Step 4: Disease state fundamentals

Understanding disease state fundamentals involves researching the anatomy and physiology, pathophysiology, symptoms, outcomes, epidemiology, and economic impact of a disease. This information is pertinent to the process of finding a clinical need or in validating a need that has already been established. The process also provides the innovator with a critical level of knowledge about a condition so s/he can be credible when speaking to external stakeholders, such as physicians and other experts in the field (Zenios et al., 2010).

Step 5: Treatment Options

The goal of any treatment is to improve outcomes in those patients with a disease or disorder. Treatment analysis involves detailed research to understand what established and emerging therapies exist, how and when they are used, how and why they work, their effectiveness, and their economics. Through the process of investigating treatments and creating a comprehensive profile of how a condition is typically addressed, areas for improvement or gaps in available therapies may become apparent. This analysis also helps provide the innovator with an understanding of the clinical and patient-related requirements that any new treatment must meet to be equivalent or superior to existing alternatives. It further establishes a baseline of knowledge against which the uniqueness and other merits of new solutions can be evaluated (Yock et al., 2015; Zenios et al., 2010).

Step 6: Stakeholder Analysis

In stakeholder analysis, the innovator systematically examines the direct and indirect interactions of all parties involved in financing and delivering care to the patient. The purpose of this analysis is to understand how these entities are affected by the need and to determine their requirements (or their stake) in how it is addressed. Stakeholders have different perspectives – for instance, some will benefit if the need is addressed, but others may be adversely affected. Uncovering these perspectives and any potential conflicts is critical to shaping and refining the need statement and need criteria. It also allows the innovator to anticipate resistance, as well as to define and prioritize the requirements that will shape the eventual solution to maximize its chance of adoption among the most important and influential stakeholders (Schmeer, 2000).


(Zenios et al., 2010)


Step 7: Market Analysis

Market analysis focuses on the systematic examination of these issues. By estimating the total potential market size associated with the need (measured in terms of revenue), an innovator can determine how many resources can realistically be dedicated toward addressing the need and whether it can support a sustainable business. Market analysis also allows the innovator to understand the dynamics of the market – whether it is growing or shrinking, becoming more or less competitive – to determine whether opportunities in the market will increase or diminish over time (How Do I Conduct a Healthcare Market Analysis? (with picture), n.d.).


(Zenios et al., 2010)


(Zenios et al., 2010)

Step 8: Needs filtering

Needs filtering uses all the data already collected through the Biodesign innovation process to identify a smaller set of needs, or sometimes a single need, that warrants further research and investigation (Zenios et al., 2010).

The process of needs filtering can be performed in many ways, but generally involves four essential steps:

  1. Select screening criteria or the factors to consider in planning;
  2. Assign ratings for each factor for each need;
  3. Combine values to produce a score that can be used to prioritize the needs;
  4. Filter the needs to produce a small set for further investigation (Zenios et al., 2010).

Last modified: Saturday, 4 February 2023, 3:54 AM