Corpus ID: 106480705

An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs

@inproceedings{McHugh2013AnAV,
  title={An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs},
  author={Martin McHugh and Ois{\'i}n Cawley and Fergal McCaffery and Ita Richardson and Xiaofeng Wang},
  year={2013}
}
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 Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This… 

Figures and Tables from this paper

CHALLENGES OF AGILE PRACTICES IMPLEMENTATION IN THE MEDICAL DEVICE SOFTWARE DEVELOPMENT METHODOLOGIES
Agile practices have transformed many segments of t he software development industry by streamlining the development process. M edical Device industry is facing new challenges as software is taking a
Adopting agile practices when developing software for use in the medical domain
TLDR
It emerged that no external barriers exist to adopting agile practices when developing medical device software and the barriers that do exists are internal barriers such as getting stakeholder buy in.
A Systematic Approach to Agile Development in Highly Regulated Environments
TLDR
The presented approach works adequately in small agile teams – independently of the underlying method such as Scrum, Kanban, etc – and is scalable to more and bigger teams or even entire subsidiaries.
An evidence-based risk-oriented V-model methodology to develop ambient intelligent medical software
  • G. Cicotti
  • Computer Science
    Journal of Reliable Intelligent Environments
  • 2017
TLDR
A novel risk-driven, evidence-oriented V-model methodology is proposed which addresses the previous issues by defining a seamless and unified development process and the novelty of this approach consists of interleaving risk management with software development activities and employing assurance cases for driving and controlling quality concerns.
Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring
TLDR
To demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy, regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed.

References

SHOWING 1-10 OF 42 REFERENCES
Integrating agile practices with plan-driven medical device software development
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
Breaking the ice for agile development of embedded software: an industry experience report
  • Peter Manhart, K. Schneider
  • Computer Science, Engineering
    Proceedings. 26th International Conference on Software Engineering
  • 2004
TLDR
A software engineering department in a Daimler-Chrysler business unit was highly professional at developing embedded software for busses and coaches, but customer specific add-ons were a regular source of hassle and established software engineering methods were considered inadequate and needed to be cut short.
Escape the waterfall: Agile for aerospace
Agile is an umbrella software methodology that incorporates many of the best practices of the last couple of decades. In this paper, we will examine some of those key techniques for possible
Agile Development in a Medical Device Company
TLDR
The experience of the software development group working in Cochleartrade with introducing Scrum as an agile methodology is discussed, showing how they automated the testing of physical devices to overcome their dependence on manual testing.
Adopting Agile in an FDA Regulated Environment
TLDR
This paper is an experience report describing Abbott’s adoption of agile software development practices in its molecular diagnostics division and has convinced Abbott that an agile approach is the approach best suited to development of FDA-regulated medical devices.
Empirical studies of agile software development: A systematic review
TLDR
A systematic review of empirical studies of agile software development up to and including 2005 was conducted and provides a map of findings, according to topic, that can be compared for relevance to their own settings and situations.
Using Scrum in Global Software Development: A Systematic Literature Review
  • Emam Hossain, M. Babar, H. Paik
  • Engineering, Computer Science
    2009 Fourth IEEE International Conference on Global Software Engineering
  • 2009
TLDR
A systematic literature review of the primary studies that report using Scrum practices in GSD projects to identify various challenges and strategies available to deal with them is presented.
Agility in the Avionics Software World
TLDR
This paper takes a look at how XP and other agile practices can improve a software process for the development of avionics software, and explains why certain agile techniques have less effect as the project progresses.
Agile Software Development, Principles, Patterns, and Practices
TLDR
This comprehensive, pragmatic tutorial on Agile Development and eXtreme programming, written by one of the founding father of Agile development, teaches software developers and project managers how to get projects done on time, and on budget using the power ofAgile Development.
Risk Management process improvement for the Medical Device Industry
This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as
...
1
2
3
4
5
...