Introduction to AAMI TIR45: Agile Guidance in Medical Device Development

Software developers in safety-critical industries like medical device technology are typically hesitant to stray from tried and proven tools, which holds them back from taking advantage of new technology and methodologies. Since patient and operator lives may be at stake, MedTech developers prefer not to take unnecessary risks. So when Agile Software Development began to gain traction in the 2000s, there were understandable concerns about whether or not this approach would be suitable for the development of highly regulated products like medical device software.

Introduction to AAMI TIR45

In order to address those concerns, the AAMI (the Association for the Advancement of Medical Instrumentation) commissioned the AAMI TIR45:2012 “Guidance on the use of AGILE practices in the development of medical device software”. The guidance, which is now an FDA-recognized consensus standard, was created by a committee of industry leaders and the US FDA to demonstrate how the concepts of Agile Software Development are in fact compatible with the regulatory requirements MedTech software developers are expected to meet. 

Read on to learn more about this guidance, what it contains, and the benefits that Agile processes can bring to the development of medical device software.

Access Dr. Andreas Birk's insights on using Agile in MedTech development in this 3-part white paper and webinar series!

Unlocking the Power of Agile in Medical Device Development with Dr. Andreas Birk

What exactly is the AAMI TIR45

The AAMI TIR45 is the Advancement of Medical Instrumentation’s guide on how to develop medical device software using Agile practices. It was introduced in 2012 in response to industry concerns. These are a result of the extremely demanding regulations developers have to comply with, which makes them hesitant to try the Agile approach for medical device software development. 

The AAMI TIR45 provides clear guidance on how to implement Agile in the development of medical device software. A few other factors also gave developers more confidence to start using this methodology:

  • Agile as a whole has gained significant popularity in the industry
  • The more teams used it, the more that Agile processes matured, and it became clear that the approach does not contradict regulatory requirements in medical software development
  • Finally, the FDA has officially endorsed Agile practices as a valid approach

Nowadays, because of the above key developments, manufacturers and regulators alike agree that Agile is appropriate for developing medical device software. However, developers still struggle to reconcile Agile’s decentralized nature with the stringent requirements of regulations they need to comply with.

Related reading:

Approaching Agile in Medical Device Development

What does the AAMI TIR45 contain

The AAMI TIR45 was created to demonstrate how to safely adopt the Agile framework in the space of medical device development. Along those lines of thinking, it focuses on addressing key misconceptions about using Agile software development processes in MedTech, such as:

  • The Agile methodology is not centralized with rigorous processes and documentation for compliance
  • The Agile methodology hasn’t been around for long enough to be a safe, effective, and reliable way to develop safety-critical products
  • The FDA ‘prescribes’ waterfall processes, so even if Agile was appropriate for MedTech software development, it wouldn’t matter because it wouldn’t meet FDA regulations anyways.

On top of that, the AAMI TIR45 emphasizes the following measures to ensure alignment between Agile and MedTech software development:

  1. Detailed lifecycle modeling is recommended in order to carry out complex development processes in a structured and disciplined manner
  2. Meticulous change management is advised for effective quality control and risk management 
  3. The Agile processes used need to align with the requirements of whichever Quality Management System the organization uses
  4. Adequate if not over the top documentation (of course, this is always advised for ensuring quality and compliance, but it's always worth reiterating)

Further reading:

AAMI TIR45: Using Agile in Medical Device Software Development

The benefits of Agile for medical software development

Agile processes can provide significant value to the developers of medical device software. In traditional medical software development processes, if an error isn’t spotted, the cost of fixing it becomes greater and greater depending on the stage you find yourself at in the product lifecycle. As the stages are more rigid and follow one after another, the cost of needing to make a change ends up being higher as solving it is delayed by the nature of this traditional workflow.

The Agile method, on the other hand, is characterized by introducing the flexibility to make rapid changes and improvements throughout the development process. This can benefit the development team overall by:

  • Making it easier to identify risks, errors, and necessary changes
  • Being able to address those changes quickly without waiting for another stage to commence, thereby letting the cost of the change augment
  • Providing more transparency and visibility to customers and stakeholders
  • Introducing testing and risk management right from the beginning instead of as an afterthought.

For more details, here is an excerpt taken directly from AAMI TIR45:2012 about the benefits of Agile for medical device software development:

  • Continuous focus on safety, risk management, and delivering customer value through BACKLOG prioritization, planning practices, and customer feedback
  • Continuous assessment of quality through continuous integration and testing
  • Continuous improvement of the software development process through RETROSPECTIVEs and team accountability
  • Continuous focus on “getting to DONE” and satisfying quality management stakeholders through the regular completion of activities and deliverables


In conclusion, Agile can bring significant value to medical device software development and is even supported nowadays by the FDA, regulators, and manufacturers alike. The processes can be adapted to the unique requirements of the field, in order to meet regulatory and compliance needs, and the values of the methodology can even enhance product quality. The key is to apply the practices within the framework of your organization’s QMS, with a fully fleshed-out lifecycle model and robust change management systems.

Up next:

Ensuring Patient Safety & Enabling Efficiency in Medical Device Software Development

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