Guest Column| May 2, 2022

Framework Methodologies For Medical Device Usability Engineering

BlackhägenDesign的研究与合成创始人兼总监SeanHägen

腹腔镜手术GetTyimages-1302119512

如何感知医学产品可以实现可用性,并在人为因素/可用性工程(UE)和工业设计方面具有科学前提。每个学科都共享一个理论,即协调一致,可以成为优化可用性的方法,这是易于使用和使用安全性。医疗设备设计,UE和审美开发过程之间的关系的重要性和挑战极大地影响了可用性和喜悦。有两种相互补充以创建适用方法的理论:负担产品语义.

UE Research已记录了用户选择和用户界面行为的性质,因为它们受到美学的影响,特别是初始内脏印象和使用的直觉。因此,这不仅仅是营销目标。考虑到设备的明显可用性可能与实际可用性一样重要。用户对设备的初始印象及其对其将如何运作和满足其需求的期望通常对使用的医疗保健环境至关重要。用户的初始印象不仅可以被描述和计划,而且实际上是故意在用户体验中设计的,从而实现了所需的负担。也就是说,用户对基于其属性的潜在互动和与对象的结果的看法称为其负担。

解决负担理论意味着了解用户对拟议的设计互动的可能和期望。设备设计师应鼓励有利于用户的能力,并阻止可能意外的互动,从而可能导致使用错误。这也可能意味着限制设备设计中的某些负担。以这种能力是产品语义的子集,这是一种实现所需负担的设计方法。产品语义的工业设计理论为设计过程提供了信息,并通过设备的美学,形式,纹理,颜色和隐喻来实现不言而喻的用户界面。设计的审美构成或语义并不能从字面上解释它的作用;相反,它影响用户如何解释它。当两种理论集成时,产品语义可以成为一种框架方法,可以主动实现设备设计中所需的负担。

For example, in the case of designing a laparoscopic instrument, the user interface features and grip need to be considered for both aesthetics and functionality in order to intuitively meet the user’s expectations. Instrument A (Figure 1) has three grip opportunities that afford the user flexibility in both learning and practice. Form, texture, and color provide visceral cues as to where and how to grip the instrument. With instrument B (Figure 1) form, color, and texture were also used to indicate grip and interaction; however, two issues influence the intended use of the device. First is how the semantics afford proper grip and are impacted by negative transfer bias due to being unfamiliar when applied to a laparoscopic instrument (as opposed to a kitchen tool or gaming control). Second, there is a rotatory control knob that was not easily identifiable during usability testing due to its colocation with the cable strain relief, despite texture indicating it is a user interface. Instrument C utilizes the metaphor of scissors to afford proper interaction and a mental model affording what the distal end of the instrument is doing.

Figure 1: Form and functi在腹腔镜仪器设计中

在设计中使用隐喻的另一个示例可以在开发新的自动注射器的开发中证明,其中现有的外形是墨水笔。在这种情况下,由于新的微流体技术,该设计比谓词更紧凑,而笔隐喻则不起作用。另外,注射的行为不再是刺伤运动。在设计自动注射器语义的设计中使用了常见桌面订书机的形式和激活,以提供具有熟悉用法模型的新用户(见图2)。

图2:使用隐喻设计语义

As the design evolved, both technologically and from user evaluations, the design semantics also evolved to enable intuitive interaction with the device and its packaging features (see Figure 3).

图3:产品语义的开发和实施

显然,结合多个语义属性在协同方面效果很好,补充和加强了预期的负担。开发设计语义的方法对于设计师来说通常很明显,尤其是在现有设计的迭代中。但是,对于医疗设备,尤其是新颖的设备,需求通常更为复杂。一致性要求的过程和影响他们的利益相关者是一种有用的方法。应用感知到的属性方法论,功能和美学属性定义了用户对价值的感知。用户对设备的评估可以基于其功能和外观结果的感知价值 - 它们相互联系并相互影响。该方法可以将产品语义和提供的两种理论连接到一种凝聚力的方法中,以通过在开发学科中提供共同的白话来实现有意义且适当的美学。

可用性工程专家为定义用户需求和翻译用户界面(UI)要求所面临的典型挑战是试图理解和表征直觉的使用,或者更糟糕的是“易用性”。具有函数,美学和最终价值的共同定义可以帮助用已记录的基线来表征这种模棱两可的要求。一旦建立了这些属性,它们就会成为阐明设计语义的一种手段,从而使所需的负担能力。

Returning to the example of developing a laparoscopic instrument, a matrix mapping function, aesthetic, and value (see Figure 4) can provide a means to establish priorities in the development of design semantics (see Figure 5). This approach can align a cross-functional team in the development of semantic design schemes and the interpretation of requirements.

图4:感知属性(从功能和外观与价值的关系改编,Privitera&Johnson 2009)

Figure 5: Prioritized perceived attributes for laparoscopic instrument

This approach for communicating attributes and the infographic (Figure 4) is an example of a process tool; it is not a prescription. It can represent user rating of importance and/or ranking of priority. The purpose of such an exercise is to provide objectives for the design semantic approach.

It should be noted that the development of the UI requirements may often occur after the industrial design, if the initial ID is conducted pre-design controls.

Use-safety impacts the design from the perspective of regulatory objectives Ease of use impacts design from the perspective of marketing business objectives and often is led by usability engineering and industrial design. However, the engineering stakeholders for regulatory objectives are not necessarily the same as those focused on technology or usability. Use-safety is the responsibility of UE, which may be initiated as part of system engineering or implemented as part of quality engineering. Proactively addressing these discrete objectives by developing design features that are perceived in a manner that is intended to initiate intended behavior as a significant impact on implementing the more challenging requirements like ease of use.

通常,这些各种议程的实施通过工业设计转化为用户界面。UI设计负责影响用户的行为和使用设备制造商和用户的意图。这些学科和目标的连接通常在要求中记录。这是产品语义方法的部署,通过诸如感知属性之类的协作工具实现预期的负担可以使所有设计师对要求的解释保持一致。

考虑使用UI设计的UE过程和验证。形成性研究通常会确定具有可用性问题的任务,告知与使用相关的风险,其中许多特征是不直观的,要求设计更具弹性和用户友好。这些评估是故意设计的,因此用户不知道该设备的目的是如何操作,以便暴露可用性问题,并且默认情况下显示了直觉。当UE报告形成性用户评估时,有语言用来描述缺陷。这些可以进一步为感知属性的发展提供信息,这些属性又为产品语义提供了信息。

结论

When a device and user interface are being developed, the decisions and anticipation of intended interactions are influenced by aesthetics and are most crucial in the design process. Usability engineering can define what affordances the design will provide the user to meet the desired expectations, and industrial designers can utilize a product semantics method to embody those affordances. Consider product semantics as a means to develop design language for optimizing usability, aesthetic, shape, form, color, and metaphor, which speaks to the end user and influences their interpretation. The syntax is the affordances and the vocabulary is its perceived attributes informed from the UE process.

About The Author:

SeanHägen是创始校长兼研究与综合总监BlackHägen Design. He has led design research and usability design, within both institutional and home environments, across 20 countries. His role focuses on the user research and synthesis phases of product development, including usability engineering, user-centric innovation techniques, and establishing user requirements. Hägen has a bachelor's degree in industrial design with a minor in human factors engineering from the Ohio State University. He is a member of IDSA (the Industrial Designs Society of America) and HFES (Human Factors and Ergonomics Society), having served two terms on the former’s Board of Directors.