Presentation by Clare Woods, Business Development Manager for MedTech, NIHR at Excel in Health: developing your innovation for business on Tuesday 12 March 2019 at the Innovation Centre, Daresbury.

1. Clare Woods
The National Institute for
Health Research:
Supporting SMEs

2. What is the NIHR?
Total: £1,032m 2016/17
Aim: ‘Improve the
health and wealth of
the nation through
research’
‘Research arm
of the NHS’
Virtual Organisation to support translational
research and management of clinical trials across
the NHS and partner universities
Supports collaborative
projects between industry,
charities, academia and the
NHS, supporting the
development of therapeutics,
medical devices and IVD
Supports 25,000
Researchers across
the UK

3. Glossary of Abbreviation can be found at the back of this document
NIHR Support
Design Clinical Evaluation Go To Market
UnmetMedical
Need/Care
Pathway
Standardsand
Evidence
Requirements
Research
Methodology
Funding
EarlyPhase
LatePhase
HealthEconomics
Evaluation
RoutetoAdoption
Regulatory
Approvals
Reimbursement
NOCRI: Collaborations and Signposting across the NIHR and UK research ecosystem
BRCs and ECMCs:
MICs:
CRFs / CRN
CPRD, CRIS, D-CRIS, HICs, HDFR
HDRUK, NHS Digital
NIHR Funding
BioResource, NPC, National BioSample Centre
Genomics England, NHS, UK Biobank
Data Provision
Expertise
Research Management
Patients, Sample and Analysis
CLARHCs
Funding
BRCs and ECMCs:
MICs:
CLAHRCs
AHSNs:

4. Access to expertise and
facilities
Support to set up and
deliver trials in the NHS
Funding for research
NIHR Services for Innovation

5. Access to Expertise
Open door to industry
SMEs are small and may have little
capacity for building networks of
investigators and KOLs
NIHR offers a SIGNPOSTING SERVICE
Service is simple and free of charge
Companies must complete a form at:
nihr.ac.uk/4industry

6. NIHR MedTech and In Vitro
Diagnostic Co-operatives (MICs)
• Development and evaluation of IVDs, medical
devices and digital technologies
• Pilot studies, technology evaluations, trials, health
economics, product development, patient
involvement, workshops, usability testing, proof of
concept, human factors
• Expertise
• Clinical, academic, care pathway, regulatory,
funding, market landscape, statistics, health
economics, product design
VR technology
developed in
collaboration with
D4D MIC

7. • NIHR MICs build expertise and capacity in the NHS
• To develop new medical technologies and IVD tests
• Provide evidence on commercially-supplied IVD tests
• Leading NHS organisations act as centres of expertise, bringing together patients,
clinicians, researchers, commissioners and industry
• More than £14 million over 5 years has been awarded across 11 NIHR MICs
• Replaced the NIHR Healthcare Technology Co-operatives (HTCs) and NIHR
Diagnostic Evidence Co-operatives (DECs)
NIHR MedTech and In Vitro Diagnostic
Co-operatives (MICs)

8. MICs - The Numbers
In FY 17/18
MICs ran 246
research
projects
Worked with
481 SMEs
Recruited
8285 patients
to studies
In FY17/18 MIC projects received over £12 million in
funding from i4i

9. Our offer to you
We can support you by identifying and introducing
you to experts from across the whole country that
have the skills, knowledge, provisions and desire
to work with you.
1.Strategic level account management
2.Create additional value to your pipeline through
strategic alliances
3.Build bespoke collaborations around your
research interests
4.Connect you to the wider UK infrastructure and
government

10. Access to expertise and
facilities
Support to set up and
deliver trials in the NHS
Funding for research
NIHR Services for Innovation

11. Support to Deliver Trials
• Clinical Research Network (CRN) provide
the Study Support Service
• You should use this service when you
have……
• Secured funding
• Developed a protocol
And
•Want to deliver
research in the NHS
If you don’t have this,
we can help you get it
through the funding
programmes!
If you don’t have this,
we can help you get it
through the signposting
service!

