Companies in the business of medical device development are often wary of trying innovative product development methodologies. Many feel that changing tried and tested methods to increase production speed and agility is incompatible with meeting the many regulatory requirements in the industry. That being said, with software becoming more and more important in medical technology over time, organizations are having to rethink the way they approach medical device development in order to meet market demands and customer needs at scale - and keep up with the competition. One of these ways is with Agile, a methodology that companies can use to speed up production and increase their productivity. Read on to learn more about how teams focusing on medical device product development can benefit from Agile!
Instead of the exhaustive (and often rigid) planning and requirements definition that Waterfall and other plan-based traditional product development methodologies require at the beginning of a project, the Agile framework allows requirements to adapt over time. In an Agile environment, cross-functional teams work on incremental releases of a product over a fixed time period, with a practice of continuous improvement via testing, reviews, and feedback from the start. This iterative approach to agile medical systems allows software development teams to adhere to industry best practices while creating safe and useful products that medical professionals and patients can benefit from greatly.
The state of Agile in medical device development
The growing importance of software in medical devices is creating a lot of business for companies in the industry, but also raising significant challenges for established organizations in the field. While using Agile in medical device development is not yet very common in this area, a lot of organizations are curious about how they can benefit from the framework and are taking the first steps to implement it in their development organizations. At a first glance, the combination of incremental development and constantly changing requirements seems to not be a good fit. However, in 2012, the Association for the Advancement of Medical Instrumentation (AAMI) published a guideline called the TIR45:2012 “Guidance on the use of Agile practices in the development of medical device software”. This guideline demonstrated that it is actually possible for businesses to leverage the benefits of Agile while still maintaining compliance with international standards like the IEC 62304, ISO 14971, or FDA requirements for example.
FDA agile software development: what’s holding people back?
Businesses on the whole tend to be a little skeptical about trying new things, because the thinking is generally that if you interrupt the status quo, it will inevitably slow down productivity, cause you to lose money, and interrupt the day-to-day operations of the business. But apart from the usual reluctance to disrupt the way they do things, there are two quite specific reasons that those working in medical device development are hesitant to try Agile.
The first is that they believe they won’t be able to achieve and maintain regulatory compliance if the requirements of the product (and therefore the outcome) constantly evolve throughout the trajectory of the project. This is why they tend to stick to the tried and tested methods, like Waterfall or the V-model, which plan exhaustively upfront using a huge list of requirements that should be met before going to market, which in theory leads to smoother compliance.
The second is that combined hardware/software development is seen to be incompatible with Agile, as it was originally used in pure software environments. Although you can turn new code around quickly and at frequent intervals, hardware requirements like the production of mechanical aspects (which requires many engineering drawings and collaboration with external vendors) usually cannot be produced at the same rate. On the same note, it’s not as easy to change hardware later in the game as it is with software code.
The solution is ‘Hybrid Agile’
Put simply, Hybrid Agile is the application of the agile methodology in combination with other traditional classical, non-agile methods (primarily Waterfall or the V-model). Sometimes, MedTech product development is so incredibly complex that not all the participants, stakeholders, and external suppliers can be gathered effectively under the Agile framework. Hardware development, as we already touched on, can face some limitations when it comes to applying Agile development methods. There are some needs when it comes to regulatory compliance which agile practices might not be suitable for. That’s why a gradual transition towards Agile involves overlapping Agile methodology and plan-based development, and that’s perfectly OK. This is the way that medical device development teams can satisfy regulatory compliance needs, even if a particular Agile practice doesn’t suit.
Benefits of Agile in medical product development
There are many benefits to implementing Agile in a medical product development environment, but here are a few of the main ones that a huge variety of teams could take advantage of:
- A faster return on your investment
Since Agile is an iterative and incremental method of development, features are typically delivered in sprints, whose duration and scope are defined at the beginning of the project. With the emphasis on quick turnaround, frequent updates or releases, and continuously improving as you go along, this method typically results in a faster time to market, even in new medical device product development.
- Increased flexibility and adaptability
- Overall project risk reduction
As we already explored above, traditional software development approaches leave risks to be discovered near the end of a project, since the software is only released for testing then, as well as user and stakeholder feedback. With Agile, risks can be identified throughout the MedTech product development process, using tactics like fail fast, verification, and validation to accomplish successful risk mitigation as you go along.
- Higher software quality
Using Agile for medical device development creates software that is of higher quality. This is due to the practice of demonstrating the software incrementally as features are implemented and getting stakeholder and user feedback earlier as a result. On top of that, the software development team can course-correct according to this continuous feedback, and change the trajectory of a project accordingly.
The next steps: transitioning to Agile medical systems
Now that you’ve explored the status of Agile in the context of medical product development, you may be wondering where to get started. Here are a couple of our favorite tips to get you set off on your journey to Agile medical device development:
- Familiarize yourself with the basic principles of Agile
- Choose an approach that suits your needs
- Pick and choose from other frameworks
- Plan and execute the transition
- Improve continuously - this is a framework, the ways of working can always be adapted
Looking for guidance on the use of agile practices in the development of medical device software? Watch our 3-part series on safely using Agile in MedTech: