{"id":6446,"date":"2012-03-31T15:17:00","date_gmt":"2012-03-31T15:17:00","guid":{"rendered":"http:\/\/www.pharma-mkting.com\/medical-device-marketing-dont-need-no\/"},"modified":"2019-02-21T01:19:48","modified_gmt":"2019-02-21T01:19:48","slug":"medical-device-marketing-dont-need-no","status":"publish","type":"post","link":"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/blog\/medical-device-marketing-dont-need-no\/","title":{"rendered":"Medical Device Marketing Don&#8217;t Need No Stinkin&#8217; ROI!"},"content":{"rendered":"<p>&#8220;Standards for devices exist, they just don&#8217;t make sense,&#8221; industry critic Dr. Diana Zuckerman, president of the National Research Center for Women &amp; Families, said in a <a href=\"http:\/\/www.consumerreports.org\/cro\/consumer-reports-magazine\/May-2012\/medical-devices.html\">Consumer Reports release<\/a> (also read this CBS report &#8220;<a href=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/forums\/showthread.php?p=78852#post78852\">Investigation: Most medical devices implanted in patients without testing<\/a>&#8220;; see video below).<\/p>\n<p>&#8220;An investigation by Consumer Reports, which included interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA, shows the following areas of concern:<\/p>\n<ul>\n<li>Medical devices often aren\u2019t tested before they come on the market. \u201cWhat they\u2019re doing is conducting clinical trials on the American public,\u201d says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a specialty catheter, cleared without testing, that malfunctioned during a procedure to treat an abnormal heartbeat.<\/li>\n<li>There\u2019s no systematic way for the government, researchers, or patients to spot or learn about problems with devices. \u201cA coffeemaker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn\u2019t,\u201d Zuckerman says. \u201cYour doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away.\u201d<\/li>\n<li>Without major changes in the system, there\u2019s not much that patients can do to protect themselves.<\/li>\n<\/ul>\n<p><img decoding=\"async\" align=\"right\" hspace=\"8\" src=\"http:\/\/ec2-54-175-84-28.compute-1.amazonaws.com\/pharma-mkting.com\/wp-content\/uploads\/2019\/02\/MedtronicDevice.jpg\" \/>According to Consumer Reports, the majority of medical implants are not tested to make sure they are safe. Most of the time device manufacturers only need to pay the Food and Drug Administration (FDA) a fee of about $4,000 with minimal testing in order to get approval for marketing. Compared to drug approval, this is a walk in the park.<\/p>\n<p>In fact, sometimes device manufacturers bypass this minimal approval process altogether as did Johnson and Johnson&#8217;s Ethicon unit (see &#8220;<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?p=77964\">J&amp;J Marketed Medical Device Without FDA Approval<\/a>&#8220;).<\/p>\n<p>Not only is the approval of medical devices by FDA more lax than the process used to approve drugs, medical device marketing is worlds apart from Rx drug marketing as I learned from a presentation made by a Medtronic marketing VP. The presentation focused on a case study of a marketing campaign for the Prestige Cervical Disc.<\/p>\n<p>That case study showed that out of an estimated 5 million spine surgery candidates (patients) in the US, Medtronic only needed to capture 125 of them to break even on a very successful marketing campaign that reached 6.2 million local TV viewers, 80.5 million radio (especially satellite radio) listeners, 4 million print readers, and 73 million Internet browsers. (Get more details about that case study by downloading this <i>Pharma Marketing News<\/i> article: &#8220;<a href=\"http:\/\/www.news.pharma-mkting.com\/pmn78-article02.htm\">Medical Device Marketing: Worlds Apart from Rx Drug Marketing<\/a>&#8220;; use discount code &#8216;<b>DEV444<\/b>&#8216; BEFORE April 15, 2012 to get it FREE!).<\/p>\n<p>While drug advertisers would sweat and moan over whether such a campaign would have a positive ROI (return on investment), medical device marketers<br \/>\ndon&#8217;t need to worry about no stinkin&#8217; ROI because of such low numbers of conversions required AND also because very little resources need to go into premarket testing in order to get FDA approval.<\/p>\n<p>Although the FDA has met most of its goals for fast-track medical device approvals, it&#8217;s taking substantially longer to issue decisions on devices than it used to, concluded a report from the Government Accountability Office (GAO). The GAO said:<\/p>\n<p>\n&#8220;FDA has begun to take steps to address GAO\u2019s 2009 recommendation about<br \/>\nhigh-risk devices that are allowed to enter the U.S. market through the less<br \/>\nstringent 510(k) process, but progress has been limited. High-risk devices<br \/>\ninclude those which are implantable or life sustaining. In 2009, GAO<br \/>\nrecommended that FDA expeditiously take steps to issue regulations for the<br \/>\ndevice types classified as high risk that are currently allowed to enter the<br \/>\nmarket via the 510(k) process. Since then, FDA has set strategic goals to<br \/>\naddress these device types, but has issued a final rule regarding the<br \/>\nclassification of only one device type. As of April 1, 2011, FDA\u2019s action on the<br \/>\n26 remaining types of high-risk devices was incomplete. Thus, these types of<br \/>\ndevices\u2014such as automated external defibrillators and implantable hip<br \/>\njoints\u2014can still enter the U.S. market through the less stringent 510(k)<br \/>\nprocess. GAO found that, since its report was issued in January 2009, FDA has<br \/>\ncleared at least 67 510(k) submissions that fall within these high-risk device<br \/>\ntypes. FDA has taken some additional steps to enhance premarket device<br \/>\nsafety since GAO\u2019s 2009 report was issued\u2014for example, it commissioned the<br \/>\nInstitute of Medicine to conduct an independent review of the premarket<br \/>\nreview process\u2014but it is too early to tell whether any forthcoming changes<br \/>\nwill enhance public health.&#8221;<\/p>\n<p>To get a copy of the GAO report, see the end of this post: &#8220;<a href=\"http:\/\/www.forums.pharma-mkting.com\/showthread.php?p=78879#post78879\">FDA Taking Longer to Approve Medical Devices, Says GAO<\/a>&#8220;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;Standards for devices exist, they just don&#8217;t make sense,&#8221; industry critic Dr. Diana Zuckerman, president of the National Research Center for Women &amp; Families, said in a Consumer Reports release (also read this CBS report &#8220;Investigation: Most medical devices implanted in patients without testing&#8220;; see video below). &#8220;An investigation by Consumer Reports, which included interviews [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":13101,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[12],"tags":[113,86,44,229,153],"topic":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Marketing Don&#039;t Need No Stinkin&#039; ROI! 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