Balancing Agility and Discipline in a Medical Device Software Organisation

Communications in Computer and Information Science

Volumn 349 CCIS, Issue , 2013, Pages 199-210

  McHugh, Martin ^a   McCaffery, Fergal ^a   Fitzgerald, Brian ^b   Stol, Klaas Jan ^b   Casey, Valentine ^a   Coady, Garret ^c  

^a DUNDALK INSTITUTE OF TECHNOLOGY   (Ireland)

^b UNIVERSITY OF LIMERICK   (Ireland)

^c BlueBridge Technologies   (Ireland)

Author keywords

Agile; Home Ground Analysis; Medical; V Model

Indexed keywords

BIOMEDICAL EQUIPMENT;

AGILE; AGILE METHODOLOGIES; AGILE SOFTWARE DEVELOPMENT; HOME-GROUND ANALYSIS; MEDICAL; SOFTWARE DEVELOPMENT LIFE CYCLE; SOFTWARE ORGANISATIONS; V-MODEL;

SOFTWARE DESIGN;

EID: 84904644560     PISSN: 18650929     EISSN: None     Source Type: Book Series    
DOI: 10.1007/978-3-642-38833-0_18     Document Type: Conference Paper

References (29)

1. Jones, P. L., Jorgens, J., Taylor Jr., A. R., Weber, M.: Risk Management in the Design of Medical Device Software Systems. Biomedical Instrumentation & Technology 36, 237-266 (2002).
2. Conboy, K., Fitzgerald, B.: Method and developer characteristics for effective agile method tailoring: A study of XP expert opinion. ACM Trans. Softw. Eng. Methodol. 20, 1-30 (2010).
3. Laanti, M., Salo, O., Abrahamsson, P.: Agile methods rapidly replacing traditional methods at Nokia: A survey of opinions on agile transformation. Information and Software Technology 53, 276-290 (2011).
4. 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).
5. 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).
6. Vogel, D.: Agile Methods: Most are not ready for prime time in medical device software design and development, DesignFax Online (2006).
7. McHugh, M., McCaffery, F., Casey, V.: Barriers to using Agile Software Development Practices within the Medical Device Industry. In: European Systems and Software Process Improvement and Innovation Conference, EuroSPI, Vienna Austria (2012).
8. Boehm, B., Turner, R.: Balancing Agility and Discipline: A Guide for the Perplexed. Addison-Wesley (2003).
9. FDA, General Principles of Software Validation: Final Guidance for Industry and FDA Staff. Centre for Devices and Radiological Health (2002).
10. FDA, General Controls for Medical Devices. Food and Drug Administration (2009).
11. Jo, H. H., Parsaei, H. R., Sullivan, W. G.: Principles of Concurrent Engineering. In: Parsaei, H. R. (ed.) Concurrent Engineering: Contemporary Issues and Modern Design Tools. Springer, Germany (1993).
12. AAMI, ANSI/AAMI/IEC 62304, Medical device Software-Software life cycle processes. Association for the Advancement of Medical Instrumentation (2006).
13. McCaffery, F., McFall, D., Donnelly, P., Wilkie, F. G.: Risk Management Process Improvement for the medical device industry. Presented at the Conference on Software Development, SWDC-REK 2005, Iceland (2005).
14. Royce, W.: Managing the Development of Large Software Systems. Presented at the Proceedings of IEEE WESCON (1970).
15. Rook, P. E.: Controlling software projects. IEEE Software Engineering Journal 1, 7 (1986).
16. Pfleeger, S. L., Atlee, J. M.: Software Engineering: Theory and Practice. Pearson Higher Education, New Jersey (2001).
17. Casey, V., McCaffery, F.: Med-Trace: Traceability Assessment Method for Medical Device Software Development. Presented at the European Systems & Software Process Improvement and Innovation Conference (EuroSPI), Roskilde, Denmark (2011).
18. Cadle, J., Yeates, D.: Project Management for Information Systems. Pearson Education (2008).
19. Munassar, N. M. A., Govardhan, A.: A Comparison Between Five Models of Software Engineering. IJCSI International Journal of Computer Science Issues 7, 94-101 (2010).
20. Rottier, P. A., Rodrigues, V.: Agile Development in a Medical Device Company. Presented at the Proceedings of the 11th AGILE Conference, AGILE 2008, Girona, Spain (2008).
21. Rasmussen, R., Hughes, T., Jenks, J. R., Skach, J.: Adopting Agile in an FDA Regulated Environment. Presented at the Agile Conference, AGILE 2009, Chicago, IL (2009).
22. Weyrauch, K.: What Are We Arguing About? A Framework for Defining Agile in our Organization. Presented at the Proceedings of the Conference on AGILE 2006 (2006).
23. AAMI, AAMI TIR45: 2012-Guidance on the use of agile practices in the development of medical device software (2012).
24. Boehm, B., Turner, R.: Rebalancing Your Organization's Agility and Discipline. In: Maurer, F., Wells, D. (eds.) XP/Agile Universe 2003. LNCS, vol. 2753, pp. 1-8. Springer, Heidelberg (2003).
25. Cockburn, A.: Agile Software Development. Addison-Wesley, Boston (2002).
26. Klens-Bigman, D.: Layers of Shu-Ha-Ri in the Practice of Iaido.
27. Highsmith, J.: Agile software development ecosystems. Addison-Wesley Longman Publishing Co., Inc., Boston (2002).
28. Mehrfard, H., Hamou-Lhadj, A.: The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software. International Journal of Information System Modeling and Design 2, 67-81 (2011).
29. Turk, D., France, R.: Assumptions Underlying Agile Software Development Processes. Journal of Database Management 16, 62-87 (2004).