News from InHealth

InHealth Launches 2010 Research Program with Requests for Proposals

Fri, 19 Feb 2010 00:00:00 EST

FOR IMMEDIATE RELEASE

Date: February 19, 2010

Contact: Robyn Stein/Caitlin Hool
212-220-4444
robyn.stein@gabbe.com / caitlin.hool@gabbe.com

InHealth Launches 2010 Research Program with Requests for Proposals

Institute Aims to Break New Ground in Understanding the Effects of Medical Technologies at Societal Levels

WASHINGTON, DC––The Institute for Health Technology Studies (InHealth) has issued the first of its 2010 requests for proposals for original, independent research examining the role and impact of advanced medical technologies—from diagnostics to devices—in transforming healthcare delivery systems and on human capital and labor productivity. Three one-year grants totaling up to $750,000 will be awarded to investigators.

InHealth, a Washington, DC-based nonprofit research and educational organization, issues the requests at a time when there is a great need for objective evidence about the roles that medical technologies play in patients’ lives, in healthcare delivery systems, and in the broader economy.

“Medical technology innovation has already transformed the way that healthcare is delivered and has contributed significantly to national economic productivity,” according to Martyn Howgill, executive director of InHealth. “What we seek to understand is how these changes have affected the systemic costs of delivering care; and how changes in health outcomes, functional status, and the overall well-being of patients can result in even broader impacts on the national economy.”

Howgill notes that the Obama administration has committed to supporting comparative effectiveness research that will provide patients and doctors with better evidence when making clinical decisions. InHealth’s research program seeks to facilitate complementary studies that will provide evidence that policy makers, payers, and regulators can use to make more-effective health policy development and coverage decisions.

Information about the costs of medical diagnostics and devices is readily available, says Howgill, but there is less information about their value and general economic contribution over the past 20 to 30 years. “InHealth aims to encourage investigators to go beyond traditional measures and examine changes in health system delivery models and costs, and the resulting economic effects on patients, families, and businesses over this time period,” he adds. “Similarly, InHealth seeks to facilitate a deeper understanding of how medical technology affects disability levels, absenteeism, workers’ compensation costs, and labor productivity.”

InHealth’s first RFP for 2010, “The Role and Impact of Advanced Medical Technology in Transforming Healthcare Delivery Systems,” calls for studies that identify and investigate economic consequences of advances in diagnostics and medical devices for healthcare delivery systems, and the consequent changes in costs and benefits to society.

Among many topics of possible research, for example, investigators might examine whether there have been meaningful changes or trends in healthcare profitability as a result of technology adoption; measurable relationships between medical technology innovation, healthcare delivery systems, and gross domestic product (GDP); changes in labor costs; or the consequences of changes in the settings where care is provided.

Studies for InHealth’s second RFP for 2010, “The Role and Impact of Advanced Medical Technology on Human Capital,” should examine the economic and contextual impact that innovation in medical technology has had on human capital, and the attendant costs and benefits to society and the nation’s economic productivity.

For example, researchers may devise projects to study how advances in medical technology have changed patterns of employee absenteeism and/or presenteeism; affected economic productivity of the workforce; changed employer costs of labor; increased or reduced workers compensation costs; and constrained or freed employees with family caregiving responsibilities.

Since its inception, InHealth has allocated more than $10 million toward sponsored research, supporting 18 distinct research programs by faculty at 10 leading universities. Research has focused on the impact of various diagnostics and medical devices on mortality, morbidity, disability, and cost, as well as on ability to work, dependence on or independence from supportive care, and quality of life.

InHealth funding has resulted in the publication of 16 articles in peer-reviewed journals. Resulting articles have focused attention on total hip and knee replacements, cardiac and carotid stents, implantable defibrillators, neonatal care, diabetes, diagnostic imaging, as well as a landmark analysis of the device-development process.

InHealth was created as an independent research organization by the Advanced Medical Technology Association (AdvaMed). InHealth’s research priorities are guided by an independent research council composed of academics, economists, policy experts, clinicians, and industry representatives who ensure adherence to scientific principles and monitor the integrity of institute-sponsored investigations.

The deadline for receipt of proposals in response to InHealth’s RFPs is April 30, 2010. The period of performance is from September 1, 2010, through August 31, 2011. Awards are expected to be announced on July 1, 2010. For more information, please visit www.inhealth.org.

At Five-Year Milestone, InHealth Assesses Progress toward Understanding the Impact of Medical Devices and Diagnostics

Mon, 1 Feb 2010 00:00:00 EST

• Founded in 2004 as an independent and nonprofit research and educational foundation
• Has provided more than $10 million to research teams at 10 leading U.S. universities
• Has funded 18 studies, so far resulting in 16 peer-reviewed publications

WASHINGTON, DC — As the Institute for Health Technology Studies (InHealth) marks its five-year milestone, the research and educational nonprofit is taking stock of its contributions to objective evidence about the roles that medical technologies play in the economy, in the healthcare system, and in patients’ lives.

InHealth’s mission to further understand the socioeconomic impact of medical devices and diagnostics addresses the mounting demand for objective data to inform the current debate about how to overhaul the U.S. healthcare system.

Since its creation in 2004, InHealth has granted more than $10 million in research funding to investigators at 10 leading U.S. universities, resulting in 16 studies published in peer-reviewed journals. The research has examined industry processes as well as specific technology advances for such acute and chronic health conditions as cardiac disease, diabetes, osteoarthritis, and obstructive sleep apnea.

