Maximizing Visibility for Medical Devices Throughout the FDA Approval Process

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
  • Launch

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.

Launch

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.

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By: Jennifer Moritz, Managing Principal

The Keys to Successful Media Pitching

As public relations professionals, one of our main responsibilities is to build relationships with the media on behalf of our clients. Developing a good rapport with a member of the media can result in interview and byline opportunities you’ve pitched as well as opportunities where a reporter proactively reaches out to use a client as an expert in an upcoming piece.

In order to foster a great relationship with a member of the media, a PR pro must first understand the keys to successful pitching. Understanding what a reporter is looking for will enable you to draft pitches that will not only be worthwhile to the reporter, but also to you and your client.

Here are five things to remember before you develop your pitch:

  1. Facts, Facts and More Facts: The media loves hard facts, so beginning your pitch with a reputable, eye-opening statistic to address a pain point is a great way to get a reporter’s attention and spur his/her interest in the topic you are pitching.
  2. Hard News Is Great News: You can pique the media’s interest by pitching them hard client news such as new products, acquisitions, partnerships, etc. In some cases – when newsworthy enough – you can even use these types of announcements to kindle their interest through embargos or exclusives.
  3. Breaking News and Events: Whether it a recent election or a major conference/event/holiday, you can use timely news hooks to get the attention of a reporter that may already be covering a related story
  4. Catchy Subject Lines: A subject line can make or break your chance of catching the eye of a reporter, as they are often working on-the-go or trying to meet a deadline. Your subject line should be as short and clever as possible, as well as readable from a smartphone or tablet.
  5. Ready-to-Go Content: Reporters are often juggling multiple stories at once, so they may pass on a story idea if it requires them to interview a source and ultimately write another piece. Having “Expert Tips” or “Top-10 Lists” at the ready can increase your chances of coverage. In some instances, it can also lead to a byline opportunity for your client.

Keeping these tips in mind, you can now confidently draft a pitch that will get a second look and help you open the door to new and greater opportunities for client coverage.

 

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By Maggie Markert, Strategist

The PR Times They Are A-Changing

“What exactly is public relations?” I get asked this question all of the time (side note: mainly from my mother). For years my answer always included some form of “we work with the media and journalists.” While this still holds true, the answer has shifted a bit as the public relations (PR) landscape has taken on new forms and new channels.

The Media

While traditional journalists are still present and relevant, bloggers are now also regular targets to pitch. Bloggers have quickly made their rise in the PR world, and in some cases can be equally or more influential than a journalist. By definition a blog is a website on which a person writes about personal opinions, activities, and experiences. According to NM Incite, 6.7 million people publish blogs, and another 12 million write blogs using their social networks. With so many people blogging today, it’s important that PR professionals tap into this segment and build relationships with these writers, just as they would traditional journalists.

It’s also important to keep in mind that a blogger may be a journalist for a traditional publication, but who also blogs on the side- perhaps about the same beat they regularly cover, or something entirely different that they are interested in. These blogs can be as equally important for consumers, especially with 81 percent of U.S. online consumers citing that they trust information and advice from blogs.

One last distinction that should be noted is the difference between bloggers and vloggers. Bloggers typically write pieces, where vloggers capture videos. With so many social video platforms taking off- Snapchat ,YouTube channels, Instagram Stories- targeting vloggers should also be a standard practice for PR professionals as well.

Embrace Contributed Content

Pitching the same reporters, bloggers, etc., can sometimes feel repetitive. As PR professionals, it’s our job to think of new ways to get our clients into key publications. It’s easy to get a client’s hard news written about, but it’s a bit more difficult when the news is few and far between.

One popular and effective way to get clients into publications is to offer contributed content or bylines. In these contributed pieces, top-level executives or experts in a particular field can discuss forward-thinking thought leadership topics. Bylines are a good way to showcase a Company’s expertise on a certain topic. As a best practice, it’s good to vary the expert who authors the bylines to showcase the depth of leadership and experience at the company.

Social Media

People tend to think of social media as an entity that is separate from PR. However, social media is just another channel that PR Pros can use. PR pros should aim to leverage all relevant social media channels to further engage audiences and build awareness. Repackaging news or articles, or creating the perfect 140-character sound bite and hashtags are all part of the new PR.

Conclusion

It’s important for PR professionals to stay current with emerging and established channels to optimize brand awareness and engagement. Public relations goes beyond pure media relations to engage multiple publics through multiple channels- and in today’s world it’s about meeting your customer where they are, whether that’s a traditional trade publication, the daily newspaper, or the latest vlog.

 

By: Lindsay Hull

Content Marketing vs. Public Relations: Why New Ways to Publish Don’t Replace PR for B2B Companies

The last five years have seen a marked changed in the way content is generated online. Instead of relying on a newsroom staffed with journalists, online media platforms are trading on their infinite column length of free content from outside sources. What was first a cost-cutting measure is now a potential money maker has the views generated help bolster advertising revenues at a fraction of the cost of internal writers and editors.

This change has given individuals the ability to publish their work alongside journalists with only small cues to differentiate them to the reader (e.g. Crunch Network on TechCrunch or being labeled Contributor on Forbes instead of Forbes Staff). Becoming a contributor can build personal brands for an executive, but often times the company’s presence is reduced to a line in the author bio.

In parallel, the value of the company internal blog is diminished (setting aside the SEO and long-term thought leadership benefits). There is more reach to be had in writing content for an external platform with vastly greater views and social media presence than a company blog where it can be hard to break out beyond an existing bubble.

In addition to contributing content to online publications, the rise of Medium and LinkedIn Pulse adds another channel for companies and individuals to share their story. These platforms facilitate sharing and “following,” which makes them a stronger blend of social media and publishing than other “unconnected” platforms.

In spite of these new ways to publish content and drive reach, earned media generated by public relations holds onto its value for three key reasons:

Credibility

While Americans have flagging trust in mass media, the outlets and topics relevant to B2B companies, especially in the technology space, still hold relevancy. If a journalist or blogger who is a respected subject-matter expert writes a positive piece on a company or product, it provides outside validation that cannot be matched by a self-written or self-published article.

Visibility

Visibility can be twofold when talking about media coverage. First is the impact in the search engines. According to Google, 89% of all B2B buying researchers use the internet as part of their process. Odds are, the weight assigned to a media site by Google outranks most corporate sites, so if a media article hits a powerful keyword phrase that reaches buyers, it creates a new indirect path to a company.

Second is the audience of the publication and writer in terms of daily readers and social media followers. Anecdotally, editorial pieces often receive better placement on websites and more attention on social media. This varies from site to site, but typically when time, effort and cost have been placed into a story, the media promotes it at a higher volume.

Subject Matter

Surprisingly, when comparing editorial coverage to self-generated content, companies can see more of their message come across in the pieces they don’t write. That’s because when contributing content, pieces must remain vendor-neutral, and when self-publishing on a blog or social publishing platform, it’s poor form to drop in self-serving superlatives to thought leadership content.

Yet in media coverage, when executives are interviewed for a story, their words are often printed verbatim and can be reinforced by the writer. One company’s talking points can become anchors of a trend story or industry roundup that has broader appeal than a single company profile.

Content marketing has its place in the quiver for B2B companies looking to drive leads, engage audiences and build brands. However, to truly hit the bullseye, classic PR and media relations efforts must remain a constant and core part of the communications strategy.

By: Bob Minkus