Tag Archives: Messaging

Clinical Evidence Plan Creation for Medical Device Marketers

The Set Up

I have found that there is often a disconnect between the desired Marketing Messaging and the Clinical Evidence proof that has been created in support of the product. Many product managers are caught between what they want to say vs. what they are allowed to say. This sets up a potential conflict that could lead to “off-label” claims.

The Problem

When there is a disconnect between messaging and proof points a number of outcomes may or will occur:

  • The message is weak
  • Un-supported claims – misleading statements
  • Failed regulatory process
  • Confusion and wasted resources
  • Frustration

What causes the disconnect?

There are a number of reasons this disconnect might occur:

  • Lack of an integrated Commercialization strategy
  • The Clinical Affairs group acting to serve the minimal required Regualtory Strategy
  • Marketing not providing input to Clinical Affairs before the evidence collection begins
  • Marketing not knowing what they want to say about the product
  • A desire to minimize cost

None of the above reasons are good ones. We have talk about the product managers role as being the keeper and communicator of the vision for the new product launch. This has to include the development of a clinical evidence plan.

What to do to prevent the disconnect?

Create a Clinical Evidence Plan – a clinical evidence plan is the thought process and document that connects your marketing message to the clinical trial/study development goals with the regulatory strategy. As with all commercialization processes there are natural tensions between the four roles that surround clinical evidence development. Getting to a consensus won’t be easy. The gains are worth the effort.

How do I create a clinical evidence plan?

There are thirteen steps to creating the plan. I’ll list them here for you, but it may not be clear to you how to actual complete each step. Steps 5-12 are particularly difficult and require some experience to do them well.

Plan creation steps (assume that you will need a working group of marketers, clinical affairs specialists, medical affairs specialists, and regualtory affairs specialists)

Step Description Type of step
1 Strategic marketing message (clarity is required on primary claims) Input
2 Proof points from messaging Extraction
3 Brain storm support claims New input
4 Brain storm desired future claims (outside current messaging) New input
5 Load all desired claims into a spreadsheet (Steps 2,3,4)(leave a comment to this post with your e-mail address for a free spreadsheet template) Team leader action
6 Populate the spreadsheet with the claims and all details

Nature of the claim, clinical end point, evidence level required, study type, study description, regulatory requirement, sample size, number of investigators needed, etc.

Team event(s)
7 Define scoring scales 5-1 for each impact variable

·      Duration of study score

·      Total cost score

·      Magnitude of market impact score

·      Likelihood of success score

Selecting weighting for each variable

Team event
8 Have an expanded group score each variable, independantly Individual input
9 Collate and compile the results from all receiptient (best to do frequency plots and averages for all variables) Team leader action
10 Review scoring and reach concensus on each score, don’t just use the average score. Team event
11 Calculate the impact scores (Duration x weight) x (Total cost x weight) x (Magnitutude market impact x weight) x (Likelihood of success x weight) = Combined impact score Team leader action
12 Apply team judgement to the scores and prioritize Team event(s)
13 Publish results Team lead and team

Cautions: Scales and weights will drive the prioritization; spend enough time on these two sets of decisions.

The Benefits of an Integrated Clinical Evidence plan are:

  • Powerful messaging
  • Team alignment
  • Effective use of resources

Lessons:

  1. Be proactive and lead
  2. Know what you want to say about the product before you start the clinical evidence collection process
  3. Build consensus on the best approach to develop clinical evidence

“Experience is what you get, right after you need it most.”

Make it a great day,

Tim Walker

Tim Walker is the Principal consultant for The Experia Group. A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success. www.theexperiagroup.com. Contact The Experia Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success.

Copyright 2018, The Experia Group®, LLC

Keeping the Strategic Message Pure in the Marketing Mix

The Set Up

Working with several clients to develop their up-stream product and corresponding messaging strategies for elements of their portfolio was relatively straight forward, right up until we needed to translate that strategy and messaging into actionable input for the down-stream activities.  Then everything came to a grinding halt.

I don’t use the word translate lightly.  It felt as though there were three or four languages being spoken in the room at the same time.  It was to say the least frustrating at the worst maddening.  How do you translate the Up-stream message to the Down-stream message?

What was going on?

