By Jim Kasic, Boulder iQ
Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product development process and, ultimately, get their devices to the market sooner.
Also known as the Pre-Submission Program, or Q-Sub for short, the program allows manufacturers of medical devices and in vitro diagnostic devices to obtain feedback on the regulatory process and requirements for devices they have in development. The Q-Sub program’s origin is in the Pre-IDE feedback system of the mid-1990s. In 2013, the FDA launched the Pre-Submission Program and expanded Pre‑IDE communications. As of 2019, the Q-Sub process has widened its reach to include a broad scope of medical device-related interactions.
When executed well, the program can be a win-win for both the FDA and device developers. The FDA heavily supports and encourages Q-subs, as its experts appreciate knowledge of what’s going on in the field. It’s to the organization’s benefit to promote conversation and discussion with device manufacturers. In turn, manufacturers get the opportunity to obtain valuable information that can help streamline their 510(k) submissions and entire development process.
Another positive is that the FDA charges no fees for Q-Subs and puts no limits on how many Q-Subs a company can request. Herein lies the issue. Device development companies may jump at the opportunity, submit a bevy of questions, and end up with little usable information six weeks later – the typical timeframe to obtain a Q-Sub written response or meeting. At that point, if they decide to try again, it will be another six weeks for the next response. Instead of helping to move things along, when used this way, the Q-Sub process can actually deter product development and delay time to market.
To derive the greatest benefit from a Q-Sub, it’s critical to keep an “eye on the prize”: obtaining specific, needed information you can use to complete your product development process as quickly as possible and get your device into the hands of intended users. Heeding the following five steps can go a long way toward ensuring the Q-Sub process works for both your company and the FDA.
1. Prepare Background Information And Questions Properly
Preparing for a Q-Sub meeting can be very difficult. The FDA needs the right kind and amount of base information on a device in order to fully and accurately answer questions. It can be tempting to give the FDA as much information as you have on your product and company. Too much, though, can be confusing. When that happens, the FDA is unable to answer questions and will likely refer you to a multitude of documents to wade through.
Let’s look at a hypothetical example of a company developing a new type of cooling cap to prevent hair loss in women undergoing chemotherapy. Without taking the time and effort for proper Q-Sub preparation, the company might submit questions along the lines of, “What testing do we need to do? What’s the reimbursement code? Is it a 510(k) device? What materials should we use?” The message the company sends to the FDA is that it hasn’t been thorough in its preparation and perhaps is not far enough down the road in development for a truly beneficial Q-Sub.
If that same hypothetical company, though, explained to the FDA that it was making a cap out of a certain grade of silicon, known to be biocompatible, and the cap will hook up to a chilling device that runs on batteries of a designated size, the FDA will have context to respond to specific questions. And rather than asking general questions (or ones the company’s regulatory professional could, and should, know), that company could then construct thoughtful questions that combine its research and perspective with a request for detailed FDA input. For example:
- My company believes that our technology falls into (x) code because of several (stated) reasons. Does the FDA agree? If not, please comment.
- My company believes we need to conduct (x) type of testing because of (stated) reason. Does the FDA agree? If not, please comment.
A good Q-Sub requires significant preparatory work to pull together, organize, and present the right background information and questions. At Boulder iQ, a team will usually put in a combined total of 20 to 60 hours to prepare a document package for a Q-Sub.
2. Proactively Manage The Meeting Schedule
Q-Sub responses can come in written form or via teleconference or videoconference, per the submitter’s request. Pre-COVID, in-person meetings were also available, and they may return in the future. When meeting via teleconference or videoconference, the time limit is one hour – one hour to manage expertly. The challenge is how to structure that hour to allow time to present necessary background, to ask specific questions, to receive responses, and to conduct productive conversations with the FDA.
In most situations, use of a short slide deck can be helpful to guide the meeting. A well-planned, well-thought-out meeting might follow this kind of timetable:
- Introductions: 5 minutes
- Presentation of background information on company and product: 5 minutes
- Review of questions, feedback from FDA on questions: 30 minutes
- Additional discussions as needed: 15 minutes
- Wrap-up: 5 minutes
The common roadblock happens in the presentation of background information. The FDA does like some background on the existing problem and unmet need, how the device will solve the problem, and the overall market for the device. However, many device development companies become mired in providing too much information on the technology and company, taking up valuable time. Along with potentially confusing the FDA, the FDA’s representative won’t have adequate time to answer the questions.
Without a good job on time management, it can be all too easy to suddenly have only 10 minutes left for FDA response, or to spend 30 minutes on one question and have virtually no time left for other submitted questions. Remember the overarching purpose of the Q-Sub: to obtain FDA input. Structure time so that they can talk and provide as much valuable input as possible. During the meeting, keep discussions on topic, and drive closure on each question/response before moving on to the next.
