Tag Archives: Insights

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. There 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

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

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

Important Aspects of Segment Targeting in the Medical Device Market

Targeting

Target as a descriptor is used in several different ways in Marketing. The Targeting that is referred to in this post is Segment Targeting. Targeting can’t be accomplished until you have the Segmentation of the Market complete. As a reminder the S-T-P in STP marketing stands for Segmentation, Targeting, and Positioning.

  • Targeting is simply selecting the segment or segments that will afford you your first right successes.

Why Should We Target a Segment at All?

Ideally, your product or company would be equally appealing to the entire market. Seldom is that the case. To gain effectiveness and efficiencies you target a limited segment which focuses your resources on the customers that you are most likely to be successful with.

Targeting Challenge

The challenge with targeting is that it is a process of inclusion and exclusion. Very few sales organizations have reached the level of sophistication where they are willing to firmly accept exclusions. Honor this and leave room for deviation from your target. By leaving a little room for individualism for the sales professionals you will avoid an instantaneous negative reaction to a rigid set of rules and you will leave open a channel for exploration for secondary targeting or follow-on targeting.

Leakage from your target segment into those you have excluded is unavoidable and in the long-term can be very beneficial, as long as it doesn’t get out of control. Leakage typically comes from three sources:

  • Physician driven to adjacent segments
  • Sales force driven through tangential relationship or opportunistic contact
  • Peer – to –Peer recommendation outside the targeted segment

Examples of Target Segment Leakage

From the segmentation example provided, lets assume you choose OR and Post-Op vs. Surgeon as the target segments for your product. Trauma surgeons work in both the ER and the OR, there will be some natural overlap of product utility that can lead to leakage; this would be an example of physician driven leakage.

Or, lets say that your Sales Professional was scheduled in surgery and that appointment was cancelled, they can go home, or they can stop by the ER to visit a loyal customer from a previous stop on their career journey, assume they close this sale; this is an example of relationship driven leakage

A real life example from my history is, that an ER physician presents at an M&M conference and one of your OR surgeons says, “in the OR we would have prevented that death by using this product, this way.” The next day your representative gets a call from the ER doc that just experienced a death. How can you not take that customer call (perhaps the product manager takes the call); this is an example of peer-to-peer leakage.

Critical Consideration for Targeting

  • Is, or are, the segments large enough for you to reach your strategic goals/objectives?
  • Even though the segments may have been differentiated enough in your segmentation scheme to be considered separately, are they similar enough to be combined?
  • Does your product deliver strong utility to the target?

Key Lessons

  • Targeting is not about a single customer, yet.
  • Targets must be large enough to be worthwhile.
  • Targets must be able to realize the utility of your product or company.
  • Practically, you will have leakage between segments.

“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.

© 2017, The Experia Group, LLC

A Practical Approach to Segmentation in the Medical Device Market

The Set Up

It just occurred to me that I had not completed the STP market trilogy. This post will introduce the concept of segmentation, the S in STP marketing. As a reminder the S-T-P in STP marketing stands for Segmentation, Targeting, and Positioning.

Segmentation Defined

  • Segmentation is a methodology to cluster customers with similar buyer behavior (i.e., desired experiences, behaviors) into meaningful groups that can be differentially targeted with unique marketing mixes

Why should we segment the market at all?

  • Segmentation can be a significant source of competitive advantage
    • If you can “see” and “act on” a group of customers — that competitors “don’t see” — you can quickly gain advantage
    • If you segment the same way as competitors you give up a very big potential source of competitive advantage

Segmentation Challenge

Of the three, segmentation has the most potential to set you apart in a significant way from your competition. Segmentation is also the most difficult to do well.   It’s potential comes from the fact that you can segment a market in a large number of ways:

  • Geographically
  • Technology
  • Customer persona
    • Customer type(s)
    • Customer charaturistic(s)
    • Customer preference(s)
    • Customer buying behavior
    • Customer attitude
    • Customer demographics
  • Therapeutic method
  • Care facility type
  • Price point
  • Distribution channel

The difficulty comes from having so many choices. How do you know which way is best for you? Difficulty also comes from the fact that you are likely to use multiple segmentation schemes for different reasons. The segmentation choice I am referring to here is to optimize your product based segmentation. In other words, how will segmenting the market help in my defining or selling the product that I currently am developing.

Segmentation Schemes

To select a segmentation scheme it must be: Meaningful and Actionable. See the table below for an example. Typically you would brainstorm the demand side variables and then score them with type of method.

