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	<title>Ubiquity Group</title>
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	<link>http://ubiquitygroup.com</link>
	<description>Medical Technology and Bioscience marketing</description>
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		<title>5 Things I Learned at OMS 2012</title>
		<link>http://ubiquitygroup.com/5-things-i-learned-at-oms-2012/</link>
		<comments>http://ubiquitygroup.com/5-things-i-learned-at-oms-2012/#comments</comments>
		<pubDate>Mon, 09 Apr 2012 16:03:49 +0000</pubDate>
		<dc:creator>John Bain</dc:creator>
				<category><![CDATA[social media]]></category>
		<category><![CDATA[Strategy]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/?p=163</guid>
		<description><![CDATA[Last month I spent a day in the basement of the Denver Marriott City Center and it was enlightening. The Online Marketing Summit was a full-day workshop highlighting a range of tactics to connect with customers. Here’s 5 useful lessons. 1. A website is a conversation No one will approach you and ask you “What<a href="http://ubiquitygroup.com/5-things-i-learned-at-oms-2012/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>Last month I spent a day in the basement of the Denver Marriott City Center and it was enlightening. The <a title="Online Marketing Summit" href="http://www.onlinemarketingsummit.com/" target="_blank">Online Marketing Summit</a> was a full-day workshop highlighting a range of tactics to connect with customers. Here’s 5 useful lessons.</p>
<p><strong>1. A website is a conversation</strong><br />
No one will approach you and ask you “What is your mission statement,” so why is it pasted on the homepage of your website? Someone who visits your website is looking for how you will make their lives easier/better/more enjoyable. Most likely you’re not the only one that provides your product or service. Engaging visitors in a conversational manner answers their questions and convinces them to provide you with useful information about themselves. This helps convert visitors into customers. Awareness of the language that you use throughout your site can make this difference. And it can be a result of something as simple as labeling a button “Buy Now”(too aggressive) vs. “Add to Cart”(passive).</p>
<p><strong>2. Marketing campaigns should truly be campaigns</strong><br />
An e-blast does not make a campaign. The average sales person will give up after contact #4, but most decision makers aren’t ready to buy until contact #9. Developing a multi-touch campaign can make the difference. By initiating a campaign that has multiple stages you are allowing prospective clients to explore what you are offering and develop a familiarity with your company.</p>
<p><strong>3. Internet tracking is creepy but effective</strong><br />
One presenter relayed a story about how he clicked on a targeted e-blast he received and within an hour he had received a phone call from the sender to follow up and see if he had any questions about the offer. Creepy. Using information that is volunteered through social media allows you to qualify prospectives before you initiate contact. Combining social media and tracking technology companies can effectively locate, engage and ultimately land new clients.</p>
<p><strong>4. Online marketing takes place anywhere you get internet</strong><br />
This is a simple reminder. A rising number of people aren’t reading your e-blast at their desk in Outlook. They are probably previewing it on their smart phone or tablet device or through web mail. So the templates you’ve used for years don’t necessarily look good in these applications. You always have to consider the wide array of options new technology provides your audience and then compensate for all the variables.</p>
<p><strong>5. It’s important to look at why you do something</strong><br />
Anyone can produce a better widget or provide outstanding service. But why do you do it? What is it about your organization that means prospective clients should choose you? If you have a passion for what you are offering, existing and prospective clients will see it and respond in a positive way.</p>
<p>All of these ideas remind me that technology, when used correctly, can be an extremely powerful tool. But, there has to be more to it. People are skeptical of one-off e-blasts and special offers. When you engage them with continuous, passionate dialog they will not only buy in, they will become your best advocates.</p>
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		<title>Doctors: Button Pushers?</title>
		<link>http://ubiquitygroup.com/doctors-button-pushers/</link>
		<comments>http://ubiquitygroup.com/doctors-button-pushers/#comments</comments>
		<pubDate>Wed, 07 Sep 2011 15:11:45 +0000</pubDate>
		<dc:creator>John Bain</dc:creator>
				<category><![CDATA[medical technology]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=125</guid>
		<description><![CDATA[I recently had the pleasure of touring Genghis Kern, a local letterpress shop. What does letterpress printing have to do with medical technology, you may ask? Simple, the human component. 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<a href="http://ubiquitygroup.com/doctors-button-pushers/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>I recently had the pleasure of touring <a title="Genghis Kern // a letterpress and design shop" href="http://www.genghiskern.com/" target="_blank">Genghis Kern</a>, a local letterpress shop. What does letterpress printing have to do with medical technology, you may ask? Simple, the human component.</p>
