scholarly journals Tailor-Made Design Guidelines for Human Factors and Usability for Medical Device Application: A Proposed Methodology

2019 ◽  
Vol 1 (1) ◽  
pp. 995-1004 ◽  
Author(s):  
Kamya Nagarajan ◽  
Arlindo Silva
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Design Guidelines ◽  
Device Application ◽  
Medical Device Development ◽  
Device Development ◽  
Tools And Techniques

AbstractWith increasing level of advancement and complexity in medical devices, there is a need for methodology, tools and techniques in practice to integrate Human Factors and Usability (HF/U) elements in design due to its increasing diversity of users and rapidly changing interface types. This paper proposes a methodology to develop a tailor-made HF/U design guidelines for medical device development with various sources and to develop heuristics for evaluation and score the product usability throughout the development process.

Using Value Stream Mapping to Improve Medical Device Development

2013 ◽  
Vol 7 (2) ◽  
Author(s):  
Christopher Sweem ◽  
Stan Crossett ◽  
Lori Lucke
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Value Stream Mapping ◽  
Medical Device Development ◽  
Value Stream ◽  
Device Development

In this paper a method is presented for using value stream mapping for improving the development process of medical devices. Two examples are shown to demonstrate the utility of this approach.

Making Human Factors Affordable for Medical Device and Global Health Startups

2018 ◽  
Vol 7 (1) ◽  
pp. 140-147
Author(s):  
Elizabeth Johansen
Keyword(s):  
Global Health ◽  
Human Factors ◽  
Case Studies ◽  
Medical Device ◽  
Medical Devices ◽  
International Electrotechnical Commission ◽  
Medical Device Development ◽  
Device Development ◽  
Multiple Levels ◽  
The U.S

Including human factors during medical device development leads to better outcomes as recognized by the U.S. Food and Drug Administration (FDA) and the International Electrotechnical Commission (IEC). Startup companies have historically been a major source of medical device innovation. However, many startups are unaware of the field of human factors or do not know the value it can bring in creating safe and effective medical devices that are well-adopted in the market. In this paper, there are four ideas for including human factors during medical device development at startups: demonstrating the value of human factors to startups; collaborating on early funding proposals; delivering value on multiple levels simultaneously; and using resources creatively and judicially. These ideas are illustrated in 3 case studies.

scholarly journals Harnessing Experience for Efficient Medical Device Product Development

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
L. Lucke ◽  
D. Anderson ◽  
D. Smith
Keyword(s):  
Product Development ◽  
Medical Device ◽  
Clinical Application ◽  
Medical Devices ◽  
New Technology ◽  
Project Planning ◽  
Time To Market ◽  
Medical Device Development ◽  
Device Development ◽  
Development Times

Transitioning new research ideas into commercial products is difficult. For medical device design, the task is especially complicated because the commercialization of research ideas requires interdisciplinary teams that understand the nature of the clinical application as well as the abilities of the technology. Device development is complicated by the need to work within a regulated environment which requires well defined processes and significant testing to demonstrate the safety and efficacy of the device. An experienced development team, well versed in the design and manufacturing of medical devices, can greatly enhance the success of a commercialization program. A study of actual programs shows how experience can reduce development times. There are several factors that affect the success of new medical device development including the use of effective development tools and the innovativeness of the product concept. Successful product development may use a number of tools to assist with planning and control of the project. However it is difficult to measure the effect of experience on the success of new product development. In this work, several medical device development programs were studied to determine the role experience plays in improving the time to market for medical devices. Time to market is measured along several dimensions including complexity, technological invention, and uniqueness of clinical application. All designs were completed by the same company. As time progressed, the time to market improved even for complex designs with new technology. Over a ten year period of time, ten significant medical device development projects were executed. All required development of complex electromechanical systems with moderate to high complexity, and more than half developed products for new clinical applications or utilized new technology. After the development group had acquired at least five years of development experience, it was clear that the development times were improving by almost 50% over the predicted development times. Among the factors that contribute to this effect are the development of experts, the creation of design frameworks, and the optimization of processes which improve product development times while reducing project and regulatory risk. Experts with specific experience in systems engineering, program management, electromagnetic compatibility, manufacturability, and usability along with expertise in electronics, mechanical and software design can significantly reduce design times. Technology platforms central to medical devices such as blood and fluid pumps, sensor interfaces, real-time control systems, batteries and power systems are necessary for rapid development. Processes including project planning and tracking, requirements management, configuration management, risk analysis, and manufacturing design transfer are essential for streamlining development as well as ensuring support for regulatory submissions and audits. It has been challenging to demonstrate this effect, which has been anecdotally known for some time, in a quantitative manner. Doing so required studying an organization with not only significant experience over time, but breadth of experience in terms of program risk and complexity. The results of this study quantify the significant benefit of organizational experience in reducing time to market.

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

2011 ◽  
Author(s):  
Lourdes A. Medina ◽  
Richard A. Wysk ◽  
Gu¨l E. Okudan Kremer
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Development Process ◽  
Regulatory Compliance ◽  
Design For Manufacturing ◽  
Design For X ◽  
Device Development ◽  
Unites States ◽  
Fda Regulations

This paper focuses on the importance of the regulations, in particular the Food and Drug Administration (FDA), in the development of medical devices. The FDA regulates medical devices to assure that these products are safe and effective before their release into the Unites States market. We introduce the concept of Design for FDA (DfFDA) and describe DfFDA guidelines for medical device development. While many researchers describe the regulations in the form of reviews and models, the literature to date has not reported a DfFDA method. Here, DfFDA is proposed as a method to be used in parallel with other DfX methods when applicable. The DfX methods identified include: Design for Validation (DfV), Design for Reliability (DfR), Design for Quality (DfQ), Design for Manufacturing (DfM), Design for Assembly (DfA) and Design for Usability (DfU). This paper also reviews the literature addressing the FDA regulations and DfX methods, and an overview of the FDA regulations is presented. DfFDA is developed to increase awareness about regulatory compliance and promote designers to consider the regulations throughout the development process of medical devices.

11.1.3 Medical Device Development Process

2008 ◽  
Vol 18 (1) ◽  
pp. 1215-1230 ◽  
Author(s):  
David J. Jones ◽  
Melissa T. Masters
Keyword(s):  
Medical Device ◽  
Development Process ◽  
Medical Device Development ◽  
Device Development

scholarly journals Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review

2020 ◽  
Vol 8 ◽  
Author(s):  
Petra Marešová ◽  
Blanka Klímová ◽  
Jan Honegr ◽  
Kamil Kuča ◽  
Wan Nur Hidayah Ibrahim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Medical Device ◽  
Development Process ◽  
Medical Device Development ◽  
Device Development

RISK-BASED TESTING APPROACH FOR MEDICAL DEVICES SOFTWARE

2020 ◽  
Vol 70 (4) ◽  
Author(s):  
Ivan Ivanov ◽  
V. Gueorguiev ◽  
D. Georgieva ◽  
M. Nenova ◽  
B. Ivanov
Keyword(s):  
Quality Control ◽  
Quality Assessment ◽  
Medical Device ◽  
Medical Devices ◽  
Development Process ◽  
Functional Requirements ◽  
Device Development ◽  
Stage Of Development ◽  
Requirements Specifications ◽  
Testing Approach

A successful "medical device" development requires the collaboration be-tween designers, developers, and quality engineers to be able to assess needs, functional requirements, specifications, and problems at every stage of development. The quality control of the developing process is achieved through a predefined set of policies, quality assessment, and the management of activities to eliminate defects and weaknesses wherever the development process.

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