All posts by timwalker317526

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Perfecting the Strategic Pivot

Set up

Several clients either have or are about to pivot their post-commercial product offering in a new direction. Strategic pivots are rare with post-commercial start-ups.

Typically, the pivot is driven by market forces.  These market forces can create a real sense of urgency, almost a state of panic, to execute the pivot. Hopefully, the pivot is not a reboot or restart of the business.  If that is the case, it is an entirely different situation than I am writing about today.

Historically, clients experiencing low revenue growth are missing one or two key elements that are readily fixable. If a pivot is required, then a more thorough assessment will be required to identify all the elements that need to be pivoted.

Before you commit to a pivot, you must audit every assumption or finding you have made from the original market scan.  The grass may look greener on the other side of the fence, but until you dig in the dirt, you won’t know the quality of the soil.  Here is a 10-point checklist you should consider during your pre-pivot planning process.

Checklist:

  1.   Is the current Product* optimized for the new target?
  2.   Is the current reimbursement still valid?
  3.   Will new regulatory efforts be required?
  4.   Will additional clinical data be required?
  5.   Is the new target’s persona significantly different from the old target?
  6.   Will the product messaging need to change in support of the a new persona?
  7.   Will the new target require a new pricing strategy or price change +/-?
  8.   Is your account targeting method still valid?
  9.   Are there different competitors in the new target?
  10.   Is your sales organization capable of accessing and supporting the new target?

This list is generalized; I encourage you to brainstorm your own list.

Failure to embrace the complete reality of the pivot can leave your company in a weaker long-term position.  Incomplete pivots will always cause disruption in realizing the true potential that the new pivot holds.

Lesson (s)

  1. When considering a pivot, conduct a holistic audit of the changes that will be required.
  2. Do proper (structured) VOC work to understand the nature of the new customer, new stakeholders, competition, methods, purchasing behaviors, price tolerance, etc.
  3. Just because it intuitively makes sense that the environment will be similar, do the work to make sure.

*Product, spelled with a capital “P,” represents the entire product or service, including, but not limited to, Indications, instructions for use, packaging, training, disposal of, and shipping methods.

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

Make it a great day!

Tim Walker, MBA

Tim is the Principal Strategist for The Experia® Group, LLC, which provides expertise and experience to medical device companies.  An author, INSIGHT:33 lessons learned in medical device marketing, available on Amazon.

One-on-one and team coaching are also available.

www.theexperiagroup.com

© 2024, The Experia® Group, LLC

 

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When you are feeling overwhelmed at work, do this.

The Story

Mentoring and coaching product managers are two of the most rewarding things I do. Recently during a session with several mentees, one of the product managers seemed down. When I asked what they were feeling, the emotions flowed out.

He was overwhelmed by the sure volume of Work that he was facing. In addition, there had been recent layoffs at his company, so he wasn’t feeling very secure. Those two conditions combined produced anxiety that he had been battling for months. So, unfortunately, he was slightly depressed.

He was new to product management and hadn’t felt this way before. He thought he was weak; no one else seemed to be struggling.

I explained that everyone feels overwhelmed from time to time; everyone, whether the teacher, the coach, or the boss, has felt overwhelmed. Deadlines, tasks, and low performance all can cause anxiety.

The other two mentees on the call sang out, confirming they, too, had felt overwhelmed.

So, what do you do?

I have to slow things down when every instinct is to speed up to get more done. It may seem simple, but when in the middle of an avalanche of work, it can be tough to see what is going on. So often, we can lose track of the facts or reality of the situation. It grows in scope and scale based on our historic insecurities. Follow these steps to ease the anxiety.

    1. Tell someone else how you feel.
    2. Find a way to let your supervisor know how you feel and ask for help.
    3. Ask yourself, what one thing must I get done today? Do this first.
    4. Make a to-do list of the only things you can do today or this week. Check the boxes as you go.
    5. Review the checklist at the end of the day and own the work you accomplished.

If you do this, day after day, you will feel better and be more productive

So, what should you not do?
    1. Don’t stall or shut down
    2. Don’t isolate
    3. Don’t complain or deflect
    4. Don’t put off the big tasks

Look and move forward, always forward, never back. You will regain the hope of control one step at a time. Believe that you will get through this difficult time. Believe me; you will be stronger on the other side.

Experience is what you get right after you needed most!

Make it a great day!

Tim Walker

The Experia Group, LLC

[email protected]

Available on Amazon.

Uncategorized

Is there ever a good reason to ‘GHOST’ a fellow professional?

Context

Over the last year, I have conducted several New Business Development activities (acquisitions and funding). In pursuing favorable decisions on both fronts, I have been what my son calls ‘Ghosted.’ In the past, my generation called it being ‘Blown Off.’

Reflection

The phenomena caused me to pause and ask why someone would ghost another professional trying to pursue a mutually beneficial goal. Is it that difficult to say no thank you? What is the downside of admitting that you don’t want to pursue the relationship, the deal, or the investment?

