An Interview With Stephen J. Ubl, President and CEO of AdvaMed

Maintaining a dialogue with the FDA and Congress can be a difficult task for medical device companies who are more rightly focused on bringing new innovations to market. Fortunately, there are organizations, such as AdvaMed, who take on this role, keeping the device makers’ best interests in mind. In this month’s interview, the president and CEO of the Advanced Medical Technology Association (AdvaMed) shares his thoughts on several issues.

By Sean Fenske, Editor-in-Chief

Stephen J. Ubl: “In the next few years, new medical technology will fundamentally transform the healthcare landscape, providing new solutions to address chronic diseases and conditions and revolutionizing the way treatments are administered to vastly improve patient care.”

Responding to questions that range from the recent AdvaMed 2007 event to next year’s presidential race, Ubl shares his insights and commentary on a number of concerns medical device makers have regarding the current regulatory environment, upcoming changes, and what’s on the horizon for the industry.

Q: What was the outcome of the recent AdvaMed 2007 event?

A: The inaugural AdvaMed 2007 conference was a tremendous success. We initially anticipated 800 attendees, but the conference exceeded expectations by bringing together more than 1,100 attendees from 35 states and 25 countries.

More than 55 educational panels in 12 tracks took place during the three days of AdvaMed 2007, as well as 40 company presentations and more than 350 business partnering meetings as part of the business development forum. AdvaMed 2007 featured a wide range of educational tracks on important business and public policy issues, as well as a full exhibition floor with more than 30 exhibitors.

In addition, the conference attracted some of Washington’s leading policy makers, government officials, and notables including Former President George H.W. Bush, Speaker of the House Nancy Pelosi, U.S. Secretary of Commerce Carlos M. Gutierrez, U.S. Senator Norm Coleman, U.S. Senator Ron Wyden, U.S. Rep. Lois Capps, CMS Acting Administrator Kerry Weems, and University of Connecticut Hall of Fame basketball coach and author Jim Calhoun.

Building off of this strong first-year showing, we announced the 2008 international MedTech conference and exhibition, AdvaMed 2008, which will be held September 21-24 at the Marriott Wardman Park Hotel in Washington, D.C.

Q: What is industry’s position on the recently-enacted FDA Amendments Act of 2007?

A: The passage of the FDA Amendments Act of 2007 (FDAAA) is good news for patients, the FDA and for the medical technology industry. It will ensure patients continue to have access to safe and effective medical devices without unnecessary delays. This legislation enhances patient safety by providing FDA's device program with the financial resources it needs to meet its medical technology review commitments, while protecting future FDA appropriations and providing manufacturers with predictability regarding user fee rates.

Q: Do you foresee any challenges in implementing the new law?

A: There are many provisions in FDAAA which have the potential to improve the regulatory process for medical devices but require careful consideration in how they are implemented to ensure efficiencies and avoid unnecessary regulatory burdens. AdvaMed is committed to working with FDA to ensure these provisions meet their intended goal.

Q: The mainstream media has reported on a number of problems with medical devices on the market. What is FDA and the industry doing to address these types of issues?

A: First, it is important to recognize that FDA has a comprehensive set of legal authorities to assure the safety of medical devices on the market, many of which are unique to medical devices—especially user facility reporting of adverse events, medical device tracking, postmarket surveillance studies, mandatory recalls, and reports of corrections and removals. AdvaMed has a long history of interacting with the agency on postmarket issues and is committed to working with FDA to identify areas where refinements to the current regulatory policies will ensure the continued safety and effectiveness of marketed medical devices. We are working closely with FDA on specific postmarket activities such as adverse event reporting, risk communication policies, and unique device identifiers.

Q: What are the top legislative priorities for the device industry?

A: There are a number of important policy issues on the medical technology industry’s radar for the remainder of the year, as well as in the run-up to the presidential election. We are pressing for passage of the Remote Monitoring Access Act to secure appropriate Medicare reimbursement for physicians who utilize remote patient monitoring systems to help manage chronic disease. Patients in rural areas who suffer from chronic conditions such as diabetes, congestive heart failure, and cardiac arrhythmias often have to travel many miles to receive care. However, many new technologies that collect, analyze and transmit clinical health information enable physicians to monitor and treat their patients outside the traditional office setting, alerting them to potential problems and giving them a better picture of their health status in the real-world setting. These remote monitoring technologies also provide better information that can lead to earlier, more accurate diagnoses and prevent costly hospital admissions.

Despite these innovations and their ability to improve care, many new clinical information and remote management technologies have failed to diffuse rapidly. A significant barrier to wider adoption and evolution of the technologies is the lack of payment in fee-for-service Medicare to reimburse for remote management services provided by a physician.

The industry also is pushing for legislation to prevent short-sighted additional payment cuts for imaging procedures. The House Children’s Health and Medicare Protection Act would have layered additional draconian payment cuts for imaging procedures on top of those mandated by the Deficit Reduction Act of 2005. Advanced imaging technologies such as CT and PET scans are vital for early disease detection, eliminate the need for more expensive and invasive exploratory surgeries, and can play a vital role in determining the best treatment options for patients.

In addition, we are continuing to push for legislation to reform Medicare policies that discourage the development and adoption of new clinical diagnostic laboratory tests. Although clinical laboratory diagnostics make up less than 5% of hospital costs and less than 2% of all Medicare costs, their findings influence as much as 70% of all healthcare decisions. Medicare’s policies and procedures for coverage and payment for clinical lab tests were created in 1984 and have not been updated since then. The legislation we seek would take us out of the current horse and buggy Medicare reimbursement system for 21st century technology.

In the wake of House and Senate activity on comparative effectiveness legislation, AdvaMed has been working to raise concerns with key members of the Senate Finance Committee about the House-passed language. Comparative effectiveness research can be a useful tool to improve clinical outcomes and promote access to quality care. However, there is a risk that research could be misused to promote national treatment formulas that interfere with the independent medical decisions of doctors and patients.

Q: Healthcare reform is a top concern for the public and likely to be a key issue in next year’s presidential election. What is the industry’s position on this issue?

A: This year, AdvaMed unveiled a health reform plan under which every American would be offered the opportunity—and given the responsibility—to obtain affordable health insurance.

Our healthcare reform proposal pays for expanded healthcare coverage through a four-part plan involving disease prevention, quality of care improvements, efficiency gains in healthcare system management, and measures to speed the pace of medical innovation. We are meeting with the Presidential candidates and their staffs to ensure that our healthcare system provides the highest quality care to every American at a price individuals and the nation can afford.

Q: What do you see on the horizon for the medical device industry?

A: This is an exciting era for the device industry with innovation in medical technology advancing at a rapid pace. The next generation of medical technology will reflect several broad trends, including earlier use of more accurate diagnostics, advances in information technology, and further miniaturization of devices.

Molecular and gene-based diagnostics will detect disease earlier in its progression, improving patient outcomes and lowering treatment costs. Information technology innovations will allow critical medical data to be processed and transmitted rapidly over great distances, saving both patients and physicians time and speeding delivery of treatment. Miniaturization of medical devices will allow for more targeted delivery of therapies and enable more minimally invasive and non-invasive procedures, which move more care from hospitals to the outpatient setting.

In the next few years, new medical technology will fundamentally transform the healthcare landscape, providing new solutions to address chronic diseases and conditions and revolutionizing the way treatments are administered to vastly improve patient care. However, to realize these benefits, we must ensure a legal and regulatory environment that facilitates innovation and patient access to the latest diagnostic tests and treatments.

For more information on AdvaMed, visit www.advamed.org.

Email for more information
Company's other products
Email to a colleague
See more Regulatory Affairs