CEO UOVO Medtech - Driving Cost-Efficient Medtech Regulatory Compliance | SaMD | AI & Machine Learning | Medical Devices | IVDs |
What is 'Regulatory Debt' and Why You Should Avoid It The concept of 'technical debt', which will be familiar to most software developers, has parallels in the world of SaMD regulatory compliance. Just as technical debt accumulates when developers opt for code that is easy to implement in the short run instead of applying the best overall solution, 'regulatory debt' can similarly accumulate in SaMD development. This form of debt arises when activities and tasks required for compliance with standards and regulations are postponed. Regulatory debt in SaMD development manifests in several ways, often stemming from a desire to create ‘working software’ quickly, though it can arise through inadequate understanding of regulation and standards and their practical application. Regulatory debt is analogous to financial debt in that, if not addressed, the "interest" (i.e., additional work and complexity) accumulates. Key contributors to regulatory debt include: 1. Not implementing and following a QMS 2. Postponing risk management activities 3. Delaying usability engineering 4. Deferring cybersecurity 5. Postponing documentation 6. Inadequate early planning 7. Creating insufficiently detailed requirements 8. Inadequate verification and over-reliance on testing Regulatory debt is not just a matter of ticking boxes; it has real-world implications. Products may face delays in getting to market, or worse, they may be recalled from the market if they fail to comply with regulatory requirements. This can lead to financial losses, reputational damage, and legal consequences. More importantly, if you do manage to get past an auditor, it can compromise patient safety. Avoiding regulatory debt is crucial for several reasons: 1. Slower time to market: Despite the illusion of rapid early progress, the overall product development lifecycle will be slower. This is especially so if regulatory submissions are rejected. 2. Development Costs: Addressing regulatory debt later in the development process can be costly. It's more efficient to integrate compliance from the outset. 3. Missed opportunity: Delayed product launch dates will result in lost opportunity to gain competitive advantage and generate revenues. 4. Reputation: Companies that consistently achieve regulatory certifications build a reputation for reliability, safety and security, with customers and investors. 5. Patient Safety: This is the most critical factor. Ensuring that products are safe and effective for patient use is the primary goal of regulatory compliance. Conclusion: Resist the temptation to see rapid progress when developing an SaMD. Progress made this way is illusory and the overall project will be slower and cost more. There's nothing wrong with research or prototyping - just not in a development project under design controls.