Medical Device Link The Online Information Source for the Medical Device Industry.

Donna Bea-Tillman, who leads the Office of Device Evaluation at CDRH, circulated an internal memo asking for “a better lay of the land” in terms of device approvals. Specifically, she wants branch chiefs to let her know when reviewers are asked to clear a new indication or use that “you have never cleared for that device type.” Several FDA staffers say that such individual applications don’t usually reach that far up the food chain at the agency.

According to the memo, FDA has already set up a working group to address 510(k) issues. Tillman also said in the memo that increased scrutiny is “just the first of what I am sure will be many things” done to improve the 510(k) process.

The following information was provided by MD&DI contributing author, Ryszard Rokicki, owner of Electrobright (Macungie, PA).

“Despite continuous research to improve nitinol properties it is still impossible to produce 100% homogenous, intermetallic inclusion free nitinol,” says Rokicki. “The best that nitinol producers came to until now is what is termed extra low inclusion nitinol. The nitinol inclusions, especially those that leave residue on the surface of finished implantable devices (e.g., stents) are the main culprits of stent fracture, nickel leaching that leads to allergies,  restenosis, and stent thrombosis. Up until this point is has been impossible to test efficiently stent for inclusions.”

“However,” he says, “a newly developed inclusion detection test has provided a way to efficiently test every single nitinol stent before implantation. On the basis of this test, a citizen petition was filed with FDA, requesting the test’s implementation.” To view and comment on the petition, please visit www.regulations.gov Under  “Enter Keyword or ID”, type the petition docket number: 2009-P-0362 and click  on the “Search” button.

Equipped with a few sensors and a motor, a robotic hand developed by researchers at Harvard and Yale Universities gives users the advantage of picking up a range of objects with the flexibility of a human hand. Each soft polymer finger has two embedded piezoelectronic sensors that allow the hand to feel objects and adjust grip accordingly. The sensors were embedded via shape deposition manufacturing, a process that deposits materials one layer at a time. This technique enables the placement as well as protection of the sensors within the material. The device currently uses a power grip to pick up larger objects, but the researchers would like to add a precision grip, which would enable users to pick up items like a pen.

Barrett Technology Inc., a company that specializes in robotic manipulators (Cambridge, MA), has licensed the technology. Barrett was spun off from MIT’s artificial intelligence lab in 1990.

FDA has issued a report saying that it will reevaluate the approval of Menaflex (a patch for injured knees manufactured by ReGen Biologics Inc.) because the device was mistakenly approved. According to the New York Times, the agency’s internal documents show that device often failed, which forced patients to get another operation. However, after receiving inquiries from four legislators about the device, agency managers approved the device, the Times says.

This case could be representative of deeper flaws at the agency. The Wall Street Journal reports that deputy director of FDA Joshua Sharfstein said that the report illustrates “definite threats” to the medical device review process.

“This failure constitutes a clear deviation from the principles of integrity used in this review and undermines the ability of the agency to counter the suggestion that lobbying on behalf of ReGen affected the decision,” the FDA report said.

ReGen has not commented on FDA’s decision.

One segment of the device world that often goes underserved is the pediatric market. Children face more risk than adults during a variety of medical situations because many devices just weren’t made for them. For example, oxygen masks may be too large for children, or pacemaker batteries may run out because children have faster heartbeats than adults. Because there hasn’t been a big demand for pediatric devices, FDA estimates that pediatric device development is about a decade behind similar devices for adults.

To help fix the problem, FDA has awarded $2 million in grants to various researchers to work with the agency to create prototypes and eventually find OEMs to manufacture and market new pediatric devices.

“Congress provided FDA with this funding so that we could help connect innovators and their ideas with experienced professionals who assist them through development,” said Timothy Cote, director of FDA’s program for orphan product development.

The money was divided as follows:
Dr. James Geiger, Michigan Pediatric Device Consortium ($1,000,000)
Dr. Pedro DelNido, Pediatric Device Consortium ($500,000)
Dr. Michael Harrison, University of California at San Francisco Pediatric Device Consortium ($500,000)

Governors from California, Indiana, Minnesota, Nevada, and Utah have sent a letter to Senator Baucus (D-MT) stating their strong opposition to the $4 billion tax on the medical device industry in the Senate Finance Committee healthcare reform proposal. The governors argue that such special taxes on the companies are counter to the goals of better healthcare. Click here to download a pdf of the letter.

