Agile – Is it Suitable for Medical Device Software Development?

  • Fergal McCaffery
  • Kitija Trektere
  • Ozden Ozcan-Top
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 609)


Medical device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the medical device industry. However, there are some concerns with using agile for medical device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional medical device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the medical device software industry.


Medical device Agile software development Plan driven V–model 


  1. 1.
    FDA: Chapter I - Food and drug administration, department of health and human services subchapter H - Medical devices, Part 820 - Quality system regulation, USAGoogle Scholar
  2. 2.
    FDA, Guidance Document - Medical Devices and Radiation-Emitting Products. Center for Devices and Radiological Health (2015)Google Scholar
  3. 3.
    Royce, W.W.: Managing the development of large software systems. In: Proceedings of IEEE WESCON, vol. 26, pp. 1–9, August 1970Google Scholar
  4. 4.
    ExecutiveBrief, Which Life Cycle Is Best for Your Project? (2008).
  5. 5.
    Rook, P.: Controlling software projects. Softw. Eng. J. 1(1), 7–16 (1986)CrossRefGoogle Scholar
  6. 6.
    Casey, V., Mccaffery, F.: Med-Trace: Traceability Assessment Method for Medical Device Software Development, vol. 1, pp. 1–5 (2011)Google Scholar
  7. 7.
    Mc Hugh, M., Cawley, O., McCaffcry, F., Richardson, I., Wang, X.: An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles. In: Proceedings of 2013 5th International Workshop on Software Engineering in Health Care, SEHC 2013, pp. 12–19 (2013)Google Scholar
  8. 8.
    McCaffery, F., McFall, D., Donnelly, P., Wilkie, F.G., Sterritt, R.: A software process improvement lifecycle framework for the medical device industry. In: Proceedings of IEEE International Conference and Workshops on the Engineering of Computer-Based Systems (ECBS 2005), p. 8 (2005)Google Scholar
  9. 9.
    Rasmussen, R., Hughes, T., Jenks, J.R., Skach, J.: Adopting agile in an FDA regulated environment. In: Proceedings of Agile Conference, pp. 151–155 (2009)Google Scholar
  10. 10.
    Schrage, M.: Never go to a client meeting without a prototype. Softw. IEEE 21(2), 42–45 (2004). [software prototyping]CrossRefGoogle Scholar
  11. 11.
    AAMI, AAMI TIR 45:2012 - Guidance on the use of Agile practices in the development of medical device software (2012)Google Scholar
  12. 12.
    McHugh, M., McCaffery, F., Fitzgerald, B., Stol, K.-J., Casey, V., Coady, G.: Balancing agility and discipline in a medical device software organisation. In: Woronowicz, T., Rout, T., O’Connor, R.V., Dorling, A. (eds.) SPICE 2013. CCIS, vol. 349, pp. 199–210. Springer, Heidelberg (2013)CrossRefGoogle Scholar
  13. 13.
    Cawley, O., Wang, X., Richardson, I.: Lean/agile software development methodologies in regulated environments – state of the art. In: Abrahamsson, P., Oza, N. (eds.) LESS 2010. LNBIP, vol. 65, pp. 31–36. Springer, Heidelberg (2010)CrossRefGoogle Scholar
  14. 14.
    Principles behind the Agile Manifesto.
  15. 15.
    Gary, K., Enquobahrie, A., Ibanez, L., Cheng, P., Yaniv, Z., Cleary, K., Kokoori, S., Muffih, B., Heidenreich, J.: Agile methods for open source safety-critical software. Softw. Pract. Exp. 41(9), 945–962 (2011)CrossRefGoogle Scholar
  16. 16.
    Rottier, P.A., Rodrigues, V.: Agile development in a medical device company. In: Proceedings of Agile Conference, pp. 218–223 (2008)Google Scholar
  17. 17.
    Paulk, M.C.: On Empirical Research into Scrum Adoption. Prentice Hall, Upper Saddle River (2011)Google Scholar
  18. 18.
    Sumrell, M.: From waterfall to agile - how does a QA team transition? In: Proceedings of Agile Conference, pp. 291–295 (2007)Google Scholar
  19. 19.
    Deming, W.D.: Accessed 06 Jan 2016
  20. 20.
    Manjunath, K.N., Jagadeesh, J., Yogeesh, M.: Achieving quality product in a long term software product development in healthcare application using Lean and Agile principles: Software engineering and software development. In: Proceedings - 2013 IEEE International Multi Conference on Automation, Computing, Control, Communication and Compressed Sensing, iMac4s 2013, pp. 26–33 (2013)Google Scholar
  21. 21.
    Sutherland, J.: Future of scrum: Parallel pipelining of sprints in complex projects. In: Proceedings of Agile Confernce, pp. 90–99 (2005)Google Scholar
  22. 22.
    Fitzgerald, B., Stol, K.J., O’Sullivan, R., O’Brien, D.: Scaling agile methods to regulated environments: an industry case study. In: International Conference on Software Engineering Proceedings, pp. 863–872 (2013)Google Scholar
  23. 23.
    Spence, J.W.: There has to be a better way! In: Agile Development Conference Proceedings, pp. 272–278 (2005)Google Scholar
  24. 24.
    Upender, B.: Staying agile in government software projects. In: Proceedings of Agile Development Conference (ADC 2005), pp. 153–159 (2005)Google Scholar
  25. 25.
    McHugh, M., McCaffery, F., Casey, V.: Barriers to adopting agile practices when developing medical device software. In: Mas, A., Mesquida, A., Rout, T., O’Connor, R.V., Dorling, A. (eds.) SPICE 2012. CCIS, vol. 290, pp. 141–147. Springer, Heidelberg (2012)CrossRefGoogle Scholar
  26. 26.
    Heeager, L.T., Nielsen, P.A.: Agile software development and its compatibility with a document-driven approach? a case study. In: Australasian Conference on Information Systems Proceedings, pp. 205–214 (2009)Google Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Fergal McCaffery
    • 1
  • Kitija Trektere
    • 1
  • Ozden Ozcan-Top
    • 1
  1. 1.Regulated Software Research CentreDundalk Institute of TechnologyDundalkIreland

Personalised recommendations