Uncategorized

To ensure a successful new medical device product launch start early with a marketing MINDSET

Set up

I have been approached recently by several start-up companies to assist in launching their New Medical Devices. All of them have worked incredibly hard on developing their technology. Brilliant scientists, physicians, and inventors, they genuinely have done great work, some spending more than five years on getting ready for their launch. More often than not, they are not prepared, for a variety of reasons, but at the core is that they didn’t have anyone with a Marketing Mindset performing the upstream marketing role.

But are they ready for their launch?

Have you put the building blocks in place?

Based on my observations of nearly 40 years commercializing medical devices, here is what I have learned. To successfully launch a new product, you have to have applied a Marketing Mindset from the very beginning. Let’s look at the upstream process steps in marketing a great new medical device.

Process notes:
    • Voice of the Customer (VOC) is the only way to validate the problem and the solution.
    • VMO = Vision, Mission, Objectives, well documented.
    • Five core documents are: (there are more, but if you don’t have these five, you are at risk of failure)
        1. Clinical need statement
        2. Product positioning statement
        3. Product value statement
        4. Customer persona
        5. Pricing strategy

Purpose of this post

My objective here is not to scare anyone, run anyone down, and I don’t want to discourage anyone. My goal is to alert you that you should not be surprised when you move to the launch phase. You may have to slow down and let someone put in place the basic building blocks of success.

Doing it right the first time may not be free, but it is the least expensive way to reach success quickly.

Offer

If you want to talk through your state of readiness, I am happy to spend 30 minutes on a call with you. Schedule the call, https://calendly.com/tegllc, and I will send you a copy of INSIGHTS: 33 lessons learned in medical device marketing, absolutely free. Also available on Amazon!

Lessons

  1. Technology is not a product
  2. Build the foundation of market knowledge and document it
  3. Beware of confirmation bias – build independence into the collection process – use a diverse set of customers.
  4. Prepare all five core documents from the perspective of the individual stakeholder.

“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 specializing 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. https://calendly.com/tegllc.

© 2020, The Experia® Group, LLC

Uncategorized

Pre or Post Covid-19 creating the right message for new medical devices is critical

Preface

Since the early 1900’s it has been well understood that we, as marketers, sell holes, not drills. Translating that adage into the 2000s and relating it to medical devices, the saying goes something like this; we sell improved clinical outcomes, not the tool that provides it. We sell greater safety, not the equipment that enables it. Yet, I still see advertisements that describe in great detail the physicality of the device. I hear sales representatives take about how their device is made of optically clear plastic.  

 We complain that it takes a decade for physicians to adopt our technology, and yet, we take decades to deploy the latest realizations in medical device marketing.

 Virtual or not, digital or not, regardless of the channel, we must deliver a clear and relevant message. We must promote the outcomes of our products, not what the product is. The clinical benefits and health economic benefits motivate the healthcare institution to purchase, not the device’s features and attributes. They never get to what clear empowers or enables. They let the clinician connect the dots.

Set-up

Recently, I was working with a client on developing the messaging for a new medical device. He went on for 15 minutes on what the product was, how it worked, its cost, how it was better, lighter, and faster than the competition. He was articulate and passionate. It was truly amazing to hear.

 When he finished, I asked a couple of simple questions. Why would I need your device? What will your device allow me to accomplish? This sparked another 15-minute download about the therapy that the device supported. He was equally articulate about the therapy description as he had been about the device description.

 He started to realize that the connection between the two revealed the benefit that the device brought; that is what we were selling.

 The features and attributes exemplify how our drill makes the hole better than our competition’s. 

 I pulled this quote out and had him read it; then, I watched as the wheels turned. 

  Leo McGivena: “Last year one million quarter-inch drills were sold, not because people wanted quarter-inch drills, but because they wanted quarter-inch holes. . .”

 How do you get to the right message?

