Yale/SEPT Module II Karen Livingstone Director SBRI Healthcare

Evidencing the value of SBRI

Yale/SEPT Module IIKaren Livingstone Director SBRI Healthcare

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.

Background & Context

Defining the Problem

Problems & objectives

Strategies & selection

Implementation Plan

Impact for patientsEvaluation Future success Lessons for

leadership

How does it work?

Problem Identificatio

n

Open call to Industry

Feasibility Testing

Prototype developmen

t

Typically undertaken by

clinicians – service driven

Workshops with industry to support

understanding Typically 6

months – max of £100k

Typically 18 months –

milestones agreed & monitored

Assessment

Assessmen

t

Open Procurem

ent





Implementation Plan


leadership

Defining the problem There is insufficient evidence for

stakeholders to see the value of the SBRI programme.

Overall objective

Create a compelling vision for stakeholders to grow the SBRI programme





Implementation Plan


leadership

+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

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





Implementation Plan


leadership

Root cause analysis

Evidence needed to address range of issues





Implementation Plan


leadership

+Possible delivery strategies

Delivery mechanism/ lead MoneyDispersal

Experience of SBRI

Service led

Businessexpertise

Stakeholder Engagement

Dispersal of products

NHSE Commission AHSNs (top down)

XXX X XX X X X

TSB manage programme

XXX XX X XXX X X

DH Procurement manage

XX XX X X X XX

AHSNs lead with central support (bottom up)

XX XXX XXX XXX XXX XXContext of NHS re-organisation & Economic partnerships localism agenda





Implementation Plan


leadership

New governance model Revised programme Health economics built in Procurement built in Stronger unmet need

identification Secure funding base

Promotion / Stakeholder engagement

Implementation Plan

Refin

ed S

BRI o

ffer

Cons

ensu

s ove

r new

ap

proa

ch

Impl

emen

tatio

n

ENGAGE

Build support

Clinicians

AHSNsTreasury

Business Agencies

LISTEN & ENGAGE

Task & Finish group

Businesses Clinical

community

Quant & Qual research

Communications & stakeholder engagement

NHS England & AHSNs

Investors NHS

managers

Plan Do Study Act





Implementation Plan


leadership

+Iterative planning

Main activity head key tasks sub tasks responsibilities timeTask & Finish group

Agree Membership KL&MA Jun-12TORs KL&SD Jun-12

Evaluation of SBRI to date KL&AB Oct-12Recommendations to IHW KL&MA Nov-12

Launch 2 new programmes MH & EoL KL&AB&CJ Jan-13Implement Recommendations AHSNs lead responsibility secure agreement NHSE MA Nov-12

EAHSN manage the programme secure agreement NHSE MA Nov-12Revise SBRI programme greater needs assessment work with MIMIT to build KL&AB 2012 & 2013

greater procurement input work with Hub to create KL&AB 2012 & 2013Stronger Health economics commission support KL&AB 2012 & 2013Stronger ROI evaluation utilise ROI calculator KL&AB 2012 & 2013

Communications Create dedicated SBRI Website commission marketing agency CJ 2012

prepare information & materials CJ 2012Promote to Clinicians keynote speaking events KL&RW 2011 & 2012 & 2013

one to ones - AHSNs KL 2012 & 2013

Network of Networks KL 2011 & 2012

Promote to Industry Keynote speaking events KL &DC 2011 & 2012 & 2013

engagement of industry partners APHI & Medilink etc 2012 & 2013

Promote to Politicians one to ones - Health & Opposition KL &DC 2012 & 2013European lobbying Horizon 2020 KL &DC 2011 & 2012

Establish SBRI Management Board

Revised thinking on evidence required

Enhanced marketing

Evolved programme

Revised governance around £





Implementation Plan


leadership

Regular tailoring of messages

+Stakeholders stakeholders stakeholders

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

Innovation Team

Commercial Directorate

Domain leads

Royal Colleges & MDsACTORS

Economic Investment team

MediLink, APHI,

Med Tech specialists

No. ten & shadow leaders





Implementation Plan


leadership

Outcomes achieved to date

Competition LaunchDate

No. of entries received

Contracts AwardedPhase 1 & 2

Value Funding lever-aged

1 DH – Pathogen detection Oct 2008 15 7 2 £2m -2 DH – Hand Hygiene Oct 2008 38 6 4 £3.1m £3m3 Managing Long Term Conditions Apr 2009 89 5 2 £1.2 m £3.19 m

3 Patient Safety Apr 2009 46 5 2 £1.25 m £1.25 m4 Keeping Children Active Apr 2009 42 1 0 £0.1 m -

5 Dementia June 2010 28 7 3 £1.2m -6 Hospital Admissions June 2010 69 5 2 £0.4m -7 Long Term Conditions Feb 2011 73 8 5 £2.2 m £3.2 m8 Medicines Management Apr 2012 49 5 4 £0.5 – +£1.5m phase 2 -

9 Behaviour changes April 2012 108 8 2 £0.68k - +£1.3m phase 2

10 End of Life Jan 2013 97 5 Tbc £2.5m tbc

11 Mental Health Jan 2013 80 4 tbc £2.5m tbcTOTALS TO DATE 734 66 31 £17.63m £2.8m due £10.64m

• 11 Programmes launched• 5 Leading edge products brought to market • 23 jobs created and 15 safeguarded• Royal colleges backed• Governance agreed with AHSNs

£1m-£3m-£5m-£10m-£32m-£64mDeveloping ROI





Implementation Plan


leadership

• NESTA interim evaluation• NHS leverage - £1 + 84p externally• BIS backing for Euro Growth funds• 100+ clinicians involved • Engagement of key business stakeholders

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





Implementation Plan


leadership

Patient impact:

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

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.

Dr Kevin Auton, MD

POLYPHOTONIXSedgefield 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





Implementation Plan


leadership

+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





Implementation Plan


leadership

www.sbrihealthcare.co.uk

+Leadership lessons

1. Clarity on vision but flexibility over delivery mechanism

2. Evaluation enhanced the programme delivery, informed communications & evidenced the value

3. Proactive political management was essential to the economic offer

4. Building bottom up takes time and careful leadership – egos

5. Building a compelling vision requires stakeholder engagement just to formulate it - if it is to be credible

6. Create success stories & enable others to tell them – don’t over control

7. The team needed a strong skill mix – my role is to keep the energy and vision

8. Personal resilience & flexibility

Lessons learned





Implementation Plan

Measuring successEvaluation Future success Lessons for

leadership

Documents

Yale/SEPT Module II Karen Livingstone Director SBRI Healthcare