Medical Device Link.

Originally Published MX July/August 2005

EXECUTIVE PROFILES

Today's medtech leaders provide worthy examples of corporate and industry leadership.

Steve Halasey and Ron Shinkman

In a time when company leaders in every sector of the economy are being challenged to meet higher standards of corporate governance, executives in medical technology companies offer some great examples of what company leadership should look like.

Whether they are developing a corporate vision, shaping an early-stage technology, conducting investor relations activities, or negotiating the acquisition of an emerging company, medtech company leaders often have a lot on their plates. Such wide-ranging involvement frequently provides medtech executives with just the sort of experience necessary to exercise leadership in an industry that is known for innovation. Whatever their company's size, many medtech executives also make significant contributions to advancing industry goals and improving the delivery of healthcare to patients.

In this issue, MX profiles a dozen company executives who are involved in notable activities on behalf of their own companies and the medical device industry as a whole. Their efforts to keep their own companies on the right track while also contributing to industry leadership provide strong examples of the level of executive ability now available to medical device companies.

Women in Charge

Not too many years ago, it would have been difficult—if not impossible—to find a woman at the head of a medical technology company. But that's all changed. Today, women executives are leading the charge at a number of medical device firms, from start-ups to major corporations. Having moved up the corporate ladder as the device industry has matured, more and more women are showing that they have the right stuff to take on the challenges of corporate leadership. Following are the profiles of three such women who are making their presence felt in their own companies—and beyond.

Tiffany P. Olson
President and CEO
Roche Diagnostics Corp.

When Tiffany P. Olson got her first job after graduating from the University of Minnesota in the early 1980s, her dream was to make a difference in the lives of people through healthcare. It appears her wish has come true.

In May of this year, Olson was named the North American head of Swiss biotech giant Roche Diagnostics and president and chief executive officer of Roche Diagnostics Corp. (Indianapolis). The promotion comes after serving in several high-profile positions for Roche, including vice president of molecular diagnostics, vice president of corporate accounts, and business development manager for Roche Diagnostics.

Nancy M. Briefs
President and CEO
Percardia Inc.

Percardia Inc. (Merrimack, NH) has received about $55 million in funding since its cofounding by president and chief executive officer Nancy M. Briefs in 1998. Its principal product, the VStent coated implant, is designed to treat coronary artery disease by increasing blood flow to arteries narrowed by plaque. First-in-human trials for the VStent are just getting under way in Italy and Argentina. A U.S. trial is expected in 2006. Although Percardia has operated lean, with just 19 employees and a handful of consultants, Briefs is confident the VStent will receive speedy FDA approval.

Kathy Ordonez
President
Celera Diagnostics and
Celera Genomics Group

The appointment of Kathy Ordonez as president of Celera Diagnostics (Alameda, CA) in 2000 and to the same position with Celera Genomics Group (Rockville, MD) three years ago represented well-deserved achievements of a nearly 30-year career. She was charged with using the treasure trove of genetic data that Celera had compiled and converting it into marketable medical products. In December 2002, FDA cleared the first Celera Diagnostics product, Viroseq, which spots gene mutations in the HIV virus.

In fiscal 2004, Celera Genomics lost $57.5 million on revenue of $60.1 million; but that's a significant improvement over the company's 2003 loss of $81.9 million. Celera Genomics continues to project improved margins as its other projects receive approval. Celera Diagnostics posted a pretax loss of $42 million in fiscal 2004 on revenue of $36.7 million, also an improvement on its $51 million loss on revenue of $20.8 million in fiscal 2003.

Successors

In a recent issue, MX profiled three corporate leaders who have announced their retirement: John W. Brown of Stryker Corp. (Kalamazoo, MI), who retired as CEO in January, remaining as chairman of the company's board of directors; Ronald W. Dollens, president and CEO of Guidant Corp. (Indianapolis), who announced his intent to retire last year; and John P. Wareham of Beckman Coulter Inc. (Fullerton, CA), who completed his retirement transition in April of this year.

