Key elements in a successful MedTech translational research and development proposal

Transcription

1 Key elements in a successful MedTech translational research and development proposal Dr. Peter Jarritt Ph.D. FIPEM. (Hon)FRCP. Deputy Director NIHR Healthcare Technology Cooperative Brain Injury Cambridge UK

2 NIHR Research Infrastructure Invention Innovation Evaluation Adoption Early-phase clinical research Late-phase clinical research NIHR Biomedical Research Centres NIHR Biomedical Research Units NIHR Clinical Research Facilities Experimental Cancer Medicine Centres > 0.5 billion p.a. investment in relevant infrastructure to support clinical research at all points in development pipeline Healthcare Technology Cooperatives Diagnostic Evidence Cooperatives NIHR Clinical Research Network NIHR Collaborations for Leadership in Applied Health Research & Care

3 NIHR Biomedical Research Centres NIHR Biomedical Research Units NIHR-supported Clinical Research Facilities NIHR Experimental Cancer Medicine Centres NIHR Healthcare Technology Co-operatives Newcastle Bradford Leeds Manchester Liverpool Sheffield Nottingham Leicester Birmingham Cambridge Oxford Bristol London NIHR Diagnostic Evidence Co-operatives Exeter Brighton Southampton

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5 Each HTC should understand their own patient s journey Scene A&E Prevention Theatre NCCU Rehab

6 The Brief The Focus Group emphasized the importance that proposals should aim to address market needs ideally by working closely with clinicians and industry. The proposal should also consider data ownerships, ethical issues and appropriate regulatory pathways. A business plan is required to provide exploitation plan(s) with support from appropriate industrial collaboration to ensure route to market.

7 The Guidance Outline Application Technical Outline Impact on the Challenge Area(s) Timescale and Outline Work Plan Project Partners Estimated Costs

8 The Guidance Full Application Background and Aims. Technical Summary Business Plan including; Freedom to Operate, Market Research, Competitor Analysis, Route to Market. Work plan and Risk Analysis Resources Project Deliverables

9 CLASP Objective To support projects that have the potential to develop viable healthcare solutions within a 3-5 year timeline. Implies concepts are mature and already in the process of translation, especially for Medical Devices subject to regulatory controls. Assessment needs to be aware of potential timelines to market for MedTech, however, this makes the supporting information more important.

10 Issues for Healthcare Applications Poor understanding of the Clinical/Healthcare problem to be addressed. Inability to articulate what healthcare problem will be addressed, what is the level of unmet need. No engagement with Patients and Public. Unrealistic timelines especially where clinical validation required. Will the product be a Medical Device (includes software & hardware)?

11 What is the problem that needs a solution? You need to love the problem!

12 Key Questions to Answer Is this an R&D proposal? Has a proof of concept study been undertaken? Is the proposal for product development? Product impact How many people/patients will benefit Evidence of Unmet Need from Users Clinicians/Public/Patients Support from carers/professionals. Advantage over competitor products. Intellectual property landscape.

13 Key Questions to Answer Type of resources required to deliver. Commercial interest in the idea. Technical feasibility. Time and Route to market (total project) Cost versus return n.b. NHS only interested in products that are cost neutral or preferably cost reducing. Regulatory pathway Is it a Medical Device, if so what class.

14 Resources Local Clinical Engineering departments with R&D capabilities. Clinical leads/specialists. Relevant patient/carer groups and charities. NIHR Health Technology Co-operatives. Academic Health Science Networks.

15 Conclusions Understand and articulate the healthcare problem that needs a solution. Explain the impact on patient care pathways including cost and outcome benefits. Understand the regulatory requirements and demonstrate an understanding of the timelines or the development of MedTech devices. Focus on de-risking an idea/concept through a proof of concept study if not already completed. Ensure you have good clinical/professional engagement.