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.
Tuesday, December 14, 2010
Web 2.0 for the medical device industry. Parts 1-3
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 1. What are web 2.0 technology, social media and new media?
These three terms have been thrown around and over used by marketers who don’t understand their meaning and completely misunderstood by everyone who has been told they MUST be involved in them.
Each term has a very valuable place in marketing strategy but not all products or services are appropriate. Just like TV is not the answer for every product and service, neither is social media or new media.
The first step is understanding what each term means and how it varies from the others.
The simple definition for web 2.0 is: websites that have been specially programmed to allow for conversations and feedback between users of the same websites and community groups.
The term "Web 2.0" was coined by Darcy DiNucci in 1999, in her article "Fragmented Future.”
“The Web we know now, which loads into a browser window in essentially static screenfuls, is only an embryo of the Web to come. The first glimmerings of Web 2.0 are beginning to appear, and we are just starting to see how that embryo might develop. ... The Web will be understood not as screenfuls of text and graphics but as a transport mechanism, the ether through which interactivity happens. It will [...] appear on your computer screen, [...] on your TV set [...] your car dashboard [...] your cell phone [...] hand-held game machines [...] and maybe even your microwave.”
Wikipedia’s definition:
"Web 2.0" refers to a second generation of web development and design, that facilitates communication, secure information sharing, interoperability, and collaboration on the World Wide Web. Web 2.0 concepts have led to the development and evolution of web-based communities, hosted services, and applications such as social-networking sites, video-sharing sites, wikis, blogs, mashup and folksonomies.
As you will notice in the Wiki definition, there are a few concepts that will not be discussed in detail in these articles; video-sharing, wikis, mashup and folksonomies.
Social media is part of the web 2.0 technology capability. The way websites are programmed, they allow for users to share photos, give updates on “what they are doing” as well as video sharing.
The clearest and best definition of social media I have found was written by Joseph Thornley.
Social media are online communications in which individuals shift fluidly and flexibly between the role of audience and author. To do this, they use social software that enables anyone without knowledge of coding, to post, comment on, share or mash up content and to form communities around shared interests.
The term “new media” has been overly used and widely misunderstood and includes technologies such as PDA’s CDs, DVDs and video games. Webopedia.com defines it as:
A generic term for the many different forms of electronic communication that are made possible through the use of computer technology. The term is in relation to “old” media forms, such as print newspapers and magazines, that are static representations of text and graphics.
So, 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 2: How is web 2.0 technology used?
Now that we know the definition of web 2.0, where the term came from, we will talk about what tactics are under the umbrella of web 2.0 technology and how they relate to the medical device industry.
It is important to know what type of information dissemination should be part of your overall marketing strategy and how web 2.0 can be implemented as part of that strategy.
How the web 2.0 technology is used for healthcare marketing and medical device specifically is an interesting subject. The regulations and restrictions are set to protect consumers and stop snake oil salesmen from deceiving the American public.
The rules are strict, when established. The FDA has yet to develop a set of guidelines for medical device marketers to follow. The FDA has been active in the pharma sector and has levied fines for misuse. In the mean time, it is prudent to work closely with your marketing team and legal regulatory team to establish rules and guides for your web 2.0 efforts.
Blogs
Blogs can be useful during the development of a new product with updates and information of the development phase and progress. When writing blogs for medical device it is important to know what the FDA regulations are for marketing. Providing information about a products benefits or making statements before it has been through the proper FDA channels will land you in a heap of trouble.
A summary of the definition of a blog from Wikipedia.org is:
A blog is a type of website, usually maintained by an individual with regular entries of commentary, descriptions of events, or other material such as graphics or video. Entries are commonly displayed in reverse-chronological order.
Many blogs provide commentary or news on a particular subject; others function as more personal online diaries.
The ability for readers to leave comments in an interactive format is an important part of many blogs.
Asking for feedback on your posts can be a valuable tool but also tricky to manage. The FDA hasn’t provided exact restrictions for medical device marketing about the regulations on who is responsible for information posted on a blog. Pharma companies have been diving into web 2.0 and the lessons learned should be taken into account for medical device.
Blogs should be optimized to ensure they are crawled by the search engines for rankings as well as tracked for unique visits for ROI measurement. While it is difficult to quantify an ROI on this type of marketing strategy you can get a clear sense of who is looking at your product updates as well as how often. Requiring visitors to register will also allow you to collect data and can allow for one on one contact with prospective buyers or even investors.
Community Groups
These groups are usually very social in nature and gather via the Internet to share ideas and information ranging from business to personal and include special interest groups dealing with topics like, religion, health and politics.
Medical device manufacturers can also find a place in these communities or create their own. Depending on the marketing strategy these types of groups can target business, consumers or even the special interest groups depending on the product going to market.