<p>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.</p>
<p>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.</p>
<p>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?</p>
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		<title>Mobile &#8216;super-user&#8217; docs utilize smartphones, tablets for research, diagnosis</title>
		<link>http://ubiquitygroup.com/mobile-super-user-docs-utilize-smartphones-tablets-for-research-diagnosis/</link>
		<comments>http://ubiquitygroup.com/mobile-super-user-docs-utilize-smartphones-tablets-for-research-diagnosis/#comments</comments>
		<pubDate>Tue, 21 Jun 2011 17:07:01 +0000</pubDate>
		<dc:creator>Lisa Herter</dc:creator>
				<category><![CDATA[Mobile]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=114</guid>
		<description><![CDATA[Here&#8217;s some interesting new stats on mobile and medical: 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&#8217;re using them primarily to research new drugs (73 percent), treatments (50 percent) and clinical research (50 percent), as well<a href="http://ubiquitygroup.com/mobile-super-user-docs-utilize-smartphones-tablets-for-research-diagnosis/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p><!-- p.p1 {margin: 0.0px 0.0px 13.0px 0.0px; font: 13.0px Verdana} -->Here&#8217;s some interesting new stats on mobile and medical:</p>
<p>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&#8217;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).</p>
<p>Most interesting: &#8220;Super mobile&#8221; 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.</p>
<p>Physicians overall are adopting mobile technology at an exponential rate, according to Quantia&#8217;s data. More than 80 percent of the survey&#8217;s respondents say they own a mobile device, compared to only 50 percent of the general U.S. population, according to the Nielsen Company&#8217;s &#8220;2011 Mobile Connected Device Report.&#8221; Forty-four percent of those who don&#8217;t currently own a mobile device say they plan to buy one this year.</p>
<p>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&#8217;re &#8220;extremely likely&#8221; to use them in the near future. Physicians with 20-plus years of experience&#8211;not rookie MDs&#8211;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.</p>
<p>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.</p>
<p>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&#8217; 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).</p>
<p>Not a surprise, but interesting data nonetheless, is Apple&#8217;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.</p>
<p>The study was conducted online in May among nearly 3,800 physician members of QuantiaMD&#8217;s service.<a title="report" href="http://www.quantiamd.com/q-qcp/QuantiaMD_Research_TabletsSetToChangeMedicalPractice.pdf" target="_blank"> Read full study.</a> Content provided by <a title="Fierce" href="http://www.fiercemobilehealthcare.com/" target="_blank">Fierce Mobile Healthcare.</a></p>
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		<title>FDA Compliance in Marketing – A Company’s Digital Experience Has the Most Violations Followed Closely by Trade Shows.</title>
		<link>http://ubiquitygroup.com/when-it-comes-to-fda-compliance-in-marketing-%e2%80%93-a-company%e2%80%99s-digital-experience-is-the-number-one-area-for-violations-followed-closely-by-trade-shows/</link>
		<comments>http://ubiquitygroup.com/when-it-comes-to-fda-compliance-in-marketing-%e2%80%93-a-company%e2%80%99s-digital-experience-is-the-number-one-area-for-violations-followed-closely-by-trade-shows/#comments</comments>
		<pubDate>Tue, 22 Mar 2011 23:12:43 +0000</pubDate>
		<dc:creator>Chris Hudson</dc:creator>
				<category><![CDATA[Strategy]]></category>
		<category><![CDATA[medical device marketing]]></category>
		<category><![CDATA[medical device trade show know-how]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=105</guid>
		<description><![CDATA[Just finished an AGG webinar that reinforced a lot of things to remember when you are planning your next trade show or digital experience. Here are a few key lessons tempered with some of the down-in-the-trenches experience at Ubiquity. As enforcement is on the rise, we want to help you get it right at the<a href="http://ubiquitygroup.com/when-it-comes-to-fda-compliance-in-marketing-%e2%80%93-a-company%e2%80%99s-digital-experience-is-the-number-one-area-for-violations-followed-closely-by-trade-shows/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>Just finished an AGG webinar that reinforced a lot of things to remember when you are planning your next trade show or digital experience. Here are a few key lessons tempered with some of the down-in-the-trenches experience at Ubiquity. As enforcement is on the rise, we want to help you get it right at the trade show and in your digital communication.</p>
<p>Where are the violations?<br />
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.</p>
<p>What can you do to prevent violations on the internet?</p>
