How an integrated data platform can reshape the medical device industry

By Medidata Solutions As big data grows and competition rises, stricter regulatory guidance looms Today’s medical device industry is being transformed by the generation and analysis of vast amounts of data. However, the traditional approaches to data collection and analyses in clinical trials don’t necessarily apply. Along with this massive volume of siloed, disparate data comes unique challenges — from unstructured datasets and data ownership and privacy issues to storing global post-market surveillance data and adhering to evolving regulatory definitions and requirements. These challenges demand the adoption of an integrated data platform at the beginning of a medical device development program. By doing so, it can help alleviate some of the current data challenges by enabling innovation, guiding regulatory pathways, and maximizing commercialization opportunities. By engaging with an experienced partner, medical device manufacturers can leverage the opportunities of an integrated data approach and enhance their medical device program. Integrated data can aid in product innovation Integrating data from disparate datasets can provide novel insights and increase product innovation. For instance, digital biomarkers (consumer-generated data from device sensors) can support evidence-based outcomes and provide novel insights into real-world use when integrated with clinical trial data. Sensors have been incorporated into more than 1,600 clinical trials (clinicaltrials.gov) a...
Source: Mass Device - Category: Medical Devices Authors: Tags: Sponsored Content Medidata Solutions Source Type: news