ASQ0618 Golden Gate Section
February 2008 Meeting Presentation Slides
|
The ASQ Golden Gate Section and ABBOTT
Invite you to participate in a Panel Discussion
"
New Developments in Biomedical Technology "Thursday, April 17, 2008 - 5:30 to 8:30 pm
Abbott Diabetes Care 1360 South Loop Road, Alameda, CA 94502
Topics of interest are as follows:
•
State of the Medical Device Industry•
Technical & Process Innovations that impact the field•
Regulatory Changes that impact the industry/ FDA topic (TBD)•
Operational Excellence - Forging Cross Functional Partnerships with R&D and Operations
State of the Medical Device industry with Dr. Sudhi Gautam: The medical device industry is one of the
fastest growing high technology sectors in the USA. Innovation in the medical device industry continues at
an accelerating pace and a number of important trends are taking root, ranging from integrated combination
devices that deliver drugs, to stem-cell therapies. What is the current technical, business, regulatory,
quality, process, and market trends that will shape the medical device sector in 2008?
Technical & Process Innovations that impact the field with Bikash Chatterjee: Innovation has been the
corners stone of biomedical product development. This presentation will explore some of the latest
innovations that are providing the driving force for the industry, the potential ramifications of overseas
product development and considerations for the future.
Regulatory Changes that impact the industry with Janet McDonald PhD: There are a number of
regulatory changes that impact the medical device industry. This section will present a very brief summary
of some of the more significant regulatory changes that will impact the Medical industry including the new
FDA medical device user fees and annual electronic establishment registration, the updated ISO 14971 risk
standard, the updated IEC 60601-1 electrical safety standard, the updated Medical Device Directive, the
Medical Vigilance reporting changes, the China medical device registration process, and the Japanese
notified body inspections of medical device manufacturing facilities for new product license approvals in
Japan.
Operational Excellence - Forging Cross Functional Partnerships with R&D and Operations with Tony
Whelan: Alignment of operational excellence and quality management is increasingly a top priority for
business leaders in the medical device industry. Whelan will facilitate discussion on how technologies
aligned with operational excellence programs improve quality and customer satisfaction, ensure regulatory
compliance and minimize direct and indirect costs to maximize global competitive advantage.
Question & Answer Session: After these presentations, this insightful panel will address these topics –
plus yours: Where are the Medical Device VCs investing their dollars? What are the new markets within the
Medical Device Sector? How new technologies affecting how medical devices are being developed? What
are the new Regulatory challenges? How is FDA helping or retarding innovation in the industry? What new
clinical development is likely to affect the Medical Device world? What are the Technical & Process
Innovations that impact the field? What new knowledge has to be acquired by medical device industry
professionals to stay abreast of the new changes and improve marketability?
Tina Mazurkiewicz
Division Vice President/ Quality Assurance and Compliance/ Abbott Diabetes Care
Host/ Panel moderator
Division Vice President/ Quality Assurance and Compliance/ Abbott Diabetes Care
Tina Mazurkiewicz is an ASQ Certified Quality Manager. Since joining Abbott Laboratories in 1987, Tina
has worked in Technical Product Development, R&D, Operations, Quality and Regulatory diagnostics
devices businesses in Chicago, Germany, Boston and Alameda. Under Tina’s direction at Abbott Diabetes
Care the quality regulatory submissions has improved and the FDA has recognized the company's CoPilot
software submission as their new training standard. Tina graduated from Winona State University and holds
a Bachelors Degree in Medical Technology.
Tony Whelan
Division Vice President Worldwide Operations/ Abbott Diabetes Care
Tony Whelan has spent more than 34 years in Healthcare manufacturing and held senior roles in Quality
and Operations in Glaxo, Serono, Hoechst and Aventis Pharma. He joined Abbott Diabetes Care in
September 2003 as Site Director, Witney, UK and assumed his current role of DVP WW Operations in
November 2007. Tony received his Bachelors Degree in Chemistry and Psychology from Liverpool John
Moores University and also holds a Masters Degree in Pharmaceutical Quality Assurance from Sunderland
University/Royal Society of Chemistry.
Dr. Sudhi Gautam
Founder/MedTech Bridge
Dr. Gautam is a surgeon-turned-biomedical engineer who after eight years of surgical practice saw the
impact that engineering technology could have in addressing clinically unmet needs. This motivated him to
pursue a Ph.D. in Engineering at the Indian Institute of Technology, Bombay and post-doctoral research at
University of Michigan, Ann Arbor. In 2005, he founded MedTech Bridge, a consulting and training
startup whose mission is to expedite biomedical innovation and enhance corporate productivity. Match
Bridge helps hi-tech and non-medical companies to enter biomedical markets by conceptualizing new
innovative biomedical products leveraging their own core technologies and strengths. It helps early stage
companies get off the ground by developing strategies and doing technology assessments, due diligence
and evaluating competitive attractiveness of opportunities to make investment decisions."
Janet McDonald, PhD
Public Affairs Specialist/ FDA
Janet is a Public Affairs Specialist with the San Francisco District of the U.S. Food and Drug Administration,
a position that she has held since 1986. She holds a BS degree in Institution Management and Dietetics
from Simmons College in Boston, completed Dietetic Internship at the University of California San
Francisco Medical Center, and has a PhD degree in Nutritional Sciences from the University of California at
Berkeley. In her capacity as Public Affairs Specialist, she serves as the first line of communication between
FDA and the general public, including the media. Her principle responsibility is public education in all
matters pertaining to FDA. Janet is a member of several professional organizations, including the American
Dietetic Association, American Society for Clinical Nutrition, Institute of Food Technologists, and the
Western Association of Food and Drug Officials.
Mr. Chatterjee/
President and Chief Technology Officer/ Pharmatech Associates, Inc.
Mr. Chatterjee is a certified ISO 9000 Lead Assessor and Six-Sigma Master Black Belt. He has extensive
experience in the design and implementation of quality systems and has successfully implemented risk
based systems, six-sigma and lean manufacturing solutions in the biotech, pharmaceutical, cosmetic and
food industries for over 15 years. Pharmatech Associates has managed and successfully deployed Lean
and Six Sigma initiatives for both large and small pharmaceutical and biotech customers. Mr. Chatterjee
holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San
Diego.
Agenda: Light appetizers/buffet dinner will be served.
5:30PM – 6:00PM – Welcome/Networking
6:00PM – 6:30PM – Guest seated and food served
6:30PM – 7:30PM – Panel discussion "New Developments in Biomedical Technology "
7:30PM - 8:00PM – QA & Wrap Up
Cost: No cost for registered ASQ members and guests of ABBOTT.
Registration: Limit registration is 75
Please send your registration to ”ASQ Golden Gate Section” to ASQ0618, P.O. Box 360985, Milpitas, CA
95036-0985 on the internet at: http://www.acteva.com/booking.cfm?bevaID=152648. For a better
headcount, email darrell.belt.b@bayer.com or/ and BChatterjee@pharmatechassociates.com for
reservation.
As a non-profit organization, ASQ is a forum for discussion of issues in the field of quality through its publications and member programs. To ensure relevant topics open to all points of view, the Golden Gate Section publishes articles and presents programs representing the opinions expressed by the authors and speakers. Such presentation does not constitute endorsement of or sponsorship by ASQ or the Golden Gate Section. In addition, advertisement in the Quality Quorum, or use of the ASQ logo does not constitute endorsement of that particular product or service by ASQ or the Golden Gate Section.