Key topics in this article…
- Why independent user research is critical for health tech companies aiming for sustainable growth and market trust.
- How value-based procurement models demand robust, third-party user evidence of real-world outcomes.
- How in-market surveillance supports compliance with evolving regulatory frameworks like EU MDR and FDA guidelines.
- Why continuous, transparent evidence generation is essential for maintaining trust and competitive edge.
- Practical steps for making independent research an integrated part of your growth strategy.
User-generated evidence in health technology
For health technology providers, user research has become an essential foundation for trust, market access, and sustainable growth. From AI diagnostics to remote monitoring platforms and digital therapeutics, health tech companies face mounting scrutiny from buyers, regulators, investors, and, crucially, the patients and clinicians who rely on their solutions.
For leaders in health tech — whether you’re an early-stage founder or steering an established scale-up — the strategic value of generating continuing, credible, independent user research cannot be overstated. It underpins value-based procurement, validates real-world effectiveness, supports compliance in regulated markets, and, ultimately, safeguards the well-being of end users.
The rise of value-based procurement
Healthcare systems worldwide are under immense pressure to deliver more with less. As a result, procurement decisions are shifting from upfront cost considerations alone to a value-based model, where outcomes, long-term savings, and patient benefit drive purchasing choices.
Buyers, from hospitals to integrated care systems, increasingly expect robust in-market evidence that a technology will deliver tangible improvements over incumbent solutions. Anecdotal claims or internal pilot results may open the door, but they rarely close the deal. Independent studies are what decision-makers trust when committing to long-term contracts.
This trend is particularly stark in markets such as the UK, where the NHS’s Value-Based Procurement Framework explicitly demands demonstrated impact on clinical outcomes and cost-effectiveness. Similar pressures are felt across the EU, the US, and APAC regions, as payers and providers align incentives with proven results.
For health tech companies, independent research becomes not only a lever to secure contracts but a strategic asset to differentiate in crowded markets where competing solutions often promise similar benefits.
Demonstrating real-world effectiveness
A prototype that works in a lab is one thing; a solution that delivers measurable improvements at scale, in the complexity of real-world settings, is another entirely. Too many promising technologies stumble when faced with real patient populations, varied clinical workflows, or inconsistent adoption by healthcare professionals.
Independent, in-market surveillance studies that validate technologies over time can move the needle where it matters most. This evidence is becoming increasingly important for helping secure procurement approvals, scale adoption within health systems, and maintain the confidence of clinicians who are, rightly, cautious about introducing new tools into patient care pathways.
Moreover, investors now look for this proof as a key de-risking signal. Many healthcare investors won’t fund significant growth rounds without clear, independently verified outcomes data. The same applies to strategic partners considering acquisitions — demonstrable real-world impact is often a deciding factor in whether an offer is made at all.
Supporting regulatory compliance and continuous improvement
Regulatory frameworks for medical devices and digital health solutions have become significantly more rigorous. In Europe, the Medical Device Regulation (MDR) has raised the bar for clinical evaluation and post-market surveillance. In the US, the FDA’s Digital Health Center of Excellence is pushing for robust evidence for AI-enabled and software-based tools.
This isn’t just about securing initial market approval — it’s about sustaining compliance as you scale and iterate. Independent post-market studies and ongoing monitoring are critical for demonstrating continued safety and effectiveness, particularly when solutions use adaptive algorithms or data-driven personalisation.
Furthermore, independent research creates a feedback loop for continuous improvement. It provides objective insights into how your product performs in diverse settings, identifies gaps, and helps prioritise product enhancements. It also shows regulators that your company takes its post-market obligations seriously — a vital trust signal when working with novel technologies that push the boundaries of existing regulations.
Protecting end-users and building trust
At its core, health tech exists to improve lives. But any technology that touches patient care carries inherent risk if its performance claims are overstated or insufficiently validated. Independent research acts as a safeguard for patients and clinicians by providing an unbiased check on your claims.
When outcomes are verified, it reinforces your credibility, strengthens clinical buy-in, and reassures patients who are becoming increasingly aware — and wary — of unproven digital health promises.
As various high-profile cases have shown, companies that neglect robust validation risk not only regulatory penalties but irreparable damage to reputation and trust.
Making independent research part of your strategy
Embedding independent user research into your health tech business model is an investment in long-term growth. It should not be viewed as a box-ticking exercise for regulatory approval but as an ongoing commitment to evidence generation and continuous improvement.
Key steps include:
- Engaging clinicians and patient groups early in the design of studies to ensure relevance and real-world applicability.
- Building robust post-market surveillance systems that gather real-world data continuously and support adaptive development.
- Communicating results transparently, whether the findings are favourable or highlight areas for improvement — honesty builds trust.
- Allocating budget and internal capacity for ongoing evidence generation — not just for regulatory milestones but to maintain competitive advantage.
Evidence as the basis for trust in health tech
In a sector where people’s health and lives are at stake, claims must stand up to scrutiny. Independent patient/user research is the foundation for that scrutiny — it builds confidence, unlocks access to value-based procurement pathways, meets evolving regulatory expectations, and ensures technologies deliver meaningful, measurable impact where it counts.
This article was prepared by Evid Health, specialists in health technology user intelligence – User experience research that evaluates the real-world performance + value + impact of health technologies.
This content was created with the assistance of AI tools. However, it has undergone thorough human review, editing, and approval to ensure its accuracy, coherence, and quality. While AI technology played a role in its creation, the final version reflects the expertise and judgment of our human editors.