The introduction of a moveable type offered a more mechanized solution for printing, but there was still a need for professionals for artful operation. In the MedTech industry therapies are being automated all the time, but the final treatment is prescribed by the physician, not the machine. There is a necessity to creatively problem solve and compensate for unseen issues that cannot be predicted by technology. The combination of flexibility and knowledge makes what the physician does an art rather than basic data entry.

One challenge of my job is to find out what doctors and nurses are saying about these new devices and incorporate their feedback for better usability and better results. When products are in development I serve as a translator between engineers and users to refine functionality. Keeping that human component in mind, my aim is to develop simplified ways for an array of users to interact with the device so that pertinent information is communicated quickly and accurately.

Truly effective solutions come from a marriage of technology and human interaction. At Ubiquity this is true for everything from user interfaces to marketing strategies. I truly enjoy the challenge of finding the compelling common ground among the seemingly unrelated. Are there skills your job requires that goes beyond the technology of your industry?

A surprising 25 percent of physicians are using both smartphones and tablets in their practices, according to a recent survey by physician training site Quantia Communications. They’re using them primarily to research new drugs (73 percent), treatments (50 percent) and clinical research (50 percent), as well as for diagnosing patients (44 percent).

Most interesting: “Super mobile” physicians, or those who have both a smartphone and tablet, use them more frequently than physicians who own just one device, the study shows. For example, 50 percent of super-mobile physicians use their devices to research new treatments, but only 39 percent of physicians who own just a smartphone do the same.

Physicians overall are adopting mobile technology at an exponential rate, according to Quantia’s data. More than 80 percent of the survey’s respondents say they own a mobile device, compared to only 50 percent of the general U.S. population, according to the Nielsen Company’s “2011 Mobile Connected Device Report.” Forty-four percent of those who don’t currently own a mobile device say they plan to buy one this year.

The data debunks part of the myth of older physicians not being as mobile-savvy. It appears true that veteran physicians (30-plus years) are less likely to use mobile technology overall; their use rates are 27 points lower than physicians in their first few years of practice. When it comes to tablets, however, 20 percent of that same group of physicians already use them, and another 25 percent say they’re “extremely likely” to use them in the near future. Physicians with 20-plus years of experience–not rookie MDs–are actually the most frequent users of tablets, the study shows. Researchers posit that the cost of tablets may be the deciding factor, as younger physicians typically earn less than more experienced MDs.

Hospitals, one of the slower adopters in recent years, are getting on board, as well. About 18 percent of respondents say their hospital supplied their mobile device.

Despite all this mobile enthusiasm, however, core obstacles to mobile adoption remain, physicians indicate. The big problems are still security/patient privacy (54 percent), concerns about physicians’ liability if they provide care via a mobile device (45 percent) and reimbursement, or how physicians can get paid for mobile-enabled care (35 percent).

Not a surprise, but interesting data nonetheless, is Apple’s continued domination of the mobile health space, at least for physicians. More than 60 percent of smartphone users have iPhones, and virtually all the tablet users had iPads, according to the study.

The study was conducted online in May among nearly 3,800 physician members of QuantiaMD’s service. Read full study. Content provided by Fierce Mobile Healthcare.

Where are the violations?
30% of DDMAC Warning Letters in 2010 cited internet violations. Trade shows were the second most common area for violations. New FDA Guidelines for internet are due out in Q1 or Q2 2011.

What can you do to prevent violations on the internet?

1. Develop a review process for all communications and use it relentlessly with a digital signature.
2. You will need to monitor what others are saying about your product. Be a good listener on social media sites. If a customer or other user is making false or misleading claims about your product, create a process to notify them and document the notification.
3. Regarding database and SEO, you may enter your product in databases or search engines for similar products or supplemental uses; you may not make suggestions or representations of unapproved uses in your communications.
4. Update promotional review policies to consider risk communication on the Internet and sponsored links.
5. Choose a marketing firm with experience and education in Medical Device promotional compliance.

What can you do to prevent violations at trade shows?

1. Always review materials for each new venue and audience.
2. Train all of your trade show staff completely prior to each and every show.
3. No hand-made materials – meaning sales staff shouldn’t show up with hand- made power point presentations!
4. Insure that you have provided all reporters and analysts with the correct information and document this. If they make a false claim later, you are protected.
5. FDA allows the display of a medical device with a pending 510(K) premarket notification under review with the qualifier that the product is not cleared for marketing. You may not take orders.
6. Separate commercial and investigational products within the booth to make clear the regulatory status of each product. A good booth design should allow for change and evolve with each new venue and audience.

