Med-tech and diagnostic device pathways in Newcastle
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1 Med-tech and diagnostic device pathways in Newcastle Andrew Sims Medical Physics Newcastle upon Tyne Hospitals NHS Foundation Trust 12/07/2016 AHSN Stakeholder Engagement Meeting 1
2 Introduction Section Innovation Pathway Example Development Evidence generation Health technology assessment Ideas Culture Intellectual Property Commercialisation Clinical Trials Evaluation Adoption Novel devices (Medical Physics) NIHR Diagnostic Evidence Cooperative, Newcastle Advice and partnerships with SMEs NICE Medical Technologies External Assessment Centre, Newcastle & York 12/07/2016 AHSN Stakeholder Engagement Meeting 2
3 Novel devices DEVELOPMENT 12/07/2016 AHSN Stakeholder Engagement Meeting 3
4 Development Track record of developing novel med-tech in Newcastle Hospitals (> 20 y) Diagnostics and therapeutic Sensors, electronics, software Motivated by local clinical needs Recognised the need to evolve: Licencing partnerships for exploitation of ideas Regulatory expertise External funding support for development and trials Examples PeePod Cas-per NIDUS CANDO 12/07/2016 AHSN Stakeholder Engagement Meeting 4
5 PeePod 12/07/2016 AHSN Stakeholder Engagement Meeting 5
6 cas-per Software tool for managing referrals for radiotherapy and chemotherapy. Based on local treatment protocols. Supports hub and spoke models for cancer treatment. Originally developed by NuTH, now licensed to Cievert Ltd. 12/07/2016 AHSN Stakeholder Engagement Meeting 6
7 NIDUS (Newcastle Infant Dialysis and Ultrafiltration System) For babies weighing from 800g to 8kg, single lumen line, without blood priming, microlitre ultrafiltration control. Recently licensed to a manufacturer of dialysis machines and filters. 12/07/2016 AHSN Stakeholder Engagement Meeting 7
8 CANDO (Controlling Abnormal Network Dynamics with Optogenetics) Wellcome/EPSRC Innovative Engineering for Health award Led by IoN (with SAgE, Imperial College, UCL, NuTH) To develop a cortical implant for optogenetic neural control. Goal is first-in-human trial in patients with focal epilepsy NuTH Medical Physics: support for device regulatory approvals 12/07/2016 AHSN Stakeholder Engagement Meeting 8
9 NIHR Diagnostic Evidence Cooperative (DEC) Newcastle EVIDENCE GENERATION 12/07/2016 AHSN Stakeholder Engagement Meeting 9
10 NIHR DECs why? Four DECs in England supported with 4m NIHR funding for 4 years from Sept 2013 The DECs have a remit to catalyse the generation of high-quality evidence on the benefit and value of in vitro diagnostic tests (IVDs): clinical validity clinical utility cost effectiveness and care pathway benefits 12/07/2016 AHSN Stakeholder Engagement Meeting 10
11 NIHR DECs what? 12/07/2016 AHSN Stakeholder Engagement Meeting 11
12 NIHR DEC Newcastle Part of the wider NIHR Infrastructure BRCs/BRUs/RDS/TRPs etc. NOCRI co-ordination Founded on excellence in delivery of clinical research: Infectious diseases Molecular genetics Cancer Musculoskeletal Liver Respiratory Stroke and cardiovascular Benefit from very close research links between Newcastle Hospital Trust and Newcastle University (Newcastle Academic Health Partners) 12/07/2016 AHSN Stakeholder Engagement Meeting 12
13 NIHR DEC Newcastle who? Newcastle DEC capabilities: DEC Director: Prof. John Simpson, Dean for Translational Research, Consultant Respiratory Physician 4 IVD evaluation methodologists Evidence-based medicine specialist Health economist & statistical support (Newcastle University) Industry liaison specialist (NuTH BDM) Closely linked to: Trust and PHE labs Academic Health Science Network (Innovation Pathway) Medical technologies experts (NuTH Med Phys/NICE-EAC) 12/07/2016 AHSN Stakeholder Engagement Meeting 13
14 NICE External Assessment Centre for Medical Technologies, Newcastle and York HEALTH TECHNOLOGY ASSESSMENT 12/07/2016 AHSN Stakeholder Engagement Meeting 14
15 Newcastle and York EAC One of four EACs contracted to the NICE Medical Technologies Evaluation Programme (MTEP) Partnership with York Health Economics Consortium (YHEC) Technology Assessment Reports Leading to NICE guidance Research facilitation For promising devices where evidence is weak Registries and observational studies Measure outcomes in real-world settings Systematic reviews Inform guidance for several programmes Technical evaluations Inform guidance and advise on effective use 12/07/2016 AHSN Stakeholder Engagement Meeting 15
16 12/07/2016 AHSN Stakeholder Engagement Meeting 16
17 Leading to and a BRC-funded PhD studentship to design and trial a device to detect AF opportunistically during ambulatory BP measurement. 12/07/2016 AHSN Stakeholder Engagement Meeting 17
18 Developing cases for adoption AHSN INNOVATION PATHWAY 12/07/2016 AHSN Stakeholder Engagement Meeting 18
19 Newcastle as an innovation partner Work with companies to develop case for adoption Identify clinical partners Identify evidence gaps Advise and develop trial design Joint applications for funding Appropriate routing IVDs referred to DEC Med-tech led by Medical Physics team, or Matchmaking with more appropriate clinician/scientist in Newcastle 12/07/2016 AHSN Stakeholder Engagement Meeting 19
20 CONTACTS 12/07/2016 AHSN Stakeholder Engagement Meeting 20
21 Contact us: DEC EAC Medical Physics (Innovation Pathway) Medical Physics Ray Waters Project Manager Helen Cole Centre Manager Liz Clements Research Manager Andrew Sims Head of Unit #NEmedtech /07/2016 AHSN Stakeholder Engagement Meeting 21
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