Using XP@Scrum for development of software in the medical domain

Presenters: Christ Vriens & Erik Bos

Objectives:

  • pros and cons of using XP and Scrum for the development of software to be used in medical devices
  • insight in a process for development of medical software based on agile methodologies
  • agile in relation to FDA and CE approval and medical standards like ISO13485, ISO14971 and IEC62304

Intended audience: Participants are expected which are interested in the applicability of agile in the medical domain. Basic knowledge of agile and his practices is expected.

Contents:

As well as in other domains, in the medical domain there is an urgency to develop software faster and against lower costs. On the other hand no compromises with respect to safety and effectiveness can be made. This presentation describes the applicability of the combination of eXtreme Programming and Scrum specifically for the development of software for medical devices (see http://www.fda.gov).

First a short overview is given of some of the medical projects of Philips Research - MiPlaza. The various regulatory requirements are described to which they should comply. Next the process is described, based on XP@Scrum, with the artifacts and activities that had to be added in order to be able to develop medical device software. Special emphasis is given to those process elements introducing a tension with agile practices and values and what we did to overcome them.

Format and length: 60 min interactive presentation