The medical device industry is rife with the exploration and development of new ideas and treatments for a startling array of health conditions. In some areas, however, medical device companies lag behind other sectors of the American economy, in particular, the number of companies that have adopted a social media strategy.

The term “social media” can refer to a number of different digital outreach strategies which are intended to connect with clients, industry, and the public at large through blogs, profiles on sites like Facebook and Linkedin, or even individual Twitter feeds managed by company employees. According to a survey conducted by MediComm Consultants and BB Marketing Plus, which was reported on by MassDevice in December of 2009, only 16 percent of 251 companies polled indicated that a social media strategy was in place. Although employees at these companies were familiar with and used online networking tools as part of their day-to-day work flow, a cohesive company-wide social media policy was not present at the vast majority of medical device organizations. Furthermore, a 2011 survey completed by MassMEDIC involving medical device industry personnel revealed that only 50% of the respondents’ companies have social media policies in place. Stakeholders assert this may be due to medical device manufacturing companies failing to challenge assumptions that more people are using social media as an avenue for guidance and to build awareness with patient communities in the device world.

It is not just medical device companies that have been dragging their feet in the social media domain. The FDA has also repeatedly delayed the publishing of its official Social Media Guidance documentation, which was first announced as being on the horizon in March of 2009. When the self-imposed deadline of December, 2010 came and went without any guidance having materialized, the Division of Drug Marketing, Advertising and Communications (DDMAC) revised its timeline to push back publication until the first quarter of 2011. That quarter is now behind us, and the FDA has announced that the development of specific guidelines has been put on hold, due in part to challenges in ensuring that whatever comes out of the Administration is applicable over the course of the long term.

Currently the FDA is studying the impact of social media on ‘net impression’, and determining its scalability in the patient and consumer-centric context. In the late 1990s, most of the FDA’s direct-to-consumer (DTC) guidance was focused on provisional guidance for TV ads, 1-800 numbers, and websites. In 2008 only 4% of DTC’s guidance was focused on internet advertising and social media. At some point, the FDA may utilize innovations like CMP.LY, which has been used to act in accordance with the Federal Trade Commission’s Final Guides Governing Endorsements, Testimonials to document compliance and measure the effectiveness of social marketing campaigns.

Medical device manufacturers have at least been given an outline of what future FDA social media guidelines could contain. The DDAMC have outlined six topics that are being focused on during guidance development. Taken directly from the Agency’s official communication, they are:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

At MDCI, we feel that for medical device manufacturers, the adoption of an internal social media policy as well as a cohesive strategy for presenting the company and interacting in the digital realm is a key aspect of business communications. With so many questions surrounding the regulatory aspects of social media interaction (Can medical device companies edit Wikipedia entries? Discuss products over Twitter? Be responsible for the content of third-party blogs which mention their products?), the vacuum created by a lack of FDA guidance in this domain is creating a gray area that is rapidly expanding due to the lightning pace of communications in the Internet era.