Hologic Joins NEST Governance Committee 

The National Evaluation System for health Technology (NEST), an initiative of the Medical Device Innovation Consortium (MDIC), has welcomed Hologic to its Governance Committee. The 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 medical device ecosystem leaders—including regulatory agencies, industry, academia, patient organizations, and health systems.

NEST 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 decision-making 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.

“We are thrilled to welcome Hologic and Jeff to the NEST Governance Committee,” NEST President Simon Mason stated. “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.”

Hologic Inc. develops medical technologies that detect, diagnose and treat women’s health conditions and raise the standard of care worldwide.

In 2016, the U.S. Food and Drug Administration (FDA) awarded the MDIC funding to establish NEST. The organization advances 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 expertise of its network collaborators to accelerate patients’ access to safe and effective medical technology and provide Quality Evidence by Design.

MDIC strives to accelerate access to medical technologies. Through stakeholder collaboration, MDIC advanced 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 healthcare providers. MDIC delivers high-impact work in quality design and manufacturing, evidence generation, digital technology and transformation, and patient engagement.