Blog Series Part 5: Selling a Medical Device — Thinking Ahead

  1. This happens more often than not — you must invest as much time as possible in the early stages of product development and strategy — it may break your business in a year or two.
  2. The regulatory consultant is the most important stakeholder — when it comes to medical devices, they are gurus (literally) and they should be involved from the very first meeting. Documentations and submissions can be prepared to anticipate the different markets, but this has to be done in advance.
  3. Changing your product cannot be done overnight — The process of doing so may take months, sometimes a full year more. Knowing this early can help you set up the possibility of change in a totally different way. With only a few sentences in your regulatory documentation, you can save yourself from a catastrophe, and make sure your product can be used in different environments or with different end-users.

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