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D. C. Consulting Firm Hires Embattled Former CDRH Director
Daniel Schultz, M.D., former director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA), has joined Greenleaf Health LLC as senior vice president,
medical devices and combination products, according to the firm. Schultz will provide strategic consulting services and work with clients to bring innovative devices to patients at the firm’s headquarters located in Washington, D.C.
Greenleaf Health is a consulting firm that provides strategic guidance to companies regulated by the FDA.
Schultz most recently served at the Washington, D.C.-based FDA as director of CDRH. He resigned from his post
in August after FDA scientists said the medical device approval process was flawed and Margaret Hamburg, M.D., was named commissioner.
His career at the agency started in 1994 as a medical officer in the general surgery devices branch of CDRH’s Office of Device Evaluation. In 1995, he was elevated to the position of chief medical officer in the Office of Device Evaluation in the Division of Reproductive, Abdominal, ENT and Radiological Devices.
Schultz |
He served as division director from 1998 to 2001. Schultz became deputy director for clinical and review policy in the Office of Device Evaluation in 2001 and director of the Office of Device Evaluation the following year. He began his role as director of CDRH in 2004.
Prior to joining the FDA, Schultz served as a member of the U.S. Public Health Service.“Dan Schultz’s service at FDA, the Public Health Service and as a practicing physician and teacher enables him to bring a unique blend of experience to the Greenleaf team,” said Patrick Ronan, founder and president of Greenleaf Health.
In addition to his new position at Greenleaf Health, Schultz serves as an assistant professor of surgery at the Uniformed Services University of the Health Sciences and a member of the surgical staff at the National Naval Medical Center, both in Bethesda, Md.
Medtronic Makes Two Appointments
Martin Rothman has been hired as vice president of medical affairs for Medtronic Inc.’s coronary and peripheral vascular business in Santa Rosa, Calif., according to the Minneapolis, Minn.-based firm. Additionally, Michael Coyle has been appointed as vice president and group president of its Cardiology businesses.
Rothman has 37 years of clinical practice in the United Kingdom as an interventional cardiologist, including 27 years at the London Chest Hospital (Barts and the London NHS Trust) in London, England, where he served for more than a decade as director of cardiac research and development. He has been involved with clinical research, training and education, and medical technology innovation in cardiovascular medicine, the company said.
According to the firm, Rothman is a regular presenter at medical meetings and has written peer-reviewed journal articles. He also has conducted many interventional cardiology-related trials.
In addition, Rothman has participated as an investigator in studies of Medtronic’s Endeavor drug-eluting coronary stents and has led cardiac stem cell research for heart failure treatment. He also established the largest heart attack center in Europe, Medtronic said.
During his tenure at the London Chest Hospital, Rothman developed a training program for interventional cardiology, in which patients with heart disease are treated through minimally invasive techniques such as angioplasty and transcatheter valves. He also has developed live case demonstrations, which enable clinicians to learn by observing and interacting with doctors performing the procedures.
In 1985, Rothman formed his first start-up company, which developed intravascular ultrasound technology to enable clinicians to see inside patients’ arteries. He sold the company in May 2000.
Prior to joining Medtronic, Coyle most recently provided leadership consulting services to private equity, venture capital and medical device firms.
From 2001 to 2007, he served as president of the Cardiac Rhythm Management division at St. Jude Medical in St. Paul, Minn., where he led that company’s global pacemaker, implantable cardioverter defibrillator and cardiac resynchronization therapy businesses.
And from 1997 to 2001, he served as president of St. Jude Medical’s Daig Catheter division, based in St. Paul, Minn. Before joining St. Jude, he held various leadership positions at Indianapolis, Ind.-headquartered pharmaceutical firm Eli Lilly & Company.
Elcam Medical Appoints President
Elcam Medical has appointed Lloyd Fishman as president of the Hackensack, N.J.-based firm. He will continue to serve as chairman of Injectech LLC, Elcam’s subsidiary in Loveland, Colo.
Fishman has been serving as Elcam’s vice president of business development and marketing for the past four years. He has more than 30 years of experience in the medical device and pharmaceutical industry in sales, marketing, business development and general management positions.
“Lloyd is a perfect fit for the position because his customer-centric view of doing business is consistent with Elcam’s commitment to its customers,” said Ehud Raivitz, Elcam CEO.
Elcam Medical is a supplier of fluid management, drug delivery and vital signs monitoring systems and devices.
AngioDynamics Names Stephen McGill as Senior VP
AngioDynamics has appointed Stephen McGill to the newly created position of international senior vice president and general manager.
McGill |
From 2000 to 2008, McGill worked at Minnetonka, Minn.-based American Medical Systems, most recently serving as senior vice president, global sales. American Medical Systems manufactures devices used by urologists and colon and rectal surgeons.
Since leaving American Medical Systems, McGill has served as a principal at AEM Global, a consulting firm that specializes in the development of market opportunities worldwide for medical device companies.
McGill has held leadership roles with Bolton Medical Inc. in Sunrise, Fla.; Natick, Mass.-based Boston Scientific Corp.; Stryker UK in the United Kingdom; and Wesley Jessen Visioncare Inc. in New York, N.Y.
“International markets represent key growth opportunities for our company, and Stephen has the strengths and expertise to drive this strategic effort,” said Jan Keltjens, AngioDynamics president and CEO. “He has demonstrated strong capabilities to build and develop sales and marketing organizations for high-growth companies throughout the world. He has an in-depth knowledge of the global healthcare industry, and extensive experience in the U.S. and international markets.”
Ximedica Adds Three to Quality Management Team
Ximedica has expanded its quality management team, according to the Providence, R.I.-based full-service manufacturing company.
The company has hired Stephen Perez as director of quality services and John Torrey and Rob Connor as quality engineers.
Perez’s career in quality and engineering spans more than 20 years. Most recently, he held senior leadership positions with regenerative medicine products firm Organogenesis Inc. in Canton, Mass.; Natick, Mass.-based Boston Scientific Corp.; and brain monitor device company Aspect Medical Systems, headquartered in Norwood, Mass.
Connor most recently was employed by Aspect Medical Systems where he helped design, develop and manufacture brain monitoring equipment. He also worked for defense technologies developer Raytheon, based in Waltham, Mass., and General Electric/Aerospace Electronics in Utica, N.Y.
Torrey has spent the last 20 years in research and development engineering. He spent the last 10 years with Smiths Medical in that capacity.
“We are pleased to have these professionals join Ximedica. This expansion is clear evidence of our focus on the quality of service that we provide and the products we develop,” said Dan Reifsteck, Ximedica’s chief operating officer. “Steve’s quality engineering team is imbedded in every one of our programs to insure that the ’voice of quality’ is integrated in the product development process.”
Accelent President, CEO Resigns
Robert E. Kirby, president and CEO of Accelent, has resigned from the company after accepting a position with a consumer products firm.
Kenneth W. Freeman, Accellent’s executive chairman since December 2006, will be actively involved with the management of the company until a successor is found, according to the Wilmington, Mass., firm.
Freeman is a member of global alternative asset management firm Kohlberg Kravis Roberts & Co. in New York, N.Y. He previously served as chairman and CEO of laboratory giant Quest Diagnostics Inc., based in Madison, N.J., and its predecessor company from 1995 to 2004.
“I have never been more confident in the company’s future. As I return to the industry to which I have devoted over 25 years of my career, I leave the company [Accelent] in the hands of a highly experienced management team,” said Kirby.
Freeman said of Kirby: “During Bob’s tenure, the company’s profitability and cash generation markedly improved as a result of a significant focus on driving operational improvements.