Anyone who follows the medical device industry is aware of the impending sale of Guidant to Johnson & Johnson (New Brunswick, NJ), which is expected to close in the third quarter of this year. Dollens has agreed to remain with the company until the completion of its acquisition.

But what about those who will take over the helms of Stryker and Beckman Coulter? Following are profiles of these successors, whose challenges will certainly include filling the shoes of those they have replaced.

Stephen P. MacMillan
Chief Executive Officer
Stryker Corp.

At just 41, Stryker Corp. (Kalamazoo, MI) chief executive officer Stephen P. MacMillan seems on the young side to helm a $4 billion medical products company, but his résumé suggests otherwise.

Before he was 30, MacMillan was responsible for marketing for Johnson & Johnson (New Brunswick, NJ) throughout Europe. By the time he was 35, he was president of Johnson & Johnson-Merck Consumer Pharmaceuticals. He joined Stryker in 2003 as president and chief operating officer, and was named CEO in December 2004.

MacMillan believes that the aging baby boomer generation will prove a source of future revenue growth for Stryker.

Scott Garrett
Chief Executive Officer
Beckman Coulter Inc.

Like all successful life sciences companies, test/diagnostic giant Beckman Coulter (Fullerton, CA) is a mixture of entrepreneurial spirit and technical expertise. Chief executive officer Scott Garrett thus seems a perfect fit.

The 55-year-old Garrett was named Beckman's CEO in February, three years after joining the company as president of its clinical diagnostics division.

Prior to joining Beckman, Garrett had spent the past several years working for himself. He founded Garrett Capital Advisors in 1998, forming an alliance with Chicago Equity Capital. The two ventures acquired several medical device and life science companies.

Healthcare IT

For many medical technology executives, the growing emphasis on information technologies in healthcare conjures a universe that is largely unknown territory. The landscape of healthcare IT is populated by companies and associations that are outside the experience of most medtech leaders, making it difficult to find a common language for discussion.

Fortunately, not everyone considers healthcare IT to be such a foreign land. Following is the profile of one executive who is well positioned to lead medical device companies into the brave new world of healthcare IT, and who has begun to make his influence felt during the past year.

Thomas N. McCausland
Chief Executive Officer
Siemens Medical Solutions USA

Since he took over as chief executive officer of Siemens Medical Solutions USA (Malvern, PA) six years ago, Thomas N. McCausland has increased sales by more than 40%.

At the same time, McCausland has also made over much of the Siemens Medical product line from mechanized to digital products.

In addition to his work at Siemens, McCausland is chair of the health information technology sector for industry association AdvaMed (Washington, DC). His goals for 2005 include the advancement of finance policies and demonstration projects that will encourage innovation in "smart" medical technologies.

Diagnostics

The in vitro diagnostics industry encompasses a wide variety of technologies and approaches to the healthcare marketplace—but also operates in a payer environment that is causing elevated concern among many of its companies. Bringing together industry representatives to address these challenges is a role that has recently been seized by the diagnostics sector of industry association AdvaMed (Washington, DC). And heading up that group is the well-known industry executive profiled below.

Henry Nordhoff
Chief Executive Officer
Gen-Probe Inc.

In addition to entering his 12th year as chief executive officer of diagnostic test manufacturer Gen-Probe (San Diego), Henry “Hank” Nordhoff also chairs the diagnostics sector of AdvaMed. For 2005, his goals include reforming reimbursement policies to receive payments for advanced molecular diagnostic lab tests; speeding up reimbursements in general; and promoting a regulatory environment that prevents "impeding continued technological advancements in the development and commercialization of diagnostic products."

Reimbursement Gurus

Of all the challenges faced by medical device companies, arranging for reimbursement from government and private third-party payers has to be considered among the most complex—and perhaps also among the most intractable. Perhaps that's why so many medtech companies today have begun to staff new offices of reimbursement specialists with high-level executive talent. The four reimbursement experts profiled below have gone beyond the realm of their own companies to help forward industry positions with regard to reimbursement policy, especially as it involves the Centers for Medicare and Medicaid Services.

