Need & Opportunity Analysis Supplemental Reading

Need and Opportunity Analysis – Supplemental Reading
Table of Contents
Marketing Research Background
How Need and Opportunity Fits in Evaluation Strategy

  • Validating the Societal Need

Additional Resources

  • Statistics on Disability
  • Search Engines
  • Standards and Guidance Documents
  • Grant Award Resources

 Market Research Background

Whether an innovation is incremental (building on another technology) or disruptive (a technology which will redefine market), understanding the market landscape and how the market works is crucial to overcoming barriers that prevent a successful product launch. The market landscape includes, among other things, increasing or decreasing trends, competition, distributors and distribution channels, conferences, key opinion leaders, and new technologies.

Marketing is communication to raise awareness about the product/service among potential customers. This is different from Market Research, which is about collecting data to analyze market need, market size, and competition informing a project’s viability.

Market Research is comprised of two categories of activities:
Primary Market Research – which involves information gathered personally (Customer Discovery interviews, surveys, and focus groups)
Secondary Market Research – which utilizes data that has previously been collected and compiled.

Both categories are required to gain an understanding of the market and opportunity. The focus of this section is on Secondary Market Research. Sources that fall into this category include existing reports, journal articles, studies by government agencies, trade associations, web portals, and other businesses within the same industry. The innovator should search each category as appropriate for the specific subject of their innovation. Look for trends, market size, who key opinion leaders (KOLs) are and popular distribution methods.

Market research should be recorded in enough detail to segment the information into meaningful groups of data. The actual segments will be unique to the market; some categories might be consumers, businesses, countries, common needs, interests, and priorities. The advantage of having this level of detail is the ability to identify and estimate the value of a given market segment, for example, which customer group has the greatest need, who has the highest sales
potential, and who may be the easiest to reach.

How Need and Opportunity Fits in Evaluation Strategy

Need and Opportunity Analysis is a critical step that innovators undertake to guide the decision to invest resources in product development. Sometimes, the decision is not to move forward or to make a major shift. If the decision is made to move forward, information from the Need and Opportunity Analysis should be brought forward into relevant components of the Evaluation Strategy.
An overview of the evaluation strategy is provided in Table 1 below.

Evaluation StrategyPotential ApproachesNecessary Version
of Product
1. Validate Societal
Literature search and synthesis None
Go/no-go decision
2. Validate the Customer
One-on-one interviews with customersNoneGo/no-go decision, initial
market requirements
3. Validate ConceptFocus groups, interviews with
ConceptRevised market requirements
Rough mockupYes/No Answer
4. Validate SolutionFocus groups, interviews, surveysBeta prototypeRevised market requirements
Revised product requirements
5. Validate the Business
One-on-one interviews with customersNoneDraft business model
List of outcomes required
6. Component Testing Laboratory tests to meet requirementsPre-production
Study reports, documentation
of properties & function
7. Safety and Usability
Feasibility, safety, and usability testing
in laboratory or ideal setting
Study reports, documentation
of confirming safety &
8. Clinical/Comparative
Effectiveness Research
Clinical research Final production
Evidence of effectiveness in real-world settings

Table 1: Overview of the evaluation steps to be conducted for product development.

For each of the evaluation steps, identify the tests, what tools are necessary, and what outcomes must be measured:
The Question: What is the question I need to answer to evaluate the technology at this stage of development?
The Test/Procedure: What test can be devised to answer the question? How would the test be structured? What tools, skills and facilities will be needed? Who would conduct the test? What is the target population? Where will the test be conducted?
Prototype Needed: The evaluation steps go hand-in-hand with technology development steps. In planning evaluation activities, the innovator will need to consider timing of technology development milestones.
Outcomes: What outcomes will be measured and how? How will success or failure be determined? The feedback will provide an early opportunity for the team to ‘pivot’, i.e. make changes to the product before development begins.

Validating the Societal Need

Customer Discovery Interviews will inform the customers’ needs or problems, however, it is important for the innovator to have a broad understanding of the challenges patients face, if they are clinically relevant, if a technology can be developed, and if there is a viable business case from the perspective of scientific evidence and the policy and funding priorities of provider, policy, or advocacy groups. Communicating what is known about the problem and what priorities have been established at the community or societal level serves as a powerful advantage in the journey toward commercialization. A market research is the main method employed at this stage, however preliminary interviews may be conducted, as necessary, to confirm and/or include additional stakeholder perspectives to ensure capture of an adequate market sample. In the case of Need and Opportunity Analysis, the objectives are to answer questions about the overall market trends. Is this a growing or dying industry? Is there a potential business case for a new technology in this space?

The Question(s)The Test/
The Outcome
1. Validate Societal the
Is there evidence of need from the perspective of advocacy,provider, or research groups?Literature search and
NoYes or no answer;
A written summary of the specific evidence about prevalence, incidence, individual or societal impact,research or clinical priorities, guidelines or standards.
Appropriate for the
significance section of grant application or an Executive Summary

Table 2: Questions to keep in mind while conducting Step 1 of the Evaluation Strategy.

Additional Resources

Statistics on Disability
Fostering Independence, Participation, and Healthy Aging Through Technology – Workshop Summary
Institute of Medicine Disability Committee Reports published by National Academies Press
Disability Statistics & Articles – Annual Disability Statistics Report

Search Engines
PubMed – National Center for Biotechnology Information
IEEE Xplore Digital Library
The Voices of Healthcare – Medline
Google Scholar

Standards and Guidance Documents
International Organization for Standards
Federal Communications Commission
Association for the Advancement of Medical Instrumentation
American National Standards Institute
American Society of Mechanical Engineers
American Heart Association
American Academy of Neurology
FDA Guidance Documents

Grant Award Resources
The federal government is another potential area of market research data, more specifically for research on federal agencies’ grant funding priorities. The federal agencies’ priorities in turn provide insight on societal needs. Make use of this knowledge to learn of competing technologies, gauge federal funding interest, make network connections, and identify potential partners.
Below are resources that lead to published grant awardee data. Insight that can be gathered from this data is:

    • Who did this research?
    • What federal agency paid for it?
    • How much was funded on this topic?
    • View all the abstracts to each grant awardee.

National Institute of Health Report Catalog
Small Business Innovation Research Awards Information