"Fast, Efficient, Robust: Designing the Right Medical Device, the Right Way”
Philip Remedios IDSA
Principal, Director of Design & Development
About our Session:
This session will deliver some practical insights and guidance for integrating usability engineering into traditional device development methodologies; staying in touch with the ultimate end-users during development while prototyping rapidly and often; and avoiding budget and time waste by going down the wrong functional and technical pathways. This presentation maps out a tried and true methodology that will minimize cost, schedule and risk burden to all regulated devices that require validation testing.
About our Speaker:
Philip earned a Bachelor of Science in Industrial Design from the Art Center College of Design in Pasadena, California, with an emphasis on Transportation Design. Previously he studied Mechanical and Aeronautical Engineering at Loughborough University of Technology in Leicestershire, England. Philip has 30 years of design and engineering experience in a variety of industries ranging from exterior and interior automotive design, consumer, industrial and medical product development, project and executive management of full-service R&D teams in corporate and consulting environments in the USA and Europe. Philip has extensive quality training and has been responsible for instituting FDA and ISO compliant Design Controls procedures at 3 different firms, leading to ISO 9001, 13485 and FDA certifications.
After joining BlackHägen Design, Inc. (BH) as a partner in 2002, Philip managed design programs, with a focus on the medical device space where he had significant prior experience. His current responsibility at BH is in the management of the design and engineering phases of product development, as well as corporate administrative and financial oversight.
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