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. 2021 Jul;22(4):509-514.
doi: 10.1177/1129729820913692. Epub 2020 Apr 18.

Innovation in hemodialysis: Using the Biodesign process to identify unmet needs

Dimitri A Augustin  1 , Glenn M Chertow  1 , Dan E Azagury  2
Affiliations

Innovation in hemodialysis: Using the Biodesign process to identify unmet needs

Dimitri A Augustin et al. J Vasc Access. 2021 Jul.

Abstract

There is renewed demand to accelerate innovation in nephrology; public and private sectors are creating programs to support its growth. The Stanford Biodesign innovation process, first developed in 2000, provides a roadmap for health technology and device innovation. There is insufficient published guidance on the application of the Biodesign process in the generation of novel devices to address nephrology- and/or dialysis-related clinical unmet needs. We present "needs finding," the initial part of the identify phase in the Biodesign innovation process and how it may be utilized for nephrology- and/or dialysis-related innovation. We describe here how to apply the Biodesign process to identify unmet dialysis-related needs, with the use of specific case-based examples based on observations within a hemodialysis unit. We then explore how to develop these needs using background research, direct clinical observations, interviews, documentation of observations and interview findings, and development of multiple needs statements. We conclude that there is an opportunity for nephrology innovators to use this methodology broadly in order to identify areas for innovation and initiated the development on novel solutions to be introduced into patient care.

Keywords: Biodesign; Dialysis access; Stanford; device; innovation; need statement; needs finding; nephrology; new devices; unmet needs.

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Conflict of interest statement

Disclosures

Dr. Augustin is an inventor/co-founder for Fluo Medical, Inc. The authors declare that there are no other conflicts of interest.

Figures

Figure 1.
Figure 1.
Biodesign process with focus on components of Identify phase: Dissecting the identify phase of the biodesign process (Adapted with permission from ebiodesign.org)
Figure 2.
Figure 2.
Part 1 of Needs Finding: Developing a strategic focus Example of factors which may drive an individual’s strategic focus
Figure 3.
Figure 3.
Part 3 of Needs Finding: Developing the need statement: Exercise of scoping the same observation for different need statements
See this image and copyright information in PMC

References

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