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TRANSCRIPT
Medical Device Conference Proposal
Credited to the U.S. Commercial Service
Created By: Mabel Oza
Medical Device Manufacturers
The following are the top international medical device manufacturers:
1. Johnson & Johnson2. Medtronic3. Boston Scientific Corporation4. Baxter International5. Thermo Fisher Scientific6. Siemens Healthcare7. G.E. Healthcare8. Phillips Healthcare9. Kendall10. Toshiba-Medical Systems
Potential Participants
Potential participants would be influencers in the medical device industry, and people that work with FDA medical device regulations and medical device clinical research trials.
Potential Participants - Private Sector
Name Title Company
Judith Andrews, Director of Quality & Compliance Service Staff
MDCI
Krista Armstrong V.P. of Global Clinical Trial Management
Premier Research
Leslie Zacks Director of Clinical Products Reed-Elsevier
Steve Norsted Founder RCRI
Potential Participants – Public Sector
Name Title Company
Vince H. Suneja Director Health Products and Technologies Team
Timothy Ulatowski Director Office of Compliance CDRH, FDA
Carolyn Clancy Director Agency for HealthcareResearch and Quality
Mark McClellan Director Engelberg Center for Health Care Reform at the Brookings Institute
Daniel G. Shultz Director Center for Devices and Radiological Health
Joy Dawson Associate Deputy Chief Counsel for Devices
FDA
Resources
The following are credible, influential, and relevant resources that deals with medical device FDA regulations, medical device, clinical trials, and the medical device industry in general:
(See next page for listings)
Resources
Resource Title Person or Organization Content
FDA – Medical Devices U.S. Dept. of Health & Human Services
Contains the exactrequirements needed to get a medical device approved.
Medical News Today MediLexiconInternational
Contains an article database on Medical Devices
Elsevier Business Intelligence
Formerly F-D-C Reports and Windhover
The Hoovers of the Health Care Industry
Clinical Trial Basics Medical College of Madison
Answers basic questions on Clinical trials
Clinical Trials.gov U.S. National Institute of Health
Details regulations in choosing and treating trial subjects
Competitive Events
The following events target people from the medical device industry, and/or are similar to our topic on efficiently testing devices to make the FDA approved:
(See next page for listings)
Competitive Events
Event Organization Content Location Days
16th MDMA Annual
Meeting
MDMA General discussion on medical
devices
Washington
D.C.
5/24-26/10
MDMA Annual
Meeting
MDMA General discussion on medical
devices
Washington
D.C.
6/1-3/2009
Premarket Approval
(PMA) and 510(k)
Premarket Notification
Seminar
MDMA Specific discussion on exactly
what companies need to do
to get their medical devices
approved
Palo Alto, CA 3/18/10
IN3 West, East, Europe, Summit
Windhover Medical device venture
capital conference & summit
Las Vegas,
Boston, Paris,
San Francisco
3/3-5/10, 6/9-11/10,
4/29-30/10,
Association of Clinical Research Professionals (ACRP)
RCRI (Regulatory &
Clinical Research
Institute)
General gathering for Clinical
Research Professionals
Tampa, FL 4/23-27/10
Regulatory AffairsProfessional Conference
RCRI (Regulatory &
Clinical Research
Institute)
General gathering for
regulatory agency & clinical
research professionals
San Jose, CA 10/24-27/10
FDA Approval Process for Medical Devices
Qmed Specifically addresses regulations in getting FDA approval
London 9/27-28/10
Session Brief 1
Improving Patient Safety and decreasing the cost of Clinical Research TrialsFor the past decades the medical device industry has continued to debate the age old question, “How can you provide quality and accessible healthcare tools?” Now its time to stop debating and start innovating. This conference will give medical device industry leaders a platform to brainstorm cost effective ways in conducting clinical research trials.
Topics Include: • Understanding the reasons behind specific FDA regulations• Utilizing previous trials and case studies to aid current clinical
research trials• Recruiting test subject randomly and cost effectively • Creating a budget for clinical research trials
Session Brief 2
Leaner Clinical Research TrialsClinical Research Trials are the most important steps and biggest hurdles in medical device development. Medical manufacturers need to put their life-saving/altering medical devices in the marketplace as early as possible. Unfortunately, in a marketplace with increasing healthcare standards this is impossible. This conference will break through the traditional procedures and help innovate leaner procedures in Clinical research trials.
Topics Include: • Applying lean six sigma in Clinical Research Trials• Testing the medical device while it is being developed• Using FDA regulations to evaluate Clinical Research Trial plans
Contact Information
Name Mabel Oza
Address 5005 Culver StreetSkokie, IL 60077
Phone (847) 239-2573
E-mail [email protected]