Topic

Establishing the National Evaluation System for Health Technology (NEST) Coordinating Center

Presenters

Bill Murray, President and CEO, and Dawn Bardot, PhD, VP of Technology Innovation, of the Medical Device Innovation Consortium (MDIC)

Keywords

Medical devices; Medical Device Innovation Consortium; MDIC; National Evaluation System for Health Technology; NEST; Real-world evidence; Surveillance; Electronic health record; EHR; Data collection

Key Points

• The Medical Device Innovation Consortium (MDIC) is a public-private partnership that brings together representatives of the FDA, NIH, CMS, industry, nonprofits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies. MDIC’s purpose is to
  - Create a forum for collaboration and dialog
  - Make strategic investments in regulatory science
  - Provide tools to drive innovation
• In establishing the NEST Coordinating Center, MDIC will foster the open science principles of transparency of governance, coordinating processes, policies, and data access. During Phase 2, the Coordinating Center will be initiating NIH Collaboratory Trials capable of providing direct value to participating stakeholders, focusing first on high-risk category devices that require tracking and EHR data from hospital systems.
• This new national model will provide active surveillance, leverage real-world evidence to support regulatory decisions, and enable the collection of data during routine clinical care.

Discussion Themes

What are some of the challenges for the NEST Coordinating Center related to data transparency and access?

Patient perspectives on outcomes that matter are integral to the science of patient input. Patient preference information sheds light on risks that they are willing to tolerate.

For More Information

To learn more about MDIC’s NEST Coordinating Center, visit http://mdic.org/cc/.

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