Here is a useful sites for FDA Promotion regulations.

It’s important to note that this wasn’t a clinical conference, rather a forum where presenters can share their ideas on health, medicine and the human spirit. The Hotel Del Coronado provided a tremendous venue to soak in all the information and a little salty air.

As a medical device marketer, I would like to share some ideas that I’ve applied to my life and business:

1. “Whatever you can say, you can say it simpler.” – Thomas Goetz, Chief Editor for Wired Magazine.

The irony here is that it took someone who makes a living writing/publishing about cutting-edge, complicated technology, to tell us to simplify.  The audience completely agreed. Medical marketing communication is thorny and convoluted due to fear of the FDA, competitors and public idiocy. Medical communication has lost its hierarchy of importance, personalism, and truth.   If we simplify that, we can get back to what’s really important.

2. Eat Less. Move More. And Relax.

Conceptually, this is as simple as it gets. Who said medicine was a tough subject to learn? Kidding aside, it turns out the US is on target to be at Pandemic levels of Type II Diabetes by 2014. The impact of Type II was a reoccurring conference theme, not just because of effected patient populations, but also the burden on our healthcare system and the economy. Type II is mostly preventable by living a healthier lifestyle, which includes eating more plants and moving more.

One of my favorite speakers was Deepak Chopra. He talked about the importance of relaxing and how it affects our physiology. How we think, our conscience daily choices and what we believe can impact our physical health, positively or negatively. It’s important to stay present, not to discount joy and be accountable for your own health.

3. Cancering – It’s a verb.

We have to think about disease and health differently in order to make any progress. Cancer is no different.  As researchers discover other strains of cancer, they also identify different stages and manifestations. Cancer is a process, like baking. It’s not a destination. What might seem like grammar semantics is actually a new way of thinking about the issue.

4. Everyone should know how they want to die.

With life comes death. As we age, it’s important that we share, with our loved ones, our final preferences. What does this have to do with medicine? Everything. Go to The One Slide Project to get the 5 questions, share them and answer them for yourself.

5. “Imagination is more important than knowledge.”  Jay Walker.

As a creative problem solver, how could I not love this quote? Jay, the founder of Priceline, has collected rare books and prints then started the Walker Library of History and Human Imagination. With his own great imagination and generosity, he has built Medica, an iphone/ipad app of medical illustrations and image from these rare volumes.

If TedMed taught me one thing it’s that our imagination is impressive. From medicine, technology, even joy… if we can think it, we can do it.

Here is an example of what I commonly see:

A well established company puts together a terrific online campaign. They have the right list, the right creative and the right offer. However what they don’t know is that the viewers will be trying to view this information on their smart phones. Some of their audience is on blackberrys, others are on android phones, while some are on the Iphone.

This email had great images, and links to their website and a downloadable white paper. This emailed failed to be opened beyond what was on the browser screen due to many reasons.

Here are some top items to consider when having a mobile experience.

1. Mobile websites only need to have about 20% of the content and navigation that your main site has.

2. Images: Have limited images as they take time to load and will have your user deleting your message.  My current recommendation is to have pages less than 20K. Remember cell companies are now charging by the download.

3. Content: Optimize your content to be viewed on a mobile phone. Offer up a smaller version of whitepapers that entices the reader to want to learn more. Have a text only version of your site in the event some only view information in this manner.

4. Utilize share buttons on the mobile page. Let your user easily email, Like you on Facebook, LinkedIn and Twitter.

5 Testing: Although many companies do not have access to multiple mobile browers and products there are online  web based emulator tools such as Iphone Tester.

6. Design: Although the experience on smartphones are becoming more intelligent, you must also think of the lowest common denominator. Some of the best mobile designs are one column and a maximum of two columns.

Using a few best practices will help your email and content get read and thus help you get through to the right contact.

Let us know what you think and what is working for you.

Happy a happy mobile day!

Maybe it would be better to just simply call this a bloated heart condition.

Thanks to Google Health for the following image: https://health.google.com/health/ref/graphic/18123

To view some of the links and thoughts: search hashtag on Twitter: #0ms10

More info will be posted on this blog.

Tuesday October 12th, 2009:
I sat in on a session called: Bringing medical devices to the U.S. market.
Great information and will post thoughts and info.
I moved to a second session as I wanted to hear what was said on social media. It is interesting that they are talking to this group as if they have never been on a blog before.
Crisis Prevention & Risk Mitigation 101: 5 things Every company must be prepared for:

We have 5 panelists who are talking on a variety of topics.

