“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

“Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren

During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.  In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. He highlighted the following key features of TAP:

An Innovative Approach

To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.”  CDRH previously described the TAP as a voluntary program that is intended “to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with CDRH, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more rapid development of high-quality, safe, effective, and innovative medical devices first in the world that are critical to public health.” At the FDLI Annual Conference, Dr. Shuren reinforced this by stating that TAP is about “reducing the time and cost and increasing the predictability of going from concept to commercialization to address the valley of death.”

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving. The TAP Advisor is supposed to serve as a conduit between the company and the FDA review team, facilitating proactive engagement and collaborative discussions.

The following enrollment criteria are used during the current TAP Pilot Soft Launch:

• Devices will be those with a granted Breakthrough Device designation;
• Potential participants will not have submitted a Pre-Submission about the device after being granted a Breakthrough Device designation;
• Devices will be early in their device development process (e.g., have not yet initiated a pivotal study for the device) at time of enrollment; and
• Each potential participant will have a maximum of one device enrolled in the TAP Pilot per fiscal year.

It remains to be seen how FDA would define and actually implement the role of a TAP Advisor. As of March 1, 2023, FDA had enrolled four cardiovascular devices in the TAP Pilot. FDA did not share whether a single TAP Advisor has overseen these four devices, or whether each device has its own TAP Advisor. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level. Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.  It would be beneficial to understand how the TAP Advisor could actually further improve the interaction with companies to facilitate the FDA’s review beyond what is being done by a lead reviewer, project manager, or review division’s management.

“This is really a potential game changer.” – Dr. Jeff Shuren

Since its pilot launch in January, FDA has enrolled four cardiovascular devices in the TAP Pilot. Dr. Shuren stated that some of the manufacturers of these devices have already experienced more interactions in the past few weeks than they otherwise would have over the entire development course of their devices. (While that observation is intended as praise for the TAP Pilot, it can be considered a sad commentary on the general state of manufacturer-CDRH interactions.) FDA plans to expand the program to other device areas with the following goals:

• In FY 2023, enroll up to 15 products in a “soft launch” in one Office of Health Technology (OHT); selection of the OHT will include consideration of the OHT’s historical number of granted Breakthrough designations, workload, and available staffing and expertise.
• In FY 2024, continue to support products enrolled in the previous fiscal year and expand to enroll up to 45 additional products in at least two OHTs (i.e., up to 60 total products enrolled through FY 2024).
• In FY 2025, continue to support products enrolled in previous fiscal years and expand to enroll up to 65 additional products in at least four OHTs (i.e., up to 125 total products enrolled through FY 2025).
• In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).
• For FY 2024 – FY 2027, in addition to the considerations above, selection of the OHTs will include consideration of experience from prior years and input from industry and other stakeholders.

Dr. Shuren described the TAP program and other programmatic changes at CDRH as a “potential game changer” in the medical device industry. We welcome CDRH’s effort and hope to see that TAP does, indeed, prove to be a “game changer” – at least for the 325 devices over the next 4 years that participate.  To put this in numerical context, in FY 2022 alone, there were 45 PMAs (original and panel-track supplements), 77 de novos, and 3,759 premarket notification 510(k)s (data from 2^nd Quarter FY2023 MDUFA IV Performance Report).

Enhancing Review Capacity

Recognizing the value of real-time interactions, particularly highlighted during the COVID-19 pandemic, FDA aims to expand review capacity. Dr. Shuren said the ability to engage with developers in near-real-time was essential to expediting the authorization of over 2,800 devices during the pandemic. FDA intends to build on its experience by moving away from rigid stage-gate processes and fostering more fluid interactions throughout the review process.

To accomplish the goals set forth in the TAP Pilot, FDA has made a commitment, as part of MDUFA V performance goals, to implement and track the following quantitative performance measures, starting with fiscal year 2024:

• CDRH will engage in a teleconference with the participant on requested topic(s) pertaining to the TAP device within 14 days of the request for 90% of requests for interaction.
• CDRH will provide written feedback on requested biocompatibility and sterility topics(s) pertaining to the TAP device within 21 days of the request for 90% of such requests for written feedback.
• CDRH will provide written feedback on requested topic(s) pertaining to the TAP device other than biocompatibility and sterility within 40 days of the request for 90% of requests for written feedback.

Understanding Stakeholder Perspectives

FDA has acknowledged the importance of incorporating voices from patients, providers, and payors into the decision-making process and evidence-generation strategies. One mechanism to incorporate payors’ voices is through the Payor Communication Task Force. The task force facilitates communication between device manufacturers and payors. CDRH can engage with the Centers for Medicare & Medicaid Services (CMS) for parallel review – the mechanism for FDA and CMS to simultaneously review the submitted clinical data to help decrease the time between FDA’s approval of a premarket application and the subsequent CMS national coverage determination (NCD). Participating in TAP, and thus having access to payors, offers the potential benefit of less time between FDA’s marketing authorization and coverage decisions by CMS.

Currently, 16 payors including CMS participate in the Early Payor Feedback Program where device sponsors can obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. If a firm would like to request that one or more participating payor organizations join a Pre-Submission meeting, they may contact FDA prior to submitting a Pre-Submission to CDRH for review by sending an email to CDRHPayorCommunications@fda.hhs.gov.

Strategic Priorities

Besides TAP, Dr. Shuren also noted CDRH’s 2022-2025 strategic priorities during his presentation – “Enhance Organizational Agility and Resilience.” By December 31, 2025, CDRH intends to reduce the average amount of time spent on “at least 10 core business processes” without reducing performance or adversely impacting outcomes. The initial target for this simplification effort is the pre-market phase.

Other CDRH strategic priorities include:

• Reduce Barriers and increase opportunities for participation by diverse populations in evidence generation,
• Support Innovation of novel technologies that address health equity gaps,
• Empower People to make informed decisions regarding their healthcare, and
• Facilitate Availability of and access to existing and novel home-use medical technologies for all populations.

Suggestion

One of the goals of TAP is to publish an assessment of the TAP Pilot on the FDA web site no later than January 30, 2026. For a successful implementation of TAP, we believe it is essential that FDA shares information about TAP in a timely manner. While we recognize it may take a few years to gather information from TAP, 2026 is toward the end of MDUFA V and may be too late for any meaningful insight for participants at that time. We suggest that FDA publish an assessment of the TAP Pilot every year, beginning this fiscal year. Such effort may lead innovative developers to decide whether participation is worthwhile and would provide a mechanism for FDA to assess how well the project is working.

We also suggest outlining any commitments and obligation for device manufacturers once they sign up for TAP. Without knowing the details of the program, it may be challenging for manufacturers to understand the benefits and any potential risks of participating in TAP.

For those who are interested in the TAP, please check out the FDA’s website for the TAP and our previous blog posts on it (here and here).