    •  We started with a one-paragraph description of the clinical problem from the perspective of the clinician. 
      • (Why we needed a hole)
    • We then wrote a two-paragraph product positioning (benefit) statement.
      • (How we provided the hole.)
    • We then wrote a one-page value proposition.
      • (Why our hole was more valuable than the hole our competitors made.)
    • We then crafted a pricing strategy.
      • (What was the realizable value of the hole.)

 Note: These documents are defined in previous posts and in INSIGHTS: 33 lessons learned in medical device marketing available on Amazon.

 Result

 Over the course of 3-weeks, we had created four of the five foundational documents (messages) that are needed to drive all the down-stream marketing activities and collateral material.

Lesson(s)

 1. Crafting a message is critical, no matter how long it takes.

2. Creating great foundational work is crucial to successful communication with the clinician customer.

 3. Who delivers the message, how the message is delivered, where the message is delivered, are all important, but are secondary to what the message is.

“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 consulting firm, which provides experience and expertise during critical device commercialization phases to increase the probability of success. Author of INSIGHTS: 33 lessons learned in medical device marketing, available on Amazon.

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. [email protected].

© 2020, The Experia Group, LLC

Uncategorized

Why Map the Patient Journey? INSIGHT

Set up

I was developing a Strategic Marketing Plan for a new company. There were so many potential use cases that it was difficult to determine which was the first right one to go after. If you want a complete understanding of whom, how, when, and why your new product might be used, then map the patient journey from the presentation of symptoms through cure. Some journeys are long, and some are short, but the mapping process will reveal much.

 

What can you gain from mapping the journey?

· Stakeholder identification

· Facility variation of care and cost

· Identify diagnostics testing

· Identify protocols

· Identify referral requirements

· Identify cost centers

· Identify service line hand-offs

· Identify reimbursement coding

· Identify the breadth and depth of in-serving requirements

· Determine the value proposition

 

There are many ways to use mapping, a journey with the patient, or frankly any aspect of any process.

 

Note:  If you just can’t access the patient directly there is still value in walking the journey in your mind.  Document it and use it as a hypothesis with others who have experienced the journey personally.

Example one

In1995, I went to work for a company that was plagued by back-orders. No one understood why, exactly. I was assigned to solve the customer service issue, so I had to follow an order from inception to fulfillment. It may sound wasteful, but I went to customer service, and when an order came in, I stapled it to my sleeve. Everywhere that order went, I went. Taking notes, starting and stopping stopwatches, asking questions, cataloging who touched the sales order, and why. What an eye-opening experience. What I learned from that experience allowed the company to redesign every aspect of demand planning and fulfillment. A new goal of 98% same-day shipment, orders received before 3:00 PM, was shipped the same day. Orders after 3:00 PM were shipped the next day. Within a year, that goal was met 94% of the time.

 

The impact of the organization was huge. Inventory carry cost went down, personnel were able to be redirected to other departments, customer satisfaction level increased exponentially, and though I could never quite prove that it was directly related, revenue grew at an unexpected rate. Probably the most significant gain was in salesforce satisfaction with the company.

 

I applied this same mapping process to several other aspects of business, but have found the highest value from following a patient on their journey through an interaction with the healthcare system, not the grand healthcare system just the micro aspects.

 

Example two

A new product opportunity was identified for possible development. We had identified all the aspects of the product opportunity, size, required clinical outcome, costs, and stakeholders in the purchasing process. Everything looked good. We then reached out to several physicians and convinced them to allow us to follow a patient from presentation to the ER through discharge. We stayed out of the way and observed everything, capturing every aspect of that process except the patient’s name. The takeaways were massive. It quickly became apparent that if we were to develop the product, there would be many challenges to our success, that had nothing to do with the physical aspects of the device.

Challenges that we identified:

The patient touched six different service lines (six different budgets), 

1. ED, 

2. Cardiology, 

3. Surgery, 

4. Post-op, 

5. SICU, 

6. General ward.  

7. Woven through all those service lines were RT, Cardiac rehab, and this list went on and on. 

 

Every one of those services was going to need in-servicing as the device would modify their protocols.  

