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2004 In-Awe Winners

Originally Published MX September/October 2004

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Medical Device Marketing

ADVERTISING, DISTRIBUTION, & SALES


(click to enlarge)

Copyright ©2004 MX

Roundtable ParticipantsPolicy

Originally Published MX September/October 2004

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Influencing Public Policy

GOVERNMENTAL & LEGAL AFFAIRS


Tom Connaughton, JD, is vice president of legislative affairs for the medical device and supply company Cook Group Inc. (Bloomington, IN), serving in the firm's Washington, DC, office, which he opened in 2003. He has been engaged in public policy efforts in the capital for more than 30 years, first as Senator Birch Bayh's chief of staff and then as managing partner of a law firm that represented medical device and pharmaceutical companies, including Cook, regarding legislative and regulatory matters. Between leaving his law practice in 2000 and joining Cook last year, Connaughton served as president of the American Association for Homecare. He can be reached via e-mail at [email protected].

Schultz Takes the Reins at CDRH

Originally Published MDDI September 2004

NEWSTRENDS

Daniel Schultz

Erik Swain

FDA in July named Daniel Schultz to lead CDRH on a permanent basis. Industry applauded the move and encouraged him to address problems with the user-fee system and inconsistencies in inspections. Industry leaders added, however, that Schultz's extensive experience at FDA makes him well equipped to take on those and other challenges. 

Schultz joined CDRH in 1994 as a Public Health Service medical officer. He rose to become chief medical officer and then director of the Division the Reproductive, Abdominal, and Radiological Devices. He later became deputy director, and finally director, of the Office of Device Evaluation. He was named acting CDRH director in April following David Feigal's departure. 

“Dan Schultz brings a true insider's perspective to running CDRH,” said AdvaMed President Pamela G. Bailey. “This expertise will serve the center well as it continues to implement the important provisions of the Medical Device User Fee and Modernization Act. Dan has been instrumental in preparing the center's review staff to meet the user-fee program's strict performance goals.”

“While we may disagree with him from time to time, we've always felt that the lines of communication are open with Dan,” said Mark Leahey, executive director of the Medical Device Manufacturers Association. “In all our dealings with him, he has been professional and capable. He has experience dealing with all the different players, from industry to public interest groups to Congress, and that will allow him to delve into the crucial issues right away.”

Hiring an insider was the right move because the center is more in need of someone who can implement policy and streamline operations than someone who needs to change policy, said device law expert Jonathan Kahan, a partner at Hogan & Hartson (Washington, DC). 

“The biggest challenge facing CDRH is keeping it on track,” Kahan said. “He knows where the skeletons are buried. He's very savvy.”
He said Schultz will have to focus immediately on fixing the user-fee program, which has produced double-digit increases for the second straight year. “This is something that is coming to a head right now. AdvaMed and MDMA are all over it.”

Where Schultz may need assistance in getting up to speed is on the compliance side, where there are “some issues that require his personal involvement and direction,” said Larry Pilot, a partner at McKenna, Long & Aldridge (Washington, DC) and MDMA's general counsel. “He needs to evaluate whether FDA is uniformly implementing and applying the laws and regulations, particularly GMPs. There is inconsistency. One way to address it is to examine the types of warning letters issued by the center and the districts.”

Schultz also needs to understand how to put into proper perspective the views of industry, which he may hear infrequently, and the views of CDRH staff, which he may hear continuously, Pilot said. “I believe he exercises good judgment, which is an essential characteristic of any responsible administrator in government.”

Copyright ©2004 Medical Device & Diagnostic Industry

Business Drivers

Originally Published MX September/October 2004

BUSINESS DRIVERS

St. Jude Medical (St. Paul, MN) has announced that its Daig division will be separated into two new divisions: cardiology and atrial fibrillation. Paul R. Buckman has been appointed president of the new cardiology division. Most recently, Buckman was chairman and CEO of ev3 LLC (Plymouth, MN), a medical device company focused on endovascular therapies. Jane J. Song has been appointed president of the new atrial fibrillation division. She has served as president of the company's cardiac surgery division since 2002, and was previously senior vice president of operations for St. Jude's cardiac rhythm management division. George J. Fazio, president of St. Jude Europe since 2001, will replace Song as president of the cardiac surgery division. Replacing Fazio will be Denis M. Gestin, who is currently vice president for northern Europe and Africa and previously managed the company's subsidiary in France. St. Jude also announced that David Adinolfi, who has served as president of the Daig division since 2001, has decided to retire.

