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International Conference on Software Process Improvement and Capability Determination

SPICE 2016: Software Process Improvement and Capability Determination pp 409–416Cite as

Investigating the Suitability of Using Agile for Medical Embedded Software Development

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Part of the book series: Communications in Computer and Information Science ((CCIS,volume 609))

Abstract

Agile has been the subject of safety and critical domain in recent years. Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. Previous literature reviews discussed the challenges of bringing Agile practices to embedded software developments in general. This paper outlines the challenges and addresses the future work from medical embedded software development perspective.

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References

  1. Espicom: United States Medical Devices Report. http://www.espicom.com/usa-medical-device-market.html

  2. Jiang, Z., Mangharam, R.: High-confidence medical device software development. Found. Trends® Electron. Des. Autom. 9, 309–391 (2015)

    Article  Google Scholar 

  3. Munzner, R.F.: Entering the U.S. Medical Device Marlket, pp. 3548–3550 (2003)

    Google Scholar 

  4. AAMI: AAMI TIR45: Guidance on the use of AGILE practices in the development of medical device software (2012)

    Google Scholar 

  5. McHugh, M., McCaffery, F., Casey, V.: Changes to the international regulatory environment. J. Med. Devices 6, 021004 (2012)

    Article  Google Scholar 

  6. Greer, D., Hamon, Y.: Agile software Development. Softw. Pract. Exp. 41, 943–944 (2011)

    Article  Google Scholar 

  7. Beck, K.: Embracing change with extreme programming. Computer 32, 70–77 (1999). (Long. Beach. Calif)

    Article  Google Scholar 

  8. Palmer, S.R., Felsing, M.: A Practical Guide to Feature-Driven Development. Prentice Hall, Upper Saddle River (2001)

    Google Scholar 

  9. Royce, D.W.W.: Managing the development of large software systems. In: IEEE WESCON, pp. 1–9 (1970)

    Google Scholar 

  10. Munassar, N.M.A., Govardhan, A.: A comparison between five models of software engineering. Int. J. Comput. Sci. 7, 94–101 (2010)

    Google Scholar 

  11. Mccaffery, F., Lepmets, M., Clarke, P.: Medical device software as a subsystem of an overall medical device. In: Proceedings of First International Conference Fundamentals and Advances in Software Systems Integration (2015)

    Google Scholar 

  12. Woodward, M.V., Mosterman, P.J.: Challenges for embedded software development. In: 2007 50th Midwest Symposium on Circuits and Systems, pp. 630–633 (2007)

    Google Scholar 

  13. Ebert, C., Jones, C.: Embedded software: facts, figures, and future. Computer 42, 42–52 (2009). (Long. Beach. Calif)

    Article  Google Scholar 

  14. Fu, K.: Trustworthy medical device software. In: Institute of Medicine Workshop on Public Health Effectiveness of the FDA 510, vol. 510, pp. 1–20 (2011)

    Google Scholar 

  15. Hrgarek, N.: Certification and regulatory challenges in medical device software development. In: Proceedings of 2012 4th International Workshop on Software Engineering in Health Care, SEHC 2012, pp. 40–43 (2012)

    Google Scholar 

  16. Fitzgerald, B., Stol, K.J., O’Sullivan, R., O’Brien, D.: Scaling agile methods to regulated environments: an industry case study. In: Proceedings of International Conference on Software Engineering, pp. 863–872 (2013)

    Google Scholar 

  17. 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)

    Chapter  Google Scholar 

  18. Cordeiro, L., Barreto, R., Barcelos, R., Oliveira, M., Lucena, V., Maciel, P.: TXM: an agile HW/SWDevelopment methodology for building medical devices. ACM SIGSOFT Softw. Eng. Notes. 32, 4 (2007)

    Article  Google Scholar 

  19. Kaisti, M., Mujunen, T., Mäkilä, T., Rantala, V., Lehtonen, T.: Agile principles in the embedded system development. In: Cantone, G., Marchesi, M. (eds.) XP 2014. LNBIP, vol. 179, pp. 16–31. Springer, Heidelberg (2014)

    Google Scholar 

  20. Kaisti, M., Rantala, V., Mujunen, T., Hyrynsalmi, S., Könnölä, K., Mäkilä, T., Lehtonen, T.: Agile methods for embedded systems development - a literature review and a mapping study. EURASIP J. Embed. Syst. 2013, 15 (2013)

    Article  Google Scholar 

  21. Xie, M., Shen, M., Rong, G., Shao, D.: Empirical studies of embedded software development using agile methods: a systematic review. J. Inf. Syst. 2, 21–26 (2012)

