Impact of Design on Medical Device Safety

Miclăuş, Teodora; Valla, Vasiliki; Koukoura, Angeliki; Nielsen, Anne Ahlmann; Dahlerup, Benedicte; Tsianos, Georgios-Ioannis

doi:10.1007/s43441-019-00022-4

Cited by 34 publications

(22 citation statements)

References 98 publications

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“…It is of utmost importance that the safety of the materials be assured in relation to the costs [ 346 , 347 , 348 ]. In the case of osseointegration implants, if the level of safety of the materials is similar to that of titanium as the base material, then the cost of production will be a comparison point.…”

Section: Current Challenges In Using Tio 2 Anodic Layermentioning

confidence: 99%

Evolution of anodised titanium for implant applications

Alipal

Lee

Koshy

et al. 2021

Heliyon

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Anodised titanium has a long history as a coating structure for implants due to its bioactive and ossified surface, which promotes rapid bone integration. In response to the growing literature on anodised titanium, this article is the first to revisit the evolution of anodised titanium as an implant coating. The review reports the process and mechanisms for the engineering of distinctive anodised titanium structures, the significant factors influencing the mechanisms of its formation, bioactivity, as well as recent pre-and post-surface treatments proposed to improve the performance of anodised titanium. The review then broadens the discussion to include future functional trends of anodised titanium, ranging from the provision of higher surface energy interactions in the design of biocomposite coatings (template stencil interface for mechanical interlock) to techniques for measuring the boneto-implant contact (BIC), each with their own challenges. Overall, this paper provides up-to-date information on the impacts of the structure and function of anodised titanium as an implant coating in vitro and in/ex vivo tests, as well as the four key future challenges that are important for its clinical translations, namely (i) techniques to enhance the mechanical stability and (ii) testing techniques to measure the mechanical stability of anodised titanium, (iii) real-time/in-situ detection methods for surface reactions, and (iv) cost-effectiveness for anodised titanium and its safety as a bone implant coating.

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Section: Current Challenges In Using Tio 2 Anodic Layermentioning

confidence: 99%

Evolution of anodised titanium for implant applications

Alipal

Lee

Koshy

et al. 2021

Heliyon

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“…The design process has been described as a problem-solving activity [18]. This is typical of the first generation of design methods.…”

Section: Design Processmentioning

confidence: 99%

“…It has been proven that multiple medical errors within hospitals could be solved with prevention activities that reduce risks for people and the unnecessary expenditure of resources. Preventive medicine should prioritize health policies and the proper design of devices, as set by quality standards in the medical field [18].…”

Section: Project Descriptionmentioning

confidence: 99%

Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

2021

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The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.

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“…The design process was initially described as a problem-solving activity [18]. This instance is typical of the first generation of the design methods movement.…”

Section: Design Processmentioning

confidence: 99%

Design Process for a Birthing Bed, Based in User Hierarchy: Promoting Improvement in User Satisfaction

Cortés-Chávez¹,

Rossa-Sierra²,

Muñoz³

2021

Preprint

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This article presents a comparative analysis of birthing beds, using two different design processes to realize if one improves user satisfaction by improving the design process. We present a comparative study between the traditional product design process (consumer product design) and the new design process based on hierarchies (proposed in this study), which improves the final design and increases user acceptance. The study focuses on pointing out the importance of a new design process for medical devices, which can improve the characteristics of the product design and thereby increase user satisfaction. The main contribution of this new process focuses on showing medical device designers the importance of considering the hierarchy of users around a medical product, considering the fluctuation of the patient's health status since depending on the progression of the disease, the patient needs the attention of various users. In turn, final users need to solve specific problems in each phase, and design needs to be prepared for each user's particular needs around the birthing bed and the patient.

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Impact of Design on Medical Device Safety

Cited by 34 publications

References 98 publications

Evolution of anodised titanium for implant applications

Evolution of anodised titanium for implant applications

Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

Design Process for a Birthing Bed, Based in User Hierarchy: Promoting Improvement in User Satisfaction

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