Tag Archives: Tim Walker

Brand vs. Branding in Medical Device Marketing

Set up

I have experienced/observed that business professionals who are not familiar with the nuance of marketing get confused between the Brand and Branding. I have found myself explaining the difference multiple times over the last few months, so here is how I think about it and explain it. You may find it useful if you ever need to explain the differences yourself.

Summary

Your brand is who you are, an internal facing belief system; branding is how your brand manifests itself outward toward your customers, your market, the world at large.

You cannot do branding without first being crystal clear about your brand. Getting clear on your brand is a profoundly unique discovery process that is at your or your products core and comes from your or your products history. It is the most authentic aspect of your company or product. If you are a new company, it may be a confluence of the founders’ personal histories.

Many companies /products have a name, a logo, a color preference, etc. These are all representations of your brand. If the outward expression of your brand is inconsistent with the brand, then your customers will be confused.

Having an understanding of the difference between the brand and branding, take a minute to reflect on the recent McDonalds attempt at deluxe burgers. Custom made to order specialty burgers.   When they announce this program, it was crystal clear that they were moving outside of their core value, their brand. McDonald’s is known for and was created from, a belief that customers wanted a quick, convenient, consistent meal that had good taste.

So they based their success on location, consistency of product, and a standardized menu. For decades that is what the golden arches stood for. They have just recently announced that they are discontinuing the specialty burger menu option.

Changing your brand is a challenge; it is tantamount to changing history, changing who you are.

Living into your Brand

Do you have to perfect in your branding on day one? No. However, you do have to be crystal clear on your brand.

Lesson

Look deep within to discover or reveal your brand, first.

“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 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.

© 2019, The Experia Group, LLC

 

 

MVP a potentially dangerous concept for the Medical Device Sector

Forward

I don’t typically repeat topics in this blog. However, I am making an exception this time. This is the third post related to the use of the Minimally Viable Product (MVP) concept with Medical Devices.

Set up

Recently, I had an email exchange with a potential client where they informed me that they were pursuing an MVP and they didn’t need any marketing support at this time. I may write a post about how that may be misguided thinking if there isn’t a Marketing Mindset in the company.   Marketing Mindset will be the subject of a future post as well. That e-mail exchange triggered an emotional response within me.

I offer this post because I feel compelled to. The Universe woke me up at 3:00 am last night to inform me that my mission in life demands that I caution inventors, scientists, engineers, entrepreneurs, investors and product marketers that are involved with product commercialization where human safety or health is at risk, that the MVP concept can be misinterpreted.

MVP is a useful concept as defined by Eric Ries; “A minimally viable product is that version of a new product which allows a team to collect the maximum amount of validated learning about customers with the least effort.” I am sure that there are many industries where this definition can be applied directly. It seems particularly applicable to entertainment sectors, like video games. I strongly recommend that everyone who is using that term, reflect on if it is a thought construct that is appropriate for his or her market sector.

In the example above, the first set of drawings do not provide full utility. The second example does. This concept applied to medical devices gets at the need for complete clinical utility (CCU).

Cautionary Note

For me, what I have come to believe is the concept of safe, complete clinical utility (CCU) is the way to think about the first product to be launched by a company or a technology platform in the medical device space. In the medical device space or any space where human lives are at risk, we should never strive for a minimum of anything.   I have found that the long-term success of any product results from maximums, maximum utility, maximum compliance, maximum clinical evidence, and maximum safety.

If you want to use a hot buzzword like MVP in a high-risk space, then I think it will be worth your time to define the scope of “Viable” for your product. It will show the clinicians, investors, and patients that you understand where their health is concerned that Viable is a big word and includes, regulatory compliance, safety, and complete utility.   If you must put the acronym on a slide, then do it this way – mVp.

For those of you who are involved in the acquisition of technologies or products that can present a risk to humans make sure you do more than financial due diligence. Be intentional about your technical and clinical due diligence as well. If you are new to M&A activity, hire a coach who has been there and done that. I have seen first hand the results of poor clinical and technical due diligence. Large follow on investment in the millions of dollars, months of delays, failed launches, investors losing confidence in management teams, negative impact to the brand, and of course worst of all, a patient injury that may result from truncated due diligence!

Marketing Mindset

What I believe is that if you have and apply a Marketing Mindset to product commercialization you will think in terms of multi-generation product releases that move you toward 100% customer satisfaction.

Lesson

Words matter, using a popular buzzword implies knowledge of the thoughts behind the term. Don’t be caught unprepared or leave an opening for misinterpretation.

