Medical Device Development Tools (MDDT) Qualification: Lunch and Learn

Join us for a “Lunch and Learn” with Shannon Lantzy and Jessica Mavadia-Shukla, fmr FDA Program Manager for the Medical Device Development Tool (MDDT) Qualification Program. 

Drs. Lantzy and Mavadia-Shukla will discuss the benefits of submitting a tool for MDDT qualification, the history of the MDDT program, and their outlook on its potential to accelerate medical device innovation. 

Event Overview

The goal of this event is to raise awareness about the FDA’s MDDT program so that all stakeholders who would benefit from it have an opportunity to learn more, beyond the guidance. 

As an expert in FDA’s MDDT program and a former FDA reviewer, Jessica will provide an overview of the program’s purpose and MDDT Qualification guidance. She will focus on practical strategies for submitting an MDDT proposal, generating evidence, and preparing to submit a full proposal. She will share some “dos and don’ts” in considering how to approach the FDA. 

As a Regulatory Innovation expert, Shannon will provide an overview of the business value of the MDDT program. As a voluntary regulatory pathway in its infancy, the benefits of this program are currently a “best-kept secret.” Shannon will offer perspectives on the expected return on MDDT qualification for MDDT-vendors. Shannon will also discuss MDDT’s benefits to the MDDT-vendor’s customers (i.e., medical device manufacturers), and to regulators. 

Who we aim to serve: 

• Medical Device Manufacturers: Both large medtech and early-stage startups will learn how MDDTs could save time, cost, and reduce regulatory uncertainty. This is for you!

• Tech-for-MedTech Innovators: Are you building technology or have a product that helps medical device manufacturers demonstrate safety, efficacy, or performance of their regulated medical device? This is for you! 

• Medtech evaluators (e.g., FDA reviewers, third-party test labs): Do you evaluate medical device safety, efficacy, and performance? This is for you! 

Ultimately, we aim is to help great medtech innovations make it all the way to the people who need them most. The MDDT qualification pathway is a scalable approach to helping the medical device industry bring devices to market faster, better, cheaper, and with more delight along the way. 

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About the Speakers

Shannon Lantzy is focused on getting medtech innovation to market faster, better, cheaper, and with more delight along the way. Specifically, we're aiming to accelerate regulatory innovation through the MDDT pathway. Dr. Lantzy has spent 20+ years consulting in R&D for NASA, FDA, and medical device manufacturers. Her Ph.D. research and academic publications center around the economics of information asymmetry, behavioral economics, and consumer decision-making under uncertainty. 

Jessica Mavadia-Shukla is the Director of Regulatory Strategy and Health Sciences, at NuraLogix, bringing over a decade of experience in biomedical engineering and regulatory affairs. She formerly served as the Program Director for the Medical Device Development Tools (MDDT) program, where she led key initiatives to advance innovative regulatory science frameworks. Under her tenure, the MDDT program reduced time to decision for MDDT qualifications and qualified 8 tools.

Her background includes extensive work as a premarket reviewer and biomedical engineer, providing expert evaluation of cutting-edge medical technologies. Her interdisciplinary expertise bridges science, engineering, and regulatory strategy to support the development and approval of safe and effective medical devices. Jessica holds a B.S. in Biomedical Engineering from New Jersey Institute of Technology and a Ph.D. in Biomedical Engineering from Johns Hopkins University with a specialization in Biophotonics.