Here is a (lightly) annotated list of online resources available dealing with adopting and applying agile practices when developing FDA-regulated medical device software. This list will be updated as new resources are discovered or become available.

White Papers/Articles

AAMI TIR45:2012 Cover

The definitive work is now AAMI TIR45:2012, a technical information report created by the AAMI to provide guidance on the use of agile practices in the development of medical device software. It is currently $150 to download a pdf ($90 for AAMI members). You can also download a preview.

Scaling Agile Methods to Regulated Environments: An Industry Case Study - By Brian Fitzgerald, Klaas-Jan Stol, Ryan O’Sullivan, and Donal O’Brien. Published in 2013 by IEEE.

Conclusions and Future Work:

This paper presents an in-depth account of how agile methods can be scaled to regulated environments. Given the successful exemplars of the use of agile methods in large teams and distributed development, the use of agile methods in regulated environments may be seen as the ’final frontier’ for agile methods. Overall, the agile development process as it has been adopted and augmented in QUMAS has worked very well in the regulated environment. Compliance is more immediate and evident in real-time—continuous compliance as we have labeled it here. Also, the concept of living traceability has been coined to reflect the end-to-end traceability that has been facil- itated by the toolset that has been implemented to support the agile development process. In summary, it seems to be the case that the assumption of incompatibility between agile methods and regulated environments is more accidental than essential

State of Medical Device Development 2014 Survey - By Seapine Software From the survey:

The 2014 State of Medical Device Development Survey was conducted from June 1, 2014 through August 31, 2014 and sponsored by Seapine Software. We gathered input from almost 500 individuals working at all levels within the medical device industry. The majority of respondents were working on Class II or Class III devices, with a smaller number also involved in the development of Class I devices. Altitude: The survey respondents represent all levels within medical device development companies.

Software Verification and Validation in High Assurance Agile Development: Verification: SRS and User Stories - Published December 17, 2010 by Dean Leffingwell. Has especially good notes from Brian Shoemaker in the comments.

Agile in an FDA Regulated Environment - Pathfinder White Paper. Published December 17, 2013.


Agile methodology, when properly adapted to the FDA’s quality systems regulations, can provide superior results to currently prevailing waterfall development methods, especially for complex systems with significant software components.

Agile methodology is designed to get feedback early and often during the course of product design and use this feedback to continuously improve the product. As a result, it is well suited to the development of complex systems with emergent requirements. The feedback loop can be adapted to incorporate risk management, human factors and verification and validation. This fast feedback cycle, coupled with agile practices such as test driven development and continuous integration, allow product organizations to:

  • Adapt to change

  • Rapidly reduce requirements uncertainty

  • Speed development and reduce waste

  • More closely align to user needs, improve user interfaces and thus adoption

  • Reduce risks and defects

Thus, companies able to adopt agile methodology give themselves a better opportunity to rise to the challenges posed by the rapidly changing regulatory, reimbursement and technology landscape and turn these to competitive advantage and market success.

Investigating the Capability of Agile Processes to Support Life-Science Regulations: The Case of XP and FDA Regulations with a Focus on Human Factor Requirements - by Hossein Mehrfard, Heidar Pirzadeh, Abdelwahab Hamou-Lhadj, Department of Electrical and Computer Engineering, Concordia University, Montreal, QC, Canada.


In this paper, we assessed the ability of XP to meet FDA regulations, which impose stringent requirements on the way software is built. These requirements are in the form of artefacts that a software process must produce for the software system to be FDA-compliance.

Although, we studied the complete set of FDA requirements, we chose in this paper to discuss our mapping process between FDA and XP by focusing on Human Factor Engineering requirements that must be met by any software process that claims to be FDA-compliant. We showed how XP does not support this aspect, and proposed an extension to it.

Barriers to Adopting Agile Practices when Developing Medical Device Software - by Martin McHugh, Fergal McCaffery, and Valentine Casey. Regulated Software Research Group, Department of Computing and Mathematics,Dundalk Institute of Technology & Lero,Dundalk Co. Louth, Ireland


As a result of the survey outlined in this paper, a number of barriers to agile adoption in the development of medical device software have been identified.Through examination of the relevant medical device regulatory requirements, international standards and guidance documents it may be concluded that none of the barriers identified are insurmountable. Each of the barriers were analysed in detail and information has been provided as to how these barriers can be addressed. The research outlined in this paper is part of a larger study and these results will be used to assist with further research into the use of agile practices for medical device software development.

Whilst this research identified the perceived barriers to adopting agile practices within medical device companies, further research will identify the critical success factors to using agile practices when developing medical device software. The research outlined in this paper will also contribute to the development of a software development lifecycle for medical device software that will integrate the stability of following a plan driven software development lifecycle with agile practices.


Moving to Agile in an FDA Environment An Experience Report - Agile 2009 presentation for Abbott. See also IEEE article, which requires payment.

From the Summary:

A strategy:

  • Use Agile processes to reduce Project risk

  • Transfer a prototype with draft documents

  • Review prototype for Product Risk ƒ** Functional, Integrity, Quality (and Compliance)

  • Introduce accepted drafts into formal iterative/evolutionary lifecycle as appropriate

  • Use formal processes to reduce Product Risk

Risk-based Agile Development of Mobile Medical Apps in Healthcare IT. Presentation slides from 22nd Annual ASQ Audit Conference Session D7: 11 October 2013 by Dr. Byron Mattingly

Key Takeaways:

  • Automate, automate, automate.

  • Embrace concurrent testing—manual, semiautomated and automated.

  • Create loosely coupled systems partitioned by risk; allocate testing assets and perform functional validations of “System of Systems” according to risk level.

Being agile while still being compliant: A practical approach for medical device manufacturers - by Keith Collyer and Jordi Manzano. Published 5 March 2013. Available as pdf download.


Experts from IBM and Diagnostic Grifols describe how Diagnostic Grifols is using agile software development approaches in the tightly regulated field of medical devices. "Many organizations believe that they must use a waterfall approach in regulated environments," they say. "We show how this is not the case."

Blog Posts

Agile Medical Device Software Development? - Published Nov 6, 2010 on Ron Rammage’s Blog

FDA Regulation of Mobile Medical Apps - Published September 23, 2013 on Bob on Medical Device Software Blog

Agile Software Development in Regulated Environments - Published October 16, 2010 on Bob on Medical Device Software Blog

FDA Endorses Agile: What Does that Mean?. Published by Heather Thompson on May 21, 2013.

The agency takes a critical first step in rapid software development for the medical devices community.

About the Author

Paul is a software design and development coach and mentor. He is available for consulting and training through his company, Virtual Genius LLC. He is the author of The EventStorming Handbook and major contributor to Behavior-Driven Development with Cucumber. He is also the founder and chair for the Explore DDD conference.