“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.

© 2019, The Experia Group, LLC

 

Subjective Review of On-going Marketing Activities

The Set Up

Recently I sent a letter to a colleague of mine asking how everything was going? He replied that he wasn’t sure. It was too early in the year to tell. So I dropped him a note that he indicated was very helpful for him to get his mind around how things were going.

He then suggested that it might make a good blog post. So here you go.

Just for full disclosure, I am a huge proponent of metrics and data. Sometime it is too early in a program or product launch to realize any of the metrics. It doesn’t mean that you as a Senior Manager shouldn’t try to take the temperature of programs, campaigns or launches early on.

It just means that you are going to do it subjectively.

Whenever I have had to subjectively evaluate progress it has been with the assistance of a  framework.

Framework

Here is how I have done it.

I attend several team meetings or review sessions. I then get a sense for the progress and capabilities of this team on this task. Then I ask which outcome from the following chart is most likely, just a feeling. It also helps me identify why.

If you feel like this team will, “Change the World”, then check in later. If your sense is that something is amiss you can act early and reduce the risk of sub-optimal results.

A bit of mentoring or coaching early will often prevent big changes and poor performance later.

Lesson

My friend discovered that they had two programs that both were missing a sound Method. He hired us to provide that methodology. One was a new product launch and the other was their annual tradeshow campaign.

“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.

© 2019, The Experia Group, LLC

Product Line Rationalization for Medical Devices

The Set Up

It has been some time since I actually performed a Legacy Product Line Rationalization. Two calls this week have prompted me to create this post. This is how I think about it.

As a Product Manager, one of the most necessary and potentially difficult tasks is to rationalize your portfolio product lines for an exit, maintain or invest strategy. If you review your product line performance on an annual basis, see AARP post, you will find that you have most of the data and insights you need.

The Goal of the Review

The goal is to rationalize your current portfolio based on the previous performance changes year over year. You pretty much have 3 options although they can be thought of as on a scale.

  • Maintain
  • Invest
  • Divest

This review will point you toward actions that are needed in support of each product line. Your annual action plan can be driven by your findings.

“The Key is to be intentional about your product line.”

How do you do the review?

Step 1 – Collect and Organize Your Data

Determine a method for objectively determining how well your product lines are performing. Elements that you should consider including in your assessment or scoring tools are:

  • The volume of revenue, ranking
  • Change in revenue
  • Gross profit dollars
  • Profitability
  • How ubiquitous the product is geographically
  • How stable is the supply chain
  • Quality yields
  • Number of customers won and lost this past year
  • What is the status of the treatment it is used on
  • Of those customers who are buying, where do they stack up on your best customer rankings list
  • Does it fit in the future strategic plan or will it become an orphan

The examples used here are designed to demonstrate a complex and murky review. Sometimes the answers pop off the page once you have organized all of the relevant data for your portfolio.

Step 2- Build Your Model

There are two aspects to this step. First, collect the data and rank each product line by element. Secondly, rank them all as a portfolio.   The first step is fairly mechanical. The second is where the lines are compared by rankings.

So if you have 10 product lines your spreadsheet would look like the one shown below.

Step 3- Analyze the Rankings for Obvious Ins and Outs

  • Product line 1 is new, so it is IN
  • Product line 2 this needs a deeper dive, a better understanding of the market conditions are required.
  • Product line 3 solid performer so IN
  • Product line 4 solid performer so IN
  • Product line 5 solid performer with few key accounts so IN
  • Product line 6 solid performer so IN
  • Product line 7 this one needs a deeper dive. It is an average performer and seems like it will stay there for a while. If it still fits with your future vision for the portfolio it appears to be IN
  • Product line 8 too big to cut, needs some mfg. improvements
  • Product line 9 too big to cut, but needs a deeper dive so IN
  • Product line 10 this needs a deeper dive but may be too big to cut without a plan

So there are six product lines that should not be cut, 4 that need a bit deeper dive. Another element that we did not take into account was synergy between product lines. Sometimes you keep an underperforming product line to support a high performing one.

So if we plot our choices on to a Boston Consulting Group grid it can really give you a clear picture of your strategic position for each product line.

Combining this review with a go-forward plan you can use a matrix like this:

Follow this simple three-step process to rationalize your product line and defend your position.  Keep the grid/worksheet with you in every meeting and you will be able to see at a glance where you are going next.

It is ok to keep all of the product lines. It is unacceptable to not know why you want to keep them.

