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Hantel Technologies – page 2

U.S. FDA “Approved Materials” for Medical Device Use

The Center for Devices and Radiological Health (CDRH) does not maintain a list of
ingredients or materials that are certified or approved for use in medical devices. That is
because the appropriateness of a material depends on the application. That is why FDA
approves finished devices and not components or materials which could be used in varied
applications. For skin or open wound contact, only short term tests may be needed, where
as for an implant, long term in vivo tests would be recommended.
The responsibility for biocompatibility of a finished device lies with the manufacturer.
This can be accomplished in several ways, one of which is to assess or characterize all
components of a device according to the ISO 10993 standard. Some testing can be
avoided if biocompatibility data is available from the component supplier. Many
component suppliers are aware of the biocompatibility requirements that finished device
manufacturers must meet and will supply testing data to meet those needs. Use of
previously qualified components with a known safety profile can save the finished device
manufacturer time and money.

It is the responsibility of each device manufacturer or specifications developer to assure
that all ingredients and component materials are suitable for their intended purposes.
The finished medical device must be safe and effective for its intended purposes when
used according to its labeling. In this context, safety and effectiveness include many
parameters such as physical properties, chernical properties, and biological effects,
including the biocompatibility of materials that contact human tissue.

If you have reviewed ISO 10993 and the ASTM methods (F748) you should be able to
develop a rational plan for documenting the biocompatibility of your device. If you are
unsure of the minimum testing requirements contact DSMICA at:

DSMlCA@fda.hhs.gov and advise them of your device and indication for use. They will identify the correct division within the Office of Device Evaluation (ODE) for you to start a dialogue.

Published by FDA for MDamp;M Anaheim 2-8-2011 to 2-10-2011

Hantel Technologies is pleased to announce the next seminar in the 2011 – 2012 Hantel Tech webinar series:

Topic: Integrating market research into the product development process
Presenter: Barry Zakar, Intellimed Consulting

Abstract:

Integration of market research into product development is among the most important aspects of the process, yet is frequently omitted, poorly implemented or its implications misunderstood.  The effort, time and cost of good market research integration into product development is far less than the cost of the development and introduction of medical devices that do not address unmet clinical needs, or are poorly designed for their end users or clinical environment.

This presentation will define market research as it applies to product development, review the research types and sources, and discuss where and how market research makes a difference in product development, both for new products, and at various points in the product life cycle.

Market research is not an optional part of product development, but is as essential to the process as product specifications, hardware/software validation and COG determination, all of which significantly benefit from market research.  Today’s product development professionals actively seek market input and get involved in the process early on to assure the introduction of well-designed medical devices that meet customer needs and contribute to improved clinical outcomes.

Barry Zakar has over 25 years experience in the medical device industry, marketing capital medical equipment, disposables and implantables to multiple medical specialties in both the hospital and office practice market sectors. Barry has developed expertise in creating new markets for innovative medical technologies in entrepreneurial environments. As Principal at Intellimed Consulting, Barry has provided guidance in strategic marketing, clinical and reimbursement issues, and market development and tactical implementation to early-stage domestic and Australian companies.

Prior to founding Intellimed Consulting, he was a Director, Center for Business Intelligence at Edwards Lifesciences in Irvine, CA, where his primary role was the acquisition and integration of primary market research into the new product/new business identification and development process. He has also worked with AUSTRADE in assisting several dozen Australian lifesciences companies with product commercialization and entry into U.S. markets. Barry is also associated with the Sacramento Area Regional Technology Alliance (SARTA) programs: MedStart, VentureStart, CEO Forum; UC Davis, and Partnership for Innovation (PFI), a NSF grant-funded program.

Date: Thursday, March 29th, 2012
Time: 11:30 AM – 1:00 PM PST

The first 30 minutes will be used as a networking session, and the lecture will begin at noon.

Location: Hantel Technologies 703 Sandoval Way, Hayward, CA

Remote: Remote Access: Register to receive weblink and please check the relevant links for system requirements. Links | Join Meeting Tips | Computer Testing Tool | OR Mobile Devices/Smartphones.

RSVP: Please register on Event Brite (http://hanteltech.eventbrite.com/) for this free seminar. You are cordially invited to attend in person (lunch provided / limited number of seats), to join live via Webinar, or to view at a later date.

Best Regards, Hantel Webinar Staff

Dear Friends and Collegues,

Today is the deadline for discounted early registration for the Bay Area Biomedical Device Conference which will be held on March 30, 2011, in the Student Union Building at San Jose State University. More information, including registration information, can be found at the Conference website: roulette flash
http://www.engr.sjsu.edu/bmes/2011Conference/index.html

Last year’s success has motivated us to plan an even better conference and we have another set of outstanding speakers who will be addressing several aspects that are particularly relevant to the biomedical device industry. We thank our Industry Advisors who have been essential in our selection of the speakers.

We are happy to report that thirteen companies, in addition to the SJSU President’s Office and the national Biomedical Engineering Society, are sponsoring this conference. We take this opportunity to thank our sponsors and co-sponsors. If your company would like to join this elite group of conference sponsors, please do let me know.

Please do register today so that you can take advantage of the reduced early bird registration fee which ends on March 17, 2011. To register please go to:
http://www.engr.sjsu.edu/bmes/2011Conference/index.html

We would appreciate it very much if you could please forward this announcement to any of your friends or colleagues who you think might be interested as well.

We look forward to seeing you at the Conference on March 30, 2011.

Abstract:

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

Here at Hantel we are always trying to serve our clients with the highest standards of services from all of our departments, and we would greatly appreciate any feedback on how we can improve these services. Please take a few minutes to fill out our Customer Satisfaction Survey and let us know how we are doing.

Welcome to our newly updated website! Feel free to browse our new sections including the Webinars page or Register an account, and don’t forget to check back in for the latest from Hantel Technologies.