March 10, 2011)

  11. Womack, J.P., Jones, D.T., Roos, D.: The Machine That Changed The World: How lean production revolutionized the global car wars. Simon & Schuster (2007)

    Google Scholar 

  12. Liker, J.: The Toyota Way 2003. McGraw-Hill, New York (2003)

    MATH  Google Scholar 

  13. Womack, J.P., Jones, D.T.: Lean Thinking: Banish Waste and Create Wealth in Your Corporation. Simon & Schuster (1996)

    Google Scholar 

  14. Cockburn, A.: Agile Software Development. In: Highsmith, C.a. (ed.) The Agile Software Development Series (2002)

    Google Scholar 

  15. Highsmith, J.: Agile Software Development Ecosystems. Addison-Wesley, Reading (2002)

    Google Scholar 

  16. Beck, K.: Test Driven Development: By Example. Addison-Wesley Professional, Reading (2002)

    Google Scholar 

  17. Poppendieck, M., Poppendieck, T.: Lean Software Development: An Agile Toolkit. Addison-Wesley Professional, Reading (2003)

    Google Scholar 

  18. Hibbs, C., Jewett, S.C., Sullivan, M.: The Art of Lean Software Development. O’Reilly Media, Sebastopol (2009)

    Google Scholar 

  19. AgileAlliance. Manifesto for Agile Software Development, Available from: 10, 20, http://www.agilemanifesto.org/ (accessed March 2011)

  20. Rottier, P.A., Rodrigues, V.: Agile Development in a Medical Device Company. In: Agile, 2008. AGILE (2008)

    Google Scholar 

  21. Lin, W., Fan, X.: Software development practice for FDA-compliant medical devices. In: 2009 International Joint Conference on Computational Sciences and Optimization, CSO 2009. IEEE Computer Society, Sanya (2009)

    Google Scholar 

  22. Cawley, O., Wang, X., Richardson, I.: Lean/Agile Software Development Methodologies in Regulated Environments – State of the Art. In: Proceedings of Lean Enterprise Software and Systems, Helsinki, Finland, October 2010, pp. 31–36. Springer, Heidelberg (2010)

    Chapter  Google Scholar 

  23. Yin, R.K.: Case Study Research: Design and Methods Paperback edn. In: Applied Social Research Methods, Sage Publications, Inc., Thousand Oaks (2009)

    Google Scholar 

  24. Miles, M.B., Huberman, M.A.: Qualitative Data Analysis: An Expanded Sourcebook, 2nd edn. Sage Publications, Inc., Thousand Oaks (1994)

    Google Scholar 

  25. Strauss, A., Corbin, J.: Basics of qualitative research: grounded theory procedures and techniques. Sage Publications, Thousand Oaks (1990)

    Google Scholar 

  26. State Economic Impact of the Medical Technology Industry. The Lewin Group, Inc, http://www.lifechanginginnovation.org/ (accessed March 10 (2010)

  27. Weyrauch, K.: What are we arguing about? A framework for defining agile in our organization. In: Agile Conference (2006)

    Google Scholar 

  28. CMMI, Capability Maturity Model Integration V1.3, http://www.sei.cmu.edu/cmmi (Accessed March 10, 2011)

  29. ISO/IEC 15504-5: 2006. Information Technology – Process Assessment – Part 5: An exemplar Process assessment model (2006)

    Google Scholar 

  30. Conradi, H., Fuggetta, A.: Improving software process improvement. In: Software, vol. 19(4), pp. 92–99. IEEE, Los Alamitos (2002)

    Google Scholar 

  31. Fowler, M.: Refactoring-Improving The Design Of Existing Code.Hardback edn. In: Booch, Jacobson, Rumbaugh (eds.) Object Technology Series, Addison-Wesley, Reading (2000)

    Google Scholar 

  32. Chisholm, R.A.: Agile Software Development Methods and DO-178B Certification. In: Division of Graduate Studies and Research, Royal Military College of Canada (2007)

    Google Scholar 

  33. Ronkainen, J., Abrahamsson, P.: Software development under stringent hardware constraints: do agile methods have a chance? In: Marchesi, M., Succi, G. (eds.) XP 2003. LNCS, vol. 2675. Springer, Heidelberg (2003)

    Chapter  Google Scholar 

  34. Herbsleb, J.D., Moitra, D.: Global Software Development. IEEE Software 18(2), 16–20 (2001)

    Article  Google Scholar 

  35. Kettunen, P., Laanti, M.: How to steer an embedded software project: tactics for selecting the software process model. In: Information and Software Technology, vol. 47, pp. 587–608. IEEE, Los Alamitos (2005)

    Google Scholar 

  36. Srinivasan, J., Dobrin, R., Lundqvist, K.: State of the Art in Using Agile Methods for Embedded Systems Development. In: 33rd Annual IEEE International Computer Software and Applications Conference, COMPSAC 2009 (2009)

    Google Scholar 

  37. Sidky, A., Arthur, J.: Determining the Applicability of Agile Practices to Mission and Life-Critical Systems. In: Proceedings of the 31st IEEE Software Engineering Workshop. IEEE Computer Society Press, Los Alamitos (2007)

    Google Scholar 

  38. Van Schooenderwoert, N., Morsicato, R.: Taming the embedded tiger - Agile test techniques for embedded software. In: Proceedings of the Agile Development Conference, DCA, Lake City, UT, June 22 - June 26, S 2004. IEEE Computer Society Press, Salt Lake City (2004)

    Google Scholar 

  39. Mueller, G., Borzuchowski, J.: Extreme embedded a report from the front line. In: OOPSLA 2002, Practitioners Reports. ACM, Seattle (2002)

    Google Scholar 

  40. Expert-Group-on-Future-Skills-Needs, Future Skills Needs of the Irish Medical Devices Sector (2008), http://www.skillsireland.ie/publication (accessed March 10, 2011)

  41. High Confidence Software and Systems Coordinating Group, High-Confidence Medical Devices: Cyber-Physical Systems for 21st Century Health Care - A Research and Development Needs Report. The Federal Networking and Information Technology Research and Development (NITRD) Program (2009)

    Google Scholar 

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Author information

Authors and Affiliations

  1. Lero - the Irish Software Engineering Research Centre, University of Limerick, Ireland

    Oisín Cawley, Ita Richardson & Xiaofeng Wang

Authors
  1. Oisín Cawley
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  2. Ita Richardson
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  3. Xiaofeng Wang
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Editor information

Editors and Affiliations

  1. Lero, The Irish Software Engineering Research Centre, School of Computing, Dublin City University, Dublin, Ireland

    Rory V. O’Connor

  2. Software Quality Institute, Griffith University, Brisbane, Queensland, Australia

    Terry Rout

  3. Regulated Software Research Group, Lero, The Irish Software Engineering Research Centre, Dundalk Institute of Technology, Dundalk, Ireland

    Fergal McCaffery

  4. InterSPICE Ltd, 23 King Street, CB1 1AH, Cambridge, UK

    Alec Dorling

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© 2011 Springer-Verlag Berlin Heidelberg

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Cawley, O., Richardson, I., Wang, X. (2011). Medical Device Software Development - A Perspective from a Lean Manufacturing Plant. In: O’Connor, R.V., Rout, T., McCaffery, F., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2011. Communications in Computer and Information Science, vol 155. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-21233-8_8

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  • DOI: https://doi.org/10.1007/978-3-642-21233-8_8

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-21232-1

  • Online ISBN: 978-3-642-21233-8

  • eBook Packages: Computer ScienceComputer Science (R0)

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