Supporting Innovation in Medical Technology Enterprises

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

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

3. 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.

4. Transforming care as a core of the STP

5. 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

6. 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

7. 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)

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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 Digitally transformed Dorset Healthy.io – Enabled by Digitally transformed Dorset One Acute Network Integrated Community & Primary Care Prevention at Scale Leading and Working Differently

15. 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

16. Digital Dorset: Questions?

17. Wessex presents: Supporting Innovation in Medical Technology Enterprises

18. 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 √ √ √

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

21. 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

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

23. 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

24. 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

25. 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

26. 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

27. 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

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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

39. 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

40. 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

41. 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

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

44. 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

45. Key Stakeholders Biomedical Research Centres

46. What we do

47. What we do

48. What we do

49. 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

50. 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

51. Offer # 2 – Market Analysis

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

53. Offer # 3 – DIY Search

54. Offer # 3 – DIY Search

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

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

58. 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

59. 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

60. 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

61. Clinical Research Network Study Support Services

62. Clinical Research Network Local offer: Technology Support Programme

63. 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

64. 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

65. 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 For more information about local support please contact us at industry.crnwessex@nihr.ac.uk Any questions?

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

69. Regulatory Cycle

70. 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

71. 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

72. 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

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

74. 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

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

76. 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.

77. • 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

78. 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

79. 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

80. 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

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

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

83. 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

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

86. 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

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

88. 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?

90. 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.

91. 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 re

Supporting Innovation in Medical Technology Enterprises

Supporting Innovation in Medical Technology Enterprises

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