1.3 Need Statement Development

Chapter 1.3
Additional Resources

When it is time to translate a problem into a need statement and define need criteria to guide the next stage of the biodesign innovation process, refer to the detailed information provided in Chapter 1.3.  The steps below have been excerpted from the chapter and are presented with active web links to assist innovators in getting started.

Translate Problem into a Need Statement
  1. What to Cover – Begin the process of translating problems into needs by asking a series of probing questions to reduce each problem to simple, causal factor that results in an undesirable outcome. Next, evaluate what change in outcome or practice the problem calls for from the target user’s perspective and determine how it can be measured. Then, capture the essence of the need in a one-sentence statement that defines the specific issue that requires a solution with a focus on the goal or desired endpoint. Writing an effective need statement may take multiple iterations. Make every word count.
  2. Where to Look
    • Primary Research – Perform more primary research with target users to validate desired outcomes (and the changes they necessitate).
    • Business Publications – Review business publications in the field such as “Turn Customer Input into Innovation” by Anthony Ulwick (Harvard Business Review, January 2002, pp. 91-97) and “Customers as Innovators: A New Way to Create Value” by Stefan Thomke and Eric von Hippel (Harvard Business Review, April 2002, pp. 74-81) for help thinking about the customer’s perspective.
    • Networking – Network with other entrepreneurs and review their need statements.

Verify the Accuracy of the Need Statement Against the Problem
  1. What to Cover – Carefully evaluate every word in the proposed need statement to ensure that it has been validated by observations and supporting research. Make sure each element of the need statement can be traced back to the critical problem that was observed and needs solving. Innovators should also challenge themselves to be certain that no assumptions, inferences, or other forms of judgment have found their way into the need statement. Try to trace the cascade of events leading to the need statement to ensure that a good understanding of all related needs at levels above and below the need are identified. Mitigate the risk of superseding needs by determining whether there are superior needs that may be more appropriate to pursue. If a superior need is subsequently chosen, follow the same process to verify the accuracy of the new need statement.
  2. Where to Look – Revisit the innovation notebook and review notes on all observations to be sure the need statement captures the critical aspects of the problem(s) observed. Clarify the language of the need with the patients, physicians, and other providers where it was identified. Confirm the need by getting other opinions from individuals at different centers or geographic locations.

Confirm that the Need Is Solution Independent
  1. What to Cover – Evaluate the need statement to confirm that there is no solution embedded within it, unless it is a fundamental component of an incremental need. This includes references to current solutions, as well as emerging possibilities. Any reference (no matter how subtle) to a specific solution or treatment path can introduce artificial constraints into future thinking. Be aware that any time a specific device is mentioned in a need statement (e.g., catheter, stent, scalpel), it is likely that the need has at least some portion of a preconceived solution embedded within it. Again, the only time this may be appropriate is for certain incremental needs but, even in these cases, the innovator should be careful not to unnecessarily constrain the need statement.
  2. Where to Look – There are few external resources to assist in this exercise. An innovator must rely on his/her own critical analysis skills to perform this assessment.

Validate that the Scope of the Need Is Appropriate
  1. What to Cover – Evaluate the need statement on a word-by-word basis to ensure that every word is necessary. Too often, superfluous words included within the need statement end up making a need too narrow and limiting the range of possible solutions (and the market opportunity). Next, evaluate the need statement on a word-by-word basis to ensure that it has not been defined too broadly. A need that has been over-generalized can result in a solution that does not effectively address the needs of the true target audience. It can also cause innovators to overestimate the size of the market opportunity later in the biodesign innovation process. Carefully confirm each word in the need statement to ensure that it can be verified with data and that nothing has been assumed.
  2. Where to Look – Innovators should refer back to observations and secondary research to perform this step. If necessary, additional observations can be scheduled.

Define the Need Criteria and Classify the Need
  1. What to Cover – Use the detailed information collected to define criteria that will meet the requirements of the people most likely to use the solution. Consider issues such as where, when, and by whom the solution is most likely to be used, as well as ease of use, time of use, duration of use, cost, and other factors that could potentially affect its adoption. These assessments should be made based on the behaviors directly observed through the observation process. The need can also be classified as incremental, blue sky, or mixed to help raise the innovator’s awareness of some of the characteristics of the need s/he is seeking to address. Depending on the innovator’s strategic focus, there may be other categories that can be used to help bring organizational clarity and direction in seeking to address the identified needs.
  2. Where to Look – Innovators should refer back to observations and secondary research for need criteria. The need statement must be directly evaluated to classify the type of need being addressed.

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