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New Market Entry: A perspective for medical devices; 10 criteria and 15 watch-outs

Prelude

I have had several discussions with companies recently that are wanting to enter new markets. We start the discussion, and they want to talk about regulatory requirements and pricing. Both topics are critical to entering a new market; these two topics and about 50 more are all critical to first, choosing the next right market, and secondly, developing a winning strategy and creating a tactical plan to make it happen.

Entering a new market will likely consume significant resources. Therefore, it is worth taking the right amount of time to determine if you will succeed. In my 40+ years of medical device marketing, I have seen many entry attempts go sideways. The great majority of the time it was related to a poor job of upfront discovery.

I believe that an integrated market entry strategy that includes: a mini-high level strategic plan, strategies for all the critical to success elements (as determined by a gap analysis between the current market and the new market), and a tactical plan with a budget, are needed to ensure success.

Understanding

I get the desire to just start. I am a big fan of Starting Ugly. But even Chris Krimitsos suggests that you should have all the basics understood before, “Starting Ugly.” Understanding the market you are headed into is not an option, it is a requirement. I am an advocate of doing only as much research and discovery as needed.

Set-up 

Right after you set your high-level goals and objectives, create a list of criteria with metrics. Use real numbers if you can. If you can’t, develop a scale. Declare the pass/fail metrics before you do the discovery work.

 

Here is a sample of potential criteria:

      1. Legal requirements cannot be overly burdensome.
      2. Regulatory requirements cannot be overly burdensome.
      3. The market must be large enough to sustain/justify the investment.
      4. The product(s) brought to market must resolve a significant unmet need in a way that is attractive to the physicians.
      5. The product(s) brought to the market are differentiated from the competition.
      6. The value proposition and corresponding price must afford profitability.
      7. The cost of customer acquisition cannot exceed that that would allow profitability.
      8. Your current brand must be perceived positively.
      9. The basis of competition must allow you a sustainable competitive advantage.
      10. Availability of trained resources to fill the need.

Each company will have unique concerns that surface during discovery. These will need criteria written as well. Scores and weights will need to be assigned to those, critical to success metrics in achieving your goals.

During discovery make sure that you challenge every assumption you would make if you were bringing a new product into your current market.

Watch-outs

Watch out areas include, but are not limited to:

      1. How the un-met is solved today
      2. Distribution
      3. Fulfillment
      4. Sales process
      5. Contracting
      6. Access to the end-users
      7. Time to close
      8. Sampling guidelines
      9. Preference for performing in-servicing
      10. Incentives
      11. Bundling practices
      12. Stocking practices
      13. Evaluation requirements
      14. Conference conduct/expectations
      15. Grant processes and rules

Lessons:

      1. Actively studying the market is not a waste of time nor money.
      2. Understanding the market is not an option, it is a must-do.
      3. Take careful aim before pulling the trigger, this way you won’t waste ammunition (cash and time).
      4. All assumptions are traps

“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 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.

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

www.theexperiagroup.com.

© 2021, The Experia Group, LLC

FOCUS is power, when the lens is set at the correct angle

Prelude

In recent weeks, I have had discussions with three potential clients about their shot-gun approach to launching their new technology platforms. My advice was the same for each of them, FOCUS is power.

Pick the right channel, or product, or therapy to go after, and then apply all your assets to entering that market segment. The return question, ‘how do I know which is the ‘right product, channel, or segment?’ 

 

Set-up 

A fourth potential client had it all figured out and was just looking for confirmation and a bit of help in doing it. He wanted to start with segmenting the market for his technology platform. This top-down-market approach is not the only approach, but it is the one that will more often than not, put you on the pathway to successfully developing the first right product and developing a strong go-to-market strategy.

Understanding the market, or sector, or sub-market that you are in is never a luxury, it is essential. 

If you are not sure which way to go or which product to commercialize then immerse yourself into the market. 

This is particularly of value when you have developed a technology platform that eventually could serve every segment of your target market. Before you invest in the first new product take the time to do a full market assessment.

 

How do I know which is the right first product?

Follow this high-level process: (note: there are many sub-steps and significant effort implied within each step).

