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Real-World Evidence: The Future of Data Generation and Usage

When: Wednesday, June 12 | 3:15 pm - 4:00 pm 
Where: Room 49 - Product Lifecycle Management Track
Level: Beginner
Participant Type: Research & Development, Product Development, Regulatory/Clinical Affairs, Sales & Marketing

 

Description

As data is captured through electronic health records, registries and unique device identifiers, the generation of evidence based on this data is expected to play a crucial role in informing orthopedic manufacturers’ decisions before and after regulatory approval. While regulators, payors, hospitals and manufacturers support this shift, they acknowledge that gaps remain in its optimal execution. Priority considerations include how to generate evidence to expedite regulatory market decisions, device indication expansion, postmarket studies, postmarket surveillance and reimbursement decisions. The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), is leading the conversation with various stakeholders, including FDA and orthopedic device companies to support the sustainable generation of Real-World Evidence (RWE) using Real-World Data (RWD). In this session NESTcc will provide context as to how RWE and RWD fit within the regulatory landscape, how companies such as DJO Global, DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet are involved in test-cases and preview the future of data generation within the NESTcc Data Network.

Attendee Takeaways

  • Gain awareness of the role of Real-World Data and Real-World Evidence in orthopedics today and in the future
  • Gather insight on ways to generate evidence and make smarter product development decisions
  • Learn how orthopedic companies are partnering with NESTcc

Speakers

Rachel R. Rath, MPH is the Deputy Director for the NEST Coordinating Center (NESTcc). She joined MDIC from the Patient-Centered Outcomes Research Institute (PCORI). Upon joining PCORI in 2014, she helped build and manage the development of the PCORnet, the National Patient-Centered Clinical Research Network, a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United States. Prior to joining PCORI, she worked in public policy for the National Multiple Sclerosis Society and the COPD Foundation and received her MPH in global health policy from The George Washington University.

 

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Orthopaedic Companies Collaborate with NESTcc on Real-World Evidence Considerations
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