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

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

“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

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:

0. Objectives

1. Research

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.

If you are interested in receiving a copy of my presentation, or learning more about the Zer0 to 5ive Roadmap™, please reach out to me via LinkedIn or at michelle@0to5.com.

A great way to promote your brand is by leveraging popular trends. Through a few well-managed steps you can create a strong link between your product and a popular trend, giving you an extra boost from the association. One notable example is the recent AR/mobile hit Pokémon GO. The game itself garnered massive amounts of media attention and numerous marketing capitalization articles to follow. In light of such a successful launch, I want to detail how you can successfully capitalize on the next big trend when it gets here.

Timing

In baseball, if you swing a second too late then you’ve missed the ball. The same applies to the launch of a PR or marketing campaign. Timing is important because there will be a surplus of companies and individuals racing to produce content surrounding any trend that beings to grow in popularity.

Pokémon GO launched in mid-July last year. If you hadn’t introduced your marketing idea by at least the first week of the launch, you were already edging on late. Joining the party a month in? You missed your chance. Trends move quickly in the digital age and it’s always better to be one step ahead of the game than even a millisecond behind.

When planning a trend-based PR or marketing campaign, make sure to carefully monitor the news for any pre-buildup of the trend and make sure to launch as close as possible with the actual hype of it. This way you ensure that you can be one of the first thought leaders commenting on the trend or one of the first brands to interact with it.

Focus on the Right Trends

Everyone loves a one hit wonder, but hits like that won’t have enough traction to sustain your PR and marketing efforts. What made Pokémon GO such a great trend to promote was the longevity of the brand and the multigenerational fan base. The first whisperings of this project had both adults who grew up in the ‘90s and young fans of today jumping with excitement to see their favorite characters come to life before their eyes. Buzz for this game started well before the release, and the hype kept growing the closer we got to the game’s release date.

If you are going to use marketing efforts in line with a popular trend, make sure it’s a trend that will last for a while. Even though Pokémon GO has had a decrease in users, it’s still popular and, more importantly, successful. It might be some time before we see another trend as popular as Pokémon GO, but it’s important to keep your eye out for the next trend that will have a potent presence in the media.

Find the Connection

Anyone can associate themselves with a trend, but the more meaningful the association, the more successful the campaign will be. To ensure people are paying attention to your brand amidst the hype of the trend, you need to make sure that your brand has a logical and meaningful connection to the trend. Don’t just talk about a trend for the sake of talking about it. Talk about it because it is relevant and you have something to add to the conversation. In any media or marketing relationship, you are looking to provide each other with relevant and useful information.

So, if you are trying to promote your brand in association with a big trend like Pokémon GO, find the logical connection before you promote. If you are a floral shop, a marketing idea could be creating Pokémon-themed floral arrangements that you give away to local stores with Pokéstops, an integral feature in the game. This type of “trend ride” is relevant, fun, and helpful for others, which is a great recipe for receiving positive media praise.

Overall, trend-based campaigns are an exciting and creative way to help promote your brand. With the correct attention to detail, you can create an interactive campaign that helps form a meaningful bond to a trend and successfully promote your brand. Pokémon GO may have had its time to shine, but will you see next year’s hit trend before it’s here? And, more importantly, will you catch it in time to capitalize on it?

By: Jaimie Yakaboski

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

Surveys and statistics can lend a powerful punch to PR campaigns. When a PR pitch is supported with credible numbers and statistics, it is much more likely to get the attention of the media and be interesting to the public.

There are multiple ways so conduct surveys – phone, online, focus groups – but among the easiest is using an online survey company, such as SurveyMonkey, which enables you to create and deploy surveys quickly and easily.

How do you create a survey that will produce interesting content, and what do you then do with that content? Below are some tips for developing, deploying, analyzing and promoting surveys for PR campaigns.

1. Pick a compelling and relevant topic – Don’t conduct a survey around a topic that no one cares about or that doesn’t align with your client’s goals. For your results to generate publicity successfully, you need to share information around a topic that will be of interest to your target audience. Along the same lines – don’t pick a topic that is so common that there are 100 other surveys on the same subject. The topic should be compelling and unique enough to make the findings newsworthy.

2. Be statistically significant – When deploying your survey, make sure you collect responses from at least the minimum number of people required for valid results. Most online survey services have tools to help you determine what that representative sample of your audience is. Not only does this generate real scientific credence, but it also gives the immediate impression of legitimacy when you have a substantial sample size bolstering your statistics.

3. Start backwards – Nothing is worse than investing effort and money in a survey only to realize you left out some key questions, or that the way in which the questions were worded failed to give you the information you wanted. When writing the survey, start by thinking through your ideal survey results first. What types of findings will support your campaign and be the most compelling? Think in pitch angles and headlines. Then write the survey with those headlines in mind.

4. Keep it short – Organize your survey questions in a way that creates a narrative flow and helps you tell a story with the findings. Ask broader questions – e.g. questions on the industry or market trends – at the start and then narrow the topic to ask more specific questions that relate directly to the product or service you are promoting. In general, surveys should be no more than 25 questions. Take the survey yourself. If you need more than 5 minutes to complete it, cut it down.

5. Ask, and then ask again – Consider asking the same “key” questions several times, in several different ways, to ensure that you get the data points that you are looking for around your main survey topic. This will provide you with multiple data points to support your campaign.

6. Check your stats – Before you publicize your findings, double-check the numbers to confirm accuracy and ensure that the information has all been interpreted as intended. One wrong statistic can impact the credibility of the entire survey.

