What is Compliance Debt – and Why Should You Care About It Now?
By Dr. Youssof Oskrochi, Head of Safety at Curistica
We've identified a critical challenge that can determine a healthtech company's future: compliance debt. Like financial debt, it compounds over time and appears when you can least afford delays.
At Curistica, we regularly hear:
"What documentation do I need for my startup?"
"Is my product a medical device?"
"My prospective client is asking for documentation I don't have – help!"
These represent a pattern across healthtech. Companies build products rapidly, only to stall at investor pitches, due diligence, or NHS procurement because essential compliance elements, particularly DCB0129 clinical safety standards, were overlooked.
What Is Compliance Debt?
We coined the term "compliance debt" at Curistica to describe the accumulation of regulatory, safety and evidence gaps that arise when compliance work is postponed. Similar to technical debt in software, it represents the future cost of taking shortcuts today.
For healthtech companies, DCB0129 compliance is crucial. This mandatory NHS standard requires clinical risk management throughout a product's lifecycle. When neglected, it becomes a significant component of compliance debt.
Dr Youssof Oskrochi, Head of Safety at Curistica
Why It Happens & Its Impact
Companies accumulate compliance debt due to limited resources, clinical expertise gaps, market pressure, and evolving regulatory frameworks. The logic seems sound initially: build fast, address compliance later. However, this approach consistently backfires.
The consequences are substantial:
Extended procurement cycles and revenue delays
Lost contracts to compliant competitors
Investment delays during due diligence
Delayed patient access to innovations
Unmitigated clinical risks
A Better Approach
Embedding compliance from day one doesn't slow innovation—it accelerates sustainable growth.
At Curistica, we've developed a methodology that transforms compliance from a checkpoint into a catalyst. We work with you to know what you can do, where you can push boundaries, and how to make better products through smart regulatory decisions. Our approach builds safety frameworks that enhance innovation, spots potential issues before they become costly, and establishes governance that scales with your growth.
Building Future Agility
When we partner with healthtech innovators, we help build resilience. By addressing compliance debt proactively, our clients can respond quickly to opportunities and scale confidently.
Don't let compliance debt limit your potential. Whether you're at concept stage or facing immediate compliance challenges, Curistica helps your business not just to launch, but to scale.
How we can help
Book a quick initial call to discuss your needs and our strategic DCB0129 services.
