Web 2.0 for the medical device industry. Parts 4-6

Web 2.0 for the medical device industry

Web 2.0 for the medical device industry. Parts 4-6

This article will be introducing web 2.0 technology as it relates to marketing strategies and the medical device industry.

There are several items that will be addressed in this series of articles;

1. What is web 2.0 technology?

2. How is it used?

3. Who are the regulators watching the use of the technology?

4. How can medical devices manufacturers market their products using web 2.0

technology while staying within the confines of the FDA?

5. How do you get started using web 2.0 technology?

6. How to track and measure the effectiveness?

Part 4. How can medical devices manufacturers market their products using web 2.0 technology while staying within the confines of the FDA regulations?

Currently, the FDA does not have a clear set of rules or regulations directed at the medical device or pharmaceutical industries specifically in regards to Web 2.0 technologies. What they have advised and acknowledge is that if marketers use the existing rules and regulations compliance should not be an issue.

The DDMAC is the FDA arm that regulates pharmaceutical companies marketing. Research of warning letters to various pharma companies demonstrates the FDA's desire for marketers to remain compliant with existing regulatory guidelines.

Medical device companies and marketers should be confident that when following the guidelines set forth by the FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) in combination with the CDRH they will not be violating any regulations.

The guidelines for advertising and marketing of products can easily be translated into social media and web 2.0. It is clear that the FDA will not allow for off label or benefit statements to be made without the proper indications and risks of use data included in all other marketing.

Social Media (Community Groups, Blogs, Mini-blogs)

An open forum for communication between patients can be a great way to develop ambassadors of your product. Personal recommendations and testimonials, especially unsolicited are very powerful tools.

Any communication where any person other than the marketer delivers the message can be frightening. There has yet to be a ruling on whether the company is responsible for a patient or physician disseminating incorrect or non-FDA compliant information.

What we can infer from what has been said and acted on so far is that there are ways to monitor and filter information between community members. Groups can and should be monitored for false or misleading information so that group members can be educated or directed to the proper source for information.

Blogs are great for posting news stories, updated information on products or stories from patients and physicians. They are not intended to create a social dialogue as much as allow for one person to post information and others to make comments if they choose to do so. Conversational stories and posts are saved for the community groups. It is not a requirement to include a comment section on a blog.

It is the manufacturers/marketers responsibility to monitor and regulate any communication channel they set up. Therefore it will be important to know who is contributing to the community information and what they are saying about the product and your company.

With any groups or blogs having a comment section there should always be a requirement for the registrant to give certain information as a registered user. Part of this registration should always include a clear user agreement, which must be signed. Not only will the registration of users allow the marketer to watch who is saying what but also to send new product information and engage the patient or physician to further develop the relationship. Medical device manufactures should continue to monitor the feeds in which patients, physicians and possibly the competition are posting information or opinions about their product.

Because of the strict guidelines enforced by the CDRH and DDMAC for all marketing communication, mini-blogs or Twitter should be used cautiously. This form of media is most useful for public relations efforts as well as customer service contact in the medical devise industry. Regulations for stating indications for use as well as potential side effects of certain medical treatments as mentioned earlier is difficult at best with the 140 character mini-blog and limited space sponsored ads. By their design they do not allow for adequate regulatory information so these tactics should be left to non-FDA regulated advertising. The FDA does have a Twitter account!

Facebook/MySpace is not an appropriate medium for medical device marketing. Due to the ability for misinformation to be spread and the difficulty in managing messages. This is not to say in the future it won't be used, but until medical device companies have clear guidance from the FDA it is dangerous territory.

Part 5. How do you get started using web 2.0 technology?

The key to effective web 2.0 marketing is to understand the limits of the technology and the benefits of reaching potential and current customers in a meaningful way.

As with any marketing strategy you should know where and who your audience is, what information you will provide and who will be responsible for distribution of that information.

There is some debate on who is best equipped to handle the web 2.0 responsibilities, especially when the FDA/CDRH are concerned. No matter which department is tasked with web 2.0, they must keep the legal and regulatory departments involved. And the legal and regulatory departments need to keep the marketing or PR person up to date on any new information or guidance from the FDA as it comes in.

The size of the medical device organization will have a major impact on how the web 2.0 technologies will be implemented. Larger organizations may have websites that do not readily allow for additional pages or section to be added to the website.

Microsites are a possibility when considering which technologies will be used and will vary greatly type of current website and final web 2.0 strategy.

Marketing and PR professional should also research other blogs and websites to see what is being said and reply appropriately to those blogs. This is a unique opportunity to not only market the product or service but actually provide customers with information that may not have or dispel any misinformation existing within other blogs or communities.

If the strategy calls for a branded community than close monitoring is required. The FDA has stated in communications that any company with a product specific website is responsible for the content even if posted by a member of the community.

In the implementation of all communities, required registration should be a best practice. This will allow for tracking of users statements and to monitor any wrong statements made. Some communities have an approval process before any posts go live onto the site. This will limit the possibility of errors in communications but it will also hamper the ease of use by members to gather information, advise and feedback from others.

The key to the implementation of web 2.0 technologies is first that the website is able to handle multiple users at one time, have intuitive navigation, and include information from experts that is accurate and trustworthy.

Next time you talk about adding web 2.0, social media or new media to your marketing strategy, ask yourself, is it necessary for what we really want to accomplish? If you are not sure what you should be using, how they work or if you are permitted to use them according to the Food and Drug Administration (FDA) and Center for Devices and Radiological Health Organization (CDRH) guidelines, talk to a professional.

Part 6. How do you measure and track results to show ROI?

As with any plan, tracking the ROI is what will keep you in your job another day. More and more, marketers are expected to show the heads of companies the financial payoffs to what we have recommended they spend money on.

Have clear and realistic goals with what you expect your efforts to achieve. It is not likely that in 30 days the brand awareness of the product you are marketing will increase all that much. As with any campaigns time is important, especially with web 2.0 technologies. Being a social form of marketing it takes time to build relationships and trust.

Set goals for how many new community registered members you will have in 3 months, how many mentions you have on Twitter, number of unique visits to your blog, or what type of or number of comments you are receiving on a blog.

There are many free and paid tracking services available so that you have a third party evaluation to present when time comes to show ROI. When the time comes to start developing the program it is important to discuss your needs and what your measurement goals are to ensure proper tracking methodologies.

Tracking awareness as we mentioned earlier can be done with online or phone surveys. Pre-launch, mid-launch and post-launch data will give enough information throughout the cycle to know what is working, what is not and help make appropriate changes.

A key way to measure success of any website to include a registration requirement. In order to post on any site or blog a registration page should be filled out. This will allow for data capture of locations, ages, knowledge of products and will capture opt-in data for future e-message correspondence. Opt-ins are required by law and if messages are tagged as spam you may be held accountable under the CAN-SPAM Act of 2003.

Part 7. Implementation considerations

When implementing web 2.0 into the overall marketing strategy of a product or service there are some questions to be answered.

What are you doing now?

What is working and what isn't?

How will Web 2.0 technology fit into the overall strategy?

Another key issue will be who will plan and implement the new program? There are two obvious options: hire an interactive marketing specialist in-house or hire an outside agency.

Rules and regulations will change and you must have a team set in place that will be responsible for constant and diligent follow up with the FDA. For most companies using an agency where they have a team of experts will be best. Agencies can not only guide you when dealing with the web 2.0 strategy but can also be sure that any plans are within the overall marketing strategy.

I have mentioned it many times here and will say it again, talk to a professional about how best to approach web 2.0. Defying or ignoring the FDA marketing rules and regulations can be a costly mistake.

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