    Google Scholar 

  22. Srinivasan, J., Dobrin, R., Lundqvist, K.: “State of the Art” in using agile methods for embedded systems development. In: 2009 33rd Annual IEEE International Computer Software and Application Conference, vol. 2, pp. 522–527 (2009)

    Google Scholar 

  23. Albuquerque, C.O., Antonino, P.O., Nakagawa, E.Y.: An investigation into agile methods in embedded systems development. In: Murgante, B., Gervasi, O., Misra, S., Nedjah, N., Rocha, A.M.A., Taniar, D., Apduhan, B.O. (eds.) ICCSA 2012, Part III. LNCS, vol. 7335, pp. 576–591. Springer, Heidelberg (2012)

    Chapter  Google Scholar 

  24. Jonsson, H., Larsson, S., Punnekkat, S.: Agile practices in regulated railway software development. In: Proceedings of - 23rd IEEE International Symposium on Software Reliability Engineering Workshops, ISSREW 2012, pp. 355–360 (2012)

    Google Scholar 

  25. Rasmussen, R., Hughes, T., Jenks, J.R., Skach, J.: Adopting agile in an FDA regulated environment. In: Proceedings of the Agile 2009 Conference (Agile 2009), pp. 151–155 (2009)

    Google Scholar 

  26. Zema, M., Rosati, S., Gioia, V., Knaflitz, M., Balestra, G.: Developing medical device software in compliance with regulations, pp. 1331–1334 (2015)

    Google Scholar 

  27. Goncalves, G.S., Luiz, G., Lima, B., Maria, R.E., Tadeu, R., Valeria, M., Ferreira, M.A., Chaves, A., Olimpio, A., Gomes, A., Otero, L., Eduardo, L., Vasconcelos, G. De, Yukio, L., Sato, C., Nunweiler, H., Silva, A., Marques, J.C., Pierre, A.L.: An interdisciplinary academic project for spatial critical embedded system agile development. In: DASC (2015)

    Google Scholar 

  28. Beck, K., Andres, C.: Extreme Programming Explained. Addison-Wesley, Reading (2005)

    Google Scholar 

  29. British Standards Online (America). http://www.bsiamerica.com/en-us/Sectors-and-Services/Industry-sectors/Healthcare-and-medical-devices/CE-marking-for-medicaldevices/

  30. EN ISO 13485:2003 Medical Device: Quality Management Systems. Requirements for the Regulatory Process, 24 July 2003

    Google Scholar 

  31. EN ISO 14971:2009 Medical Devices. Application of Risk management to medical devices, 31 July 2009

    Google Scholar 

  32. EN 60601-1 Medical Electrical Equipment. General requirements for basic safety and essential performance. Collateral standard. Usability, 31 May 2010

    Google Scholar 

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Acknowledgments

This research is supported by the SFI through Lero - the Irish Software Research Centre (http://www.lero.ie) grant 10/CE/I1855 & 13/RC/20194.

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Authors and Affiliations

  1. Regulated Software Research Centre and Lero, Department of Computing and Mathematics, Dundalk Institute of Technology, Dundalk, Co. Louth, Ireland

    Surafel Demissie, Frank Keenan & Fergal McCaffery

Authors
  1. Surafel Demissie
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  2. Frank Keenan
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  3. Fergal McCaffery
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Corresponding author

Correspondence to Surafel Demissie .

Editor information

Editors and Affiliations

  1. Lero Irish Software Research Centre, Dublin City University Lero Irish Software Research Centre, Dublin, Ireland

    Paul M. Clarke

  2. Dublin City University , Dublin 9, Ireland

    Rory V. O'Connor

  3. Software Quality Institue, Griffith University Software Quality Institue, Brisbane, Queensland, Australia

    Terry Rout

  4. Impronova AB , Drabergsvagen, Lindome, Sweden

    Alec Dorling

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Demissie, S., Keenan, F., McCaffery, F. (2016). Investigating the Suitability of Using Agile for Medical Embedded Software Development. In: Clarke, P., O'Connor, R., Rout, T., Dorling, A. (eds) Software Process Improvement and Capability Determination. SPICE 2016. Communications in Computer and Information Science, vol 609. Springer, Cham. https://doi.org/10.1007/978-3-319-38980-6_29

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  • DOI: https://doi.org/10.1007/978-3-319-38980-6_29

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-38979-0

  • Online ISBN: 978-3-319-38980-6

  • eBook Packages: Computer ScienceComputer Science (R0)

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