NESTcc Overview
In the NESTcc overview video, learn more about our role in the ecosystem and how we are advancing real-world evidence in the evaluation of medical devices.
Active Surveillance Roadmap Webinar
NESTcc’s Active Surveillance Roadmap summarizes progress made to date and describes forward-looking plans and activities needed to develop NESTcc’s active surveillance capabilities.
The Roadmap details the technical characteristics of a cloud-based, federated learning environment to perform safety signal refinement and signal detection using real-world data via a planned data network. Additionally, the document describes planned research methods and procedures to ensure data quality along with guiding principles around signal management and communications to ensure active surveillance capabilities are scalable, secure and equitable to all stakeholders.
On Thursday, September 23, 2021, NESTcc held an information webinar to give an overview of the Active Surveillance Roadmap, answer questions from the medical device ecosystem and provide guidance on submission during the public comment period, which ended October 11.
Active Surveillance Roadmap Webinar
RWE²
On September 21, 2021, key opinion leaders from across the medical device ecosystem gathered to share the latest advancements and practical uses of RWE, including presentations on three of NESTcc’s completed Test-Case research projects.
NESTcc’s Test-Cases provide insights into 10 therapeutic areas across all stages of the total product life cycle (TPLC), and experts shared their perspectives on the use of real-world data (RWD) to move safety and innovation forward.
NEST RWE Forum
On May 20, 2021, key opinion leaders from across the medical device ecosystem gathered to share the latest advancements and practical uses of RWE, including presentations on three of NESTcc’s completed Test-Case research projects.
NESTcc’s Test-Cases provide insights into 10 therapeutic areas across all stages of the total product life cycle (TPLC), and experts shared their perspectives on the use of real-world data (RWD) to move safety and innovation forward.
NEST Forum
On September 22, 2020, key opinion leaders from across the medical device ecosystem, including FDA, gathered to share the latest advancements and practical uses of RWE through the 21 NESTcc Test-Cases underway, with deep-dive presentations on 5 of the research projects.
NESTcc’s Test-Cases provide insights into adult and pediatric populations in 10 therapeutic areas across all 5 stages of the total product life cycle. At the NEST Forum, experts offered their perspectives on the use of real-world data (RWD) to move safety and innovation forward and change the paradigm of clinical research.
Delivering on the Vision of NEST for the Medical Device Ecosystem
Developing Objective Performance Criteria (OPC) for Outcomes after Hip and Knee Replacement
The Feasibility of Using Real-World Data in the Evaluation of Cardiac Ablation Catheters
Creation of a Patient-facing Mobile App for a Stress Urinary Incontinence (SUI) Surgery Registry
Testing the Use of RWD from Three Unique Sources to Expand Indications
Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using EHR Data
Real-World Evidence: Current Perspectives and Future Innovation
Emerging Issues in UDI – A NEST Collaborative Community Discussion
On October 15, NESTcc hosted a virtual event to kick off the NEST Collaborative Community Unique Device Identifier (UDI) initiative.
Our inaugural NEST Collaborative Community event gathered leaders from across the medical device ecosystem, including FDA, industry, payers, and patients, to discuss emerging issues related to unique device identifiers (UDI).
The NEST Collaborative Community provides a forum for stakeholders to work proactively to improve the speed of innovation and enhance the safety and effectiveness of medical device and health technology.
UDI was selected as the initial Collaborative Community focus because of its broad relevance across the medical device ecosystem, the importance of policy decisions to multiple stakeholders, and the urgent need for cooperative engagement.
Emerging Healthtech Media Interview
In late 2020 Joe Mullings, Chairman and CEO of the Mullings Group Companies, sat down with MDIC President and CEO Pamela Goldberg and NESTcc Senior Vice President Sandra Siami to discuss MDIC’s focus on real-world data (RWD) and real-world evidence (RWE).
The discussion considers how NESTcc can provide an efficient way to execute studies using RWD, refine the risk/benefit ratio for a product earlier in the total product life cycle (TPLC) and assist healthtech companies in generating high-quality RWE for their needs across the TPLC.
View the interview segments below or on the Emerging Healthtech Media site.
