Supporting Innovation in Medical Technology Enterprises

Wessex presents:
Supporting Innovation in Medical Technology Enterprises
9th May 2018
Dunwood Oaks Centre, Romsey

Digital Dorset
Transforming care in a progressive integrated care
system
Dr Phil Richardson
SRO Digital
Dorset Integrated Care System

Digital Dorset: digital vision
Our vision is to support the transforming health and social
care system with a collaborative Dorset Digital
service. Local people and sustainable delivery of better
outcomes will be at the core of everything we do. We will
adopt and exploit the best available technology to ensure
appropriate digital services safely empower people in their
homes, communities and care settings.

Transforming care as a core of the STP

Digital Dorset: the system commitment
• CIOs and CCIOs with system leadership came together as one team
• SRO member of the System Leadership Team (SLT)
• Risk share funding contribution following withdrawal of national
funding
• Resource commitment for key portfolios of work
• Individuals often meeting in evening and working longer hours to
contribute
• Conflicting priorities addressed immediately by SLT
• CCG contingency to provide resilience

Frail elderly
• Combatting loneliness/isolation
• empowering peer-group support – brokering physical and virtual buddying
• Using same tech for virtual professional visits, buddying and relatives use
• Joined up care
• Solving problems as a single team
• Nutrition – early warning of decline
• Heating
• smart monitoring of room temperature/movement
• Thermal efficiency of buildings
• passive heating/cooling, shading
• renewable energy combatting fuel poverty
• District heating systems

Maternity
• Empowered
• birth plans – available for parents to update, shared entire team
• online live chat 24/7 to answer queries, especially postnatally
• Organised
• Future appointments online
• Test results online
• Linked
• To Post-natal eRed Book
• To professional records
• To social media (if want it)
• Birth as a key life event to celebrate
• (wherever possible)

Working age – with a long term condition
• Interpretation from wearable devices
• reminders to self
• supportive proactive interventions from professionals
• Ability to email or Skype care professionals
• Availability of services at evenings and weekends

Digitally Supported Experience
Booking
Arriving
Registering
ConsultingReferring
Follow up
Self Care
Check In
Navigation/wayfinding
Automated preliminary
checks
Parking
Booking in the
Consultation
Consultant/Specialist
conversation
Remote
consultation
Remote monitoring
Record
Coproduction
AI Diagnosis
AI Referral to the right
place
Prevention Educational
opportunity
Continuing
Monitoring

DigitallyTransformed Dorset
Strategic
IT
Initiatives
Migrations complete - CCGFirst Phase DCR Live
STP
demands
and
Portfolios
Implemented
Patient Wi-Fi - GP
Employee Development
CCG & DCH
Automation of marketing
campaigns - CCG
95% migration from EMIS to
SystmOne in GP Surgeries
New Mobile phone contract
(soon to expand to GP
Surgeries)
100% IT Team within CCG
Certified
Zero operational impact or
Dorset wide power outage72% usage of E-RS in GP
Practices
One Acute
Network
Integrated Community
& Primary Care
Prevention at Scale Leading and Working
Differently

In Implementation
Strategic
IT
Initiatives
Business Intelligence for AI, Analytics, Risk Stratification and Population Health Analytics
STP
demands
and
Portfolios
Migrations underway - GP
Single GP Platform
Single Integrated Medicines Management solution
GP Template set framework
On-Line Digital Consultation
Telehealth & Assistive
technologies
Current Waiting time at
urgent care centres
Upgrade from N3 to HSCNIntegrated Clinical
Environment Radiology &
Pathology image network
Single Domain, Tech Update
& Mobilisation
One Acute Network Integrated Community
& Primary Care
Prevention at Scale Leading and Working
Differently
Digitally Transformed
Dorset

Digital Dorset: rich engagement ecosystem
• Microsoft, Samsung, Sony, Oracle, Deep Mind, IBM, Limbix, Vitae VR, Psious, Physium,
• Clinical Research Network
• Clinicians involved in digital innovation
• AHSN
• Strategic Clinical Networks
• HEE
• CLAHRC
• Research Active Dorset
• Public Engagement Group (an ICS public partnership)
• Pharma and Medtech companies
• Global Digital Exemplars
• BCS

Our digital philosophy
• A digital hub that delivers community care
• A digital hospital that delivers emergency or planned care
• A design led approach to patient experience
• Evidence based, research led, experience designed, clinically crafted,
public produced,
• Making it easier for our staff to deliver safer care in a sustainable way
• Asking why it isn’t digital
• Supporting staff and patients to be digital enabled
• Working with the local authorities on infrastructure

Planned
Strategic
IT
Initiatives
Single Signon
Paperless
Digitally Transformed Dorset
STP
demands
and
Portfolios
DCR Public Portal
Platform integration
Cloudification
Platform harmonisation
HSCN Deployment
Common Telephony
Platform
Seamless Wi-Fi service
Social Prescribing
Digital Active Dorset
Employee Development
System Wide
Shrewd – Enabled by
Digitally transformed
Dorset
GPTeamNet – Enabled by
Digitally transformed Dorset
Vscan Ultrasound – Enabled
by Digitally transformed
Dorset
Virtual Reality – Enabled by
Healthy.io – Enabled by
One Acute Network Integrated Community
& Primary Care
Prevention at Scale Leading and
Working Differently