<ol>
<li> Develop a review process for all communications and use it relentlessly with a digital signature.</li>
<li> 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.</li>
<li> 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.</li>
<li> Update promotional review policies to consider risk communication on the Internet and sponsored links.</li>
<li> Choose a marketing firm with experience and education in Medical Device promotional compliance.</li>
</ol>
<p>What can you do to prevent violations at trade shows?</p>
<ol>
<li> Always review materials for each new venue and audience.</li>
<li> Train all of your trade show staff completely prior to each and every show.</li>
<li> No hand-made materials – meaning sales staff shouldn’t show up with hand- made power point presentations!</li>
<li> 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.</li>
<li> 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.</li>
<li> 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.</li>
</ol>
<p>Here is a useful sites for <a title="FDA promotions regulations" href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance" target="_blank">FDA Promotion regulations</a>.</p>
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		<title>5 things I learned at TedMed</title>
		<link>http://ubiquitygroup.com/5-things-i-learned-at-tedmed/</link>
		<comments>http://ubiquitygroup.com/5-things-i-learned-at-tedmed/#comments</comments>
		<pubDate>Mon, 07 Mar 2011 19:00:18 +0000</pubDate>
		<dc:creator>Lisa Herter</dc:creator>
				<category><![CDATA[bioscience]]></category>
		<category><![CDATA[medical technology]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=101</guid>
		<description><![CDATA[It’s hard to fully express how profound Ted Talks are without going onto Ted.com and experiencing them for yourself. Even harder, is to fully express how inspiring they are in person. In October 2010, I had the pleasure of going to TedMed, which is a three-day relay race of intense presenters. And they’re all somehow<a href="http://ubiquitygroup.com/5-things-i-learned-at-tedmed/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>It’s hard to fully express how profound Ted Talks are without going onto Ted.com and experiencing them for yourself. Even harder, is to fully express how inspiring they are in person. In October 2010, I had the pleasure of going to TedMed, which is a three-day relay race of intense presenters. And they’re all somehow related to improving the human condition.</p>
<p>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.</p>
<p>As a medical device marketer, I would like to share some ideas that I’ve applied to my life and business:</p>
<p><strong>1. “Whatever you can say, you can say it simpler.” &#8211; Thomas Goetz, Chief Editor for Wired Magazine</strong>.</p>
<p>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.</p>
<p><strong>2. Eat Less. Move More. And Relax.</strong></p>
<p>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.</p>
<p>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.</p>
<p><strong>3. Cancering – It’s a verb.</strong></p>
<p>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.</p>
<p><strong>4. Everyone should know how they want to die. </strong></p>
<p>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 <a href="http://www.engagewithgrace.org/Questions.aspx" target="_blank">The One Slide Project</a> to get the 5 questions, share them and answer them for yourself.</p>
<p><strong>5. “Imagination is more important than knowledge.”  Jay Walker. </strong></p>
<p>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.</p>
<p>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.</p>
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		<title>Tips for creating a mobile website</title>
		<link>http://ubiquitygroup.com/tips-for-creating-a-mobile-website/</link>
		<comments>http://ubiquitygroup.com/tips-for-creating-a-mobile-website/#comments</comments>
		<pubDate>Tue, 01 Feb 2011 21:24:11 +0000</pubDate>
		<dc:creator>Greg</dc:creator>
				<category><![CDATA[Mobile]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=91</guid>
		<description><![CDATA[Many companies are now considering creating a mobile site. You must understand your audience and what types of smart phones and computers they will be using. Whether it is a smart phone, computer or tablet such as the Ipad or Android Samsung Galaxy, the experience should be optimized for these devices. Here is an example<a href="http://ubiquitygroup.com/tips-for-creating-a-mobile-website/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>Many companies are now considering creating a mobile site. You must understand your audience and what types of smart phones and computers they will be using. Whether it is a smart phone, computer or tablet such as the Ipad or Android Samsung Galaxy, the experience should be optimized for these devices.</p>
<p>Here is an example of what I commonly see:</p>
<p>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&#8217;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.</p>
<p>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.</p>
<p>Here are some top items to consider when having a mobile experience.</p>
<p>1. Mobile websites only need to have about 20% of the content and navigation that your main site has.</p>
