Why You Need an Evidence Strategy

The term evidence strategy isn’t widely used across medtech. It’s often subsumed under clinical evaluation, especially since the introduction of the MDR. But framing evidence solely in regulatory terms is limiting. It focuses on just one stakeholder group: regulators.

In reality, evidence is generated throughout a product’s lifecycle. Being strategic about how it’s collected, stored, analysed, and communicated should be a core consideration. An evidence strategy means knowing:

• What evidence you have

• Where it’s stored

• What it reveals about your product

• How to maximise its value across multiple audiences

  
  

Evidence Is Everywhere—Use It Wisely

From early development to clinical use, data generation is constant. Yet much of this data remains internal, locked in files or patient records, never reaching the public domain. Often, this is for good reason: pre-market test data is commercially sensitive, and clinical data may be inaccessible depending on the context of use.

Still, being aware of what data exists, or will emerge, at each stage of the product lifecycle allows you to be strategic. You can plan how to leverage it for maximum impact, not just compliance.

Beyond Regulatory Compliance: Strategic Value

Post-market surveillance requirements mean ongoing data collection is mandatory. The volume and quality of data will vary depending on your device’s classification and risk profile, but the principle is consistent: ensure the risk-benefit ratio remains favourable and that patients receive safe, effective treatment.

However, evidence can do more than satisfy regulators. Sharing data externally, through publications, presentations, or stakeholder communications, can build excitement ahead of product launch, establish credibility through peer-reviewed support and advance the field by contributing to collective knowledge.

Early publications, such as clinical feasibility studies, can be particularly powerful. So yes, protect your data, but also ask: Would publishing this add more value?  You can share insights without revealing proprietary details, while still:

• Advancing research

• Generating market interest

• Supporting product claims with credible references (rather than “data on file”)

  
  

Building Your Evidence Strategy

When developing your test and clinical plans, think beyond regulatory checkboxes. Ask:

• When will evidence become available?

• Who, beyond regulators, might benefit from it?

• How will you document and analyse it efficiently?

• Through which channels can you maximise its impact?

An evidence strategy isn’t just a compliance tool, it’s a competitive advantage. Use it to tell your product’s story, build trust, and drive innovation.

If you want help developing your evidence strategy, get in touch via info@evistratconsulting.com