“We’ve placed an objective lens on diseases that have the greatest impact on the nation’s mounting medical costs, generating findings that reveal complex relationships among innovation and healthcare delivery, the economy, and patients lives,” says Martyn Howgill, InHealth’s first executive director. “By changing how healthcare is provided to patients, technology has had enormous influence on patients’ lives and on the productivity of the workforce.”

“Healthcare reform and its implementation will require even more data than ever before,” says Howgill. Meeting this need offers an opportunity to foster better understanding of the relationships among medical technologies, healthcare systems, and the economy, he adds.

InHealth has awarded research grants to Duke University, Harvard/Beth Israel Deaconess Medical Center, Johns Hopkins University, Medical College of Georgia, Northwestern University, Stanford University, Tufts University, University of Houston, University of Pennsylvania, and the University of Southern California. Notable findings emerging from InHealth-funded research include:

• Among elderly patients diagnosed with congestive heart failure, there is a 38% average improvement in mortality rate for those who receive implantable cardioverter-defibrillators (ICDs) that monitor the heart and deliver a lifesaving shock when needed. (University of Pennsylvania)

• Among elderly patients with osteoarthritis, those who receive total hip or knee replacements show significant improvements in physical functioning and increased ability to care for themselves. The procedures offer benefits to patients at any age, and cost less than long-term healthcare for the disabled. (Duke University)

• Patients with continuous glucose monitors and insulin pumps manage their diabetes better, with greater adherence to regimens and less daily pain, than those using conventional fingerstick monitors and daily injections. But research shows the newer methods aren’t widely used because physicians may be reluctant to prescribe them, and patients using them may not be deriving their full benefits. (Duke University)

• Cardiac patients treated with drug-eluting stents rather than bare-metal stents enjoy a 2% lower rate of mortality and require fewer repeat procedures. While initial costs for using drug-eluting stents are higher, they break even with the costs for bare-metal stents after one year. (University of Pennsylvania)

“By advancing a rigorous research program, InHealth has established its role as a credible source for a wide range of impactful health-sector data,” says John W. Brown, chairman emeritus of Stryker Corp. and chair of InHealth’s board of directors. “As the nation considers healthcare reforms, InHealth’s work is more important than ever for policy makers, regulators, and providers—and most especially for patients.”

InHealth, a 501(c)(3) organization, relies on charitable gifts to commission original academic research, to support technology leadership forums, and to disseminate information about the impact of medical technologies.

As InHealth looks ahead, it is refining future research goals to explore in greater depth the financial impact of devices and diagnostics on patients, healthcare systems, and the economy. The institute encourages qualified investigators to review the requirements of its recently released 2010 requests for proposals, and to submit their research proposals by the April 30 deadline. Proposals will be reviewed by an independent panel of scholars, clinicians, and industry experts. Results of the competitive review will be announced in July, for grants expected to begin in September 2010.

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Contact: Robyn Stein Caitlin Hool 212.220.4444

InHealth Research Council Maps New Directions

Thu, 21 Jan 2010 00:00:00 EST

Members of the Institute for Health Technology Studies (InHealth) Research Council gathered in December at the National Press Club in Washington, DC, to provide guidance for the institute’s future research into the social and economic value of medical technologies.

Led by research council chair Robert J. Rubin, MD, clinical professor of medicine at Georgetown University and a member of the InHealth board of directors, the research council is an independent advisory group comprising academics, economists, policy experts, clinicians, and industry representatives. The seven-member panel meets each year to assess the progress of current research and develop a slate of research priorities for the coming year.

In making its recommendations, the council takes into account current trends affecting medical technologies, including the needs of policymakers for independent, unbiased assessments of the socioeconomic and health effects of medical technology innovation.

“It has become clear during the healthcare reform discussion that we need information about medtech’s role in changing how healthcare is delivered in more effective and less-invasive ways,” says Martyn Howgill, InHealth executive director. “Even more needed is a deeper understanding of the relationship between advanced technology and improvements in human capital that actually contribute to the nation’s GDP.”

The research council recommended an expansion of the conceptual framework for InHealth’s research interests, suggesting that the institute support studies that go beyond the realms of previous research. “Past InHealth studies have focused on clinical outcomes and the impact of individual technologies at the population level, rather than on the economic impacts of those technologies,” says Howgill. “But the need now is for studies that go beyond this ‘pixel’ level and provide the data necessary to create a broader picture whose significance can be recognized by policymakers.”

The council recommended that InHealth actively pursue studies focused on two, broader levels: the shaping influence and economic impact of medical technologies on healthcare delivery systems, and the relationships between technology-enhanced healthcare services and the nation’s economic output.

The recommendations of the research council help to inform the creation of InHealth’s research and educational agenda, including the organization’s requests for research proposals, which are distributed to qualified investigators at leading academic institutions.

Trends noted by members of the council embraced a variety of concerns and perspectives affecting the adoption and use of medical technologies, including:

• What is the impact of medical technologies on labor productivity?

• What cost improvements in the healthcare delivery system are being made possible through the use of medical technologies?

In order to deliver the results of InHealth studies outside the Washington, DC, area, the council also encouraged InHealth staff to partner with local sponsors to develop a series of regional symposia. Such events would make it possible to involve InHealth-funded researchers in presenting their own findings at the local level, and to communicate related perspectives to medical technology audiences whose access to such programming would otherwise be limited.

Higher carotid arterial stenting rates associated with poorer clinical outcomes

Fri, 6 Nov 2009 00:00:00 EST

Increase in adverse outcomes coincides with expanded Medicare coverage of procedure

PHILADELPHIA—Among eligible Medicare beneficiaries, increased use of carotid arterial stenting (CAS) procedures to treat carotid stenosis—the narrowing of the carotid artery—is associated with higher rates of mortality and adverse clinical outcomes, including heart attack and stroke, according to researchers from the University of Pennsylvania School of Medicine.