7. Promote the findings in multiple formats – Announce the findings of the survey through a press release and through your social media channels. You can also create an executive summary to showcase the details and post it on your website. Use the findings throughout the year in media and marketing efforts, including pitches, social media, press releases and web copy.

8. Get graphic – The media loves visual content that they can share with readers. Incorporate colorful graphics and charts into your executive summary to illustrate the findings in exciting ways. Create an infographic that summarizes key data points and tells a story. Make it easy to share via social media and watch your reach increase.

9. Slice and dice – Parse your data in different ways to tailor your results for specific reporters and/or target markets. Create pitches, infographics and press releases on different key themes from your survey, or break down the stats by age, gender or geographic region to uncover additional insights.

10. Time it right – Time the release of the findings with a key event, such as a conference or tradeshow, or a relevant awareness day to maximize the news value and increase visibility. You can also create a survey that you conduct annually to give a year-over-year update on key data points and track changes and trends within your industry.

There are many ways that surveys can be used in PR campaigns to educate target audiences and increase awareness for products and services. What are some ways you use surveys for PR?

By: Jennifer Moritz

Getting great coverage for your clients isn’t always easy. It takes creativity, determination, and strategy.

The task becomes even more difficult when a major, global news story is breaking, and that becomes the only topic that editors are interested in.

As a PR person working with healthcare clients, it seems as though every reporter is looking to link their stories to Ebola in anyway they can. If that’s not an option for you, as it isn’t for me, here are some tips that will help ensure that your clients get the visibility they deserve.

1. Address the obvious. Attention grabbing subject lines that acknowledge the “crisis” are a must. Examples might include: “Stop reading about Ebola and read my pitch” or “Not another Ebola story idea”.

2. Utilize your “friendly” contacts. Establishing relationships with reporters and staying in touch, even when you have no news, is important. Building these relationships over time can lead to you becoming a reliable and credible resource for the reporter, and as a result, one that can reach out no matter what is going on in the world.

3. Get personal. I imagine that reporters loathe the standard “Hi, here is my press release, please speak with X and write an article.” Actually, I’m not imagining it…reporters despise emails like this. Acknowledge that you know what the reporter covers, reference the awesome article or Tweet he or she just posted, and why your client/product would be such a great fit. This can move mountains, and it is how many friendly relationships begin (see above).

4. Widen your net. You’re trying to secure coverage for your client with a health-related product in the middle of a health crisis. Avoid reaching out to general news, breaking news and main health editors. Expand your reach and try to think of unexplored avenues – what about women’s health outlets, natural health outlets (if applicable), or mommy blogs?

5. Social media is your friend. After you have flooded the inbox of the reporter who is just so perfect for this pitch and you know it deep down, so much that it hurts with 7 “just following-up” emails, it’s time to try a different route. Follow the reporter on Twitter, connect on LinkedIn, invite him or her to like your client’s product/company page on Facebook, and start following up. Plus, the limited characters will help you to avoid babbling on and on – make it short, sweet and convincing. Example: @reporter, being an annoying PR girl, bc I really want to introduce you to [product]. Know it would be a great fit. Best way to connect?

Post by Maggie Deiseroth, Strategist

Every August, I feel the end-of-summer blues and come Labor Day, I am over them – energized by the Fall sprint for sales, lead gen, brand building and awareness. I love the adrenaline that comes with taking a tally of the year so far, but knowing that there are four great months left to make an impact. Have you ever wondered why there are so many conferences, trade shows and new product launches in the Fall – it’s because this is a great time to re-engage – and our prospects and customers are ready to pay attention. There is electricity in the air.

Last summer, we launched the award-winning Popmoney payments service for CashEdge, but it was the momentum and marketing support that we rolled out last Fall that really made the difference – webinars, HTML emails, ongoing media relations, speaking opportunities, online engagement, demos, etc. The result was literally hundreds of leads, top-tier media coverage and the buzz that comes with the engagement and awareness of an entire industry that was ready to engage and pay attention.

This September, we are preparing for the launch of a major innovation in healthcare, the launch of a new brand for a client, a new day in cash handling, new solutions for food safety and the ongoing drum beat of HIV/AIDs awareness and testing.

I can feel the excitement in the air and the sense of urgency ramp up as business closes its doors on the summer, customers and prospects send their kids back to school and Fall begins.

The start of every year brims with opportunities for great marketing and results. Here are some key take-aways from 2009 as we move into 2010.

Key Marketing Take-Aways From 2009

1. Your message and brand fundamentals are as critical as ever

2. The addition of a multitude of new channels via social media only means that it is more important than ever to understand who your audience is and where they get their information

3. The press release is not dead – in fact it is more versatile and useful than ever before

4. SEO is critical, but it must be aligned with traditional marketing strategies

5. Customers and prospects still love – and react to – great creative in all its forms

6. Customers will tell you what you want to know if you ask the right questions

7. In an age of electronic communications, a phone call or hand-written note goes a long way. Along those lines, bulky direct mail gets opened

8. Despite the decline of print media, nothing makes a client more excited than seeing their name in print

9. A great customer reference is invaluable

10. Measurement in all its forms continues to be a challenge – but it can be done and with the growth of web analytic, instant metrics are becoming an industry standard.

And, as always, an integrated strategic communications plan that takes into account all facets of marketing and public relations always delivers the best results! Begin 2010 with a resolution to make your marketing count.

Post by Zer0 to 5ive CEO Michelle Pujadas