 

We both positively and negatively impacted the cost of care. The value propositions were complex and needed to be based on the total cost to the organization. We would need to make that case higher up in the administration of the hospital.

 

The clinical outcome potential was much greater with the new device than we expected.

 

This realization caused us to rethink every aspect of our marketing, market development, promotional process, the evaluation process – just about every aspect of the device’s impact on the patient and the hospital proved different and more complex than we understood.

 

After our patient mapping exercise, we reworked every aspect of the budget and plan. What we thought would be a quick 18-month development program that would lead to a quick resolution of an un-met need and increased sales, was not this opportunity. 

 

Results

We went forward with product development and ultimately produced a very successful product. There is no doubt that this product would have failed if we had not done the mapping exercise. We went into the opportunity with all of our eyes wide open. Outcome – we spent more time in the concept phase than any other product I have commercialized – nearly a year. We reduced the adoption curve slope, and there was no hockey stick at the end. The marketing budget was three times that of the R&D budget. The good news was that we uncovered cost reductions directly tied to our device, so the price went up dramatically. What we thought would be 18-months to market morphed to 36-months to market.

 

Note: Looking forward, performing these types of exercises is becoming more difficult as hospitals are restricting access to industry personnel. They are also becoming more and more valuable. Restricting access in the actual care setting is just something we all will need to workaround. Partnering with academic institutions and getting them to conduct observational studies seems the only way.

 

Lesson(s)

 

1. It is ok to go slow to go fast.

 

2. Emersion in the patient experience pays enormous dividends.

 

3. A deep understanding before you begin can save significant time and money from re-starts and failures.

 

“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 which, provides 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. [email protected].

 

© 2020, The Experia Group, LLC

 

 

Lesson

COVID-19 a new dawn for Medical Device Marketing?

 

 

From time to time, great events shape, speed, or cause change to our World. You know the list as well as anyone, war, famine, pandemics, climate shifts, geological shifting of the tectonic plates each of these significant upheavals has set in motion many dimensions of change. Biology, technology, and society evolve in an adjustment to the new parameters of the new age that results from the energies released during these global events.

Whether COVID-19 is one of these upheavals or not is yet to be seen. But reflecting on how it might impact the world of medical device marketing, it begs the question, are we ready?

The energy that will most likely drive this resulting change to our time will be fear. While fear is a primal motivator for action and is key to survival, it often lends itself to noise and overreaction. It creates the opportunity for those less honorable to take advantage of those not prepared.

Let’s all keep our priorities straight, facts matter, safety first, regulatory processes can be useful, oversight is proper, in a pure capitalist system the safety of each member of society is equal.

Tactics will change, strategies not so much

The strategies won’t change, the tactics will shift away from 80% face-to-face selling toward the digital, or virtual worlds.

One Potential Impact

For a decade, the desire to use the Internet more as a means of influencing behaviors of clinician purchasing, or product selection, has been stunted by the overwhelming majority of clinicians who are resistant to change. Their resistance to change is not only relating to the adoption of new best practice therapy but extends to the way they get information about new products.

Based on the last survey The Experia Group conducted, clinicians identified the top three ways of receiving new product information as 1) colleague recommendations, 2) congress trade show symposium and booths, and 3) from trusted manufacture representatives.

Additionally, the way clinicians prefer to evaluate new products is by having a trained clinically oriented representative of the company present in the hospital or procedure room so that they are present to answer any questions that might come up.

There have been several environmental pressures to move toward digital or remote training on new products. Among these pressures are The Sunshine Act, HIPPA, the restrictions on access to hospitals, the number of administrative processes that are now required to get approval to trial new products, including the expanded use of IRB’s, to name just a few.

Now that face-to-face contact between industry and clinicians has been reduced dramatically, and rightfully so, the COVID-19 pandemic may be the last push needed to total re-orient the selling, evaluation, and training processes for new product awareness and adoption of medical technology.

Are you ready?

What new skills will we all need to develop if this new World comes into existence?

