Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle

Abstract:

Medical device software organisations face challenges not faced by generic software development organisations.  These challenges include the adherence to regulatory controls.  Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable.  To produce this, regulatory bodies require a number of deliverables which must be achieved.  However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables.  Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle.  By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software.  The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome.  The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews. 

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development ...

Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development ...

A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen
amendments to the original directive (93/42/EEC).  A number of these changes directly affect the development
of software for use ...

Software to be used in or as a medical device is subject to user requirements.  However, unlike
unregulated software, medical device software must meet both the user’s requirements and
the requirements of the regulatory ...

The popularity of Agile software development is growing rapidly with an increasing
number of projects being developed following Agile methodologies such as Scrum
and XP [1].  Research has revealed that following Agile ...