13. NIHR Delivering Clinical Trials
(2017/18)
2070
new
studies
697
commercial
725,333
patients
recruited
50,112
commercial
99%
NHS trusts
research active
82%
commercial
1300+
new CDAs
signed since
2006

14. Access to expertise and
facilities
Support to set up and
deliver trials in the NHS
Funding for research
NIHR Services for Innovation

15. Funding for research

16. Medtech funding landscape
EPSRC
NIHR HTA
SBRI Healthcare
NIHR i4i NIHR EME
WT/Seed Awards
Innovate UK
Biomedical
Catalyst
Innovate UK
Feasibility
Studies Primer Award
BBSRC
MRCMRC
Biomedical
Catalyst
WT/MRC
Joint Global
Health Trials
Confidence in
Con (CiC) Development Pathway
Funding Scheme (DPFS)
Angel Investors
Venture capital
Industry
Charities
Basic research
Translational
development
Clinical evaluation
Adoption &
diffusion

17. The i4i Programme
• Focuses on innovative MedTech
solutions
• De-risking projects for follow-on
investment
• Requires collaboartive R&D team –
any 2 of NHS, University and SME
• Takes roughly 9 months
• Funds: R&D, health economics,
regulatory, IP & commercial,
manufacturing, clinical trials
Investing over £107 million
Supporting over 200
organisations
Funding over 150 projects
Has been running for 10 years…
If you don’t have this, we
can help you get it through
the signposting service!

18. Our value proposition
Dedicated medtech funding programme
Uncapped awards
Risk- and impact focused award monitoring
Can be led by academics, clinicians, SMEs
Peer review & commercially oriented panel
Thorough due diligence for de-risking
Links to early stage investor community

19. i4i Awards
Product Development Award (PDA)
• Research and development of medical devices
• Derisking of products that have achieved proof of principal but are not yet
suitable for follow on funding or commercialisation
Challenge Award
• Themed Call
Connect Award
• Specifically for SMEs
• Offering between £50,000-£150,000 over a 6-12 month period

20. RAND Report
“…We felt we had the
opportunity to drive our platform
and technology forward…”
“The i4i team was
instrumental in
raising the
visibility and the
overall impact
of the work”
“When we seek
advice from NHS
stakeholders…they
are more willing
to help if you have
an NIHR award”
Valuable support
from i4i team
Less bureaucratic
than other funders
Adaptable and
responsive
Open to diverse
healthcare needs
i4i support
helps secure follow-
on funding
i4i provides support
beyond usual
suspects
i4i process helps
proposal
improvement
i4i is a rare funder of
high risk early
innovation
The NIHR Invention for Innovation (i4i) programme, RAND (2015), A review of progress and
contributions to innovation in healthcare technologies.
https://www.rand.org/pubs/research_reports/RR1101.html

21. i4i portfolio - diseases
Blood, 0.8%
Cancer, 16.9%
Cardiovascular, 6.9%
Ear, 0.8%
Eye, 10.0%
Generic health relevance,
3.1%
Infection, 10.8%
Inflammatory & Immune
System, 0.8%Injuries & Accidents, 3.8%
Mental health, 1.5%
Metabolic &
Endocrine, 3.1%
Muscoloskeletal, 6.9%
Neurological, 3.1%
Oral & Gastrointestinal,
5.4%
Other, 0.8%
Renal & Urogenital, 5.4%
Reproductive health &
Childbirth, 6.2%
Respiratory, 5.4%
Skin, 3.1%
Stroke, 5.4%

22. i4i portfolio - regions
East Midlands
8%
Eastern
3%
Greater Manchester
5%
Health Innovation
Network - South
London
8%
Imperial College Health
Partners
8%
Kent, Surrey & Sussex
3%
North East Coast and
North Cumbria
4%
North West Coast
8%Oxford
8%
South West
3%
UCL Partners
14%
Wessex
4%
West Midlands
5%
West of England
4%
Yorkshire
&
Humber
9%
Wales
5%

23. i4i portfolio
SME Led
11%
SME co-app
42%
No SME
47%
SME Involvement
61%
26%
2%
11%
Funded portfolio, % organisation per type
HEIs
NHS
Research Institutes
SMEs

24. A successful application
Proof-of-
concept
Clinical need and
impact on
NHS/patients
Innovation
Project plan
&
Team
Patient and
public
involvement
Regulatory
IP & commercial
strategy
NHS adoption Value for money

25. Words of wisdom
• Don‘t leave it until the last minute
• Clear and achievable deliverables
• Accurate budgeting
• Clinical trials:
− Approvals
− Recruitment rate
− Link with Clinical Trial Unit
− Statistical input

26. Compact dialysis machine
• Quanta Fluid Solutions Ltd, £2.4M from i4i
• CE-marked home dialysis machine
• Compact, user-friendly, simple cartridge system
• Reduced time burden, improved survival
• Estimated NHS cost savings £15k per patient per year
• Secured £45M of VC funding

27. Access to expertise and
facilities
Support to set up and
deliver trials in the NHS
Funding for research
NIHR Services for Innovation

28. Questions?
clare.woods@nihr.ac.uk
@ClareLucyWoods @NIHR_Industry