Digital Dorset: opportunities to be involved
• VR and the use in mental health
• AR for assisted living
• Social prescribing and self care platforms.
• Block chain
• AI as a system
• Untethering from old infrastructure
• Man out-of-the-loop-for-frailty-care
• Population decision support systems
• Adoption research
• Learning systems
• Self healing, self repair, self aware design
• Collaboration through O365
• The intelligent locality

Wessex presents:
Supporting Innovation in Medical Technology Enterprises

Nottingham
6 Feb 2018
Daresbury
1 March 2018
Southampton
9 May 2018
Leeds
7 June 2018
London
16 Nov 2017
Birmingham
2018
Cambridge
Oct 2018
Bristol
2018
The NIHR SME Roadshow
√
√
√

The NIHR
Supporting Medtech SMEs
i4i Programme Director
Martin Hunt

NIHR: Investing in Health
To improve the health and
wealth of the nation
through research
666,630+
patients recruited
34,648 recruited
into commercial
studies
27% into medtech
= 9297 patients
To improve the health and
wealth of the nation
through research

NIHR & Medtech SMEs
Project # funded 2015/16 15 Regions (=AHSN)
Collaborators & Experts Trial sites and support
Rapidly changing
environment
Funding

i4i: Who We Are, What We Do
NIHR translational funding scheme
Led by Programme Director, Martin Hunt
Supported by a team of Programme Managers
We fund breakthrough technologies
• Through collaborative R&D
• By de-risking projects for follow-on investment
• Focusing on innovative medtech solutions and patient benefit

Five i4i highlights
~ £107m
invested
>200
organisations
i4i3
Now x3 funding streams:
i4i Connect
i4i Product Development
i4i Challenge
150 projects
funded
>£105m
funding leveraged

Applying to i4i
Evidence of:
Well articulated clinical need
and patient benefit
Detailed and clear project plan
Team skills/experience adequate
Good business case
IP and commercialisation strategy
Justifiable costs – cost/benefit
Effective PPI
Health Economics:
Essential
Care pathway based
Developed throughout the project
NHS adoption strategy/Barriers identified
Call Launch 25 April 2018
Stage 1 deadline 06 June 2018
Invitations to stage 2 01 August 2018
Stage 2 deadline 26 September 2018
Panel meeting w/c 26 November 2018
Funding decision End of December earliest
PDA Call 16
Stage 1
Stage 2
Ratification
Award
Two PDA calls per year
Two stage process
Collaborative
Up to 100% of costs for SMEs

i4i Success
Executive Summary
Business Proposition
The Market
Business Strategy
Marketing and Sales plans
Team
Product development
Regulatory pathway
Financial Forecast
Appendices
Prepare your pitch to the panel

Funded by i4i
Sarissa (SMARTChip for Stroke diagnosis)
SBRI Phase 2 funding (£2m)
QuantumDx (POC DNA diagnostic platform)
Now over 60 staff; recent £12m investment
Stephen Hicks (Smart Glasses)
OxSight spun out
Second i4i award for AMD
STOpFrac (AI-based detection of vertebral fractures)
Being commercialised through Optasia

Help!
If Then
• Talk to us today
• Take the brochure away
• Contact us:
supportmystudy@nihr.ac.uk

NIHR’s role in supporting research and innovation for MedTech SMEs:
Access to Expertise
Clare Woods
NIHR Business Development Manager
clare.woods@nihr.ac.uk | supportmystudy@nihr.ac.uk
@clarelucywoods | @NIHR_INDUSTRY

Emerging Challenges
• Rising healthcare costs
• Increasing international
competition
• BREXIT
• Supporting companies, in
particular SMEs, that want to
work with the NHS and sell into
the UK healthcare system

UK National Strategy
• UK Industrial Strategy –A series of grand
challenges, initially targeted around AI & Data,
Mobility, Clean Growth, and the Ageing
Society
• Life Sciences Industrial Strategy and Life
Sciences Sector Deal – investment to support
collaborative projects between industry,
academic and the NHS in areas such as AI,
Genomics, Diagnostics and Precision
Medicine
• Accelerated Access Review – recommended
a process for identifying and pulling
transformative innovations into the NHS
quickly, now being implemented
NIHR– ideally placed
to support these
strategic initiatives

The Lovely Baby Problem
NIHR provides industry with
access to academic and
clinical experts who can
provide input early on in the
development of new
technologies

