Category Archives: Lesson

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


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 usabilityperformance, 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.


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.


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


  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. 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.


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.


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


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. 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.



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. 



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.




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. Contact The Experia® Group for a free 30-minute consultation to determine if 30-years of experience can contribute to your success. [email protected].




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.


  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. 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