Medical Device Link.

Biomet's Miller: Abrupt departure.

The orthopedics industry is still reeling from the sudden resignation late last month of Dane Miller as chairman and CEO of Biomet Inc. (Warsaw, IN). Industry analysts were genuinely surprised by the move, which is now generally attributed to a rift between Miller, one of the original founders of Biomet, and the company's board about the future direction of the company. Daniel Hann, senior vice president, chief counsel, and secretary, was named interim president and CEO.

Shortly after announcing Miller's departure, the board reported that it had retained the services of financial

Citing a growing market demand for specialty diagnostics, Fisher Scientific International Inc. (Hampton, NH) has announced a definitive agreement to acquire Athena Diagnostics Inc. (Worcester, MA), a manufacturer of neurological and other genetic tests, for $283 million in cash. In addition, Fisher has said it will purchase a 9% stake in molecular diagnostics equipment and test producer Nanogen Inc. (San Diego) for approximately $15 million in cash. Together, the two companies will work to develop Athena's markers and tests.

In establishing its position in the personalized medicine arena, Fisher will benefit from its existing, broad portfolio of kits, reagents, and related diagnostic supplies. In 2005, the company's healthcare division recorded revenues of a little more than $1.3 billion, or 23% of the company's total sales.

"The acquisition of Athena Diagnostics is consistent with our strategy to expand our offering of high-value, high-margin products and services in growing markets," said Paul M. Montrone, chairman and CEO of Fisher. "Building on our extensive suite of life-science and diagnostic products, Athena provides Fisher with a deep portfolio of proprietary genetic and other markers, as well as tests to identify those markers." [ More ]

Signalife Inc. (Greenville, SC) and Rubbermaid Medical Solutions, a division of Rubbermaid Commercial Products LLC (Winchester, VA), have entered into an exclusive, multiyear marketing agreement. Under the terms of the agreement, both companies will jointly brand, market, and distribute Signalife's Fidelity 100 electrocardiogram heart monitor. The agreement may also include other products as they are developed.

"As Rubbermaid continues to invest in expanding our presence in the medical arena, we have been looking for new technologies that complement our growing medical platform," said James J. Roberts, Rubbermaid's group president. "We believe that Signalife has developed an innovative platform, and we are thrilled to be their partner."

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The end is finally in sight for Guidant Corp. (Indianapolis), which has spent more than 15 months as an acquisition target. On March 31, shareholders of Guidant and acquirer Boston Scientific Corp. (Natick, MA) overwhelmingly approved the merger. Soon after, the companies reached a consent agreement with the Federal Trade Commission (FTC; Washington, DC) and received antitrust clearance from the directorate-general for competition of the European Commission (Brussels). With these hurdles overcome, the companies expect the deal to close later this month, following final FTC review. [ More ]

Responding to increasing concern about the safety and reliability of cardiac rhythm management (CRM) devices, industry association AdvaMed (Washington, DC) has released a draft proposal for pulse-generator product performance reports. According to the association, the proposal is designed to "improve communications between the manufacturers of cardiac rhythm management devices and patients, providers, and the public."

The proposed reporting format is based on an ISO standard and establishes specific definitions, procedures, and requirements for medtech companies to follow when issuing performance reports on such CRM devices as implantable cardioverter defibrillators and cardiac pacemakers. AdvaMed president and CEO

Stephen J. Ubl commented that the proposal "will help ensure these key stakeholders have a better understanding of the performance of these lifesaving medical technologies."

The AdvaMed proposal was developed with the help of FDA and the Heart Rhythm Society (HRS; Washington, DC). Last fall, HRS commissioned a task force to develop more-effective ways of gathering and disseminating information about CRM device performance. According to The New York Times, HRS plans to issue the report of its task force on May 2. [ More ]

In mid-March, the Senate Judiciary Committee's subcommittee on antitrust, competition policy, and consumer rights held the fourth in a series of hearings to investigate the practices of healthcare group purchasing organizations (GPOs). The proceedings represent an effort to determine if GPOs are engaging in anticompetitive practices and whether congressional action is needed to ensure a competitive climate in hospital purchasing. Within the next several months, the subcommittee is expected to decide whether GPO self-regulation is sufficient or if specific legislation is needed.

