Public Funding for Reg Metrics 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

Regulations are essential to keep the general public safe. They cover the legal obligations you have to abide to as manufacturer. Companies need to follow the regulations in order to bring their products to market. A good understanding of the regulations and the regulatory pathway defines how fast and at what cost the manufacturer can introduce innovations to the market. A new digital platform will be developed that can support users to understand and explore the regulatory pathways for their product. The initial focus will be on healthcare products and the team will develop smart solutions to support and guide the innovators through the relevant regulations. The platform will also provide innovators with a device specific regulatory strategy pathway, which includes the general safety and performance requirements (GSPR). It connects device-specific information to standards, test labs and suggest the clinical route. This process will be user driven and the project includes studies to verify the user needs, as well as the technology developed. This platform will be a proof of concept that in the long term can be scaled to other regions, as well as sectors. It aims to create a breakthrough innovative digital platform that tackles the challenges users have with the regulatory process.