Patients
Bench-to-Bedside
Translational
Research
Trials/
Device Data
Adoption/
Sales
Research Idea
Define Research
Methodology
NIHR Collaborators
Secure Funding
Deliver and
Publish Results
Feasibility Study
Planning / Site Selection /
Trial Design
Approvals /
Agreements
Recruit Patients/
Delivery
Plan Route to
Adoption
Regulatory
Approvals
Sales
Reimbursemen
t/Pricing
AHSN – Academic
Health Science
Networks
NICE - National Institute for Health
and Clinical Excellence
MHRA - Medicines and
Healthcare products
Regulatory Agency
Monitor Performance/
Health Economics
NIHR Clinical Research Network
(end-to-end clinical trials support)
NIHR Medtech and
In vitro
diagnostics Co-
operatives
NIHR
Collaborations
for Leadership in
Applied Health
Research
Academic Health
Science Centres
NIHR Office for Clinical
Research Infrastructure
(NIHR navigation support
to industry)
NIHR Research Design
Service – (advice on research
design and health economics)
NIHR i4i Programme – (funding
targeted to support SMEs)
NIHR Research Programmes
– (funding to support
translational research)
Patient Cohorts, Data and
Samples
NIHR Experts – BRCs*,
Specialty Groups,
Schools, STEP**
*Biomedical Research Centres
**Surgical Technology Evaluation Portal

Access to the leading
clinical research expertise
across the country
Cutting-edge research
facilities embedded in the
NHS and Universities
Expert support for the set
up and delivery of clinical
trials on a national basis
Well characterised cohorts of patients
suitable for research, including ability to
recall based on genotype and phenotype
Signposting to relevant
funding schemes
NIHR working with Industry
Access to Expertise

Open door for industry
• Navigating the NHS is complex,
even more so when you include other
related organisations
• NIHR will signpost you directly to
the best people to help you on your
journey
• Service is simple and free of charge

NIHR Research Infrastructure
Innovation
Late-phase clinical research
NIHR Biomedical Research Centres
Early-phase clinical research
Evaluation
Adoption
NIHR Collaborations for Leadership in Applied
Health Research & Care
> £0.5 billion p.a. investment in
relevant infrastructure to
support clinical research at all
points in development pipeline
NIHR Clinical Research Facilities
Experimental Cancer Medicine Centres
NIHR Medtech and In-vitro Diagnostic Cooperatives
Adoption

NIHR and Industry
In FY 16/17 NIHR
industry studies
leveraged more than
£1.2 billion
Since 2014 NIHR has
completed 9689
research studies with
industry
NIHR is completing more
medtech studies every year:
250
260
270
280
290
300
2014/15 2015/16 2016/17

Working with NIHR
“We could not be on the journey we’re taking
without our guides at NIHR MindTech. I am sure
your own journey will be different, but I would not
try it without finding knowledgeable friends
who can guide you through the complex,
labyrinthine systems of modern healthcare.”
Andrew Jackson, CEO, ProReal Ltd

Access to the leading
clinical research expertise
across the country
Cutting-edge research
facilities embedded in the
NHS and Universities
Expert support for the set
up and delivery of clinical
trials on a national basis
Well characterised cohorts of patients
suitable for research, including ability to
recall based on genotype and phenotype
Signposting to relevant
funding schemes
NIHR working with Industry

Get in touch!
clare.woods@nihr.ac.uk
supportmystudy@nihr.ac.uk
@clarelucywoods @nihr_nocri @officialNIHR

Mapping Medical Innovation:
Using technology and Big Data to see what's going on and where
Dr. Sarah Khan
W: www.io.nihr.ac.uk I E: info@io.nihr.ac.uk
14.03. 18

Key Stakeholders
Biomedical Research Centres

Offer # 1 - Insight
Rapid Consumer Insight
10k+ members of the public have
signed up to our website to learn
and be asked questions about
products or services (or anything!).
We can help you rapidly get
feedback on your product or
service.
Delivered Nationally in 2018.
Contact us for details or
notifications on SME offers:
E: info@io.nihr.ac.uk

Offer # 2 – Market Analysis
Market Analysis
We can provide rapid
overview of clinical trials
activity / market analysis
of a disease or technology
to help inform your
decision making.
Contact us for notification
on SME offers:
E: info@io.nihr.ac.uk

Offer # 3 – DIY Search
Common Cloud
Common Ontology / Dictionary
Reports Dashboards Searches API Outputs
www.OpenScan.io

Contact: info@io.nihr.ac.uk
Web: www.io.nihr.ac.uk
Product / Service insight Market Analysis DIY Search
www.OpenScan.io

Supporting the life-sciences industry in UK clinical research delivery
Clinical Research Delivery :
CRN offer to support MedTech
Dr Carolina Paras ,Industry Operations Manager
CRN Wessex

Clinical Research Network
National Institute for Health Research:
integrated health-research system
> £0.5 billion p.a. investment in
relevant infrastructure to
support clinical research at all
points in development pipeline
Invention Evaluation Adoption
Early-phase clinical Research Late-phase clinical Research
NIHR Biomedical Research Centres
NIHR Clinical Research Facilities
Experimental Cancer Medicine Centre
Medtech and In vitro diagnostic
Co-operatives (MICs).
Collaboration for Leadership in Applied Health Research and Care

• Research active engaged
clinicians across all 30 therapy
areas
• Detailed understanding of care
pathways
• 15 Local Clinical Research
Networks (LCRNs)
• Allows flexible deployment of
resources
• Links with rest of UK

