Tuesday, October 21, 2008
9:00 AM - 4:00 PM (Lunch 12:00 PM - 1:00 PM)
| Session 103 - Designing a Better Medical Device |
Instructors: Mike Drues, PhD, Vascular Sciences and Brian Callahan, EEC & Associates
This session will cover:
- Understanding biology as a precursor to better engineering
- Implementing the necessary design controls to ensure compliance without stifling creativity
- Case studies from various clinical specialties (i.e., cardiology, neurology, gastroenterology, etc.) to demonstrate how to "design" better and more-effective devices
- Transferring R&D concept to pilot manufacturing and maintaining device integrity
- Selecting from materials available on today's market and what may be available in the near future
- Validating today's new Medical Devices based on FDA's current concept of risk and 21 CFR Part 820
- Maintaining a state of control in manufacturing and transferring lessons learned to next R&D device
- Effective design transfer to manufacturing
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About the Instructors
Michael Drues, PhD, President, Vascular Sciences
Michael Drues, Ph.D. is President of Vascular Sciences in North Grafton, Massachusetts. Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA). Dr. Drues is an Adjunct Professor of Medicine & Biotechnology at Northeastern University (Boston), University of Wisconsin (Madison) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include Designing Cardiovascular Devices, Designing Neurovascular Devices, Designing Peripheral Vascular Devices, Minimally Invasive Technologies, Combination Products, Overview of Biotechnology and Regulatory Affairs.
Brian Callahan, President, EEC & Associates
Brian Callahan is an independent consultant in the medical device regulatory field. He was formerly director of education for Quintiles Consulting and provided compliance training to clients worldwide. He has designed and delivered training modules that include IQ, OQ, PQ, process validation, preparing for an FDA investigation, validation master planning, SPC, executive management responsibility, reagent manufacturing, and test methods. Brian has more than 12 years of industry experience, nine within medical devices, IVDs, and drugs. He has validated facilities domestically and internationally to ensure cGMP compliance for the production of Class I, II, and III medical devices.
