flowchart TD
id1(Functional Deficiency / Operational Deficiency)
id2(Identify Stakeholder Expectations / User Needs)
id3(Generate System Concepts / Define System Context)
id4(Identify Operational View & System Objectives)
id5(System Requirements)
id6(Develop Functional View)
id7(Develop Physical View)
id8(System Model)
id9(Design Detail)
id1 --> id2
id2 --> id3
id3 --> id4
id4 --> id5
id5 --> id6
id5 --> id7
id6 --> id8
id7 --> id8
id8 --> id9
5 Methodology
Caution
The report published on this website is a draft and subject to frequent updates. Please be aware that the content may change over time as revisions are made. Thank you for your understanding.
Tip
If you have questions, comments, or feedback, please contact Esteban Solorzano.
The study adopts a Systems Engineering approach, which involves analyzing the entire Medical Device Systems Engineering content management process as a system with interconnected components. This methodology allows for a holistic understanding of the system’s requirements, interactions, and potential improvements. The research methodology encompasses:
- Requirement Analysis: Identifying the key requirements for efficient content management, including version control, compatibility with various file formats, and ease of collaboration.
- System Modeling: Utilizing SysML (Systems Modeling Language) based on ISO/IEC 19514:2017 (Information technology - Object management group systems modeling language (OMG SysML)) (“ISO/IEC 19514:2017 | IEC Webstore,” n.d.) to model and create diagrams such as use case diagrams, block definition diagrams, sequence diagrams, and activity diagrams to visualize the content management process and its interactions.
- Evaluation: Assessing existing tools and technologies for content management, including Quatro and its capabilities in rendering content into different formats like HTML and PDF.
- Proposal: Proposing a refined content management methodology tailored to the specific needs of online reference books in medical device systems engineering.
- Standards that specify Knowledge Management for Systems Engineering: Apply the knowledge management process as defined in IEC 15288 (“ISO/IEC 19514:2017 | IEC Webstore,” n.d./). The main goal of this process is to empower organizations to exploit opportunities to reuse existing knowledge. Also the INCOSE Systems Engineering Handbook (INCOSE Systems Engineering Handbook 2023) defines the Knowledge Management process as a way to leverage existing knowledge within an organization for systems engineering projects.
5.1 General methods
The following methodology was used for the Masters Project in Systems Engineering.
Use Stevens Institute of Technology guidelines and templates for masters project.
Develop the “knowledge repository” as a system: stakeholder needs, concept, architecture, models, requirements, verification/validation.
Select and utilize systems engineering methods and tools from courses of Stevens School of Systems and Enterprises.
Select and utilize industry standards such as IEC 15288 and the INCOSE (International Council on Systems Engineering) Systems Engineering Handbook INCOSE (2023).
Literature Review: Conduct an extensive review of existing literature, research papers, and relevant resources in the field of systems engineering and medical devices.
Interviews and Surveys: Collect insights and best practices from industry experts, professionals, and academics in both systems engineering and medical device development.
Content Development: Create well-structured chapters and sections based on the outlined scope, ensuring clarity and coherence.
Graphics and Illustrations: Include diagrams, flowcharts, and illustrations to enhance understanding and provide practical examples.
Peer Review: Seek input and feedback from experts in the field to validate the content’s accuracy and relevance.
Use Git and/or GitHub as repository for the master’s project artifacts.
5.2 Systems Engineering Methods
5.2.1 System Engineering constraints and considerations
Table 5.1 provides an outline of the system engineering constraints and considerations of the system.
| Domain | Plan |
| Strategy | The generation of the system engineering artifacts will follow the systems engineering framework provided in Stevens Institute of Technology course SYS-625. |
| Documentation | The system engineering documentation will be generated as Quatro report that is rendered in HTML and PDF. |
| Units | The system of units used in this document will be the International System of Units (SI) unless otherwise indicated. |
| Diagrams | System modeling will be made using OMG Systems Modeling Language (OMG SysML).(“About the OMG System Modeling Language Specification Version 2.0 Beta. The Object Management Group” 2023) |
| Tables | All table templates are customized for purposes of this report. There is no work instruction or standard operating procedure that is define the table layouts to use. |
| Document Navigation | Hyperlinks are embedded in the document to facilitate navigation of information with identifications. |
5.2.2 Systems Engineering Model
Figure 5.1 shows the system engineering roadmap used for the Medical Device Knowledge Repository (MDSE-KR). This roadmap provides a structured approach to system engineering.
The roadmap outlines the following key steps in the system engineering process:
Functional/Operational Deficiency: Identify areas where the operation of interest may be lacking.
Stakeholder Expectations/User Needs: Gather requirements and expectations from stakeholders and users3.
System Concepts/System Context: Define the system’s context and generate concepts.
Operational View & System Objectives: Establish the operational perspective and objectives of the system.
System Requirements: Detail the requirements that the system must fulfill.
Functional View: Develope a view of the system’s functions.
Physical View: Create a view of the system’s physical components.
System Model: Build a model that represents the system.
Design Detail: Work out the detailed design of the system.