Jeremiah Owyang of Silicon Valley writes in his blog Online Community Best Practices:
Communities Are A Powerful Tool, As Long As You Put Members’ Needs First “An online community is an interactive group of people joined together by a common interest. It’s also one of the most powerful tools a marketer can deploy for customer retention, word of mouth, and customer insight. To host a successful community, think of it as you would product development: Start by focusing on objectives, chart a road map, assemble the right team, and plan to be flexible. Then build your success by launching the community with the backing of your most enthusiastic customers and staying engaged as the community grows. Above all, remember that control is in the hands of the members, so put their needs first, build trust, and become an active part of the community.”
Business community groups have become a very popular form of networking for the busy professional who finds less time in their schedule for the face to face lunch and cocktail networking.
Websites like LinkedIn allow for businesses to network as well as individuals. This particular community has sub-communities called networking groups where you can target your interests and be part of a group that is even more specialized. Even the FDA has a company page with connections to their staff.
Consumer community groups range from fans of products like Pepsi World to AngiesList.com where consumers can review companies and post grievances online. Consumer community groups are sometimes set up by the corporation or by consumers on sites like wetpaint.com.
Special interest community groups created on-line include, health, politics, religion and more. These groups are similar to a consumer group but are brought together for personal reasons and tend to be like-minded individuals looking for news, information, support groups, events, and relationships.
Micro-Blogs
Micro-blogging has become a major topic in marketing communications over the past 6 months or so. One major reason, Twitter, a micro-blogging website designed to tell people “what you are doing” in 140 characters or less.
Twitter came about from the application on Yahoo! Mail, status update, to tell people who also have Yahoo! Mail accounts, what you are doing. In an interview with the LA Times Jack Dorsey explains why he created twitter and the history behind it. Other websites have included the mirco-blog concept into their programming.
Twitter is great for PR needs in medical device marketing. While there are multiple websites that post news releases, having a Twitter account and asking your followers to re-tweet (RT) your posts helps with SEO and gives your followers up to date information that they want.
Facebook and MySpace
Facebook and MySpace are a different type of community from the other three groups mentioned above. These communities are typically very personal in nature. There are some companies that have jumped into the water to test out how having a fan page or group of people who love their product will work. This type of word-of-mouth marketing for some companies will be beneficial.
Medical device companies need to look at their individual product carefully before deciding to go this route. Unless the product has a wide target market these social media sites will not pull the quality traffic needed.
Part 3. Who are the regulators watching the use of the technology
“The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.”
The Food and Drug Administration (FDA) is one of the sections under the HHS. Other sections include the Centers for Disease Control (CDC), Indian Health Service, National Institutes of Health and others.
Within the FDA there are seven centers and offices that are managed under the FDA commissioner. One of the centers is the Center for Devices & Radiological Health (CDRH). The CDRH breaks down even further into another six offices that are “…responsible for regulating firms who manufacture, re-package, re-label, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions,” according to the FDA website.
This is where it becomes a little more complicated. Depending on the type of device one of the 6 offices will be responsible for the monitoring of regulation compliance.
There are standard marketing rules for medical devices that manufacturers must meet in order to be compliant with the FDA. Each of the following requirements are listed on the FDA website under Overview of Device Regulation.
* Establishment registration,
* Medical Device Listing,
* Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
* Investigational Device Exemption (IDE) for clinical studies
* Quality System (QS) regulation,
* Labeling requirements, and
* Medical Device Reporting (MDR)
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.
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 1. What are web 2.0 technology, social media and new media?
These three terms have been thrown around and over used by marketers who don’t understand their meaning and completely misunderstood by everyone who has been told they MUST be involved in them.
Each term has a very valuable place in marketing strategy but not all products or services are appropriate. Just like TV is not the answer for every product and service, neither is social media or new media.
The first step is understanding what each term means and how it varies from the others.
The simple definition for web 2.0 is: websites that have been specially programmed to allow for conversations and feedback between users of the same websites and community groups.
The term "Web 2.0" was coined by Darcy DiNucci in 1999, in her article "Fragmented Future.”
“The Web we know now, which loads into a browser window in essentially static screenfuls, is only an embryo of the Web to come. The first glimmerings of Web 2.0 are beginning to appear, and we are just starting to see how that embryo might develop. ... The Web will be understood not as screenfuls of text and graphics but as a transport mechanism, the ether through which interactivity happens. It will [...] appear on your computer screen, [...] on your TV set [...] your car dashboard [...] your cell phone [...] hand-held game machines [...] and maybe even your microwave.”
Wikipedia’s definition:
"Web 2.0" refers to a second generation of web development and design, that facilitates communication, secure information sharing, interoperability, and collaboration on the World Wide Web. Web 2.0 concepts have led to the development and evolution of web-based communities, hosted services, and applications such as social-networking sites, video-sharing sites, wikis, blogs, mashup and folksonomies.
As you will notice in the Wiki definition, there are a few concepts that will not be discussed in detail in these articles; video-sharing, wikis, mashup and folksonomies.
Social media is part of the web 2.0 technology capability. The way websites are programmed, they allow for users to share photos, give updates on “what they are doing” as well as video sharing.
The clearest and best definition of social media I have found was written by Joseph Thornley.
Social media are online communications in which individuals shift fluidly and flexibly between the role of audience and author. To do this, they use social software that enables anyone without knowledge of coding, to post, comment on, share or mash up content and to form communities around shared interests.
