A Semantic Framework to Integrate Healthcare and Clinical Knowledge in Medical Device Innovation and Design

Author(s):  
Thomas J. Hagedorn ◽  
Ian R. Grosse ◽  
Sundar Krishnamurty ◽  
Jack C. Wileden

Within the medical field, there has been significant progress in the development of ontologies and their subsequent use to represent and utilize knowledge more effectively. These have culminated in the creation of large, curated medical ontologies for use in a wide array of applications, as well as higher level frameworks to organize and mitigate conflicts between disparate ontologies. While the engineering field has not been a similar progress in developing and adopting curated ontologies, there has been extensive research into how to effectively use semantic frameworks in engineering knowledge management and design in general, and specifically for the effective creation and documentation of functional basis models. Functional models are a useful tool in the early phases of product design, as they can help more effectively define goals and represent how a product must behave to accomplish these goals. In the specific realm of medical device design however, this process is complicated by a number of factors, including the complexity of the healthcare system and clinical knowledge, as well as a lack of domain specific expertise in the engineering field. Because of these challenges, effective transfer of information from medical domain experts to an engineering context and subsequent utilization of this information are essential to the success of a medical device innovation project. Despite the magnitude and importance of this challenge, few tools exist to help designers record, contextualize, and utilize medical knowledge for the specific purpose of engineering design. In this paper, we present a framework for directly integrating clinical knowledge relating to medical science and practice into the early phases of the engineering process to assist in medical device innovation and design. To accomplish this, existing medical and engineering ontologies were researched, obtained, and interlinked so as to explicitly tie functional models of medical device designs to the underlying medical clinical knowledge and procedures that define a product’s operational environment. The result is a framework that unifies the knowledge embodied in large medical ontologies with the functional basis ontology. This integration facilitates the effective preservation and use of medical knowledge in functional model creation and in the engineering design innovation process in general. To demonstrate the potential usefulness of this framework, we present a simple example of how our framework can be used to associate a functional model with a deconstructed medical procedure, thus enabling the seamless integration of a medical perspective directly into an engineering model.

Author(s):  
Benjamin Kruse ◽  
Clemens Münzer ◽  
Stefan Wölkl ◽  
Arquimedes Canedo ◽  
Kristina Shea

Even though the concept development phase in product development is arguably the most important phase in mechanical and mechatronics design, the available computer-based support for this stage is marginal. This paper presents a new computational model-based method to improve the early phases of mechatronic product design and to facilitate the application from early designs to detailed designs. The paper focuses on model-based Function-Behavior-Structure (FBS) libraries in SysML to support both the manual and computational generation of standard and innovative concepts. In this paper, an approach to re-usable functional models in SysML is presented. The method uses an operator-flow formulation of functions, based on the NIST functional basis, and is validated against a model of an electric car. The generated functional models are validated with respect to the consistency of the flows and tested by associating the functional model directly to the target product component structure. The results of the research are a new modeling approach for function and component libraries in SysML, an associated workflow for modeling of mechatronic systems, and the necessary extensions of the NIST functional basis. The modeling approach provides means for formal functional decomposition followed by an allocation of the functions to structural components that form the target structure.


Author(s):  
Robert L. Nagel ◽  
Matt R. Bohm ◽  
Julie S. Linsey

The consideration of function is prevalent across numerous domains as a technique allowing complex problems to be abstracted into a form more readily solvable. In engineering design, functional models tend to be of a more generalized nature describing what a system should do based on customer needs, target specifications, objectives, and constraints. While the value of function in engineering design seems to be generally recognized, it remains a difficult concept to teach to engineering design students. In this paper, a study on the effectiveness of an algorithmic approach for teaching function and functional model generation is presented. This paper is a follow-up on to the 2012 ASME IDETC paper, An Algorithmic Approach to Teaching Functionality. This algorithmic approach uses a series of grammar rules to assemble function chains which then can be aggregated into a complete functional model. In this paper, the results of a study using the algorithmic approach at Texas A&M in a graduate level design course are presented. The analysis of the results is discussed, and the preliminary evidence shows promise toward supporting our hypothesis that the algorithmic approach has a positive impact on student learning.


