October 10, 2019 @ 6:00 pm – 8:00 pm
SPEAKERS: Timothy Littlefield and Jeff Riggs
TOPIC: Treating abnormal head shape in infants; quality challenges in customized medicine.
ABSTRACT: In 1998, the U.S. Food and Drug Administration (FDA) cleared the first cranial orthosis for treatment of abnormal head shape (deformational plagiocephaly) in infants. These devices gently reshape the cranium over a period of 5 weeks to 4 months, with the devices being custom made to address each infants’ unique deformity. As such, each device represents a lot size of one in the manufacturing process.
This presentation will cover the rewarding, yet somewhat unique challenges associated with manufacturing and provision of ‘custom’ medical devices including post-market surveillance, root cause analysis, risk assessment and others.
BIO: Tim Littlefield and his wife Nicole have two children and reside in Mesa, AZ. Tim is one of the leading researchers on deformational plagiocephaly. Tim has published dozens of articles as well as serves as an expert reviewer for several medical journals.
Tim has a BS in Mechanical Engineering from Michigan State University and an MS in Biomedical Engineering from the University of Iowa. Tim was Director of Engineering for a startup medical device company, which in 1995 was named National Incubator Company of the Year for its pioneering work in the developing technology for refractive surgery (LASIK).
Tim is currently the Chief Science and Technology Officer at Cranial Technologies, Inc. in Tempe, AZ. He is responsible for the company’s manufacturing, quality, regulatory, intellectual property, and R&D functions as well as clinical research and medical publications. He currently holds over 25 patents on technology developed for the company.
Jeff Riggs is a Quality professional with almost a decade of experience working with GMP’s and FDA regulations. For the last 4 years he has been the Quality Manager at Cranial Technologies Inc., where he has had responsibility for the Company’s Quality System and FDA compliance.
Jeff is a strong believer in collaboration, and he has partnered with departments throughout the company to improve operations. He has developed and implemented numerous programs to track KPI’s, reduce non-conformances and improve manufacturing efficiencies. Outside of work, Jeff enjoys playing with his two young daughters and keeping up with the latest in science and technology.
LOCATION: Edward Jones Training Facility, Classroom 103, 8333 South River Parkway, Tempe, AZ 85284
COST: All meetings are free and open to the public
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Free live, webcast:
Dial-in number (US): (515) 604-9593
Access code: 732496#
Online meeting ID: asq0704contactus
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