Agile and the FDA — Biotech Devices get a High-Touch Makeover

The Agile Method for software development (and more recently in hardware/connected device development) has been growing in prominence since its inception in 2001. The previous methodology for development, named Waterfall, was the process of developing software in one run and testing upon completion. As we see now, this just not the only way or there are other (better) ways to do it!

New conditions or needs evolve during the course of an enterprise project sometimes on a daily basis. The Agile method presents a very different way of thinking, one more in line with the realities of ever evolving Enterprise business needs. The Agile methodology breaks down each part of the software development cycle into stories and epics which would allow developers to focus on one specific element at a time and do real time testing of each segment upon completion.

Agile Methodology of end-to-end of development applies a ranking to each piece depending on its criticality to the function of the software or the hardware development. The iterated testing model built into Agile meant testing after each phase of deployment to ensure the foundation the software is built upon is robust. For a holistic approach, each stakeholder group would have input into each part of the development and testing, bringing a much more complete software-hardware melody to life at the end.

By bringing in more teams to each part of the process, issues and improvements could be made, almost, on the fly. Attempting to make these changes in the old Waterfall method could cost extensive amounts of money and time to reconfigure. Agile brings collaboration on all levels of the organization ensuring each angle is being thought of and account for. The increase collaboration does take some getting used to, but as we see now, it is not an impediment to development and in the long term saves money and time.

Back in 2012, the FDA proposed AAMI TIR45 which endorsed Agile as the optimal software development process to fit the needs of an ever evolving and highly regulated biotech industry. To many of us, Agile is commonplace but there are still companies coming around to the value of this process. However, to successfully navigate the caveat-fraught FDA approval process, it is key to be able to make changes and updates on the fly based off of recommendations as well as user testing. As our industry innovates, so does the FDA. As more approvals are being sought for highly technical devices, the technical prowess of the FDA grows.

To clearly understand the complexity of this process, it is crucial to understand the classification of medical devices and why they fall in the categories that they do.

According to the FDA, approaches classification by ascertaining the “level of control necessary to assure the safety and effectiveness of the device”. In essence, if your device or the code within the device malfunctions, what are the level of potential harms that could be caused as a result? Most Class I/II devices are not life crucial or harm-inducing upon failure. It allows these devices, like a fitness monitoring patch, to go through a much more simplistic process. If someone fails to record their steps for the day due to a malfunction in their device, they will inevitably survive to walk another day. However, depending on the device’s function, there can be additional approvals required on both the hardware and software level although less common.

Class III devices all have a crucial function in support of human life. Meaning a glitch or malfunction can cause the death or serious bodily harm of the user. Obviously the approval process for devices like connected pacemakers and other life saving devices are more rigorous to ensure the safety of the public.

What this all means is that the approval process will continue to get longer and yes, much more technical each passing day. For device class III and select I/II devices, both the hardware and the software must be approved by the FDA based of their intended use. Meaning the FDA can ask clarification questions and make product recommendations on both hardware and software aspects of your device. This doubles the amount of effort required to submit and recalibrate as well as dual opportunities for changes to be requested.

According to FDA statistics, 24% of recalls occur due to software related issues. Software failure persist as one of the top 3 concerns for massive and boutique biotech firms alike.

This makes sense taking into account almost 1 in 4 devices recalled are due to software failures or security concerns.

With the amount of revenue being spent to develop these devices, it becomes clear that an Agile methodology is the only true sustainable process to ensure consistent check ins on product changes throughout the product lifecycle, as well as including QA/RA throughout the entire software/hardware development process.

Through the well established development process laid out by the FDA, Agile can be interwoven effectively to provide greater introspection at each stage. The first step is creating a concept or idea for the new device meaning a Proof of Concept document with required future steps is used to determine whether the concept is workable. By bringing in all stakeholders initially instead of at the end or in phases, good ideas can be raised and bad ones discarded to ensure greater success of the device. Second is the design validation and preclinical trials to gather data on its usability and any potential harms or issues. Again, using Agile methodology to interface with hardware/software teams, clinical, QA/RA, and other stakeholders early in this process will allow for a holistic development approach with higher levels of internal regulation before it ever is showcased to the regulatory bodies.

Once that stage is complete it moves to a clinical testing phase and then to a market approval phase. Throughout these two stages, having additional insights from hardware and software teams during testing can prove key to making small tweaks that could pose issues for approval or garnering insights for product improvements. After these stages, the device is approved and moves into the last post-market monitoring phase. Here the device is complete and users are monitored for experience with the product. As more is collected, trends take place and indicate to the internal teams what direction the next generation device should take to cover a greater market need.

By employing the Agile process effectively, companies can do regression testing for quality and safety continuously throughout the design process. They can also gather extensive usage data which is now required to be submitted during the FDA approval process. Initially it can take a moment to get used to this high-touch mindset but once people have familiarized themselves with it, the benefits become apparent. Hardware teams talking to software teams and corresponding with QA/RA means that during each sprint every aspect of the device is being scrutinized before it ever reaches outside regulatory bodies.

By applying these tests before submission to the FDA, companies will better be able to proactively weed out issues that would inevitably pop up during the approval process. This will not negate all design changes asked for by the FDA, but it will certainly allow for a much smoother process and reduction in overall retooling costs. It will also help to reduce the chances of recalls after the product has been approved due to the extensive testing done throughout the process.

In an industry where millions of dollars can be spent on R&D before a product can even begin the approval process, it becomes crucial for a change in mindset of how these sensors and biotechnology are developed. It is important that companies and their partners understand how to effectively use Agile to integrate teams that in the past worked separately. Each group provides insights and details that the other one cannot. Nowhere is this more important considering the costs and possibly pitfalls that exist.

If your company is looking for a software solutions partner in this industry, make sure they understand that FDA requirements for software approval are advancing in technicality daily and how much effort will be required to get your product to market.