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

The medtech industry has long been considered a recession-resistant segment of the economy. Although it is not recession-immune, it does show signs of optimism, according to Millennium Research Group (MRG).

The research firm says that the medtech markets have already felt the impact from the downturn, although not all segments have been equally affected. Aesthetic and elective markets have been hardest hit, with capital-intensive markets, such as diagnostic imaging, also feeling the pinch. Markets that address critical, acute care concerns such as cardiology have suffered little damage from the economic crisis, but are nonetheless showing that nothing is isolated from the recession’s effects.

Not all indicators are negative, however. The company says its exclusive MRG data from its new Medtech Confidence Index (MCI) suggests that there is some reason for optimism. The MCI looks at the general economic outlook of practitioners in medtech. Many market players, based on preliminary 2009 MCI data, are cautiously feeling more bullish about the medtech industry’s short-term prospects. Overall, however, MRG says that general sentiment remains highly negative, and thus the relative optimism should only be interpreted as a slight increase in outlook relative to a dismal fourth quarter in 2008.

AdvaMed spent $364,638 on lobbying the federal government in the first quarter of 2009, according to Forbes. While the medical device advocacy group lobbied for legislation that would require device makers to disclose payments to physicians, it’s using some of its funds to try and stop the Democrat-backed Medical Device Safety Act. This legislation would give patients more rights to file personal injury lawsuits against device companies.

The company also used its funds to lobby for improved FDA safety inspections and patent reform, says Forbes. In a statement on the organization’s Web site, Stephen J. Ubl, president and CEO of AdvaMed, takes issue with the apportionment of damages provision in the Patent Reform Act of 2009. He says, “a reduction in damages to the injured company serves to cheapen medical technology intellectual property and could have the perverse consequence of encouraging infringement.”

You remember the brouhaha surrounding Lester Crawford’s ownership of stock of an FDA-regulated company right? Newly appointed FDA commissioner Margaret Hamburg will likely take care of any potential conflict-of-interest stock ownership early on. In fact, she and her husband (hedge fund executive Peter Fitzhugh Brown) have already sold their Abbott and Johnson & Johnson stock. The Government Ethics Office has conducted a thorough review of her and her husband’s financial affairs to determine what the couple must divest in stock and fund holdings. It turns out that Hamburg is one of President Obama’s wealthiest appointees; she had $10 million in income last year. Her new post at FDA will earn her just a fraction of that: $150,000.

A miniature crawling robot is set to be unveiled in Israel during the ILSI-Biomed Israel Conference, June 15–17. The robot is designed to travel within the body, possibly to treat lung cancer through performing medical procedures. An interview with the head researcher can be found here (the presentation is partly in French).

According to the release, the ViRob can navigate and crawl in different spaces within the human body, including blood vessels, the digestive tract, and the respiratory system. In addition, it’s structure gives it the ability to move in tight spaces and curved passageways as well as the ability to pause within the body. These functions could be harnessed to perform minimally invasive medical procedures.

ViRob could also assist in targeted drug delivery to lung tumors, as well as take samples from different areas within the body. Several of these microrobots could simultaneously treat a variety of metastases. Researchers also plan to install additional equipment on the robot, including cameras, miniature tongs, and other equipment.

The ViRob prototype measures 1 mm in diameter and 14 mm long. It was developed by the Medical Robotics Laboratory at the Israel Institute of Technology. A basic prototype of the ViRob that can move as fast as 9 mm per second has been developed.

The unit for business development at the Israel Institute of Technology is currently in the process of establishing a company for technology commercialization.

All in all, it makes me want to rewatch Innerspace and reread Snow Crash.

In a memo released on Wednesday, President Obama called for a reversal of policies enacted by the Bush administration that protect companies from product liability suits. “Throughout our history, state and local governments have frequently protected health, safety, and the environment more aggressively than has the national government,” Obama wrote in the memo.

Although the Supreme Court’s 2008 decision in Riegel v. Medtronic has shielded the medical device industry from product liability suits brought in state courts, the tide could be turning. Democrats have introduced the Medical Device Safety Act of 2009, which would render the Riegel decision ineffective.

Additionally, some have argued that Supreme Court seems to have taken a contradictory stance on the issue of preemption. As recently as March, it struck down preemption related to pharmaceuticals in the case Wyeth v. Levine.

With no resolution from Congress and a confusing stance from the Supreme Court, executive departments and agencies are left, in the meantime, to follow the guidance in Obama’s memo: Don’t include statements of preemption in regulations.

Vermont has become the latest state to pass legislation to crack down on gifts given to physicians by drug and device makers. The state’s law, which will take effect July 1, requires these companies to publicly disclose all money given to doctors and other healthcare providers, including names and dollar amounts. The following people and entities would be prohibited in most circumstances from receiving gifts, including meals: doctors, nurses, medical staff, pharmacists, health plan administrators, and heatlthcare facilities.

