Set up

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

 

The Process

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

 

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

 

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

 

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

• • Product
  • Price
  • Promotion
  • Place
  • Process

 

Considerations for Product

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

Considerations for Price

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

Considerations for Promotion

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

Considerations for Place (Distribution)

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

Consideration for Process

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

Do you have in place:

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

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

 

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

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

 

Lesson(s)

 

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

 

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

 

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

 

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

 

Make it a great day!

 

Tim Walker

 

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

 

One-on-one or team coaching is available.

 

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

 

© 2019, The Experia Group, LLC

 

  [1] McCarthy, 1960