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Designing Medical Devices with Human-Centred Thinking: what is it?


In human-centred design (HCD), products and services are designed to meet the needs, desires, and limitations of end users. In order to improve patient outcomes, safety, and satisfaction, this approach is increasingly applied to and arguably integral to medical device design.


Human-centred medical devices are designed with the patient in mind. This means that they are designed to be safe, effective, and easy to use. It is also important that they are designed to meet the needs and preferences of the patient. Clear instructions, ergonomic design, and intuitive controls can all contribute to this.


One key aspect of HCD is the involvement of end-users in the design process. This means that patients, caregivers, and healthcare professionals are consulted throughout the design process to ensure that the device meets their needs and preferences. It is imperative that this process starts early on in the development of your medical invention. The reason for this is to avoid mistakes and ensure you receive as much feedback as possible to improve your design before investing more time and money.


This can involve user testing, feedback sessions, and focus groups to gather insights into how the device will be used and what features are most important. At Fearsome Medical Device Design Agency, very often our design team implements user testing at an early stage, involving stakeholders and customers. It’s important to share the findings with your client to make sure everyone is involved and open conversations can happen.


Recently Fearsome conducted some formative user testing towards the development of a new ophthalmology imaging device, which provided valuable insights into the user interactions and informed future iterations of the design. By involving end-users, such as ophthalmologists and technicians in the testing process, fearsome were able to give the manufacturer first hand feedback on device usability, functionality, and overall user experience. This feedback helps identify areas for improvement and refine the device's design, features, and workflow to better meet user needs and preferences.

Additionally, user testing helps the device manufacturer strategize their development efforts more effectively. By observing how users interact with the device, you can identify pain points, bottlenecks, and areas of confusion that can hinder optimal performance or hinder clinical workflow efficiency. This information is used to guide the manufacturers in prioritising enhancements, allocating budgets and implementing design changes that address user concerns and improve overall device performance.


HCD can also be helpful in addressing issues regarding usability and accessibility. It is possible for medical devices that are difficult to use to cause errors or incorrect usage, which can have an impact on the safety of patients. Designing devices with usability in mind can reduce the risk of errors and make them easier to use for patients. It is possible for safety issues to cause harm to users and to result in product recalls. In the event of a medical device recall due to safety concerns, manufacturers may face significant financial implications, including costs associated with investigations, product replacement, and potential legal liabilities. The involvement of regulators adds another layer of complexity, resulting in increased scrutiny, potential fines, and reputational damage, which may negatively impact the commercial viability of the company and its products.

More than half of all medical device recalls in the US are linked to failures in the design or manufacturing process that govern the manufacture of the device, rather than a fundamental flaw in the idea or an engineering blueprint. The FDA acknowledged this as early as 2011.


The FDA report ‘Understanding Barriers to Medical Device Quality’ identified that many developers were facing:

“Significant difficulties in designing medical products for actual, and not merely intended, use. Firms struggled with designing and validating devices for the diversity of applications and environments in the field.”



Medical device development can be positively impacted by HCD in several ways. How do you start designing medical devices with the user in mind, and what are the main objectives? We work closely with clients and health practitioners to implement the HCD approach to our end-to-end service, incorporating this process across all team members and adhering to tight project timelines. What you need to know and how to get started:


User Research

HCD involves conducting extensive user research to understand the context in which the medical device will be used. This includes studying the workflow, environment, and user requirements. By gathering insights from healthcare professionals, patients, and other stakeholders, designers can gain a comprehensive understanding of user needs and incorporate them into the device design.


Empathy and User Engagement

HCD emphasises empathy towards end users and encourages their active participation throughout the design process. Engaging with healthcare professionals, patients, and caregivers allows designers to understand their experiences, challenges, and aspirations. By involving users as co-creators, designers can ensure that the device meets their specific needs and addresses their concerns.


Iterative Design Process

HCD advocates for an iterative design process, where prototypes are developed and tested in collaboration with users. This approach allows designers to gather feedback early on and make necessary improvements at each stage of development. By involving end users in usability testing and incorporating their input, the final product is more likely to be intuitive, safe, and effective.


Usability and User Interface Design

HCD places a strong emphasis on designing intuitive and user-friendly interfaces. Medical devices can be complex, and HCD aims to simplify interactions and reduce the potential for errors. By considering the cognitive abilities, physical limitations, and user preferences, designers can create interfaces that are easy to learn, efficient to use, and minimise the risk of user-related incidents.



Safety and Risk Mitigation

Human-centred design pays attention to safety considerations and risk mitigation. By involving end users in the design process, potential safety hazards and usability issues can be identified and addressed early on. This can help prevent adverse events and improve overall patient safety.


Feedback and Continuous Improvement

HCD promotes continuous improvement by gathering user feedback after the medical device is deployed. This feedback can be used to identify areas for enhancement, identify unmet needs, and guide future iterations or updates of the device. By embracing a feedback loop, manufacturers can refine their products based on real-world usage and improve patient outcomes.

By incorporating a user-centred design approach, designers can mitigate these risks, create more successful medical devices, and positively impact patient care.



Ultimately, by ensuring that devices are created with the patient in mind, human-centred medical devices have the potential to enhance patient outcomes and experience. HCD can assist in producing devices that are safe, efficient, and simple to use, as well as those that satisfy the requirements and preferences of patients and healthcare professionals.


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