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Document Type

Open Access Dissertation

Degree Name

Doctor of Philosophy (PhD)

Degree Program

Mechanical Engineering

Year Degree Awarded

2018

Month Degree Awarded

February

First Advisor

Sundar Krishnamurty

Second Advisor

Ian Grosse

Third Advisor

Frank Sup

Fourth Advisor

Jack Wileden

Subject Categories

Biomedical Devices and Instrumentation | Computational Engineering | Computer-Aided Engineering and Design | Manufacturing

Abstract

Medical environments pose a substantial challenge for engineering designers. They combine significant knowledge demands with large investment for new product development and severe consequences in the case of design failure. Engineering designers must contend with an often-chaotic environment to which they have limited access and familiarity, a user base that is difficult to engage and highly diverse in many attributes, and a market structure that often pits stakeholders against one another. As medical care in general moves towards personalized models and surgical tools towards less invasive options emerging manufacturing technologies in additive manufacturing offer significant potential for the design of highly innovative medical devices. At the same time however these same technologies also introduce yet more challenges to the design process.

This dissertation presents a knowledge-based approach to addressing the existing and emerging challenges of medical device design. The approach aims to address these challenges using knowledge captured in a suite of modular ontologies modeling knowledge domains that must be considered in medical device design. These include ontologies for understanding clinical context, human factors, regulation, enterprise, and manufacturability. Together these ontologies support design ideation, knowledge capture, and design verification. These ontologies are subsequently used to formulate a comprehensive knowledge framework for medical device design, and to enable an innovative design process. Case studies analyzing the design of surgical tools in several medical specialties are used to assess the capabilities of this approach.

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