Medical Device Software Process Improvement - A Perspective from a Medical Device Company

Marie Travers, Ita Richardson

Abstract

When manufacturing medical devices there are many constraints that have to be taken into account such as safety, compliance with regulations and traceability. To do this, well-defined processes are used. With this in mind we examine how process improvement is implemented in a medical device company while managing the resultant change. The case study presented in this paper investigates the use of Kotter’s Change Model to support the implementation of process improvement in a medical device company. The results of the case study demonstrate that Kotter’s change model was an appropriate model to use. The sense of urgency Kotter stipulates was inherent in the company. The team was aware that change was needed. A flaw in Kotter’s approach is that there is no recommendation for a pilot project. Having a pilot project worked well for this company as it helped to eliminate stress and anxiety. A further case study is planned in the company to observe how the process is working after implementation of the full project.

References

  1. AAMI (2012) TIR45:2012 Guidance on the use of AGILE practices in the development of medical device software 2012, Association for the Advancement of Medical Instrumentation.
  2. ANSI/AAMI/IEC (2006) 62304:2006 Medical Device Software-Software life cycle processes, 2006, Association for the Advancement of Medical Instrumentation. p. 67.
  3. Burton, J., (2008) A Software Risk Management Capability Model for Medical Device Software, Unpublished thesis (PhD), University of Limerick.
  4. Cawley, O., Wang, X., Richardson, I., (2013) Regulated Software Development-An Onerous Transformation, in Foundations of Health Information Engineering and Systems: Springer, 72-86.
  5. Cawley, O., Richardson, I., Wang, X., (2011) Medical Device Software Development - A Perspective from a Lean Manufacturing Plant, O'Connor, R. V., Rout, T., McCaffery, F., and Dorling, A., 'Software Process Improvement and Capability Determination', Berlin, Springer, 84 - 96.
  6. EU, Council Directive (1993) 93/42/EEC of the European Parliament and of the Council, Concerning Medical Devices, E. Council, Editor 1993, Official Journal of the European Union.
  7. EU, Directive (2007) 2007/47/EC of the European Parliament and of the Council, 2007, Official Journal of the European Union.
  8. FDA (2009) Code of Federal Regulations 21 CFR Part 820, U.F.a.D. Administration, Editor April 2009.
  9. Forte, G., (1997) Managing Change for Rapid Development, IEEE Software 14(6), 114-123.
  10. Hayes, S. & Richardson, I., (2008), Scrum Implementation using Kotter's Change Model, 9th International Conference on Agile Processes and eXtreme Programming in Software Engineering, Limerick, Ireland, Lecture Notes in Business Information Processing 2008, vol 9, Part 6, 10th-14th June, pp. 161-171.
  11. Kotter, J., (2005) Leading Change: Why Transformation Efforts Fail, Harvard Business School Press, Boston.
  12. McCaffery, F., Casey, V., Sivakumar, M.S., Coleman, G., Donnelly, P., Burton, J., (2012) Medical Device Software Traceability, Software and Systems Traceability, Ed. Zisman A., Cleland-Huang J. and Gotel, O., Springer Verlag Publishers, pp 321 - 340.
  13. MEDDEV 2.1/6 (2012) Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices, European Commission.
  14. Miles, M., Huberman, A. (1994) Qualitative Data Analysis, 2nd edn. SAGE Publications, USA.
  15. Spence, J.W. (2005) There has to be a better way! [software development] in AGILE Conference, July 24 - July 29, 2005. Denver, CO, United states: Inst. of Elec. and Elec. Eng. Computer Society, 272-278.
Download


Paper Citation


in Harvard Style

Travers M. and Richardson I. (2015). Medical Device Software Process Improvement - A Perspective from a Medical Device Company . In Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015) ISBN 978-989-758-068-0, pages 462-469. DOI: 10.5220/0005223904620469


in Bibtex Style

@conference{healthinf15,
author={Marie Travers and Ita Richardson},
title={Medical Device Software Process Improvement - A Perspective from a Medical Device Company},
booktitle={Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015)},
year={2015},
pages={462-469},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0005223904620469},
isbn={978-989-758-068-0},
}


in EndNote Style

TY - CONF
JO - Proceedings of the International Conference on Health Informatics - Volume 1: HEALTHINF, (BIOSTEC 2015)
TI - Medical Device Software Process Improvement - A Perspective from a Medical Device Company
SN - 978-989-758-068-0
AU - Travers M.
AU - Richardson I.
PY - 2015
SP - 462
EP - 469
DO - 10.5220/0005223904620469