Preparing for advisory panel meetings
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. To ensure a successful outcome, device companies should begin planning well ahead for these important meetings.
Receiving FDA clearance or approval is critical for any medical device company looking to bring new products to market. A handful of pre-market approval applications (PMAs), as well as some de novo reclassifications, must brave the advisory panel process each year. Panel meetings —which result in a recommendation to the FDA that can ultimately “make or break” a product — mean consolidating and presenting years and years of product development and clinical findings, which can be a difficult undertaking for companies who aren’t prepared.
Gerry Prud’homme, partner, and Kristin Zielinski Duggan, counsel, in Hogan Lovells’ Medical Device Group, say that device companies should keep six key points in mind when preparing for an advisory panel meeting.
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1. Advisory panels are not scientific meetings
“Scientific meetings typically involve a more academic presentation of data and information that's been collected during a clinical study,” Duggan says. “An advisory panel is more about advocacy. You're presenting data and information to an advisory committee in a manner to convince them that your product is safe and effective and should be approved by FDA. “Sometimes companies will say, ‘we've got the biggest expert in the world, they don't need any preparation,’ and they're often surprised by how different an advisory panel meeting can be. It’s a completely different audience.”
2. Be ready to step into the public eye
“At an advisory panel meeting, both FDA and the company will present,” says Prud’homme. “There will be some information about the product itself and results from pre-clinical testing, but the main focus of the meeting is usually on the clinical study that the company has conducted to support its application. It’s important to note that advisory panel meetings are public meetings. There are news reports on it and news outlets that actually come to the meeting itself. Everything about the device becomes very public, their information and data included.”
3. Make sure key messages get across
Duggan says that because advisory panel meetings are short, time management needs to be a priority. “It’s critical to quickly convey key messages, stay on point, and keep a high-level overview of the issues so that the most important points are conveyed up front. Getting sidetracked by issues that aren’t the major focus of the panel meeting can make for an ineffective presentation.”
4. Ensure your clinical study sets you up for success
“Some of the best preparation can come at the time when [a company] is initially designing the clinical study that they're going to be presenting years later. They should be thinking about how they are they going to present the important parts of their device and of their study design,” says Prud’homme. “Panel preparation is key, but it cannot make up for years of [mis]direction.”
5. Enlist the help of an outside partner — and start early
Duggan urges companies that are unfamiliar with the advisory panel process to work with a knowledgeable, experienced partner. “One of the other major challenges [for companies] is anticipating issues that will be raised at the meeting,” she says. “Sometimes companies get so close to their data and information that they may not always see all (these) issues. I think that's somewhere where it can really help to have an outside consultant or an outside party involved in the process early on. Having somebody take a fresh look at the data can identify issues before they arise.” This deep understanding of the scientific, data, and regulatory issues is critical, as it is not just about the style of communication, but the substance of the message.
6. Practice makes perfect
Duggan and Prud’homme emphasize that companies who invest time and effort in the panel preparation process stand a better chance of success on panel day. “One of the key things we recommend to our clients is to hold mock panel meetings. These are essentially practice sessions that are intended to mimic the panel meeting itself,” says Prud’homme. “Mock panels give companies a chance to anticipate questions or issues that may be raised by the FDA and can serve as a critical team building exercise so that everybody is reading from the same book when panel day arrives.”