The term “new media” has been overly used and widely misunderstood and includes technologies such as PDA’s CDs, DVDs and video games. Webopedia.com defines it as:
A generic term for the many different forms of electronic communication that are made possible through the use of computer technology. The term is in relation to “old” media forms, such as print newspapers and magazines, that are static representations of text and graphics.
So, 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 2: How is web 2.0 technology used?
Now that we know the definition of web 2.0, where the term came from, we will talk about what tactics are under the umbrella of web 2.0 technology and how they relate to the medical device industry.
It is important to know what type of information dissemination should be part of your overall marketing strategy and how web 2.0 can be implemented as part of that strategy.
How the web 2.0 technology is used for healthcare marketing and medical device specifically is an interesting subject. The regulations and restrictions are set to protect consumers and stop snake oil salesmen from deceiving the American public.
The rules are strict, when established. The FDA has yet to develop a set of guidelines for medical device marketers to follow. The FDA has been active in the pharma sector and has levied fines for misuse. In the mean time, it is prudent to work closely with your marketing team and legal regulatory team to establish rules and guides for your web 2.0 efforts.
Blogs
Blogs can be useful during the development of a new product with updates and information of the development phase and progress. When writing blogs for medical device it is important to know what the FDA regulations are for marketing. Providing information about a products benefits or making statements before it has been through the proper FDA channels will land you in a heap of trouble.
A summary of the definition of a blog from Wikipedia.org is:
A blog is a type of website, usually maintained by an individual with regular entries of commentary, descriptions of events, or other material such as graphics or video. Entries are commonly displayed in reverse-chronological order.
Many blogs provide commentary or news on a particular subject; others function as more personal online diaries.
The ability for readers to leave comments in an interactive format is an important part of many blogs.
Asking for feedback on your posts can be a valuable tool but also tricky to manage. The FDA hasn’t provided exact restrictions for medical device marketing about the regulations on who is responsible for information posted on a blog. Pharma companies have been diving into web 2.0 and the lessons learned should be taken into account for medical device.
Blogs should be optimized to ensure they are crawled by the search engines for rankings as well as tracked for unique visits for ROI measurement. While it is difficult to quantify an ROI on this type of marketing strategy you can get a clear sense of who is looking at your product updates as well as how often. Requiring visitors to register will also allow you to collect data and can allow for one on one contact with prospective buyers or even investors.
Community Groups
These groups are usually very social in nature and gather via the Internet to share ideas and information ranging from business to personal and include special interest groups dealing with topics like, religion, health and politics.
Medical device manufacturers can also find a place in these communities or create their own. Depending on the marketing strategy these types of groups can target business, consumers or even the special interest groups depending on the product going to market.
Jeremiah Owyang of Silicon Valley writes in his blog Online Community Best Practices:
Communities Are A Powerful Tool, As Long As You Put Members’ Needs First “An online community is an interactive group of people joined together by a common interest. It’s also one of the most powerful tools a marketer can deploy for customer retention, word of mouth, and customer insight. To host a successful community, think of it as you would product development: Start by focusing on objectives, chart a road map, assemble the right team, and plan to be flexible. Then build your success by launching the community with the backing of your most enthusiastic customers and staying engaged as the community grows. Above all, remember that control is in the hands of the members, so put their needs first, build trust, and become an active part of the community.”
Business community groups have become a very popular form of networking for the busy professional who finds less time in their schedule for the face to face lunch and cocktail networking.
Websites like LinkedIn allow for businesses to network as well as individuals. This particular community has sub-communities called networking groups where you can target your interests and be part of a group that is even more specialized. Even the FDA has a company page with connections to their staff.
Consumer community groups range from fans of products like Pepsi World to AngiesList.com where consumers can review companies and post grievances online. Consumer community groups are sometimes set up by the corporation or by consumers on sites like wetpaint.com.
Special interest community groups created on-line include, health, politics, religion and more. These groups are similar to a consumer group but are brought together for personal reasons and tend to be like-minded individuals looking for news, information, support groups, events, and relationships.
Micro-Blogs
Micro-blogging has become a major topic in marketing communications over the past 6 months or so. One major reason, Twitter, a micro-blogging website designed to tell people “what you are doing” in 140 characters or less.
Twitter came about from the application on Yahoo! Mail, status update, to tell people who also have Yahoo! Mail accounts, what you are doing. In an interview with the LA Times Jack Dorsey explains why he created twitter and the history behind it. Other websites have included the mirco-blog concept into their programming.
Twitter is great for PR needs in medical device marketing. While there are multiple websites that post news releases, having a Twitter account and asking your followers to re-tweet (RT) your posts helps with SEO and gives your followers up to date information that they want.
Facebook and MySpace
Facebook and MySpace are a different type of community from the other three groups mentioned above. These communities are typically very personal in nature. There are some companies that have jumped into the water to test out how having a fan page or group of people who love their product will work. This type of word-of-mouth marketing for some companies will be beneficial.