Published in the November 2009 issue of the Journal of Vascular Surgery, the study adds to a growing body of research about the effectiveness of stenting for preventing heart attack, stroke and death. Findings lend further insight into factors influencing how medical technology performs when integrated as treatment among the general Medicare population as opposed to in a controlled clinical trial setting.

For treatment of moderate to severe carotid stenosis, CAS is an alternative to carotid endarterectomy (CEA), a surgical procedure that opens blocked arteries that supply the brain. Introduced in the 1990s, CAS was initially available to Medicare patients only when they were enrolled in clinical trials testing the effectiveness of the minimally invasive procedure. When Medicare expanded coverage of the procedure in 2005, the rate of CAS utilization nearly quadrupled—from 266 to 1,015 procedures per month—as the procedure was available for the first time to the general Medicare population, including elderly patients deemed too ill for surgery who would have had no other treatment option.

“Our study showed that in areas where CAS was used more commonly during the coverage era, the clinical outcomes from the combined population of CAS and CEA patients worsened. Nevertheless, stenting should remain a viable and effective treatment option that doctors and patients consider judiciously,” says lead author Peter Groeneveld, MD, MS, assistant professor of medicine at the University of Pennsylvania School of Medicine. “CAS is often the only option for patients who are not healthy enough to undergo surgery. However, this state of health may inevitably affect clinical outcomes from the procedure.”

Using a national sample of 46,784 Medicare patients older than 66 years of age, the study examined clinical outcomes of both methods in the two ‘eras’––when CAS was covered only in clinical trials and after it became widely covered under Medicare. For each ‘era,’ researchers assessed clinical outcomes at 90 and 270 days after the procedure in patients who had received either procedure for the first time over a twelve-month period. Key findings showed that in geographic areas that widely adopted CAS during the coverage era, the rate of heart attack, stroke and death was greater in the 90 and 270 days following the procedure than in the pre-coverage era.

Key findings from the retrospective study included:

• When adjusted statistically, more 270-day adverse outcomes in the era of Medicare coverage.
• In geographic areas with higher adoption rates of CAS during the expanded coverage era, there was a higher rate of 90-day mortality and adverse outcomes, and a higher rate of 270-day mortality and adverse outcomes.
• No difference in mortality or adverse outcome rates between eras in locations with lower CAS adoption.

Groeneveld, who is also affiliated with the Philadelphia Veterans Affairs Medical Center and has researched the impact of cardiac devices, including drug-eluting stents and implantable cardioverter-defibrillators, for more than 15 years, notes that in a time of healthcare reform, clinical trials and comparative effectiveness research may influence policymakers’ decisions about which procedures receive coverage. “Some procedures may receive coverage because clinical trials show them to be more effective, even if by a small percentage, than the current standard treatment. But that rate of effectiveness can change drastically as more patients with unique medical characteristics begin to receive the procedure, and as more doctors with varying skill levels perform it.”

In the study, researchers used propensity scoring to match patients across eras and locations in order to reduce bias arising from variables such as sex, race, age, clinical comorbidities, and hospital characteristics, among others. The ‘pre-coverage era’ was defined as October 1, 2002, through September 30, 2004, and the ‘coverage era’ was defined as August 1, 2005, through March 31, 2006, after the Centers for Medicare and Medicaid Services implemented a national coverage decision expanding patient eligibility criteria for CAS.

The University of Pennsylvania School of Medicine research was supported by a grant from the Institute for Health Technology Studies (InHealth). The coauthors of this study are Lin Yang, MS; Alexis Greenhut, MPH; and Feifei Yang, MS.

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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 economic and social effects of diagnostic and therapeutic medical devices.

Contact: Robyn Stein/Caitlin Hool 212-220-4444
Robyn.Stein@gabbe.com / Caitlin.Hool@gabbe.com

InHealth Panels Examine Medtech Innovation after Healthcare Reform

Tue, 3 Nov 2009 00:00:00 EST

InHealth’s Evidence of Innovation symposium, held on the second day of AdvaMed 2009: The MedTech Conference, brought together experts in health policy, economic research and innovation to explore what healthcare reform will mean for the medical technology industry.

The day-long symposium explored the impact of proposed reform measures on policies and procedures relating to medical product development; medical technology company interactions with government agencies, professional associations, healthcare facilities and patient advocacy groups; and the traditional relationships between start-ups and established companies.

In October, InHealth presented a special mini-symposium during the AdvaMed annual meeting in Washington, DC. In the second session, panelists discussed how healthcare reform may affect medical technology company interactions with government agencies, professional associations, healthcare facilities, and patient advocacy groups (from left): James S. Breivis, MD, orthopedic surgeon and technology assessment expert (ret.); Paul Citron, independent medical device industry consultant and former vice president of technology policy and academic relations at Medtronic; and Stephen J. Northrup, former vice president for federal affairs at Wellpoint Inc.

“From changes in health coverage and delivery to efforts to contain costs, healthcare reform holds the potential to either further or impede advances in medical device technology––advances that may hold the key to improving the public health,” said Martyn Howgill, executive director of InHealth. “Evidence of Innovation proved to be an engaging and valuable forum for exploring the ways that healthcare reform efforts are changing rules, roles and relationships in the healthcare arena.”

