Kenny Wang

CEO
Kentron Medical and  Environmental Technology Inc.​​

Dr. Kenny Wang holds a Ph.D. in Environmental Engineering from the University of Southern California (USC), where he also earned his M.S. degree. He received his B.S. in Chemistry from National Taiwan University. With deep expertise in regulatory affairs and practical implementation in both environmental and medical device sectors, Dr. Wang currently serves as Executive Director of Hua-Mei Innovation Center and Kentron Think Tank, focusing on supporting Asia-Pacific companies in their U.S. market entry and expansion.
 
During the COVID-19 pandemic, Dr. Wang observed that many Taiwanese medical device manufacturers encountered serious delays—and even product destruction at U.S. Customs—due to unfamiliarity with FDA regulations. In response, he co-founded Kentron Medical and Environmental Technology, bringing together FDA regulatory experts to assist companies in securing FDA approvals and successfully entering the U.S. healthcare market.
 
Dr. Wang has extensive experience in FDA regulatory pathways, SBIR/STTR government grant programs, U.S. immigration strategies for entrepreneurs, and cross-border technology collaboration. He continues to serve as a bridge between Asian innovation and the U.S. regulatory and commercialization landscape.​

 

Speech title & Synopsis

Navigating U. S. FDA Regulations and Government Grants (e.g., SBIR/STTR)

For medical device developers, biotech startups, and digital health entrepreneurs in Taiwan or Asia, entering the U.S. market offers enormous potential—but also significant regulatory and financial challenges. This presentation provides a practical guide to navigating the two critical pillars of successful U.S. market entry: FDA regulatory compliance and access to government funding through programs like Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR).
 
Dr. Wang will begin by introducing the U.S. Food and Drug Administration (FDA) pathways for healthcare technologies. For medical devices, he’ll cover the 510(k), De Novo, and PMA processes; for biotech solutions, he’ll outline IND/NDA and BLA requirements; and for digital health tools, he’ll explore how the FDA evaluates software-as-a-medical-device (SaMD) under evolving digital health frameworks. Innovators will learn how to classify their products correctly, engage with the FDA early via Pre-Submission meetings, and design appropriate clinical or usability studies.
 
The second half focuses on leveraging U.S. federal grants—particularly SBIR and STTR—which offer from $200,000 up to $1 million in two-phase funding to support R&D and regulatory activities. He’ll explain how international companies can participate through U.S. subsidiaries, form university partnerships, and align grant strategy with product development milestones.
 
By combining regulatory strategy with targeted funding opportunities, healthcare innovators can de-risk their U.S. commercialization journey, build investor confidence, and accelerate market access.
 
This session is ideal for startups, researchers, and tech transfer professionals seeking to bring Taiwan or Asian healthcare innovation into the U.S. healthcare market.