The Department of Health and Human Services (HHS) reported last month that it will form a multi-department task force charged with speeding the development of medical technology. The task force will involve the FDA, the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia), Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) and the National Institutes of Health (NIH; Bethesda, Maryland). According to HHS, the group will be charged with promoting new solutions and to encourage innovation in healthcare, while decreasing the development time of effective new medical technologies, such as medical devices and drug and biological products.

HHS said that given the number of different organizations engaged in medical development research, the amount of money spent each year in the near future could conceivably approach $100 billion. One of the task force's goals will be to help industry and government use those funds more effectively. "This task force will look for opportunities across the department to promote speedier access to new innovative medical technologies that can improve people's health and save lives," HHS Secretary Tommy Thompson said in a statement. "Often, a new technology must clear several hurdles in different parts of HHS before it can reach consumers." Thomson said that by better coordinating the development and review process, HHS "can streamline the way we do business and make safe, effective medical technologies more quickly and readily available."

He has asked the task force to issue a report this year on appropriate steps that can be taken across the department to speed availability of new products. The task force's efforts will build on similar efforts under way at the FDA and other agencies, with a goal of improving coordination across agencies. As part of a similar effort, the FDA initiated its Critical Path program in March to address ways in which the product development cycle could be modernized to make it more predictable and less costly. Similar to FDA's Critical Path, the NIH's Roadmap initiative, unveiled last September, is the institute's effort to "transform the nation's medical research enterprise" and speed research discoveries from laboratory to patient. Current Roadmap areas include molecular imaging, bioinformatics and computational biology, and nanomedicine. Over the next five years, the NIH budget will double to $27 billion.

The task force's participants will include CDC Director Julie Gerberding, MD; CMS Administrator Mark McClellan, MD, PhD; Acting FDA Commissioner Lester Crawford, DVM, PhD, who will serve as the task force's chair; and NIH Director Elias Zerhouni, MD. "We hope to remove some of the biggest roadblocks that are keeping research findings from reaching the public as swiftly as possible," Zerhouni said. "These efforts cover a broad spectrum of points between the lab and the clinic from basic biological research, such as determining protein structure, to the front lines of clinical research, such as improving the training of the physicians and nurses who run clinical trials."

NASPE undergoes name change

Just in time for its 25th annual scientific sessions in San Francisco, California, last month (see conference report, pages 1-6) the North American Society of Pacing and Electrophysiology (NASPE; Natick, Massachusetts) changed its name to the Heart Rhythm Society. The society also said it will be moving its headquarters from Natick to Washington this fall.

Michael Cain, MD, outgoing president of the society, said the name change idea came about two years ago as part of the development of a three-year strategic plan. That plan "focused on the problem that, here we were as true heart rhythm specialists, but when you went outside our inner group and spoke to the public, patients and other physician groups, they didn't know it existed," he told Cardiovascular Device Update.

As to the permanent move to Washington the organization already had an office there Cain said it's a benefit to have people on site "that would have their finger more directly on the pulse of the federal government and other healthcare agencies and societies that are headquartered there."

Founded in 1979 to address the scarcity of information about the diagnosis and treatment of cardiac arrhythmias, NASPE has become an international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders.

Since Cain became a member of the now-Heart Rhythm Society in 1983 as a practicing electrophysiologist, he said he has seen the membership grow from 300 to 3,500, an increase of 7% to 9% each year. He also noted that in 1981 when he first entered the field, an electrophysiologist's primary function was to diagnose heart rhythm disorders and assess the benefit of pharmacologic therapies. Today, through catheter-based systems, the field has expanded to ablation and device therapy (including implantable cardioverter defibrillators, more complex pacemakers and biventricular pacing) that can now cure heart rhythm disorders and prevent sudden cardiac death.

Medical device advertising eyed

Prescription drug advertising has become a ubiquitous presence in print and via radio and TV. Next up: an increased amount of broadcast medical device advertising, especially on our TV screens. That would seem to be the outlook based on comments from the staff of the Federal Trade Commission (FTC), issued last month, supporting a proposed FDA guidance that would reduce the amount of information to be included in broadcast ads of "restricted" medical devices that is, those devices requiring a prescription. The FTC's comments supported the FDA's positions on two other guidances issued earlier this year for direct-to-consumer (DTC) print ads for prescription drugs and on "help-seeking ads" by drug companies.