Just off the top of my head:

      • Community building
      • Hosting webinars
      • Digital copywriting
      • Educational content creation
      • Remote customer engagement and interaction
      • Video content editing
      • Technical skills in managing and utilizing apps and facilitate communication
      • Empowering your field organization to use the new skills
      • Label copy review processes may need to modified for speed w/o giving up the proper level of controls.

One challenge that I don’t see an emerging answer for is, how to teach clinicians to optimize their ability to learn remotely.

Perhaps the more significant challenge is how to teach, feel, and touch that so many products require, remotely.

For me, the above list of skills to learn are all tactics and abilities. The strategies for success don’t change. The choice of tactics may be more digitally biased.

Breathe

Not all of the historical sales, education, training, and support techniques will go away. New hybrid approaches will evolve. Regardless of your current skill level, you need to develop a higher level of awareness and execution capability as a person and as an organization. Even if everything settles down after the pandemic passes, what have you lost by learning a new skill set?

Typically, I would offer a solution to the issue.  Sorry, but I don’t have one just yet. For me, I have some learning to do.

Go to www.theexperiagroup.com, where I will be building a resource list (over time) as I develop or refine new skills.

 Lessons:

1) Never stop learning

2) Always keep your environmental scans up and running

3) It is ok to go slow, to go fast, but you need to start

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

Make it a great day!

Tim Walker, MBA

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

One-on-one and team coaching are 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. [email protected].

© 2020, The Experia® Group, LLC

Available from Amazon.

 

 

Uncategorized

Trade shows Importance in the Go-to-Market Strategy for New Product Launches

Set up

Trade show attendance is a tactic, a tool, not a strategy or objective. They have a habit of developing a life of their own due to the expense and time investment they require. Additionally, it is easy to fall into a pattern of planning for and attending the same congresses year after year without even considering if they are achieving their objective.

What if?

As trade shows are significant events, it is also easy to use as a launch mechanism for new products. I would propose that the new product launch plan become an 18-month campaign, of which, one, two, or three congresses might be a part of the campaign.

The tradeshow can be considered the centerpiece or the anchor, but attending a show is not a goal or objective onto itself.

To truly optimize and make a step function change in your thinking, consider congresses or tradeshow as the highlight of the process by which you are building a community of customers. The tradeshow serves as a celebration, an acknowledgment, a recruiting tool, and a prospecting tool for future community members, and of course, a lead generation tool for the sales organization.

The launch plan/campaign can be a story. With all good stories, there is a prologue, introductions, body, conclusions, and epilogue. With all the proper caveats and warnings that follow along with regulatory listings, clearance, and approvals regarding the promotion of Medical Devices, great care should be taken.

Another thought construct to consider is that every new product launch is an opportunity for customer engagement; you could even think about it as a recruiting tool for your clinician community.

Story Timing New Product Launch Campaign Objective
Prologue 6 months prior to launch Targeting Create a target persona

Identify KOLs
Introduction 6-1 month before launch Pre-approval channel preparation

(Trade show activities)
  • Recruit targeted KOLs at a national, regional and local level.
  • Collect feedback on the problem statement from the community that you created in the KOL world.
  • Collect proof that there is a problem.
  •  Frame the problem’s impact on patient outcomes.
  •  Frame the economic impact on the institution of the problem.
  • Recruit for pre and/or post-market clinical trials
Main body Once FDA approval/clearance is received
  •   Awareness (Trade show activities)
  • Customer Contact(Trade show activities)
  • Engagement (Trade show activities)
  • Sales process (Trade show activities)
  • Evaluation
  • Social media (SM) campaign
  • Leads from SM or Digital awareness
  • Tradeshows leads
  • Document and communicate the buzz
  •  Sell
Ending Market and Sales execution

 

 VAC, New Product committee approval
  • Document and communicate success stories
  • Package the testimonials
  • Collect product improvement
  • Conduct post-market studies
Epilogue Customer service monitoring Successful integration into the standard workflow
  • Post-market surveillance
  •  Constantly provide evidence that the buyers made the right choice (Tradeshow activities)

A Quick Review of Customer Engagements 

Customer engagement is a two-way equal value exchange of information, experiences, desires, hopes, and dreams that leads to a more in-depth professional relationship between the two parties.

