Stryker announced on its Web site today that chairman John W. Brown is retiring from his position of chairman of the board. Brown served as the company’s president and CEO from 1977 until 2003. He will replaced on January 1 by Stephen P. MacMillan, Stryker’s current president and CEO.
This announcement follows the recent indictment of four employees at Stryker Biotech, a unit of Stryker, on charges of wire fraud and conspiracy. According to the Kalamazoo Gazette, the indictment alleges that the employees promoted medical devices used to stimulate bone growth in long bones and the spine for broader uses than they were approved for.
The Kalamazoo Gazette says that if Stryker does not resolve these charges, it could be excluded from federal and state healthcare programs.
It is more difficult today than ever before to be a successful medical device company. Patients are more educated and demanding about therapies, the global market is diverse and expanding, and regulatory and documentation requirements are stringent. It is for these reasons that companies need a strong IT program, according to Dan Staresinic, senior director of consumer products and life sciences at Siemens PLM Software. And these days, it’s not just about the “occasional special design but [instead is about] the trend towards mass customization of your therapies in the market at large,” said Staresinic during yesterday’s Siemens Webinar, “Transforming the Business of Patient-Specific Medical Products.”
Staresinic said that having a strong IT platform for innovation, which remains a gray area for some medical device companies, involves using product lifecycle management (PLM) software. PLM links plan, development, manufacturing, and support processes together for manufacturers. Although many companies use such software, a study by the firm AMR Research shed some light on software adoption and how this can affect patient-specific design processes. Only 31% of respondents claim to be using PLM at least partial basis. By the end of 2010, nearly 90% of respondents will have at least evaluated the impact that PLM could have on their business. So, the question remains—what is the rest of the industry doing?
Alex Winber, director of OrthoRecon Knees at Wright Medical Technologies, said using PLM software as part of a product development process allowed Wright Medical to advance its Prophecy knee implant from inception to launch in less than one year. Wright Medical used Siemens’ PLM Software to develop the interface for the product. However, despite this success story, AMR Research’s study found that there’s a lack of clarity surrounding the roles of R&D and operations at companies, especially within companies that are focusing on developing patient-specific devices. Custom products are being seen as a way to differentiate a product portfolio in an increasingly competitive marketplace, and a strong, cross-functional relationship between R&D and operations is essential.
A district court judge in Minnesota has dropped more than 600 personal injury claims against Medtronic springing from the company’s recalled Sprint Fidelis defibrillator leads. The judge ruled that these claims were—you guessed it—preempted by federal law. Back in January, another judge dismissed a group of federal cases against Medtronic, also citing the Riegel v. Medtronic decision. The Medical Device Safety Act, which would allow these types of lawsuits to move forward, is pending in Congress.
The device industry saw a victory against Congress, which is searching for ways to pay for much-needed healthcare reform. Earlier this month, the Senate passed a tax on medical devices that would cost the industry around $40 billion in the next ten years (4$ billion a year, based on a company’s market share). Now, that burden has been cut in half and revised.
The House will propose a $20 billion fee, and Senate leaders have whittled down plans to tax the industry to pay for the health overhaul. The Senate bill is expected to levy a fee of between $15 billion and $20 billion over a decade on device makers, reports the Wall Street Journal.
According to WSJ, “The lower fee comes as big device makers like Medtronic Inc., St. Jude Medical Inc., and Johnson & Johnson have lobbied furiously against the Senate proposal. Their congressional allies from Minnesota, California, Massachusetts and elsewhere have barraged Democratic leaders with calls and letters.”
This new version is an excise tax imposed on the device at the point of sale, rather than levied by the prior year’s market share, as the original tax proposed. The medical-device tax will bring revenue that Democrats have sought to ensure their proposals expanding coverage to the poor and to the uninsured won’t add to the deficit.
Becton, Dickinson and Co. (Franklin Lakes, NJ) is acquiring HandyLab Inc. (Ann Arbor, MI) to further expand into “other molecular opportunities,” according to BD President Vincent Forlenza. The acquisition is part of a strategy that builds on a development and distribution agreement between the two companies earlier this year. BD plans to integrate its GeneOhm molecular assay for MRSA and VRE (Vancomycin-resistant Enterococcus) with HandyLab’s platform technology. The combined technology will be marketed as the BD Max system. More details about the acquisition will be made during BD’s fourth quarter earnings call next week.
Researchers at USC, Northwestern, and Stanford just got a few hundred thousand dollars richer thanks to grants from the nonprofit group InHealth. Each university has been tasked with examining the socioeconomic impact of medical technology, something that executive director Martyn Howgill believes is critical as the United States debates healthcare reform.
“Examining the innovation process from beginning to end—from the roles of clinicians in developing new products to the technology’s long-term effects—gives physicians and policymakers the knowledge and evidence they need to make the best-informed decisions for patients and the public,” he says.