Step 1: Perform a high-level market scan

Step 2: Establish acceptance criteria for selecting the segment, this will be unique to your company.

Step 3: Map the relevant populations, map the disease(s), map the therapies, map the buying processes, map the projected patient journey, for each possible segment.

Step 4: Review the information from step 3. Retire segments that clearly do not have a chance of meeting the entry criteria.

Step 5: Treat each of the remaining segments as a singular opportunity. Conduct Opportunity Assessments based on the product you have identified for each segment.

Step 6: Compare and contrast the Opportunity Assessments (discussed in an early post or in Lesson 22 in Insight: 33 lessons learned in Medical Device Marketing available on Amazon).

Step 7: Select and commit.

If these steps sound like a ton of work, they are. Is there a way to cheat ahead and get things moving while you finish the work? Of course, you could deploy a Monte Carlo method, however, you still have to collect the information needed for the first three steps before you run a qualitative simulation.

Once you have these pieces in place, then you need to recruit 3-5 true experts in these types of assessments and or in the market segments they seem to have the ability to meet your criteria.

Give them the data and let them apply their intuition to fill in the gaps. During a day-long interactive process, you come to an understanding of all their points of view. If consensus is possible, even better. These types of processes are directionally accurate about 80% of the time.  

With the finding of the group, get started on defining the product concept using appropriate VOC techniques.

But don’t stop the process. In parallel continue to define the alternate possibilities. If any of the assumptions that were used to reach the findings prove to be incorrect, adjust.

The narrower the focus, the deeper you can go into the customer’s true unmet need. The deeper into the unmet need, the higher the probability that you have a commercially viable product.

What if we don’t figure it out and just pick one and go for it?

That certainly is one way of doing it, it has worked for others. But more often than not, it results in costly re-directs, failed launches, a loss in investor confidence, and a host of lesser issues. Time and cash are the critical aspects of any project.

The narrower the focus, the deeper you can go into the customer’s true unmet need. The deeper into the unmet need, the higher the probability that you have a commercially viable product.

It is all about risk and capital. 

Being intentional about the decision you make and the desired outcome you want, is a whole lot better than wandering about looking for something you haven’t even defined. A worthwhile read to get your mind around the process for sorting out the critical few, essentialism: The Disciplined Pursuit of Less, by Greg McKeown. While I don’t agree with everything that is advocated in this book; I do agree that focusing on the critical few is far better than trying to do everything and just hoping something works.

Lessons:

  1. Actively studying the market is not a waste of time nor money.
  2. Understanding the market is not an option, it is a must-do.
  3. Take careful aim before pulling the trigger, this way you won’t waste ammunition (cash and time).
“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 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.  tim@theexperiagroup.com

Available on Amazon

© 2021, The Experia Group, LLC

Medical Device New Product Launches Are Not a Singular Event, or Point in Time: A series of launch campaigns as you move through the product life cycle

Set up

In a coaching session that I held yesterday with a Sr. Product Manager we were preparing for his first-ever new product launch when, it occurred to me that in all the blog posts and in my book, INSIGHTS: 33 Lesson Learned in Medical Device Marketing[1] I have never really explained that a new product launch is not a single event. The launch never really ends. It is made up of events that track the product life cycle. So, it might serve us better to think of them as a series of Launch Campaigns. Across the life cycle, your device will be exposed to different target customers, geographies, cultures, and healthcare systems. Your messaging, channel, proof points all will need to evolve to keep pace with the various clinical evidence changes, new personas, environmental shifts, and learnings that have taken place with time. The goal is to optimize the strategic product message for the point you find yourself in the product life cycle, optimizing lifetime revenue.

 

Purpose

The purpose of this blog post is to broaden your thinking about the messaging evolution that might be required to facilitate the optimization of adoption at each stage in the product life cycle. To start, what might be some of the indicators that trigger an evolution of messaging.

The first three triggers are obvious ones, but if you don’t have metrics in place you might miss a trigger.

Persona shifts When the majority of your audience has shifted right along the adoption curve the persona of the target audience will shift towards a more conservative one. Language and strength of clinical evidence, colors, and media channel will need to be tweaked to optimize the impact you will have on the new audience.

