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Hands-Off Approach Best for Preapproval Publicity

Originally Published MDDI January 2005


Erik Swain

Despite federal court rulings that decreed FDA went too far in restricting promotion of medical products, the agency hasn't changed its policies on advertising and promotion. Therefore, panelists at a session of the RAPS annual meeting in October said device companies need to treat this issue with caution, especially at the clinical stage.

FDA officials present at the discussion said that it is not appropriate for a device company to conduct advertising or promotion of a premarket approval product that is not cleared for marketing.

Therefore, before approval, public pronouncements about a device's efficacy should be left only to the clinical investigators, as FDA does not regulate discussion of research.

"Publicizing live cases is a good way to disseminate valid scientific information, but the sponsor must remain distant," said panelist Michael Morton, senior director of regulatory affairs for CarboMedics Inc. (Austin, TX), a Sorin Group company. "But the investigator must present science. You want to protect your investigator's reputation."

If a hospital organizes press coverage of an investigational device, that is fine, Morton said. But the device manufacturer must not coach anyone involved or conduct any advertising as part of the effort. The firm should, however, ensure that the device's commercial unavailability is mentioned, along with a disclaimer that the device is being studied for safety and effectiveness.

Displaying an investigational device at a trade show is acceptable as long as the firm mentions that the product is not available in the United States, and that "there are no claims, no preselling, and no prequalification of accounts," Morton said.

A gray area, however, is that while regulations don't allow promoting or test-marketing an investigational device until after FDA approval, "the regulations have no definition of 'promote'," said Robert Klepinski, president of Klepinski & Duval PA (Minneapolis). "And 'you can't say anything' would be unconstitutional," given the court decisions of the past few years.

Device companies, then, may be best served by heeding Morton's advice: "Use your judgment. Make sure what you do makes sense."

Copyright ©2005 Medical Device & Diagnostic Industry

IP Strategy and the Quest for Capital

Originally Published MX January/February 2005


Clearly connecting a company's intellectual property strategy with its business plan can secure a vital link to venture capital funding.

Steven C. Furlong

An idea for an artificial liver could lead to a breakthrough invention benefiting millions of people in critical need. But without adequate funding to bring such an invention to fruition, the potentially life-saving device may never get to market, remaining simply someone's dream. Companies that do bring to market useful medical technology innovations tend to succeed in this by crafting a business plan that includes a well-conceived intellectual property (IP) strategy that protects all facets of the medical device. Such an IP strategy can also win investor interest.

Patents on medical devices don't last forever. Trademarks and other forms of IP protection (distinctive shapes and colors, for example) can help protect a medical technology market space.

Torts and Courts: Managing a Product Liability Crisis

Originally Published MX January/February 2005


Bad things happen to good companies.
They need not destroy their financial health.

Kevin M. Quinley

Litigation disasters can befall all types of medical and life-sciences companies today. Medical innovations that bring new therapies to patients sometimes create new risks of product liability claims as well. Ten years ago, few would have guessed that we would now aim lasers at our eyes to improve vision or inject botulism toxin into our faces to smooth out wrinkles. Technologies like these may be laying landmines whose eventual explosion aggressive lawyers can exploit.

Mass-tort and class-action lawsuits are the legal contests du jour. Medical device firms can easily find themselves in the crosshairs of plaintiff attorney gun sights, targets of a well- organized personal-injury bar. These days, the tort and litigation climate holds the prospect of heavy weather for device companies.

Electrode System Could Aid Paralysis Patients

Originally Published MDDI January 2005


Maria Fontanazza

The system moves an implanted electrode through the brain, while the electrode translates the data it collects to a computer, robot, or prosthetic limb.
(click to enlarge)

Mechanical engineers and neurobiologists are collaborating to develop a neural prosthetic that may help people who are suffering from severe paralysis. The movable electrode system has the potential to detect neural signals, translating them to a computer cursor, robot, or even a prosthetic limb, offering hope to patients who cannot communicate or who have body parts that cannot function.

While research on the device is intended for the recording of neurons, it also can be used as a stimulation device. "We're thinking about how this might be a useful technology as a deep brain stimulator for Parkinson's disease," says Joel Burdick, professor of mechanical engineering and bioengineering at the California Institute of Technology (Pasadena, CA). It could allow doctors to reposition electrodes without having to perform surgery, or it could be used for locomotion in spinal cord injuries to pinpoint and manage stimulation. But, he says, right now these are just theories.