 “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.

© 2019, The Experia Group, LLC

New Product Opportunity Discovery

The Set Up

I just returned from VIVA2018 and was called out for not addressing the topic of Opportunity Discovery, as promised in the Opportunity Assessment post.

So the question at hand is how do you discover new product opportunities? To figure out the answer we need to turn the coin over and see what is on the other side of this question. How do I discover unmet clinical needs? Once again, the answer is simple; it depends.

It depends on whether you are looking for a disruptive product, groundbreaking new platform product, an improved product, a line extension, or, an adjacent use for your current product.

There are formal and informal ways of identifying unmet needs. Both lead to the same unpredictable place, Insight. Both formal and informal methods require you to “live” in the World of your clinician customers. Both ways need you to collect experiential data.   That experiential data can come from ‘true to life’ or ‘vicarious’ sources. They can be observed, reported first hand, or reported second hand.

 The Formal Way

If possible, the formal process should

start with a loose objective. By this I mean it should be consistent with your current corporate positioning. I.e., if you are known for safety, then you should be looking for opportunities to provide a higher level of protection. If you are known for quality, then look for opportunities surrounding improving quality. If you are known as a company that brings therapeutic products then identify an underserved disease or patient type.

Approaches

The MAUDE database (where mfg. report complaints, defects, and injuries) can provide rich experiential data with respects to needed product improvements.  There are several challenges to using this database, but it is still a great first point of discovery.

Polling thought leaders is a formal way of identifying “pain” points. Just be sure to ask the open-ended questions first and then drill down. Don’t look for solutions yet. Secure an understanding in as much detail as possible first. E.g., your company has identified through an environmental scan that adjacent diseases state or technology is a direction they want to move in. It is emerging or already has high growth rates with little competitive activity.

Once you have polled the thought leaders in this new area and have developed a hypothesis; invite 10-20 physicians to a panel meeting and have an open discussion surrounding the needs of this emerging therapy.   Concretely come to understand the challenges from all dimensions, science, clinical, business, reimbursement, regulatory, to name several.

Attend clinical presentations at medical conferences. Product managers get pulled in two-directions at these conferences. Booth duty, sales support and discovery. If one of your roles is up-stream marketing, then you must attend papers.

 Hospital/Clinic time is becoming more difficult. There was a time where I had free access to spend a day wondering between OR’s just being there, listening to issues, watching for problems. Those days are no longer with us. Often you need to be in the OR for legitimate teaching purposes. There is often downtime between cases. Don’t waste that opportunity. Be curious. Be assertive. Be careful.

Conduct formal ethnographic studies staying consistent with the tenants of the discipline but realizing you are restricted in your ability to remain independent of the environment.

The Informal Way

Just because I label these as informal methods doesn’t discount them. You still have to be observant, aware and present to see them.

Approaches

Wait to be approached by a physician or other clinician with an idea. It is better to have a formal process in place to handle these situations. IP and financial issues are often at stake.

Listen to the buzz at a trade show and see where it leads. It could be a start-up company displaying a product concept for the first time. It could be an established company that is holding a panel meeting; I always check the conference hotels’ directory for events of the day.

Have lightning strike, not literally, but rather from a position of immersing your self in the World of your clinician customer.

Look for parallelism, if your clinician customer is having a problem it is likely that it has been experienced before, in a similar disease or therapy or time. Don’t leap to a solution, but use the parallel experience as a guide to come to understand the problem.

 Learning’s

 You may have noticed that I have kept finding a solution separate from identifying the problem. They are two different processes. It is valuable to keep them separate.

It will prevent you from leaping to the first apparent solution and therefore missing the right answer.

“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

Six Critical Differences with Life Cycle Planning for Medical Devices

The Set Up

I was just in front of a number of Medical Device professionals this past week-end and an observation was made that Product Life Cycle Planning wasn’t a point of focus with many of their organizations. A number of these professionals thought that it was a missed opportunity to optimization their product portfolios.

Product life cycle planning is a great concept, difficult to execute in many industries, simple in some.

Defined

The product lifecycle is just that, a lifecycle. Birth, growth, maturity, and a decline to death are the four phases of the product life cycle.