Author(s):  
Robert B. Stone ◽  
Kristin L. Wood

Abstract Functional models represent a form independent blueprint of a product. As with any blueprint or schematic, a consistent language or coding system is required to ensure others can read it. This paper introduces such a design language, called a functional basis, where product function is characterized in a verb-object (function-flow) format. The set of functions and flows is intended to comprehensively describe the mechanical design space. Clear definitions are provided for each function and flow. The functional basis is compared to previous functional representations and is shown to subsume these attempts as well as offer a more consistent classification scheme. An example is provided for using the functional basis to form a functional model. Applications to the areas of product architecture development, function structure generation, and design information archival and transmittal are discussed.


Author(s):  
Mark A. Kurfman ◽  
Robert B. Stone ◽  
Jagan R. Rajan ◽  
Kristin L. Wood

Abstract As more design methodologies are researched and developed, the question arises as to whether these new methodologies are actually advancing the field of engineering design or instead cluttering the field with more theories. There is a critical need to test new methodologies for their contribution to the field of design engineering. This paper presents the results of research attempts to substantiate repeatability claims of the functional model derivation method. Three experiments are constructed and carried out with a participant pool that possesses a range of engineering design skill levels. The experiments test the utility of the functional model derivation method to produce repeatable functional models for a given product among different designers. Results indicate the method is largely successful and identify its key strengths as well as opportunities for improvement.


Author(s):  
Robert L. Nagel ◽  
Robert B. Stone ◽  
Daniel A. McAdams

Conceptual design is a vital stage in the development of any product, and its importance only increases with the complexity of a design. Functional modeling with the Functional Basis provides a framework for the conceptual design of electromechanical products. This framework is just as applicable to the conceptual design of automated solutions where an engineered product with components spanning multiple engineering domains is designed to replace or aid a human and his or her tools in a human-centric process. This paper presents research toward the simplification of the generation of conceptual functional models for automation solutions. The presented methodology involves the creation of functional and process models to fully explore existing human operated tasks for potential automation. Generated functional and process models are strategically combined to create a new conceptual functional model for an automation solution to potentially automate the human-centric task. The presented methodology is applied to the generation of a functional model for a conceptual automation solution. Then conceptual automation solutions generated through the presented methodology are compared to existing automation solutions to demonstrate the effectiveness of the presented methodology.


2015 ◽  
Vol 137 (5) ◽  
Author(s):  
Robert L. Nagel ◽  
Matt R. Bohm ◽  
Julie S. Linsey ◽  
Marie K. Riggs

An engineering design curriculum that introduces functional modeling methods is believed to enhance the ability to abstract complex systems, assist during the concept generation phase of design, and reduce design fixation. To that end, a variety of techniques for considering function during design have been proposed in the literature, yet there are a lack of validated approaches for teaching students to generate functional models and no reliable method for the assessment of functional models. This paper presents a study investigating students' ability to generate functional models during a homework assignment; the study includes three different treatment conditions: (1) students who receive only a lecture on functional modeling, (2) students who receive a lecture on functional modeling as well as a step-by-step example, and (3) students who receive a lecture, a step-by-step example, and an algorithmic approach with grammar rules. The experiment was conducted in a cornerstone, undergraduate engineering design course, and consequently, was the students' first exposure to functional modeling. To assess student generated functional models across all three conditions, an 18 question functional model scoring rubric was developed based on flow-based functional modeling standards. Use of the rubric to assess the student generated functional models resulted in high inter-rater agreement for total score. Results show that students receiving the step-by-step example perform as well as students receiving the step-by-step example and an algorithmic approach with grammar rules; both groups perform better than the lecture-only group.


Author(s):  
Benjamin W. Caldwell ◽  
Gregory M. Mocko

Functional decomposition is used in conceptual design to divide an overall problem with an unknown solution into smaller problems with known solutions. The procedure for functional decomposition, however, has not been formalized. In a larger effort to understand and develop rules for functional decomposition, this paper develops rules for composition of reverse-engineered functional models. First, the functional basis hierarchy is used in an attempt to compose the functional model of a hair dryer, which does not produce the desired results. Second, a set of rules for composition is presented and applied to the hair dryer functional model. This composed functional model is more similar to the desired decomposition result than the functional model developed by changing hierarchical levels. Ten additional functional models are also composed and the results shown. The findings demonstrate that composition rules can be developed empirically through analysis of functional models.


