Submissions due September 1, 2017
Over the past decade, two societal trends have affected the way we think about clinical data for medical technology, and have driven the need for an organized strategy to collect and analyze data in near real-time to optimize patient health outcomes. First, the notion that we can predict the performance and clinical outcomes of medical technologies in common clinical settings via inference derived from a historical pivotal clinical trial, or set of pivotal clinical trials, has been challenged. Second, is the extensive and widespread digitization of medical information in clinical practice, although there are still significant challenges in converting clinical practice digital data into useable evidence for regulatory decision-making.
NESTcc is looking to the wider ecosystem to provide possible solutions that employ state-of-the-art data and computer science technologies, as well as data flow infrastructure that will deliver low cost, high-quality, longitudinal medical device information in near real-time. The reliance on data use agreements (DUAs), data licensing, data standards and data processes to enable data flow models from decentralized data warehouses has the potential to create a responsive ecosystem of innovative data integration and data warehousing services.
NESTcc is looking to identify companies, organizations, collaborations and strategically coordinated registries from the academic, private and non-profit sectors that can offer third-party solutions to the problems described above. These solutions must develop, verify and operationalize methods of evidence generation and data use that are of high quality, cost-effective, in near real-time, and that contribute to informing NESTcc as it builds out its critical functions and processes for sustainability. We are interested in identifying a range of collaborators with access to high quality data that can integrate areas such as cloud services, data aggregation, data storage and data analytics that will support NESTcc with addressing the needs of the medical device industry, the FDA and other key stakeholders in the ecosystem.