Vermont’s law is regarded as the strictest state law so far because it is the first to ban free meals, which have been a classic tactic in marketing to physicians. It also does away with a loophole that had allowed drug and device firms not to reveal certain expenses by claiming they were trade secrets.

Margaret A. Hamburg, MD, has been confirmed as the next commissioner of FDA, reports Bloomberg. She has previously served as New York City Health Commissioner. The commissioner has stated that her focus will be on food safety and tobacco.

Hamburg’s candidacy was announced in March. It is likely that she will be assisted by Joshua Sharfstein, who has been acting commissioner since the departure of Andrew von Eschenbach.

AdvaMed’s Stephen J. Ubl released the a statement following the confirmation. “We applaud Dr. Hamburg’s expressed priorities of fostering innovation and further advancing the safety of medical products and we look forward to working with her to ensure the continued safety and effectiveness of medical technologies,” he said.

The media aren’t always easy to please, but one columnist is speaking up on behalf of a large device company. The writer is Michael Kinsley, who has Parkinson’s disease. He testified earlier this week to the House Energy and Commerce Committee on behalf of Medtronic—or more specifically, the company’s Activa deep-brain stimulator, which has helped Kinsley control the symptoms of his condition.

“Now I walk around with wires in my head and two pacemaker type batteries in my chest. But thanks to these devices and these pills, I am walking around,” Kinsley said. (Medtronic asked him to testify but did not pay him.)

Looking at the larger picture, Kinsley is part of the device industry’s efforts to protect itself from product liability lawsuits (see the Supreme Court’s decision in Riegel v. Medtronic). Many in the industry hold to the belief that lawsuits could prevent patients from having access to beneficial medical technologies. And with a bill circulating in Congress to overturn the Riegel decision, device firms may need all the help they can get.

At a meeting in Boston, the Heart Rhythm Society urged medical device companies such as Medtronic to better alert physicians about safety problems. Their plea revolved around recent complications with lead wires, such as the Sprint Fidelis, that are used to connect defibrillators to patients’ hearts.

Robert Hauser, MD, a well-known advocate of transparency and coauthor of the Society’s recommendations, suggested that manufacturers provide public reports about the performance of lead wires twice a year and post on their Web sites all information related to safety issues.

According to the Pioneer Press, a Medtronic spokesperson says that the company generally supports the Heart Rhythm Society, but is still reviewing its recommendations.

Medtronic Inc. announced today that the company has chosen San Antonio, TX, as the home of its new Diabetes Therapy Management and Education Center. Medtronic is expected to hire nearly 1400 people during a five‐year period to staff the new 150,000‐sq‐ft facility. The device company, which develops advanced diabetes management management systems, insulin pump therapy, continuous glucose monitoring systems, and therapy management software, expects to begin recruiting immediately with the facility opening for operations in late summer. The proposed site for the new center is the Overlook at the Rim office building.

“We are excited to add the city of San Antonio to the Medtronic family and look forward to becoming an active member of the growing biomedical community in South Texas,” said Chris O’Donnell, president of the diabetes business and senior vice president at Medtronic. “Medtronic offers exciting and fulfilling career opportunities helping people with chronic diseases live healthier, more-productive lives.”

Texas Governor Rick Perry said that by expanding their diabetes division in San Antonio, Medtronic is “sending a clear message that the core strength of Texas economy, built on our low taxes, fair legal system and predictable regulatory climate make the Lone Star State the best place to live, work and raise a family.”

Based on analyses made by the San Antonio Economic Development Foundation, when fully staffed, the new operation is expected to generate more than $750 million in economic benefit for San Antonio and Texas each year. This includes an investment of more than $23 million in capital improvements. Because of the significant economic benefit this facility will make to the local community, and the high‐skill jobs it provides, Medtronic was awarded a Texas Enterprise Fund grant of more than $6 million dollars from the state, an important factor in the company’s decision to come to Texas, according to the company. The company also received grants and incentives from local governments. Grants and incentives from all parties totaled more than $14 million.

As a sign of Medtronic’s commitment to the San Antonio Community, the company also announced two grants it is giving to local healthcare organizations. The Social & Health Research Center and CentroMed were both awarded $50,000 to expand programs that reduce diabetes risk factors and increase education and access to diabetes care.

The final decision to choose San Antonio resulted from an evaluation of more than 930 locations across all 50 states. Medtronic assessed several criteria including employee quality of life, availability of skilled labor, local costs and business environment. Medtronic continues to invest and grow its headquarters in Northridge, CA, and commitment to California employees remains strong. For individuals interested in employment opportunities with Medtronic at the new San Antonio facility, please visit the diabetes business unit on the Web.