Beckman Coulter CEO Resigns
It’s been a problematic year for Beckman Coulter Inc. In the first eight months of 2010, the Brea, Calif.-based company incurred the wrath of the U.S. Food and Drug Administration, lowered its full-year guidance twice, recalled a biomedical test due to faulty results, and watched its stock price fall 31 percent.
Then in the ninth month—almost as if on cue—Chairman, President and CEO Scott Garrett abruptly resigned, continuing the succession of dispiriting setbacks. Beckman Coulter bigwigs had little to say about Garrett’s resignation other than that management changes are in the company’s best interest at this time.
“The leadership changes are not related to any one event or issue,” Cynthia Skoglund, investor relations officer at Beckman Coulter, said in an interview.
Maybe not, but there is no denying the financial impact those “issues” have had on the biomedical testing product manufacturer this year. When they cut the firm’s full-year guidance for the second time in July, executives acknowledged that the recall and corrective actions had negatively impacted earnings. Product delays added to the misery, as did a weak performance by the division that makes research equipment for drug companies and academic centers.
Garrett’s sudden exit led some investors to question the future direction of Beckman Coulter. “While BEC’s performance has clearly been disappointing of late, the abruptness of this resignation surprises us, and suggests that the issues facing BEC are not improving, forcing the board to consider alternative approaches,” Manhattan-based Jefferies & Co. Inc. analyst Bruce Cranna wrote in a research note.
Garrett’s resignation took effect Sept. 6, but the 60-year-old will remain a full-time employee through Jan. 15 to help the company’s board of directors. He has been with Beckman Coulter for eight years and spent the last five as CEO.
“Over the past eight years, I’ve had the pleasure and privilege to lead the company through many significant improvements,” Garrett said in a prepared statement. “Today, the company continues making good progress, even in a very challenging environment. I ... believe the company is positioned to achieve its long-term potential.”
Beckman Coulter’s board replaced Garrett on an interim basis with J. Robert Hurley, a senior vice president of human resources and chairman of the firm’s Japan operations. Hurley joined the company in 2005 and most recently led the integration of Tokyo, Japan-based Olympus Corp.’s diagnostic systems business after Beckman Coulter purchased it last year for $800 million.
The board also named Glenn S. Schafer, a lead independent director, as non-executive chairman. In a brief news release, Schafer commended Garrett for his contributions to the company’s success, and reinforced his support of Beckman Coulter’s current management team.
“We remain confident in and supportive of the company’s management team and are committed to our strategy of leadership in biomedical testing and superior customer service,” he said. “Our initiatives to address previously disclosed quality issues are proceeding and we are continuing to invest in opportunities to build shareholder value and further strengthen our ability to meet the needs of our customers.”
Pacific Plastics Appoints Program Manager
Dorothy “Dot” Cordova’s new job description is longer than her title.
As program manager at Pacific Plastics & Engineering, Cordova will develop, implement and monitor production programs. Her duties include outlining a project’s scope, timeline and budget parameters; ordering tooling; managing prototype production and first article testing; developing manufacturing and assembly process instructions; and implementing design controls, according to the Soquel, Calif.-based company.
Pacific Plastics executives believe Cordova’s past experience (10 years) in project management for biomedical and biopharmaceutical firms will help her succeed in her new position. “I want to make a positive difference here at Pacific Plastics & Engineering,” she said in a three-paragraph news release announcing her appointment.
Before joining Pacific Plastics, Cordova worked for AcelRx Pharmaceuticals Inc. of Redwood City, Calif., Alza Corp. (now part of Johnson & Johnson), and PDL BioPharma Inc. of Incline Village, Nev.
Pacific Plastics & Engineering provides manufacturing and custom injection molding services to medical device and biotechnology firms.
MRI Medical Names New RA/QA Director
MRI Medical has added a Regulatory Affairs and Quality Assurance director to its management team.
Ira Duesler, a medical device industry veteran with more than 18 years of experience in quality engineering and regulatory affairs, has joined the Tucson, Ariz.-based medical manufacturing firm as its director of Regulatory Affairs and Quality Assurance (RA/QA).
Duesler will oversee efforts to streamline, expand and strengthen MRI Medical’s regulatory affairs and quality systems to support rapid growth, company executives said in a news release announcing the appointment.