The engagement events can be:

      • Digital
      • Social media
      • Panels
      • Animal labs
      • Training validation
      • IFU validation
      • Installation validation
      • Clinical trial recruitment for pre or post-market studies
      • Plant tours
      • Design input processes
      • Human factors validation
      • One-on-one interviews
      • Product improvement reviews

Challenge

      • Can you see the potential in having all these touchpoints identified?
      • Can you see the power in having collateral to support each step specifically?
      • Can you see how a tradeshow is a component of a grander process?
      • Can you see how thinking of a trade show as a media channel gives you a new perspective?
      • Can you see how tying the trade show into an entire campaign makes funding it easier?
      • Can you see how laying out an 18-month plan builds flexibility into the calendar, making you proactively prepared for regulatory delays?

Lesson(s)

  1. It is ok to think differently about trade show attendance
  2. Build metrics and mini-goals into every step
  3. Follow-through is critical, discipline

“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. [email protected].

© 2020, The Experia Group, LLC

 

 

 

Lesson

Know Before You Go: Trade show optimization for Market and Product managers

Set up

I was reviewing my travel calendar and saw that the Spring season of Medical Congresses was coming up when it occurred to me that I had not dealt with tradeshows planning nor attendance conduct for product and marketing managers. Reviewing this topic in my mind, I have decided to break up the lessons learned into multiple posts.

 

If you have been following this blog for a while, you will recognize a common theme. 

 

Background

For a national level tradeshow, the direct budget will range from $80,000 to $2 million. Even the lower end of that range could be a considerable percentage of a marketing department budget, add in the indirect costs of travel at $600 per day per attendee, and for any company, a floor presence is a significant investment.  Without taking into account the opportunity cost of non-selling days for salesforce attendees, it is evident that tradeshow attendance is a significant commitment of time and resources. The key is to think of the expense as an investment. All investments are measured on their projected and actual return (ROI); tradeshows are no different.

 

For a company to “just attend” a congress will make for an expensive social gathering, which can have value but is a low return on the cost of attending. To realize a significant return on your tradeshow investment will require crystal clear goals with metrics. I typically look at the number and quality of customer engagements, the daily and total cumulative number of sales leads, the duration of time to follow-up all leads, the total dollars in new business that results from those leads, and finally look at the overall ROI, as a start. 

 

This introduction and explanation are enough for now on the macro aspects of tradeshows. The point of this post is optimizing the micro (personal) level of tradeshow attendance.

 

Personal responsibility

There is also a micro side of optimizing tradeshows, the individual attendees; this is particularly true for market and product managers. Know your objectives before you go. Write them out and tape them to your hotel room’s bathroom mirror, seeing them every morning and evening will reinforce and guide your daily activity. I encourage the mirror thing even in this digital age, of course, put them in your daily calendar as well.

 

Here is an example of my personal goals for an SIR meeting in the mid-’90s.

 

    • Gather input for the R&D team, regarding catheter tip shape, length, and stiffness, conduct at least ten private conversations with qualified IR’s.  
    • Contribute to the booth set up by having my product station set up and sparkling clean 30 minutes before the deadline. Write 15 high-quality sales leads per day.
    • Brief the salesforce on my product goals and show messaging 
    • Attend and take notes on three live case presentations relating to SFA stenting, write up and present to the marketing team at the post-show briefing.
    • Identify and sound out a regional level expert KOL in SFA treatments from an influential hospital for potential recruitment to our corporate advisor board.
    • Visit every booth where there was a new competitive product to get a feel for how they merchandise their products and observe and report customer reactions to their new product.
    • Twice daily, check-in with the MRI research team (covertly) to determine how they are progressing with the blinded attribute survey goal of 150 completed the three-day show.