The system is designed to move an implanted smart electrode through the brain. The autonomous quality of the electrode gives it the ability to continually readjust while following a neuron. "It's been a challenge for a long time to get a good interface between a neuron and an electrode," Burdick says.

When implanting an electrode inside the brain, the targeted region is usually so small that an error of a millimeter can have a negative effect. And even if it is implanted in the right area, it might not be sitting next to the best neuron. "If the electrode is really smart, we can figure out if there's another neuron that is better suited for the neural prosthetic task," says Burdick. "We've demonstrated that the electrode can continually adjust itself, but we're still working on how to hunt for the right neuron."

The microdrive uses a matchstick-sized motor. The team hopes to bring the size down to the micron scale for the implant.

The second challenge is to figure out a way to make the technology small enough and safe enough for use in the brain. The prototype uses a piezoelectric motor, which measures in millimeters and inches, to drive electrodes. Burdick wants to downsize to the micron scale and use microminiature motors. His team also needs to develop a method that can generate high forces without high voltage that will allow the electrode to travel. Excess heat generation can destroy delicate brain cells.

The technique currently uses a bellows-like device to push the electrode around. Once fluid is sealed inside the bellows, a current is pumped through to transform the water molecules into hydrogen and oxygen. This process, called electrolysis, causes the bellows to expand and propel the electrode forward. The reverse current pulls the gas back and turns it into water again. "Basically, we can generate and remove gas with just a small amount of electrical current," says Burdick. "Once you turn water into gas, it stays there until you reverse it. There's no power loss, and it doesn't generate much heat."

The next step involves studying a safe surgical technique. Implants introduce the potential for inflammation in the brain. "Just our device won't solve this problem," says Burdick. As technology is refined, it must be combined with advances that address the biochemical aspect.

"There are plenty of challenges ahead for [developing] human uses, but right now we're on a path that suggests we're going to get there," Burdick says.

Copyright ©2005 Medical Device & Diagnostic Industry

HHS's Tommy Thompson Resigns

Originally Published MDDI January 2005


HHS secretary Tommy Thompson announced in early December that he will resign from his post on February 4, 2005, or when a successor is confirmed.

Likely successors include the Centers for Medicare and Medicaid Services administrator Mark McClellan, MD, who previously led FDA, and HHS deputy secretary Claude Allen.

Thompson, a former four-term Wisconsin governor with more than three decades of public service, is the eighth Bush cabinet member to resign from the 15-member cabinet since the president won reelection.

Copyright ©2005 Medical Device & Diagnostic Industry

The Home-Healthcare Marketplace

Originally Published MX January/February 2005


The rapidly growing home-healthcare segment represents win-win potential for both consumers and manufacturers.

Alpesh Gandhi

One of the fastest growing—and most opportunity filled—sectors of the healthcare marketplace is that devoted to home healthcare. As a product-generating sector of the medical device industry, the key segments of the home-healthcare market are those for respiratory devices, infusion-therapy devices, and durable medical equipment (DME).

Figure 1. Revenue forecast for the home-healthcare segment of the U.S. medical device market, 2002–2008. Source: Frost & Sullivan.
(click to enlarge)

Studies on Heart Cell Cultures Could Improve ICDs

Originally Published MDDI January 2005


Maria Fontanazza

Nenad Bursac: Reprogramming ICDs may make them safer for patients.

Research conducted at The Johns Hopkins University (Baltimore) suggests that reprogramming implanted cardioverter-defibrillators (ICDs) may help prevent a rare episode in patients suffering from ventricular tachycardia, or abnormally rapid heartbeat.

The device usually jolts the heart back to a normal rhythm. However, in rare instances, the pulse has an adverse effect and sets off a faster, more hazardous rhythm. The rapid pumping of the heart can become indistinguishable from ventricular fibrillation, a condition that can cause death in minutes if medical attention isn't provided. When this happens, the ICD delivers a painful shock in an attempt to reestablish a normal heartbeat.

