INTRODUCTION
5 Min.
30 Min.
We recommend using this online book as a companion to the e-C3i summer course and for phase 1 of the C3i course. The book is a guide to validate the viability of the project you are pursuing. We look at viability from two angles. From the user ’ s perspective and from the business perspective. Researchers and companies in medical technologies including, diagnostics, devices, pharmaceuticals, health IT, life science tools, often have a technology and an idea of how their technology can sole a medical problem that is of interest to them or than a user has made them aware of. When we talk of a problem, first we must validate if the problem is what we call an “ unmet need”. We ask the participant to understand the problem that could be in the medical field in research or in the pharmaceutical space. This is what we call understanding the cycle of care, patient journey or research or pharmaceutical process. This understanding will help elucidate where the touch points are and who are the individuals that will be involved, the stakeholders. With the knowledge of the stakeholders that will be impacted by your solution, we focus on planning and conducting interviews to validate what problems these stakeholders have and if the problem that you are trying to solve is a major pain point, that if solved, will change the way that they solve their problem and will be willing to adopt. In the medical field we talk of changing medical practice. As you progress in the interviews, you will either validate that the problem you were trying to solve rises to that level of importance and that it will be adopted, find another problem that you could solve, or find out that you should dedicate your time and effort in a different endeavor. As you progress with the interview, you will start the iterative process of crafting a need the statement that will be used to guide all your development efforts and that will be used in case of FDA regulated products, as the first input for the FDA required process. During this process you will discover what is the value proposition that your future solution must have for each of the stakeholders involved in the cycle of care or process and what are the most relevant attributes that your product must have for widespread adoption.
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