There are four phases that every product goes through:

  • Introduction
  • Growth
  • Maturity
  • Decline

Typically the characteristics of each phase are represented in the table below:

Phases >>> Introduction Growth Maturity Decline
Characteristics vv
Sales Low sales Rapidly rising sales Peak sales Declining sales
Costs High cost per customer Average cost per customer Low cost per customer Low cost per customer
Profits Negative Rising profits High profits Declining profits
Customers Innovators Early adopters Middle majority Laggards
Competitors Few Growing number Stable numbers beginning to decline Declining numbers

The lifecycle curve is often depicted as a very neat predictable curve.

The challenge is that each product has its own equation for the curve. How long a product resides in each of the different phases is unique to the segment, product, competition, etc.

The Concept Deployed

So how can we effectively use the concept of a product lifecycle in our day-to-day work lives?   Assuming you can recognize which

 

 

 

 

 

 

phase your in, there are strategic plays to make.

Each of the 4 Ps of the marketing mix can be deployed to optimize marginal profit. Or if you get bold and creative you can actually change the trajectory of the lifecycle and extend the growth or maturity phases, essentially prolonging the life of the product.

My personal experience has shown that product lives can be as long as three decades to as short as a few months. The dream scenario is to have a very steep Introduction and Growth phase with a very long Maturity phase followed by a quick Demise.

Nuances from the Medical Device World

Within the medical device space, there is an elemental difference that changes the average life-cycle curve. The need for innovation, patent landscapes, regulatory affairs processes, high switching cost, conservative adoption practices, a required familiarity and consistency of tools that physicians use and how that contributes to the quality of care.  These six critical differences must be accounted for in your life cycle planning.

  1. Innovation
  2. IP landscape
  3. Regulatory processes
  4. High switching cost
  5. Conservative adoption practices
  6. Safety comes from familiarity

I often repeat the finding of a study done a number of years ago. On average it takes 14 years for 50% of physicians to adopt a new gold standard technique or technology. Of course, this varies by physician type and therapy and may well have changed over the years, but it makes the point that a lifecycle curve for a consumer product and a medical device are quite different.

The most difficult thing to do is to remove a tool from a physician. The tool that your company commercialized and which, the physician bought into the story and has faithfully used in treating their patients. If you ever find yourself contemplating this unenviable task, just remember that the way you treat the customer during this necessary process is what will make all the difference in the World; communicate, communicate, communicate.

Lessons

  • Not all product segments behave the same
  • You can manipulate the curve with creative strategies
  • When obsoleting a product be plan full and communicate, communicate, communicate

“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, and author of INSIGHTS: 33 Lessons Learned In Medical Device Marketing.  Contact The Experia Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success.   www.theexperiagroup.com.

© 2018, The Experia Group, LLC

Five Critical Elements to Include in all Medical Device Marketing Campaigns

The Set Up

I was invited to give a talk to a group of local marketing professionals in the Medical Device Sector and after sorting through all the things I could share with them, from pricing to promotions to channel development and everything in between, here is the essence of that talk. Look for your golden nugget.

At the Core

“Vision without action is merely a dream.

Action without vision just passes the time.

Vision with action can change the World.”

                                          Joel Barker

The above quote from Joel Barker made a significant impact on my life thinking. I first heard it in the 1990’s. It has become my mantra as a marketer. With every campaign, new product launch, strategy and tactic I have created my goal has been to change the World, well maybe just a small part of it. As time marched on I combined the essence of this quote with the Dow Chemical Model of Organizational Transformation and you will see the results in the model below.

So the first declaration to the group after introducing the Barker quote was my beliefs surrounding the neccessity of integrating marketing activities throughout the department and the organization as a whole.

Over Arching Philosophy

I believe that an integrated commercialization strategy is necessary to create and sustain success for all effective medical devices over both the short-term and long-term.  That integrated strategy is as equally important as the actual invention and development of the new product itself.

The creation and execution of an integrated commercialization strategy is more complex now than ever before. When faced with complexity I find it best to return to the basics. There are six key elements to creating successful marketing programs in the medical device space. If any of the six elements are missing then an undesired result occurs.

Vision, Knowledge, Experience, Method, and Action are all required to create effective programs. See the chart titled Five Critical Element Model for the elements and what happens when one is missing.

Core beliefs…

1.    Safety comes first and always.

2.    The clinician customer is your most important guide, not King.

3.     Constant customer engagement in its many forms is the source of the product manager’s influence and is critical to success.

4.     Minimal regulatory strategies never serve the good of the patient nor the product.

5.     There should always be structure to the input that you are receiving from the field.

6.    Tension is natural and valuable between all stakeholders in the commercialization process.

7.    Going slow to go fast is the right approach, most of the time.

8.    Starting with the end in mind is the best way to ensure success.

9.   You can’t bring positive change to a process without being able to measure that process, never skipping a step or cheapening the ingredients.

