Premier, Inc. and NEST partner to advance medical device evaluation with real-world evidence

Premier, Inc. and NEST are collaborating to enhance real-world data (RWD) and real-world evidence (RWE) in medical device evaluation, with the objective to streamline regulatory submissions and accelerating innovation. 

Premier, Inc. has announced a partnership with the National Evaluation System for Health Technology (NEST) to advance the use of RWD and RWE in medical device evaluation. As the first partner selected through the NEST Medical Device Real-World Evidence Marketplace request-for-participation (RFP) process, Premier will leverage its data assets and research expertise to support regulatory decision-making. This collaboration aims to enhance confidence in RWD, streamline submissions, and drive innovation in medical technology. 

NEST, an initiative within the Medical Device Innovation Consortium (MDIC), focuses on generating reliable and cost-effective RWE throughout the total product lifecycle of medical devices. A key component of this collaboration is the use of the NEST Mark approach, which assesses the relevance and reliability of RWD to ensure it meets regulatory-grade standards. This structured evaluation helps reduce risks in regulatory submissions. 

Simon Mason, President of NEST, emphasized the importance of rigorous data assessment: 

"Real-world data must meet high standards to be useful in regulatory decision-making. The NEST Mark approach provides a structured way to assess study design and data quality elements of relevance and reliability, giving industry greater confidence in generating regulatory-grade evidence." 

Premier’s healthcare data network, spanning nearly 4,400 hospitals and health systems, provides extensive RWD for medical device evaluations. The Premier Healthcare Database (PHD), a HIPAA-compliant, retrospective database, is one of the most comprehensive electronic healthcare data repositories in the US. A key component is its chargemaster data, which captures medical device and drug use during inpatient and outpatient encounters. This dataset can provide critical context for analyses and regulatory submissions, helping identify off-label use and detect adverse device effects that may not appear in traditional claims data. 

Ariann Polasky Stone, Vice President of Business Development and Strategic Relationships at Premier Applied Sciences, highlighted the potential benefits for medical device companies:  

"We view this partnership as an incredible opportunity to help shepherd medical device innovations to market. Often, these companies face steep challenges on the path to commercialization. We believe the NEST Mark process, coupled with our rich data and research expertise, will help our partners abbreviate timelines, reduce costs and achieve their regulatory goals while improving patient outcomes." 

Premier’s Applied Sciences (PAS) research team, which specializes in regulatory submissions, will collaborate with NEST to guide medical device companies through the evaluation and submission process. By integrating high-quality data with robust methodological standards, the collaboration aims to enhance predictability in medical device evaluations.