Hall

A Product with a Vision

Originally Published MX September/October 2004

COVER STORY

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Achieving the vision of an IT-based healthcare system will require a lot more than just run-of-the-mill software. But some manufacturers are making great strides toward the goal.

A new entry in the field is Soarian, a new-generation, enterprisewide healthcare information solution from Siemens Medical Solutions (Erlangen, Germany). The system powers the integrated digital healthcare enterprise by managing workflow from all points throughout the organization. The company designed Soarian to deliver on an ambitious set of goals:

  • Seamless automation of manual processes across the enterprise.
  • Continuous reengineering of processes to enable best practices and eliminate redundancies.
  • Development, analysis, and instant electronic sharing of best practices to create knowledge that will advance standards of care industrywide.
Soarian integrates clinical, financial, diagnostic, and administrative processes to support patient-centered care.

Communicating Core Strengths

Originally Published MX September/October 2004

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Medical Device Marketing

ADVERTISING, DISTRIBUTION, & SALES


Hill, Holliday assisted a rebranding effort by Syneture by creating a patient-focused print campaign featuring the tag line "The Thread Between Science and Healing."
(click to enlarge)

Last fall, medical device manufacturer Syneture (Norwalk, CT) introduced a rebranding campaign that covered a lot of ground. The campaign was designed not only to launch a new company brand with new positioning, but also to regain the company's strength as an innovator and trusted partner and establish an emotional connection with target audiences.

Formerly USS/DG, Syneture is a leading manufacturer of innovative wound-closure products and is part of the U.S. Surgical family of companies. The company's award-winning rebranding effort was created by Hill, Holliday (Boston and New York City).

Roundtable Participants Policy

Originally Published MX September/October 2004

Return to Article:
Influencing Public Policy

GOVERNMENTAL & LEGAL AFFAIRS


Tom Connaughton, JD, is vice president of legislative affairs for the medical device and supply company Cook Group Inc. (Bloomington, IN), serving in the firm's Washington, DC, office, which he opened in 2003. He has been engaged in public policy efforts in the capital for more than 30 years, first as Senator Birch Bayh's chief of staff and then as managing partner of a law firm that represented medical device and pharmaceutical companies, including Cook, regarding legislative and regulatory matters. Between leaving his law practice in 2000 and joining Cook last year, Connaughton served as president of the American Association for Homecare. He can be reached via e-mail at [email protected].

Chinese Market: Lucrative but Challenging

Originally Published MDDI September 2004

NEWSTRENDS



The potential for U.S. companies to sell medical devices in China is great, but it may take some time to understand the people and processes involved.

China's device market is $3.9 billion, and spending for devices has been increasing at greater than 20% per year. “As the republic matures economically, there will continue to be phenomenal growth rates and demand,” said consultant Edward Rozynski, president of Rozynski Associates.

How the system will evolve is not yet clear, Rozynski said. On the positive side, however, he said that in China getting access to the market is not the troublesome process that it is in Japan.

Copyright ©2004 Medical Device & Diagnostic Industry

Visions of the Future

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

To stay in step, medtech manufacturers will have to begin developing their products to meet increasing demand for integration and interoperability.

Brad Burg

There's no way to sugarcoat this news: when it comes to making use of the tools developed by the information technology (IT) revolution, the world's healthcare systems are lagging behind nearly every other industry.

There's no dearth of arguments in favor of the adoption of such systems. Among the most frequently adduced grounds for implementing IT systems are the potential for improving patient safety, gaining greater efficiency, and reducing overall healthcare costs. But these terms themselves incorporate a wide variety of potential benefits—and they're just a part of the picture.

A Product with a Vision

Originally Published MX September/October 2004

COVER STORY

Return to Article:

Achieving the vision of an IT-based healthcare system will require a lot more than just run-of-the-mill software. But some manufacturers are making great strides toward the goal.

A new entry in the field is Soarian, a new-generation, enterprisewide healthcare information solution from Siemens Medical Solutions (Erlangen, Germany). The system powers the integrated digital healthcare enterprise by managing workflow from all points throughout the organization. The company designed Soarian to deliver on an ambitious set of goals:

  • Seamless automation of manual processes across the enterprise.
  • Continuous reengineering of processes to enable best practices and eliminate redundancies.
  • Development, analysis, and instant electronic sharing of best practices to create knowledge that will advance standards of care industrywide.
Soarian integrates clinical, financial, diagnostic, and administrative processes to support patient-centered care.