Critical Pathways for Successful Medical Devices Launch in the U.S.(2010/5/20)

April 19th, 2010 | Categories: 2010 | Tags:

Medical device industry is one of the most important industries of this century, and its competition is becoming strong. To successfully launch a medical device on the market, it heavily depends on seamless technology integration, correct strategic product development plan (e.g., including patent analysis, regulatory pathway selection, market entry strategy, and product life cycle management, etc.), and manufacturing products that fulfill users’ requirement according regulatory instructions.

Medical device manufacturers that complied with regulatory quality systems have become an essential prerequisite to enter the medical device industry, thus, selection of best practice process and document preparation impact commercialization efficiency. In Sep. 23, 2009, FDA commissioned the Institute of Medicine (IOM) to study the 510(K) process. The IOM will convene a committee to determine whether the current 510(K) process optimally protects patients and promotes innovation, and if not, what legislative, regulatory, or administrative changes are recommended to achieve these goals. It is worthy to pay attention of this new development and be well prepared for the coming challenges.

Taiwan has established good foundation in medical device industry, and recently companies have progressed to develop novel medical devices. How to systematically establish critical pathways, e.g., finding the unmet needs, designing user friendly products, raising fund, getting regulatory administration approvals, establishing partnership with international distributors, as well as building up enterprise core competence have become critical lessons to learn.

The seminar, “Critical Pathways for Successful Medical Devices Launch in US”, is designed with the main purpose to help participants to learn essential concept of FDA regulation on medical devices and implementation process of a medical device project from concept to commercialization. Experts from the United States, Mr. Lewis Ward has more than 30 years experience in consultation of device companies to get FDA approvals. Dr. William Cimino has over 23 years of professional experience, from Senior Engineer to CEO/Chairman, covering all aspects of medical device business including device design and technology development, clinical studies and assessment, regulatory affairs, strategic market development, distribution, business management/growth, and financial/funding requirements. They will share their experience and insights.

Agenda

Time Topics Speaker
9:00~9:30 Registration
9:30~9:40 Opening Remarks
9:40~10:40 Overview of The 510(k) & PMA Process Mr. Lewis Ward
10:40~11:00 Coffee Break
11:00~12:00 Current eHealth and Fitness Devices Market and Marketing Strategy Dr. Jya-Li Tsau
12:00~13:20 Lunch
13:20~14:20 Tips for quick FDA 510(K) Clearance for Medical Devices Mr. Lewis Ward
14:20~14:40 Coffee break
14:40~16:10 The Process of Novel Medical Device Development ~From Concept to Commercialization Case Study Dr. William Cimino
16:10~16:30 Panel Discussion


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