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Human Factors, Usability and Regulatory Readiness
It includes usability engineering to ensure technologies are intuitive to use, formative studies to identify and reduce use-related risks early, and summative evaluations to demonstrate safe and effective use for regulatory compliance.
Market Access and Economic Value
It involves analysing clinical impact, costs, and system value to demonstrate how a technology delivers benefit within real healthcare pathways. This work is essential for securing adoption, supporting reimbursement decisions, and enabling technologies to scale within healthcare systems.
Prove it. Place it. Scale it.
Lumina Health Tech helps medical technologies move safely and successfully into the market.
Our mission is to minimise risk in adoption and maximise real-world impact through human factors, regulatory-ready evidence, and market insight.
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Founded by a team of consultants with over a decade of experience in medical device development, we work at the intersection of regulated healthcare, public funding, and real-world use. We specialise in real-world evidence generation and studies in context of use, helping organisations understand how technologies perform where it matters most.
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We have supported startups, consultancies, MedTech, and pharmaceutical companies to reduce use-related risk, meet regulatory requirements, secure public funding for research and development, and scale adoption within healthcare systems.
We understand the complexity of healthcare — and we know how to unlock your value and make your technology succeed in the real world.
Built around user engagement
Theory doesn’t sell. Practice does.
Whether working with clinicians, patients, final users, or technical teams, our studies place users at the centre through validated, human-centred methods.
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By engaging users at every stage of product development, we generate real-world evidence that improves usability, strengthens clinical utility, and increases the value of medical devices in the market.

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Contact
Kemp House 160 City Road
London
EC1V 2NX
United Kingdom (UK)
TEL: +447426960255
Email: info@luminahealthtech.com



