Medical Device Link.

IP and Equivalence Under a recent court ruling by the United States Court of Appeals for the Federal Circuit, device manufacturers’ premarket notification (510(k)) submissions may be fodder for invalidation of U.S. patents. This month, attorney Linda E. Alcorn, Esq., reviews the key elements in the case of Bruno Independent Living Aids Inc. v. Acorn Mobility Services Ltd. and Acorn Stairlifts Inc., with an eye on what the recent decision means for medical technology executives. Alcorn is a director at the law firm of Sterne, Kessler, Goldstein & Fox PLLC (Washington, DC) and is the head of the firm’s medical device patent practice. [ More ]

Alcorn: On the medtech IP watch.

Federal Investigators Target Orthopedics Sector

One by one, subpoenas from the U.S Department of Justice (DOJ) were issued, each followed by a company news release pledging complete compliance and cooperation with the investigation. And with each communication, it became increasingly clear that orthopedics—medtech’s hottest sector—was under fire.

U.S. Attorney Christie: Ortho under fire

In April, Christopher Christie of the Newark, NJ, office of the U.S. Attorney issued subpoenas to the nation’s five leading orthopedics firms. The subpoenas requested information regarding the companies’ consulting, professional service, and remuneration agreements with orthopedic surgeons dating from January 2002 to the present.

The orthopedic companies under investigation are Biomet Inc. (Warsaw, IN); DePuy Orthopaedics Inc. (Warsaw, IN), a Johnson & Johnson company; Smith & Nephew plc (London); Stryker Corp. (Kalamazoo, MI); and Zimmer Holdings Inc. (Warsaw, IN).
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MX Launches Executive Webcast Series

Medical technology executives who are seeking to anticipate industry trends will benefit from a new series of free on-line discussions presented by MX magazine. Scheduled to launch this May, the MX Executive Webcast Series will bring actionable information directly to executives’ desktops. Presentations in the series will also include live question-and-answer sessions, enabling attendees to get further details pertinent to their companies.

The first presentation in the series, “Managing Healthcare Customers: The Essentials of CRM Systems for Medical Device Manufacturers,” will focus on customer relationship management strategies that medtech companies can use to improve sales effectiveness, profit from healthcare influencers and thought leaders, collaborate with GPOs and distributors, and build customer loyalty and demand.

Sponsored by Pivotal Medical Devices, the Webcast will feature presentations by Judd Banks, business manager at Pivotal Corp., and Don Patulo, senior director of sales support and training at Sysmex America Inc. The Webcast will finish with a live Q&A session moderated by Steve Halasey, editor in chief of MX Magazine.

“Managing Healthcare Customers: The Essentials of CRM Systems for Medical Device Manufacturers,” will take place on Tuesday, May 24, at 1:00 P.M. EDT (12:00 P.M. CDT, 10:00 A.M. PDT). To register for the event click here.

AdvaMed Updates Code of Ethics

At the beginning of April, industry association AdvaMed (Washington, DC) released an updated version of its “Code of Ethics on Interactions with Healthcare Professionals,” the industry guidance document commonly known as the AdvaMed code of ethics. Members of the AdvaMed committee that framed the code expected that it would be a living document, subject to periodic revision and updating. But with federal investigators and healthcare industry watchdogs keeping a closer watch on the business practices of medtech companies than ever before, AdvaMed may soon have trouble keeping up with requests for guidance on corporate ethics.
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FDA: Manufacturers Failing to Comply with Postmarket Conditions of Approval

Seeking to protect the public health without hindering the movement of innovative technologies into the marketplace, FDA has long struggled to find the elusive balance between premarket and postmarket review of medical devices. In recent years, the agency has increasingly required the manufacturers of Class III medical devices to establish patient registries and reporting mechanisms or to undertake significant postmarket studies as a condition of approval for their premarket approval (PMA) applications. According to a recent FDA report, however, all of the agency’s hand-wringing over postmarket requirements may be for naught.
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Gainsharing: Saving Costs or Stifling Competition?

In the lexicon of medical device manufacturing, gainsharing isn’t a term that has broad recognition. But medtech manufacturers may soon find themselves undertaking a crash course in the concept, now that the U.S. Department of Health and Human Services Office of Inspector General (OIG) has approved a number of gainsharing arrangements
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Rubicon CEO Linder: On the move.

Boston Scientific Consummates Purchase of Rubicon Medical

April was an eventful month for device maker Rubicon Medical Corp. (Salt Lake City). At mid-month, Rubicon announced that its Rubicon Filter embolic protection system had received the CE mark, making it eligible for marketing in the European Union. And on the same day, Boston Scientific Corp. (Natick, MA) exercised its option to purchase Rubicon for $71.7 million, plus up to $83.7 million more if postacquisition milestones are met.
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Medtronic to Pay $1.3 Billion to Settle Spine Patent Dispute

Michelson: Settling, big time.

Medtronic Sofamor Danek (Memphis, TN), the spinal business unit of Medtronic Inc. (Minneapolis), has agreed to pay $1.3 billion to Gary Karlin Michelson, MD, a Los Angeles-based orthopedic surgeon and inventor, to settle a long-standing patent dispute. In settling the case, Medtronic gains access to Michelson’s portfolio of spinal product patents, currently valued at $800 million. The agreement also includes $550 million to settle all outstanding legal claims between the two parties. [ More ]

GPO Initiative to Promote Best Business Practices

The value of healthcare group purchasing organizations (GPOs) continues to engender lively controversy among medical device manufacturers and healthcare policy makers. In recent years GPOs have been widely accused of employing a variety of anticompetitive business practices, and have consequently found themselves on the defense against the possibility of strict federal regulation and congressional oversight of their activities. But anyone who imagines that the GPO industry is on the ropes and about to go down for the count had better take another look.
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Medtronic Offers Indemnity Program to Corporate Defibrillator Buyers

Healthcare consumers are widely considered to be more savvy and attuned to the use of medical technologies today than ever before. But apparently that fact isn’t enough to convince businesses that they should equip their workplaces with automatic external defibrillators (AEDs)—devices that can dramatically increase the survival rate among victims of sudden cardiac arrest (SCA). Instead, many companies have so far sidestepped recommendations to install AEDs, frequently citing the liability claims that could arise from use of the devices. But that trend could soon be changing. To eliminate the liability barrier to greater adoption of AEDs in the workplace, Medtronic Emergency Response Systems (Redmond, WA), a business unit of Medtronic Inc. (Minneapolis), has introduced a liability protection program for corporate AED buyers. [ More ]

Medtronic’s LifePak CR Plus AED.

FDA Panel Sends Mixed Signals on Silicone Breast Implants

Just one day after rejecting the revised premarket approval (PMA) application of Inamed Corp. (Santa Barbara, CA) for the company’s silicone gel breast implants, FDA’s general and plastic surgery devices advisory panel voted to recommend approval of similar implants from Mentor Corp. (Santa Barbara, CA). Among medtech analysts, opinion about the panel recommendation is mixed. Citing the virtually identical design of the two devices, some analysts believe it is highly unlikely that the agency will rule differently on the two implants. So what’s FDA likely to do?
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The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas. —Steve Halasey, Editor in Chief, MX