“Ira’s appointment is a significant step in expanding our commitment to surpassing the highest quality standards like the ISO, CE and FDA requirements,” said Robert Kelliher, MRI Medical’s CEO. “His guidance will accelerate our ongoing device developments in gastroenterology, minimally invasive surgery, cardiology and urology. Ira understands the challenges of getting a device to market and creating a quality system that supports customers’ goals and does not overburden manufacturing operations.”
Duesler has held a variety of quality and regulatory jobs during his tenure in the medical device industry, including quality engineer, quality manager, RA/QA director and corporate regulatory affairs director. His experience ranges from quality assurance and engineering to domestic and international regulatory affairs and quality management system design and oversight, according to MRI Medical executives.
He has managed the compliance of many devices and technologies, including ECG monitoring, pulse oximetry, electrosurgery, endoscopic/laparoscopic surgical instruments, TENS/NMES, defibrillation and IV administration.
Duesler is a member of the Regulatory Affairs Professional Society, Association for the Advancement of Medical Instrumentation (AAMI), American Society for Quality, and a former member of the AAMI Technical Committee.
‘Bold Leadership’ Team Formed at RS Medical
Call them the leaders of tomorrow.
An eight-member executive team has been hatched at International Rehabilitative Services Inc. (RS Medical) and charged with charting future growth for the company in new markets with new partners.
RS Medical President and CEO John Konsin called the new team “bold leadership for a growth era.” He expects the team to help the Vancouver, Wash.-based company take advantage of future market growth in electrotherapy applications and pain management technologies. The firm develops physician-prescribed pain management and rehabilitation products and services for patient home use.
“RS Medical is prepared for the predicted, continuing market growth in the applications of electrotherapy and non-invasive technologies that address pain and function needs,” Konsin said.“We are positioning RS Medical for new markets and new partners.” Locating those new markets and new partners are a new chief financial officer, four new executives and three members of RS Medical’s senior leaders in “refocused roles.” The members of this new executive team report directly to Konsin and are effective immediately. The new appointments include:
• Doug Brunner, vice president of operations. He plans, organizes, directs and controls the company’s IT operations and its supply chain. Brunner previously worked for Medtronic Inc. in Minneapolis, Minn., where he was general manager and vice president of operations for the company’s energy component center. Brunner has a master’s degree in business administration, a master’s of science degree in electrical engineering and a mechanical engineering degree.
• Patrick Cougill, promoted to vice president of legal, quality and regulatory affairs. He is responsible for all legal functions and services at the company, and serves as the company’s compliance officer. Cougill also manages the quality and regulatory departments. Before he was named to the team, Cougill worked as a house counsel at RS Medical. He graduated from the University of Oregon and received a law degree from the University of Denver.
• Bob Harmon, promoted to director and general manager of RS Medical Direct. He will supervise the strategic direction and daily operations of the company’s new direct physician supply program. Prior to his promotion, Harmon was a sales director. A U.S. Air Force veteran, he graduated from Concordia University in Austin, Texas.
• Rick Harper, vice president of sales. He will manage the overall direction of company sales and build relationships with doctors, surgeons and medical centers. Harper previously served in the same capacity at Covidien plc in Colorado. He has a bachelor’s degree in university studies with a focus on marketing from the University of New Mexico.
• Tom Pierce, vice president of human resources. He will oversee compensation and benefits, employee relations, performance management and company training. Previously, Pierce was vice president of finance and human resources at RS Medical. He has a degree in business administration and a master’s of science degree from the University of North Dakota.
• Sam Reinkensmeyer, chief financial officer. He is responsible for finance, accounting and treasury operations. Formerly the CFO of Portland, Ore.-based Down To Earth Designs Inc., as well as a certified public and managerial accountant, Reinkensmeyer earned a master’s of business administration degree in finance and international business from the University of Chicago Graduate School of Business, and a bachelor's degree in accounting from the University of Illinois.
• Dominic Tong, M.D., vice president of medical and clinical affairs. He will help develop and support RS Medical’s product portfolio and pipeline. Tong previously served as chief medical officer at VPDiagnostics in Seattle, Wash. He received his doctorate in medicine from the College of Physicians & Surgeons at Columbia University. He completed his diagnostic radiology residency at Columbia and his fellowship at UCLA Medical Center.
• Patricia White, vice president of marketing and business development. She will develop and execute marketing strategies as well as direct business development to expand the company’s product depth and market reach. Prior to her recent consultancy work in the medical device and healthcare IT markets, White was founder and CEO of Portland, Ore.-based Inovise Medical Inc. She has a master’s degree in business administration from the Wharton School at the University of Pennsylvania.
