In GCMI’s experience, the decision to commit to a design and development plan for a new medical product should not be understated in its significance. Prior to making this commitment of time, money, energy and focus, an innovator must truly understand the tasks ahead of them, what the finish line looks like, how long it will take to get there, and what resources are required.

Key areas of risk include:

  • Business / Financial – How much money do you need, for how long will you need it, what is the return on the investment, and when would your investors expect to get that return?
  • Reimbursement – Does your innovation have an established market value and payment mechanism or does this need to be established? Establishing value can be as difficult as developing the product, itself!
  • Intellectual Property (IP) – Do you understand the competitive patent landscape and have novel IP covering your innovation? Do you have “freedom to operate?” Patents are valuable, but many GREAT products have no patent protection. Is your patent truly exclusive or are there multiple ways around your IP barricade? Worse, did you build your patent barricade inside someone else’s IP fortress?
  • Clinical Scenario – Establishing a new clinical value proposition is exciting and difficult. Do you understand the clinical need and how your innovation will be used? Who will use your product, and what is the clinical demand for it? Are you aiming at improving outcomes or are you directly competing with a similar device? Competing as a similar product may require a more sophisticated marketing strategy.
  • Product Realization – Do you have confidence your innovation will function as intended? Have you built and evaluated a prototype? Have you thought about how to manufacture your product and which contractors might be capable of making it?
  • Commitment – Have you prepared yourself for the emotional and financial journey? If your goal is noble and worthwhile, it is easier to withstand the buffeting winds and waves of medical device development. Great innovators have incredible confidence in their product and plan. They persevere. They build upon that confidence with every positive step. They learn from missteps and get smarter. They find great team members who can sustain their energy and confidence as they collect objective evidence that their innovation is becoming a real product.

These are the questions that must be answered honestly and objectively before a significant investment in design and development in a new medical product is made. If you have a good business opportunity and resources, plus confidence in your innovation and the market’s desire for your product, you might be ready for design and development.

GCMI certainly wants to help you get there. Let us know your goals so we can consider how to help you achieve success! For further information or inquiries visit our website and fill out our online form.