From Concept to Clinic: How TRLs Measure Progress in Digital Health

The digital health revolution is upon us, with a wave of innovative technologies promising to transform healthcare delivery. But how do we gauge the maturity of these projects and predict their real-world impact? This is where the concept of Technology Readiness Levels (TRLs) comes in.

TRL: A Roadmap for Innovation

Developed by NASA in the 1970s, TRLs are a standardized framework for assessing the maturity of a technology. It assigns a level (from 1 to 9) based on its development stage, with higher levels indicating greater progress towards real-world application.

Here's how TRLs translate to the world of digital health:

• TRL 1-3: Early Days - The initial concept is being explored. Research is underway, and basic functionalities are being established. Think of it as a scientist brainstorming a new app to help patients manage chronic conditions.
• TRL 4-6: Taking Shape - A prototype is built and tested in controlled environments. Imagine a pilot program where a diabetes management app is trialed with a small group of patients.
• TRL 7-9: Ready for Prime Time - The technology is fully developed and validated through large-scale clinical trials. The diabetes app is now commercially available and shows positive outcomes in improving patient self-management.

Why TRLs Matter for Digital Health

Understanding TRLs offers several benefits:

• Investment Decisions: Investors can use TRLs to assess the risk and potential reward of a digital health project. A TRL 3 project might be high-risk but potentially groundbreaking, while a TRL 8 solution offers more certainty but might be less revolutionary.
• Project Management: For developers, TRLs provide a clear roadmap for development stages and milestones. Knowing what needs to be achieved at each level helps to keep projects on track.
• Regulatory Navigation: Regulatory bodies can utilize TRLs to determine the appropriate level of oversight required for different digital health solutions. A TRL 2 project might require minimal oversight, while a TRL 9 application might need rigorous testing before approval.

Beyond the Technical: Service Readiness

While TRLs are excellent for assessing technical maturity, some argue they don't fully capture the readiness of a digital health solution to integrate seamlessly into healthcare systems. This is where the concept of "Service Readiness Levels" (SRLs) comes in. SRLs consider factors like user adoption, data security, and reimbursement models – crucial aspects for real-world success.

Road Ahead

By combining TRLs with SRLs, we gain a comprehensive view of a digital health project's development journey. This allows us to effectively track innovation, make informed investment decisions, and ultimately, ensure that promising digital health solutions reach their full potential and improve patient care.