<p>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.</p>
<p>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.</p>
<p>4. Utilize share buttons on the mobile page. Let your user easily email, Like you on Facebook, LinkedIn and Twitter.</p>
<p>5 Testing: Although many companies do not have access to multiple mobile browers and products there are online  web based emulator tools such as<a title="Iphone Web Emulator" href="http://iphonetester.com/" target="_blank"> Iphone Tester.</a></p>
<p>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.</p>
<p>Using a few best practices will help your email and content get read and thus help you get through to the right contact.</p>
<p>Let us know what you think and what is working for you.</p>
<p>Happy a happy mobile day!</p>
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		<title>Medical Word(s) of the week</title>
		<link>http://ubiquitygroup.com/medical-words-of-the-week/</link>
		<comments>http://ubiquitygroup.com/medical-words-of-the-week/#comments</comments>
		<pubDate>Mon, 20 Dec 2010 21:26:18 +0000</pubDate>
		<dc:creator>Greg</dc:creator>
				<category><![CDATA[Strategy]]></category>

		<guid isPermaLink="false">http://ubiquitygroup.com/blog/?p=76</guid>
		<description><![CDATA[Cardiac Tamponade: This sounds like a type of drink we should order but really it is the build up of fluid in the space between the muscle of the heart (mycocardium) and the out covering sac of the heart (pericardium). Maybe it would be better to just simply call this a bloated heart condition. Thanks<a href="http://ubiquitygroup.com/medical-words-of-the-week/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p><strong>Cardiac Tamponade: </strong>This sounds like a type of drink we should order but really it is the build up of fluid in the space between the muscle of the heart (mycocardium) and the out covering sac of the heart (pericardium).</p>
<p>Maybe it would be better to just simply call this a bloated heart condition.</p>
<p>Thanks to Google Health for the following image: <a class="aligncenter" title="Google Health Cardiac Tamponade Image" href="https://health.google.com/health/ref/graphic/18123" target="_blank">https://health.google.com/health/ref/graphic/18123</a></p>
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		<title>Online Marketing Summit thoughts and banter</title>
		<link>http://ubiquitygroup.com/online-marketing-summit-thoughts-and-banter/</link>
		<comments>http://ubiquitygroup.com/online-marketing-summit-thoughts-and-banter/#comments</comments>
		<pubDate>Mon, 22 Feb 2010 19:10:35 +0000</pubDate>
		<dc:creator>Greg</dc:creator>
				<category><![CDATA[social media]]></category>

		<guid isPermaLink="false">http://ubiquity-design.com/wordpress/index.php/2010/02/22/online-marketing-summit-thoughts-and-banter/</guid>
		<description><![CDATA[I am attending the annual OMS conference in San Diego. Today is about social media integration and execution.  Many of us have been working on integrating social media into campaigns and tactics. We finally have a number of case studies and processes to follow. To view some of the links and thoughts: search hashtag on<a href="http://ubiquitygroup.com/online-marketing-summit-thoughts-and-banter/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p>I am attending the annual OMS conference in San Diego. Today is about social media integration and execution.  Many of us have been working on integrating social media into campaigns and tactics. We finally have a number of case studies and processes to follow.</p>
<p>To view some of the links and thoughts: search hashtag on Twitter: #0ms10</p>
<p>More info will be posted on this blog.</p>
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		<title>Advamed 2009: Thoughts and Banter</title>
		<link>http://ubiquitygroup.com/advamed-2009-thoughts-and-banter/</link>
		<comments>http://ubiquitygroup.com/advamed-2009-thoughts-and-banter/#comments</comments>
		<pubDate>Mon, 12 Oct 2009 22:00:43 +0000</pubDate>
		<dc:creator>Greg</dc:creator>
				<category><![CDATA[Strategy]]></category>

		<guid isPermaLink="false">http://ubiquity-design.com/wordpress/index.php/2009/10/12/advamed-2009-thoughts-and-banter/</guid>
		<description><![CDATA[I am at Advamed 2009 Conference in Washington D.C. capturing content by Flip Video, Apple Video and putting thoughts on Twitter. @ubiquity check out #advamed and #advamed09. I will work to blog various sessions I sit in. This blog will be cleaned up as I have Internet connections, so be kind with any spelling or<a href="http://ubiquitygroup.com/advamed-2009-thoughts-and-banter/"> Read more...</a>]]></description>
			<content:encoded><![CDATA[<p> I am at Advamed 2009 Conference in Washington D.C. capturing content by Flip Video, Apple Video and putting thoughts on Twitter. @ubiquity check out #advamed and #advamed09.  I will work to blog various sessions I sit in.  This blog will be cleaned up as I have Internet connections, so be kind with any spelling or run on sentences. <img src='http://ubiquitygroup.com/wordpress/wp-includes/images/smilies/icon_smile.gif' alt=':)' class='wp-smiley' /> </p>
<p><strong>Tuesday October 12th, 2009:</strong><br />
I sat in on a session called: Bringing medical devices to the U.S. market.<br />
