In the "fuzzy front end" of innovation there is a lot of uncertainty:

  • How do FDA requirements interact (and depend) on your intended design, indications, and claims?
  • Does the current reimbursement (and trends in the near future) allow your device to succeed?
  • Should you launch first in the USA, or in Europe, or somewhere else?
  • Do you have to establish a quality system to enter our market, or can we leverage partners?
  • How many of those FDA and ISO rules are going to be applicable?
  • What milestones and data sets are going to be needed to partner or exit?
  • What kind of management team will be needed to start – and then to launch or exit?
  • What supply chain is sensible from the first prototypes through to volume?

Fundraising challenges:

  • Preparing for Angel or Series A{C} rounds and wondering how to structure the raise.
  • Sorting out the requirements for your financial and fundraising projections.
  • How should we structure the story to create a compelling presentation?
  • What should be our elevator pitch?
  • Do we need special tag lines and affiliations for online (social media) visibility?


If you want to progress from the proverbial “cocktail napkin” sketches to planning for product commercialization and launch, we offer you the same advice and assistance that we offer to our institutional and university partners.

To get from the multitude of questions to a sound strategy, there are tools and techniques that are very helpful. Using our combined century of experience in medical device innovation we have developed business methods, templates, forms, and collaboration tools that enable effective decisions. With coaching and introductions added, getting to a sound and executable business plan is very likely. 
We call it Idea To Market (I2M) and here's a bit more information.