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

Four Tips to Getting Client Coverage When They Have No News

A client with a strong pipeline of newsworthy announcements is as exciting as winning the lottery to most PR professionals. The media craves hard numbers, customer partnerships, funding, and new products. More often than not, however, early stage companies don’t have a never-ending stream of announcements. This can be a major challenge, but nearly ten years in the industry and numerous start-up clients have given me some great ways to make sure that a lack of hard news doesn’t mean a lack of great hits.

Look to Executives and Unique Employees

It might be time to refresh your media contacts that cover entrepreneurial journeys. There are full publications that solely focus on productiveness, leadership, and management styles. Entrepreneur.com and Inc.com often feature small companies and start-ups with distinct perspectives. The New York Times has a recurring section called “Corner Office” dedicated to leadership and management.

In addition, find out if any of the company’s employees have any extreme hobbies or interests that impact their business style. Does the CEO fly a plane or volunteer with his therapy dogs? Sometimes it’s the people at an organization and their stories that grab the attention of reporters, which can lead to coverage of the company.

Stay Local

Local publications like to see the impact that your client is making in the community. Does your client participate in local volunteer work? Has their company grown recently in size and/or revenue, adding more jobs? Do they simply have a cool office space? All of these angles can lead to securing media coverage. Explore the various news sections of your clients’ local media outlets and see what angles are available.

Create Your Own Content

With a 24-hour news cycle, publications are always looking for high-quality, pre-packaged content from experts. Now is the time to pick a couple of “topics to own” – areas where your client is expert – and pitch targeted bylines to publications that accept them. If you’re not sure where to start, set up an interview with the executive you’re working with. Ask good, reporter-style questions and look for an angle that’s a little bit different than all of the other articles on the topic.

What’s Trending?

Chances are that you are already monitoring news in your clients’ industries. Use this to your advantage. If a competitor is getting covered, pitch those same media contacts. If a certain topic is trending that your client can speak to, introduce them to the relevant reporters and editors for follow-on stories. In times of sparse news, it also pays to think outside your core media list and look to writers in associated areas or verticals.

There is no shortage of PR professionals working to get their clients media coverage. In fact, it is estimated that there are four times more PR pros than journalists in the U.S., all competing to get their clients coverage. With that in mind, it’s important to remember that no matter which path you choose to secure media coverage, knowing your audience and standing out from the crowd should be at the core of your strategy. Happy pitching!

By: Alyson Kuritz

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

Five Steps to Ghost Writing the Perfect Byline

A byline article is a great opportunity for a client to tell their story. They can use their own words and voice and are typically positioned as an industry thought leader. Often written by public relations professionals, these articles are published with the client’s name. For PR pros, that means delivering a well thought out and written piece. Luckily, with a little planning and attention to detail, your byline article can be perfect. Here are a few tips to remember:

  1. Research: This sounds simple, but there are many factors you need to consider before writing. Reading past interviews of your client is a great way to get a feel for how he or she communicates and will help you to determine the right tone. Reviewing approved language on the client’s website and in their marketing materials, such as brochures and case studies, will help you accurately describe things like the company’s mission, products and more. In addition, make sure you research the publication in which the byline will be placed. This will help you understand how the publication wants pieces written.
  1. Plan and Outline: Creating an outline for your byline before you begin to write will not only help with time management, but it will also strengthen the structure of the piece. In the outline, you can include statistics, facts, key statements and more. The more detailed your outline is, the easier it will be to write the article. If you need to interview your client (which is always a great idea), this helps keep you on track.
  1. Write: With your research completed and a strong outline in place, you can get started writing. Research shows the best time to write is first thing in the morning, so make sure you carve out some time at the beginning of the day. Take time to stop and read what you have developed every so often to make sure you are on track. Also, give yourself time to write a good first draft – some people can do it in one sitting; others need more time – fine what’s best for you.
  1. Review and Edit: One of the most important steps in the byline writing process is editing. You should review your piece at least three times and always have a colleague review it as well. This will help you catch and correct issues or errors before sending the byline to your client for review.
  1. Get Approval: Having your client’s approval to send in the byline for publication is crucial. Not only does this step allow the client to be aware of exactly what you are submitting, but it will give them an opportunity to make updates or changes to the piece. In addition, make sure that your client approves the piece in writing before you submit to the publication. When submitting the piece, make sure your client’s name and title are included and accurate.

