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"Meet the Experts"
Implantable Medical Device
Design for Reliability Forum

March 3, 2011

The "Meet the Experts" Implantable Medical Device Design for Reliability Forum will include discussions on the engineering, blood flow, testing and FDA requirements and guidelines associated with the development and manufacture of implantable medical products. The program will include an interactive panel discussion composed of several experts in the field of Implantable Medical Device design and manufacture.

 

After the presentations and panel discussion there will be a door prize drawing and a complimentary lunch for all attendees.

 

Time and Place     
10:30 AM to 1:00 PM
Thursday, March 03, 2011
University of California, Santa Cruz Extension Center in Silicon Valley
Room 106, 2505 Augustine DriveSanta Clara, CA 95054


Sign up to the March 3 "Meet the Experts" Implantable Medical Device Design for Reliability

"Meet the Experts" 2011 Schedule.

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Medical Product Validation Presentation Overview.

Lee Carmack, Ph.D.will present design information on the Biologic and Hemodynamic Compatibility of Implantable Medical Devices. This presentation describes key design factors required for biocompatibility of an implantable medical device. This includes some of the basics of device compatibility with the flowing blood and how the biological complexity of the flowing blood makes it one of the most demanding challenges of the internal environment. Some strategies for achieving compatibility of synthetic vascular materials and intravascular devices with the flowing blood are described.

Lee Carmack is a Biomedical Device Consultant and has been developing implantable medical devices, biologics, and biomaterials for 22 years. Lee has developed polymer structures for optimizing tissue integration and bioactive coatings for thrombosis reduction, and he has provided strategic leadership in blood and plasma coagulation technology. He has experience in drafting technical components of PMA and 510K applications, preparing teams for FDA audits and responding to FDA and TUV queries. Lee has been a biomedical science advisor to corporate leadership on strategic biomedical device design. He also served as the Study Director for preclinical implant teams at Stanford University Medical Center and 3 other research centers at the Cleveland Clinic, University of Pittsburgh, and the Ottawa Heart Institute, in the Novacor LVAS and HeartSaver VAD studies. Lee has authored a number of articles and conference presentations, co-organized symposiums, and served as the Vice-President of the Memphis Society of Biomedical Engineering. Lee brings a vast amount of experience to the table on biomedical device design and development.

Mike Silverman (OPS A La Carte) will explain the basic steps an implantable manufacturer must follow in developing a new medical product, as well as strategies for the efficient evaluation of risk-based testing for reliability, FDA and human safety. The presentation will include case histories and testing recommendations.

 

 

Ops A La Carte ® is the leader in reliability and quality solutions for the medical industry. We provide Confidence in Reliability. We offer a flexible method of engagement: End-to-end reliability solutions, solving specific problems, or providing individual reliability services. We consult in every life cycle phase, train in every aspect of reliability, and test in our state-of-the-art HALT and HASS Labs™. We are committed to Highly Reliable Systems that save human lives. We successfully analyze and test critical medical products with confidence, deliver accuracy and precision to extend product and human life for each application, and provide customized solutions & consultancy to address all program risks.

Jack Coulter will explain the specification and manufacturing requirements for an implantable medical device. His talk will include the transfer from engineering into manufacturing, FDA qualification, process control, preventive action procedures and outside supplier quality.

 

 


Tom Roberts of SMP Tech will be the forum and panel discussion moderator. A complimentary lunch will be served to all attendees after the presentations and panel discussion.

For Additional Information Contact SMP Tech, Inc. at:
Ann Roberts@smptech.com

220 Vineyard Court, Suite 100 Morgan Hill, California 95037-5461
Phone: 408.776.7776   Fax: 408.776.7772