Medical device companies need to look at their individual product carefully before deciding to go this route. Unless the product has a wide target market these social media sites will not pull the quality traffic needed.
Part 3. Who are the regulators watching the use of the technology
“The Department of Health and Human Services (HHS) is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.”
The Food and Drug Administration (FDA) is one of the sections under the HHS. Other sections include the Centers for Disease Control (CDC), Indian Health Service, National Institutes of Health and others.
Within the FDA there are seven centers and offices that are managed under the FDA commissioner. One of the centers is the Center for Devices & Radiological Health (CDRH). The CDRH breaks down even further into another six offices that are “…responsible for regulating firms who manufacture, re-package, re-label, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions,” according to the FDA website.
This is where it becomes a little more complicated. Depending on the type of device one of the 6 offices will be responsible for the monitoring of regulation compliance.
There are standard marketing rules for medical devices that manufacturers must meet in order to be compliant with the FDA. Each of the following requirements are listed on the FDA website under Overview of Device Regulation.
* Establishment registration,
* Medical Device Listing,
* Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
* Investigational Device Exemption (IDE) for clinical studies
* Quality System (QS) regulation,
* Labeling requirements, and
* Medical Device Reporting (MDR)
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.
Wednesday, December 8, 2010
How to optimize your site's conversion rate - iMediaConnection.com
"This is a great article! It is certainly refining what I have done with my CPL and Axciom data! "
Optimization tactics can tell you who your users are and what they want. Use these essentials to ensure you're making the right moves.
Tuesday, December 7, 2010
Creative Services Manager at National Marketing Department at MDC Holdings Denver
This sounds like an amazing opportunity! The company can not pay relocation costs but like many of us, if you qualify and are in the market, covering those costs on your own is worth it. If interested feel free to send resumes to me direct and I will send them to my contact.
Headquartered in Denver, CO, Richmond American Homes is one of the nation's top homebuilders. Our leading position in the homebuilding industry can provide you with a chance to learn, develop and move ahead. Working within our National Marketing Department provides you with a unique opportunity to work on a national brand. You will be part of an in-house ad agency that plans, creates and implements marketing campaigns from coast to coast. From online to outdoor, you will have an opportunity to work on many integrated marketing programs.
We are seeking a Creative Services Manager that will lead a team of traditional and online designers, working directly with both the Directors of Creative and Account Services to manage our brand and our overall workload. In this position you will be responsible for understanding Richmond American’s business goals and objectives, and for insuring that all marketing material meets these objectives. You will work closely with National Marketing Managers to define and solve communication needs and challenges within our business model as well as working in conjunction with National Marketing Managers to present solutions to stakeholders. The Creative Services Manager will direct a team of print and web designers and maintain brand integrity across mediums.
Essential Job Functions and Supervisory / Project Management Duties:
· Responsible for overseeing Brand Development and Management
· Responsible for maintaining strategy and consistency
· Review and critique design departments’ work
· Helps Traffic jobs among team members
· Responsible for managing direct reports career growth by leading the team with inspiration and motivation to follow strategic objectives
· Responsible for recruitment, termination and performance reviews
· Manages and mentors graphic design staff, including approving daily work product and ensuring daily productivity levels are met
Our ideal candidate will possess a four year degree in graphic design with 5+ years of graphic design experience, preferable in an agency setting.
Additional Requirements:
· Excellent communication and art direction skills
· Advanced knowledge of Macintosh operating systems and troubleshooting
· Advanced knowledge of Adobe Creative Suites including Adobe Illustrator, Adobe Photoshop, Adobe Acrobat and knowledge of Adobe InDesign
· Pre-press preparation skills and understanding of the printing process
· Experience in hand-coding HTML, CSS and Actionscript
· Knowledge of the capabilities of browsers and design constraints on the Web
· Thorough understanding of email design standards and best practices
· Attention to detail and ability to prioritize in a fast paced environment
· Strong visualization and conceptual skills
· Successful track record of management experience
Our successful history in this industry comes from developing a culture that rewards employees for hard work, perseverance and integrity. We have high expectations for employee performance that produces positive business results and a performance management system that measures activities objectively. Additionally, our organization has a strong commitment to compliance with operational standards that all employees must adhere to. This philosophy has helped to not just make us an industry leader but also a place where people are challenged, encouraged and supported to make a positive impact every day. A competitive benefits program including Medical, Dental, Vision and 401(k) are just some of the features available to you.
If you are ready for more than a job and seek a career with one of the most respected organizations in a top industry then we want to hear from you. Please also visit our website at www.richmondamerican.com for more information.
MDC Holdings, Inc. / Richmond American Homes is an Equal Opportunity Employer
Headquartered in Denver, CO, Richmond American Homes is one of the nation's top homebuilders. Our leading position in the homebuilding industry can provide you with a chance to learn, develop and move ahead. Working within our National Marketing Department provides you with a unique opportunity to work on a national brand. You will be part of an in-house ad agency that plans, creates and implements marketing campaigns from coast to coast. From online to outdoor, you will have an opportunity to work on many integrated marketing programs.
