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On-Demand Digital Customization for Perfect-Fit Medical Product-Distributed Design Agent Approach(本文)

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On-Demand Digital Customization for Perfect-Fit Medical Product-Distributed Design Agent Approach(本文) Doctoral Dissertation Academic Year 2018 On-demand Digital Customization for Perfect-fit Medical Product -Distributed Design Agent Approach Graduate School of Media and Governance Keio University Jianyou Li Keio University Thesis Abstract No. Registration □ “KOU” □ “OTSU” Name: Number: No. *Office use only Title of Thesis: Summary of Thesis: 主 論 文 要 旨 No.1 報告番号 甲 乙 第 号 氏 名 主 論 文 題 目： （内容の要旨） On-demand Digital Customization for Perfect-fit Medical Product -Distributed Design Agent Approach by Jianyou Li ・31 !1 On-demand Digital Customization for Perfect-fit Medical Product -Distributed Design Agent Approach by Jianyou Li Certificated by: Dr. Hiroya Tanaka Professor, Graduate School of Media and Governance, Dissertation Supervisor Dr. Daijiro Mizuno Associate Professor, Graduate School of Media and Governance Dr. Fumitoshi Kato Professor, Graduate School of Media and Governance Dr. Masaya Nakamura Professor, School of Medicine. Dr. Shoko Miyagawa Associate Professor, Faculty of Nursing and Medical Care. !2 Abstract This dissertation addresses the technical and social issues that inhibit the use of digital fabrication, such as 3-D printing, in the medical field and proposes a new sociotechnical collaborative framework that includes the designer (design engineer), user (patients and demanders) and design agent (clinical practitioner) as solutions. In this approach, the designer and clinical practitioner (as design agent) can exchange their professional knowledge to develop a special design tool and related training, and the programmable modeling language is applied to develop a semiautomatic modeling sequence of product customization. Such a tool enables the nondesigner clinical practitioner to perform design capability and play the role of distributed design agent to customize medical products for patients or demanders through digital fabrication technology on demand. Background Along with the widespread increase of Fab Labs and the maker movement in recent years, digital fabrication technology has become more accessible to people in widely available personal fabrication at an affordable cost. The medical field also benefits from the technical popularization, especially in orthopedic, surgical and physical medicine and in rehabilitative and assistive technology. In these fields, many customizable medical devices applied to the human body are realizable with digital fabrication. Furthermore, the implementation of 3-D scanning and existing medical imaging technologies provide precise 3-D anatomic models for digital landmarks and have become critical factors for improving the fit quality for customized devices. Question However, the high digitalization of customizing workflow brings the challenge of digital design to medical applications, and the digital design technique and professionals of CAD are necessary in the process of designing medical devices. This technical gap contributes to more complex digital customization, implying that the clinical practitioner cannot apply this process alone. The research question is as follows: How can the distribution of medical device digital customization be realized by new tools, roles and process in a closer collaboration? !3 Method I submit a collaborative design framework for a local medical engineer and clinical practitioner to develop a specialized digital design tool that enables the clinical practitioner to overcome the technical gap of digital design and perform the role of design agent in customizing perfect-fit medical products. In the beginning of the collaboration, the medical engineer studies the product function, customizing requirements, landmark principles and operative limitation of CAD skill of the clinical practitioner and combines the advantages of digital fabrication into the design workflow. The digital design tool is a semiautomatic model generator that is constructed by the programmable modeling language in a CAD context, and the tool’s interface and landmark method can be customized to accommodate the design agents’ limited CAD capability. A quick training and design exercise are formulated for the design agent to gain familiarization with the customization task, and a method that can visualize the design agent’s behavior in the design exercise is developed to evaluate the design tool, design agent’s performance, and training content. With the assistance of the design tool and the vantage point that connects to multiple demanders, the design agents can form a distributed fabrication network of digital customization and deliver design service efficiently. I conducted this approach in two experiments, while playing the role of