In the first session, Saving Money and Saving Lives: The Magic of Health Reform, panelists discussed the potential elements of a final healthcare reform bill, the emerging importance of comparative effectiveness research as a basis for health technology policy and the role of economic analyses in a post-reform healthcare system. Moderated by Martyn Howgill, the session featured panelists Jeffrey J. Kimbell, president of the legislative advocacy firm of Jeffrey J. Kimbell & Associates; Sheldon Greenfield, MD, cochairman of the Institute of Medicine’s committee on comparative effectiveness research prioritization, and professor of medicine and executive director of the Center for Health Policy Research in the School of Medicine at the University of California, Irvine; and Tomas J. Philipson, PhD, professor of public policy studies at the University of Chicago.

In the second session, Learning to Play Together: The New Healthcare Sandbox, panelists examined the ways that healthcare reform may alter the relationships between innovators and payers. Panelists noted the irreplaceable roles that physicians play in device innovation, including work as inventors as well as experts who can offer important clinical insight and identify improvements to current technologies. They explored the long-term ramifications of healthcare reform through many lenses, including how it will impact both new and experienced physicians and the coverage that devices, drugs and procedures will receive. The session was moderated by Steve Halasey, vice president for programs at InHealth, with panelists: Stephen J. Northrup, former vice president for federal affairs at Wellpoint Inc.; James S. Breivis, MD, a retired orthopedic surgeon and technology assessment expert; and Paul Citron, an independent medical device industry consultant and former vice president of technology policy and academic relations at Medtronic.

In the final session, entitled Healthy Businesses, Healthy Lives: Growing Medical Technologies in the Post-Reform Era, panelists examined where potential opportunities in medical technology innovation lie given the many challenges the industry faces. Young inventors and start-ups are being hit particularly hard, even as higher education programs construct a new pipeline of biomedical engineers that emphasize the importance of innovation. Between changes in the patent office, tighter scrutiny at FDA, healthcare reform, diminished venture funding and the vilification of physician-industry collaboration, panelists noted that the medtech industry is beginning to appear a less than lucrative career path. The panel was moderated by John H. Linehan, PhD, director of the Center for Translational Innovation and professor of medicine and biomedical engineering at Northwestern University, with panelists: Paul G. Yock, MD, professor of medicine, cochair of the department of bioengineering, and director of the program in biodesign at Stanford University; Allan W. May, chairman and founder of Life Science Angels; Jack W. Lasersohn, JD, general partner of the Vertical Group; and John B. Hernandez, PhD, vice president for health economics and reimbursement, Boston Scientific Neuromodulation.

The symposium was the latest in a series of educational programs designed to provide objective information and credible insights about the role of medical technology innovation in society, the economy and people’s lives. On November 12, InHealth will hold a special health technology summit titled Evidence and Reform: Healthcare Policy and the Challenges of Health Technology Research, where healthcare policy professionals, medtech industry leaders, academic partners and clinical professionals will explore realms of health technology research that can produce useful evidence for healthcare policymakers.

InHealth’s Fifth Anniversary Summit to Examine Challenges for Health Technology Research

Fri, 30 Oct 2009 00:00:00 EST

Health Sector Experts to Critique Approaches and Evidence Needed for Successful Healthcare Reform

WASHINGTON, DC – The Institute for Health Technology Studies (InHealth) will host Evidence and Reform: Healthcare Policy and the Challenges of Health Technology Research, a summit to mark the organization’s fifth anniversary, on Thursday, November 12, 2009, at the Hilton Garden Inn in Washington, DC. The summit will bring together medtech industry leaders, academic researchers, and clinical professionals to explore the dimensions of health technology research—from clinical outcomes data to socioeconomic analyses—needed by healthcare policymakers for the successful reform of America’s healthcare system.

The day-long summit includes four dynamic sessions featuring discussions led by prominent health economists, regulators, healthcare delivery professionals, and patient advocates. Panelists will discuss how health technology research fits into the overhaul of America’s healthcare system, affecting healthcare payment models, delivery systems, and policy objectives.

Martyn Howgill, InHealth’s executive director, notes that relying on comparative effectiveness research alone may shortchange policymakers on critical information needed to guide healthcare reform—a risk that few are considering. “Comparative effectiveness research can help clinicians determine the appropriate course of treatment for an individual patient, but it is not a tool that should alone determine public policy,” he says. “While clinical evidence is valuable, lawmakers also need to understand the broader socioeconomic impact of healthcare policies and procedures.”

The summit is the latest in a series of educational programs sponsored by InHealth to promote the exchange of ideas about the role of medical technology innovation in society, the economy, and the lives of individuals. According to Howgill, the summit aims to increase understanding of how rapidly advancing healthcare technologies are contributing to the enhancement of healthcare systems in the United States and around the world by improving patient outcomes, productivity, and quality of life.

The summit will be moderated by Robert J. Rubin, MD, clinical professor of medicine at Georgetown University, former assistant secretary of health and human services and assistant U.S. surgeon general, and chair of the InHealth research council. Summit sessions include:

Session I: The Growing Need for Evidence: In the world of health systems design, evidence-based medicine is not the same as evidence-based policy—and each concept means different things to different stakeholders. The clinical data needed to guide patient care are rarely a match for the broader information needs of third-party payers, lawmakers, or regulators. In this session, researchers with specialties in clinical, economic, and policy issues will examine how current research priorities are influencing health system designs as well as regulatory and reimbursement policy—with potentially unpredictable results for patient access to advanced medical technologies. Panelists will include Naomi Aronson, PhD, executive director of the Technology Evaluation Center, and director of the Evidence-Based Practice Center, for the Blue Cross-Blue Shield Association; John F. P. Bridges, PhD, assistant professor of health policy and management in the Bloomberg School of Public Health at Johns Hopkins University; and J. Michael McGinnis, MD, MPP, senior scholar and director of the evidence-based medicine roundtable at the Institute of Medicine.

