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RAPID or RABID? : Making the Most of your Breakthrough, STeP & TAP Interactions
May 19, 2026

SDRAN Virtual Program Event

Strategic FDA Engagement in Accelerated Pathways: Breakthrough, STeP, TAP & RAPID

Speaker: Michael Nilo
Former FDA Reviewer, President & Principal Consultant, Nilo Medical Consulting Group, LLC

Event Details

Date: Tuesday, May 19, 2026
Time: 12:00 PM – 1:00 PM PT
Location: Virtual Event via Zoom
Pre-registration is required.
The Zoom link will be emailed to registered attendees 1–2 days prior to the event.
Registration Fees
SDRAN Members: $15
Non-Members: $25
Register for this Event

Event Agenda

12:00 – 12:10 PM Welcome & Speaker Introduction
12:10 – 12:50 PM Speaker Presentation
12:50 – 1:00 PM Live Q&A

Program Overview

Early and strategic engagement with the FDA can significantly impact the success and timeline of innovative medical device development. This presentation will explore how companies can effectively navigate accelerated pathways including the Breakthrough Devices Program, STeP, TAP, and the newly announced RAPID pathway.

Attendees will gain practical insight into:

• Breakthrough Devices Program
• STeP and TAP pathways
• RAPID pathway strategy
• FDA and CMS engagement best practices
• Regulatory and reimbursement alignment
• Common sponsor pitfalls and how to avoid them
• Real-world examples and lessons learned

This session is ideal for professionals in Regulatory Affairs, Clinical Affairs, Product Development, and Medical Device Innovation.

Speaker Biography

Michael Nilo is the Founder and Principal Consultant of Nilo Medical Consulting Group, where he advises medical device, biotechnology, and pharmaceutical companies on regulatory strategy and FDA submissions.

A former FDA lead reviewer, Michael brings more than 15 years of experience spanning both the Agency and industry. He has supported numerous Breakthrough Designation, STeP, and TAP submissions and regularly represents industry during FDA Sprint discussions.

His expertise includes pre-IDE, 510(k), HDE, IDE, and PMA submissions, with specialized experience in cardiovascular and combination products.

Questions

For questions regarding the event or to pre-submit questions for the Q&A session, please contact: