Hologic Joins NEST Governance Committee to Advance the Use of Real-World Data in Medical Device Evaluation

The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC), is pleased to welcome Hologic, a leading global medical device and diagnostic company, to its Governance Committee. This appointment reflects Hologic’s commitment to advancing the use of real-world data (RWD) to support medical device evaluation and drive innovation in women’s health.

Hologic is the latest partner to join the NEST Governance Committee which convenes a diverse group of leaders from across the medical device ecosystem—including regulatory agencies, industry, academia, patient organizations, and health systems.

NEST’s mission aims to accelerate patient access to life-changing innovation by supporting the sustainable generation and use of timely, reliable and cost-effective real-world evidence (RWE) solutions throughout the medical device total product lifecycle. To advance this mission, NEST’s Governance Committee plays a pivotal role by jointly identifying and prioritizing key initiatives that drive RWE generation for medical devices in support of regulatory submission packages, all while ensuring a patient-centered, inclusive, accountable, and transparent approach.

“Hologic is honored to join the NEST Governance Committee and contribute to advancing the use of real-world evidence in diagnostic and medical device evaluation,” said Jeff Hergesheimer, Senior Director, Regulatory Affairs at Hologic and newly appointed NEST Governance Committee member. “Real-world data plays a critical role in accelerating innovation and improving patient outcomes. Through collaboration with NEST and other stakeholders, we look forward to driving solutions that enhance regulatory decisionmaking and deliver impactful healthcare advancements.”

Through NEST Governance Committee involvement, Hologic will help accelerate patient access to cutting-edge technologies, bring a unique perspective as an industry leader in women’s health, and contribute to the evolution of RWE approaches in regulatory decision making. Through its contributions, Hologic brings a valuable perspective grounded in both technical expertise and an enduring commitment to innovation in women’s health.

"We are thrilled to welcome Hologic and Jeff to the NEST Governance Committee,” said Simon Mason, president at NEST. "Their pioneering leadership in women’s health meets an untapped need on our committee coupled with their commitment to employing RWE in regulatory submissions will bring invaluable insights and experience and most importantly, improve patient care and quality of life."

For more information about Hologic, visit https://www.hologic.com.

About Hologic, Inc.

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.

About NEST (National Evaluation System for health Technology)

In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NEST). NEST is advancing the use of real-world evidence (RWE) in medical devices for regulatory decision-making and committed to transforming the way medical device technologies are tested, approved, and monitored. The Coordinating Center combines RWE system infrastructure with the unparalleled expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design™. For more information on NEST, please visit nestcc.org or connect with us on LinkedIn.

About MDIC (Medical Device Innovation Consortium)

At MDIC, we unite in a shared mission to improve health and save lives by accelerating access to medical technologies. Through stakeholder collaboration, MDIC leads the way in advancing the scientific and technical foundations of medical device design, manufacturing, regulation, reimbursement and clinical integration. Founded in 2012 as a nonprofit, public-private partnership to elevate regulatory science, MDIC develops new approaches and tools for addressing shared challenges among medical device manufacturers, researchers, regulators, payers, patients, and health care providers. We deliver high impact work in the core areas of quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement. To learn more and join us in our mission, visit MDIC.org.

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