Author(s):  
Robert L. Nagel ◽  
Matt R. Bohm ◽  
Josh Cole ◽  
Phillip Shepard

The consideration of function is prevalent across numerous domains as a technique allowing complex problems to be abstracted into a form more readily solvable. In engineering design, functional models tend to be of a more generalized nature, and consequently, engineering design derived functional representations do not aim to replace domain specific models but to encapsulate those models at a higher and more integrated system level. While the value of function in engineering design seems to be generally recognized, it remains a difficult concept to teach to students of engineering design. In this paper, an algorithmic approach to teaching function and functional model generation is presented. The approach uses a series of grammar rules to assemble function chains from a list of enumerated functions desired of the final product. Function chains can then be aggregated into a complete functional model. The approach has been trialed with senior capstone design students taught about functionality as well as how to generate a black box model and how to enumerate functions. Student-generated functional models are compared to expert generated functional models in the paper. Preliminary results indicate that a student with limited functional modeling experience could follow the prescribed algorithm to generate an aggregated functional model based solely on a black box model.


2013 ◽  
Vol 07 (04) ◽  
pp. 377-405 ◽  
Author(s):  
TRAVIS GOODWIN ◽  
SANDA M. HARABAGIU

The introduction of electronic medical records (EMRs) enabled the access of unprecedented volumes of clinical data, both in structured and unstructured formats. A significant amount of this clinical data is expressed within the narrative portion of the EMRs, requiring natural language processing techniques to unlock the medical knowledge referred to by physicians. This knowledge, derived from the practice of medical care, complements medical knowledge already encoded in various structured biomedical ontologies. Moreover, the clinical knowledge derived from EMRs also exhibits relational information between medical concepts, derived from the cohesion property of clinical text, which is an attractive attribute that is currently missing from the vast biomedical knowledge bases. In this paper, we describe an automatic method of generating a graph of clinically related medical concepts by considering the belief values associated with those concepts. The belief value is an expression of the clinician's assertion that the concept is qualified as present, absent, suggested, hypothetical, ongoing, etc. Because the method detailed in this paper takes into account the hedging used by physicians when authoring EMRs, the resulting graph encodes qualified medical knowledge wherein each medical concept has an associated assertion (or belief value) and such qualified medical concepts are spanned by relations of different strengths, derived from the clinical contexts in which concepts are used. In this paper, we discuss the construction of a qualified medical knowledge graph (QMKG) and treat it as a BigData problem addressed by using MapReduce for deriving the weighted edges of the graph. To be able to assess the value of the QMKG, we demonstrate its usage for retrieving patient cohorts by enabling query expansion that produces greatly enhanced results against state-of-the-art methods.


Author(s):  
Yoshinobu Kitamura ◽  
Riichiro Mizoguchi

Function is an important aspect of artifacts in engineering design. Although many definitions of function have been proposed in the extensive research mainly in engineering design and philosophy, the relationship among them remains unclear. Aiming at a contribution to this problem, this paper investigates some ontological issues based on the role concept in ontological engineering. We discuss some ontological distinctions of function such as essentiality and actuality and then propose some fundamental kinds of function such as essential function and capacity function. Based on them, we categorize some existing definitions in the literature and clarify the relationship among them. Then, a model of function in a product life-cycle is proposed. It represents the changes of existence of the individuals of each kind of function, which are caused by designing, manufacturing and use. That model enables us to give answers to some ontological questions such as when and where a function exists and what a function depends on. The consideration on these issues provides engineers with some differentiated viewpoints for capturing functions and thus contributes to consistent functional modeling from a specific viewpoint. The clarified relationships among the kinds of function including the existing definitions in the literature will contribute to interoperability among functional models based on the different kinds and/or definitions.


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