IEEE Robotics and Automation Society Central New England Chapter Tuesday, February 11, 2003 Informal Discussion: 6:00 PM Program: 6:30 PM Medical Devices, a Regulated Industry from an Engineer's Perspective Presented by Luis J Maseda, Senior Engineer - R&D Boston Scientific Corporation ABSTRACT Robotic systems have begun to play a greater role in medical and surgical fields, where there's need for addressing certification requirements from agencies such as the Food and Drug Administration (FDA). We have asked Luis Maseda to present the important issues involved in certification for these fields. The talk will focus on describing the process required to develop and market a medical device. A brief overview of the industry and relevant regulations will also be presented. The presenter will attempt to draw a direct parallel between a sound engineering design process and the design process as required by federal regulations. The talk will build on knowledge many engineers receive during their academic training and during their professional career to provide an understanding of the medical device industry. With over two decades of expertise, Boston Scientific/Microvasive Endoscopy provides gastroenterologists, oncologists, pulmonologists, colorectal and general surgeons with interventional and palliative treatment and diagnostic options for patients with diseases of the digestive and pulmonary systems. Boston Scientific/Microvasive Endoscopy is part of the Endosurgery Group, which includes the Boston Scientific/Microvasive Urology and Boston Scientific/Meditech Surgery/Oncology divisions. Boston Scientific/Microvasive Endoscopy's devices, used in conjunction with an endoscope, are inserted through natural body openings, allowing physicians to access the esophagus, stomach, colon and pancreatic-biliary system without subjecting a patient to a major surgical procedure. Boston Scientific/Microvasive Endoscopy's devices are typically used to biopsy, retrieve gallstones, remove polyps, open esophageal and biliary strictures (narrowing of a bodily passage), stop internal bleeding (due to ulcers or ruptured blood vessels), palliate (ease) symptoms of some types of digestive tract cancers, and enable enteral feeding. Boston Scientific/Microvasive Endoscopy also provides less-invasive technologies for the pulmonary system. SPEAKER BIOGRAPHY Luis Maseda has spent most of his career in the medical device and biotech industry. He's worked in a variety of organizations, from small start-ups to large corporations. Most of his work has been focused on Product and Process-Development of Class II and Class III disposable devices. Mr. Maseda has also held responsibilities in regulatory affairs, manufacturing supervision, document control, tooling and calibration departments. Currently, Mr. Maseda is a Senior Engineer and Core Team Leader in Boston Scientific's Endoscopy division. He is active within many industry professional groups and currently holds a board position on the Association for the Advancement of Medical Instrumentation (AAMI) Risk Management Committee working towards the development of industry standards (ISO/ANSI/AAMI). MEETING INFORMATION The IEEE Robotics and Automation Society will meet on Tuesday, Feburary 11, 2003 at Wellesley High School at 6:00 PM for informal discussions and for the formal presentation between 6:30 and 7:30 PM. The group will have a no-host dinner afterwards at Bertucci's, where more conversations can take place with the guest speaker. The meetings are open to the general public, and all are welcome at the dinner afterwards. For more information, contact Rich Maynard at 978-439-5511 ex 6221 or check the Chapter email address: info@robotics-boston.org DIRECTIONS From Route 128, take either Route 9 or Route 16 west. From the junction of Routes 9 and 16, follow Route 16 (Washington Street) west past the Wellesley Hills commuter rail station (within walking distance of the school, then turn left onto Rice Street. Wellesley High School is on the left. Parking is available in a lot just beyond the school. For a web map showing the location of Wellesley High School, go to the Yahoo map site at http://maps.yahoo.com/ and enter the following information in the indicated lo cations: Address: 50 Rice St City, State or ZIP: Wellesley, MA The star marker is misplaced slightly to the south. Imagine it about 1 cm toward the top of the map at Rice St. For more information about our Section and Chapter, visit our web site at: http://www.robotics-boston.org/