We are seeking a Creative Services Manager that will lead a team of traditional and online designers, working directly with both the Directors of Creative and Account Services to manage our brand and our overall workload. In this position you will be responsible for understanding Richmond American’s business goals and objectives, and for insuring that all marketing material meets these objectives. You will work closely with National Marketing Managers to define and solve communication needs and challenges within our business model as well as working in conjunction with National Marketing Managers to present solutions to stakeholders. The Creative Services Manager will direct a team of print and web designers and maintain brand integrity across mediums.
Essential Job Functions and Supervisory / Project Management Duties:
· Responsible for overseeing Brand Development and Management
· Responsible for maintaining strategy and consistency
· Review and critique design departments’ work
· Helps Traffic jobs among team members
· Responsible for managing direct reports career growth by leading the team with inspiration and motivation to follow strategic objectives
· Responsible for recruitment, termination and performance reviews
· Manages and mentors graphic design staff, including approving daily work product and ensuring daily productivity levels are met
Our ideal candidate will possess a four year degree in graphic design with 5+ years of graphic design experience, preferable in an agency setting.
Additional Requirements:
· Excellent communication and art direction skills
· Advanced knowledge of Macintosh operating systems and troubleshooting
· Advanced knowledge of Adobe Creative Suites including Adobe Illustrator, Adobe Photoshop, Adobe Acrobat and knowledge of Adobe InDesign
· Pre-press preparation skills and understanding of the printing process
· Experience in hand-coding HTML, CSS and Actionscript
· Knowledge of the capabilities of browsers and design constraints on the Web
· Thorough understanding of email design standards and best practices
· Attention to detail and ability to prioritize in a fast paced environment
· Strong visualization and conceptual skills
· Successful track record of management experience
Our successful history in this industry comes from developing a culture that rewards employees for hard work, perseverance and integrity. We have high expectations for employee performance that produces positive business results and a performance management system that measures activities objectively. Additionally, our organization has a strong commitment to compliance with operational standards that all employees must adhere to. This philosophy has helped to not just make us an industry leader but also a place where people are challenged, encouraged and supported to make a positive impact every day. A competitive benefits program including Medical, Dental, Vision and 401(k) are just some of the features available to you.
If you are ready for more than a job and seek a career with one of the most respected organizations in a top industry then we want to hear from you. Please also visit our website at www.richmondamerican.com for more information.
MDC Holdings, Inc. / Richmond American Homes is an Equal Opportunity Employer
Monday, December 6, 2010
Answers to pre-interview questions.
I was contacted by a recruiter last week for a position with an agency who markets themselves as a hybrid agency. They are currently seeking an account manager to join their team who has a mix of traditional and interactive agency experience. The recruiter and I discussed the position over the phone and decided I would be a good candidate for the position.
Part of the interview process includes answering some questions about my social media experience, what I have been doing since my layoff in 2009, and what my hobbies are outside of the office. While I know I have addressed most of this in my past blog articles I thought that the focus of social media is an interesting twist on my experience.
Answering the question of my participation, involvement and execution of social media programs requires me to discuss how I use the various tools personally and how I have used it in the past in a professional work environment.
Using social media tools I have been working diligently to build my personal brand. Utilizing my LinkedIn network, posting blog articles to ArticlesBase, Google and Twitter, reading and commenting on other blogs I have been developing a community of fellow job seekers and recruiters looking to fill positions for clients.
One of the tactics in marketing my personal brand has been to spread the news that I am in the job market, send out my LinkedIn profile to every person I know and use as many websites as possible to post my information. The results from LinkedIn as of 9:00 am on 12/2/10 had my profile views listed as 8 people in 3 days with an appearance in search results 12 times in 7 days.
Another tactic I have used for my personal brand is blogging. The purpose of my blog is to discuss my skills and qualifications while at the same time offering helpful information to other job seekers. I post my blog articles to Google Blogger as well as ArticlesBase which helps increase my search rankings, allows me to communicate with readers, and gives prospective employers an opportunity to read on their own time how I can benefit them as a team member. I use Google Analytics to track my blog stats and have a measurable success rate of 109 unique visitors from 10/1/10 thru 12/2/10.
Twitter has allowed me to not only post updates and interesting articles I have read, but also to connect and communicate with the community of Denver bronco fans. Hootsuite is the platform I use to monitor various topics including healthcare, broncos, and mentions. I am currently following 224 people and companies and have 243 followers. My goal for Twitter is not to have millions of followers but to be part of a community.
The results of my personal branding campaign using social media are measurable not only in the stats from each site I use but also when doing a Google search for my name as well as the term marketing manager Denver, no quotes. I was contacted by a MBA student here in Denver who found me on Google and needed to interview a marketing manager. He told me he found me listed #1 on Google.
In the professional work environment the use of social media can be a challenge when the client base and agency team is unfamiliar with the use and power these tools can provide. One challenge was educating the agency team on how social media can drive new business and promote the agency knowledge and background in such a niche market. Another challenge is marketing niche medical device products which are regulated by the FDA. Many times the client fears repercussions from using the tools incorrectly and the agency needs to speak intelligently about how and when to use social media.
