Our offering
The NIHR HRC-DDR will deliver a national centre of excellence to support the translation of new healthcare technologies safely, effectively, and efficiently into routine care for NHS patients and follow-on social care. We will do this by supporting industry, clinicians and academia to develop novel HealthTech, with the aim of bringing patient benefits and to improve healthcare efficiency.
We will provide the following key support to partners, innovating to address unmet clinical needs:
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Grant application support
The NIHR HRC-DDR can support in scoping for suitable funding opportunities, reviewing applications, and including work packages of support.
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Expert Reviews
Conducted early in the development process of HealthTech, expert reviews, gain detailed insight into the unmet clinical needs and important design and functionality requirements.
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Pre-regulatory human factors/ usability testing with patient simulators in realistic environments
Conducted iteratively throughout the development of technologies, formative usability studies highlight user errors and gain end user feedback to support future design iterations. Once a near final version of the technology has been developed, summative studies are delivered with a near final version of the technology. These studies identify use errors in a larger number of volunteers, within a highly realistic clinical environment, and collect key end user feedback. Completed in line with IEC 62366, the reports can be used in regulatory technical files.
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First-In-Human Clinical Investigations
The NIHR HRC-DDR have expertise in preparing study documentation and completing IRAS form submissions. These form part of the application process for regulatory approval of first-in-human clinical investigations. These studies are designed to assess essential safety and performance of technology. Through collaboration with clinical colleagues in chief investigator capacity, the team also support the delivery of clinical investigations.
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Patient and Public Involvement and Engagement Support
The NIHR HRC-DDR can support industry in identifying and engaging with relevant patient and public members in a meaningful and mutually beneficial way, ensuring the patient voice is heard throughout technology development.
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Health Economics Support
The NIHR HRC-DDR fund a dedicated health economist who can provide support including value proposition calculations for grant funding opportunities, calculation of optimal pricing strategies and model-based, supply side, economic analyses.
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Regulatory Support
Provide advice on the regulatory pathway, considering the appropriate regulations and evidence generation requirements for regulatory approval, where required.