Biomedical engineers at Johns Hopkins performed a study on heart cell cultures and found that the cause of these dangerous arrhythmias may be a result of multiarm spirals. The spirals are waves of electrical activity that form when the pulse from an ICD is applied. Upon electrical stimulation, the single wave, or arm, can multiply.

"Multiarm spirals could be a mechanism by which ICDs sometimes accelerate the ventricular tachycardia, making it more dangerous and more likely to turn into fibrillation, rather than stopping it," says Nenad Bursac, assistant professor in the biomedical engineering department at Duke University (Durham, NC). Bursac performed the research and data analysis at Johns Hopkins.

Bursac explains that the regular jolt of an ICD can cause harm by trying to alleviate all the spirals at once. "ICDs could be programmed to try to first annihilate one of the spiral arms and slow down the tachycardia, making it safer, before attempting to finally terminate it," he says.

Based on the experiments, it may be possible to program a pacing rate slower than that of accelerated tachycardia in ICDs. "Current devices always use a faster rate than the tachycardia rate in order to terminate it, which sometimes can worsen the situation," says Bursac.

The optimal antitachycardia algorithm has yet to be determined. "Eventually, it is possible that these studies can improve understanding on how tachycardias get accelerated into fibrillation by rapid pacing, and yield ways to prevent it," says Bursac.

The research was funded by the Mid-Atlantic Affiliate of the American Heart Association (Baltimore) and the National Institutes of Health.

Copyright ©2005 Medical Device & Diagnostic Industry

Devices of the Future Must Incorporate Nanotech and Biotech

Originally Published MDDI January 2005


Sherrie Conroy

Devices of the future must incorporate information technology, nanotechnology, and biosciences, according to an industry expert. "Biologics and nanotechnology are important to the future of devices," said Bill Van Antwerp, chief scientific officer for Medtronic MiniMed (Northridge, CA), at a recent nanotechnology conference.

Device companies must change in the next 10 years if they want to survive, he warned. They need new skills in molecular and cell biology, and they need to move from device-based thinking toward new areas of expertise. Most of the difficult issues in the next generation of devices will be in the interface, which means the interface disciplines are more important than ever.

Van Antwerp noted that molecular medicine is now driving the way patients are treated. Device companies, however, spend most of their time focused on mechanical and electrical systems because this is their expertise, he said. To get the optimal benefit of the convergence, he said, device companies must incorporate more biology.

Diabetes management, for example, presents one such opportunity for device companies. "Diabetes is a data-driven disease with management of the data on a day-to-day basis. Despite advances, the challenge is how to take the data and put it into daily living."

As industry trends move toward smaller, lower-power, sensor-driven devices, he said new sciences such as protein-based therapies present new targets and new opportunities. "These therapies will need delivery systems," he said. "Pills are not the only way for these therapies to be successful. Today, much of the electrical stimulation is based on old pulse-generation systems using new electrodes. Biologicals offer significant potential for improved outcomes with built-in intelligence." For example, he said that since diabetes uses beta cells, nanotechnology applications could define the biological device interface for diabetes management.

Gene therapy is another opportunity for device manufacturers. "Most gene therapy is done with retroviruses," he said. "There is an opportunity to use synthetic systems. Nanotech constructs can be used to get into tissues at the local site (for example, into the brain)." One possibility for device manufacturers, he said, is to find a way to get vectors in. Systems could be developed that use macro delivery devices such as pumps, which could be done with both viral and nonviral vectors (such as ultrasound, synthetic polymers, and virus-like synthetic vectors). "A totally synthetic system is better than a natural virus and much more likely to be better received by FDA," he said.

He noted, however, that a critical decision for device companies is how to move into these new areas. They may choose to buy other companies or develop in-house expertise. Options for device companies include single partnerships (such as Medtronic's partnership with Genzyme) or in-house integral programs, he said. Multiple partners for targeting the molecules of different disease states may also present opportunities. "It may take a smaller biotech partnering with a larger device company to get some of these new combination products to clinical trials."

Copyright ©2005 Medical Device & Diagnostic Industry

Major Players in the Respiratory Segment

Originally Published MX January/February 2005


Hudson RCI
Nellcor Puritan Bennett
Omron Healthcare
Sunrise Medical

Copyright ©2005 MX