The Office of Compliance, Center for Devices and Radiological Health, FDA, continues its efforts towards improving quality by focusing upon employees, processes, customers and stakeholders. Training and development of employees has transitioned to a coordinated effort to improve staff competencies at all levels. The internal quality system has been reinvigorated and we are driving towards systematic, disciplined control of our processes.  The office is constantly working to achieve better quality in and timeliness of our products.  We have reorganized some key functions, focused our decisions based on critical data and risk analyses, and are optimizing our resources all in an effort to help ensure the public health. Mr. Ulatowski will provide an update on the FDA’s outlook for quality in device manufacturing.

Timothy A. Ulatowski is the Director, Office of Compliance, Center for Devices and Radiological Health.  He manages four divisions tasked with promoting consumer health and safety, promoting product quality, and enforcing the medical device and radiological health laws and regulations.  Mr. Ulatowski has been with FDA since 1974, and with the Office of Compliance since January 2003.

Prior to his recent appointment he was Director, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.  He served as the U.S. government representative for Study Group 1 (Premarket) of the Global Harmonization Task Force and on several cross-cutting FDA committees dealing with such topics as reuse of single use devices, user fee implementation, and international standards implementation.

"Organizational Integrity": The Cornerstone in Establishing World Class Quality in Innovative Medical Devices

Advanced Neuromodulation Systems, Inc. is an exciting, high-technology medical device company. The term "Neuromodulation" refers to the delivery of electrical stimulation or drugs directly to targeted nerve fibers to modulate the nervous system. This is accomplished by using either an implantable neurostimulator or an implantable drug pump. There are several types of implantable neurostimulators - such as spinal cord stimulators, vagal nerve stimulators, sacral nerve stimulators and deep brain stimulators - that are used around the world to treat a range of conditions, from chronic intractable pain, epilepsy, incontinence, to Parkinson's disease. Hear from President and CEO, Chris Chavez about how a young innovative high tech medical device firm promotes quality grounded on organizational integrity.

Christopher G. Chavez joined Advanced Neuromodulation Systems as President, Chief Executive Officer, and Director in April 1998. Mr. Chavez has extensive leadership experience and has served with several Fortune 500 companies in the medical device industry. In his sixteen years with Johnson & Johnson Medical, Inc., a major division of Johnson & Johnson, he progressed through several positions in finance, strategic planning, domestic and international marketing, new business development, and general management to the position of Vice President and General Manager of the Infection Prevention Business Unit, one of four worldwide business units with approximately half a billion dollars in sales. Prior to joining ANS, Mr. Chavez was Vice President of Worldwide Marketing and Strategic Planning for Eastman Kodak’s Health Imaging Division, where the division’s five worldwide profit centers reported to him. He received his MBA from the Harvard Graduate School of Business in 1979. Mr. Chavez currently serves as a member of the board of directors for Advanced Medical Optics, Inc. and The North Texas Visiting Nurse Association and as Chairman of the Board for the Medical Device Manufacturers Association and The Dallas/Fort Worth Health Industry Council.

Early in 2003, President George W. Bush and U.S. Secretary of Commerce Donald Evans presented the 2003 Malcolm Baldrige National Quality Award (MBNQA) to executives of Medrad, a manufacturer of medical devices and services related to human body imaging procedures based in Indianola, Pa. Medrad is one of seven recipients of the prestigious honor-and the only Medical Device manufacturing company. The award's evaluation criteria emphasizes overall company performance. As a keynote speaker, Julio Rivera, Senior Vice President of Corporate Compliance will share Medrad's Performance Excellence journey emphasizing, use of the Baldrige framework to identify opportunities for improvement and Medrad's best practices that have led them to being a role model company.

Julio Rivera joined Medrad in 1998 with the responsibility for all quality assurance and regulatory affairs activities for new product development, suppliers and manufactured products, along with the responsibility for Regulatory Compliance. In 2004, Mr. Rivera was promoted to Senior Vice President, Corporate Compliance, responsible for refining Medrad's performance in an increasingly complex environment of legal and regulatory compliance.

Prior to joining Medrad Julio held positions in the medical device and pharmaceutical industries with Sherwood Davis and Geck, and Baxter Health Care.  He specialized in directing quality assurance and regulatory affairs with primary focus in international operations.  He was responsible for a number of locations world wide, including Europe, Latin America, the Pacific Rim, Central America, and the Far East, with pharmacy operations in Mexico, Brazil and Puerto Rico.  Julio's international accomplishments include the successful startup of an LVP manufacturing operation in China and a joint venture operation in Indonesia.