• Brett Berty: Sr. Recall Strategist, Stericycle, ExpertRECALL
• Christian Haller: General Manager: MPR Product Development
• Don Houghton: Director of Crisis Contact Center, Academic Network
• David Bartlett: Levick Strategic Communications
• Willie Bryant: Former FDA Senior recall coordinator, Steri ExperRECALL

Recall Communication Strategy by David Bartlet of Levic Strategic Communications:

I enjoyed listening to David and I see he even has a book. If I had a medical device recall and needed a spokesman, this would be the guy.

• Get out in front of the story: Who better to tell the story than you. Don’t let others tell your story, good or bad.
• Think like your audience: Are you in the medical device business or the safety business.
• Choose the right spokesperson: Someone who knows how to say, “I don’t know”.
• Understand the importance of the online blogs: It is not your father’s media anymore. There is no such thing as the new media. There is the media and the “old” traditional media. Treat bloggers like journalists. Journalists turn towards bloggers for info. If your not playing in that arena, your dead before you begin. The people you are trying to reach are not being reached through old media.
• Ensure your statements match regulatory actions:
• Know the regulators and stay in touch:

When a recall happens you need to think of the following.

Apologize: Don’t grovel, emphasize with your audience about the future not about the past. What your doing to make this right. The more you defend yourself you send the message that you are trying to defend against something.

Describe what happened: Don’t let the story dribble out. We have all seen the stories that should have been a one day negative story and was dragged on for weeks.

List steps you are taking so FDA and your team understands direction.

Advise consumers: Give public something they can do, they can control to solve the problem. They were reassured and started to relax. Thing about the emotional predicate with the audience your trying to reach. They want to make sure they are doing something to be involved.

EColi in Ground Beef: If you cook a hamburger to 160 degrees to kill all bad things you will be eating charcoal briqets, not many people do, but knowing about this makes you feel better with decisions you are making.

Provide frequent updates: Continuously update information and don’t be afraid I don’t know. Practice saying this: “We don’t know that yet, we are trying to figure it out and you’ll be the first to know when we have figured it out. ”

Present a human face: Remember you are communicating with real people, just like you. Remember the crisis is about them, not about you. It is understandable for you to worry about you, the millions of dollars your spending or losing but it is magnificantly irrelevant. Think patient first then the company or there could be no company in the future.

FDA Recall Audits with Willie Bryant who was the former FDA Sr. Recall Coordinator.

Here is a quick review on what happens with FDA recall audits. Lets hope you don’t have this happen.

An audit is an inspection by FDA, audit checks and status reports. The Investigation Operations Manual (IOM) is the guidance to FDA investigators.
Class 1 & @ recalls “should” have an inspection to determine the “root cause” of the problem(s).
In most cases for devices or pharmaceuticals, inspection is after notification to FDA and the public. May be immediate (class 1) or months later.

The FDA inspector will be looking at key areas and asking questions:

• Review complaint investigations for adequacy.
• Injury/Illness complaints reported under MDR?
• Has the manufacturer taken appropriate corrective action? If not, get timetable!
• Investigate all areas, control points, and circumstances which may a bearing on product deficiency including batch records, processing logs and other related logs.
• Industry conducts “effectiveness” checks, FDA conducts “audit checks”
• Class 1 recalls: FDA expects 100% documentation of consignee notification and appropriate reponse.
• Documentation of notifications, responses and returned product important to justify termination of recall.
• Weekly, bi-weekly, or monthly depending on recall circumstances and FDA desire for info.
• Critical to FDA’s evaluation of recall and your request for follow-up.

Reference: FDA’s Investigations Operations Manual, Subchatper 7.2 Recall Notification/Inspection

You can download for free on FDA’s website.

Brett Berty, Sr. Recall Strategist for Stericycle ExpertRECALL: Going to talk about comman mistakes that people make when making a recall. Have done over 1500 recalls for companies.

Three Goals of any recall:

Protect the Public

Protect Your Brand

Recall Lifecycle: 7 Steps to consider.

So many companies do not even have a plan about what they would do if they get a recall. Practice, Practice Practice.

1: Preparation: What are you doing right now to be prepared for recall. Do you have team in place? SOP in place? Do you understand your roles and responsibilities? Do a mock recall and get everyone together and watch decision making process? Everything you think is right will be wrong.