Following these steps can help you write a great byline on behalf of your client. Your client will appreciate it and you will feel confident each time the opportunity arises!

By Maggie Markert

Are you Working on Marketing Outputs, or Outcomes?

During a recent conference, I spent seven hours with local entrepreneurs, marketers, and PR professionals sharing first-hand experiences around marketing challenges and how they solved them. One of the main topics was digital trends and what we, as content producers, should know.

One speaker who really stood out for me was the charismatic Wil Reynolds, Founder and Director of Strategy at SEER Interactive, a digital marketing agency specializing in SEO, PPC, and Analytics.

Wil challenged the group to to ask themselves if they were working on marketing “outputs” or “outcomes.”

What did he mean?

We all get so caught up on making sure we are meeting certain bars or KPIs in terms of numbers and metrics – how many articles did we get mentioned in? How many media impressions did we secure? Did we get more clicks than last month? How many page views did we get? How many more followers?

These are all metrics that PR and digital marketing professionals are expected to report against, on a daily, weekly or monthly basis; and when our numbers are where they are supposed to be, it’s easy to think “hey, we are doing what we are supposed to do, and all is good.”

But at the end of the day, how do all of these metrics translate to customers and sales?

What so many of us forget to do is close the loop on our PR and marketing efforts. Did those extra followers lead to a new prospect? Did the articles you secured get placed in the publications that your customers read? Has our new messaging come across in our media placements? In other words, did all of our efforts result in actually “moving the needle” against our goals?

Wil continued, “In our business, we need to think like a child and ask “why” at least five times to everything we do, to get to the root of the problem. If we don’t know WHY we are doing something, or have any way to measure its effectiveness, then we are just going through the motions and wasting precious time, money and resources.”

So, as you look at your marketing mix, be critical. Don’t just “do”. Ask yourself why are we doing this and how is it going to translate into meeting our business objectives? That’s how you deliver more strategic outcomes, not simply outputs.

By Colleen Martin, Director

Book report: Tips for social media success

A review of social media-pro Guy Kawasaki’s book, “The Art of Social Media”

Sure, you’re engaging in social media efforts for your clients, but are they reaching the right people? Did they make any impact?

If you are already implementing, or are planning to implement, a social media campaign, Guy Kawasaki is a name you need to know. Formerly an advisor at Google and Chief Evangelist at Apple, Guy is an authority on all things social media.

In his book, “The Art of Social Media”, Guy outlines best practices and tips that all circle back to the main focus: Are you earning the right to promote?

What does that mean? It’s easy to share your latest news article or link to your event, but what does that offer your audience? That’s right: little or nothing. It’s too promotional.

Guy uses the example of NPR. Every day of the year, NPR offers commercial-free, quality news, which provides a true value to its listeners. It’s for that reason, a few days per year, they are able to run a pledge drive. NPR has earned the right to promote the drive with 363 days of uninterrupted, respected content.

“The Art of Social Media” uncovers various ways to make sure that you are continuing to provide new, and useful content.

One example is using curation and aggregation services – many of them are free and can provide a wealth of articles and the latest studies to share. Examples that Guy provided include: Alltop, Buffer, Feedly, Google Scholar, LinkedIn, NPR, and Reddit.In addition to these tools, it can be helpful to set up Google alerts on key terms: competitors, industry hot topics, etc. This way, you receive up-to-the-minute information that is worth sharing.

Once you have the content, the next step is to share. There are best practices in how to craft posts for the various channels.

  • Be brief: Posts on Google+ and Facebook should be 2-3 sentences and Twitter has a limit of 140 characters, but 100 characters is really the best practice.
  • Be visual: Every post, no matter where it is, should contain “eye candy” in the form of a picture, graphic, or video. According to a Skyword study, views of a client’s content increased by 94% if a published article contained a relevant photograph or infographic.
  • Be sly: Use key phrases that let readers know they are about to get useful and practical information (i.e. “How to rock___, Quick guide to ___, Essential steps to___)
  • Be active: While this seems obvious, it’s one of the most important tools. Don’t be afraid to repost the same exact post a few times per day. According to Moz, the prime lifetime of an average Tweet is only 18 minutes! It’s much more likely that you’ll gain new followers, retweets, likes, etc. by posting the same content multiple times than it is you’ll lose any due to annoyance.

By Alyson Kurtiz, Strategist

Best Practices: Writing Website Copy

As content marketing continues to drive many of today’s integrated marketing programs, perfecting writing skills for the various marketing channels has never been more critical. Copy for a brochure is not the same as copy for a press release, white paper or social media.

