Pursuing FDA approval for your medical device can be an exciting time for any company in the healthcare space. Whether you are taking the path of the FDA’s premarket approval (PMA) process or the 510(k), the regulatory milestones along the way create multiple opportunities for a company to begin generating visibility and awareness for the product.
These key milestones include:
- Clinical Trials
- PMA/510(K) Submission
- Advisory Committee Meeting
- FDA Approval
A PR strategy that beings at the start of clinical trials and keep key stakeholders informed along the way will enable you to be prepared for each step, maximizing visibility throughout the process, and hit the ground running once your product receives FDA approval.
Clinical Trials – Announcing the commencement of clinical trials (first patient enrolled) and the achievement of key milestones can be announced through press releases and promoted to the media. At this stage, it is important to identify your top media contacts and influencers so that you can keep them informed throughout the process. Phase I and II clinical trials will generate the most interest among trade publications, while Phase III trials will be of interest to a wider array of media, potentially including mainstream media.
Once the clinical trials end and the submission is being prepared, it can be a good time to launch an issues campaign that supports the need for your device in the industry, educates stakeholders and helps build awareness. This type of campaign can help lay the groundwork for the filing and advisory board meetings.
PMA/510(K) Submission – Prior to the company submitting its application for FDA approval, it’s important that all the pieces of the communications strategy are in place to support the company through the advisory meetings and begin the push toward launch. This includes finalizing key messages and supporting points, identifying and preparing KOLs, and conducting any non-clinical research that will help support the launch of the product, such as market research or surveys. The PMA submission should be announced through a press release and interviews with key reporters should be scheduled with company executives.
Advisory Committee Meetings – Advisory Committee meetings leading up to approvals are a key milestone for awareness and visibility. It is important to issue a press release in advance of each meeting – to announce the scheduled meeting date and to inform media of this important milestone – and also to announce the outcome immediately upon the close of each meeting, preferably the same day. Industry media are likely to attend these meetings, particularly if your device is high profile. You can contact the FDA communications team assigned to your device category for additional insight into which media have registered to attend the meeting or might be there. Therefore, company spokespeople should be prepared with media talking points and a QA in advance of the meeting for on-site interviews. Key media contacts not in attendance should be briefed via phone as soon as possible following a successful meeting.
FDA Approval – Assuming that all goes well, the FDA will alert the company that the product is “approvable” and a date will be set by which time your company will receive official word of approval. While it is sometimes hard to know the specific date that the approval will be received, you should be prepared with all materials and communications plans in place so that you can push out the press release immediately upon notice. All key reporters should be pre-briefed on milestones to date and the outcome of the advisory board meeting. Key KOLs, clinical trial sites that you are using for media, and others who will serve as media references should be media trained and provided with key message points. Photos, videos and other multimedia assets should be prepared, captioned and made available on your website for download (this page can be hidden until the approval is official.) Once the FDA approval is formalized, an aggressive PR campaign in support of the product can begin.
Likely there will be some time between FDA approval and the actual commercial launch of the product to target market. At this point, you should have a strong foundation of visibility and awareness for your product, which will help you build momentum towards the commercial launch. But that, my PR friends, is a topic for another blog!
Any tips to share for maximizing visibility through the FDA process? Let us know.
This past Thursday, I had the opportunity to be the keynote speaker at the Plexus Healthcare Innovation Hub in Philly. What an amazing place for health tech startups, especially medical device companies to get started – the space, equipment, people and networking at Plexus are incredible!
I was lucky enough to follow two amazing demonstrations that kept everyone glued to their seats and fully engaged – the first from Dr. Alan Flake of CHOP, who demonstrated an artificial womb that has the potential to significantly decrease the mortality and birth defects that can arise with premature births, and the second from Dr. Johann deSa, founder of Instadiagnostics, which is innovating healthcare at the point of care. Both companies have the potential to have a tremendous impact for patients.
My presentation was focused on how to develop a GTM plan for these types of startups that can stand up to the scrutiny of seed or first round funding. I was excited to present because not only do I love to see what’s coming next, I want to help what’s coming next get funded, get to market and get adopted.
My presentation followed the steps of the Zer0 to 5ive Roadmap™ – what you need to do to get to the point where you can develop a defensible GTM plan, especially necessary when you are looking for funding. These steps are:
2. Positioning and Messaging
3. Brand Strategy
4. Brand Identity
5. GTM Plan
As part of the presentation I also gave out this handout, which includes tips for conducting research. Basic competitive, industry and prospect research is within any entrepreneur’s grasp – you just need to know where to look and what to look for. My Tip Sheet will help!
One thing that I emphasized throughout the presentation was setting realistic and measurable goals. Too often entrepreneurs, in an attempt to impress investors, are unrealistic as to how hard it is, and how long it takes, to actually get your product market-ready, launch and acquire customers. Your objectives need to reflect your reality of time, money and resources, as well as market readiness and competition. Seasoned investors will appreciate that you understand the road ahead.