Abstract:
There are many aspects to consider in the all-important electronic medical devices development. Starting with the urgency of getting to market fast to not making a mistake in the selection of a medical manufacturer, a developer can save time in attending this presentation.

This seminar will introduce the latest medical design and concepts follow by an in depth discussion of what are the most important ingredients when managing the release process for marketing, engineering and production. Attendees will have a chance to learn the new compact ECK device, new Wireless Health momentum and how to stay competitive. One has to pay attention to the new FDA regulations and ISO 13485 certification and other safety compliance for medical products. What other design and production aspects should be considered including compact requirements and geographic selection (USA vs. China). A flow chart/ check list will be provided to make the process management a little easier.

We will discuss:

• Introduction of new medical products Class 2 and 3 FDA 501K
• Development considerations: size, reliability and safety compliance. FDA clearance process
• Production considerations: cost vs. convenience; USA vs. China. How to manage overseas production?

Intended audience: Developers of electronic medical devices, Marketing professional of such products, QA/QC and test engineers and managers

About the speaker:
John W. Koon, Consultant

Mr. John Koon is the study of the medical electronic devices. Previously he authored the USB Technology and Market Reports, version 1.1, 2.0, OTG, Wireless USB Technology and Market Report and many technical articles including what should medical device OEMs expect from their suppliers? He published numerous technical articles throughout the years. Additionally, he made various public presentations including New Product Introduction Overviews and Project Management for Medical Devices. For the past 25 years, Koon held senior management positions in product development and marketing management for high-tech companies including HP, Western Digital. Koon obtained a BSEE degree from California State Polytechnic University, Pomona, CA and an MBA degree from San Diego State University.

Education:
BSEE (California State Polytechnic) MBA (San Diego State University)