Bednar: Support for
GPO self-regulation.

Last year, the nation's leading healthcare GPOs established the Healthcare Group Purchasing Industry Initiative, a formal program designed to promote and monitor best business practices in purchasing for hospitals and other healthcare providers. "The initiative is off and running on a sure path to success," says Richard Bednar, senior counsel at Crowell & Moring LLP and coordinator of the Healthcare Group Purchasing Industry Initiative. He urged the subcommittee to support the "organizational culture of compliance" promoted by the group rather than impose external restraints.  [ More ]

According to a recently released survey from PricewaterhouseCoopers LLP (PwC; New York City), medtech firms are recognizing the need to put in place compliance systems and procedures to combat the potential for fraud and abuse in their marketing programs and sales practices. The findings revealed a nearly 100% adoption rate for the "Code of Ethics on Interactions with Healthcare Professionals" developed by industry association AdvaMed (Washington, DC).

"The industry has taken the AdvaMed code to heart," says Peter Claude, a partner in PwC's life sciences advisory practice. "It is clear that medical device firms have seized the opportunity to better integrate ethical standards into

their organizations. The key will be to do this in an efficient manner and to connect their compliance obligations with broader corporate goals to improve their performance and competitive advantage." [ More ]

Richard A. Gonzalez, president and chief operating officer for the medical products group of Abbott (Abbott Park, IL), has been promoted to the role of president and COO for all of the company's medical and pharmaceutical products. His promotion comes following the departure of Jeffrey M. Leiden, MD, PhD, president and COO of the pharmaceutical products group.

"Rick is a 29-year Abbott veteran and an exceptional leader with a proven record of achievement," said Miles D. White, chairman and chief executive officer of Abbott. "He has created a portfolio of global medical products businesses that is delivering double-digit growth, built a strong medical products pipeline, and attracted and developed an impressive leadership team. I have great confidence that Rick will lead the organization to take advantage of the many opportunities in both areas of our business." [ More ]

The federal government's push for a national health information network continues. Last month, the Senate approved a reserve fund for healthcare information technology (IT) as part of its fiscal year 2007 budget resolution. Earlier in the month, the Electronic Health Information Technology Act of 2006 was introduced in the House. In addition to other measures designed to encourage the adoption of healthcare IT, the bill would make exceptions to certain parts of the healthcare antikickback laws.

According to Dave Roberts, vice president of government relations for the Healthcare Information and Management Systems Society (HIMSS; Chicago),

Medical Alley/MNBIO, the medical sciences trade organization formed through the 2005 merger of Medical Alley and the Minnesota chapter of the Biotechnology Industry Organization, has changed its name to LifeScience Alley and expanded its focus to include the broad reach of the term life sciences.

"We are committed to acting, partnering, and strengthening the business climate for the life sciences in Minnesota and the surrounding region to compete on a global scale," said Don Gerhardt, president and CEO of LifeScience Alley. "This presents our members with a powerful opportunity to access expertise and information from diverse resources." [ More ]

Telemedicine company Visicu Inc. (Baltimore) fared well in its initial public offering (IPO) this month, with shares soaring from its offering price of $16 to more than $24 on the day of its trading debut. Headed by chairman and CEO Frank T. Sample, the company develops and markets a remote monitoring system for intensive care units designed to boost the productivity of specialists.

The company reports that widespread market acceptance of its system, the eICU, will be necessary for Visicu to achieve profitability, and the company notes in its prospectus that this milestone might never be reached. As of the end of

The board of directors of Swedish medical supply giant Gambro AB (Stockholm) on April 3 recommended that its shareholders accept a buyout offer from Nordic investor group Indap AB, a joint venture of Investor AB and EQT IV. At the time of the offer, the bid of 38.26 billion Swedish kronor (nearly $5 billion) represented a more than 30% premium over the company's average share price over the past three months, according to Indap. Since then, however, Gambro's stock price has surged to a value higher than the offered price, leaving some analysts to speculate that shareholders may see a higher bid.

"We believe that Gambro, in this stage of its life cycle, will benefit from being privately owned, and that Investor and EQT are well suited to accelerate the