Needs-Based Innovation in Cardiovascular Medicine: The Stanford Biodesign Process

Abstract

More than a decade ago, a formalized fellowship training program in medical device innovation, the first of its kind, was created at Stanford University. Now in its 15th year, the Stanford Biodesign Fellowship Program is a 10-month program whereby postgraduate students with a prior background in medicine, engineering, and/or business form interdisciplinary teams for an experiential process of identifying unmet clinical needs, inventing new solutions, and implementing these ideas (the 3 "I's"). A key component of this structured process is focused attention on needs finding and characterization, which differs from the traditional "tech-push" model (i.e., technologies looking for problems to solve). Although the Stanford Biodesign process can be applied to a wide variety of clinical areas, cardiovascular medicine is particularly well suited, given the breadth of clinical presentations it touches and its history of innovation to solve important clinical problems. Physicians play a vital role in the process, especially for needs identification and characterization. This paper outlines the Stanford Biodesign process and presents an argument for its repeat applicability, discusses its relevance to physicians and to cardiologists in particular, and provides a case study of the process that resulted in a currently available cardiovascular medical technology that came directly from the Fellowship Program.

Keywords: EP, electrophysiologist/electrophysiology; IP, intellectual property; Stanford; biodesign; cardiology; innovation; invention; medical device; medical technology; needs-based; translational.

Graphical abstract

Figure 1

The 3 Phases of the Stanford Biodesign Process The 3 phases of the Stanford Biodesign process (3 I’s)—identify, invent, and implement—are outlined, with 2 specific stages performed during each phase. The process is both iterative and cyclical and often requires returning to prior stages and phases as new information becomes available through research. Key activities performed at each stage are detailed below each step in the process.

Figure 2

An Example of 2 Possible Need Statements An example of 2 possible need statements from a fellowship group in the Stanford Biodesign Program. The need statement on the left contains a solution embedded within the statement (a better stent), which limits the potential concepts that can fulfill this need statement. The need statement at right no longer contains an embedded solution and instead places focus on the outcome (the consequences of emboli). Many more potential concepts that fulfill this revised need statement can thus be brainstormed.

Figure 3

Phase 1: Identify In the first phase of the process, the identify phase, needs finding is the primary focus. Many needs are recorded through clinical observations and are then screened and filtered down to those with the greatest opportunity and most interest.

Figure 4

Phase 2: Invent During the second phase of the process (invent), concepts are created after multiple brainstorming sessions. These concepts are then subjected to a rigorous screening process that leads to final concept selection.

Figure 5

A Novel Single-Use, 14-Day Cardiac Event Monitor This device is an example of a successful medical device initially conceived by a fellowship group in the Stanford Biodesign Program. It is currently commercially available in the United States and Europe.