Yale/SEPT Module II Karen Livingstone Director SBRI Healthcare

1. Evidencing the value of SBRI Yale/SEPT Module IIKaren Livingstone Director SBRI Healthcare

2. What is the SBRI Programme? • Small Business Research Initiative (SBRI) is a pan government model for funding the development of early stage technology designed to meet unmet need & accelerate availability. • SBRI is a pre-procurement public investment programme based on the US SBIR model. Each year the US SBIR programme makes over 4000 awards to US small businesses totaling over $2billion in value . • The NHS started to utilise SBRI in health in 2009 when the EoESHA commissioned a £1m regional programme to test the water. Today the NHSE is investing £32m with £64m planned for next financial year. • This presentation charts the route, the challenges & leadership of this dynamic innovation programme.

3. How does it work? Assessment Assessment Open Procurement Workshops with industry to support understanding Typically undertaken by clinicians – service driven Typically 6 months – max of £100k Typically 18 months – milestones agreed & monitored

4. Defining the problem There is insufficient evidence for stakeholders to see the value of the SBRI programme. Create a compelling vision for stakeholders to grow the SBRI programme Overall objective

5. Problems & Objectives • Clinical impact needs evidence • Economic value needs evidence • AHSNs embryonic & new to SBRI • New NHS & economic context • New governance model needed • Piece meal funding • Political change Problems Objectives • Establish shared understanding of appropriate methodology & develop health & economic impact data • Refine programme methodology • Establish new delivery forum & build consensus • Bottom up governance style • Secure funding for 2013 & beyond • Secure support from all sides

6. Root cause analysis Evidence needed to address range of issues

7. Possible delivery strategies Context of NHS re-organisation & Economic partnerships localism agenda

8. Implementation Plan Plan Do StudyAct LISTEN & ENGAGE ENGAGE Build support Clinicians AHSNs Treasury Business Agencies • New governance model • Revised programme • Health economics built in • Procurement built in • Stronger unmet need identification • Secure funding base • Promotion / Stakeholder engagement Refined SBRI offer Consensus over new approach Implementation Task & Finish group NHS England & AHSNs Businesses Clinical community NHS managers Investors Quant & Qualresearch Communications & stakeholder engagement

9. Iterative planning Revised thinking on evidence required Evolved programme Enhanced marketing Revised governance around £ Regular tailoring of messages

10. Stakeholders stakeholders stakeholders ACTORs • Innovation Team • Commercial Directorate • Domain leads • Royal Colleges & MDs Clinical evidence • Programme identifies unmet need • Clinical efficacy for each product is met • Spread of knowledge & uptake of products • Programme saves NHS £ Stakeholders • NHS England • Department of Health • Clinicians in specialty • Wider clinical community Stakeholders • Treasury • Businesses & business representatives • Venture Capitalists & investors • Wider political community Economic evidence • Evidence of support for early stage SMEs • Evidence of jobs & business growth • Evidence of international sales • ROI for public purse ACTORS • Economic Investment team • MediLink, APHI, • Med Tech specialists • No. ten & shadow leaders

11. Outcomes achieved to date • 11 Programmes launched • 5 Leading edge products brought to market • 23 jobs created and 15 safeguarded • Royal colleges backed • Governance agreed with AHSNs • NESTA interim evaluation • NHS leverage - £1 + 84p externally • BIS backing for Euro Growth funds • 100+ clinicians involved • Engagement of key business stakeholders £1m-£3m-£5m-£10m-£32m-£64m Developing ROI

12. Patient impact: Edinburgh based Edixomed have developed a Nitric Oxide dressing for diabetic patients with chronic leg ulcers to enable rapid healing. The company have grown 3 new jobs and safeguarded 2. They have regulatory approval and significant investor interest. Oxford University Spin out Company, Eykona technologies has devised a novel 3D camera which allows for improved monitoring and clinical intervention of chronic wounds in clinics, hospitals and in patient homes. The company have grown from 3 to 13 staff – they are selling to 12 NHS organisations, have secured international sales in Scandinavia and the US My belief is that had we not had the SBRI funding we would not have raised additional private equity funding and had it not been for SBRI validation I don’t think this company would be around now. Peter Bannister, Chief Scientific Officer

13. SBRI is a case of relatively small amounts of money making the difference and being able to develop the new products the public sector needs and support the development of new companies. Patient impact: Dr Kevin Auton, MD Huntingdon based start up Aseptika Ltd has devised a home-based rapid quantitative test for bacterial respiratory infections in patients with cystic fibrosis (CF) The company have safeguarded 2 jobs and are looking to expand into CoPD POLYPHOTONIX Sedgefield based SME has worked with the Liverpool University Hospitals Ophthalmology team to create a LED mask that stops the damage of diabetic retinopathy & wet and dry AMD. Phase II trials are going well and Phase III are commissioned by Moorefield's starting in Sept. The company have increased 5 fold and have all their manufacturing in the UK

14. Measuring success for future KPIs will include: Dispersal of monies to companies Industry participation & satisfaction rates – commercial partners funding Products to market (and/or near to market) ROI - NHS Institute model – Benefits-Costs=Dividends or as a % Health Impact – health economics modeling Economic Impact – modeling conservative impact on GVA with jobs focus International sales and revenue Adoption and spread of products through NHS AHSN engagement and enthusiasm Political backing for more SBRI post the election KPIs are still being agreed www.sbrihealthcare.co.uk

15. Leadership lessons Lessons learned • Clarity on vision but flexibility over delivery mechanism • Evaluation enhanced the programme delivery, informed communications & evidenced the value • Proactive political management was essential to the economic offer • Building bottom up takes time and careful leadership – egos • Building a compelling vision requires stakeholder engagement just to formulate it - if it is to be credible • Create success stories & enable others to tell them – don’t over control • The team needed a strong skill mix – my role is to keep the energy and vision • Personal resilience & flexibility