InHealth’s board of directors has approved two follow-on grants totaling more than $830,000 for studies by faculty teams at Northwestern University and Duke University.

Northwestern investigators will study opportunities for improving FDA’s 510(k) product review process. The work builds on their previous InHealth-funded research that for the first time documented in detail the medical technology development process.

Duke researchers will focus on the lifetime benefits of implantable devices, including replacement knees and hips, and cardiac pacemakers. This research will add to the Duke team’s previously published analyses of the shorter-term impacts of total knee and total hip procedures.

“The current healthcare landscape requires more evidence about the medtech sector than ever before,” says Martyn Howgill, executive director of the Washington-based research and analysis organization. “We are pleased to continue supporting these investigations of the economic effects of medical devices and diagnostics.”

The Northwestern team will receive $240,000 for a new study, “A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform.” The team will undertake a systematic collection of information, data, and constructive input from those who participate in the 510(k) process and know it best—those involved in the design and development of regulated medical products, including entrepreneurs, academic physician-inventors, and federal regulators.

The Northwestern study team is led by principal investigator John H. Linehan, PhD, professor of medicine and biomedical engineering and director of the center for translational innovation at the Northwestern University Clinical and Translational Science Institute. Collaborating in the study will be Jan B. Pietzsch, PhD, consulting associate professor of management science and engineering, advisory faculty member of the Biodesign program at Stanford University, and president and CEO of Wing Tech Inc.

The Duke team will be led by co-principal investigators Linda George, PhD, professor of sociology and associate director of the center for the study of aging, and Frank Sloan, PhD, McMahon professor of health policy and management and professor of economics. The team will receive almost $600,000 over three years for their follow-on study, “Assessing the Impact of Implantable Medical Devices on Disability, Health, and Medicare Expenditures.”

The grantees will investigate the effects of three commonly used implantable medical devices—total knee and total hip replacement systems, and cardiac pacemakers—on multiple outcomes, including disability rates, changes in comorbidities, and the recipient’s total Medicare expenditures.

The two follow-on grants support InHealth’s research mission to measure the effects of advanced medical technologies. More information about these grants will soon be available via InHealth.