scholarly journals A continuum of human factors considerations, from medical device development to hospital implementation

2020 ◽  
Vol 9 (1) ◽  
pp. 134-135
Author(s):  
Fiona F. Tran ◽  
Shanqing Yin
Keyword(s):  
Human Factors ◽  
Medical Device ◽  
Product Life Cycle ◽  
Improve Patient Safety ◽  
New Paradigm ◽  
Healthcare Organizations ◽  
Medical Device Development ◽  
Device Development ◽  
Adoption And Implementation ◽  
Effective Use

Today’s medical devices are the product of many human factors considerations. Beyond the device design, healthcare organizations increasingly incorporate usability as a factor in medical device procurement. Yet, organizations’ visibility into evidence of a product’s usability is often constrained to marketing materials or results of studies executed using in-house resources. In the process from medical device development to implementation in clinical environments, a communication gap remains between the human factors professionals in medical device development and those in healthcare organizations studying the same product for adoption and implementation. This gap limits organizations’ ability to accurately review product options. This gap also results in lost opportunities for healthcare organizations to inform manufacturers’ future medical device development. A new paradigm for communicating human factors work across the full continuum of the product life cycle is essential for both manufacturers and healthcare organizations seeking to improve patient safety and effective use.

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.

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.

Recent Statistical Contributions to Medical Device Development

2014 ◽  
Vol 48 (1) ◽  
pp. 90-97 ◽  
Author(s):  
Brian L. Wiens ◽  
Theodore C. Lystig ◽  
Scott M. Berry
Keyword(s):  
Medical Device ◽  
Medical Device Development ◽  
Device Development

scholarly journals The medical device development landscape in South Africa: Institutions, sectors and collaboration

2017 ◽  
Vol 113 (5/6) ◽  
Author(s):  
Kylie de Jager ◽  
Chipo Chimhundu ◽  
Trust Saidi ◽  
Tania S. Douglas ◽  
◽  
...  
Keyword(s):  
South Africa ◽  
Medical Device ◽  
Centrality Measures ◽  
Collaboration Network ◽  
Medical Device Development ◽  
Device Development ◽  
Healthcare Needs ◽  
Scientific Papers ◽  
Future Policy ◽  
Local Healthcare

A characterisation of the medical device development landscape in South Africa would be beneficial for future policy developments that encourage locally developed devices to address local healthcare needs. The landscape was explored through a bibliometric analysis (2000–2013) of relevant scientific papers using co-authorship as an indicator of collaboration. Collaborating institutions thus found were divided into four sectors: academia (A); healthcare (H); industry (I); and science and support (S). A collaboration network was drawn to show the links between the institutions and analysed using network analysis metrics. Centrality measures identified seven dominant local institutions from three sectors. Group densities were used to quantify the extent of collaboration: the A sector collaborated the most extensively both within and between sectors; local collaborations were more prevalent than international collaborations. Translational collaborations (AHI, HIS or AHIS) are considered to be pivotal in fostering medical device innovation that is both relevant and likely to be commercialised. Few such collaborations were found, suggesting room for increased collaboration of these types in South Africa.

Engineering Design Controls for Efficient Medical Device Development

2008 ◽  
Author(s):  
Lisa Henn
Keyword(s):  
Medical Device ◽  
Early Stage ◽  
Design Team ◽  
Medical Device Development ◽  
Device Development ◽  
Development Teams ◽  
Final Design ◽  
Design Proposal ◽  
Effective Design ◽  
University Setting

Early stage medical device development teams investigate many alternatives before selecting a final design proposal. The team must be able to retrace and reproduce successful designs and understand factors that underpin decisions that came before. This is especially important in a university setting due to the natural turnover on the team that is inherent in a successful research group. Effective design control provides this support to the design team.

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.

scholarly journals Spinal dura mater: biophysical characteristics relevant to medical device development

2018 ◽  
Vol 42 (2) ◽  
pp. 128-139 ◽  
Author(s):  
Sean J. Nagel ◽  
Chandan G. Reddy ◽  
Leonardo A. Frizon ◽  
Matthieu K. Chardon ◽  
Marshall Holland ◽  
...  
Keyword(s):  
Medical Device ◽  
Dura Mater ◽  
Medical Device Development ◽  
Device Development
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