InHealth awards grants to research teams at Northwestern, Duke

September 09, 2010

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.
-end-
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.

InHealth: The Institute for Health Technology Studies

Related Disability Articles from Brightsurf:

Raising the bar on disability care
Encouraging paid workers to employ the 'right kind' of respectful personal relationship with young people with disability will lift standards in the sector, experts say.

Keep moving to prevent major mobility disability
According to research, being physically inactive is the strongest risk factor for disability as we age.

How gene mutation causes autism and intellectual disability
Scientists have discovered why a specific genetic mutation causes intellectual disability and autism spectrum disorder in children.

Is disability a risk factor for miscarriage?
A new study compared the proportion of women with any cognitive, physical, or independent living disability who experienced a miscarriage during the previous 5-year period to women without disabilities.

'Climate change is a disability rights issue'
In a high-profile Letter in Science, University of Konstanz climate scientist and ecologist Dr Aleksandra Kosanic, an Associate Fellow of the University of Konstanz's Zukunftskolleg, draws attention to the fact that disabled populations have, until now, been absent from international conversations about climate change and its impact.

Predicting frailty, disability and death
In a study led by investigators from Brigham and Women's Hospital, researchers analyzed patterns of movement among elderly study participants and found that irregular, spontaneous fluctuations could predict a person's risk of frailty, disability and death years later.

Movement patterns predict frailty and disability in the elderly
Elderly people who show more random changes in daily movement tend to be at greater risk of frailty, disability and death, according to a large study involving 1,275 individuals over the course of 13 years.

IQSEC1 gene mutations cause new intellectual disability syndrome
Researchers identify gene causing intellectual disability syndrome that is common in countries where consanguineous marriages are prevalent.

Best medications to reduce drooling for those with developmental disability
A new study has revealed the most effective medications to reduce drooling in young people with a developmental disability, which can affect their socialisation, relationships and community life.

Obesity worsens disability in multiple sclerosis
Obesity is an aggravating factor in relapsing-remitting multiple sclerosis, the most common form of the disease.

Read More: Disability News and Disability Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.