Sue Dunkerton

NIHR Devices for Dignity MedTech Co-operative

D4D is funded by the NIHR to act as a catalyst within the NHS for the development of new medical devices, healthcare technologies and technology-dependent interventions. D4D has developed an adaptable approach to addressing unmet clinical needs. After a clinical need has been identified, we use our networks of patients and experts to independently refine and validate the need. Once we know exactly what the problem is, and that it has a high clinical priority, we can start exploring creative conceptual approaches to addressing the problem, before moving towards producing and refining prototypes. This approach ensures that valuable time and resource are not wasted in developing technologies that are ultimately unlikely to reach the clinic or marketplace. Having developed prototypes, we then evaluate how they can work in clinical practice and as part of people's daily lives. This helps us to obtain the evidence that we need in order to achieve the vital CE mark, and to provide the information needed by clinical departments and NHS purchasers to enable the device to be used in clinical practice. D4D supports businesses to: De -risk innovative projects; Identify and address unknowns from project outsets; Eliminate surprises through the development and commercialisation process; Identify the best people and organisations to work with. Four areas which have proven value are: Concept validation: Checking that product concepts match real user needs; avoiding the trap of trying to sell products to customers who don't really want them. Regulatory services: Establishing a reliable route to regulatory approvals; addressing specific unknowns right from the project outset. Grant Application Support: Helping businesses to identify appropriate sources for development grants and putting together winning grant proposals. Clinical Evidence Planning: Understanding the immediate business needs for clinical evidence and defining