There are many pressures on medical device companies today—reduced venture capital investment, changing health-care reform, smaller and more complex devices, advanced materials, and the ever-present push from OEMs to keep costs down but get products to market faster, to name a few—all while increasingly managing their supply chains and meeting FDA regulations.
One of the greatest challenges, of course, is dealing with an evolving FDA—there is more scrutiny, more guidance and review, more requirements, and more confusion as the FDA presents new guidance and directives that are incomplete, poorly defined, or still changing.
Receiving FDA approval is typically the slowest step in getting a new product to market. The overall goal—delivering the best possible product in the shortest amount of time—is best achieved by doing everything possible to understand the FDA thought process and best-guessing how the FDA will respond during the approval process. Therefore it is important to establish meaningful communications with the FDA as quickly as possible—so seriously consider a pre-IDE (investigational device approval) or pre-submission meeting with the FDA—especially if you have a new or complex device. Not only will you hopefully get critical feedback that will speed up the process, it’s a good way to establish a positive relationship with your future FDA review team.
Although it takes up to three months to book a pre-IDE meeting with the FDA, that time can be wisely used to prepare for the meeting. Don’t request the meeting too early in the R&D process; it’s usually best to have the meeting after a prototype has been developed and preliminary data has been collected. The meeting is only about 60 minutes in length, so it’s a good idea to practice beforehand to make sure all your key questions will be presented to the FDA team. It is imperative to stay focused (this also means keeping the FDA representatives from straying off topic).
To have an even more successful pre-IDE meeting, keep the following advice in mind from Healing Innovation (www.healinginnovation.com), a website for clinician inventors. It reports that “the Office of Device Evaluation (ODE) has received complaints from the medical device companies that the pre-IDE process, in some cases, was too burdensome and time-consuming. Here are some reasons why:
- Set-up time. There is a 60-day lead time to set up a meeting. This is after the FDA officially receives the pre-IDE submission packet.
- Open-ended questions. Many questions that cannot be answered at the session need to be eventually addressed. It becomes challenging to schedule a follow-up meeting to address them.
- Lack of commitment. Some of the input and guidance provided can become obsolete if team members change.
- Subjectivity. Pre-IDE meetings are good if you have a good team leader.
Unfortunately, these team leaders are becoming rare, which often results in a company leaving the pre-IDE meeting with more questions than those answered.”
Medical device companies can’t do anything about the first complaint, but can easily manage the following three complaints by being dedicated and prepared. To have a successful pre-IDE meeting with the FDA, keep the questions sharply focused and maintain a committed team with a strong leader who will keep the meeting focused and on course. When done properly, a pre-IDE meeting will provide critical guidance that will make your 510(k) process smoother and more predictable and give you a jump on your competition.