Virtual MedTech Roundtable | Understanding FDA pathways to medical device marketing


The Arizona Technology Council’s MedTech Committee will be holding its August round-table virtually.

“Follow the yellow brick road – understanding FDA pathways to medical device marketing.”

For most Medical Device Innovators, the path to FDA approvals can be a journey that is filled with surprises and can be hard to navigate. In this session, seasoned veterans Neil O’Flaherty and Evan Phelps from Amin, Talati & Wasserman will share their knowledge to help you better understand FDA approval pathways.

This session will be informational to innovators, consumers, investors, and providers.

In addition, this year we will have an Innovators Innovation Pitch, allowing the audience to hear about local up and coming MedTech innovations. The audience will be encouraged to provide confidential and constructive feedback to the innovator following the presentation.


Transformation Advisor,
Karcsay Consulting Group, LLC
Event Moderator



Partner, Amin Talati Wasserman

Evan Phelps specializes in medical device law and has been advising and representing companies before FDA for nearly 20 years. His experience spans the breadth of the FDA’s medical device regulatory requirements from helping clients to obtain marketing authorizations, comply with ongoing regulatory controls, and providing his clients with assistance in avoiding or addressing the aftermath of an FDA enforcement action. As an advisor to start-ups, mid-sized, and large medical device manufacturers, Phelps recognizes the operational and financial considerations involved in managing compliance and creating regulatory strategies.

Partner, Amin Talati Wasserman

Neil O’Flaherty is a seasoned veteran with over 28 years of legal experience representing medical device and other clients regulated by the U.S. Food and Drug Administration (FDA). From multinational firms to start-ups, companies look to OFlaherty for key guidance and assistance because of his strong substantive knowledge of complex FDA requirements and policies, combined with his ability to provide insightful advice which allows firms to succeed and accomplish their business goals in a highly-regulated industry. He also is highly sought after as an accomplished and effective advocate and problem-solver for clients when they face compliance, enforcement and other FDA issues. O’Flaherty has extensive experience in shepherding clients through recalls and other field actions involving distributed product. Besides product manufacturers, he routinely represents distributors, trade associations, hospitals and venture capital and private equity groups. He has even provided advice and counsel to a foreign governmental entity.

Partner, Amin Talati Wasserman

Shelly Garg practices in the areas of food, beverage, dietary supplements, cosmetics, medical devices, over-the-counter and homeopathic drugs, and animal and veterinary products. She assists foreign and domestic businesses, manufacturers, distributors and importers with regulatory compliance, trade and enforcement matters involving FDA, FTC, USDA, EPA, CPSC, TTB and other federal, state and local authorities. Noted for her creative leadership, she provides counsel to clients in strategic business planning, product development, testing and approval, advertisement and promotion, liability risk, inspections, import detentions, import alerts and related issues. Her keen insights into the FDA have proven to be of significant value to her clients in successfully resolving matters before the agency. A frequent speaker and author, Garg has presented at conferences and seminars sponsored by the Food Drug Law Institute, the American Bar Association, the America’s Food and Beverage Show, the FIME Medical Device Expo, and many others. She has been a regular contributor to FDLI’s Top 20 Food and Drug Cases published annually, and to FDLI’s Update Magazine where she sits on the Editorial Advisory Board.

Event Agenda:
3:30 – 3:40 | Welcome and Announcements
3:40 -4:40 | Follow the Yellow Brick Road: FDA Pathways to Medical Device Marketing
4:40 – 4:55 |  MedTech Pitch 
5:00 | Closing Remarks/Event Ends

Key Takeaways:
• Understand the basics of FDA approval and what it means to have an FDA approved product.
• Recognize the pathways for FDA approval, what is required, and how to start
• Recall 5 key points that consumers, physicians, and healthcare providers need to know about FDA approval and Medical Devices

Who Should Attend:
MedTech Innovators consumes of medtech innovation, investors, manufacturers, health providers, insurers, and Health care innovation officers.



The meeting will be virtual and registration is needed to receive the virtual meeting information.

Arizona Technology Council Members: Free  |  Non-Members: $20


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Presented By

AZTC MedTech Committee


Virtual Tech Event , Join us!|


Virtual Meeting


August 26, 2021


3:30PM - 5:00PM


[AZTC Member - Free] [Non AZTC Member - $20]