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Northwestern University

Assessing the Impact of Medical Technology in the Diagnosis and Treatment of Obstructive Sleep Apnea
One-year Research Study
$191,231 Grant Awarded in 2008

According to the Institute of Medicine, as many as 6 million Americans suffer from obstructive sleep apnea, a severe sleep disorder that can lead to obesity, diabetes, stroke and depression and a profound economic impact on the health care system. Researchers John Linehan, Ph.D., professor of Medicine and Bioengineering at Northwestern University, and Jan Pietzsch, Ph.D., consulting assistant professor in Stanford University's Department of Management Science and Engineering, and President and CEO of Wing Tech Inc, will apply the one year, $191,231 grant to deliver new insights about the role of medical technology in diagnosing and treating obstructive sleep apnea. The team will explore efficacy, cost-effectiveness and access to diagnostic and therapeutic technology used to treat the disorder. Researchers will build a predictive model to assess the effects of improved diagnosis and treatment of the condition that can be used for future policy and technology development.


Assessing the Impact of Medical Technology in the Treatment of Chronic Wounds
One-year Research Study
$249,269 Awarded in 2009

As a major source of morbidity and mortality, chronic wounds and their management represent a substantial burden to the healthcare system, costing the nation up to $25 billion a year. Medical technologies have greatly improved the effectiveness of wound care and reduced healing time for many patients, but the effects, benefits, and costs of such new technologies have never been quantitatively measured. John H. Linehan, PhD, was awarded a one-year grant of $249,269 to develop a comprehensive, decision-analytic modeling framework that will enable researchers to assess the impact of innovative technologies in the treatment of chronic wounds. Effects on the individual patient level will be extrapolated to the population level, enabling a larger view of the efficacy of existing devices, the implications of emerging wound care technologies, and the opportunities for targeted design of future clinical trials. 


A Comprehensive Analysis of the FDA 510(k) Process: Industry Practice and the Implications for Reform
One-Year Research Study
$242,429 Grant Awarded 2010

For this study, the Northwestern 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, and will also contrast regulation in the United States with other systems, primarily the European CE marking process.

The study team is led by principal investigator John H. Linehan, PhD, professor of biomedical engineering at Northwestern University. 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.


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