Tag Archives: Voice of the customer

The role of Marketing in Validation testing for Medical Devices

Set up

I had the opportunity to reflect on an experience that I had a few years back. Here is the story. First and most importantly, this post is not an R&D bashing.  As you read the story, you will see that there are plenty of opportunities for improvement by many functional team members as well as culturally throughout the commercialization process.

The Story

I had recently joined a team late in the R&D process as the marketing representative. I was not involved in collecting nor documenting the user needs or technical requirements of the product that was being developed. Not a perfect situation.

The team had completed verification testing and was moving full force into the Validation test phase of development. I asked to review the validation test protocols and was ignored for several weeks, not a good sign. Unfortunately, I had to take my request to the Vice President of Marketing and Vice President of R&D before I could get a copy of the protocol. I had to read the protocol several times before it became clear it was just enhanced verification testing, not real Validation.

I sat down with the team to share my concerns that the test protocol did not link back to user needs. After two hours of going point by point through the protocol, it became clear to all that the protocol did not Validate the user needs. I was told that Marketing did not have to approve validation test protocols, and they were going forward with the test as is.

Completely ignoring the fact that over half of the critical needs were not being challenged. Perhaps more telling was that only team members were conducting the protocols.

What do I do now?

It was clear that there was a cultural issue that would take some time to change. The first line of my marketing ethos requires that patient safety come first, always. I had no choice but to be their advocate on the team. But how? I felt that I needed to make the Validation testing more real for the R&D team.

I took two parallel paths to solve this dilemma. First, I worked with Quality engineering and Regulatory compliance team members to better understand their role in Validation protocol development. They were eventually asked if they would like to see their roles better defined? They agreed and set up a task force to review the roles and responsibility chart in the QS for Validation testing.

Second, I arranged for five physicians and five, field-based clinical specialists to visit with the team. These five physicians had been involved in the needs identification process (almost 3-years earlier). As near as I could tell, they provided the first and only input during the design and development process. This meeting was very structured, and the team explained why they reached the design they had.

In the back of the room restricted to observation only were the functional department heads. Truthfully, I felt terrible for everyone in the room as it became apparent that the team had missed on several fronts.

After three additional months of re-design to eliminate any safety issues, verification, and validation phases were re-started. A total delay in the project launch of six months at the cost of many millions of dollars was the result of this story. Who won in the upheaval, the patients and the clinicians won, which should have meant everyone won, that is not how the company perceived it. The finger-pointing started soon afterward.

In the end, everyone had done their best to do what they individually thought was best for the company and the project. The entire team was made up of competent professionals. No one should have lost their job over this; it was, in essence, a complete failure to understand what the real goal of the project was, a safe, compliant, product that offered solutions to unmet needs of the physician customer.

Marketing’s role in Validation testing

Specifically, marketing represents the customers’ voice on the team. They should be actively involved in every aspect of creating a new product. They need to facilitate access for the R&D team to the customer in the right way at the right time. Should they be required to sign-off on the Validation protocols? I think there is room for discussion about that, however the voice of the customer needs to be heard!

 

I strive to be so valuable to the team that they ask me to be involved with developing the Validation protocols.

Lesson(s)

  1. The clinician customers must have input throughout the development of the new product development process. This input is the only way to prevent costly surprises at the end.
  2. First-time marketers must have a marketing coach to take them through the process. Whether it be, the supervisor or a more experienced marketer, it is essential to know that an inexperienced marketer will not know what to look for.
  3. Marketing serves as the keeper of the new product vision, every chance you get, speak to the vision.

“Experience is what you get, right after you needed 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.

One-on-one or team coaching is available.

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. tim@theexperiagroup.com.

Available on Amazon.

© 2019, The Experia Group, LLC

Beware of bad data in Medical Device marketing decision-making

Set up
I was listening to an MLB game the other evening and the announcers we spouting statistics right and left. They were reporting data. I then waited for the analysis, for the insight, for the reasoning that explained an action taken by a manager or player. We never got there.

I turned off the TV and realized that the announcers for that game were doing what I see prevalent today in inexperienced marketers.

Collecting data without knowing why they are gathering it and then spouting that data as if there was some type of magic in numbers.  The magic comes from deriving (analysis) from the data insight, converting that insight into wisdom by contextualizing it and then applying that new wisdom to form a solution or make a great decision.

Is there a time and place for making observations, collecting subjective data? Absolutely. It is the source for developing the questions or problem statements that you will then apply the “scientific method” against.

An Example

An example of the power of observation: I was in an open-heart case, and the perfusionist and I were talking about how cold they keep the OR rooms. She had three layers of jackets on (observation 1). The conversation continued, and she made the point that they are trying to cool the heart to protect it. One way they do that is by recirculating cold water around the heart and pumping a cardioplegia solution into the heart itself. By having the OR rooms too warm, they are defeating that goal. That made sense to me. Then I noticed that the source of the cold fluid was being pumped through 6 feet of tubing (observation 2). The question that resulted was, is there a way to get the cooling source closer to the heart, so the ambient temperature does not have time to impact the fluid adversely and is there a new product opportunity to be realized?

These observations resulted in two streams of exploration, 1) a technical stream, and 2) a marketing stream.

This blog is not about how to analyze data. However, instead, to caution that unless you are willing to collect the data correctly, then don’t start, garbage in, garbage out.

When do you need to collect data?

Recently, I have been mentoring several individuals who are new to marketing as a role. They struggle with determining when and how to collect voice-of-the-customer (VOC) data, as did I for the first 5-years of my career in marketing. The answers are painfully simple. How to do it well is difficult and takes years of experience.

The answer is to collect VOC data whenever you have an unanswered question.

Does that mean that you need to collect data for every marketing question? Yes, you do. However, how much data, what kind of data, how you gather that data, from how many, of what types of customers, is where you can apply judgment. Save the significant data collection efforts for the huge questions, ones where a wrong answer or misinterpretation could cause severe negative consequences if it leads to a poor critical decision.

Commit to writing could questions

So once you decide that you have a critical unanswered question, you have to frame the question (s). The better the question (s), the more informed the decision.

I typically will rewrite the questions up to a dozen times. With each revision, I work hard to remove any real or implied bias.

Data’s value comes from using it to inform a decision-making process. If you’re lucky, you will convert data to information, information to insight, insight to wisdom, and then apply that wisdom to excellent decision-making.

Lessons

  1.  Most of the time, biased data is worse than no data.
  2. Spend all the time that you require to frame great, unbiased questions.
  3.  Risk adjust your VOC efforts to optimize the value of the undertaking.

“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. tim@theexperiagroup.com.

© 2019, 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

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.