Session II: Shaping the Evidence: Because health technology studies influence clinical adoption, reimbursement policy, and a wide range of other issues, researchers often find themselves challenged to design rapid studies to serve the needs of many stakeholders, including clinicians, manufacturers, policymakers, regulators—and the broader public. In this session, experts will look at the challenges faced by healthcare researchers in finding the proper balance among such disparate interests, the roles of such stakeholders, and how the public interest can be both served and protected. Presenters will address the differences between clinically focused comparative effectiveness research (CER) and impact-focused research into socioeconomic effectiveness (RISE). Panelists will include John E. Calfee, PhD, resident scholar at the American Enterprise Institute; Gregory de Lissovoy, PhD, MPH, senior research scientist in the Center for Health Economics and Science Policy, and vice president of health technology at United BioSource Corp.; and Bill Fox, JD, MA, executive director of the National Center for Patient Interactive Research.

Session III: Evidence in the Media: To build public understanding and shape better policy, health technology researchers need journalists and other members of the media who are willing to report their results. In this session, representatives of ‘old’ and ‘new’ media channels—including peer-reviewed publications—will describe how their media report health technology studies to professional and public audiences, and explore ways to sustain public interest and avoid contextual confusion in the face of often-conflicting findings. Presenters will discuss how to maximize policy utility when reporting technology-related research. Panelists will include A. Mark Fendrick, MD, professor of internal medicine and health management and policy at the University of Michigan Medical Center, and co-editor in chief of the American Journal of Managed Care; Mark McCarty, Washington editor of Medical Device Daily; and John J. Whyte, MD, vice president for continuing medical education for the Discovery Health Channel.

Session IV: Using Evidence to Reshape Healthcare: Developing insights into the socioeconomic impact of medical technologies is fundamental to sound policy development and healthcare reform. This final session will review influences shaping health technology studies, including InHealth’s own grant-making. Panelists will examine the relevance of comparative effectiveness research, the success and limitations of socioeconomic research, and the value of selected research for policymakers, patients, clinicians, payers, and manufacturers. Panelists will include Ted R. Mannen, partner in the law firm of Manatt, Phelps & Phillips LLP; Steve E. Phurrough, MD, MPA, medical officer in the Center for Outcomes and Evidence of the Agency for Healthcare Research and Quality; and Margo Thorning, PhD, senior vice president and chief economist at the American Council for Capital Formation.

For registration information on the fifth anniversary summit, click here.

Contact: Robyn Stein/Caitlin Hool 212-220-4444
Robyn.Stein@gabbe.com / Caitlin.Hool@gabbe.com

InHealth-Funded Researchers Present Preliminary Findings on Patient Preferences and Genomic Diagnostics

Mon, 24 Aug 2009 00:00:00 EST

What if you could undergo a diagnostic test that uses your genetic information to determine what drug therapies will work best for you? How accurate would such a test have to be for you to pay for it out of pocket? What if the results of the test were available to your insurance company?

As the emergence of genomic diagnostic tests gradually makes personalized medicine a reality for both doctors and patients, these and many similar questions are revealing issues of fundamental importance in today’s healthcare arena.

To address these questions, a team of researchers from the University of Houston is conducting a study that explores the decisions and trade-offs many breast and colon cancer patients face when deciding whether to undergo genomic testing––which holds the potential to enable doctors to tailor drug therapies to the individual’s specific case. Leading the study is Amalia M. Issa, PhD, MPH, associate professor in the College of Pharmacy and founding director of the university’s initiative in personalized medicine and targeted therapeutics.

Preliminary findings from the InHealth-funded study, titled “Assessing the Clinical Adoption and Value of Genomic Diagnostics for Personalized Medicine,” will be featured as poster presentations at the annual meetings of the American College of Clinical Pharmacology (September) and the Association for Molecular Pathology (November). Findings will also be published in a forthcoming issue of the Journal of Molecular Diagnostics. Although preliminary, the findings are attracting the attention of clinicians, health policy experts, and the diagnostics industry.

For the study, researchers are surveying breast and colorectal patients about what factors are most influential in their choice to undergo genomic testing. The conjoint analysis instrument mimics real-world decision making by having patients make trade-offs between sets of conditions that may vary in terms of cost, accuracy, privacy, side effects, and other factors. For instance, when a study participant chooses to pay $1000 out of pocket for a diagnostic test that is 70% accurate but makes the results available to the participant’s insurance company, rather than paying $500 out of pocket for a test that offers 40% accuracy but private results, the participant indicates that accuracy is more important than cost or privacy. Using this model, researchers are able to quantify and measure patient preferences to discern how they might make similar decisions in a real-life situation––indicating what barriers are preventing patients from utilizing this technology.

“Of the many factors affecting a patient’s decision to undergo genomic testing, early findings suggest that clinical validity is the issue that stands out as most important,” says Issa. “Because the test results may help optimize therapies and eliminate trial and error during treatment, many patients are indicating a willingness to spend time and money to achieve accurate test results.”

Preliminary results are based on pilot studies designed to develop and test the conjoint analysis instrument in focus groups. Findings from the full study are expected next year.

The study is expected to provide insight into patient preferences and their willingness to adopt, pay for, and use genomic diagnostics. “Findings could have an impact on policy and clinical practice guidelines by providing evidence-based guidance to policymakers, regulatory agencies, and pharmaceutical and diagnostic companies,” says Issa. “The study results will help physicians and others understand how these technologies can best be introduced and implemented to personalize medicine for cancer patients.”