Great information and will post thoughts and info.<br />
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.<br />
Crisis Prevention &amp; Risk Mitigation 101: 5 things Every company must be prepared for:</p>
<p>We have 5 panelists who are talking on a variety of topics.</p>
<ul>
<li>Brett Berty: Sr. Recall Strategist, Stericycle, ExpertRECALL</li>
<li>Christian Haller: General Manager: MPR Product Development</li>
<li>Don Houghton: Director of Crisis Contact Center, Academic Network</li>
<li>David Bartlett: Levick Strategic Communications</li>
<li>Willie Bryant: Former FDA Senior recall coordinator, Steri ExperRECALL</li>
</ul>
<p><strong>Recall Communication Strategy by David Bartlet of Levic Strategic Communications: </strong></p>
<p>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.</p>
<ul>
<li>Get out in front of the story: Who better to tell the story than you. Don&#8217;t let others tell your story, good or bad.</li>
<li>Think like your audience:  Are you in the medical device business or the safety business.</li>
<li>Choose the right spokesperson: Someone who knows how to say, &#8220;I don&#8217;t know&#8221;.</li>
<li>Understand the importance of the online blogs: It is not your father&#8217;s media anymore. There is no such thing as the new media. There is the media and the &#8220;old&#8221; 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.</li>
<li>Ensure your statements match regulatory actions:</li>
<li>Know the regulators and stay in touch:</li>
</ul>
<p>When a recall happens you need to think of the following.</p>
<p>Apologize: Don&#8217;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.</p>
<p>Describe what happened: Don&#8217;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.</p>
<p>List steps you are taking so FDA and your team understands direction.</p>
<p>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.</p>
<p>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.</p>
<p>Provide frequent updates: Continuously update information and don&#8217;t be afraid I don&#8217;t know. Practice saying this: &#8220;We don&#8217;t know that yet, we are trying to figure it out and you&#8217;ll be the first to know when we have figured it out. &#8221;</p>
<p>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.</p>
<p><strong>FDA Recall Audits with Willie Bryant who was the former FDA Sr. Recall Coordinator.</strong></p>
<p>Here is a quick review on what happens with FDA recall audits. Lets hope you don&#8217;t have this happen.</p>
<p>An audit is an inspection by FDA, audit checks and status reports. The Investigation Operations Manual (IOM) is the  guidance to FDA investigators.<br />
Class 1 &amp; @ recalls &#8220;should&#8221; have an inspection to determine the &#8220;root cause&#8221; of the problem(s).<br />
In most cases for devices or pharmaceuticals, inspection is after notification to FDA and the public. May be immediate (class 1) or months later.</p>
<p>The FDA inspector will be looking at key areas and asking questions:</p>
<ul>
<li>Review complaint investigations for adequacy.</li>
<li>Injury/Illness complaints reported under MDR?</li>
<li>Has the manufacturer taken appropriate corrective action? If not, get timetable!</li>
<li>Investigate all areas, control points, and circumstances which may a bearing on product deficiency including batch records, processing logs and other related logs.</li>
<li>Industry conducts &#8220;effectiveness&#8221; checks, FDA conducts &#8220;audit checks&#8221;</li>
<li>Class 1 recalls: FDA expects 100% documentation of consignee notification and appropriate reponse.</li>
<li>Documentation of notifications, responses and returned product important to justify termination of recall.</li>
<li>Weekly, bi-weekly, or monthly depending on recall circumstances and FDA desire for info.</li>
<li>Critical to FDA&#8217;s evaluation of recall and your request for follow-up.</li>
</ul>
<p>Reference: FDA&#8217;s Investigations Operations Manual, Subchatper 7.2 Recall Notification/Inspection</p>
<p>You can download for free on FDA&#8217;s website.</p>
<p>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.</p>
<p>Three Goals of any recall:</p>
<p>Protect the Public</p>
<p>Protect Your Brand</p>
<p>Recall Lifecycle: 7 Steps to consider.</p>
<p>So many companies do not even have a plan about what they would do if they get a recall. Practice, Practice Practice.</p>
<p>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.</p>
<p>2: Target / Consignee Identification:</p>
<p>3: Notificaton Management: Who are your customers? How does the notification work? Can&#8217;t just email out to a list?  If you sell through distributor, will they give you a list, will they notify their customers.</p>
<p>4: Response Management:</p>
<p>5: Product Processes:</p>
<p>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.</p>
<p>7: Resolution Management:</p>
<p>Additional questions to ask:<br />
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.</p>
<p>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.</p>
<p>More info to follow as I continue to listen and meet some amazing people.</p>
<p>Greg Olson :: Ubiquity<br />
Ubiquity specializes in generating demand for life science companies.<br />
Greg@ubiquitygroup.com   303-962-8700</p>
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