After demonstrating to the team the need for social media in our new business efforts and how other agencies were using it I began setting up accounts on Google, LinkedIn and Twitter. Prior to this the agency was not measuring website traffic so I also had our team add Google Analytics to the website so I could track and measure our progress. It wasn’t long before we were ranking in the top 5 on Google and in July 2009 our website traffic was up 36% from the month before.
We had started doing new business projects and I was providing prospective client lists and information to the owner of the agency. Most of my time at this point was spent researching companies who fit in our area of expertise, getting information on what products were being developed by them, finding contact information and making initial contact via LinkedIn.
One of the challenges was to show the agency team and clients that using social media and web 2.0 technologies for marketing medical devices was possible. I began researching the current regulations set by the FDA and what they meant for social media. At the time the FDA didn’t have any clear rules set so existing advertising guidelines needed to be construed for social media. I began writing a blog increase our visibility and demonstrate our expertise when it came to web 2.0 technologies and the FDA and what role social media would play in medical device marketing.
It could be said that using social media and web 2.0 technologies to market medical device products was a big idea. Unfortunately the agency went out of business before we could implement programs for clients. Which brings me to what I have been doing since the layoff. There is always a friend or family member who needs help writing a brochure or designing a flier they can print a Kinkos.
Looking for a new position in marketing has been my full time job. As I mentioned above I have been very active in building my personal brand and working on my Google rankings. I find that I spend at least 6 hours a day researching companies, participating in webinars, reaching out to my network, and writing.
Beyond that I have been helping a friend in Las Vegas market his business. Unfortunately he has no budget and is under contract with DexKnows. I have been helping him with changing his website to include content management, increase his search engine rankings, and encourage him to participate in social media and networking.
I also was asked to help with a fund raising campaign for local after school programs in the city I grew up in. A few alumni got together and decided to hold an alumni softball tournament where the three local junior high schools would compete for bragging rights. We had three weeks to pull it all together and it was a great success. I created a Facebook fan page, wrote a news release and used word of mouth tactics . Our initial goal was to raise $600 and once I began the marketing we quickly realized we could raise more. Our total donation to the program was $1100.
Working in advertising agencies for over 9 years has allowed me to be part of teams large and small. Marketing Partners was my company and I provided marketing services to clients. I worked with Hugh Roper who was a freelance graphic designer on a campaign to launch a new condo conversion property in Las Vegas, NV. I started out by evaluating who our prospective buyers were using Acxiom data and from there we designed all the ads and collateral based on those profiles.
Where the “big idea” comes into play is how I planned and bought the media for the client. Using the data from Acxiom I was able to segment consumers into buying groups and use this information to purchase the most effective media schedule. I would then use a company called Who’s Calling to place unique phone numbers into all ads (print, radio, Internet and TV) to track who was responding to which ad and from what media outlet. Also, I used unique URLs and Google Analytics to track web traffic.
So, each month I would pull a call report, Google report and sales team report and track the cost per lead down to each newspaper ad, radio station, email, and even the signage. That way I was able to adjust my media buys and messaging as needed. At the end of the campaign I was able to calculate a total cost per lead for the entire marketing plan.
The goal for traffic was determined at the very beginning of the planning process. It was figured that 4% of all traffic should result in sales. We had at one time 267 units to sell and were able to calculate how many units of traffic needed to be driven to the sales team to sell out. The final results of the campaign generated over 1,200 prospective buyers in a six month period at a cost per lead of $162.
Now, jumping to the personal side of life, being new to Colorado I am looking forward to learning how to ski this winter. My husband claims he knows how and we plan on going on our first adventure this month. Our past summer vacations have been spent camping, hiking and biking in Yosemite National Park. This past summer we camped in Tuolumne Meadows for the first time and fell in love. While we did miss seeing the bears that are so often roaming around the lower valley, the hiking and fishing was amazing. Next summer we may go to Yellowstone but with so many amazing camping opportunities close by, we have yet to decide.
Watching the Denver Bronco games is a big part of what I do during the football season. One of the reasons my husband and I started dating was because we were both fans. When he was offered and excepted a job with Denver Water we couldn’t believe we would live in the state where our team was. The excitement of watching our team with other fans has been amazing!
Part of the interview process includes answering some questions about my social media experience, what I have been doing since my layoff in 2009, and what my hobbies are outside of the office. While I know I have addressed most of this in my past blog articles I thought that the focus of social media is an interesting twist on my experience.
Answering the question of my participation, involvement and execution of social media programs requires me to discuss how I use the various tools personally and how I have used it in the past in a professional work environment.
Using social media tools I have been working diligently to build my personal brand. Utilizing my LinkedIn network, posting blog articles to ArticlesBase, Google and Twitter, reading and commenting on other blogs I have been developing a community of fellow job seekers and recruiters looking to fill positions for clients.
One of the tactics in marketing my personal brand has been to spread the news that I am in the job market, send out my LinkedIn profile to every person I know and use as many websites as possible to post my information. The results from LinkedIn as of 9:00 am on 12/2/10 had my profile views listed as 8 people in 3 days with an appearance in search results 12 times in 7 days.
