Step 1: Strategic Focus

One of the first, most important steps in the biodesign innovation process is for innovators to discover and explicitly commit themselves to the strategic focus area that stimulates their personal enthusiasm.

To make an effective, meaningful decision about a strategic focus area – which could be represented by a medical practice area, a specialty, or a specific need – innovators must ask themselves questions about why they want to pursue this path, what they hope to accomplish, and how their strengths and weaknesses may affect their efforts

Taking the time to perform a comprehensive personal inventory can lead the innovator to the identification of an appropriate and exciting strategic focus.


 (Zenios et al., 2010)

Determine a mission= Innovators need to be explicit about their mission. A mission is a broad, directional aspiration that defines what an individual or group wants to accomplish (Zenios et al., 2010).

Identify strengths and weaknesses= In addition to thinking about a mission, individual innovators, academics/researchers, small teams, young companies, and large corporations will all benefit from assessing their strengths and weaknesses. Specifically, they should evaluate what they do well, and how they can capitalize on these strengths. They should also consider in what areas they are less experienced, competent, or confident, and how they can compensate for these relative weaknesses (Zenios et al., 2010).

Define acceptance criteria = At their most basic, acceptance criteria are parameters that must be met to make an innovation project attractive to the innovator (Zenios et al., 2010).


(Zenios et al., 2010)

Step 2: Observation and problem identification

Before the development of new solutions can take place, innovators must first identify and understand the clinical problems that are associated with their chosen strategic focus area. The process of identifying important clinical problems requires innovators to utilize observation skills and find new ways of looking at processes, procedures, and events (Zenios et al., 2010).

Medical needs exist in abundance. The key is to target needs that arise from genuine and important clinical problems. Problems are significant issues that have been identified in a diversity of real-world healthcare settings. While some problems are obvious, others have not yet been recognized, even by those closest to them. For this reason, the process of identifying a clinically relevant project must begin with objective, direct observation. Clinical observations are not problems themselves, but rather a component of the methodology for identifying them (Zenios et al., 2010).

This methodology includes three important steps:

  1. observing a specific clinical situation
  2. identifying the problem inherent in that situation
  3. reshaping one’s understanding of the problem into a need (Zenios et al., 2010).

Consider the following example

Observation: A medical resident in training struggles to intubate a patient (place a breathing tube into a patient’s trachea) in the emergency room, leading to a drop in the patient’s oxygen levels.

Problem: For the unskilled practitioner, the time required to place an endotracheal breathing tube in an emergency setting can, at least in some cases, be extensive and can dramatically impact the outcome for the patient (Zenios et al., 2010).

Need: A way to reduce the time required for unskilled medical practitioners to place endotracheal tubes in an emergency setting (Zenios et al., 2010).

Step 3: Need statement development

Needs, which represent the change in outcome or practice that is required to address a defined clinical problem, may be thought of as the bridge between problems and solutions. Far too often, clever innovations fail because they have not been developed to address “real” customer and/or market needs. Once a need is clearly articulated, the most important parameters or criteria that will guide the design and development of the solution can be defined. Concepts and potential solutions can then be evaluated against these criteria to ensure that they effectively meet the clinical need.

Developing effective need statements is highly experiential – many innovators master this skill “the hard way” (by making mistakes and learning from them). This can be a costly process, since a poorly defined need statement usually is not discovered until the solution for that need statement misses the mark much later in the biodesign innovation process, after significant time, money, and effort have been invested. While there is no specific approach that can guarantee the crafting of successful need statements, there are at least two common mistakes that can be recognized and avoided: (1) embedding a solution within the need, and (2) inappropriate definition of the scope (Zenios et al., 2010).

Need statement development_img-03

(Zenios et al., 2010)

Last modified: Saturday, 4 February 2023, 3:52 AM