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Shore team conducting an internal user study to ensure patient safety is considered in the design process

Patient safety at every step of the design process

Published: June 2023

Bex Jones
Bex Jones
Design Consultant
Caroline Mackie
Caroline Mackie
Design Consultant
Caitlin McPhee
Caitlin McPhee
Graphic Design Consultant

Safety is an important factor when designing, but in the medical sector it is crucial, as an oversight or poor design feature could lead to serious consequences for the user or patient. There are multiple safety standards that a medical device must adhere to, and understanding what is required to ensure compliance with these standards is a key element of the design process.  

Bex, Caroline and Caitlin each contribute their expertise to prioritise patient safety at every step of the design process. Here, we explore how their roles ensure the highest levels of safety.

Human factors

Human factors plays a vital role by placing users at the forefront of device development. Through user journeys, online resources, human factor studies and iterative prototyping we can gain a clear understanding of how different users may interact with a device. This can be applied across a wide range of aspects such as device design, packaging, software and hardware. By accounting for the wide range of human strengths and weaknesses, we ensure safety and efficiency by reducing user error.

User studies

Bex:

As a design engineer, one of my roles during a project is conducting user studies. These can be done within the Shore team as a method of formative user testing, where early and often studies allow us to gain valuable insights throughout a project on how users interact with a device and identify potential usability issues or user-related errors.

Through user journey mapping, prototyping, and extensive user feedback, we create a clear understanding of the user’s needs, preferences, and limitations. This information guides our design decisions and allows us to develop devices that are intuitive, easy to use, and minimise the risk of errors.

By conducting multiple user studies internally, we have the advantage of quick iterations and immediate feedback. This enables us to verify the product against the product requirements, ensuring that it aligns with them, and therefore the user’s expectations and needs.

Shore team conducting an internal user study to ensure patient safety is considered in the design process

Bex conducting an internal user study

To then validate the final design, formal summative user testing is carried out to assess the usability, safety, and overall performance. This is conducted with the target user group who are given specific tasks to perform using the device, and their interactions, feedback, and overall experiences are carefully observed, recorded, and analysed. This ensures the device meets regulatory requirements and delivers a high level of safety and user satisfaction.

Risk analysis

Risk analysis is crucial in device development. By mapping all the risks associated with the device and the consequences they have on patients and healthcare professionals, they can then be graded into which are critical and low risk.

It is important to map out a full risk analysis of a device for specifications and test plans to be created to mitigate these risks from happening in normal use. By evaluating this throughout the project, especially at the initial stages, it allows for design and usability measures to be put in place to reduce the likelihood of these high risks occurring. Risks are mapped out for functionality and usability, for both if a risk is likely and relates to the user’s safety this is deemed critical.

Testing and analysis

Caroline:

In my role as a design engineer, I conduct rigorous tests and analysis to identify any potential risks in a medical device. By adhering to international safety standards and conducting thorough risk analysis, I ensure that the device meets the necessary specifications and mitigates potential hazards.

Testing plays a vital role in validating a device’s performance and ensuring its functionality under various conditions. Prioritising early testing enables us to address issues promptly, saving time and costs associated with changes later in the development. Ultimately, my role is to contribute to the creation of a safe and reliable medical device that users can trust.

There are many testing types and set ups throughout a project, depending on the mechanism and product requirements. This can range from tensile testing to compare against ergonomic data, to sterility and packaging testing.

In Shore’s testing suite we have a wide range of equipment that allow us to obtain accurate measurements that enable us to verify against engineering safety standards. Having this in-house means we can easily run testing even at the early stages of device development.

‘Day in the life’ video of Caroline, featuring testing and analysis

Usability

Usability is crucial for device safety. Even if a device functions accurately 100% of the time, if the user is not following the correct use steps then the intended performance will not occur. Shore’s expertise in the medical device sector ensures effective compliance with safety standards while prioritising a positive user experience.

It is vital to design devices that are easy to use, with clear instructions on proper usage, to maximise their intended functionality and minimise user errors.

Instructions for Use (IFU)

Caitlin:

As a graphic designer, I collaborate closely with Shore’s design and engineering teams to develop clear, informative, and visually engaging IFUs, labelling & packaging graphics.

IFUs are crucial in the medical industry for ensuring patient safety. They provide clear direction on how to use medical devices, medications, and treatments properly. IFUs outline important steps, cautions, warnings and risk mitigation, helping healthcare professionals and patients understand and follow the correct procedures in either a clinical or at-home setting. By having accurate and user-friendly IFUs with well-illustrated images, they can minimise user risks, aid comprehension, and reduce overall errors.

Through user studies, we gather feedback on the IFUs to ensure that they are comprehensible and user-friendly. It has also been shown frequently in user studies that participants often only focus on the illustrations when performing a set of steps. This conveys the importance of ensuring IFU illustrations are clear and accurate, so that intended healthcare outcomes are achieved.

Caitling creating and designing an IFU

Whether it’s a device, the IFUs, or the packaging, we understand the critical importance of ensuring the highest levels of safety in medical device design.

Through our rigorous testing and validation procedures, we ensure that your device not only meets but exceeds industry specifications. We pay careful attention to considerations such as sterility and packaging integrity, mitigating medical risks, and ensuring the highest quality products for healthcare professionals and patients.

If you’re currently involved in the development of a medical device and would like to discuss any specific aspects covered in this article, then please contact us.

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