I reviewed this list with my supervisor well in advance of the show, she approved.

 

Did I achieve all the goals? Sadly no. But even missing two, guaranteed that I had optimized my time and reap

ed value from the investment the company had made by sending me to the show.

 

I believe that I was allowed to attend domestic and international congress even during cost-cutting cycles due to my development of personal show goals, routinely meeting those goals, and reporting out my findings in an organized fashion to the organization as a whole.

 

Lesson(s)

 

1. Ensure you get a high rate of return on your investment of time and resource at every trade show you attend no matter what your management level by setting your goals. Know before you go!

 

2. Make sure you complete your personal goals first, then contribute to others achieving theirs’.

 

3. Ensure that the macro goals get incorporated into your objectives.

 

“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 experienced 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. [email protected].

 

 

 

Uncategorized

Are You Ready to Launch?

Set up

Recently I have had two potential clients ask during their free 30-minute consultation if they were ready to launch their new medical devices. Thirty minutes is no-where near enough time to answer that question. As I thought through both scenarios, it occurred to me that I usually ask myself a series of questions when I am trying to make that determination. I am going to share those questions with you in this post.

 

The Process

The questions I usually ask have multiple layers to them and fit into at least six categories. Now, if you think I am over complicating this fundamental question, let me remind you that when I am preparing a launch, I consider over eighty elements in the design. If you are not confident in the answers, a more in-depth review is warranted.

 

The categories won’t be new to you if you have been reading this blog for a while. If you are new, then you will recognize them from Marketing 101.

 

Before you even dive into the next level, ask yourself if there is a launch goal? If you don’t have a clear expectation from the launch of the product, then stop. Work as a group to set a goal that has more than just revenue as the target.

 

Categories (the 4 p’s of marketing[1] + business Process):

    • Product
    • Price
    • Promotion
    • Place
    • Process

 

Considerations for Product

    • Have I demonstrated that the product is safe for the patient, the user, and the environment?
    • Am I sure that I can reliably predict the performance in any situation the device is used?
    • Do I have an evaluation process in place that lets the user see the product in its best light?

Considerations for Price

    •  Do you understand how the price will impact the uptake of the product?
    • Do you have a complete understanding of the reimbursement that the buyer will be eligible for?

Considerations for Promotion

    • Have you validated your value proposition?
    • Have you validated all your clinical claims?
    • Are your promotion claims within the boundaries of your regulatory clearance or approval?
    • Do you have a plan to collect additional clinical evidence in support of your current and future claims?

Considerations for Place (Distribution)

    • Does your distribution channel selection fit with your product?
    • Have you tested your sales process? 
    • Have you adequately designed product and sales training for those who will be representing your product?
    •  Have you tested your in-service procedure?

Consideration for Process

    • Have you developed all the business processes that will allow you to provide high-quality professional service to your customers?

Do you have in place:

        • Complaint handling procedures
        • An escalation process for technical and clinical questions from the field
        • A returned goods process that has the right level of Biohazard safety
        • Environmental considerations

These are just a sampling of the questions you should ask yourself and your team before you authorize the launch. There are many, many, more. The answers are not, yes or no. The implied question is, is there evidence that you have answered these questions correctly. Now is the time to hold each other accountable, no surprises to the best of your resources and abilities.

 

In launching or directing the launch of nearly 100 new medical devices, I have made mistakes. 

Many of those mistakes would have been prevented if I had been honest and thorough in answering the question, “are we ready?”

 

Lesson(s)

 

1. No one wants to fumble the ball in the red zone after driving down the field for months or years.

 

2. Small issues will come up. However, you need to do everything in your power to prevent the big ones.

 

3. The sooner in the launch prep process, you all agree on the “readiness checklist” and the required pre-launch performance and knowledge, the better.

 

“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. [email protected].

 

© 2019, The Experia Group, LLC

 

  [1] McCarthy, 1960

Lesson

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. [email protected].