The proposed new policy for broadcast advertising of prescription medical devices would essentially overturn, or at least modify, a 1990s ruling by the FDA that served as a barrier to DTC broadcast ads for restricted medical devices. That ruling at the same time eased the requirements for DTC broadcast ads for prescription drugs -- opening the door for the current spate of such drug advertisements. The FTC said that DTC advertising for prescription drugs ballooned from $791 million in 1996 to nearly $2.47 billion in 2000.

The barrier to device advertising was to require inclusion in a broadcast ad the FDA-approved labeling information. The new guidance proposes that ads for restricted medical devices need only include a "major statement" of risks in other words, a brief summary of the labeling, plus the "adequate provision" for consumers to obtain the FDA-approved product labeling. The methods for providing labeling information would be:

  • A toll-free telephone number to call for the approved package labeling.
  • An Internet address that provides access to the package labeling.
  • Reference to a method of accessing this labeling information by consumers unable to use the Internet, such as reference to print advertisements appearing concurrently in publications that reach "the exposed audience."
  • Disclosure that healthcare practitioners may provide additional device information.

In backing the less restrictive approach for advertising of medical devices, the FTC offered a rationale parallel to what it has seen happening for DTC broadcast advertising of drugs: that "truthful, non-misleading DTC advertising benefits consumers by providing them with useful information about their healthcare and treatment options."

Specifically, the staff comments say that DTC drug advertising appears to have provided sufficient drug/benefit risk information "that prompts consumers to seek out information about medications and medical conditions, some of which may not have been diagnosed previously." The FTC said that providing the same leeway for broadcast medical device advertising is likely to increase the amount of such advertising and offer a benefit to consumers by providing not only more information but also more competition in the device arena. It said that the current guidelines requiring the complete description of side effects and contraindications for restricted medical device products "provides a substantial disincentive for manufacturers to use such ads, just as these requirements previously had proved to be substantially too onerous" for prescription drug manufacturers.

Technologies convergence energizing

After hearing a wide-ranging discussion by a panel probing "The Convergence of Technologies and Applications Shaping Medical Devices Today," many members of a final-day audience at last month's 3rd annual Medtech Investing Conference in Minneapolis, Minnesota bought into the belief that med-tech's future will be painted on a surface of new combination materials with replacements for brushes that have not yet been invented.

Saying "we're seeing a realization that there are going to be many biologic solutions" to health problems, Jay Schmetler, managing director of Rivervest Venture Partners (St. Louis, Missouri), told attendees that large med-tech companies "are seeing this both as an opportunity and a threat." As a result, he said those companies are "trying to get smarter about biotechnology," looking at partnerships and making investments in biotech firms. Expressing the belief that there will be "a lot of missteps along the way," Schmetler said that we nonetheless "will see more and more of these combination products."

Panel moderator Michael Sweeney, general partner with InterWest Partners (Menlo Park, California), cited the convergence of information technology (IT) into the overall healthcare picture, with a particular focus on how IT works with medical products to improve both the speed and the quality of care.

Using the example of technology developed while he served as chief executive officer of Ventritex (Sunnyvale, California), which was later acquired by St. Jude Medical (St. Paul, Minnesota), Sweeney said that firm's early implantable defibrillator technology generated "what we thought was a massive amount of data." Now, just a few short years later, that "massive amount" appears "a ridiculously small amount" compared to what is being generated today thanks to the rapid advancements made in data capture and transmission. The question today and for the future, he said, is "what are we doing with this data?"

Scott Jenkins, PhD, worldwide segment executive for pervasive healthcare in IBM Life Sciences' Healthcare & Life Sciences division, had a ready answer. "In order to get personalized medicine," he said, "we have to capture and pump information to all the people who need to see it." The three main points of that capture/pump equation, Jenkins said, are the point of origin of the data, knowing where to put the data and understanding how the data works within the healthcare "ecosystem."

Chris Coburn, executive director of CCF Innovations, the technology licensing and commercialization arm of the Cleveland Clinic Foundation (Cleveland, Ohio), said the convergence of technologies has generated "great excitement from the clinical end." Saying that "for centuries, diagnosis and treatment have been snapshot-based," he posed the rhetorical question, "What happens when the entire thing is real-time?"

The answer, according to Coburn, is that "Longstanding areas of clinical domain are blurring." He said that clinicians largely are "energized" by the pace of such developments, even though many questions remain, such as whether the future job of a cardiologist "is going to be more data-driven, with less human interactivity."

The Medtech Investing Conference is produced by International Business Forum (Massapequa, New York) in conjunction with Medical Alley (St. Louis Park, Minnesota), an Upper Midwest-focused trade association for the healthcare industry.

No Comments