Digging a little deeper I determined that it was much more than just a language issue. The promotions and branding teams that were put together to “package” the message into an attractive and readily acceptable set of collateral materials and campaigns came from different cultures where specific tools had been developed, practiced, and became so engrained that they could no longer accept input without it being in the format they were individually accustomed to.

 This was a challenge as there were at least six different formats that were being used.  When you stepped back from the translation process it was amazing to see that the majority of these forms, templates and formats all used the same words and phrases, but they all had slightly different meanings due to the contextual difference from the user perspective.  Words and phrases such as: segmentation, positioning, targeting, persona, value proposition all meant different things.

 This translation issue was significant and any hope for efficiencies went right out the window.  My role was to make sure we didn’t lose effectiveness as well.

What to do?

Admittedly my thinking is not complete on this issue, but here is what I did.  For those of you who have read some of my other posts you’ll know that I am a huge fan of writing down concepts as a vehicle of communications.  It became clear to me that that would not be enough in this case.  I had to make sure that the messaging did not become confused. I had to make sure that the Strategy was not “thrown over a wall” to those responsible for putting a beautiful wrapper around the execution of the strategic messaging.

I asked myself what brought clarity to me regarding the positioning of the product.  The answer was, perspective and context that I had gained through immersion in the customer environment.  Somehow I had to translate that perspective that insight to the down-stream creatives.   

So?  Here is what the team did.  We held several sessions where market research findings were presented to the creative team with discussion.  We made available digital recordings of customer interviews.  We used their forms and we stayed intimately involved as a “technical advisor” to their creative process.  We attended their creative workshops.  The tone of our input was one of a knowledgable guide.  When the creatives seemed to be diverting from the message we assumed that it was us that didn’t understand and we listened carefully.  We would reassert an insight and show where we derived that insight from an interview or the research in real time.

We did everything we could and more to “tear down the wall”.  Did this approach work?  Couldn’t hurt.  Time will tell.

Lessons:

1.     Don’t assume that just because we are all marketers that we speak the same language.

2.     Sometimes we can’t see the walls that we ourselves helped to build.

3.     Tear down the walls, don’t throw vision over the wall and think it will land correctly.

 “Experience is what you get, right after you need it most.” 

Make it a great day, 

Tim Walker

 

Tim Walker is the Principal consultant for The Experia Group.  A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success.  www.theexperiagroup.com.  Contact The Experia Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success.

 

© 2018, The Experia Group, LLC

Social Media and Medical Device Marketing

Magnified illustration with the word Social Media on white background.

The Story

A good friend of mine called me and started asking a lot of questions about the use of social media in medical device marketing. It seems that his VP read an article on social media and wanted an assessment of how i it would benefit their big product launch that is scheduled for 6-months from now.

We spoke for an hour and I truly felt bad for him. He interpreted his bosses question as an order to utilize social media.

Keeping Things in Perspective

whySocial media is a very power tool. In and of itself it is not a goal. When some one tells me that they need social media I often ask why? Not that I don’t believe in the power of social media, I do, but if you can’t tell me why you need social media there is a step missing. All marketing actions need to begin with a goal or objective, a strategy to achieve the goal and then followed-up by a series of tactics to realize the goal aligned with the strategy.

The Goal is Customer Engagement

Customer engagement is one of those objectives that should be obvious to everyone, but it is not. It is well worth adding a section to your launch pltemperature gage customer engagementan titled Customer Engagement, outline the detail about how, who, when and why the engagement will occur. Please remember to calculate the cost!

Methods of Customer Engagement in Medical Device Marketing

Customer engagement has been happening since the first medical device was invented. It is nothing new. It is ever increasing in importance and sophistication, as there are new messaging channels and quote-if-all-you-have-is-a-hammer-everything-looks-like-a-nail-abraham-maslow-12950technologies for conducting the engagement. No one set of tools is optimal for any one market, segment, customer or product. You need to customize your plan. Don’t fall into the trap of being a hammer, and everything looks like a nail. Choose the right tool for the job.

The following list identifies a number of engagement approaches:

  • Key Opinion Leader involvement
  • Speaker’s bureaus
  • Hand-on workshopsCustomer engagement
  • Tradeshow events (training, contests, quizzes)
  • Blogs that encourage feedback and discussion
  • Chat rooms
  • Panels
  • Webinars
  • Social media pages that are interactive
  • Plant tours
  • Direct consultive selling

You note that advertising, selling, telling, You-Tube videos, e-mail blasts, Internet messaging are not on the engagement list. There is a fundamental reason for that.

