REGISTER

5pm – 8pm PDT:  April 23, 2026

San Diego, CA  Hologics GCD 1-Auditorium

Launching a medical device start-up requires more than great ideas,It requires thoughtful regulatory strategy from the beginning. Sponsored by MDSS and in partnership with PRN Medical, this event will explore key regulatory considerations for early-stage medical device companies, including selecting the appropriate FDA pathway and preparing for regulatory submissions and global market entry.  More and Register

Program Speaker:

Michael Nilo

Former FDA, President and Principal Consultant - Nilo Medical Consulting Group, LLC

Event Agenda:

DATE/TIME:          Tuesday, 19 May 2026 / 12:00-1:00 PM PT 

TIMELINE:      12:00 – 12:10 PM        Welcome and Intro of Speaker

                       12:10 – 12:50 PM        Speaker Presentation

                       12:50 – 1:00 PM          Q & A

LOCATION: This event is being offered VIRTUALLY.

Pre-registration is required for this event.

The Zoom link will be sent to registered attendees 1-2 days before the event

Click here to register for this event

Program Topic:

Early and frequent engagement with the U.S. Food and Drug Administration can significantly shape the trajectory of innovative medical devices, especially for those participating in programs designed to accelerate development and review. Accelerated pathways such as the Breakthrough Devices Program, Safer Technologies Program (STeP), and the Total Product Life Cycle Advisory Program (TAP) offer sponsors valuable opportunities for enhanced interaction with FDA.

These programs are intended to facilitate timely patient access to technologies that address unmet medical needs by offering more frequent communication, prioritized review, and collaborative feedback. However, without a thoughtful strategy, increased access to FDA can lead to inefficient use of time and resources—or worse, misaligned expectations that slow progress rather than accelerate it.

Adding to this evolving landscape, FDA and CMS recently announced the RAPID (Regulatory Alignment for Predictable and Immediate Device) coverage pathway, a new initiative aimed at aligning regulatory approval with Medicare coverage decisions earlier in development. By bringing CMS into the premarket process, RAPID enables early agreement on evidence requirements and has the potential to reduce the time from FDA authorization to national Medicare coverage from a year or more to as little as a few months. This shift further elevates the importance of strategic, cross-agency engagement throughout the product lifecycle.

This presentation will explore how to effectively navigate FDA interactions within the Breakthrough, STeP, and TAP programs; now in the context of the emerging RAPID pathway. It will highlight key differences between programs, outline best practices for high-value engagements, and discuss how to align regulatory and reimbursement strategies from early development through market authorization. Attendees will gain insight into common pitfalls, including over-engagement without clear objectives, and how to avoid turning RAPID interactions into RABID ones.

Real-world examples and practical tips will be shared to help sponsors optimize their communication with FDA and fully realize the benefits of these expedited pathways. The session is designed for regulatory, clinical, and product development professionals seeking to enhance their approach to FDA engagement and drive more efficient, predictable outcomes for innovative medical technologies.

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, giving him a uniquely balanced perspective on the medical device approval process. He has submitted many Breakthrough Designation, STeP, and TAP applications for clients and represents industry at Sprint discussions for those granted an accelerated pathway by FDA.

Throughout his career, Michael has led and supported a wide range of regulatory submissions, including pre-IDE, 510(k), HDE, IDE, and PMA applications, with particular expertise in cardiovascular and combination products such as drug-eluting stents. He has also played a key role in clinical trial development, quality system compliance, and strategic FDA engagement.

Prior to founding his consulting firm, Michael worked within FDA’s Office of Device Evaluation and in industry roles collaborating with global teams to develop regulatory and testing strategies. He is known for helping companies navigate complex regulatory pathways with a practical, solutions-oriented approach that balances compliance with innovation.

Registration Information:

Click here to register for this VIRTUAL event.

You will receive the Zoom link 1-2 days before the event

Registration Price:

$15.00 SDRAN Member                                         $25.00 Non-member

For questions about the event or to pre-submit questions for the Q&A portion of the evening, please email: [email protected]