Presentations from the NIHR Roadshow for Medical Technology SMEs on Thursday 1 March 2018 at Sci-Tech Daresbury.

1. The NIHR London roadshow
for MedTech SMEs
Search ‘National Institute for Health
Research (NIHR)’
OfficialNIHR@OfficialNIHR

2. The NIHR
Supporting Medtech SMEs
i4i Programme Director
Martin Hunt

3. Text
• Bullet text
Subhead
NIHR: Investing in Health
To improve the health and
wealth of the nation
through research

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

5. i4i Bridges the Medtech
‘Valley of Death’
Innovation Regulatory
IP & commercial
strategy
NHS adoption
plan
Technology that is
attractive to follow-on
funders and investors
for commercialisation
Proof-of-
concept
Clinical need
Basic research
produces proof of
concept data
Project plan &
Team
Value for
money
Patient and public
involvement
The Graveyard of Good Ideas

6. i4i: Who We Are, What We Do
i4i
NIHR translational funding scheme
Support collaborative R&D and clinical adoption
Focus on innovative medtech
solution
De-risk projects for follow-on investment
Patient benefit
Led by Programme Director, Martin Hunt
Supported by a team of Programme Managers

7. i4i Highlights
~ £107M
invested
>200
organisations
150 projects
awarded
i4i3
Connect
Product Development
Challenge
>£105M
funding leveraged

8. Applying to i4i
Call Launch 01 Feb 2018
Stage 1 deadline 04 April 2018
Invitations to stage 2 23 May 2018
Impact Workshop TBC
Stage 2 deadline 26 September 2018
Panel meeting w/c 26 November 2018
Funding decision End of December earliest
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
Mental Health Challenge 2018
• 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
• Essential
• Care pathway based
• Developed throughout the project
• NHS adoption strategy/Barriers
identified
Stage 1
Stage 2
Ratification
PDA Call 16

9. 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

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

11. NIHR’s role in supporting research and innovation for MedTech SMEs:
Access to expertise via NOCRI
Clare Woods
NIHR Business Development Manager
clare.woods@nihr.ac.uk | supportmystudy@nihr.ac.uk
@clarelucywoods | @NIHR_NOCRI | @officialNIHR

12. 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

13. 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

14. 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

15. 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

16. 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
NIHR Clinical Research Network
Adoption

18. 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

19. Working with NIHR
“NIHR supported research has played an
important role in the decision to commission
this revolutionary treatment, which will have a
significant impact on quality of life after a stroke.”
Professor Christine Roffe
NIHR National Lead for Hyperacute Stroke Research Centres

20. 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

21. Patients
Training
Funding
Expertise
Study Support
supportmystudy@nihr.ac.uk

22. Supporting the life-sciences industry in UK clinical research delivery
NIHR Clinical Research Network
Sarah Fallon Life-Sciences Industry Delivery Lead

23. 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).
NIHR Clinical Research Network
Collaboration for Leadership in Applied Health Research and Care

24. Clinical Research Network
NIHR Clinical Research Network
Use us when you have……
Secured funding
Developed a protocol
And
Want to deliver research in the NHS

25. Clinical Research Network
• 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
NIHR Clinical Research Network

26. Clinical Research Network
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

27. Clinical Research Network
Service summary

28. Clinical Research Network
• 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

29. Clinical Research Network
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

30. Clinical Research Network
Case study: Healum
Cassandra Baiano, Research Lead and Partnerships Manager
for Healum:
“The response was huge, more than we expected. Some
of the expressions of interest were from clusters of
practices and even one CCG, which meant the total
number of practices interested in piloting our app was
over 130. This was great because immediately we knew
there was an appetite out there and a clinical need to be
met….We now have a strong list of sites we intend to work
with.”
“The Network team in Manchester helped us to complete
the costing template which was invaluable. We quickly
realised we needed to reduce the number of sites from 20
to 15 to stay within planned budget.”

31. Clinical Research Network
Case study: MarginProbe
• Study into whether intraoperative use of MarginProbe could reduce the
number of operations women need after breast conserving surgery.
• The MarginProbe measures the edges (margins) of any tissue removed
during surgery to make sure they are clear of cancer cells.
• Recruiting 460 women, across 7 NHS Trusts aged between 18-90 at high
risk of needing further surgery because of incomplete removal of the
tumour.
• Began in 2016 and due to close in 2018
Potential Impact:
 Reduction in surgery requirement
 Economic benefits
 Improve cosmetic outcome

32. Clinical Research Network
• April 2017 NHS England
announcement - commissioning
mechanical thrombectomy
• Two NIHR-supported studies
informed the decision
– PISTE confirmed the benefit and
safety of thrombectomy in the
NHS
– PEARS estimated 8,000 patients
will benefit in coming years.
Thrombolysis: “Time is brain”
NIHR supported
research has played
an important role in
the decision to
commission this
revolutionary
treatment, which will
have a significant
impact on quality of
life after a stroke.
Professor Christine
Roffe, NIHR National
Lead for Hyperacute
Stroke Research
Centres

33. Clinical Research Network
• Further related NIHR-supported
research
– STABILISE - looking into the
efficacy and safety of a new
device for thrombectomy
– PISTEi - will test different imaging
strategies to identify patients who
are most likely to benefit from
thrombectomy
Thrombolysis: “Time is brain”
…time is brain. Now
that we know that
thrombectomy is
effective, we need to
find ways of ensuring
the treatment is given
as soon as possible
after patients develop
symptoms of stroke.
Professor Christine
Roffe, NIHR National
Lead for Hyperacute
Stroke Research
Centres

34. Clinical Research Network
Network Industry Information Centre
Phone: 00 44 113 34 34 555
Email: supportmystudy@nihr.ac.uk
Web: www.supportmystudy.nihr.ac.uk
sarah.fallon@nihr.ac.uk
Any questions?

35. NIHR Roadshow for
Med Tech
Alastair Clarke, Weaver Technical Solutions Ltd
and
Richard Hall, QMS Consultancy Ltd

36. RoundTable
Med Tech
(&Combination/Medicina
l Product) Regulations
Providing an overview of the regulations
and introducing you to the information
sources, resources, and support ensuring
non-compliance does not de-rail your
company strategy, development activities
and launch plans
©2018 Weaver Technical Solutions Ltd
36

37. Med Tech Reg Affairs Workshop
• Regulations Overview (US CFRs and EU medical device
directive)
• Approval Processes for the US and EU
• Company Responsibilities (legal aspect)
• Governance, Quality (QP), Safety and Compliance (CE Mark)
• How to deliver successful regulatory submissions
• Strategy through Compliance to Evidence Submitted
• What organisations do I need to be liaising with?
• Lessons Learned
• FDA MedWatch
A number of Resource Suggestions are included in the slide pack after the End Sli
©2018 Weaver Technical Solutions Ltd
37

38. What are we talking about?
Medical Devices Medicinal Products or Combination
Products
IVDs
IMDs
DDDs(EU)
DDDs(US)
DDD+Apps(US)
Apps(US)
©2018 Weaver Technical Solutions Ltd
38

39. And Not Forgetting……
• Labelling, Packaging, Cartons, Presentation Trays,
Shipper boxes, IFUs, PIL, Palleting – all need defining,
planning, designing, developing, optimising and scaling
up.
• Ensure specific req’ts for the clinic are captured at the
start
Clinical
©2018 Weaver Technical Solutions Ltd
39

40. Regulations Overview
• History
• 1938 US FD&C Act (Sulfanilamide containing diethylene
glycol)
• 1960s Thalidomide Triggers Rapid Global Increase in
Regulations
• 1965 CD 65/65/EEC Proprietary medicinal products
• 1996 21CFR 820 QSR
• 2003 MDD 93/42/EC
• Harmonisation
• 1990 ICH
• 1992 – 2011 GHTF – IMDRF*
Standards impact the product require
* International Medical Device Regulators©2018 Weaver Technical Solutions Ltd
40

41. Quality Management Systems &
CE Marking for the Medical Device
Industry
Global Regulations
CE– ISO
13485
MDS
AP
FD
ACMDC
ASANVIS
APMDA
TGA
Quality Management Systems &
CE Marking for the Medical Device
41

42. Medical Device Approvals Process
The EU Process The US Process
The same but different
and so it is for combination/medicinal products
©2018 Weaver Technical Solutions Ltd
42

43. Regulate
Comply
Record
Approvals Process - Simply Put…..Define
Govern
Submit
Approval
Launch
Plan
DesignandDevelop
VerifyandValidate
Clinic(ifreq’d)
©2018 Weaver Technical Solutions Ltd
43

44. Approvals Process – Even More
Simply Put…..
Make sure
you are
designing
the right
device
1
Make
sure you
design
the
device
correctly
2
Make
sure the
product is
safe and
effective
3
Provide
the
evidence
in the
right
format
4
©2018 Weaver Technical Solutions Ltd
44