Radio Interview - Martyn Howgill Featured on America Tonight

Wed, 5 Aug 2009 00:00:00 EST

On July 29th, Martyn Howgill was a featured guest on America Tonight with host Kate Delaney. During the ten minute segment, Martyn discussed the role of medical technology in health reform including electronic medical records, Obama's proposal for another public insurance option and the need for more information about the economic and social impacts of medical devices and diagnostics. An estimated 26 million people tune in every evening to America Tonight.

Play Audio(MH_America_Tonight)

Radio Interview - Martyn Howgill Appears on the Paul Clayton Morning Show

Wed, 5 Aug 2009 00:00:00 EST

On August 5th, Martyn was featured on St. Louis's KFUO morning show. In an interview with host Paul Clayton, Martyn discussed the role of medical technology in health reform, why physician-patient relationships shouldn't be impacted as a result of health reform initiatives and the benefits and drawbacks of examining health systems around the world.

Play Audio(MH_KFUO)

InHealth Appoints Two Distinguished Members to Board of Directors

Mon, 27 Jul 2009 00:00:00 EST

The Institute for Health Technology Studies (InHealth) has announced the appointment of two new members to its 10-member board of directors. Elected at the June meeting of the institute’s board were Catherine M. Burzik, president and chief executive officer of Kinetic Concepts Inc. (KCI); and Ravi Thadhani, MD, MPH, director of clinical research in nephrology at Massachusetts General Hospital (MGH), and associate professor of medicine at Harvard Medical School.

Burzik has been at the head of medical device manufacturer KCI (San Antonio) since 2006. An industry veteran, she has brought broad and deep experience in research, development, and management to her position with the company.

Prior to taking the helm at KCI, Burzik served as president of Applied Biosystems, a unit of Applera Corp., and held senior positions at Eastman Kodak and Johnson & Johnson. At Eastman Kodak, her executive positions included president and CEO of Kodak Health Imaging Systems and general manager/vice president of corporate marketing. At Johnson & Johnson, Burzik ran the Critikon medical technology business, and was subsequently appointed president of Johnson & Johnson’s Ortho-Clinical Diagnostics business unit.

“Ms. Burzik’s breadth of knowledge in several sectors of the medical device industry will be an invaluable asset to the board,” said InHealth executive director Martyn Howgill. “Her insights in the diagnostic technology arena along with her corporate experience complements a very strong leadership group.”

A mathematician who began her career as a software designer and researcher, Burzik holds a BA in mathematics from Canisius College (Buffalo, NY), and an MA in mathematics from the University of Buffalo. She has attended executive management programs at Penn State, Northwestern University's Kellogg School of Management, and the Center for Creative Leadership.

Thadhani grew up on the Western Pacific island of Guam, a U.S. territory. He received his BS degree summa cum laude from the University of Notre Dame, his MD from the University of Pennsylvania, and his MPH from the Harvard School of Public Health. He spent a year as chief medical resident at MGH, where he completed his training with a specialization in nephrology.

Thadhani directs academic courses at the Massachusetts Institute of Technology, MGH, and Harvard Medical School. He has served as a reviewer for, and has been published in, several journals, including the New England Journal of Medicine and Lancet. He is an active member of the National Kidney Foundation and the clinical research section of the American Society of Nephrology. He reviews grants for these organizations as well as for the National Institutes of Health. His research interests include hypertension and diabetes in pregnancy, and dialysis mortality, the latter with a focus on the role of vitamin D.

“Dr. Thadhani offers outstanding academic and clinical credentials that are an excellent match for InHealth’s research and educational activities,” said Howgill. “His influence will assist the board in determining the best approaches to medical technology research—including comparative effectiveness research—and in working with the members of InHealth’s independent research council.”

The appointments of Burzik and Thadani follow the recent departure of board members Roger C. Herdman, MD, and Douglas W. Kohrs. Herdman is a former director of the U.S. Office of Technology Assessment, and is now director of the National Cancer Policy Forum and director of the Board on Health Care Services at the Institute of Medicine (IOM). He tendered his resignation in order to avoid a conflict of interest with his latest high-profile position as board director for the IOM Committee on Comparative Effectiveness Research Prioritization, which released its first report, Initial National Priorities for Comparative Effectiveness Research, on June 30.

“InHealth has been honored to have Dr. Herdman serve the institute so generously with his time, attention, and expertise for the past three years,” said Howgill. “He has provided invaluable advice, counsel, and perspective representing public policy, healthcare delivery, and medical technology—and has shown great professionalism, dedication, and leadership.”

Also departing, after completing his term of appointment, was Douglas W. Kohrs, president and CEO of Tornier Inc. (Edina, MN), an orthopedics manufacturer specializing in extremity implant designs for the shoulder, elbow, hand, and ankle.

“Doug Kohrs’ term of office began in 2005, and he has served InHealth faithfully and most generously since then—even while serving as president and CEO of two different medical technology companies,” noted Howgill. “Doug has been a generous benefactor to InHealth, and frequently offered assistance in promoting and raising funds for the institute and its mission, showing great leadership.”

Upon their departures, both Herdman and Kohrs were honored with resolutions of gratitude from the InHealth board of directors, thanking them for their leadership and service to the institute.

InHealth’s board of directors is composed of medical technology leaders, innovators, scholars, and clinicians who support the institute’s mission to deliver objective information about the social and economic impact of medical technologies through research and education.