medical engineer. In the first experiment, through collaboration with an orthopedist, we developed a customization system to help the doctor design a 3-D printed splint for fracture immobilization of an upper limb. In the experiment with a 3-D printed respirator, a customization system was designed to help the Infection Control Practitioner with customization of a personalized respirator for hospital employees to improve the seal between the edges of the respirator and the wearer’s face. Results The results of the two experiments were as follows. (1) A clinical practitioner can operate a digital design tool to customize designs independently after a short training. (2) The design tool can generate qualified models based on the design agent’s landmark input for digital fabrication rapidly. (3) Compared to the traditional products, the customized artifacts generated in the experiments have better performance on comfortability and function. (4) The customized products can help the clinical practitioner and users solve the problem or improve the device performance in a medical environment. !4 Contribution The main contribution of this research is the collaborative framework whereby a medical engineer can cooperate with a local clinical practitioner to develop a digital customization workflow for a specific medical product and a responding digital design tool to enable the clinical practitioner to execute the customized task independently. Through prior study with the clinical practitioner, the engineer can define the product features, customize the steps and 3-D scanning solution with the practitioner to ensure the product feasibility and eliminate the technical gap for the clinical practitioner. From the observation to the design agent’s visualized behavior in the design exercise, the medical engineer can track where the operative fault occurs and improve the design tool or training directly. Such an approach can help the medical engineer develop other product customizations for the clinical practitioner’s needs. !5 Contents 1 Introduction & Overview 1.1 Background ……………………………………………….……………………..…15 1.2 Toward distribution of design and fabrication …………………..…….…………...19 1.3 Research object ………………………………………….……………...………….20 1.4 Dissertation outline ……………………………………………..….………………21 2 Related Researches 2.1 Introduction …………………………………………………….……...….….……23 2.2 Method of investigation…………………………………..….…………………..…24 2.3 Classification…..……………………………………………………………..….…27 2.3.1 Summary…………………………………………..….…..………………….27 2.3.2 CAD approach study……………………………………...…………………29 2.3.3 Approach patterns……………………………………………………………32 2.4 Findings…………………………………………………………………………… 33 3 Design Process 3.1 Introduction …………………………………………………..…………..………..36 3.2 FDA guidance ………………………………………………..……….………..…..37 3.3 From handcraft customization to digital customization……………………………39 3.3.1 Complexity and variability of customizing medical device………………… 39 3.3.2 Medical Engineer’s background ……………………………….…….………39 3.4 Modeling approach…………………………………………………………………40 3.5 Collaborative relationship …………………………………………………………42 4 Collaborative Framework 4.1 Introduction …………………………………………………………..………..… 44 4.2 Framework overview ……………………………………………….……………..45 4.2.1 Small-scale development…………………………………………………….45 4.2.2 Unitary software environment and specific device …………………………46 4.2.3 Design concept of device function…………………………….…………….47 4.3 Skillset and toolset of main roles ………………….………..………………….… 48 4.3.1 Medical engineer ……………………………………………………………48 4.3.2 Clinical practitioner …………………………………………………………50 5 Digital Design Tool, Workflow and Training Formulation 5.1 Introduction …………………………………………….……………….…………51 5.2 Digital design toolkit.……………………………………………….…………….. 52 !6 5.2.1 Software environment and modeling strategy…….…….………………….52 5.2.2 Input methods …………………………….…………….………………….54 5.2.3 Design principle of interfaces…………………….…….………………..…56 5.3 Training, design exercise and evaluation ………….…………….……………..…58 5.3.1 Training formulation and design exercise ………….….………………..…58 5.3.2 Visualization of design agent’s behavior and analysis ….…………………59 5.4 Quality check……………………………………………….……………………..60 5.4.1 Mechanical test …………………………………….…………………..…..60 5.4.2 Biocompatibility, cleaning and sterilization ……………...………………. 61 5.4.3 Comfort investigation ………………………………..…………….………63 6 Experiment 6.1 Introduction………………………………………………….…………….……64 6.2 Experiment 1: Upper-limb splint for fracture immobilization ….…………...…65 6.2.1 Introduction …………………………………….…………...…….………66 6.2.2 Method ……………………………………...……………………….…….67 6.3 Experiment 2: Filtering face-piece respirator…………………..…………….…82 6.3.1 Introduction ………………………………………….…………..………. 82 6.3.2 Method …………………………………………………….………………84 7 Analysis 7.1 Introduction ………………………………………………..…………..………..92 7.2 Experiment 1 ……………………………………………….…………..…….…93 7.2.1 Stability and efficiency of generating printable models
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