Available on Amazon.

© 2019, The Experia Group, LLC

Coaching

Expanded Coaching Opportunities for Medical Device Marketers

Are you stressed?

Is that stress due to a new level of responsibility, a new campaign or project that you haven’t done before? Do you need some practical guidance? From VP of Marketing-to-Associate Product Manager, it can be both exciting and frightening to embrace new challenges.

• New product definitions
• VOC planning and execution
• Tradeshow campaign development
• Strategic planning
• Portfolio rationalization
• Portfolio planning
• Product launches

 

 

 

 

You don’t have to do it alone!

Tim Walker, author of Insights: 33 Lessons Learned in Medical Device Marketing, has announced that he is providing one-on-one or team coaching for those professionals who are expanding their roles or skills set and would like some practical guidance.

• Build confidence
• Add new skills
• Relieve that unhealthy stress
• Feel supported

Declare your interest in living gracefully into the new challenges of your career by contacting Tim; mailto:[email protected].

Relieve some or all of the unhealthy stress and pressure you are feeling, lean on Tim’s experience, expertise, methods, and processes.

“I know I can provide the support you need as I have for so many of those who have worked with me in the past.”

Tim Walker
Author, consultant, coach, and mentor
https://www.linkedin.com/in/meddevicestrategist/

Available on Amazon

Announcement

Walker Announces one-on-one coaching opportunities for Medical Device Marketers

Are you new to the Medical Device Commercialization world and would like guidance on a new product launch, product messaging, strategic planning, product management, and many more elements of marketing?

Tim Walker, author of Insights: 33 Lessons Learned in Medical Device Marketing, has announced that he is providing one-on-one coaching for those professionals who are new to commercializing medical devices and would like some practical guidance.

Every great athlete in America relies on coaches who have access to processes and methods to reinforce the fundamental. Why not you?

“To excel at the highest level – or any level, really – you need to believe in yourself, and hands down, one of the biggest contributors to my self-confidence has been private coaching.”  Stephen Curry, Golden State Warriors

Stephen CurryAwards  All-NBA Team
NBA Most Valuable Player Award
2016, 2015
All-NBA Team
2019, 2018, 2017, …
NBA All-Rookie Team
2010
Best NBA Player ESPY Award
2015
NBA Community Assist Award
Best Male Athlete ESPY Award
2015
NBA Sportsmanship Award
2011
BET Award for Sportsman of the Year
2019, 2017, 2016, …
Teen Choice Award for Choice Male Athlete
2017, 2016, 2015
Assist of the Year Fan Award
2017
Southern Conference Men’s Basketball Player of the Year
2009, 2008
Best Record-Breaking Performance ESPY Award
2016
Associated Press Male Athlete of the Year
2015
Shorty Award for Best in Sports
2016

Feeling alone, a little overwhelmed, find yourself inventing work processes from scratch? Are you a top performer that suddenly finds themselves supervising others and are not sure how to go about the mentoring and coaching of your team?

Relieve some or all of the unhealthy stress and pressure you are feeling, lean on Tim’s experience, expertise, methods, and processes.

I know I can provide the support you need as I did for Lauren.

Lauren Rhodes, IMBA

Lauren Rhodes, IMBA

Medical Device Marketing/Product Manager

“Few people have the opportunity to work with and learn from a recognized industry expert like Tim Walker during their careers. I am privileged to have been personally mentored by Tim at a start-up medical device company during the launch of our flagship product last year.
Tim’s extensive knowledge and contagious passion for standout medical device marketing have been instrumental to the success of our company and to my own professional development in the medical device industry. His insights enabled us to quickly develop an effective value proposition for our customers, craft unique and consistent product messaging, and launch our product using a results-driven commercialization strategy.”

Declare your interest in living into the new challenges of your career by contacting Tim, send an email to [email protected]. Limited space is available for this new service, so act now.

You don’t have to do it alone!

Tim Walker

Author, consultant, coach, and mentor

30 Years of Lessons Learned