InHealth had the following to say about each grant:
University of Southern California to Develop Registry, Examine Effects of Devices for Diabetics
Intensive management of diabetes can prevent premature death and improve quality of life for diabetic patients, who represent more than 8% of the U.S. population.[1] While insulin pumps and continuous glucose monitors offer patients an effective way to manage their diabetes, little is known about how these devices affect quality of life and productivity. Dana P. Goldman, PhD, will receive $879,808 over two years to study how medical technology affects workplace productivity, health outcomes, quality of life, and functional status of diabetic patients. Researchers will develop a Web-based, longitudinal registry of patients aimed at enabling improvement of treatment patterns, effectiveness, and adherence to effective technology.
Northwestern University to Develop Conceptual Model of Impact of Wound Care Technologies
As a major source of morbidity and mortality, chronic wounds and their management represent a substantial burden to the healthcare system, costing the nation up to $25 billion a year.[2] Medical technologies have greatly improved the effectiveness of wound care and reduced healing time for many patients, but the effects, benefits, and costs of such new technologies have never been quantitatively measured. John H. Linehan, PhD, was awarded a one-year grant of $249,269 to develop a comprehensive, decision-analytic modeling framework that will enable researchers to assess the impact of innovative technologies in the treatment of chronic wounds. Effects on the individual patient level will be extrapolated to the population level, enabling a larger view of the efficacy of existing devices, the implications of emerging wound care technologies, and the opportunities for targeted design of future clinical trials.
Stanford University to Examine the Roles of Clinicians in Medical Device Innovation
With recent political and legislative developments suggesting that clinicians’ involvement in medical innovation requires greater scrutiny, the need to accurately measure the benefits of clinician and company collaboration has never been greater. With an InHealth grant of $330,623 over 18 months, Stefanos A. Zenios, PhD, will develop a conceptual model that examines the roles that clinicians play in the medical device innovation process—whether as inventors, clinical investigators, company directors, or other roles—and quantifies the impact of efforts that would dampen physician-company collaborations. While prior research used patents to measure clinicians’ impact, Zenios’s study will measure impact through FDA approval and the successful commercialization of devices.
Senator Sherrod Brown (D-OH) has introduced a bill that would make hearing aids covered under the Medicare program. According to a release sent by the senator’s office, the “Medicare Hearing Enhancement and Auditory Rehabilitation (HEAR) Act would help the more than one-third of seniors who require hearing aids afford devices.” The Medicare program has never covered hearing aids. Seniors currently pay $500–$5000 for the devices, the release says.
Pacemakers have been around for decades, but that’s not to say that we’ve exhausted their capabilities. A few pacemaker success stories from around the globe:
A miracle baby in Melbourne recently became the smallest ever pacemaker user. She was born this summer at 26 weeks gestation and weighed 540 grams (about 1.19 lb). In June, the baby was connected to an external pacemaker that kept her alive for 130 days. She received a permanent device last week after putting on more weight.
Gastric pacemakers for gastroparesis (paralysis of the stomach, which causes a host of digestive problems) is a relatively new technology. When the user is eating, the pacemaker sends electrical impulses to the stomach muscles and they contract, helping with digestion. In the UK, this device solved the problems of a woman who was unable to properly digest food for four years.
Pacemakers sometimes even get a second life. Financially strapped patients in the Philippines were recently given refurbished pacemakers by the Detroit-based nonprofit outfit World Medical Relief. The devices—50 of them in total—were donated by funeral homes in the Detroit area. This was part of a study whose results were published in the Journal of the American College of Cardiology earlier this month.
FDA announced that an investigation has been launched into problems with certain types of medical device power cords, after a number of reports that the cords are sparking, causing fires, and potentially resulting in device failure.
At least 122 reports of medical device cord malfunctions have been received by the agency, which issued an initial communication to patients and healthcare professions about the problems. FDA says that the plugs have the potential to cause electric shock, interruption of therapy, device failure, and fires, which could lead to serious injury or death.
The reports all involve Hospira or Abbott devices that have AC power cords with a black plastic bridge manufactured by the Electri-cord Manufacturing Company. The cords are used with a number of medical manufacturers, and FDA is in the process of determining which specific medical devices may be affected.
Investigations so far suggest that the problems are caused by the prongs of the power cords cracking and failing at, or inside, the plug.
FDA warns that all users of medical devices should be aware of the wear and tear on power cords. The agency recommends that any users who find they have cords with the black plastic bridge between the prongs should look closely for bent or cracked prongs, visible burns on the outer sheath, black residue or excessive signs of use and damage.
If you’re in Boston either this week or next week, there are two events you should consider checking out. Both conferences will explore the changing world of healthcare that is increasingly focusing on using the Internet to bring together patients, doctors, and medical devices. The first is the Connected Health Symposium, which is going on this week, October 21 and 22. Speakers will discuss how the industry can use modern IT such as cell phones and the Internet to manage chronic diseases and help older patients live more independently. The second event, the CIMIT Innovation Congress, is next week, October 27 and 28. Speakers from academia, the device industry, and the military will be discussing topics from innovations to treat injured soldiers to using IT products to prepare for disasters such as a pandemic or mass casualty event. Both conferences are sure to generate a lot of conversation about where the new health interface of the 21st century is heading and the challenges that the industry will face.
