Sarah Knight, Head of Healthcare Technology at 42 Technology, and Michaela Hume, Engineering Consultant at 42T examine the critical role of user feedback in shaping surgical devices.
In the high-stakes environment of the operating room, surgical devices need to do more than meet regulatory standards – they must empower clinicians to work safely, efficiently, and confidently. The most successful medical devices are those developed in partnership with healthcare professionals, not just for them. By embedding user feedback into every stage of development, manufacturers can ensure their products are intuitive, effective, and widely adopted.
Testing designs with end users is essential in uncovering valuable insights that can inform and enhance the development process. And it’s not just about safety, taking a user-centric approach to design leads to better device performance, improved patient outcomes, and greater adoption by healthcare professionals.
This article explores the essential role user insights can play in medical device development, the power of hands-on prototype testing, and the numerous ways these interactions can lead to more effective devices.
The importance of hands-on user testing
Early-stage device prototypes may perform flawlessly in lab settings, whereas real-world conditions reveal subtleties the design team could easily miss. Engaging surgeons, nurses, and technicians in prototype testing enables direct observation of real-use dynamics: not just safety risks, but also workflow friction, ease of adoption, and decision-making under pressure.
When users interact with prototypes, their feedback and behaviour provide immediate and often surprising insights. This practical feedback allows teams to address usability and adoption issues long before regulatory testing or product launch, saving time, costs, and reputation down the line.
Uncovering diverse techniques across surgeons
One of the most critical insights that can emerge from direct user testing is the wide variety of techniques employed by surgeons. Even within the same specialty, surgeons use different techniques based on how they were trained, their personal preferences, and their physical capabilities and proportions.
For instance, two clinicians performing the same procedure may hold or manoeuvre an instrument in entirely different ways. One surgeon may prefer a specific grip that offers them control, while another individual with smaller hands may find the same grip limits their dexterity. Commonly, female surgeons can struggle with certain devices, as they tend to be shorter and have smaller hands than their male colleagues.
Device requirements can vary between procedures too. Depending on the patient anatomy, users might need more precise control to avoid damaging important vessels, or they might need to apply higher forces to move or dissect certain tissues. Experienced users can share a wide range of their experiences, beyond the ‘textbook’ cases.
A device designed with a single technique in mind might alienate surgeons who use alternative methods or limit its use only to certain procedures. But involving surgeons in prototype testing allows designers to see these differences firsthand, leading to the development of more versatile tools to accommodate a range of approaches and users.
Accounting for different user profiles
In surgical environments, not all users have the same background or level of expertise, nor do they use the same technologies. This becomes particularly important when designing a device that could be used across different specialisms.
For example, surgeons trained in robotic-assisted surgery may have different experiences with certain tools than those who specialise in manual laparoscopy. Both groups have unique strengths and challenges, and it’s essential to understand how their skillsets influence their interaction with a device. When designing for these varied user groups, insights gathered from prototype testing can help tailor the device to suit the needs of both highly skilled robotics users, those newer to robotics systems, and those who specialise solely in manual techniques.
By involving users from different training backgrounds in the testing process, designers can create devices that cater to a diverse range of users, enhancing versatility and market appeal.
Designing for diverse clinical contexts
The context in which a device is used can vary dramatically too: from state-of-the-art hospitals in global healthcare centres to clinics operating under tighter resource constraints. Even within the same country or city, facilities and workflows can vary across sites.
For example, interviews with reprocessing technicians may identify practical issues with sterilisation or reuse due to aging equipment or specific processes at their site. Nurses or operating room technicians might provide feedback on how the device fits into the procedure preparation process alongside other surgical tools or equipment in the operating room.
Testing prototypes with users from a range of clinical settings can help designers better understand these differences, account for constraints and preferences, and adapt their devices accordingly. The outcome is a device that’s flexible, adaptable, and better suited for global adoption.
The power of user-centred design
As product design consultants, our approach for gathering user insights is based on user-centred design, a methodology that prioritises the needs and experiences of the end user throughout the development process. By using structured interviews, workshops, and observational studies, our team engages directly with the healthcare professionals who will ultimately be using the medical device.
These activities typically include areas such as :
- Observing existing practice to understand not just the procedure steps where the device is used but the context of use in the operating room.
- Interviews and co-design workshopswith a variety of surgeons from different training levels and specialties, as well as users in other roles.
- Prototype testing and iteration – from basic nonfunctional models to gather feedback and reveal issues early, to high-fidelity samples tested in simulated environments to evaluate detailed design features.
Some of these activities also form part of formative usability studies. As well as being a key component of human factors engineering and risk management processes, the feedback from these sessions is invaluable in identifying areas for improvement, such as ergonomics, intuitiveness, performance versus competitor devices, and compatibility with existing tools, environment, or procedures.
Creating market-dominating solutions
In our experience in developing new surgical devices, we have learned that it isn’t enough just to check boxes for regulatory approval. But there’s a need to dig deep to ensure designs are fully aligned with the everyday challenges that healthcare professionals face.
Incorporating user insights throughout the development programme guarantees that devices aren’t just compliant but also practical, intuitive, inclusive, and built for real-world conditions. All of which helps ensure better device performance, enhanced patient outcomes, and faster, wider adoption by the medical community.