Another tactic I have used for my personal brand is blogging. The purpose of my blog is to discuss my skills and qualifications while at the same time offering helpful information to other job seekers. I post my blog articles to Google Blogger as well as ArticlesBase which helps increase my search rankings, allows me to communicate with readers, and gives prospective employers an opportunity to read on their own time how I can benefit them as a team member. I use Google Analytics to track my blog stats and have a measurable success rate of 109 unique visitors from 10/1/10 thru 12/2/10.
Twitter has allowed me to not only post updates and interesting articles I have read, but also to connect and communicate with the community of Denver bronco fans. Hootsuite is the platform I use to monitor various topics including healthcare, broncos, and mentions. I am currently following 224 people and companies and have 243 followers. My goal for Twitter is not to have millions of followers but to be part of a community.
The results of my personal branding campaign using social media are measurable not only in the stats from each site I use but also when doing a Google search for my name as well as the term marketing manager Denver, no quotes. I was contacted by a MBA student here in Denver who found me on Google and needed to interview a marketing manager. He told me he found me listed #1 on Google.
In the professional work environment the use of social media can be a challenge when the client base and agency team is unfamiliar with the use and power these tools can provide. One challenge was educating the agency team on how social media can drive new business and promote the agency knowledge and background in such a niche market. Another challenge is marketing niche medical device products which are regulated by the FDA. Many times the client fears repercussions from using the tools incorrectly and the agency needs to speak intelligently about how and when to use social media.
After demonstrating to the team the need for social media in our new business efforts and how other agencies were using it I began setting up accounts on Google, LinkedIn and Twitter. Prior to this the agency was not measuring website traffic so I also had our team add Google Analytics to the website so I could track and measure our progress. It wasn’t long before we were ranking in the top 5 on Google and in July 2009 our website traffic was up 36% from the month before.
We had started doing new business projects and I was providing prospective client lists and information to the owner of the agency. Most of my time at this point was spent researching companies who fit in our area of expertise, getting information on what products were being developed by them, finding contact information and making initial contact via LinkedIn.
One of the challenges was to show the agency team and clients that using social media and web 2.0 technologies for marketing medical devices was possible. I began researching the current regulations set by the FDA and what they meant for social media. At the time the FDA didn’t have any clear rules set so existing advertising guidelines needed to be construed for social media. I began writing a blog increase our visibility and demonstrate our expertise when it came to web 2.0 technologies and the FDA and what role social media would play in medical device marketing.
It could be said that using social media and web 2.0 technologies to market medical device products was a big idea. Unfortunately the agency went out of business before we could implement programs for clients. Which brings me to what I have been doing since the layoff. There is always a friend or family member who needs help writing a brochure or designing a flier they can print a Kinkos.
Looking for a new position in marketing has been my full time job. As I mentioned above I have been very active in building my personal brand and working on my Google rankings. I find that I spend at least 6 hours a day researching companies, participating in webinars, reaching out to my network, and writing.
Beyond that I have been helping a friend in Las Vegas market his business. Unfortunately he has no budget and is under contract with DexKnows. I have been helping him with changing his website to include content management, increase his search engine rankings, and encourage him to participate in social media and networking.
I also was asked to help with a fund raising campaign for local after school programs in the city I grew up in. A few alumni got together and decided to hold an alumni softball tournament where the three local junior high schools would compete for bragging rights. We had three weeks to pull it all together and it was a great success. I created a Facebook fan page, wrote a news release and used word of mouth tactics . Our initial goal was to raise $600 and once I began the marketing we quickly realized we could raise more. Our total donation to the program was $1100.
Working in advertising agencies for over 9 years has allowed me to be part of teams large and small. Marketing Partners was my company and I provided marketing services to clients. I worked with Hugh Roper who was a freelance graphic designer on a campaign to launch a new condo conversion property in Las Vegas, NV. I started out by evaluating who our prospective buyers were using Acxiom data and from there we designed all the ads and collateral based on those profiles.
Where the “big idea” comes into play is how I planned and bought the media for the client. Using the data from Acxiom I was able to segment consumers into buying groups and use this information to purchase the most effective media schedule. I would then use a company called Who’s Calling to place unique phone numbers into all ads (print, radio, Internet and TV) to track who was responding to which ad and from what media outlet. Also, I used unique URLs and Google Analytics to track web traffic.
So, each month I would pull a call report, Google report and sales team report and track the cost per lead down to each newspaper ad, radio station, email, and even the signage. That way I was able to adjust my media buys and messaging as needed. At the end of the campaign I was able to calculate a total cost per lead for the entire marketing plan.
The goal for traffic was determined at the very beginning of the planning process. It was figured that 4% of all traffic should result in sales. We had at one time 267 units to sell and were able to calculate how many units of traffic needed to be driven to the sales team to sell out. The final results of the campaign generated over 1,200 prospective buyers in a six month period at a cost per lead of $162.