  • Innovators / Pioneers
  • Early adopters
  • Early majority
  • Late majority
  • Laggards

 

Clinical evidence shifts – the focus, driven by good, or, no so good, results toward a different clinical target, or a new class of patient. Perhaps you discover that your economic story is stronger than you had originally thought.

  • KOL editorials /Testimonials
  • Posters
  • Single-center case series
  • Controlled clinical trials
  • Multiple controlled trials
  • Meta-analysis
  • Economic data

Launch phases – depending on what phase in the initial launch you are in your goals, focus, targets, and media channel may well need to be optimized to a new type of customer.

  • Clinical trial recruiting of PIs
  • User trials
  • Controlled launch
  • Limited launch
  • General launch – primary geography
  • Repeat for each region of the World into which you are launching.

Other aspects of the product life cycle that can trigger the need for a new campaign are:

  • Competitive response
  • Pricing shifts
  • Contracts being secured
  • Reimbursement changes
  • Device enhancements
  • Complaints
  • FDA actions
  • Achieving a number one share position
  • Therapeutic/clinical practice changes
  • Major environmental changes
  • Regulatory policy or guideline shifts

A cautionary note

As mentioned in several earlier posts “message congruency” is critical.

You can’t isolate one group of customers from another completely. Your message optimization should not cause dramatic changes and the core value position must remain in tack. So be careful. The one time you can be a bit bolder in your changes is where you can control access to an “event”.

As a rule of thumb, I try to maintain a campaign for 18 months. With digital marketing it is so much easier to change the message you will be tempted to jerk the message around too often. Don’t. Remember the fundamentals you need to validate every messaging change you make before it is released to the target audience.

The only thing worse than not occasionally optimizing the messaging, is changing it so often or so dramatically the device loses its core identity, and you begin to confuse the clinician.

Examples of optimization that might focus a campaign –

  • First – to – Best
  • Best – to – Gold standard
  • Innovative – to – Proven
  • Premium – to – The highest value

Metaphor –

We have often thought of launching a rocket as a metaphor for launching a new product. I have only written about lift-off. To reach outer space, often booster stages are required, second and third stages might be needed to break free of the earth’s gravity. Depending on the size of the payload, more stages or booster engines may be required. The same goes for new products.

Metrics –

Another lesson from NASA for us is that if we don’t have a course to follow, we can’t know if we are on, or off, trajectory. Set your course pro-actively, check it periodically, and then correct by firing your navigational boosters, gently.

Challenge –

Here is a challenge for you, if you strive to become an even better product manager or up-stream marketer.

The next time you are planning a launch, create a campaign progression map. Imagine covering the entirety of the product’s life cycle.

Lessons:

  1. Uncertainty is not to be feared, be bold and think the whole product life cycle through from the very beginning to the end.
  2. Targeted customer personas shift with time and distance along the adoption curve.
  3. Having effective metrics is critical.

“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 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.  tim@theexperiagroup.com

© 2021, The Experia® Group, LLC

[1] Available on Amazon

January 6th, 2021 the FDA released the Safer Technologies Program [STeP], implications for medical device marketers[1]

Prelude

With the creation of the STeP process the FDA finally, after 45-years, signals that they are proactively trying to fill the implied mandate from Congress to protect the US population by ensuring that safety is proactively promoted in the medical device space.

Set-up 

Safety has always been a prime motivator for change within the human population.  When I think about the motivators for physicians to change their purchasing (use) behaviors I reflect on a model that we have all seen before,  Maslow’s hierarchy of needs.  Modifying Maslow’s labels for the five levels to those of a physician’s we might see something like this.  Of course, there are more and different ways of saying them, but essentially this is what motivates physicians to buy or try new technology.

The STeP Process

The STeP process allows the FDA to expedite the review of devices that have the potential to significantly improve safety.  If you are defining a device that will:

  • Reduce the occurrence of a known serious adverse event
  • Reduce the incidence of a known failure mode
  • Reduce a known use-related hazard or use error
  • Improve the safety of another device or intervention

You should factor in the STeP time and cost savings into the justification for proceeding with the R&D project.  Having your product designated as a STeP device has real messaging and PR potential.  More importantly, as you consider how to prioritize competing products for your new product road map, the STeP designation should provide additional consideration.