Customer Engagement Defined

Customer ENGAGEMENT is a real time, active, two-way exchange of information, feelings and thoughts that afford participants to deepen their understanding of each others needs, wants and desires. To further invest in each other!

“Consumer Engagement may be a broad topic, but it’s the lifeblood of any sophisticated marketing organization’s strategy. We define consumer engagement as the interactions between a brand and it’s customer. These interactions can – and should – happen simultaneously across multiple online and offline marketing channels. Skilled marketers can guide this engagement to serve their business needs, while also providing consumers with an authentically enjoyable experience.”1

If the right vehicle for that engagement includes social media or digital marketing then go for it!

How Does The Story End

My friend took a breath and revaluated the launch plan. He added a section (3-slides) on customer engagement. He correctly identified that the broad-based social media effort was not the right approach for engaging Pioneers and Early Adopters. He did identify a strategic intent to capture the engagement with Pioneers and Early Adopter and create an opportunity to “report” out that progression to the Early Majority users.

He added a tactic to his plan a tactic to create a private chat room (password protected, non-public access) for the “soft launch” users to exchange experiences with early use experience. Part of the plan to promote distance engagement called for a discussion forum every two weeks via a virtual meeting room, where engineers, marketers and clinicians could relate user successes and issues.   I did recommend that a Quality representative attend to assess in real-time if a complaint needed to be filed and to record any and all clinical suggestions that might be proposed by an engineer.

An incredibly smart move on his part was to hire a digital marketing (DM)/social media (SM), consulting firm to review the engagement strategy and educate him and his team in where DM/SM might add value. The mission is to optimize an integrated launch media strategy in time to convince the Early Majority users to leap the “innovator chasm”.

Selling the expense for the consultant was easy. He presented it as way to increase the competency of his marketing organization, making sure that the tools available in the 21st century were appropriately applied, exactly what his VP was after.

[1] https://www.offerpop.com/definitions/what-is-consumer-engagement/

“Experience is what you get, right after you need it most.”

Make it a great day,

Tim Walker

Tim Walker is the Principal consultant for The Experia Group. A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success.  Contact Tim for a free 30-minute consultation to see how he can contribute to your success at www.theexperiagroup.com.

© 2016, The Experia Group, LLC

Message Congruency in Medical Device Commercialization

The Story

Have you ever seen messaging related to a new product that was clearly disjointed? Maybe you saw a tradeshow booth that spoke of the product a bit differently than the sales brochure and the salesman’s pitch was a different story all together?

A VP of Marketing hired me to figure out why their dynamite new product wasn’t gaining the momentum that they had expected. This is one of the most enjoyable and potentially beneficial services that I get to perform for clients. Consider it a launch autopsy.

There are many other causes for a slow takeoff of a new product. For this particular client the issue was a confusing message.   So confusing that one might describe it as conflicting. Why is this a big deal? Walker’s Law of Congruency™ states, “As human beings we seek congruency. We constantly are trying to connect the dots. The price has to match the value of the product. The color schemes have to represent the claims, etc. When our minds detect an incongruent message we start to doubt everything about the issue or in our case the product. The customer loses trust in the product.”

How do we prevent incongruent messages as marketers? There are lots of factors, but simply we need to know exactly what our message is, more importantly everyone that is working on or near the launch must understand the message.

How do we stay on message?

We write. We publish the five documents that then serve as the source for every piece of collateral, every training script, every creative brief.

  • Segmentation
  • Targeting (user and buyer)
  • Product positioning statement
  • Product value proposition
  • Pricing strategy

These are the five documents that act as the base. Everything else flows from here.

Slide1

In addition to these five basic documents there is a format to the story line. It is not mine; it is something that is adapted from other sources.

  • Problem statement
  • Solution statement
  • Reasons to believe
  • Proof set
  • Call to action

If you publish the five core documents and keep any promotional materials and sales pitches in the five-element format it is unlikely that you will have incongruent or even worst conflicting messages.

“Experience is what you get, right after you need it most.”

Make it a great day,

Tim Walker

Tim Walker is the Principal consultant for The Experia Group. A small consulting firm that specializes in providing experience and expertise during critical device commercialization phases to increase the probability of success. www.theexperiagroup.com.

 

© 2015 The Experia Group, LLC