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


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.


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.


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 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


      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.

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