2: Target / Consignee Identification:

3: Notificaton Management: Who are your customers? How does the notification work? Can’t just email out to a list? If you sell through distributor, will they give you a list, will they notify their customers.

4: Response Management:

5: Product Processes:

6: Remedy : Have to know what the remedy will be before you send out recall info. You may need to send out recall before having an remedy but control this with proper press release and communication as David Bartlett from Levick Strategic Communications discussed.

7: Resolution Management:

Additional questions to ask:
What is my call to action. Keep the call action simple. Here is what you need to do and here is what we are going to do.

The big take away: Have a plan, practice your plan, re-work your plan, prepare and have a spokes person and train your executive team on what to say and how to say it.

More info to follow as I continue to listen and meet some amazing people.

Greg Olson :: Ubiquity
Ubiquity specializes in generating demand for life science companies.
Greg@ubiquitygroup.com 303-962-8700

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What is Social Media? It’s the use of technology combined with social interaction to engage and participate in conversations. Instead of one-to-one conversations, it’s one-to-many conversations.

The social media space includes blogs, RSS, social search, social networking and bookmarking.  This quiver of tools gives the savvy marketer the ability to create richer communications to generate new business.  Now, it is easier than ever to build up thought leadership and credibility online by posting articles, blogs, video and pictures.

A Quick Snapshot of Social Media Tools:
LinkedIn: Most likely, you are already using LinkedIn for your professional network, quite possibly with a group related to your association.  If you don’t have a profile set up or have an updated profile, go to LinkedIn.com. Tip: Use the Q & A section to build up thought leadership.  You can join up to 50 groups and submit relevant news articles that you enjoy to the groups you belong.

Facebook: Many people are only using this for their personal online community. I recommend that you keep this to friends and family.  Business contacts can join your association’s Facebook fan page. Tip: Join relevant Facebook groups to find potential members/customers, articles and industry information.

Jigsaw: This is a great tool for prospecting and an excellent way to find contacts within an organization. Note: There is a fee for this service. Tip: Combine Jigsaw with LinkedIn to find contacts.

Twitter:  This is really just a Microblogging site. Twitter is a great tool to use for research. Tip:  Download Tweetdeck and use the search tool to find conversations about topics of interest to you and your business.

Social Media Submission Sites: Digg is a social news website made for people to share content. Digg allows you to submit articles that people can give a thumbs ups or thumbs down. Tip: Digg is another way to build up thought leadership, and a treat place to search for content.

Slideshare: This is a great site to post your PowerPoint, PDF and Word presentations. However, be sure not to post any proprietary information. Posting builds up your credibility and adds to your thought leadership reputation. Tip:  You can also link Slideshare with your LinkedIn profile.

Blogs: Technorati is an online tool to search for relevant blogs. I don’t recommend starting a blog until you are committed to keeping it updated. Tip:  Rather than starting your own blog,  find blogs that are interesting and post your comments and feedback for others to read.

Ning.com: This tool allows you to search existing online communities or start your own for free. Tip: Ning is a good place to join online communities that are of personal interest.

Social Media Monitoring:  It’s important for you and your organization to listen to the online world first, before engaging. This will allow you to formulate a plan and determine the key online communities that are a fit for you. Social media monitoring uses key words to search for information. This is a great way to keep up on what people are saying about your company, industry and competitors. Tip:  Try one of the social media monitoring free services (Tweetdeck, Google Alerts, Yahoo Pipes, coComment and Commentful) or use a professional monitoring service like Radian6 and Filtrbox.

A few tools and tips:
1.  Manage your time with social media. Like any new tool, learning to use social media will take time. Take a little time every day to review, respond and engage in the online community.

Follow the rules:
• Remember that getting involved requires a commitment. Your readers will easily get turned off if you start and then leave them hanging.
• Be honest and authentic with what you post.
• Do not spam. Nobody likes a hard sell.
• Review your employee handbook and make sure you have rules for employees to engage social media tools.
• Assign social media responsibilities to various employees, including your customer service team. Your employees should report back anything relevant to your industry.

There are new social media tools coming out every day, and most of these tools are very simple.

Spend a little time learning about these new tools and finding the ones that make sense for your company. Put your plan together with few simple goals and assess it quarterly.  You will be on your way to conversing and contributing in the Social Media Space!

Ubiquity Group specializes in generating demand for life science companies.

Greg@ubiquitygroup.com
303-962-8700
Follow on Twitter: @ubiquity

For more information: Follow my blog:
www.ubiquitygroup.com/resources