Fast track answers to critical questions that de-risk medtech innovations


When an innovator has identified a medical problem, taking an efficient approach to minimize risk and identify the viability of potential solutions is key. Our Phase Zero focuses on evaluating critical product elements early, minimizing risk, cost and effort. 


Key questions:

  • What is the clinical need or problem to be solved?
  • How will the product’s critical features address clinical need?
  • What is the product’s regulatory pathway?
  • Can the innovator’s intellectual property be protected?
  • Is there a market for the product?
  • Who are the competitors?


Answering these questions validates the project direction and anticipates your resource requirements, timeline and team needs. What, then, should medical technology innovators with a ‘napkin sketch’ or research idea expect to get out of GCMI’s Phase Zero service offering?


In short, at the completion of Phase Zero, an innovator will have a customized scope for product development. This process is a collaborative approach with the innovator and GCMI’s knowledgeable team of engineers and project managers. It removes the emotional side of the equation and delivers data that directs innovators to a go / no-go decision and starts the path to commercialization. Phase Zero deliverables and results are based on facts and data supporting the value in launching a full development program for the product. 


Minimizing risk focuses on resources, technical hurdles, time and cost within each of the key questions:


Clinical Need / Market / Reimbursement: Phase Zero helps innovators answer the most critical questions like, “What is the current need and how is it being addressed? Why would someone change from a device already on the market to my product? Is my product “me too” in the market, or am I proposing something different?” The process delivers an initial assessment of who will buy your product and at what price, along with a strategic assessment of potential competitors and their market share, average sales price and target sales volumes. These are fact-based statements to help you understand your market risks.


Technology: Phase Zero deliverables minimize risk by clarifying the important inputs for the design and ensuring all major features of the product have been identified and incorporated.  The process addresses major product risks and unknowns through performance and usability testing. Identifying the main product features in this phase allows us to iterate on the design quickly, saving time and cost in the later phases of product development. 


Intellectual Property (IP): Phase Zero deliverables consider whether your design risks infringe on someone else’s patent, and whether your product has features that may be patentable.  This research not only identifies intellectual property risk, but drives design and prototyping as well.      


Regulatory: Phase Zero reports include insights into the regulatory pathway of similar products and a regulatory strategy in which you can have high confidence. Looking into others’ regulatory pathways can inform the regulatory pathway for your product.  It also brings to light existing product failures that could lead to useful product features and opportunities for new ideas. This process reduces the uncertainty risk for the regulatory pathway.


At the end of Phase Zero, you will know your target product and which market to aim for. Phase Zero narrows your project scope and focus, tightening your product development timelines and helping eliminate the potential for shifting midstream.


Related – “Six things to know at Phase Zero”