It’s been a problematic year for Beckman Coulter Inc. In the first eight months of 2010, the Brea, Calif.-based company incurred the wrath of the U.S. Food and Drug Administration, lowered its full-year guidance twice, recalled a biomedical test due to faulty results, and watched its stock price fall 31 percent.
Then in the ninth month—almost as if on cue—Chairman, President and CEO Scott Garrett abruptly resigned, continuing the succession of dispiriting setbacks. Beckman Coulter bigwigs had little to say about Garrett’s resignation other than that management changes are in the company’s best interest at this time.
“The leadership changes are not related to any one event or issue,” Cynthia Skoglund, investor relations officer at Beckman Coulter, said in an interview.
Maybe not, but there is no denying the financial impact those “issues” have had on the biomedical testing product manufacturer this year. When they cut the firm’s full-year guidance for the second time in July, executives acknowledged that the recall and corrective actions had negatively impacted earnings. Product delays added to the misery, as did a weak performance by the division that makes research equipment for drug companies and academic centers.
Garrett’s sudden exit led some investors to question the future direction of Beckman Coulter. “While BEC’s performance has clearly been disappointing of late, the abruptness of this resignation surprises us, and suggests that the issues facing BEC are not improving, forcing the board to consider alternative approaches,” Manhattan-based Jefferies & Co. Inc. analyst Bruce Cranna wrote in a research note.
Garrett’s resignation took effect Sept. 6, but the 60-year-old will remain a full-time employee through Jan. 15 to help the company’s board of directors. He has been with Beckman Coulter for eight years and spent the last five as CEO.
“Over the past eight years, I’ve had the pleasure and privilege to lead the company through many significant improvements,” Garrett said in a prepared statement. “Today, the company continues making good progress, even in a very challenging environment. I ... believe the company is positioned to achieve its long-term potential.”
Beckman Coulter’s board replaced Garrett on an interim basis with J. Robert Hurley, a senior vice president of human resources and chairman of the firm’s Japan operations. Hurley joined the company in 2005 and most recently led the integration of Tokyo, Japan-based Olympus Corp.’s diagnostic systems business after Beckman Coulter purchased it last year for $800 million.
The board also named Glenn S. Schafer, a lead independent director, as non-executive chairman. In a brief news release, Schafer commended Garrett for his contributions to the company’s success, and reinforced his support of Beckman Coulter’s current management team.
“We remain confident in and supportive of the company’s management team and are committed to our strategy of leadership in biomedical testing and superior customer service,” he said. “Our initiatives to address previously disclosed quality issues are proceeding and we are continuing to invest in opportunities to build shareholder value and further strengthen our ability to meet the needs of our customers.”
Pacific Plastics Appoints Program Manager
Dorothy “Dot” Cordova’s new job description is longer than her title.
As program manager at Pacific Plastics & Engineering, Cordova will develop, implement and monitor production programs. Her duties include outlining a project’s scope, timeline and budget parameters; ordering tooling; managing prototype production and first article testing; developing manufacturing and assembly process instructions; and implementing design controls, according to the Soquel, Calif.-based company.
Pacific Plastics executives believe Cordova’s past experience (10 years) in project management for biomedical and biopharmaceutical firms will help her succeed in her new position. “I want to make a positive difference here at Pacific Plastics & Engineering,” she said in a three-paragraph news release announcing her appointment.
Before joining Pacific Plastics, Cordova worked for AcelRx Pharmaceuticals Inc. of Redwood City, Calif., Alza Corp. (now part of Johnson & Johnson), and PDL BioPharma Inc. of Incline Village, Nev.
Pacific Plastics & Engineering provides manufacturing and custom injection molding services to medical device and biotechnology firms.
MRI Medical Names New RA/QA Director
MRI Medical has added a Regulatory Affairs and Quality Assurance director to its management team.
Ira Duesler, a medical device industry veteran with more than 18 years of experience in quality engineering and regulatory affairs, has joined the Tucson, Ariz.-based medical manufacturing firm as its director of Regulatory Affairs and Quality Assurance (RA/QA).
Duesler will oversee efforts to streamline, expand and strengthen MRI Medical’s regulatory affairs and quality systems to support rapid growth, company executives said in a news release announcing the appointment.