Example

 

 

For each segment you need to consider:

  • Size?
  • Competitive implications?
  • How this might drive future success?
  • How these might box you in?
  • Is there a pathway for future growth?
  • Is it possible to prioritize the segments?
  • What are the channel implications?

Key Lessons

  • Segmentation can help you see your customers differently than competition.
  • Segments must be meaningful and actionable.
  • Segmentation must lead to a targeting that works with your current sales force or be prepared to change it.

“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.

© 2017, The Experia Group, LLC

Voice of the Customer in Medical Device Product Development

The Set Up

Over the past year I have been involved with a number of mentoring, coaching and consulting projects and one question that keeps coming up time and time again is, “When do I need to collect the Voice of the Customer (VOC) for input into my new product development process?”

There is a simple answer, which is, “all the time”. Now the context and design constraints surrounding that answer are significant. In this posting I will elaborate on the simple answer offered above. Hopefully you will gain from this perspective. Suffice it to say that regardless of the magnitude of the effort it is one of the most important ongoing aspect of what the marketer does to ensure successful resolution of the problem in an attractive way.

Context

The way I think about VOC is that it is the first right activity to minimize risk of missing the mark with the utility of a new product. How much time and money you dedicate to the effort really depends on how well you understand the problem statement, how many unknowns there are, how different the solutions might be from technology there are used to using and how much of a change to their clinical practice might occur. In other words, how much design risk is there?

The age old concept of, “if we build it they will come” is not the case in Medical Device Commercialization.

There are too many preferences and nuances to believe that: a marketer, engineer, inventor, single physician could in isolation determine the right design approach for a device that solves a clinical problem and would be attractive to the entire market.

As far as timing goes, the right time to begin collecting VOC is to test your hypothesized problem statement. Remember that you have to determine if the opportunity is real? The, “is it real?” question is one that requires a deep understanding of the customer, their environment and the problem space. You need to collect insights through VOC to know if it is a real problem, how wide spread the problem is, and how accepted is the belief that the problem needs solving.

Once you understand the nature of the risks, I would recommend designing a customer input plan to parallel the design and development activities and make that part of your marketing plan.

For details regarding the VOC process itself see the post, VOC Input for Product Requirements Development. Look to this blog for a future post on developing a Customer Input Plan for the Medical Device Product Development.

The Bigger Question

The bigger question isn’t when, but rather how extensive. The answer to that question is, “it depends.” If the nature of the project is that its success is critical to your business, has a long development cycle or will require a huge amount of resources, then plan to get a significant amount of input throughout the development process.

If the risk is low or the technology is well understood, then maybe a customer input plan that involves fewer touch points or fewer physicians is ok. Just make sure that every stakeholder’s views are represented.

An Example

The project I am currently working on has six different types of clinicians in three different care setting that will be targeted in the first 24 months post-launch. Normally, I would segment these groups out and prioritize their inputs based on the number or participants or by the dollar or unit volume that they represent. This time there is essentially no basis to prioritize the input.

 So for this project I will interview a high volume user in each category before I propose a problem statement. That problem statement will be tested with 10 inputs from each category or 60 physicians before I submit it to the R&D group for their concept generation process. I estimate that I will spend on average $500 per input and take six-weeks to collect the information. For the entire project (through technical design release), I am budgeting $240k- $360k that will be used over a two-year period at different points in the process identified below.

Key Points for VOC

  1. Pre-problem statement development
  2. Problem statement integration
  3. Product requirement generation
  4. Design concept ideation
  5. Design concept selection
  6. Design detail input
  7. Clinical evidence plan input
  8. Prototype utility study
  9. Prototype human factors study
  10. Validation protocol generation input
  11. Design validation
  12. Messaging input

Of course this list is not the only time customer input would be collected, as mentioned in the first paragraph, VOC is collected all the time. The unique aspect of this device is that it is not intended for use internationally, this reduced the complexity and cost substantially.

Key Lessons

  • When in doubt ask a customer, not just one.
  • Watch for bias in your sampling.
  • Never stop listening.
  • Risk-adjust your VOC efforts.
  • Beware of KOLs representing the mainstream users.

Caution

If you are asked to cut corners or reduce your sample size make sure that Management understands the residual risks of doing so.

“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.

© 2017, The Experia Group, LLC

New Product Launch Planning Topics for the Medical Device Market

The Set Up

Over the years I have been privileged to launch or direct the launch of nearly 100 medical devices. With that experience I have learned that launching a new product is not a marketing function. It takes an integrated team with an integrated mind set. I have assisted a number of clients in designing their new product launch plans. Several long-time colleagues have recently asked me to provide a thought check-list for their less experienced team members to aid in launch planning.

So I have decided to share that check-list with everyone. I caution that this is a list of decisions or thinking that should occur as you are designing your launch. Following this check-list doesn’t gaurentee success. So much of the success comes from the quality and deepth of thinking you put into the topics. So with that cautionary note here is the check-list. A conceptual thought that might make this clear to you is to think about the topics as section title slides for the Launch deck.

The Intent with an Integrated Launch

The way I have always thought about a product launch is parallel to a rocket launch. Planned well (correct trajectory to achieve the proper orbit) you apply a tremendous amount energy (time, resources, targeting) to a launch and once you break free of Earth’s gravity (market resistance to change) you fly along at a speed of 17,500 miles per hour with no fuel being utilized at all.

 

 

 

The Thought Check-list

 Launch Summary

 Product vision

 Elevator pitch regarding the launch, not the product

 Market Understanding

 Therapy understanding

 Technology understanding

 Macro segmentation

 Competition defined

 Market drivers determined

 Key success factors identified

 Product Understanding

 Product definition

 Product description

 Positioning statement

 Value proposition

 Health-economic story

 FAQ

 Trouble shooting guide

 Allowed claims

 Competitive comparison

 Portfolio revelance

 Launch Strategy

 Launch goals/objectives

 Financial

 Revenue

 Profit

 Share shifting rate

 Non-Financial

 Quality

 Complaint

 Close success rate

 Compliance to targeting

 Business process metrics

 VOC

 Customer satisfaction product

 Customer satisfaction service

 Customer targeting

 Channel considerations

 Customer profile

 Customer engagement strategy

 External communication strategy

 Launch Tactics

 Launch structure (Controlled, Limited, General)

 Launch campaign development

 Team membership

 Launch calendar

 Sales process (Controlled, Limited, General)

 Product sampling plan

 Evaluation process steps identified and facilitated

 Pricing (Controlled, Limited, General)

 Reimbursement

 Demand generation plan

 Sales pipeline projections (1-12 months)

 Demand/Supply plan

 Revenue projections

 Share penetration rates

 Service plan

 Sales training progression plan

 Messaging Mix Development

 Message development

 Collateral development plan

 Video

 In-service video

 Promotional video

 Testimonial video

 Digital

 Print

 Promotion

 Trade show plan / calendar / collateral

 Poster and Potium plan

 Advertising plan / calendar / collateral

 PR plan / collateral

 Social Media Use plan

 Launch Controls

 Team dashboard

 Mgt. dashboard

 Quality dashboard

 Sales detail dashboard

 Product Claims

 Current claims

 Desired claims

 Gap analysis

 Clinical evidence collection plan

 Regulatory strategy

 Multi-generational Product Portfolio Plan

 Launch budget / spending plan by quarter over 12 months

Guidance

Not every launch will require all the check boxes to be checked. However, I strongly recommed that you think through the inclusion and exclusion of content from the list, defend the “in” and “out” decisions.

The higher the complexity of the technology / product / launch process the more likely it will be that you need to address each and every thought.

“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.

© 2017, The Experia Group, LLC

VOC Input for Product Requirements Development

The Set Up

Regardless of how you package or communicate the Product Requirements for a new product there must be a customer input process that precedes finalizing of those requirements. Collecting the Voice Of Customer (VOC) is critical to the success of new product creation.

The Double Diamond™ Process

Sometimes a picture is worth 10,000 words. The chart shown to the right is the way I explain the approach to building that VOC into a fully validated set of requirements.

Caution

If you want to assure the greatest chance of success don’t skip a step or stop early.

“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.

© 2017, The Experia Group, LLC

High Level Product Requirement Creation for New Medical Devices

The Set Up

After the series of blog posts relating to portfolio planning it only make sense to take the next step. New Product Requirement planning. This will be a tough series to write. So once again the goal will be to provide an awareness of the process and provide a couple of tips regarding “How To”.

If you gain nothing more than one “aha” out of this series then it was well worth reading.

There are three or four approaches to requirements planning. All of them can work. The process I layout for you here is a straight forward practical approach.

The big caution is reflected in the adjacent cartoon. To avoid the mis-communication take your time creating the Vision statement, Business problem statement, Clinician problem statement and ultimately the initial Product positioning and Value proposition statements.

The High Level Process

Recognize a New Product Opportunity

From the portfolio planning process we have identified that we are vulnerable to collateral share loss in one specific area of our portfolio. Our market scan produced the realization that we don’t have a product in a fast growth segment of the market, perhaps more importantly three of our key competitors do.

Write the Business Problem Statement(s)

Write the problem statement(s) using general language. Note that you may have two or more problem statements. That’s cool. You could write it as a business problem, a portfolio problem, and /or a risk problem. A good start. Eventually you need to write it as a customer problem. Capturing the un-resolved issues that the fast growing segment is resolving.

Conduct a Qualitative Market Scan

Before you write the solution hypothesis you need to gather additional input from the market. At this point in the process I would urge you to collect structured well document qualitative data; don’t skip forward to conducting statistically valid market research just yet. I have spent as little as $25,000 and as much as $1.4 million on market research to determine a winning product definition. It is too big of a financial investment to dive right in without a little background work first.

Now is the time for a little sleuthing, search the MAUDE data base for complaint histories on all three competitive products. Categorize the complaints by type.   I typically will capture the categorized data in an excel table.   Obtain product specification for each of the three products (sale literature, IFUs from the website, 510k applications, general web search). Next, interview a couple of your top territory managers who have reported competitive activity in their hospitals. Have your sales force poll their accounts to determine who is using this new products. Identify which of your friendly accounts have committed to purchasing the new product (try to interview at least one representative account for each of the three competitive products). Arrange personal one-on-one interviews with each of these committed friendly accounts. The typical product marketing questions should suffice at this point:

  • What is/are the challenge(s) you are/were trying to overcome by using this new product?
  • How did you try to meet these challenges before you had the new device?
  • Why do you believe that this type of product will meet your needs?
  • What do you like about the product?
  • What don’t you like about the product?
  • What type of proof and metrics would you need to see to believe that the product will meet your needs?
  • What are important features or attributes of this type of product? (try to get this input prioritized, at least ranked and rated)
  • If there was one aspect of the product you could improve what would it be?

Write the Clinical Problem Statement 

At this stage the problem statement can be several pages long. In general, the contents of a good problem statement should include:

  • A re-statement of the original problem statement that the competitive products were design for,
  • The residual un-met needs for each of the three product solutions (gap assessment),
  • A summary of the MAUDE database review,
  • A summary of claims made in the regulatory filings,
  • A summary of warnings and cautions from the IFUs,
  • A summary of the clinical trial data if any were required,
  • A summary of any editorials or press announcements regarding the products,
  • Competitive metrics: share, growth rate, revenue, ASP, archetypal description of customers

Caution: don’t become so focused on the gaps or potential solutions for the gaps that you forget to use fresh eyes on the original problem.

The discovery process that has been described can be done in as little as a couple of weeks or it could take a few months. The creativity comes from you as to how you do the work economically or efficiently. Just don’t skip this step.

Now you have enough information to define the problem. This will be the vision statement for your R&D team as well as management. A problem statement post will also be a part of this series.

Quantitative Market Research

Hopefully, your vision statement / problem statement has been compelling enough to warrant a further investment by Sr. management to execute a formal VOC process that will include additional qualitative and your initial quantitative research.

I will go into great detail is a subsequent post regarding how to do the quantitative research. For now lets focus on the output. For me the most effective way to look at the output of the initial quantitative research is in a stacked spider /radar chart. A spider/radar chart produces a geometric picture of the shape of possible solution sets for the un-met needs.

Description of a Radar/Spider Chart

Each of the axis of a radar chart represents a benefit/feature/attribute of the solution set. These are the most critical aspects of the product to the customer.The scores are a reflection of how well the product meets their needs. The scale is arbitrary, I typically will use 0-10. The end product in this scenario would have five (5) separate geometric plots.

  1. The ideal or perfect scores for the general market
  2. The ideal or perfect set of scores for your chosen segment
  3. Competitor 1 scores
  4. Competitor 2 scores
  5. Competitor 3 scores

In the example provided you can see that the two series of data have markedly different shapes. The ideal solution for this general population would be the connecting of all the highest scores of each axis. This would provide you with a third geometric shape. By looking at the differences between the first two series and the newly created third one you get a feeling for the gaps. You can plainly see that the red series has a biased solution that delivers on the left axis and the blue to the right. Knowing this and combining it with the balance of what you learned from your competitive analysis you can determine what your new product strategy could be. There will be several biases that you can select from.

The big watch out here is to use the qualitative research to make sure your axis are the critical ones for success of your new solution. Your ultimately success with this new product will be directly linked to how well you determine the critical success factors or axis to plot.

“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.

© 2017, The Experia Group, LLC

The Problem Solver Dilemma™

The Set Up

After attending a personal development seminar, I am a huge believer in continual learning, a realization occurred to me that would have been great to discover when I was managing large teams. So, I thought I would reveal my discovery in the hopes that someone out there will benefit.

The Dilemma

I discovered how much of my sense of “selfworth” was tied up in solving marketing problems in the Medical Device space. I sometimes actually refered to myself as a “marketing engineer” . Solving problems is what has lead to many of my successes, so I don’t discount the value of solving problems. I now realize that defining myself as a problem solver is self- limiting and can cost valuable time solving irrelavant problems.  Knowing how to solve problems is a powerful skill to have. That is why I call it the “Problem Solver Dilemma”. Solving the right problems, at the right time, in the right way, for the right reasons is a boundless way of receiving contributions to your self-esteem. When you are caught in the “Problem Solver Dilemma” it doesn’t matter if the problem solving is contributing to the business imperative or not. A solved problem reinforces your self-definition whether it is the problem that can make the greatest contribution to the larger mission or not.


The deck chairs probably were a mess and needed re-arranging. But having orderly chairs would not save the ship or the passengers.

Reflecting back on my work history, my significant contributions came from seeing an opportunity to serve the larger mission (business imperative) in a new and creative way.   Creating a vision surrounding that “new way” and effectively communicating the “new way” to others, who could help achieve the “new way” and then executing it regardless of opposition. I call this the “Vision Realization Loop”.

So how did I, or perhaps you get caught up in this “Problem Solver Dilemma”?  We forgot to ask several fundamental questions before we solved the problem.

What to do

Once you have become aware that you, or one of your employees are caught in the “Problem Solver Dilemma” here is what you can do. Problem solvers need to be monitored closely. Why? They won’t ask permission to solve a problem, they will just start solving it. When this happens it doesn’t take long for a series of non-focused solutions to make a key resource in-effective with respect to their contribution to your greater vision or mission. They will experience a series of satisfying experiences that will lead them to believe they are being very valuable when the truth is that they are not contributing to the team effort. A disconnect that if not dealt with, will create a personnel problem in the future.

So how should I avoid the “Problem Solver Dilemma” before it becomes a problem. As this is a discovery that has just entered my conscious thought processes; I don’t have a tested answer for you. But here is what I am going to do differently.

If you sense that you are solving a problem, stop. Ask yourself the following questions:

  1. First, does this problem need solving right now?
  2. Does solving this problem serve me or the greater mission that I am trying to support?
  3. Am I solving this problem because I don’t want to solve the real problem that would move us toward accomplishing the greater mission?

I have scheduled weekly meetings with myself (or perhaps with other team members) to monitor the problems that are being solved. I open each meeting by asking, how is the work I or You have worked on over the past week directly supported the goals of the company? What else have you worked on?   If the answers are not aligned with the assigned goals that directly impact the imperatives of the company, department or project then you need to, honor the work, repaint the grand vision , guide them to understand how their effort, though valuable, do not support the goals.

It will be natural for you or them to make an argument that it does. Almost any problem that is solved can be indirectly related to the goals, however you are looking for a direct linkage. Listen carefully, they may be right. Either way the discussion needs to end with a clear commit to re-align their labor to support the bigger goal.

Weekly reflection time (weekly monitoring agenda)

  • Review the “imperatives”
  • Ask for a loose accounting of the preceding weekly effort
  • Ask for a loose accounting of activity
  • Honor the effort
  • Check on alignment
  • Repaint the grand vision (if needed)
  • Let them or your inner self connect the Vision to effort
  • Restate the future alignment

As perfection does not exist this re-aligning process is not a one time thing. That is why a weekly opportunity for reflection is important for everyone.  Apollo 11 was off course 90+% of the time.   Many small corrections allowed it to reach its destination successfully.

The Key Learning

The difference between the Vision Realization Loop and the Problem Solving Dilemma is that you are aligning your work with efforts that are serving the grander mission. If you can convert from just a problem solver to a problem solver who spends their efforts on moving the mission forward you will realize dramatic career growth.

“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.

© 2016, The Experia Group, LLC