45. EU the new MDR
45

46. Company Responsibilities (legal
aspects)
• Governance
• Infrastructure (internalisation verses outsourcing)
• Use the principles in ISO44001 CBR
• Quality
• Strong and independent – separate reporting line.
• Use the solutions defined in Design Control/ISO
13485/14971/62366 etc and this will address the needs
• Policy, Continuous Improvement, Data Integrity
• Compliance
• Financial, Ethical, Clinical, Bribery & Corruption, Surveillance
and most important evidence based training
(https://www.fda.gov/MedicalDevices/InternationalPrograms
/MDSAPPilot/)
©2018 Weaver Technical Solutions Ltd
46

47. Compliance will be checked by Notified Bod and Local and Foreign Health Authori
©2018 Weaver Technical Solutions Ltd
47

48. How to deliver successful regulatory
submissions
Consider the total product life cycle
48

49. Consult with the Experts
Notified Bodies
Regulatory Authorities
FDA EMA
MHRA
Quality Service
Providers
QMS ConsultancyLtd
Bespoke QualityManagement Systems and
CE Markingforthe Medical DeviceIndustry.
Richard Hall, Director
e-mail: richard@qms-consultancy.com
Website: http://www.qms-consultancy.com/
LinkedIn: www.linkedin.com/in/richard-hall-13485-ce-mark
Tel: +44 (0) 79080 88250
Address: TheInnovation Centre,Sci-TechDaresbury,KeckwickLane,Daresbury,Cheshire,WA44FS
©2018 Weaver Technical Solutions Ltd
49

50. What can go wrong?
• Most problems lead from a failure to Plan…..
“Planning is an unnatural process; it is much more fun to
do something. The nicest thing about not planning is that
failure comes as a complete surprise, rather than being
preceded by a period of worry and depression.” Sir John
Harvey-Jones (ex ICI and tv’s The Troubleshooter)
• It is possible to create an Reg Affairs plan that is
hardwired to the product development and
commercialisation process
©2018 Weaver Technical Solutions Ltd
50

51. What can go wrong?
• Product Need
• Risk/Product and Project
• Planning/Roles&Responsibility
• Quality
• Money
• Robustness
• Suppliers/Vendors
• Knowledge/Training
©2018 Weaver Technical Solutions Ltd
51

52. Questions
Weaver Technical Solutions Ltd
+44 (0) 7960482165
alastair_clarke@lineone.net
52

53. End of Slides

54. Resources – Learn from others
• FDA db • EU sources
• The wider community
McKinsey
54

55. Resources - Web Sites
• UK Gov
• https://www.gov.uk/government/collections/regulatory-
guidance-for-medical-devices
• EU Regs
• https://ec.europa.eu/growth/sectors/medical-
devices/regulatory-framework_en
• US Regs
• https://www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/Overview/default.htm
55

56. Resources – Books and Standards
56

57. Resources – Authority Guidance
57

58. Resources - IDEs
58

59. Resources – USA: MDSAP
• The Medical Device Single Audit Program allows an MDSAP recognized
Auditing Organization to conduct a single regulatory audit of a medical
device manufacturer that satisfies the relevant requirements of the
regulatory authorities participating in the program.
• International partners that are participating in the MDSAP include:
• Therapeutic Goods Administration of Australia
• Brazil’s Agência Nacional de Vigilância Sanitária
• Health Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese
Pharmaceuticals and Medical Devices Agency
• The World Health Organization (WHO) Prequalification of In Vitro
Diagnostics (IVDs)Programme and the European Union (EU) are Official
Observers
59
(https://www.fda.gov/MedicalDevices/InternationalPrograms/MDSAPPilot/)

60. What is IMDRF?
(International Medical Device
Regulators Forum)
• IMDRF is a voluntary group of medical device regulators
from around the world that was created in 2011:
• to replace the Global Harmonization Task Force on Medical
Devices (GHTF) and build on its strong foundations and
previous work.
• to accelerate international medical device regulatory
harmonization and convergence.
• The IMDRF Management Committee comprises
regulatory authority representatives from Australia,
Brazil, Canada, China, Europe, Japan, Russia and United
States of America.
60

61. EU the new MDR
61

62. The NIHR London roadshow
for MedTech SMEs
Search ‘National Institute for Health
Research (NIHR)’
OfficialNIHR@OfficialNIHR