Other members of the InHealth board include board chairman John W. Brown, chairman of Stryker Corp.; treasurer Timothy M. Ring, chairman and chief executive officer of C.R. Bard Inc.; Charles M. Fleischman, entrepreneur and venture capitalist; Scott Garrett, chairman, president, and CEO of Beckman Coulter Inc.; Dennis N. Longstreet, retired company group chairman of Johnson & Johnson; Edward J. Ludwig, chairman, president, and CEO of Becton Dickinson and Co.; Robert J. Rubin, MD, clinical professor of medicine at Georgetown University; and Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association.

Changes in Functional Status Among Persons Over Age Sixty-Five Undergoing Total Knee Arthroplasty

Mon, 29 Jun 2009 00:00:00 EST

Abstract: Medical Care (July 2009)

Stanford Researchers Publish Comprehensive Model for Medical Device Development

Mon, 29 Jun 2009 00:00:00 EST

Abstract: Journal of Medical Devices (July 2009)

Stanford Researchers Publish Comprehensive Model for Medical Device Development

Mon, 29 Jun 2009 00:00:00 EST

FOR IMMEDIATE RELEASE

Date: June 29, 2009

Contact: Robyn Stein/ 212-220-4444

Stanford Researchers Publish Comprehensive Model for Medical Device Development

Five-phase stage-gate model captures process complexity from product ideation through postmarket surveillance

WASHINGTON, DC—In an effort to increase understanding of the medical device development process and help companies execute the bench-to-bedside process of product development more effectively, researchers at Stanford University have published the first comprehensive model representing the medical device development process.

Published in the June 2009 issue of the Journal of Medical Devices, the model was constructed based on best-practice analysis and interviews with more than 85 seasoned experts actively involved in the development, commercialization, regulation, and use of medical devices.

“Medical devices contribute significantly to the continuous improvement of healthcare,” says lead author Jan Pietzsch, Ph.D., consulting assistant professor in the department of management science and engineering at Stanford University. “Depending on the type and complexity of the technology, the device development process can take anywhere from 15 months to several years. As a result, successfully bringing innovative products to patients hinges on knowledge of and planning for this process.”

Presented in linear form with five major phases and four decision gates, the model [see sidebar 1] describes a process that is applicable to a broad range of medical technologies and innovation settings. According to the authors, the model is used by the developers of both highly sophisticated premarket approval (PMA) and premarket notification (510(k)) devices, for which FDA approval typically requires some risk-appropriate form of bench or clinical data, as well as by the makers of less sophisticated devices that may be exempt from most regulatory requirements. The five major phases and decision gates include:

Phase 1/Gate 1: Initiation, opportunity, and risk analysis.
Phase 2/Gate 2: Formulation, concept, and feasibility.
Phase 3/Gate 3: Design, development, verification, and validation.
Phase 4/Gate 4: Final validation and product launch preparation.
Phase 5: Product launch and post-launch assessment.

Pietzsch adds that the medical device development process has become increasingly complex in recent years because of the advent of advanced technologies, stricter regulatory requirements, and the increasing importance of reimbursement decisions.

The Role of FDA’s Quality System Regulation

The study results demonstrate that a significant portion of the development process is governed by regulations that influence the manner in which medical devices are developed, approved, and brought to market. The pace at which such regulatory requirements can be met determines when the device will reach the clinic.

Specifically, FDA’s Quality System Regulation plays a substantial role in the development process and serves to assure the public that critical elements of safe design practices are followed. However, the researchers point out that such standardization does not always permit product developers to streamline their processes where it would make sense. In turn, such rigidity can inhibit innovation, which often occurs in a less-structured way.

“Clearly there are benefits associated with having a rigorous process and clearly defined procedures for all stakeholders in the process—from investors and engineers to researchers and regulators,” says coauthor John Linehan, Ph.D., professor of medicine and biomedical engineering and director of the Center for Translational Innovation at Northwestern University, and a consulting professor of bioengineering in Stanford University's BioDesign Program. “The challenge for companies inventing and developing technologies is to strike a balance between sufficient process rigor and enough room for flexibility and creativity.”

Drug-Device Differences

Among the key results of the study is a detailed explanation of the significant differences between medical devices and pharmaceuticals [see sidebar 2], and the corresponding differences in their development processes and regulatory requirements. Such variations have dramatic downstream effects that distinguish the capital requirements, product development methods, clinical testing requirements, manufacturing methods, and overall life cycle for products in the two sectors.

“Drug-device differences underscore challenges associated with developing combination products, such as drug-eluting stents, which play an increasingly important role in healthcare innovation,” says Pietzsch. “It is our aim to contribute to a greater understanding of such differences, particularly as policymakers and regulators work to design the least burdensome approaches to medical device regulation.”

The article emerged from research performed by the authors as part of a study, “Medical Device Development Models,” funded by the Institute for Health Technology Studies (InHealth). A review of the background, mission, and statutory requirements for medical device regulation in the United States was published by the authors in the December 2007 issue of the Journal of Medical Devices.

J. Pietzsch, L. Shluzas, M. Paté-Cornell, P. Yock, and J. Linehan, “Stage-Gate Process for the Development of Medical Devices,” J. Med. Devices 3, 021004 (2009).

Click here to read the full study abstract.

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About InHealth (www.inhealth.org)

Launched in 2004, InHealth: The Institute for Health Technology Studies is a nonprofit research and educational organization supporting independent analyses of the social and economic effects of diagnostic and therapeutic medical devices.

About Stanford BioDesign (http://innovation.stanford.edu/bdn/index.jsp)

The BioDesign Program at Stanford is dedicated to training tomorrow’s leaders in medical technology using an experiential approach to technology innovation. The focus of the BioDesign Program is to train the next generation of medical technology innovators, taking advantage of the wealth of experience of BioDesign faculty and affiliated industry advisors. BioDesign has established curriculum and teaching methods that provide innovation tools to engineers, physicians and business people, allowing them to create and develop innovative healthcare solutions.

