RESTON, Va.--(BUSINESS WIRE)-- Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces a significant expansion of its medical device research capabilities in Europe. Most notably, the company announces the appointments of Mr. Bernard Sweeney as Senior Vice President, Medical Devices and Mr. Erdmann Zippel as Senior Director, Clinical Operations. Mr. Sweeney and Mr. Zippel will be based in Allschwil, Switzerland and Cologne, Germany, respectively. They will lead a rapidly growing team that specializes in providing regulatory and clinical research solutions to the medical device and diagnostics industry in Europe and includes more than a dozen new European specialists who joined since the start of 2013.
Mr. Sweeney brings more than 20 years of experience that includes operational, strategic, regulatory and clinical trial expertise. He provides a strong skill set to assist medical device clients with product development, global regulatory requirements, and clinical trial management.
Most recently he served as Vice President at D-TARGET, the medical device division of Premier Research, where he supported corporate development activities. Before that, he was Director of Healthcare at the British Standards Institute (BSI), a full-service Notified Body, where he led healthcare certification operations and oversaw a team of 80 technical specialists providing assessments, certifications and standards services to medical device and IVD companies.
In industry, Mr. Sweeney worked as Managing Director for Femcare-Nikomed Ltd, a global organization of medical device companies with a portfolio of products in gynecology, general surgery and urology. He also held Director and senior management positions at Huntleigh Healthcare and Beiersdorf.
Mr. Sweeney holds a Bachelors of Pharmacy degree from the University of Manchester, Manchester Business School, and a Master of Business Administration degree from the Open University in the United Kingdom. He is a member of the Regulatory Affairs Professionals Society (RAPS) and previously served on the society’s European Advisory Committee.
Mr. Zippel brings more than 13 years of experience within the medical device, CRO, and biotech industries, and has specific expertise managing medical device clinical studies throughout Europe in the fields of cardiology, angiology, anesthesia/intensive care, orthopedics and neurology. He most recently served as Executive Director, Europe at D-TARGET, responsible for project management and resourcing of all EU projects, and overseeing a team of project directors, clinical research managers, clinical research associates, regulatory affairs managers, and quality assurance managers.
His industry experience includes senior clinical research positions at Laryngeal Mask Company Ltd., now a Teleflex company, where he supported the development of anesthesia, urology and orthopedic devices. At Biotronik, a market leader in the CRM business, he was involved in clinical research, training, regulatory and technical support activities for pacemaker, ICD, heart failure and telemedicine devices. Prior to joining industry in 2001, he spent 12 years as a registered nurse focused on hospital intensive care and anesthesia.
In addition to these positions, Aptiv Solutions has further added to its operational expertise in medical devices by hiring more than a dozen project managers, clinical research associates, and business development professionals with specific experience in supporting medical device clients in Europe. These hires complement the medical device team Aptiv Solutions has based in North America.
“I am pleased to welcome Bernard, Erdmann, and the rest of our new hires to our growing medical device team in Europe,” says Pat Donnelly, Chairman and CEO of Aptiv Solutions. “Their experiences and expertise in the medical device market, gained from roles in industry and as service providers, bring a unique perspective and will benefit our European clients who are seeking to develop and commercialize innovative medical devices and diagnostics.”
“In the complex and evolving medical technology landscape, Bernard’s and Erdmann’s experience in the international market and combined depth of knowledge of global device regulations and clinical research will be of significant benefit to our clients,” adds Luis Gutierrez, Executive Vice President and Chief Commercial Officer at Aptiv Solutions.
About Aptiv Solutions
Aptiv Solutions is a global development services company that is focused on enhancing clinical trial decision-making, efficiency and productivity in the pharmaceutical, biotech and medical device markets. The company offers clients an extensive portfolio of innovative services including adaptive clinical trials, translational research services, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has more than 850 professionals in North America, Eastern & Western Europe, Israel, and Japan. Visit the website at www.aptivsolutions.com.
Source: Aptiv Solutions