Some stats
Financial year 2016/17:
99.9% NHS
trusts research
active
79% commercial
666,630+
patients recruited
34,648 recruited
into commercial
studies
27% into medtech
= 9297 patients
Of the
729 commercial
new studies
added last year
12% were
medtech
= 88 studies
Of the
1008 commercial
studies that were
open to recruitment
15% were medtech
= 148 studies

Study Support Services

Local offer:
Technology Support Programme

• UK medtech SME company
• Creates digital solutions that enable healthcare professionals to empower,
support and motivate their patients to make healthier choices to tackle chronic
diseases
• The product is a digital solution formed of two parts:
1. online software for use by GPs which is linked to
2. a mobile app for use by patients on their phone, tablet or laptop
• Pilot - product it has been customised to help manage type 2 diabetes
Case study: Healum

Case study: Healum
Early Feedback
• confirmed that the study would be feasible in the NHS
• highlighted some potential problems to avoid
Site Identification
• seeking 20 sites
• used single online submission
• returned 117 expressions of interest meeting company criteria
• included clusters and CCG = total 130 sites
Effective Study Set-up
• guided in using the Primary Care Costing Template
• company reduced the number of sites to stay within budget

Network Industry Information Centre
Phone: 00 44 113 34 34 555
Email: supportmystudy@nihr.ac.uk
Web: www.supportmystudy.nihr.ac.uk
For more information about local support please
contact us at industry.crnwessex@nihr.ac.uk
Any questions?

Clinical Investigations for
medical device evaluation
Dr Camilla Fleetcroft – May 2018

What is a medical device?
 Any instrument, apparatus, appliance, software, material or other article, whether
used alone or in combination, including the software intended by its manufacturer to
be used specifically for diagnostic and/or therapeutic purposes and necessary for
its proper application, intended by the manufacturer to be used for human beings
for the purpose of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
 investigation, replacement or modification of the anatomy or of a physiological
process,
 control of conception, and which does not achieve its principal intended action
in or on the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means

Classification
- Low Risk – Class I
Plasters, Walking Sticks, Wheelchairs, Stethoscopes, Medicine Spoons, Administration
Sets, Syringes, Re-usable Surgical Instruments
- Medium Risk – Class IIa and IIb
Needles, Dental Filling Materials, Contact Lenses and Solutions, Diagnostic and
Monitoring Equipment, Condoms, Infusion Pumps, Blood Bags, Haemodialysis
Concentrates, Hearing Aids, Ventilators, Incubators, Surgical Lasers, Anaesthetic
Machines, Nebulisers
- High Risk – Class III and active implantable devices
Pacemakers, Cochlear Implants, Breast Implants, Devices containing Medicinal
Substances, Devices containing Animal Materials, Cardiovascular and Devices,
Neurological Implants, Absorbable Sutures

Classification rules
Annex IX
Non-invasive devices: Rules 1-4
Invasive devices: Rules 5 – 8
Additional rules applicable to active devices: Rules 9 – 12
Special rules: Rules 13-18

Clinical evidence generation
PMS/PMCF: justify
presumptions made
at market entry

Clinical data requirements
• Characteristics and performances referred to in ERs, evaluation of the
side-effects and of the acceptability of the benefit/risk ratio must be based
on clinical data
• All classes of device need clinical data
• Clinical Investigations shall be performed for Class III and implantable
devices unless justified to rely on existing clinical data.
• Must justify where clinical data is not used

Not equivalent if device differs:
• Intended purpose
• Mode of action
• Anatomical location
• Design
• Materials
• Manufacturing processes

Clinical Investigations
Notify MHRA when:
- it is a non-CE marked device
- a CE-marked device being used outside of its intended use
Where possible please give MHRA prior warning of an application – this
allows us to identify relevant external assessors where necessary.
Application: complete IRAS form and submit to MHRA along with the relevant
documents – a checklist is available on the MHRA website.

• Validation – this takes up to 5 working days (usually within 2)
• 60 day period – starts day after validation is confirmed
• Allocation to assessors – Clinical, technical, biocompatibility,
pharmaceutical, sterilisation, statistics and external.
• Questions & responses
• Grounds for objection
• Letter of no objection – with or without conditions.
• Ethical approval

What are we expecting?
Demonstration of Safety and Performance.
Annex X 2.1: The objectives of clinical investigation are:
• to verify that, under normal conditions of use, the performance of the
devices conform to those referred to in Section 3 of Annex I, and
• to determine any undesirable side-effects, under normal conditions of use,
and assess whether they constitute risks when weighed against the
intended performance of the device

Study design – Key points
- Generating evidence for safety and performance
- Small sample sizes
- No comparators
- Simple stats
- Short follow-up or continue post-market
- No phases
- Difficult to blind
- Learning curve for users

Grounds for objection <10%
• Lack relevant clinical end points
• Clinical parameters insufficient/ inappropriate
• Inadequate pre-clinical testing/ assessment
• Inadequate toxicological testing/ analysis
• No sterilisation validation
• Inadequate electrical testing
• Risks outweigh benefits

