🔬 Clinical Evidence Generation: A practical guide for HealthTech companies

Summary

• This guide introduces practical strategies for generating credible clinical evidence for digital health technologies (DHTs), especially when traditional methods like RCTs are misaligned with the speed of innovation.
• It outlines why evidence is critical—not just for regulatory approval, but also for clinical safety, economic justification, and market access.
• The content also addresses the structural barriers healthtech startups face, such as funding constraints, misaligned incentives, and digital health literacy gaps.

What this carousel covers

• Three pillars of evidence: technical, clinical, and economic
• Why traditional clinical trials are often impractical for digital health solutions
• Alternative approaches to evidence generation including clinical simulation, real-world data (RWD), and platform trials
• The trade-offs and limitations of each approach, along with where they fit in the broader evidence strategy

Key takeaways

• Digital health evidence must be agile, pragmatic, and still rigorous—especially given the rapid pace of product iteration
• Clinical simulation offers cost-effective, scalable evaluation but isn’t a substitute for regulatory-grade evidence on its own
• Real-world data is invaluable for measuring effectiveness in practice, but lacks standardization and may not reveal causal impact
• Platform trials are a flexible, future-oriented model for testing evolving digital interventions—but require significant infrastructure and collaboration

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