Mike Russell and Brian Lewis Pate of SoftwareCPR.com just informed me of an important new development with respect to the use of agile in medical device development (we are using medical device development as the exemplar for high assurance development in this blog series).
Specifically the AAMI (Association for the Advancement of Medical Instrumentation) is developing a Technical Information Report (TIR) which is devoted precisely to this topic. The description of the TIR is below. Mike and Brian tell me that it will likely be published sometime next year. (Hopefully, I might become involved as a reviewer). In any case, I’ll proceed apace with this blog series over the next few months, because Rally Software (my sponsor for some of this work) and I have some groundwork that we need to lay well prior to next year. Thanks for the tip Brian and Mike!
The foreword and abstract is include below:
Agile software development (hereafter referred to simply as “Agile”) has been evolving for many years. Agile began as a niche concept being used in small pockets of the software industry, and has since grown to be well established in many different software development contexts. As it has grown, it has been adapted to fit the unique needs of a specific context. For Agile to be established in the medical device software industry, guidance is needed to adapt it to fit that unique context. This TIR fulfills that need.
Agile was developed in response to quality and efficiency concerns posed by existing methods of software development. Too often software projects would deliver software with low customer value, poor quality, and were late to market/costly to develop. Agile attempts to solve those problems that are common to any type of software development.
In addition, Agile brings many quality and safety risk management benefits that are good for the Medical Device world. Some of those include:
- Continuous focus on safety and customer value through backlog prioritization/management and customer feedback
- Continuous assessment of quality through continuous integration and testing
- Continuous evolution of the product and the process that produces it
- Continuous focus on getting to “done” to demonstrate the completion of deliverables and activities that satisfy the Quality Management System
- Continuous participation in and collective ownership of risk management
Agile’s principles, practices, and life-cycle model have been viewed as incompatible with regulatory agency requirements and expectations for a medical device software quality management system. For example, the Agile Manifesto has value statements that seem contrary to the values of a quality management system. Fortunately, along with some strong and perhaps controversial values and principles, Agile also brings the concept of adapting the needs of the context, taking into account all of their customer’s and shareholders needs.
Purpose of this TIR
Agile is compatible and can be used in a regulated environment.
This TIR will examine Agile’s goals, values, principles, and practices, and provide guidance on how to apply Agile to medical device software development. It will:
- Provide motivation for the use of Agile.
- Clarify misconceptions about the suitability of Agile.
- Provide direction on the application of Agile so as to meet Quality System Requirements.
This TIR will provide guidance on the proper way to apply Agile.
(NEED TO REVISIT THIS)
This TIR provides guidance on how to achieve the benefits of Agile while being compliant with medical device regulations.
This TIR provides perspectives on the application of Agile during medical device software development. It relates them to the following existing standards, regulations and guidance:
- EN 62304 – Life Cycle Requirements for Medical Device Software
- Design Controls as required by CFR – Quality System Regulations
- FDA guidance on premarket software guidance and general principles of software validation
- The following groups are the intended audience for this TIR:
- Medical device manufacturers who are planning to use Agile techniques
- Manufacturers who are currently practicing agile and are entering the regulated (medical device) space, for example, Electronic Health Record manufacturers
- Software development teams, including software test and quality groups
- Senior Management, Project Managers, Quality Managers
- Quality systems and Regulatory affairs personnel
- Internal and external auditors
- Regulating bodies, agencies and organization’s responsible for overseeing the safety and effectiveness of medical devices
This TIR is not intended to be used as an educational tool or tutorial for the following:
- Agile Development practice
- Quality System Regulations
This TIR does not provide perspectives for the following standards:
- ISO 14971
This Technical Information Report (TIR) should be regarded as a reference and as a guidance which is intended to provide recommendations and perspectives for complying with international standards and FDA guidance documents when using agile practices in the development of medical device software. This TIR is not intended to be a prescription for a specific situation or method.