No Objection - What next?
• Interim reports – case by case
• SAE reports – as and when
• Final report – assessment

Medical Device Regulation
Big change? - YES
• A change in classification
• Greater emphasis on clinical evidence
• Impact on clinical investigations
• Post-market expectations

A little help..
MHRA
https://www.gov.uk/guidance/notify-mhra-about-a-clinical-
investigation-for-a-medical-device#how-to-notify-mhra-of-your-
clinical-investigation
Devices.regulatory@mhra.gov.uk
ISO 14155
MEDDEV 2.7.1 rev 4

Any Questions?
Camilla.Fleetcroft@mhra.gov.uk
020 3080 5164

Tuesday 8th May 2018
Prof AJ Chauhan
Professor of Respiratory Medicine
Director of Research and Innovation
WESSEX MEDTECH EVENT
Innovation Pathway Support
Chain:
Connecting Support Streams for Innovation

The Opportunity
• Could it work?
• Does it work
• Is it worth it (HE)?

Both contribute to Health and the Economy:
1. Services we both provide
A healthy population is more productive, and more economically active
2. Stimulate Innovation
Productivity delivers more health benefit
Growth rates higher among Innovative SMEs
3. Accelerating adoption and diffusion
Support growth in life sciences industry
SMEs spur competition which raises productivity and economic growth
4. Exporting innovation, ideas and expertise
Provide new business opportunities here and abroad
SMEs that export are more likely to flourish
5. Create a World Class Brand
Catalyst to improve our services
SMEs make a disproportionately large contribution to job creation
Why should the NHS work with SMEs?

Financial
2007: A Study by the MRC, Wellcome Trust and Academy of Medical
Sciences - economic benefits of 17 years of UK medical research
The health and gross domestic product (GDP) from UK public and
charitable investments in research were equivalent to an annual rate of
return of around 39%
i.e. for every £1 the taxpayer or health charity invests in research,
yields a wider chain of events equivalent to earning 39 pence each
year, forever.

Innovations should fit e.g. COPD
No symptoms Symptoms but no
diagnosis
MILD
stage
MODERATE
stage
SEVERE
stage
The earliest point
at which COPD
may be detected
by lung function
VERY SEVERE
stage
IMPROVE DIAGNOSIS: case finding, screening
EXACERBATIONS: onset, treatment, prediction
MEDICINES OPTIMISATION: adherence, education
MAINTAIN PHYSICAL ACTIVITY
Pulmonary rehab, self management
RESPIRATORY FAILURE
recognition, monitoring
Alert bracelets, Severe Clinics
Help and support with smoking cessation

An online self- management plan to improve control
Better Treatment: myCOPD

MISSION Patient journey
• GRASP:TECHNOLOGICAL
INNOVATION
• HIGH SYMPTOM BURDEN
• PATIENTS AT RISK OF
HARM FROM POOR
DISEASE CONTROL
NOVEL CASE FINDING
• SPECIALIST REVIEW, PRIMARY CARE
• INHALER TECHNIQUE
• HIGH QUALITY PHYSIOLOGY
• SMOKING CESSATION
• TARGETED EDUCATION
• SELF-MANAGEMENT TOOLS
• LINKS TO CHARITY SUPPORT
RAPID CLINIC
• ONE-DAY REVIEW, MEDICINES OPTIMISED
• ADVANCED DIAGNOSTICS
• ASSESSMENT OF COMORBIDITY
• ACCESS TO PSYCHOLOGY, DIETICIAN, SOCIAL
WORKER IN ONE VISIT
• TERTIARY MDT WITH DETAILED PLAN
SEVERE
CLINIC
New Care Models

Type of contact
Asthma
(cohort=79)1
COPD
(cohort=108)2
Breathlessness
(cohort=42)3
ED visits 67% (6 to 2) 52% (13 to 3) 100% (4 to 0)
Hospital admissions 100% (6 to 0) 71% (7 to 1) 100% (2 to 0)
Out of hours contacts 80% (5 to 1) 46% (15 to 4) 100% (2 to 0)
Unscheduled GP visits 49% (61 to 31) No change 84% (92 to 15)
Exacerbations
37% (43 to 27) 52% (259 to 62) 89% (46 to 5)
1 12 months before compared to 6 months after (annualised)
2 12 months before compared to 6 months after (annualised)
3 12 months before compared to 6 months after
Combinatorial Outcomes
Measured Reductions in Healthcare Contacts

Actions
NHS
R&D
RDS AHSN CRN HCP Univ.
Ideas ✓ ✓ ✓
Identify NHS needs ✓ ✓
Start-Ups ✓
SME Introductions ✓ ✓ ✓
Trial design ✓ ✓ ✓
Patient Public Involvement ✓
Grant applications (complete) ✓ ✓ ✓ ✓
Protocol Writing ✓ ✓
Business Support ✓
Business Surgeries ✓ ✓ ✓
Research Delivery ✓ ✓
PPI / Communications ✓ ✓ ✓
Dissemination ✓ ✓ ✓ ✓
Impact ✓ ✓ ✓
Spread and Adoption ✓ ✓