I am exploring the potential motives and the drivers behind ‘Ghosting.’ Six emotional continuums are drivers for all our behaviors and actions—Anger, Joy, Sadness, Fear, Envy, and Jealousy. In my opinion, Hope is an independent emotion and perhaps the strongest of all.

So, of these seven, Fear seems the most likely driver to me. But Fear of what?

  • Fear of hurting someone’s feelings?
  • Fear of being wrong?
  • Fear of closing off an opportunity?
  • Fear of commitment to the decision?
Great strategy requires a lot of NOs to make room for the right YESs

Well, whatever the driver(s), we are all taught that great strategy closes more doors than it opens. Commitment to a strategy, a set of goals, and a mission are critical to progressive achievement.

Remember that every time we say no, we open ourselves up to saying yes. Yes, to activities aligned with our strategies and tasks that move us toward our goals to fulfill our life or corporate missions.

Conclusion

There isn’t a good reason to Ghost anyone ever. Just say no, with empathy.

If someone asks why the decision is no, tell them; or if you can’t be transparent, explain that the opportunity did not align with your current strategic intent. If the decision is made timely, it is better to know so that they may direct resources elsewhere.

Lessons:

1) Most often, people would prefer honesty.

2) Ghosting is unprofessional.

3) Make timely decisions.

“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 that specializes in providing experience and expertise 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].

© 2023, The Experia Group, LLC

 

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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. [email protected]

www.theexperiagroup.com.

© 2021, The Experia Group, LLC

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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.  [email protected]

Available on Amazon

© 2021, The Experia Group, LLC

Uncategorized

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.  [email protected]

© 2021, The Experia® Group, LLC

[1] Available on Amazon

Uncategorized

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 [email protected]

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.  [email protected]

© 2021, The Experia® Group, LLC

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

Uncategorized

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.  [email protected]

© 2021, The Experia® Group, LLC

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

Lesson

Does Marketing have a role to play in Postmarket Surveillance? for medical devices

Prelude

The core focus of the EU MDRs is Postmarket surveillance [PMS], with the recent guidance document, TIR 20416:2020 reinforces this quite clearly[1]. The goals of PMS are:

  1. Monitoring medical device safety and performance
  2. Meeting regulatory requirements
  3. Contributing to lifecycle management

To achieve these goals the guidance document wants manufacturers to:

  1. Actively and systematically gather data
  2. Record and analyze relevant data
  3. Focus on quality, safety, and performance
  4. Engage in PMS data gathering and, more importantly, analysis as a lifecycle activity
  5. Use this data to draw conclusions regarding quality, safety, and performance
  6. Modulate rigor of PMS activities based on the risk class

Further, the guidance states what is to be done with the collected data:

  1. To update the benefit-risk determination and to improve the risk management as referred to in Chapter 1 Annex I;
  2. To update the design and manufacturing information, the instructions for use. and the labeling;
  3. To update the clinical evaluation;
  4. To update the summary of safety and clinical performance referred to in Article 32;
  5. For the identification of needs for preventive, corrective, or field safety corrective action;
  6. For the identification of options to improve the usability, performance, and safety of the device;
  7. When relevant, to contribute to the PMS of other devices; and
  8. To detect and report trends in accordance with Article 88.

Set-up 

So, does Marketing or Product management play a role in PMS? Well look at it this way, if you don’t, then you are in for some surprises.   Just look at the concepts in the lists above [bolded], do you currently play a role with regards to these concepts? 

What role should we play?

At the very least, you as a marketer need to be aware of, and involved with, any PMS findings that might impact your product line or device.

I got involved with the design of the PMS process and reviewed every Incident Investigation. Communication to the field was only a small part of the role I always played. 

The only thing worst than not having a formal PMS process is not knowing that you need one.  

The PMS process should not be feared or viewed as a necessary evil but as an opportunity to better satisfy your customer and provide a safer product to the field.

Two types of data collection are required, proactive and reactive. As a marketer you need to support quality or customer service in writing and interrupting: 

Proactive data from-

  1. Surveys
  2. Questionnaires
  3. Clinician user interviews
  4. The use or membership in registries
  5. PM clinical follow-up studies (if you have to do them make them worthwhile as a promotional opportunity
  6. Monitor the market environment for activity by competitors

Reactive data from-

  1. Complaints
  2. Service reports
  3. Maintenance reports
  4. Unsolicited observations from all stakeholder (good and bad)

All this data should be feedback to your new product development teams regularly.

Conclusion:

You must, as a marketer, be involved with the PMS process!

Lessons:

  1. Make the regulatory processes work for you.
  2. If you are acting as a customer advocate get involved with every aspect of your product line.
  3. You are responsible for protecting the brand, PMS is a great early warning system when the brand is in jeopardy.

“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. [email protected]

© 2021,  The Experia® Group, LLC

  [1] Risk-based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation, Jayet Moon, December 11, 2020.  Med Device Online.