The path to achieving digital health compliance in software as a medical device (SaMD) and digital health product development can feel like walking a tightrope. With compliance accounting for about 50% of development spend for digital health products  – approximately $31B annually in the EU and US – the task is significant. Worse yet, nearly half of this expenditure is sunk into unnecessary meetings and costs. 

Alongside this financial burden, a vast knowledge gap plagues the industry; 20% of developers are unaware of the regulatory requirements for their digital products, and a worrying 75% are uncertain about the correct regulatory path to tread. 

Ultimately, achieving compliance for SaMD and digital health offerings creates tremendous financial, organisational and product design burdens that are stifling digital health innovation and our industry’s ability to fix healthcare. What can we do about this? 

The Traditional Approach: A Square Peg in a Round Hole?

The conventional 'waterfall approaches' to development of regulated digital health solutions, taken from the realm of medical device development, simply aren't cutting it for digital health. Regulatory confusion and organisational complexity stand as twin pillars of the problem, leading to repetitive rework and stalled product development. 

Current strategies, such as introducing user-centred design and incorporating pre-approved digital components (using such reusable compliance elements can alleviate the compliance burden for the complete solution), are but small improvements. The industry's go-to method of throwing more manpower at the problem isn't sustainable. These adaptations, although improvements, are incremental, and we need a revolution to ensure SaMD and digital health compliance that fosters the innovation that’s at the core of this field.

The Ideal: Intertwining Business and Compliance

So, what's the better alternative to simply increase manpower that can actually address the issue, and help alleviate the burden of navigating compliance? Businesses need to operate more efficiently and develop business models that give more consideration to regulatory pathways during development. The design of a product must be conducive to its launch and use, taking into account current regulatory requirements. Business models and forecasts must plan and account for this from the start to stand a chance of adoption, as early consideration can streamline the compliance process. Moreover, the development process should focus not only on expected outcomes and scalability but also on revenue generation. 

The Future: Agile Compliance

The future of digital health compliance lies in agile, feature-based development. By launching a compliant minimum viable product (MVP), developments can be made using an agile methodology to iteratively improve based on real user feedback. By focusing on small, iterative improvements and releases, we can reduce patient harm and swiftly respond to market feedback. Regulators, too, are seeing the value in this approach, with initiatives like the PCCP and the new TIR45 encouraging more agile development methods. These changes can't wait for the future; organisations need to build these agile competencies now to stay competitive.

The shift towards agile compliance isn't without its barriers. The structural and organisational obstacles are significant, often leading to fragmented, inefficient approaches. But these hurdles can be overcome. By utilising tools that facilitate collaboration, creating clear processes, and integrating quality and regulatory management systems, we can streamline the compliance journey and deliver smoother, more predictable outcomes.

While the road to compliance may be rocky, the direction is clear: more integration, more agility, more efficiency. If you missed our recent masterclass, where David Feygin (CEO & Founder of Anavo DX) and Randy Horton (Chief Solutions Officer at Orthogonal) walked us through “A Roadmap to Digital Health Compliance: Navigating Regulations, Security & Privacy”, check out the key takeaways and presentation deck here. 

We hope to see you at a HealthXL event soon!