• Number of interactions with companies
• Number of industry projects
• Number of bespoke services provided
• Grant funding won
• Investment raised
• Number of CE marks and patents
• Number clinical trials
• Number products on the market
• Number of sales
• Impact on NHS finances
• Number of Awards won
• Impact on lives saved
Metrics of Success

• An innovations has to fit an unmet need
• A proactive approach in seeking SME solutions
• F2F meetings with interested clinicians always valued
• Be prepared to share gains if in a partnership
• Create more Chief Investigator Trials, improve care
Summary

Non-NIHR Funding Sources & Support
Kevin Brooks
 Wessex AHSN FSS

ACCESS TO GRANT
FUNDING  The Industrial Strategy and the
push for the leading edge = £
billions in grant funding.
 Case study: Innovate UK
 Service: Wessex AHSN - FSS
 Tool: The Funding Map

 The Challenges:
 Data to early diagnosis
and precision medicine
 Healthy ageing/ageing
 The importance of the
leading edge & SMEs.
The Industrial Strategy

Innovate UK
© Candescence
For more information about Innovate UK grants click on the logo below:

Wessex AHSN
© Candescence
For more information the Funding Support Service click on the logo below:

ACCESS TO GRANT
FUNDING Wessex AHSN:
Dr. Frank Ratcliff
Frank.ratcliff@wessexahsn.
net
BrooksKebbey Ltd:
Kevin Brooks
07495 781731
Brookskebbey@gmail.com

www.sbrihealthcare.co.uk
@sbrihealthcare
SBRI Healthcare Programme
Joop Tanis
Director MedTech Consulting
Health Enterprise East Ltd.

Needs based
Service led
SBRI Healthcare Programme - are you ready for the Den?

• Helping the Public Sector address challenges
o Using innovation to achieve a step change
• Accelerating technology commercialisation
o Providing a route to market
• Support and the development of Innovative companies
o Providing a lead customer/R&D partner
o Providing funding and credibility for fund raising
SBRI is a pan-government, structured process enabling the Public
Sector to engage with innovative suppliers:

SBRI Key features
• 100% funded R&D
• Operate under procurement rules rather than state aid rules
• UK implementation of EU Pre-Commercial Procurement
• Deliverable based rather than hours worked or costs incurred
• Contract with Prime Supplier
o Who may choose to sub contract but remains accountable
• IP rests with Supplier
o Certain usage rights with Public Sector – Companies encouraged
to exploit IP
• Light touch Reporting & payments quarterly & up front

Things to Note
• Any size of business is eligible
• Other organisations are eligible as long as the route to market is
demonstrated
• All contract values quoted INCLUDE VAT
• Applications assessed on Fair Market Value
• Contract terms are non-negotiable
• Single applicant (partners shown as sub contractors)
• Applicants must fully complete the application form

Assessment Criteria
1. How will this solution address the competition theme brief ?
2. What is the degree of technical challenge? How innovative is the project?
3. Will the technology have a competitive advantage over existing/alternate technologies that can meet
the market needs?
4. Are the milestones and project plan appropriate?
5. Is the proposed development plan a sound approach?
6. Does the company appear to have the right skills and experience to deliver the intended benefits?
7. Does the proposal look sensible financially? Is the overall budget realistic and justified in terms of the
aims and methods proposed?
8. Does the proposed project have an appropriate commercialisation plan and does the size of the market
justify the investment?

Thank you
joop.tanis@hee.co.uk
01223 826823
www.sbrihealthcare.co.uk
www.hee.co.uk

• Labour costs broken down by individual
• Material Costs (inc consumables specific to the project)
• Capital Equipment Costs
• Sub-contract costs
• Travel and subsistence
• Other costs specifically attributed to the project
• Indirect Costs:
o General office and basic laboratory consumables
o Library services/learning resources
o Typing/secretarial
o Finance, personnel, public relations and departmental services
o Central and distributed computing
o Cost of capital employed
o Overheads
Eligible costs (all incl. VAT)

Enabling adoption and spread of medical technologies
Frank Ratcliff, Senior Project Manager, WAHSN

Data is gold.
Does it work?
Is it worth it?

Research Idea
http://www.porthosp.nhs.uk/departments/archive/copy_of_Research/study-set-up_2.htm

Target resources at the problem…..