Robin R. Bostic
Vice President of Reimbursement
Thoratec Corp.

Robin R. Bostic began her career in the insurance industry. Then a friend at a start-up firm sought her advice about how physicians could get paid for using its product. Something clicked. Bostic later had stints at Smith & Nephew (Memphis), Exogen (Piscataway, NJ) and Orthofix (Dallas) before arriving at Thoratec Corp. (Windham, NH), where she is vice president of reimbursement.

Bostic says her best life experience for her career was being in a country and western band while she attended Baylor University. "In both arenas, you have to be able to align agendas and have someone understand objectives," she says.

Jo Ellen Slurzberg
Vice President of Reimbursement and Health Policy
Almyra Inc.

Jo Ellen Slurzberg, vice president of reimbursement and health policy at Almyra Inc. (Boxborough, MA), believes reimbursement goes to the very value proposition of the developed product. "The hurdles are very high to achieve coverage. That's not a bad thing in its own right, but the market should have guidelines for the necessary evidence to convince certain populations," she says. As a result, Slurzberg stresses teamwork between the business development and regulatory groups to ensure success.

In addition to her regulatory and reimbursement work, Slurzberg cochairs the Medical Device Manufacturers Association reimbursement committee and is the CPT coding subcommittee chair.

Daniel Waldmann
Vice President of Government Relations
Tenet Healthcare Corp.

After more than a decade working in reimbursement for the medical device industry, Daniel Waldmann is leaving to enter the hospital field.

Previously the director of federal affairs and reimbursement for Johnson & Johnson (New Brunswick, NJ), Waldmann has recently accepted a new position as vice president of government relations for Tenet Healthcare Corp. (Dallas).

Waldmann will be setting up a Washington office for Tenet, a first for the company. He is also expected to be active in the Federation of American Hospitals and Health Systems (Washington, DC), the major lobbying group working on behalf of for-profit hospitals; the American Hospital Association (Chicago); and the Healthcare Leadership Council (Washington, DC).

Sarah Wells
Director of Health Policy
and Payment
Boston Scientific Corp.

In her nearly seven years with Boston Scientific (Natick, MA), Sarah Wells, director of health policy and reimbursement, has played a significant role in securing reimbursement codes for many of its most important products, including key vascular and interventional radiology products for its Medi-Tech division. She also helped the company get adequate reimbursement for its drug-eluting stent when it was approved by FDA last year.

In 2001, Wells relocated from corporate headquarters to Washington, DC. "I can go to all the major CMS town hall and open-door meetings, and we're very involved in meeting CMS one-on-one," she says.

Clinical Affairs

With regulatory and competitive pressures always on the minds of company leaders, it's sometimes easy to forget that everything medical technology companies do is ultimately intended to benefit patients. But for those who specialize in clinical affairs, that isn't a lapse that occurs often. And with ever-greater importance being placed on the results of clinical studies—whether they are conducted to determine safety and efficacy or economic outcomes—companies are also unlikely to forget the importance of this area. Following is the profile of one such expert whose work has had a significant impact on patient care over the past year.

Joerg Koglin, MD
Senior Medical Director and Vice President
Cardiovascular Medical Sciences
Boston Scientific Corp.

Joerg Koglin, a German-born cardiologist, is vice president and senior medical director for cardiovascular clinical services for Boston Scientific (Natick, MA). Among his roles are helping to identify ways of applying new technologies to vascular and cardiovascular care, and eventually developing new vascular technologies beyond stents.

Koglin manages a group of about 23 high-level researchers, mostly physicians and PhDs. "It's a team that can take data and dig deep to come up with relevant results," Koglin says, adding that their work drives many of Boston Scientific's decisions regarding product development and technology acquisition.

Copyright ©2005 MX