NEWS TRENDS

AdvaMed is pushing for more funding, payment policies that promote innovation, and expanding global opportunities in 2009. It's also tackling impending healthcare reform and the call for transparency.

One of the more critical aspects of encouraging innovation is ensuring that small companies have funding to move forward. “Many small companies become pillars of this industry,” said Nadim Yared, president and CEO of CVRx (Minneapolis), at an AdvaMed press conference. “We're often the incubators of new therapy or next-generation advances.” He added that the last quarter of 2008 saw a decline of about 30% in the dollars invested in devices and biotech.
“We need to support entrepreneurs, the backbone of the U.S. economy,” said Yared. Among the association's efforts is a push for funding for the National Institutes of Health (NIH), National Science Foundation, and Small Business Innovation Research. And although the recent federal stimulus package included $10.4 billion for NIH, it's not enough, said Yared. Upcoming appropriation bills must increase funding to cover the inflation of medical costs.
AdvaMed also advocates for a permanent extension of the R&D tax credit, scheduled to expire at the end of 2009. An extension would increase incentives to locate R&D in the United States, and create or save skilled research jobs, says the organization.
In the area of payment policies, more attention must be given to pay for performance and comparative effectiveness. Shifting the system from one that pays for the number of patient services to one that is based on the quality and outcomes could improve care and cost savings, according to Bill Hawkins, chairman and CEO of Medtronic.
Comparative effectiveness research improves clinical decisions by giving patients and doctors more information about which treatments are appropriate for an individual's need. Hawkins stressed AdvaMed's support for the program, along with the need to encourage better care for patients with chronic diseases.
“Chronic disease is the most prevalent and costly healthcare problem in the United States and [is] rapidly becoming the most burdensome around the world,” said Hawkins. With 45% of all Americans suffering from at least one chronic disease, more than two-thirds of deaths are caused by one or more of five chronic conditions—heart disease, cancer, stroke, diabetes, and chronic obstructive pulmonary disease.
Promoting health for patients with such conditions requires a strong FDA, along with appropriate resources, said Edward Ludwig, chairman and CEO of Becton Dickinson. Although user fees have provided more than $400 million, Ludwig said that more appropriations are needed for IT infrastructure improvements, critical path initiatives, and reviewer training and education.
Finally, AdvaMed hopes to help manufacturers with global regulatory bodies when introducing products. The association has been working with Japan in efforts to reduce time to market. Under a new program, Japan will nearly triple its device reviewers from 35 to 104 over the next five years, said Jim Mazzo, president of Abbott Medical Optics Inc. (Santa Ana, CA). China and India are also emerging sectors, but their regulatory systems are challenging to device industry. Mazzo noted that China is investing more than $100 billion to improve healthcare for its citizens.
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