The NENC Medical Technology Initiative: MeDConNecT North

Transcription

1 The NENC Medical Technology Initiative: MeDConNecT North Sam Eldabe Deputy Clinical Director: Clinical Research Network North East and North Cumbria dd/mm/yyyy

2 Medical Technology Industry Why Medical Technology? Med Tech Research vs. Drug Trials MeDConNect Initiative Activity 2015/16 2

3 Why Medical Technology? Far reaching Impact on clinical practice and cost of healthcare Rapid pace of innovation Incremental improvement Disruptive technologies Licensing vs. Reimbursement Pathway to research partnerships with the NHS 3

4 Medical Technology Far Reaching Impact Disruptive Innovation Angioplasty and Stents Fibreoptics and Robotics Electronic publishing Category Precursor Impact Clinical Coronary Artery Bypass Grafting Premature death Acute cardiac intervention Myocardial salvage Clinical Open Surgery Minimally invasive and outpatient surgery Informatics Paper journal slow dissemination Rapid dissemination Open Access 3 D Imaging Technology X-rays CT, MRI, PET Noninvasive diagnostics/ Therapeutics J.L Jameson Disruptive innovation as a driver of science and medicine. J Clin Invest. 2014; 124(7):

5 Med Tech Research: Stages Stage Idea Development Assessment Long Term Study Purpose Investigators Proof of concept Few innovators CE marking/ Learning Innovators/ Early adopters Patients Single digit More, Highly selected Method Case series Single arm cohort/ feasibility RCT Adoption Many Many less highly selected Comparative RCT Surveillance All eligible All eligible Registry Output Description Benefit/Risk Comparative Audit, centre variation Intervention Evolving Evolving/Lock down Stable Stable REC/MHRA Usually Yes/Yes Yes/No Yes/No 5

6 HTA of Drugs vs. Devices Drugs Unchanging compound Complications increase with use Results unrelated to physician skill Placebo usually available Crossover rare Devices Constantly evolving Complications decrease with use Results vary with operator No placebo, complex Crossover common

7 Health Technology Development Basic biomedical research Safety & efficacy Effectiveness and costeffectiveness General clinical use Phase I studies Phase II/III trials Phase IV trials Licensing Reimbursement

8 North East and North Cumbria Clinical 8 Research Network

9 MeDConNecT Initiative Joint Initiative with funding from AHSN NENC and NENC LCRN Based at South Tees with regional remit Medical Technology Manager/Admin Medical Technology Expert Steering Group Facilitate interaction between the NHS and Med Tech companies at all stages of the Medical Technology pathway Enhance Health and Wealth through collaboration with Industry Attract Medical Technology Research to NENC LCRN Smooth the pathway to medical technology research in the NENC 9

10 Med Tech Initiative: Achieving Aims Access via a single entry point into clinical and academic expertise in the North East Access to NHS expertise in all areas through LCRN SG Sign-Posting to expert academics and health economists Establishing collaborations with Industry Provide links to regional national stakeholders NHS innovations NENC AHSN Newcastle DEC NOCRI (HTCs) 10

11 The Team Prof. Nick Linker (Cardiology) Prof Amar Rangan (Trauma & Orthopaedics) Mr. Anirvan Banerjee (Ear Nose and Throat) Prof. Andrew Owen (Cardiac Surgery) Prof. Yan Yiannakou (Gastroenterology) Dr. Andrew Turley (Cardiology) Prof. Sam Eldabe (Anaesthesia and Pain Medicine) 11

12 The Important members Morag Burton BSc MSc Industry Operations Manager NENC Research Network Rachel Forrest BSc MSc Medical Technology Industry Manager NENC Research Network Amanda Goodman MeDConNecT Administrator 12

13 MedConNecT Activity 2015/16 MedConNecT North interacted with 43 companies in 2015/16 Some companies needed support with more than one project MedConNecT North assisted with 51 projects as per breakdown below 14 Technology/Device Types

14 MedConNecT Activity 2015/16 Delivering companies initial request i.e. connection to a clinician, review of a product, introduction to an NHS trust. MedConNecT received 62 project requests during 2015/16 35 initial project requests have been acted upon: 20 of these projects are still on-going 9 successfully completed 6 studies are now in study set up 5 Commercial Portfolio 1 Non-commercial Portfolio 21 project requests are still underway 2 exploring joint Grant applications 6 Project requests were not met and were unsuccessful

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16 Thank You 16