Tag Archives: COVID-19

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  Due to the liberal use of this allowance, the FDA issued draft guidance in 2014 with the ultimate non-binding guidance document released in 2019.[1]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

COVID-19 a new dawn for Medical Device Marketing?

 

 

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

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

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

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

Tactics will change, strategies not so much

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

One Potential Impact

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

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

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

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

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

Are you ready?

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

Just off the top of my head:

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

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

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

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

Breathe

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

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

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

 Lessons:

1) Never stop learning

2) Always keep your environmental scans up and running

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

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

Make it a great day!

Tim Walker, MBA

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

One-on-one and team coaching are available.

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

© 2020, The Experia® Group, LLC

Available from Amazon.