10. Practicing unethical behaviors will never lead to success.

11. Authenticity of purpose and action – to truly serve, is the best way to build important relationships.

12. Multifunctional teams are required in the absence of true genius.

13. There are no limits to what is possible, only practical limitations that we choose to put on ourselves.

14. Hands on experiences for customer input are superior to any mental exercise.

15. Competitive analysis is often over done, it can dilute your differentiation strategies, know they self.

What are your core beliefs? Take a few minutes and write them down. Knowing your self and what you believe can go a long way to bringing peace and contentment in your work.

Five Critical Element Model

The two critical elements that are most often forgotten or discounted are Experience and Method (process can be interchanged with method). Many believe that intellect can replace experience and method. Is just isn’t true. “The only source of knowledge is experience.” – Albert Einstein

So, if something is not going well with your campaign review the Model and see what is missing. Better yet, review the model before you create the campaign and get it right the first time.

Lessons

  1. When faced with complexity make it simple by re-visiting your core beliefs
  2. Don’t be afraid to try and change the World.
  3. Use the model for both planning and diagnosis

“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

The Sales Pipeline role in Medical Device Commercialization

The Set Up

Recently I had a interesting discussion with a VP of Sales about who owns the Sales Pipeline, marketing or sales. Truth be told both functions own the pipeline at different times in the Commercialization process. Same holds true for the sales process.

My view is that the pipeline and process can’t be seperated. The process dictates the drop out points along the pipeline.

The Problem

If you don’t understand the sales process and the sales pipeline you can’t predict the need for demand generation (leads). If the pipeline progression is not under control or is not predictable you can’t calculate a success rate. Without understanding the process and efficiency you can’t determine the cost of account acquision.

What is a “Sales Process”?

The sales process is simply the step-by-step progression of activity that the sales professional goes through to successfully close the sale. Is it the same every time? It depends on the type of product and the type of sales approach required. It is not at all unusual that within the same company there will be nuance that change the process steps or important of the steps.

Simplified sales process

For this lesson a very simple sales process will be used.

  1. Lead generation
  2. Local qualifying
  3. Messaging
  4. Evaluation
  5. Value analysis
  6. Close

Example: You may sell a product that needs very little hands on experience by the physician to understand the value. In the same portfolio you may have a new product that requires hands on expeirence, touch and fell to understand the value. The Evaluation step will be more critical with the second product.

What is a “Sales Pipeline”?

The sales pipeline is the aggregate production by step of the sales process. The sales pipeline as shown here is a great visualization of the success of each process step. As shown the sales process has a 65% success rate. From the progression we can see that most of the loss is in Messaging. A deeper dive on how the messaging is not connecting with the physician is warranted.

 

 

So who owns the process and the pipeline?

It is always best to work as a team. Bring in some of the best sales professionals during the development of the process.

The way I see it pre-launch, the marketer acts as the architect of the process and conducts a validation of the pipeline. The marketing’s job is to make the pipeline as efficient as possible at launch. Where the leads come from and at what rate is the marketer’s job. Determining the qualifying criteria is the marketer’s job. Crafting the messaging is the marketer’s job. How the evaluation is conducted is the marketer’s job. Having a strong value proposition is the marketer’s job.

Post-launch it is the Sales professional job to nuance and perfect the steps in the pipeline. Use their local knowledge of the account to their advantage. Produce a 65% success rate or better. Communicate improvements into marketing so they can validate the process improvement and communicate outward the new best practice.

The advantages of understanding the nature of the sales process and the drop out points of the pipeline are:

Advantages

  1. Predictable demand forecasting
  2. Metric for sales force performance
  3. Diagnostic tool for macro and micro improvements
  4. Produces a common language
  5. Provides a tool for sales management to monitor the sales force path to competency

Other key aspects of the pipeline

Other key aspects of the pipeline are the velocity and progression through the pipeline. The sales cycle may take 15 days to 2 years to complete. Momentum is important to carrying the “good news” throughout the process. If you stall out in any step it will take extra effort to kick-start the process forward. Cost of acquisition goes up at an escalating rate.

  1. Velocity
  2. Momentum
  3. Continual progress

Lessons

  1. Partner with sales professionals to develop the sales process
  2. Validate the drop out points during a controlled or limited launch
  3. Use the pipeline as a quality tool not as a fault hammer

“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

 

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