Why Software is Hard: And How to Make it Easier
As the sophistication of medical devices continues to grow, software is becoming increasingly fundamental to an ever-expanding range of products. Delivering effective products to the market quickly while still meeting the requirements of US and European regulators requires a fresh approach to medical device software development.
Developing medical device software under IEC 62304 and FDA guidelines...
The exponential advancement in consumer technology kick-started by the smartphone over a decade ago, has trained consumers to expect much more from the products they use. Whilst many medical device manufacturers are keen to provide improved user experiences and leverage the latest technologies it can be hard to balance 'pushing the envelope' with achieving regulatory compliance whilst simultaneously meeting budgets and timescales.
Conversely, consumer technology companies are increasingly interested in adding more 'health' functionality to their devices in an effort to respond to maintain growth by targeting more sustainably high-value product offers. This leads them ever closer to considering medical regulatory compliance. Apple's CEO Tim Cook has publicly stated that despite his company’s desire to expand into the health space, it would never put a device such as the Apple Watch through the medical device regulatory approval process out of concern that it would hold back innovation. How then can we help to bring the user focus and pace of innovation seen in the consumer space, to the world of medical devices?
Fresh and new thinking is required in order to balance the need to innovate quickly with the structured and rigid approach required to achieve regulatory compliance.
Innovative solutions which are intuitive to use can be key to a product's success, but the formalised procedural medical development process can be stifling to innovation. Early stage prototypes when used appropriately can help in formulating requirements and architectures which are both robust and appropriate, helping to minimise costly changes later in the development process. High level programming languages and the widespread availability of powerful library code mean that software and user interfaces can be prototyped, just as easily as prototype parts can be 3D printed.
Rapidly building early stage prototypes ensures key product assumptions can be tested up front and also allow formative human factors studies to be conducted; enabling refinement of the user experience well before expensive development work is undertaken.
The right process...
Whilst medical device regulations for software are explicit in the phasing of development and required design inputs and outputs they do not mandate a specific development lifecycle.
FDA guidance and IEC 62304 may be interpreted as implying a rigid "waterfall" process, but an Agile approach to software development activities can also meet regulatory requirements. By leveraging the Agile development methodology, our electronics and software team at Kinneir Dufort have been able to respond more reactively to the natural evolution of products during their development, supporting the need to respond to change whilst ensuring regulatory compliance.
By tackling the development phase of medical software in 'Sprints', functional (though incomplete) aspects of the code can be seen by stakeholders as the code base evolves, rather than in one block at the end of the project. This not only increases the engagement of all those involved in making the product a success, it also ensures that any changes which need to be made can be identified as early as possible.
Use your tools...
Development frameworks and tools play an important role in maintaining compliance whilst minimising overheads in the development process. In particular, the results of software unit verification and integration testing must be documented for some classes of software component. By applying tools such as an automated test framework (a tool developed by the Kinneir Dufort software team) we are able to not only reduce software test cycle times but also more efficiently produce verification documentation in accordance with IEC and FDA guidelines.
It’s not just the tools used, but how they interact. By tightly integrating software configuration management, automated test and bug tracking systems, traceability can be maintained at a highly granular level with minimal time consuming overheads and far less opportunity for human error associated with paper based systems. This allows developers to spend more time focused on producing creative solutions and less time updating documentation.
Innovation and the Changing Regulatory Framework...
Regulators are now responding to the challenges of fast-moving software products. In a move last month, as part of its Digital Health Innovation Action Plan the FDA announced that it has created a pilot programme to speed the regulatory pathway for digital health products. Medical product manufacturers and software developers selected to participate in the pilot programme include: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Roche and Samsung. Launching the initiative, FDA Commissioner Scott Gottlieb noted:
"We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices. These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product."
Despite the efforts of regulators to keep up with the rapidly evolving landscape of digital technology, IEC and FDA guidelines will undoubtedly continue to place significant requirements on manufacturers to maintain safety and efficacy standards. However, with effective early stage prototyping, the correct development process and use of the latest development tools, safe and effective software can be brought to the market without having to sacrifice the opportunity to innovate.