Mastering Clinical and Technology Trials in MedTech

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The University of Portsmouth SIGHT Program and NIHR Surgical MedTech Co-operative invite you to join our 4-session course in September 2022

The Mastering Clinical and Technology Trials in MedTech course is a free-of-charge initiative to help collaborative companies and organisations keen to engage in its key pathways of support to clinical trials and help to facilitate clinical engagement and help signpost to the relevant partners that have supporting projects and to determine the correct stage of the support offering.

It will take place over 4 virtual sessions will take place in September 2022 (13th, 15th, 20th, 22nd) for 3 hours (9:30 am – 12:30 pm GMT) hosted by the University of Portsmouth SIGHT Programme and the NIHR (National Institute for Health and Care Research) Surgical MedTech Co-operative powered by Empact Ventures with the aim of:

It will help to raise awareness and knowledge of the process of trialling new technologies and providing a service to SMEs and SIGHT member companies to support them with the different aspects of getting ready for clinical trials within the NHS from evidence requirements to funding, data and patient involvement. It will also share the offering of the SIGHT Programme and the NIHR Surgical MedTech Co-operative in supporting you on this journey as leaders in MedTech Education across the South, the UK and beyond.

The course will feature SIGHT member companies to showcase their technologies and demonstrate how they have mastered clinical trials through our MedTech Showcases involving startups, scaleups and SMEs across the UK, Ireland and Europe

It will feature Key Note Speakers (Stage), Roundtable Discussions (Sessions), PhD Clinic, Speed Video Networking, Expo Area, Live Chat and Polls. For those who register, attend and opt-in you will receive 3 warm email introductions to potential collaborators that match your requirements facilitated after the event by the Empact Ventures team for those that attend.

Our Replay area will enable you to watch any recorded sessions you have missed during the event only and recordings will be posted on this page by mid-Oct 2022

September 2022

Our Partners

Topics Covered

Topics covered include;

Tuesday 13th September: Introduction to Clinical & Technology Trials for MedTech
Thursday 15th September: Designing Your Clinical Trial & Securing Clinical Champions
Tuesday 20th September: Identifying and Securing the Right Funding for Clinical Trials
Thursday 22nd September: Maximising your Clinical Trial Results for the Next Steps

Who is this course aimed at?

Primarily UK-based MedTech start-ups and scale-ups wanting support to take their idea to clinical trials
Small to medium-sized enterprises or larger organisations seeking training
Professionals wanting to support MedTech companies on this process
Researchers and clinicians developing innovative medical technologies

Course Details

How to join: We use Hopin online virtual platform, when registered you will be able to gain access on the day of the course

Dates: 13th, 15th, 20th, 22nd

Times: 9:30 – 12:30 pm

Each session included:

Live Pitches & 3 expert Key Notes
Key Roundtable Education Discussions from supporting partners
Video Networking & Expo: In our Speed Video Networking area, you can get super connected with potential partners, clients or funders. In our Digital Expo area, where you can view pitch decks, connect over video or requested to be super connected.
Open Roundtable; MedTech companies can share their challenges by going on video with expert advisors and industry organisations who can provide answers

Weekly Sessions & Speaker Presentations

Please select the collapse / expand options below for te subtopics within each session

Tuesday 13th September : Introduction to Clinical & Technology Trials for MedTech

Topics

Topic 1 – The importance and reasons to conduct clinical trials and what comes before clinical trials
Topic 2 – Common Myths about clinical trials answered
Topic 3- Understanding the different types of clinical evidence required in clinical trials (e.g with NICE, Integrated Care Systems, etc) and the importance of the procurement process (cover notified bodies)
Topic 4- The importance of protocols and adhering to them including CE Marketing & the Upcoming (Brexit) Changes
Topic 5 – The importance of clear data management principles (e.g. Device Master Records)

Thursday 15th September : Designing Your Clinical Trial & Securing Clinical Champions

Topics

Topic 1 – The Role of Partners in a Clinical Trial will cover who should be involved in clinical trials and how they should be approached for involvement moving forward including finding sites for the study
Topic 2 – Securing Clinical Champions in Your Clinical Trial and Understanding their role in the design of your study
Topic 3 – Costing out a Clinical Trial (e.g. sites, clinical champions, PPI, etc.)
Topic 4a – The Role of Patient and Public Involvement (PPI) will cover the planning, recruitment, management, ethics, protocols, user testing, human factors, and processes
Topic 4b – The Patient Perspective on PPI and Clinical Trials
Topic 5 – The Role of the National Institute for Health Research (NIHR) e.g. research design service, grant funding support, finding suitable sites

Tuesday 20th September : Identifying and Securing the Right Funding for Clinical Trials

Topics

Topic 1 – The Funding Options (Grants, Investment, Loans, R & D Tax Claims), preparing to pitch for funding, the pitch deck, negotiation, due diligence etc. (relevant to clinical trails)
Topic 2 – Identifying, writing, and securing grant funding to support your clinical trials
Topic 3 – Preparing for Pitching to Angel Investors and Venture Capitalists
Topic 4 – Securing Debt Funding
Topic 5 – Making a success of R & D Tax Credit Claims

Thursday 22nd September : Maximising your Clinical Trial Results for the Next Steps

Topics

Topic 1- Summary of Learning & Next Steps (e.g. insights developed, patient feedback, marketplace factors)
Topic 2 – Disseminating the clinical trial results, how, and who needs it (e.g. clinical bodies)
Topic 3 – Critical Success Factors of Clinical Trials
Topic 4 –Marketing and safety surveillance of approved medical devices or treatments after approval to monitor their effectiveness, safety, long-term effects, and best use