Technology Support Programme;
1) Ask our regional NHS organisations to identify problems which seem solvable but
do not yet have evidenced solutions
• Specific problem
• Specific clinician to work with
2) Ask the industry for solutions which seem to address the problem.
3) Shortlist potential matches down to 3-4
4) Presentations to a panel….Clinician, CRN, AHSN
5) Pick 1-2 innovations to help establish research
6) Support for establishing a research trial in the NHS; does it work? Is it worth it?
7) Go to (1)
Point of care diagnostics
Cardiology??
MH?

https://www.eventbrite.co.uk/e/the-golden-rules-of-bidding-into-the-nhs-tickets-45653598141

Current link no longer working.
New Link Below
https://youtu.be/2EMIO3Stl0I

MedTech Brings Life Moments
So whyThe Adoption Challenge?
Michael Branagan-Harris CEO Device Access UK Ltd

Clinical communities are
always interested in
research associated with
new technologies
NHS is investing £11.5m
a day in research
however, many of the
solutions already exist
154
We need to do better
VC / Investors in MedTech losing interest
Less than 1% of new surgical
devices are widely adopted
globally
Innovation?
Products which drive
efficiencies, currently
without reimbursement
Are we looking at the
right outcomes to
facilitate adoption?
Industry continues to use
traditional marketing
approaches which are no
longer effective
Clinical features and
benefits without
addressing the financial
requirements in the NHS

155
We need to do better
17,000 more beds
Years
Numberofbeds
2022 6.2 million bed stays
Nuffield trust 2014 – NHS hospitals under pressure: tends in acute activity up to 2022
The current system is unsustainable
We need to change
22 x800 beds each

156
The traditional approach
Industry Wide spread adoption of
innovative procedures /
products

4.6 years
$30 million
Limited adoption of
products
Industry

158
Clinical safety and efficacy evidence
Traditional PPPP marketing
(price, product, promotion and place)
Recognition
Funding from industry
Keen to learn more about new technologies
Relatively easy straightforward set process for
research through
NHS framework
Limited adoption of
products
Industry

159
Limited adoption of
products
Unaware of:
Evidence required for NICE
medical device approval
Unaware of: Hospital pressure or payment flows
Real value of technology to hospital
Industry
approach

160
Wide spread adoption of
products
Industry

161
How the NHS works
Reimburses procedures and not products
Requires health economic arguments in addition to safety and
efficacy to instigate significant change
Complicated decision making process
No centralised procurement processes. Funding divided
between CCGs
1geoportal.statistics.gov.uk
2 NHS statistics, facts and figures
Flow of funding
through the NHS
Clinical Commissioning
Groups (CCGs)
Parliament
England
TRUST

162
Payers of care
Objective is to get the best possible health outcomes for the local
population
CCGs / payers of care must constantly respond and adapt to changing
local circumstances
Buy services
1geoportal.statistics.gov.uk
2 NHS statistics, facts and figures
Clinical Commissioning groups (CCGs) / payers of care
Assess local needs
Flow of funding
through the NHS
Groups (CCGs)
Parliament
England
TRUST

163
How the National Institute for Health and Care
Excellence (NICE) works
Paid by the NHS to advise on best practise
Demonstrate safety, efficacy and cost effectiveness.
Flow of funding
through the NHS
Groups (CCGs)
Parliament
England
TRUST

164
Excellence (NICE) works
Paid by the NHS to advise on best practise
Demonstrate safety, efficacy and cost effectiveness.
World respected by global payers and authorities
for their processes and methods.
Flow of funding
through the NHS
Groups (CCGs)
Parliament
England
TRUST

165
Excellence (NICE) work?
Provides recommendation for best practice, reduces
uncertainties and adoption barriers.
Opens doors for other reimbursement payment programmes
with NHS England e.g. InnovationTechnology Payment
programmes
Benefits
Interventional Procedures Guidance (IPG)
MedTech Innovation Briefing (MIB)
MedicalTechnical Guidance (MTG)
DiagnosticAssessment Program (DAP)
Technology Appraisal Program (TA)
Clinical Guidelines (CG)
Provides guidance
Flow of funding
through the NHS
Groups (CCGs)
Parliament
England
TRUST

National strategy
inside and outside of the NHS
166
Accelerate time to adoption

167
What is National Market Access?
Patient
Current treatment
Outcomes
Hospital
Performance
Finances
Industry
Value to patient,
provider and payer
We all need to understand the true value of a device to the NHS

168
Our Access to NHS England data
Can Device Access UK
identify individuals?
The information we get from out license with NHS
Digital is pseudonymised and non-identifiable.
This means individuals cannot be identified from
the data we receive

950 million episodes of care for past 48 months
169
Our Access to NHS England data
Diagnosis and demographics Treatments performed and outcomes Hospital impacts
Bed days
Day case
Readmissions
Cost of episode
HRG/DRG = Payment code
Invoice to payer (CCG)
=
ICD-10 + OPCS = HRG/DRG, length of stay + Local Market Forces
Cost calculation
Primary treatment
OPCS = Treatment Code
Secondary treatments
Laterality
Recurrent
Approach - open, laparoscopic or
robotic
Complications
Time in intensive or critical care
Number admitted
Type of admission – i.e emergency or
elective
Primary diagnosis
ICD-10 = diagnosis code
Secondary and subsequent Diagnosis
Age, sex ethnicity
Time on waiting list

170
What programs do NICE run?
Medical device
Safety & efficacy
B
A
Interventional ProceduresGuidance (IPG)

171
Medical device
Data sheet
Program timeline: 10-15 weeks
What the device /
car is and how it
works

172
Program timeline: 48 weeks
Safety & efficacy
Cost implications
Medical device & diagnostics
B
AVs.

173
DiagnosticAssessment Programme (DAP)
Program timeline: 1 year
Complex diagnostics
Safety & efficacy
Cost implications
B
AVs.