Note: The FDA has prioritized Breakthrough Technology above the STeP program for resource allocation.  Breakthrough Technology program is mandated by Congress.

Conclusion

Yes, the STeP program is significant to medical device marketers.  To learn more visit SaferTechnologyProgram@fda.hhs.gov

Lessons:

  1. Know the regulations so you can get the most out of your partnership with the FDA
  2. Patient safety is not assumed, it must be advocated for by every department and person, the FDA just made that advocacy easier for you.
  3. Scan the grand environment constantly for changes that can help and sometimes detract from your product line success.

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 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.  tim@theexperiagroup.com

© 2021, The Experia® Group, LLC

[1] MED DEVICE ONLINE, Mark Durivage, January 25, 2021

Live Case Presentations, more or less relevant in today’s World of medical device marketing?

Prelude

Before we look at the title question let me declare some personal bias.

  • Because of what I have seen over the last 40 years, I am now and have always been an advocate for patient safety.
  • I believe in regulatory control over the medical device industry, so I have never cut regulatory corners. I must admit that there were times when I used those regulations to my advantage.
  • I am not a regulatory compliance professional.

Set-up 

Live case presentations at major medical conferences can provide a huge momentum surge for a new product or technique if all goes well.  If things don’t go well, then the opposite is true.  High business risk, high business rewards or penalties.

 

There has been an allowance in the regulations that prevent the promotion of new medical devices without proper regulatory approvals, going back decades, that allowed for the promotion of pre-clearance and pre-approval devices. This allowance was the recruitment of investigation sites and investigators for IDE studies.  Due to the liberal use of this allowance, the FDA issued draft guidance in 2014 with the ultimate non-binding guidance document released in 2019.[1]

This guidance document, from my perspective, recommends some really commonsense requirements:

  • Ensure the patient is not exposed to extra-risk.
  • Ensure the integrity of the study.
  • To the best of your ability foresee the use of live case demonstrations and make them integral to the study plan.
  • Declare your intentions, in grave detail, to the FDA during the initial IDE application and then provide additional information to the application as more details are available.
  • Communicate the clinical results of those live case-patients to the FDA as required.
  • If there is an adverse event report that within 10-days. 

Are live case still relevant today?

With the increased regulatory scrutiny and the lack of live case event theaters (almost all congress going to virtual formats), one might think that conducting live cases for marketing purposes (investigator recruitment) may no longer be worth it.

Personally, I believe that they are more relevant than ever.  Whether you go through the work with your regulatory team to do it pre-clearance or pre-approval is really a question of your ability to recruit investigators and the belief that your expert clinician can safely perform a novel procedure under the light and cameras.

Because of COVID-19, the medical device marketing World will be forever changed.  Will live Congresses come back, most certainly.  Will the virtual World of medical device marketing ever return to its former practices, no.  With these two realizations pre-recorded or rebroadcasted live cases will be even more important as digital content. Content that is by its very nature on demand.  This convenience and lower cost type of education, branding, and promotion of new technology will remain a popular option.

 Lessons:

  1. Know the rules so that you can comply with regulations
  2. Patient safety is not assumed, it must be advocated for from every department and person
  3. It is okay to play the long game with your reputation and the safety of the patients that you serve, if your Management team wants short-term results at the expense of your core beliefs, well……………

“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 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.  tim@theexperiagroup.com

© 2021, The Experia® Group, LLC

[1] Live Case Presentations During Investigational Device Exemption (ISE) Trials. US FDA, July 11, 2019.

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

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. tim@theexperiagroup.com.

© 2020, The Experia Group, LLC

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. tim@theexperiagroup.com.

 

© 2020, The Experia Group, LLC

 

 

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. tim@theexperiagroup.com.

© 2020, The Experia Group, LLC

 

 

 

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. tim@theexperiagroup.com.

 

© 2019, The Experia Group, LLC

 

  [1] McCarthy, 1960