Introducing The Innovation Pathway AHSN Stakeholder Event Dr Nicola Wesley 2 nd half of presentation 23 rd June 2015

Provided by the NIHR Clinical Research Network: North East and North Cumbria, this service can assist with the establishment of an evidence base for the effectiveness of the product or service in clinical practice. This may vary from observational or questionnaire based research, through to full randomised controlled trials (RCTs). Key Features: Dedicated infrastructure to guide, advise and support you through the intricate research processes in the UK Access to regional healthcare expertise in the design and delivery of research relating to medical products by NHS organisations Benefits High quality clinical studies that meet the stringent regulatory requirements and the ensuing approval Provision of an evidence base supporting the safety and effectiveness of the product or service, to drive adoption by the healthcare system Clinical Trials

Assistance with the clinical evaluation of new medical devices and diagnostic products can be provided, which is an essential requirement for securing regulatory approval. An appropriate strategy to secure CE marking is vital to ensure that the most cost and time effective route is adopted. This in turn requires reliable clinical resources to design and conduct the evaluation, as well as a solid infrastructure to comply with ethics requirements. Furthermore, this can generate the evidence required to validate the claims of improved patient care, cost benefits, and improved service quality. Key Features: Provision of assistance with regulatory approval including CE marking Availability of expertise relating to regulatory strategy within the regional supply chain Provision of assistance from the NIHR Diagnostic Evaluation Co-operative specialising in generating evidence relating to the benefits associated with in-vitro diagnostic products Access to an External Assessment Centre to undertake assessments of medical devices on behalf of NICE Access to extensive peer reviewing by key expert clinicians. Benefits: Generation of high quality ‘evidence of benefit’ to encourage and drive adoption of the new product or service by NHS organisations Evidence

The Ideas that have been assessed and protected can be taken from the concept stage through to functioning prototypes ready for clinical trial and regulatory approval. In parallel with this, commercialisation strategies and routes to market are developed and assessed. Key Features: Provision of access to a regional network and supply chain to support the design, prototyping and development of new products, as well as their manufacture/assembly Assistance with commercialisation including the sourcing of potential licensees, the preparation and negotiation of licences, and the preparation of joint venture agreements Acceleration of the time to market for new products. Benefits: Acceleration of the time to market of new products Income Commercialisation

Raising the profile of the proven innovations as well as the organisations they originate from, will promote wider and faster uptake, adoption and market impact. Key Features: Provision of access to the wide ASHN network to ‘spread the word’ and implement new products and services across healthcare organisations in England and potentially overseas Provision of assistance with the development of bespoke dissemination and implementation strategies Delivery of technology transfer and action planning stakeholder workshops Implementation of bespoke conferences covering specific topics, for example tele-health and mental health applications. Benefits Increase of the rate of adoption of proven innovations, leading to early revenue generation Supporting an increase in regional economic wealth Acceleration of the availability of high quality patient care across the region and beyond Adoption

New ideas will be paired with those organisations in a position to bring them to reality, as well as facilitating valuable connections with the regional supply chain. Key Features: Access to stakeholder engagement events Access to multi-disciplinary forums Provision of sector focussed events, such as tele-health and mental health Access to a specialised resource pool comprised of the AHSN and its partner organisations Benefits: Provision of opportunities for productive collaborations between parties Acceleration of the time to market for products and services Increasing the availability of high quality and profitable products targetted at improving patient care Facilitation of the sustainability of new businesses in order to promote regional wealth Brokering

The Bright Ideas in Health Awards is the leading healthcare event for the North East region, most recently being attended by more than 400 delegates. Key Features: Provision of an annual forum to celebrate innovation as well as providing recognition for the innovators themselves. Benefits: Raising the profile of innovation and the innovators themselves, both on a regional and a national scale Provision of financial support to assist with the development of the award winning ideas Showcasing of potential commercial opportunities for businesses and SMEs Success

Case Study: PolyPhotonix (Innovation In) Currently undergoing a Phase III, multi-centre RCT to demonstrate clinical efficacy for the Noctura Sleep Mask Sunderland Eye Infirmary and South Tees NHS FT involved in the RCT for the Noctura Sleep Mask Sunderland Eye Infirmary providing clinical evaluation for other products City Hospitals Sunderland NHS FT assisting with procurement and coding advice for the Noctura Sleep Mask NIHR Clinical Research Network evaluating other therapeutic areas for the photonics technology Newcastle Hospitals NHS FT assisting with procurement and clinical pathway advice NHS Innovations North involved in market research and specialist information Other bodies include NHS England, SBRI and other AHSNs

Case Study: Safe Place™ (Innovation Out) A neonatal ECG catheter for use in premature babies Original idea developed by the Special Care Baby Unit at the RVI RMPD involved in prototype design, clinical evaluation and development, regulatory approval and clinical trials NHS Innovations North responsible for initial market research, prototype development, patent and registered design protection Two local SMEs involved in the supply chain (non- healthcare) NHS Innovations North negotiated two patent licences with Vygon (developmental and long term) Safe Place™ device soon to be launched Signing fees and royalty payments generated for the inventor and Newcastle Hospitals NHS FT

Any Questions?