WASHINGTON, DC—The Institute for Health Technology Studies (InHealth) has awarded two follow-on grants totaling more than $830,000 to research teams at Northwestern University and Duke University.
Northwestern investigators will study opportunities for improving the Food and Drug Administration's 510(k) product review process for medical devices. The work builds on 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 replacement procedures.
"Evidence-based policy is at the center of the new healthcare landscape, placing even more importance on measuring the effects of medical technology," said Martyn Howgill, InHealth's executive director. "InHealth's continued support of faculty teams at Northwestern and Duke offers the opportunity for these accomplished researchers to build much-needed evidence about the regulation and lifetime benefits of medical devices to ensure that future policy decisions save, improve, and extend lives."
Northwestern University: Measuring the Effectiveness of the 510(k) Process
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 study will extend research funded by an InHealth grant awarded in 2006.
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 on 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, Wing Tech Inc.
The grant coincides with heightened debate surrounding FDA's plans to revamp the 510(k) product review process, which permits companies to make new products commercially available when they are "substantially equivalent" to a predicate device already on the market. The process governs Class II products, which make up the vast majority of medical devices cleared for market entry each year.
"Healthcare reform has brought the 510(k) process under increased scrutiny, transforming a decades-old process into a hot-button issue," Howgill said. "Critics of the process are concerned about patient safety and supporters worry that overhaul will disrupt the industry and innovation. Any reform must be based on unbiased evidence about the effectiveness of the process itself."
Duke University: Examining the Impact of Hips, Knees, and Pacemakers
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, J. Alexander McMahon professor of health policy and management and professor of economics. The team will receive nearly $600,000 over three years for "Assessing the Impact of Implantable Medical Devices on Disability, Health, and Medicare Expenditures," which will explore the effects of three commonly used implantable medical devices––total knee and hip replacement systems, and cardiac pacemakers––on multiple outcomes, including disability rates, changes in comorbidities, and the recipient's total Medicare expenditures.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, approximately 773,000 Americans undergo knee- or hip-replacement surgery each year. Researchers will measure how these orthopedic devices have contributed to the decline in elderly disability over the past quarter century. They will also explore the lifetime benefits of joint replacement devices for patients, including physical functioning; the onset or worsening of comorbid conditions such as diabetes and obesity; and the impact of joint replacements on Medicare expenditures and personal and institutional care costs. This analysis will also be applied to implantable cardiac pacemakers.
The new study builds on the team's previous research, which demonstrated that, in the short-term, total knee- and hip-replacement systems lessened disability for the elderly at any age. Findings will shed light on how these devices impact both the economy and patients––an issue at the center of healthcare reform implementation.
The two follow-on grants support InHealth's mission to measure the effects of advanced medical technologies. Since its establishment in 2004, InHealth has invested more than $11 million in research-related activities, including grants to Duke University, Harvard/Beth Israel Deaconess Medical Center, Johns Hopkins University, Medical College of Georgia, Northwestern University, Stanford University, Tufts University, the University of Houston, the University of Pennsylvania, and the University of Southern California.
More information about these grants will soon be available via the InHealth website at www.inhealth.org. Grant recipients from InHealth's 2010 requests for proposals will be announced this fall.
About InHealth (www.inhealth.org): Launched in 2004, the Institute for Health Technology Studies (InHealth) is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices.