All posts by timwalker317526

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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

 

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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

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Keeping the Strategic Message Pure in the Marketing Mix

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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

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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

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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

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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

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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

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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.

The key in the progression of confidence as you move down the double diamond. As you move through each section you gain the understanding and confidence in the data to which you need to apply your insight to.

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.

 

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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

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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.

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