Now, jumping to the personal side of life, being new to Colorado I am looking forward to learning how to ski this winter. My husband claims he knows how and we plan on going on our first adventure this month. Our past summer vacations have been spent camping, hiking and biking in Yosemite National Park. This past summer we camped in Tuolumne Meadows for the first time and fell in love. While we did miss seeing the bears that are so often roaming around the lower valley, the hiking and fishing was amazing. Next summer we may go to Yellowstone but with so many amazing camping opportunities close by, we have yet to decide.
Watching the Denver Bronco games is a big part of what I do during the football season. One of the reasons my husband and I started dating was because we were both fans. When he was offered and excepted a job with Denver Water we couldn’t believe we would live in the state where our team was. The excitement of watching our team with other fans has been amazing!
Friday, December 3, 2010
What have you done for me lately? Job search tips
As a very active job seeker I find myself sending connection requests to fellow LinkedIn members asking for help. Most of the time I need help connecting with hiring managers to get my foot in the door. And one of the things I have learned is that you have to offer up your help to others as well. Easier said than done for sure. I’ve started sending job leads from recruiters to my connections that are also seeking a position. I answer as many questions as I can and start discussions in my groups to show I am an active participant.
So, in an attempt to really help others I want to list out some of my favorite recruiters and job search websites. My hope is that I can do for others what I hope they can do for me.
Of all the job search websites I prefer InDeed.com. This is mainly due to the ease and accuracy of the job alerts. I have signed up to receive an email everyday with jobs that match my selected criteria. I have been sure to include the terms that I don’t want. I’ve found that because the term marketing is an umbrella term for so many positions and is included in the job descriptions of so many listings that excluding certain terms keeps me from getting jobs that I would never be interested in.
Of course I am on CareerBuilder.com and Monster.com as most job seekers are. The job alerts from CareerBuilder usually include positions for sales as well as entry level positions. I don’t ask Monster to send alerts because it is too repetitive of the jobs I am already getting.
I have received a few emails and calls from recruiters from CareerBuilder and that is great. At one time I actually paid for Marketing Ladder.com and was terribly disappointed. It was expensive and after some time I realized it was a recruiter database. The worst part was positions I would apply for I would also find on the free sites. I had been told that the staff would review your resume and let you know if you had the right experience to be included on their site. It was supposed to be exclusive to upper level management. They actually had commercials during the Superbowl one year touting the exclusivity of the site.
I really like to look at LinkedIn for positions because I can send my profile along with my resume. Unfortunately, many of the groups have started listing jobs in the group pages and those are much more cumbersome to sift through. There is no way to search through the listings for positions in your area or by job title. I’d like to see LinkedIn change that.
A really big tip is signing up with the temp/placement agencies. Most of my interviews and job leads have been from a recruiter. I have had varying results from these companies. What I really appreciate is that they return calls, emails and are never rude.
Here is a list of sites/companies to sign up with. If you want an actual contact, leave a comment and I’ll get the contact information for you.
Note: I am in marketing/advertising and some of the companies specialize in my industry.
The Creative Group
The Kleeman Group
Source Executive
DCM Staffing
Aquent
I hope this helps in your search!
So, in an attempt to really help others I want to list out some of my favorite recruiters and job search websites. My hope is that I can do for others what I hope they can do for me.
Of all the job search websites I prefer InDeed.com. This is mainly due to the ease and accuracy of the job alerts. I have signed up to receive an email everyday with jobs that match my selected criteria. I have been sure to include the terms that I don’t want. I’ve found that because the term marketing is an umbrella term for so many positions and is included in the job descriptions of so many listings that excluding certain terms keeps me from getting jobs that I would never be interested in.
Of course I am on CareerBuilder.com and Monster.com as most job seekers are. The job alerts from CareerBuilder usually include positions for sales as well as entry level positions. I don’t ask Monster to send alerts because it is too repetitive of the jobs I am already getting.
I have received a few emails and calls from recruiters from CareerBuilder and that is great. At one time I actually paid for Marketing Ladder.com and was terribly disappointed. It was expensive and after some time I realized it was a recruiter database. The worst part was positions I would apply for I would also find on the free sites. I had been told that the staff would review your resume and let you know if you had the right experience to be included on their site. It was supposed to be exclusive to upper level management. They actually had commercials during the Superbowl one year touting the exclusivity of the site.
I really like to look at LinkedIn for positions because I can send my profile along with my resume. Unfortunately, many of the groups have started listing jobs in the group pages and those are much more cumbersome to sift through. There is no way to search through the listings for positions in your area or by job title. I’d like to see LinkedIn change that.
A really big tip is signing up with the temp/placement agencies. Most of my interviews and job leads have been from a recruiter. I have had varying results from these companies. What I really appreciate is that they return calls, emails and are never rude.
Here is a list of sites/companies to sign up with. If you want an actual contact, leave a comment and I’ll get the contact information for you.
Note: I am in marketing/advertising and some of the companies specialize in my industry.
The Creative Group
The Kleeman Group
Source Executive
DCM Staffing
Aquent
I hope this helps in your search!
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