Need-led device development and data-driven regulatory support
Our 'Need-led device development and data-driven regulatory support' theme ensures that HealthTech meets technology development objectives and regulatory requirements.
We support NHS pull-through innovation and contribute regulatory, as well as design perspectives early in the research and stages to accelerate the path from identification to implementation.
Key areas of focus:
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Current projects
- HealthTech needs mapping
Developing solutions and materials to identify and priorities unmet healthcare needs across different clinical areas and patient populations. - Regulatory navigation
Creating data-driven solutions to guide HealthTech innovators through the complex landscape of medical device regulations. - User-centered design
Supporting design orientated methods for device development by bringing together clinicians, patients, and developers to co-create HealthTech solutions.
Impact
Our work in this theme aims to:
- Ensure HealthTech innovations address genuine healthcare needs
- Accelerate the regulatory approval process for new devices
- Improve the usability and adoption of new technologies
- Reduce the risk of late-stage product failures
Collaborations:
We work closely with NHS clinicians, patients, regulatory bodies (such as the MHRA, FDA or EMEA), HealthTech companies, and academic researchers across various disciplines.
Get Involved
Are you a healthcare professional with ideas for new devices, a HealthTech company navigating regulations, or a patient interested in shaping future technologies? We'd love to hear from you! Contact us to learn about opportunities to contribute to need-led innovation or receive regulatory guidance.
Theme lead
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Jeroen Bergmann
Professor of Engineering Innovation, fellow in Engineering Science
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