RAPS Convergence 2024 to Feature Session on Accelerating Breakthrough Device Commercialization — Led by HPM Medical Device Regulatory Expert Adrienne Lenz

July 1, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape.

Session Details:

  • A Path to Faster Breakthrough Device Commercialization – CDRH’s Total Product Life Cycle Advisory Program (TAP)
  • Thursday, September 19, 2024, 4:30 PM – 5:30 PM
  • Session Leader: Adrienne Lenz, RAC – Principal Medical Device Regulatory Expert, Hyman, Phelps & McNamara, P.C.; Presenter: Laura Gottschalk – TAP Advisor, FDA

Session highlights include:

  • An in-depth overview of the TAP Pilot
  • Options for participant interactions with the FDA
  • Real-world experiences and benefits of the TAP Pilot Program
  • This session is a must-attend for professionals seeking to understand the intricacies of the TAP Pilot and leverage this program for breakthrough devices. To register visit the official conference website, here.

Meet the Expert: Adrienne R. Lenz

Adrienne R. Lenz, a highly esteemed Principal Medical Device Regulatory Expert at HPM will lead the session. Ms. Lenz brings a wealth of experience, having provided consulting to medical device and combination product manufacturers on a wide range of pre and postmarket regulatory topics. Her expertise includes developing regulatory strategies, preparing regulatory submissions, drafting policies and procedures, and addressing enforcement matters.

Ms. Lenz has an impressive track record in the premarket area, where she prepares IDEs, 510(k)s, de novos, and PMAs, along with pre-submissions and representing clients in pre-submission meetings with the FDA. In the postmarket domain, she advises on design controls, risk management, MDRs, field actions, and QSR compliance, and assists with quality system audits and regulatory due diligence.

About the FDA’s TAP Pilot Program:

CDRH introduced the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in late 2022. This program was designed to address the significant challenges known as the “medical device valley of death,” where many technologies fail to reach the market due to developmental hurdles.

To participate in the TAP Pilot, a device must be in its early development stages, have received a Breakthrough Device designation, and not have submitted a Q-Submission request post-Breakthrough status. The TAP Pilot aims to expedite the time from concept to commercialization by improved engagement between developers and the CDRH, increasing the predictability of the review process.

The program is structured to provide early identification and mitigation of risks, as well as aligning expectations regarding evidence generation. Moreover, the TAP Pilot offers opportunities for strategic interactions with non-FDA stakeholders, enhancing the overall developmental ecosystem.

Categories: Medical Devices