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 is not the only way—there are 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 different way of thinking—one more in line with the realities of ever-evolving enterprise business needs. Agile breaks down each part of the software development cycle into stories and epics, allowing developers to focus on one specific element at a time and conduct real-time testing upon completion.
The Agile methodology applies a ranking to each task based on its criticality to the overall functionality. Iterative testing after each phase ensures that the foundation remains robust. A holistic Agile approach also invites all stakeholder groups to provide input throughout development, resulting in a more complete software-hardware harmony at the end.
By involving more teams throughout the process, improvements and fixes can be made quickly. In the Waterfall method, such changes would require costly and time-consuming reconfiguration. Agile enables collaboration across all levels of the organization, ensuring every angle is considered. Though this increased collaboration may take time to adapt to, it ultimately saves time and money.
In 2012, the FDA proposed AAMI TIR45, endorsing Agile as the optimal development methodology for the highly regulated biotech industry. While Agile is now standard in many places, some companies are just realizing its value. Navigating FDA approvals requires the ability to adapt based on feedback and user testing. As the FDA becomes more technologically adept, this agility becomes crucial.
To grasp the complexity of this process, one must understand how the FDA classifies medical devices. Classification is based on the level of control necessary to ensure safety and effectiveness. If a device or its code malfunctions, what are the potential harms?
Most Class I and II devices are not life-critical. Devices like fitness patches can follow a simpler approval process. If someone fails to record their steps due to malfunction, they’ll survive. However, some Class I/II devices may still require additional scrutiny, depending on functionality.
Class III devices serve critical life-sustaining functions. A glitch in a pacemaker, for example, could be fatal. These devices undergo a far more rigorous FDA review to ensure public safety.
This increasing complexity means that the FDA approval process is becoming longer and more technical. For Class III—and some Class I/II—devices, both hardware and software must be approved. The FDA may request clarifications or changes to either, doubling the effort required.
According to FDA statistics, 24% of device recalls are due to software-related issues. Software failure remains one of the top concerns for companies of all sizes in biotech.
Given the vast investment in developing these products, Agile emerges as the only sustainable methodology. It enables continuous testing and quality assurance throughout the lifecycle, not just after development.
Agile can be seamlessly woven into the FDA’s established development process. The first step, concept creation, is followed by stakeholder engagement to validate feasibility. Involving hardware, software, QA/RA, and clinical teams early helps surface good ideas and discard bad ones early.
The next phase is design validation and preclinical trials to identify usability issues or risks. Agile allows these teams to coordinate closely, ensuring high internal standards before submission.
Subsequently, the process moves to clinical testing and then to market approval. During these phases, insights from software and hardware teams are vital for making final adjustments that could be the difference between approval and rejection.
Finally, the post-market monitoring phase observes how users interact with the device and generates insights for future iterations. Agile allows for continuous regression testing and user data collection—both now required for FDA submissions.
In an industry where millions are spent on R&D before even reaching FDA submission, a mindset shift is critical. Agile encourages previously siloed teams to collaborate, share insights, and proactively address risks. Nowhere is this more vital than in connected medical devices.
If your company is looking for a software solutions partner, ensure they understand the FDA’s rapidly advancing requirements. Knowing how much effort is needed to bring a product to market is essential—and Agile is the key to meeting those demands efficiently.
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