California has been a national leader and pioneer in food and drug measures, with the first pure food and drug legislation created in the nation a year after the gold rush. It might not be well known that current FDA medical device regulation is based on the California Department of Public Health – Food and Drug Branch, which has nearly an 80-year-old history. The mission of the Food and Drug Branch is to protect and improve the health of all California residents by assuring that foods, drugs, medical devices, cosmetics, and certain other consumer products are safe and not adulterated, misbranded nor falsely advertised; and that drugs and medical devices are effective.
Manufacturers and start-ups might be less aware that in addition to federal requirements for medical device manufacturing, that there are also state requirements. According to the 2012 California Biomedical Industry Report, California biotech and medical device companies are responsible for 27% of the products in the nation’s biomedical pipeline. This seminar will include a description of the role and function of the Food and Drug Branch in California, and how the Sherman Food, Drug and Cosmetic Law applies to medical device manufacturers, with an emphasis on the shared goal of improved healthcare and outcomes for patients between medical device manufacturers and regulatory bodies.
Lilly Chin is a Program Specialist for the Medical Device Safety Section of the California Department of Public Health, Food and Drug Branch (CDPH, FDB). Her duties are to provide technical and program support. Prior to becoming a Program Specialist, she was a field investigator responsible for the investigations of food, drug and medical device manufacturers to ensure that firms were compliant with laws and regulations, and to ensure that products were manufactured such that they were safe and effective for use. Ms. Chin earned her Bachelor of Science degree from San Francisco State University in Clinical Science. Prior to joining the Food and Drug Branch, she worked in the pharmaceutical industry where she was involved in the development of new drugs.
Come join us at the Heart Rhythm 2011 event at the Moscone Center in San Francisco – May 5th to 7th. For more information visit the Heart Rhythm website.
Hantel Booth Number: 2041
Everybody talks about innovation. How many companies can define it, and how many actually do it instead of just talking about it? In this engaging and thought-provoking presentation we explore some of the various definitions of innovation are and some of the surprising drivers and techniques for generating innovation, and tools for approaching innovation, and illuminating historical illustrations.
Ted Kucklick has worked on innovative medical devices for numerous companies including RITA Medical (RITA) acquired by ANGO; AfX, (acquired by Guidant); Somnus (SOMN) acquired by Smith and Nephew; Sleep Solutions (now Novasom) and Starion Instruments (acquired by Pentax). Ted is founder and CEO of Cannuflow, Inc., dedicated to developing innovative technologies for arthroscopic surgery. Ted has a degree in product design from CIA, and a certificate from the UC Berkeley Haas School of Business Global Bio-Entrepreneur program, and is a member of the IEEE/EMBS, AMI, and SME professional societies, two-term board member of the SF Bay Area chapter of the IDSA, and inventor on over 31 patents. Ted is author/editor of The Medical Device Handbook, helped develop the SME video production, Medical Applications of Rapid Prototyping, and is a regular contributor to BoneZone and MD Design magazine Notebook, and a frequently invited speaker on the subject of medical device innovation.
1. MEDevice Forum- San Diego- Sep 13th and 14th. Booth # 408
2. MDM- BIOMEDevice 2011- San Jose – Dec 6th and 7th. Booth # 214
3. MDM West in Anaheim – February 14th to 16th, 2012. Booth # 2170
Come join Hantel Technologies at Sacramento Med Tech Showcase on May 6th 2011 at Sacramento State University. For more details and registration visit their WEBSITE.
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