10110641MARGARITA: a Multi-Agency ReGulAtory RIsk management neTwork for Accelerating diagnostic pathwaysClosedCollaborative R&DInnovate UKWe want to create a network called MARGARITA to help innovators to reduce risks when developing and regulating medical tests (In vitro diagnostics or IVDs). This network will bring together experts in technology, research, and healthcare, along with input from regulatory bodies and policy makers. We'll have meetings and workshops to assist IVD developers, especially those just starting out, in setting priorities and creating practical uses for their tests. We will gather knowledge from these engagements to develop better ways of understanding different settings and users. This will help innovators to select appropriate settings for their products and regulators to set up appropriate safety and performance standards. MARGARITA also provides an opportunity for horizon scanning and testing regulatory theories for new and innovative technologies. Our project is innovative because currently there is no system to examine such decisions which happen at a very early stage of product development. Innovators often do not have opportunities to validate their ideas. This understanding is however crucial, as it defines the route an innovation will be commercialised, for whom, where and how to use. Our ambition is to systematically integrate into commercial planning such information on risks, benefits and costs. This, we believe, would bridge the gap and increase the chances that the technology better fits the needs and can reach the market. Regulators will benefit from influencing early stage developments, and set appropriate performance goals as well as develop new schemes. Ultimately this means safer, more effective tests for the patients and public. We will borrow insights from best practices in related fields, including regulating risks in drugs, decision making, risk analysis, and behavioural sciences. At the core of our network we have academic centres (e.g. London IVD, Imperial College), healthcare providers (e.g. Imperial College NHS trust), and industry body (e.g. ABHI). We are already connected to larger networks including BIVDA, Royal Marsden, UCLH, CRUK, PCUK etc as well as Patient and Public Involvement and Engagement (PPIE) groups. These allow us to gather the expertise, experiences required and to disseminate our learning widely.