Top Device Companies

Stryker Indicted By Federal Grand Jury For Fraud In Device Case

Stryker Biotech has been indicted by a federal grand jury, along with several employees, on charges of marketing its OP-1 Implant and OP-1 Putty medical devices for unapproved purposes. The FDA had approved the devices only for use in rare cases to stimulate bone growth, but federal prosecutors convinced the grand jury Stryker encouraged doctors to use them with an unapproved bone-filler never tested in humans. The prosecutors sought the indictment, alleging some patients suffered serious medical problems from having the devices combined with Calstrux. Stryker faces a penalty of at least $4 million in fines. (Click here for more)

“Medical Device Maker Accused Of Fraud, Lying” – Boston Globe (10/29/09)

Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny -- Click Here To Find Out Why...

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Stryker Creates Quality, Manufacturing Post, Names First President

Stryker created the new post of president for quality and manufacturing issues and named Lonny Carpenter to the job. The move was motivated in part by Stryker’s need to resolve three warning letters it received from the FDA regarding medical devices. Stryker has said it spends at least $50 million a year attempting to improve quality and compliance at its facilities. Carpenter had served as group president of the instruments and medical divisions. (Click here for more)

“Stryker Names Group President For Quality” – MLive (9/2/09)

Medical Device Manufacturers’ Employee Training Programs Are Under FDA Scrutiny -- Click Here To Find Out Why...

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Stryker Heir Serving On Board Cashes in $50 Million In Stock

Stryker’s lone member of the founding family serving on the company’s board cashed in her shares in the company for $50 million. Ronda Stryker, granddaughter of firm’s founder, sold the 1.2 million shares of stock that had been held in a revocable trust. She and two siblings decided last year to dissolve a joint trust. Ronda Stryker still holds about 9 percent of the company. (Click here for more)

“Stryker Corp. Heir Scores $50 Million From Stock Sales” – MassDevice (7/31/09)

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Boston Sci, Medtronic, Stryker Could See Impact Of Medicare Changes

Boston Scientific, Medtronic and Stryker are among leading makers of costlier medical devices expected to weather changes in the Medicare program’s procedures for covering devices. Proposals revealed so far for the next fiscal year should have little impact on key heart and orthopedic devices, whose reimbursements are to undergo little change. But more-expensive products such as replacement hips and implantable defibrillators sold to hospitals might be affected. Medicare statements indicate there will be greater pressure on hospitals to hold down prices in the near future, eventually leading to negotiations with makers over prices. (Click here for more)

“Medicare Changes Benign For Device Companies, But Pressures Loom” – Money (CNN) (5/4/09)

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A Last Gasp for Stryker with OP-1? Not Likely.

Article preview from IN VIVO - April 2009

Few were surprised when an FDA advisory panel recommended against approving Stryker's OP-1 device for spinal fusion. Plus, given the recent focus on off-label use of orthobiologics, OP-1 was not likely to displace its only competitor, InFuse. That said, the off label issue may well influence the future of OP-1 as Stryker contemplates whether and how to retool clinical development.  

Israel's Device Community: Opportunities and Challenges Ahead

Article preview from Medtech Insight - February 2009

Few medical device industry executives would quarrel with the notion that Israel has been one, if not the leading, source of new device technology over the past decade or so. Anecdotally, some large US device companies now say that one-third to one-half of the new companies and devices they look at either come directly from Israel or originated there. Today, Israel ranks number-one in the world in patent applications for medical device technology and first in patents per capita. And the list of innovative devices that have come out of Israel covers all therapeutic areas and all technological fields—including some where Israeli companies seem to have a particular affinity or expertise, such as innovative imaging devices and robotics. So why are so many Israeli device executives, both company types and investors, so anxious these days?

Obstacles Ahead for TJR Market

Article preview from Medtech Insight - February 2009

With few new treatment options on the horizon for patients suffering from joint pain associated with hip and knee osteoarthritis, it should come as no surprise that the business of joint replacement is booming and will continue to do so for the foreseeable future. Even in the current economic environment where elective joint replacement procedures are likely to slow down, there has not (yet) been a significant impact on implant sales.The industry admits it is not immune to the global economic crisis, at least in the short term. However, over the long haul, the general consensus is that this market will remain strong owing to solid growth in the patient pool.

Challenges Ahead for TJR Market

Article preview from IN VIVO - February 2009

A reprint of a feature in the February 2009 issue of Medtech Insight. With few new treatment options on the horizon for patients suffering from joint pain associated with hip and knee osteoarthritis, it should come as no surprise that the business of joint replacement is booming and will continue to do so for the foreseeable future. Even in the current economic environment where elective joint replacement procedures are likely to slow down, there has not (yet) been a significant impact on implant sales.The industry admits it is not immune to the global economic crisis, at least in the short term. However, over the long haul, the general consensus is that this market will remain strong owing to solid growth in the patient pool.

Stryker Subject Of U.S. Probe Of Device-Marketing Tactics

Stryker Corporation's effort to promote its OP-1 and Calstrux devices has drawn a U.S. grand jury investigation into the legality of its methods. Stryker revealed it had been notified by the Massachusetts U.S. attorney’s office of the probe into its bone growth products. The grand jury also is checking assertions Stryker sold misbranded devices and made false reports to the FDA about treatments under humanitarian-device exemptions. The inquiry began last year, and Stryker previously revealed subpoenas served on current and former employees. (Click here for more)

“Stryker Says It Target Of Federal Probe” – Reuters (3/10/09)

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Boston Sci, Medtronic, Zimmer, Stryker, Others See Stocks Tumble

Boston Scientific, Medtronic, Zimmer Holdings, Stryker and other leading medical device makers are seeing their stock tumble as investors worry about the toll of health care reform. The four leaders have gross profits of around 70 percent because of their heart and orthopedic devices, but the industry saw indexes falling by as much as 15.2 percent in the two weeks since the new administration issued its budget proposal. Michael Mussallem, chairman of the Advanced Medical Technology Association as well as CEO of Edwards Lifesciences, said there was no rational reason for investor concerns. (Click here for more)

“Medical-Device Stocks Rattled By Push For U.S. Health Reform” – CNNMoney (3/12/09)

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