Getting Started

The final decision about which concept to pursue can be a source of anxiety for some innovators. Using a well-structured, rigorous approach, like the one outlined below, can help boost innovator confidence and increase the likelihood of a successful result.

Complete Research, Prototyping, and Preliminary Concept Screening

What to Cover

The concept screening stage of the biodesign innovation process begins with innovators confirming that the concepts chosen through initial concept selection meet the previously defined need criteria (see chapter 3.2). Next, high-level research is performed for each concept on IP, regulatory, reimbursement, and business models, as well as prototyping. Based on the information gathered, innovators eliminate concepts on a rolling basis that have killer risks that make them infeasible or unattractive. Then, they create a risk scoring matrix to help prioritize and further winnow the list of concepts from viable to leading concepts. If for any reason this work has not yet been performed, revisit these steps before proceeding with the next steps in final concept selection.

Where to Look

Follow the guidance provided in the following chapters:

• 3.2 Initial Concept Selection
• 4.1 Intellectual Property Basics
• 4.2 Regulatory Basics
• 4.3 Reimbursement Basics
• 4.4 Business Models
• 4.5 Concept Exploration & Testing

Identify User and Design Requirements

What to Cover

Apply the new information gathered through chapters 4.1 through 4.5 (as well as other steps in the biodesign innovation process) to compile more detailed user and design requirements. Pay particular attention to information gathered through prototyping, as this may affect the overall feasibility of a concept. Find an appropriate balance between being so general that the requirements are meaningless and so specific that they apply only to a single concept. Choose the top three to seven requirements

Where to Look

Refer to Pugh’s book Total Design (Addison-Wesley, 1991), or the follow-up Creating Innovative Products Using Total Design (Addison Wesley Longman, 1996), for more information about the methodology. In addition, revisit the output from the following chapters:

• 2.5 Needs Selection
• 3.2 Initial Concept Selection
• 4.1 Intellectual Property Basics
• 4.2 Regulatory Basics
• 4.3 Reimbursement Basics
• 4.4 Business Models
• 4.5 Concept Exploration & Testing

Weight User and Design Requirements

What to Cover

Define a weighting scale (e.g., a scale of 1 to 5, where 5 is the most important). Then prioritize the concepts based on how critical they are to the potential success of the final solution.

Where to Look

Refer back to the chapters listed above for input in assigning appropriate weightings.

Confirm the Concepts and Choose a Baseline

What to Cover

Choose the most promising concepts that have “survived” concept screening (i.e., those that have not been eliminated due to undue IP, regulatory, reimbursement, business model, and/or technical risks or constraints). As noted, no more than three to five concepts should be included as part of the selection matrix. Select a baseline concept that reflects the established (or most promising) treatment alternative in the medical field. This can be the current standard of care, an emerging competitive product, or the most promising solution concept being considered by the team. Because all other concepts will be compared against this baseline, be sure that enough information is known about the baseline to allow the other concepts to be effectively evaluated against its performance relative to the requirements.

Where to Look

Refer back to 2.2 Existing Solutions in choosing a baseline concept. Network with experts in the field to validate that the appropriate baseline has been chosen.

Assign Scores and Rank the Concepts Using the Selection Matrix

What to Cover

Set the score for the baseline concept to (0) for each requirement. Then, carefully evaluate the individual concepts against the defined criteria in the matrix, assigning a (1) to concepts that outperform the baseline, a (-1) for concepts that underperform, and a (0) for those that achieve parity. Calculate the total score for each concept by multiplying the score for each requirement against its defined weight. The concept with the highest score is the leader. If no concepts score particularly well, or multiple concepts score the same, reconsider the requirements and the way they have been weighted. Additionally, evaluate the concepts to determine if one or more elements from disparate solutions might be combined to create a stronger overall solution concept. Additional prototyping can also be an invaluable source of information for making adjustments to the selection matrix. Perform the assessment again, in an iterative manner, until a clear leader emerges. Exercise judgment to make the final decision on which concept to pursue.

Where to Look

If it becomes necessary to revisit the requirements and/or the way they are weighted, network with experts and users in the field for additional input, as needed. These individuals can also serve as effective sounding boards for solution concepts that may combine different elements of previously prototyped concepts. Note that additional prototyping of these hybrid solutions may be required before a final decision can be made.