Copy development for a website has its own voice or tone. The great part about web copy is that it can be changed and adjusted on the fly and new messages and call to actions can be tested dynamically for each campaign or target audience. The hard part about web copy is that you need to think about the SEO implications of the text and how what is put on each page affects the visibility of a website or web page in a search engine’s “organic” (un-paid) search results.

SEO is an animal. It is dynamic, always evolving, and quite frankly one of the most technical and, as a result, more difficult aspects of digital marketing. SEO can also often be overlooked. This is often because the role of keeping up with the SEO best practices resides with many people from both technical teams and content developers. There are standard best practices today that, no matter who your audience is or the purpose of your site, should be applied if you are looking to attract visitors.

Off-page SEO: Linking & Content Marketing

Websites can be optimized through activity that does not even occur on your site. For example, links from third parties in media placements or links from partners can drive additional, credible traffic.

Additionally, third party content that results from a contributed article, a blog post on another site, a video or social media, could also drive traffic.

Research: Targets & Keywords

Compiling web copy can be a daunting task. However, what you say is just as important as how you say it.

As with every marketing channel, copy that is optimized for SEO takes into account the target audience or audiences. Identify the audience the pain point they are looking to solve and what unique benefits will drive interest in your product or service. These benefits and differentiators will inform calls to action that are effective and create engagement.

Traditional SEO copy writing focused on keywords. However, these are usually way too broad and have too much competition – the result: you’re lost.

Today, it is best to optimize keyphrases for long tail search queries in order to attract highly targeted traffic. This takes time and research to identify the most popular and common phrases.

In addition to keyword and keyphrase research, Google Adwords provides valuable ranking and insight into the popularity of terms, helping to formulate intelligent decisions on what phrases and words to incorporate on the web page copy.

Technical Aspects of SEO Copy

While dated, the Google SEO Starter guide is a great source of information for the development of optimized content.

This guide breaks down important best practices on how to:

• Create unique, accurate page titles

• Make use of the “description” meta tag

• Structure your URLs logically

• Write better anchor text

• Make use of image alts

Metadata still plays an indirect role in optimizing SEO copy. Metadata is the information within thetag code that doesn’t get displayed on a webpage, but is used by search engines. Metadata influences Google’s and Bing’s algorithms directly. However, user behavior such as click-through rate and dwell time does. Meta descriptions factor into which results a user clicks.

Additionally, as the copy of the webpage comes together, keep in mind that the main body of the text is the most important – not the sidebars, headers or call outs.

Composing Optimized Copy

With the keywords identified and the plan of attack outlined, it is time to start composing the text for the webpages.

For each page, target 2-3 keyphrases, include headers (with keyphrases incorporated), and give headers hierarchical structure. In the body of the copy, weave in keyphrases, synonyms and natural variants.

Implementation

Check your work. There are plug-ins available to verify and confirm that best practices are intact, such as Yoast for WordPress. Yoast is installed during development, manages on-page SEO and publishes XML sitemaps for search engines to crawl.

Once your site is developed and ready to launch, run a pre-launch check to make sure everything is ready to launch.

Now you’re ready to be found!

The Do’s and Don’ts of Writing for SEO

Launching a new website? What is your copy saying? Print this out and make sure you are following these simple rules. Best practices go a long way and can dramatically impact your site’s visibility.

Do:

  • Vary sentence structure to have a combination of longer and shorter sentences for rhythm. Keep sentences under 30 words.
  • Keep paragraphs short and break them into logical sections with headers. Readers need the white space for legibility. Headers also help a page look more visually interesting and are easier to scan. This goes double for mobile view!
  • Use bullets to break up paragraphs and help readers scan list info quickly.
  • Maintain the right tone for target readers.
  • Don’t copy sections of other websites in order to appear more content rich. You may be penalized.

Don’t:

  • Be boring
    • Attention spans are super short. The more readers you lose early, the more your SEO takes a hit. Be dynamic. Web copy isn’t a white paper. It has a mission—give readers what they need quickly and drive them to action.
  • Forget to answer questions
    • Visitors are coming to your site to answer a question, make sure you are answering it so they come back or engage more.
  • Create dead-end pages
    • There must be clear, focused calls to action on every page.
    • Primary CTA—get potential clients and partners to contact
    • Secondary CTAs—newsletter sign up, link to related content