Public Funding for Element Materials Technology Holding UK Ltd

The AMRI (Accelerating Medical Technology Regulatory Science Innovation) Network is a virtual network focused on medical device regulation and innovation. It brings together academia, industry, regulators, and healthcare stakeholders (including patients) to collaborate and develop regulatory guidance, tools, and standards to address current challenges in medical technology translation. The network will actively participate in shaping regulations and support partnerships and collaborations in the non-commercial, academic, and industry sectors through innovative regulatory science. The network is underpinned by 4 broad closely aligned workstreams, each engaging specialist healthcare stakeholders, expert regulatory and ethics bodies and industry partners. Academic expertise in these areas presents a unique opportunity for the network to provide significant value. 1. Digital Medicine (application of advanced digital technologies such as artificial Intelligence (AI), Data and Machine Learning) 2. Drug/device combination Products and Drug Delivering Medical Devices 3. Robotics and digital Surgery and Rehabilitation 4. Digital diagnostics and investigations Each workstream will establish national workshops to facilitate networking between network stakeholder leading to the establishment of coordinated national approaches to accelerate innovation. This will include the implementation of surveys to identify current national activity (e.g. established QMS systems, clean rooms etc) and unmet needs. It will furthermore promote the development of a database of established disease specific research datasets and implement Best Practice Guidance for its Management, Access and Use to enhance innovation. To ensure continued innovation, the network will facilitate the establishment of clear career pathways in regulatory science, via internships, fellowships or PhDs involving academia, industry, trusts and regulatory bodies as key collaborators, mentors, and beneficiaries. **Our goal** is to accelerate innovation by empowering our partners to advance medical device technologies through a flexible and collaborative regulatory science network which will identify where innovation regulation is required, developing regulatory guidance, tools and standards and develop the underpinning regulatory workforce. **Our objectives:** The AMRI Network aims to: * **Accelerate the research pathway (bench to bedside):** accelerate the translational research journey that benefit patients whilst maintaining safe and effective medical devices. * **Increase information sharing:** raise awareness and understanding, and advance best practices. * **Building the regulatory workforce:** support regulatory science innovation and improve uptake/use of innovative device technologies. **Anticipated outcomes:** Through delivering on these objectives, we anticipate the following: * Mobilised network on national expertise, knowledge, and tools to accelerate translation of medical device technologies. * National training and support programmes in regulatory science. * Evidence based medical device guidance and national regulation

The Healthcare Technology and Medical Technology sectors are currently worth £17billion per annum to the UK, and with the ageing population and poor health following the pandemic, are projected to grow to £21billion per annum by 2027\. However, the relatively high levels of regulation in these sectors, can make it slow and expensive for new companies to bring their technologies to the UK market, something that has hindered growth comparative to other global competitors. The West Midlands '6D' Innovation Accelerator (6D-IA) will unite key players across the region (universities, hospitals, industry and government-funded 'Catapults' for manufacturing innovation) to address these problems by creating a supportive environment to accelerate new technologies towards commercialisation. The partners will run a centrally coordinated series of activities that will help companies to navigate "pinch-points" in the process of medical translation. Our '6Ds' include diagnosis of company needs; definition of NHS or corporate challenges to respond to; development and refinement of prototype products or services; deployment of innovation in real-world NHS settings; diversification of cross-sectoral collaborations; and demonstration of economic benefit for our interventions. Together, this will create a cluster of commercial activity in this sector, helping to drive regional economic growth and enhance resilience. It will also ensure that local patients will benefit first from new medical technologies targeted at reducing significant regional healthcare inequalities. The 6D-IA will also provide a national focus for the development and deployment of new healthcare technologies, growing a vibrant and self-sustaining cluster of activity centred in the new Precision Healthcare Technology Accelerator, leveraging major recent private investment alongside significant regional assets to attract and support medical innovators. The 6D-IA will place the West Midlands at the forefront of UK medical innovation by supercharging a cluster of activity in the Greater Birmingham area with strong regional and national links. It will boost economic activity within the region, attracting up to £80-100million in additional private investment by 2026/27\. It will also facilitate the transformation of the delivery of healthcare by creating a strong focus on the development of new digitally-enabled innovations, providing strong secondary care proof-of-principle with associated pilot work in community and primary care.