Duke Study Finds Total Knee Replacements Increase Mobility and Motor Skills in Older Patients

Thu, 25 Jun 2009 00:00:00 EST

FOR IMMEDIATE RELEASE

Date: June 25, 2009

Contact: Robyn Stein/Caitlin Hool

212-220-4444

Robyn.Stein@gabbe.com / Caitlin.Hool@gabbe.com

Duke Study Finds Total Knee Replacements Increase Mobility and Motor Skills in Older Patients

Findings demonstrate the positive impact of surgery on health-related quality-of-life outcomes and maintenance of independent lifestyles

DURHAM, NC—According to a new study from researchers at Duke University, total knee arthroplasty (TKA) procedures performed in older patients with osteoarthritis of the knee result in long-term, significant improvement of physical functioning and motor skills when compared to patients who do not receive TKA.

Published in the July 2009 issue of Medical Care, the study examined physical functioning and gauged outcomes in a national sample of Americans aged 65 and older for up to four years—a longer period than previous TKA studies. Relative to the untreated comparison group, recipients of total knee replacements experienced significant improvement in function, including a 17.5% increase in mobility, a 39.3% improvement in motor skills; and a 46.9% decrease in limitations in activities of daily living such as bathing and dressing oneself.

The number of total knee replacements performed in the United States has increased dramatically since 1990; currently 581,000 such procedures are performed every year.[1] This number is expected to increase markedly as Baby Boomers age.

“In this era of cost-cutting, policymakers have underscored the importance of evaluating treatments in terms of effectiveness and benefits to patients,” says lead author Frank Sloan, Ph.D., McMahon professor of health policy and management and professor of economics at Duke University. “Our findings show that knee replacements are effective in treating patients with advanced osteoarthritis, contributing to reduced disability and improved quality of life for these individuals. Such findings are extremely important for the broader context of discussions about healthcare reform, cost-containment, device quality, and patient safety.”

For the study, Duke researchers identified 2272 patients diagnosed with osteoarthritis of the lower leg using data from the Health and Retirement Study (HRS) linked to Medicare claims from 1994 through 2006. [2] Of that group, 516 underwent TKA procedures and 1756 did not. Researchers used propensity score matching to generate 515 pairs of treated and untreated individuals who were matched on relevant, measurable factors such as baseline functional status, other health conditions, socioeconomic characteristics, and time before TKA or diagnosis.

Among the patients who underwent TKA, baseline physical functioning measures were taken at an interview before and closest to surgery. For the comparison group, these measures were taken from an interview preceding and closest in time to the year of their first diagnosis with osteoarthritis of the lower leg. Each pair was followed for up to four years, and their resulting physical abilities were compared.

The study’s mobility, gross motor skills, large muscle activities, and limitations in activities of daily living indices accounted for a wide breadth of physical activities, including getting in and out of bed; the ability to bathe and dress oneself; sitting for two hours; getting up from a chair; stooping, kneeling, and crouching; walking across the room, one block, and several blocks; climbing one flight and several flights of stairs; and pushing and pulling a large object.

The study comes at a time when Congress and the nation’s healthcare agencies are looking for ways to identify diagnostics and therapies that offer the greatest value to patients and the healthcare system. Representatives Bill Pascrell Jr. (D–NJ) and Lloyd Doggett (D–TX) have introduced legislation to establish a federally-funded registry of patients who have received artificial hips or knees, providing researchers and policymakers with an ongoing source of data about patient outcomes with such devices and related surgical procedures.

According to Sloan, total knee replacement has repeatedly been shown to offer clinical benefits for patients with osteoarthritis, a major risk factor for disability in the United States. Recently, a team at Brigham and Women’s Hospital and the Boston University School of Public Health confirmed that, for older adults with advanced osteoarthritis, total knee replacement also appears to be a cost-effective procedure across all patient risk groups.[3]

“We know that the inability to perform activities of daily living is highly predictive of nursing home admittance, as patients can no longer care for themselves,” says Sloan. “TKA offers the potential for extending independence and therefore delays the need for assisted living.”

The Duke University research was supported by a grant from the Institute for Health Technology Studies (InHealth). The coauthors of this study are David Ruiz Jr., MA, and Alyssa Platt, MA.

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Click here to read the full study abstract.

About InHealth (www.inhealth.org)

Launched in 2004, InHealth: The Institute for Health Technology Studies is a nonprofit research and educational organization supporting independent analyses of the economic and social effects of diagnostic and therapeutic medical devices.

[1] American Academy of Orthopaedic Surgeons

[2] HRS is a longitudinal household survey of health and functional status, demographic characteristics, expectations, income and wealth among five cohorts of elderly persons in the United States.

[3] Losina E, et al., “Cost-Effectiveness of Total Knee Arthroplasty in the United States,” Arch Intern Med 2009;169 (12): 1113–1121.

2008 Annual Report Now Available

Mon, 22 Jun 2009 00:00:00 EST

Delivering Evidence, InHealth's 2008 Annual Report, is now available in print and online.

The new report provides summaries of the key findings of all InHealth-funded research conducted to date and lists 13 of the corresponding peer-reviewed studies published so far.

Also included are reports on the progress of InHealth-funded studies now under way at universities throughout the United States, InHealth's financial performance, fundraising, and who's involved in supporting and directing the institute's activities.

Click here to view the online version of the Annual Report or click here to download a PDF version.