174
TechnologyAppraisal Program (TA)
Program timeline:Years
All
Funding unlocked
350 completed since 1999
2 now in process – first since 2009
35 Medical device315 Other
100%
Funding

175
ClinicalGuidelines (CG)
Decision tree
for care pathway
Conditions
Treatment pathway

176
What do NICE want?
Clinical and
economic evidence
Patient experience
Physician feedback
Clincal use practice

177
Local Market Access
Local data
Local hospital

178
VNUSVaricoseVeins revolution
Understanding payment and
activity helped transform the
treatment of varicose veins to
ambulatory day case.
>10,000
VNUS procedures
2018
Noofproceduresayear
<100
Vein stripping

179
How do we use this information
Improving patient outcomes
Patients most likely to develop a pressure
ulcers were those admitted with pneumonia
If a pressure ulcer developed the average cost
increase in bed stay alone was £4,550
Yes NoDeveloped pressure ulcer?
22 daysAverage hospital stay 9 days
Average cost £3,150£7,700
£4,550Difference

180
Reducing 71% disposal of donated hearts

181
Portable Severe StrokeTriage Device
VIPS: Volumetric Integral Phase-shift Spectroscopy

info@deviceaccess.co.uk | www.deviceaccess.co.uk | www.marketaccess.co.uk | @deviceaccess
Device Access UK Ltd, Albertine House, Michelmersh,
Hampshire SO51 0AG, England
Device Access, Market Access. Accelerated and the Device Access Logo are registered and protected trademarks of Device Access UK Ltd

Mechanical Muscle Activity with
Real-time Kinematics (M-MARK)
A novel combination of existing technologies to improve
arm recovery following stroke

IDEA
•Is it worth doing?
•Are you the right team?
•Strong PI
Level of
confidence
•Objectives clear and achievable
•Project is feasible
Build
Consortium
•PPI
•Technical/design
•Clinical partner
Stage 1
Application
•Plenty of time
•Delegate
•Cost accurately
Stage 2
Application
•Don't leave it too late
Peer review
rebuttal
•At least 1 will hate your project
Presentation
•Rehearse
•Expect unexpected questions
Agree
contracts
•Can take months
Start project
•Share problems with MO

Patrick Hall
07734 110942
Patrick.hall@maddison.co.uk

Shaping the
Future of
Medical
Diagnostics

A major disruptive change has
happened in medical customer
experience
1. How medical centres operate.
 (preventative diagnosis, Internet of Things,
remote assistance and surgery).
2. How patients control their health.
 (self-monitoring, home robotics, health apps).
3. How doctors and patients relate.
 (Big and Small data, virtual reality, medical
chatbots, Skype).
• In the next five years, connected health and
PoC devices will be major enablers in helping
the healthcare systems and empowering
patient.

New generation of PoC to
enable patients and
physicians work together
in monitoring disease
progression.

IR spectroscopy biomedical
fingerprint can identify and
distinguish healthy samples
from diseased samples.
We are miniaturising this
technology and bringing it out
of the laboratory for early
diagnosis and precision
medicine at Point of Care.
Acute and chronic
conditions
Disease Phenotyping
Patient stratification
Predicting disease
events
Monitoring disease
events
EarlyDiagnosis
PrecisionMedicine

Glyconics platform will be 1st to market with
a hand held InfraRed Medical Device.
One platform,
One device,
Multiple applications.

Enabling broad applications across many therapy areas
G
•Pulmonary Embolism
•Asthma, COPD
•Bronchitis, Atelectasis
•Emphysema,
Pneumonia
•Diabetes Type 1
•Diabetes Type 2
•Lung Cancer
•Bladder Cancer
•C Diff
•Tuberculosis
Infectious
Diseases
(2023)
Cancer
(2022)
COPD
(2021)
Diabetes
(2021)
Sample media

Company Device
Regulatory
Clinical
Development
Device
Development
Systems
People
Funding
Life of
a SME
Partnership

Glyconics – Achievements to date…
• The company was formed in 2014
• Winners of two EU Seal of Excellence Awards
• Winners of Small Business Research Initiative for Healthcare
(SBRI Healthcare) by NHS England
• Innovate UK Grant winner
• Established Clinical Partnerships with NHS
• Finalisation of agreements with hardware partners underway
• Established Clinical Advisory Boards
• Discussions on other clinical application areas underway

• Patented
• Clinical validated detection of diabetes
by scanning the fingernails of diabetic
versus control persons
Glyconics has an exclusive worldwide license on the
measurement of Diabetes and Renal insufficiency using
infrared (IR) absorption with Ghent University.

COPD does affect work, family,
everything really. It’s the fear that it
could be life threatening.
If you can find out 24 hour minimum
before , then you can at least do
something or contact the GP to
prevent it. For COPD nothing like
that is available.
COPD Patient
“

Supporting Innovation in Medical Technology Enterprises

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