scholarly journals Is User Experience a suitable goal in the development of medical devices?

2021 ◽  
Vol 7 (2) ◽  
pp. 807-810
Author(s):  
Matthias Reisemann ◽  
Angelina Krupp

Abstract Product development in medical technology is largely governed by Regulatory Affairs. In contrast, for consumer products Human-Centred Design (HCD) is the guiding principle. Both approaches are laid down in international standards and overlap many aspects such as procedure, applied methodologies and development activities. For medical devices patient safety and therefore risk management is the guiding development goal. In HCD the focus lies on User Experience (UX), a positive experience throughout the entire product life cycle. The question arises whether UX could play a more important role in medical device development, particularly considering the similarities of the two development processes

Author(s):  
Delma P. Thomas ◽  
Dianne E. Godar

Ultraviolet radiation (UVR) from all three waveband regions of the UV spectrum, UVA (320-400 nm), UVB (290-320 nm), and UVC (200-290 nm), can be emitted by some medical devices and consumer products. Sunlamps can expose the blood to a considerable amount of UVR, particularly UVA and/or UVB. The percent transmission of each waveband through the epidermis to the dermis, which contains blood, increases in the order of increasing wavelength: UVC (10%) < UVB (20%) < UVA (30%). To investigate the effects of UVR on white blood cells, we chose transmission electron microscopy to examine the ultrastructure changes in L5178Y-R murine lymphoma cells.


i-com ◽  
2016 ◽  
Vol 15 (1) ◽  
Author(s):  
Holger Fischer ◽  
Michaela Kauer-Franz ◽  
Dominique Winter ◽  
Stefan Latt

AbstractThe establishment of human-centered design within software development processes is still a challenge. Numerous methods exist that aim to increase the usability and user experience of an interactive system. Nevertheless, the selection of appropriate methods remains to be challenging, as there are multiple different factors that have a significant impact on the appropriateness of the methods in their context of use. The present article investigates current strategies of method selection based on a conference workshop with practitioners. The results show that usability and user experience professionals concentrate on five to seven well-known methods and will need more support to select and use further ones.


2021 ◽  
Vol 56 (3) ◽  
pp. 262-273
Author(s):  
Mohd Qadafie Ibrahim ◽  
Fairuz Izzuddin Romli ◽  
Hassan Alli ◽  
Eris Elianddy Supeni ◽  
Hambali Arep

One of the primary issues with many product design and development processes today is having a good balance between the elements of form and function. While all products must be able to perform their intended functions, considerations of aesthetic features are also necessary for them to be accepted as a good quality design. However, most available design and development processes of consumer products have been more focused on achieving the functional aspects and have tended to treat the aesthetic aspects as less crucial features. This approach has led to many failed functional products in the market, as their physical design lacks appealing factors to targeted users. To improve the situation, a new product design and development framework is proposed in this study to better facilitate designers or engineers in creating an all-rounded quality product design. This new method is developed based on the findings from a survey conducted among engineering students, who are future product design engineers, in order to identify and also resolve issues with the current methods that they typically apply for their design tasks. All in all, the new proposed method is fundamentally tailored to offer a structured guide for developing beautiful and useful products based on a semantic design approach.


1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.


Author(s):  
Wei-Tek Tsai ◽  
Ray Paul ◽  
Lian Yu ◽  
Xiao Wei

Systems change often, and each change requires reverification and revalidation. Modern software development processes such as agile process even welcome and accommodate frequent software changes. Traditionally, software reverification and revalidation are handled by regression testing. This chapter presents a pattern-oriented scenario-based approach to rapidly reverify and revalidate frequently changed software. Key features of this approach are (1) classifying system scenarios into reusable patterns; (2) application of a formal completeness analysis to identify missing scenarios; (3) identifying scenario patterns (SPs) and corresponding verification patterns (VPs) and robustness patterns (RBPs); (4) rapid test script generation by reusing test script templates. This approach is also compatible with formal approaches such as model checking. This approach has been used at industrial sites to test safety-critical medical devices with significant savings in cost and effort. The chapter presents several examples to illustrate the effectiveness and efficiency of this approach.


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