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
of California, Santa Cruz Extension Center in Silicon
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.
Upcoming Meetings and Events...
Product Validation Presentation Overview.
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.
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.
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.
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.
Additional Information Contact SMP Tech, Inc. at:
220 Vineyard Court, Suite 100 Morgan Hill, California 95037-5461
Phone: 408.776.7776 Fax: 408.776.7772