“Ira’s appointment is a significant step in expanding our commitment to surpassing the highest quality standards like the ISO, CE and FDA requirements,” said Robert Kelliher, MRI Medical’s CEO. “His guidance will accelerate our ongoing device developments in gastroenterology, minimally invasive surgery, cardiology and urology. Ira understands the challenges of getting a device to market and creating a quality system that supports customers’ goals and does not overburden manufacturing operations.”
Duesler has held a variety of quality and regulatory jobs during his tenure in the medical device industry, including quality engineer, quality manager, RA/QA director and corporate regulatory affairs director. His experience ranges from quality assurance and engineering to domestic and international regulatory affairs and quality management system design and oversight, according to MRI Medical executives.
He has managed the compliance of many devices and technologies, including ECG monitoring, pulse oximetry, electrosurgery, endoscopic/laparoscopic surgical instruments, TENS/NMES, defibrillation and IV administration.
Duesler is a member of the Regulatory Affairs Professional Society, Association for the Advancement of Medical Instrumentation (AAMI), American Society for Quality, and a former member of the AAMI Technical Committee.
‘Bold Leadership’ Team Formed at RS Medical
Call them the leaders of tomorrow.
An eight-member executive team has been hatched at International Rehabilitative Services Inc. (RS Medical) and charged with charting future growth for the company in new markets with new partners.
RS Medical President and CEO John Konsin called the new team “bold leadership for a growth era.” He expects the team to help the Vancouver, Wash.-based company take advantage of future market growth in electrotherapy applications and pain management technologies. The firm develops physician-prescribed pain management and rehabilitation products and services for patient home use.
“RS Medical is prepared for the predicted, continuing market growth in the applications of electrotherapy and non-invasive technologies that address pain and function needs,” Konsin said.“We are positioning RS Medical for new markets and new partners.” Locating those new markets and new partners are a new chief financial officer, four new executives and three members of RS Medical’s senior leaders in “refocused roles.” The members of this new executive team report directly to Konsin and are effective immediately. The new appointments include:
• Doug Brunner, vice president of operations. He plans, organizes, directs and controls the company’s IT operations and its supply chain. Brunner previously worked for Medtronic Inc. in Minneapolis, Minn., where he was general manager and vice president of operations for the company’s energy component center. Brunner has a master’s degree in business administration, a master’s of science degree in electrical engineering and a mechanical engineering degree.
• Patrick Cougill, promoted to vice president of legal, quality and regulatory affairs. He is responsible for all legal functions and services at the company, and serves as the company’s compliance officer. Cougill also manages the quality and regulatory departments. Before he was named to the team, Cougill worked as a house counsel at RS Medical. He graduated from the University of Oregon and received a law degree from the University of Denver.
• Bob Harmon, promoted to director and general manager of RS Medical Direct. He will supervise the strategic direction and daily operations of the company’s new direct physician supply program. Prior to his promotion, Harmon was a sales director. A U.S. Air Force veteran, he graduated from Concordia University in Austin, Texas.
• Rick Harper, vice president of sales. He will manage the overall direction of company sales and build relationships with doctors, surgeons and medical centers. Harper previously served in the same capacity at Covidien plc in Colorado. He has a bachelor’s degree in university studies with a focus on marketing from the University of New Mexico.
• Tom Pierce, vice president of human resources. He will oversee compensation and benefits, employee relations, performance management and company training. Previously, Pierce was vice president of finance and human resources at RS Medical. He has a degree in business administration and a master’s of science degree from the University of North Dakota.
• Sam Reinkensmeyer, chief financial officer. He is responsible for finance, accounting and treasury operations. Formerly the CFO of Portland, Ore.-based Down To Earth Designs Inc., as well as a certified public and managerial accountant, Reinkensmeyer earned a master’s of business administration degree in finance and international business from the University of Chicago Graduate School of Business, and a bachelor's degree in accounting from the University of Illinois.
• Dominic Tong, M.D., vice president of medical and clinical affairs. He will help develop and support RS Medical’s product portfolio and pipeline. Tong previously served as chief medical officer at VPDiagnostics in Seattle, Wash. He received his doctorate in medicine from the College of Physicians & Surgeons at Columbia University. He completed his diagnostic radiology residency at Columbia and his fellowship at UCLA Medical Center.
• Patricia White, vice president of marketing and business development. She will develop and execute marketing strategies as well as direct business development to expand the company’s product depth and market reach. Prior to her recent consultancy work in the medical device and healthcare IT markets, White was founder and CEO of Portland, Ore.-based Inovise Medical Inc. She has a master’s degree in business administration from the Wharton School at the University of Pennsylvania.
