By now, you have probably heard of Breakthrough Device Designation and/or STeP Designation, and it’s likely you have considered whether your medical device qualifies for one of these two programs.
(If you’re still trying to figure out whether BDD is the right path for your device, take our quick 2-minute quiz to find out if BDD will work for you.)
Whether you have breakthrough device or STeP designation or are considering one of the two, you likely want a comprehensive understanding of what benefits these designations afford you. Namely, why should (or did)you go through all the trouble of applying for Breakthrough Device Designation or STeP Designation?
Of course, having your device designated a “breakthrough” sounds sexy. (“STeP” - maybe not so much.) While being sexy is appealing, that isn’t all there is to it though, right?
The goal of FDA Breakthrough Devices Program is to get potentially life-saving or life-improving innovative medical technologies into the hands of patients and healthcare providers faster.
To achieve this goal, product development, testing, review, and assessment need to occur in a more efficient manner, while still preserving the quality of development and assessment of the devices. To develop a product faster, a company needs access to resources—both from FDA and otherwise—and the breakthrough designation and STeP provide medical device companies with this opportunity.
So, what are all of the benefits of breakthrough device and STeP designation? Let’s take a closer look:
While you’re still able to request the customary q-submission types, one of most popular advantages of breakthrough device designation or STeP designation comes in the form of three different q-submission types: Sprint Discussions, Data Development Plans, and Clinical Protocol Agreements.
These requests follow the same general Q-submission process—submission of a cover letter along with a packet but also offer earlier and more frequent interactions with FDA.
A. Sprint Discussions
Sprint discussions are a series of discussions held on a specific topic within the time period set by the sponsor (aka you). These discussions allow for rapid and repeated interactions with FDA about a single topic. Because FDA hopes to engage with breakthrough device designees early and often, the goal of sprint discussions is to reach an agreement in a shorter time frame than would occur by a typical pre-submission process.
To this end, there are a few primary differences between pre-submissions and sprint discussions that should be highlighted:
While these benefits are spelled out in the FDA Guidance document [Breakthrough Devices Program Guidance for Industry and Food and Drug Administration Staff], there are a few important things to remember when engaging FDA in a sprint discussion.
At the conclusion of your sprint discussion, you will provide FDA with meeting minutes based on the timeline outlined in your schedule. FDA will review and provide any edits to the minutes and send it back to you based on the timeline. These minutes, along with the interactions, will go into the record for your company your medical device.
B. Data Development Plan (DDP)
Similar to a pre-submission meeting request that covers the testing plan, a DDP outlines the expectations for testing and data collection at various stages during the product lifecycle, including premarket and post market. Depending on the stage of development, you may want to engage in a DDP on only the non-clinical testing or engage in a full testing (non-clinical and clinical)DDP. Regardless of which you choose first, it’s best to engage with FDA on both non-clinical and clinical testing to ensure the most efficient and effective path forward. For example, earlier engagements on non-clinical testing might allow for some non-clinical testing to occur pre-clinical, while other non-clinical testing may be delayed until after clinical testing has begun. The timeframe in which you engage with FDA on the DDP and the contents will be dependent on your device and timeframe for development.
Like a sprint discussion, the engagement by FDA may be more interactive and timelier, depending on the FDA’s bandwidth for the submission.
C. Clinical Protocol Agreement
During the process of a clinical protocol agreement, you will work directly with the Office Director to determine the safety and effectiveness requirements and how to obtain these via your clinical study plan. The Office Director initially assesses the specific scientific issues that are necessary to demonstrate safety and effectiveness of the device. After which, you will meet with the Office Director and other select review team members to discuss the expectations. Just like the other breakthrough device methods of engagement, the objective is for you and the FDA to work together in a collaborative fashion. Upon agreement, the Office Director will then provide the decision to you in writing, documenting the agreement reached. After agreement, any changes to the protocol must be agreed to by you and the FDA in writing.
Another perk of Breakthrough Device Designation is that fact that is that it provides more opportunities for marketing and securing investor funds. Having a breakthrough device is essentially a nod from FDA that your device meets an unmet clinical need, and because it does so, FDA is willing to work with you to make your regulatory process smoother. This is appealing to investors because it means untapped market potential and less risk going through the regulatory process.
Additionally, if done properly, the process of writing a breakthrough designation should highlight key areas of use that support the overall value proposition for the product. Because investors are especially interested in products that are unique and open new market potentialities, being able to communicate your value clearly and having FDA’s buy-in will benefit companies during pitches and investor conversations.
Sharing the same investor perks as BDD, STeP reduces the regulatory risk by allowing for the same types of interactions with FDA, and it also requires stakeholders to educate themselves to fully understand the benefits of their device and the program in order to submit a successful application.
Breakthrough device designation products that receive FDA marketing authorization are considered new and not substantially similar to an existing technology, making them eligible for the New Technology Add-On Payment (NTAP)pathway. For breakthrough devices, because the goal is to get them into the hands of patients and providers quickly, CMS is aware that there won’t be enough time to demonstrate clinical improvement, so these devices don’t have to meet the typical newness or substantial improvement criteria under the NTAP program (they still must meet cost criteria though).
So, what does this mean?
While keeping some of the incentives characteristic of an average-based prospective payment system, the add-on payment provides additional payments for certain cases that have high costs when they involve eligible new medical technologies, like breakthrough devices. The finalized add-on payment through this pathway is equal to the lesser than 65%of the cost of the new service or the breakthrough device, or 65 percent of the costs over the standard DRG payment.
However, it’s important to keep in mind that this does not necessarily lead to reimbursement. There are other factors that come into play when talking about coverage.
Breakthrough Device Designation and/or STeP Designation could be perfect for your medical device. Each path offers solutions to problems in patient care. These innovations could potentially save and improve the lives of millions of individuals.
The process of getting your medical device on the market can be intimidating, especially for BDD and/or STeP. It’s important to align yourself with an experienced CRO that knows the process and can guide you to market approval with ease.