And what can you do if the answer is „no“?
Medical device manufacturers continuously have to evaluate the following question: Does our device still reflect the latest scientific, technological, and clinical expectations, or has the field moved on?
In this post, you’ll learn why evaluating the State of the Art (SOTA) is more than a regulatory checkpoint, how it directly affects your device’s purpose and indications, and why timely updates can secure long-term market success.
The SOTA evaluation is more than a regulatory requirement
Most manufacturers view SOTA evaluations as part of regulatory due diligence. It’s a required task but often filed under “regulatory burden.”
Yet, the SOTA can be much more: it’s a benchmark of whether your device is still part of the standard of care.
Clinical practice evolves, guidelines change, new alternatives enter the market. What used to be best practice five years ago may now be outdated or incomplete.
A SOTA evaluation answers the critical question:
➡️ Does our device, including its purpose, indications, and risk profile, still match current clinical practice?
Refining indications can be the solution
When SOTA analysis reveals misalignment, refining the indications is often the most effective corrective action.
Updated, precise indications can:
- Strengthen the foundation for clinical evaluation
- Clearly differentiate the device from outdated competitors
- Enable more targeted risk-benefit reasoning
- Improve acceptance among clinicians and notified bodies
- Support a more robust and compliant market strategy
💡 What looks like a regulatory exercise can become a strategic repositioning of your device in a competitive environment.
Manufacturers who proactively revise their device’s SOTA make sure to:
- Identify misalignment early
- Adjust the device’s purpose and indications
- Avoid recertification delays or rejections
If you want support evaluating your device’s SOTA, refining indications, or preparing clinical evidence, I’m happy to offer a free initial consultation to explore your situation and define next steps.