They say the tax could have a negative effect on industry, employees, healthcare providers, and patients. The tax, as outlined would apply regardless of the size of the company or its profitability, which would have an undue effect on small and mid-sized firms.

In addition, the letter states the governors’ belief that such a tax would ultimately increase healthcare costs.

This is the second such letter sent by leaders of states that have strong ties to medical devices. Earlier this month (September 16, 2009), a letter from Senators of Minnesota and Indiana to Baucus carried a similar message to the one issued today.

In related news, the Associated Press released news that Baucus has backed down from a portion of the tax, which had previously included over-the-counter devices, including condoms and tampons. The tax will no longer include exempted consumer items of $100 or less. This last-minute switch means that contact lens solution, maxi-pads, and home pregnancy tests — among many other items — will not be taxed.

However, items that are not exempt in this back pedal, such as wheelchairs, insulin pumps, and hearing aids, coould still have an effect on patients. AP reports that “The medical devices industry says that eventually, the taxes will get passed on to consumers.”

New industry research says that quality problems faced by global manufacturers, such as costly and inconsistent quality management and execution, are best addressed by taking an architectural or enterprise platform approach to quality processes.

According to AberdeenGroup (Boston), which conducted the study, a system that standardizes and shares best-practice operating procedures for quality across all manufacturing operations enables real-time visibility and control for best-in-class quality performance. Download a free copy of this research at:  http://3.ly/qJp. (Note: the study is available for free until October 2, 2009. After that, it costs $399.)

The report also cites an increased investment by best-in-class manufacturers in manufacturing operations management systems, especially those with embedded capabilities to perform enterprise quality management across all manufacturing operations. The results involve high overall equipment efficiency, on-time and complete shipments, and regulatory compliance for a reduced cost of quality.

Using drugs, electrical stimulation, and exercise therapy, UCLA researchers are helping paralyzed rats walk again after a spinal cord injury. Their findings, which are published in the online edition of Nature Neuroscience, indicate that the regeneration of severed nerve fibers might not be necessary in helping paralyzed rats walk while also supporting their weight. First, the researchers placed paralyzed rats that had no voluntary movement of their hind legs on a moving treadmill. Then they gave the rats drugs that act on serotonin and administered low levels of electrical currents to the area below the spinal cord injury. This combination sparked walking in the rats’ hind legs. The continual treadmill therapy during the course of weeks helped the rats regain weight-bearing walking, but they were not able to walk on their own due to the spinal cord injury. Although this is early-stage research, it could have implications for neuroprosthetic devices in terms of how the devices activate the spinal cord’s rhythmic circuitry.

FDA commissioner Margaret Hamburg is worried about home glucose meters. According to The Wall Street Journal, the FDA has asked ISO to tighten accuracy requirements for the devices.

If ISO doesn’t toughen its requirements, Hamburg says that the FDA will consider pursuing higher-peformance standards. The commissioner says that there hasn’t been any significant improvements in the accuracy of glucose meters over the past few decades, possibly because manufacturers haven’t been challenged by stricter requirements. “The agency believes the current standard is too lax because it allows inaccuracies of up to 20% in the devices,” WSJ says.

Four senators sent a letter to Max Baucus (D-MT) that protested his plan to impose $4 billion in annual fees on device makers. The letter was signed by Senators Amy Klobuchar (D-MN), Evan Bayh (D-IN), Richard G. Lugar (R-IN), and Al Franken (D-MN).

The senators opposed the tax on the grounds that it would threaten U.S. jobs and stifle innovation in the industry. The politicians also expressed concern about the potential of job losses in the states that they represent. As the New York Times notes, Minnesota is home to huge device companies like Medtronic and St. Jude Medical, and Indiana is the base for several orthopedic companies.

The letter argues that the medical device tax is too much of a drain on industry, given that manufacturers would also be negatively affected by the proposed cuts to hospital reimbursements. “These hospital cuts will translate into $15-$17 billion in estimated cuts to the medical device industry over 10 years,” the letter says.

Medical device tax opponents are getting support from congressional tax estimators. According to The Wall Street Journal, the estimators found that the government would assess “$123 billion in fees on health insurers, drug and medical device manufacturers, and medical labs,” but only collect a net revenue of $93 billion.