3. Limit The Number Of Questions
It’s also important to limit the number of questions asked in a Q-Sub. While every device, company, and situation is unique, in general, the recommendation is to ask a maximum of four very well-thought-out, specific questions. For developers with many questions and/or complex devices, this may sometimes mean doing more than one Q-Sub meeting.
The first may take the FDA from Point A to Point B, with relevant questions; the second may go from Point C to Point H. Splitting things up may give the FDA enough information on each set of questions to offer the help you need to make well-educated decisions on your product development. If you’re going this route, keep in mind that doing more than two Q-Subs per 12-month period would be very difficult because of both the six-week window and the length of the preparation process.
4. Choose Your Spokesperson Carefully
If you have requested a teleconference or videoconference (or, down the line, an in-person meeting), the selection of the spokesperson to handle the meeting is critically important. For optimal results, almost all companies find that a regulatory professional is the best choice, by far.
In contrast, a CEO will tend to dive into a monologue on the company or the device’s benefits or “revolutionary” technology. A scientist may over-focus on the science behind the device; an engineer can get stuck in the nitty-gritty details. Since the Q-Sub is, after all, designed to obtain regulatory information and clarity, a regulatory professional will be better equipped to stick to relevant facts and discussion and to talk with the FDA representative. And if the FDA does not fully understand a question or provides a response with which your company does not agree, a regulatory professional can prepare to have a constructive conversation on the issue.
Once you’ve selected the spokesperson, it’s a good idea to do a rehearsal of the meeting with an internal colleague acting as the FDA representative. Just as with any important presentation, this exercise can improve flow, pinpoint any issues, and help identify potential areas of confusion or interest.
5. Time Q-Subs Appropriately
One of the most frequently asked questions about the Q-Sub process is when in the development process to do one. Too early is a problem, because the device manufacturer doesn’t yet have enough information to get helpful answers from the FDA. Too late is a problem because the company risks delays in the development process by not getting important information in time to make needed adjustments in a time- and cost-efficient manner.
Whether or not to do a Q-Sub meeting during Phase 0 (before the design control process starts) depends on the device and the manufacturer’s process. On one hand, if the company has been able to plan a solid regulatory route to market for its device by a professional regulatory expert, it may not need a Q-Sub at all. On the other hand is a device manufacturer with enough unknowns and questions to really need FDA input on product classification code and under what standards or guidance documents the device will fall. In the latter case, a Phase 0 Q-Sub may be in order.
Returning to our hypothetical company developing a new cooling cap, perhaps the device will use laser beams for cooling instead of a cold material. The developer may want to query whether the device falls under a standard category for scalp-cooling or a different one since it’s using a different technology for the same purpose. In this case, it could also make sense to do a Q-Sub very early in the design process. (Note that a Q-Sub is a non-binding way to ask questions and should not be confused with a 513(g), a binding decision on a product classification code.)
When making the decision on when to do a Q-Sub, keep in mind that all materials presented for and at the meeting go in the company file for future FDA reference. If you ask the FDA questions and then pivot significantly, it may confuse the FDA down the line. Since most device developers tend to make significant changes from where they are in Phase 0, the better course of action often is to wait until completion of Phase 1, the design input phase. At that point, the company can provide the product requirements document, the regulatory strategy, and instructions for use to the FDA. This usually gives the FDA enough information to intelligently answer relevant questions.
Preparation Pays Off
A Q-Sub is a double-edged sword. The FDA likes and encourages Q-Subs as an excellent way to communicate with device developers and provide feedback before they do their 510(k) submissions. But doing a Q-Sub well, so that it produces the information you need to speed the product development process, is a tremendous amount of work. If not done correctly, the information can be confusing to the FDA, and the developer won’t receive the responses it really needs.
A bad Q-Sub is a waste of everyone’s time. To avoid that outcome, make sure to take time to prepare, working closely with your regulatory expert. Many companies work with professional consultants who specialize in Q-Subs to help them prepare. The FDA Q-Sub program can prove especially valuable for devices utilizing new technologies or for ones that are "first of a kind" devices. Fully understanding the purpose, methodology, and outcomes can mean the difference between success and failure in market launch of your device.
About the Author:
Jim Kasic is the founder and chairman of Boulder iQ. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patients. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a Bachelor of Science in physics and a Master of Science in chemical/biological engineering from the University of Colorado and a Master of Business Administration from the University of Phoenix. He can be reached at email@example.com or on LinkedIn.