Surgical instrument design: understanding surgeons’ needs, hopes and fears

Understanding surgeons’ requirements –
a collaborative approach

A surgeon’s top priority is the health and wellbeing of the patients under their care. Every decision they make has a direct consequence on their patient’s life – as they hold ultimate responsibility for their wellbeing. Every second their patient is on the operating table counts. They want to do the best job they can in a timely manner to minimise patient risk, expedite a speedy recovery and ultimately give their patients a life that is as long and fulfilled as possible.

Unfortunately, sometimes things don’t go to plan. However, surgeons continue to strive for excellence, collaborating with their colleagues to explore new methods and innovative surgical designs to improve clinical outcomes and reduce the burden on our healthcare systems.

This is where the need for effective and collaborative design, human factors and engineering comes in. User-centric surgical instrument design requires more than just an effective team. However, what is essential is the close collaboration and input from surgeons themselves.

Learn about the OrganOx Metra liver perfusion system here.

The importance of human factor user studies - failing before we succeed

As a product designer, praise and (sometimes) harsh criticism is something that I have to accept in equal measure. It is an inherent part of my job. Had I been a young designer when, in a formative user study a few years ago, a surgeon scoffed and threw my valued prototype across the operating table in apparent disgust, I might have crumbled and thought about a new career. Fortunately, it was not a live procedure. That experience emphasised to me and my observing colleagues the importance of what a surgical device has to do. It has to work. More importantly, it has to work reliably, effectively, consistently, predictably and safely.

A surgical device failure is not acceptable and could have fatal consequences. The device manufacturer will not be given a second chance, certainly not by the same surgeon or peers within their expansive network. That is why the surgical devices we develop follow an established design and development process, adhering to strict regulatory guidelines and directives. Extensive device development and iteration is required, using multiple user touch points to inform the design development throughout this journey. Once the design is fixed, many more months, sometimes years, of verification and validation testing is still required before a device is even considered for approval by the regulatory authorities.

One of the most important aspects of surgical device development is to take on board the requirements, hopes, desires and fears from all the relevant stakeholders. This includes your commercial, clinical, manufacturing and logistical teams, as well as those of each intended user group. Only then can we develop a design that not only meets the requirements from a regulatory and technical point of view (you could say delivered ‘as standard’), but offers so much more in terms of usability, suitability, longevity and commercial success.

Form, function and familiarity of surgical devices

What a new surgical device should look like is not the first question to be asking surgeons. However, when it is asked, you might get one of two responses: “I don’t really care as long as it works”, or “it needs to look like it will do the job.” I heard the former response recently when we were reviewing some initial design concepts with an ophthalmic surgeon and his team. But before I put down my pen and sketch pad, he went on to say “…but it should look like an ophthalmic device.” This may seem like a vague, non-committal response, but it is exactly how it needed to look.

The necessity for a surgical device to function reliably is without question. However, aesthetic design should not be disregarded. On the contrary, as our ophthalmic surgeon was telling us, surgical devices and other instruments should ‘look’ like they belong to their respective family of devices. Devices for surgical use should portray quality, reliability and a level of familiarity.

In addition to aesthetic design, familiarity also requires good ergonomic design. In every laparoscopic procedure I have observed, there is one common theme: the surgeon’s point of focus is not on the devices in their hands but 100% on the image on the heads-up monitor in front of them. Often, they won’t even see the device they are handling during the procedure. It will be placed in their open hand by an assistant, for them to use sometimes only for a second. It will then be taken from them, with their eyes still fixed on the monitor ahead.

With a good, ergonomically designed surgical device, the surgeon will know how to handle it intuitively. Whatever function the device has to do – whether it’s at the very centre of the surgeon’s focus and being manipulated in the surgeon’s hand, being used by an assistant or on a trolley behind them delivering power to an instrument (it might even be the trolley itself) – in the surgeon’s mind, every piece of equipment being used in the procedure has to perform as intended.

Getting to know a surgical device’s use environment

Under no circumstances should surgical devices add burden to what the surgeon is doing. If a device has to be held in an unfamiliar or unintuitive orientation, this could result in misuse, surgeon fatigue or the surgeon switching to an alternative device. Knowing as much as possible about the use environment, the procedure and the requirements of the surgeon and support staff, helps us to improve the usability for a wider range of users.

Learn more about the ProFibrix surgical device here.

In a recent user study, we observed how a particular surgeon’s wrist was having to twist to use the device more effectively. In other studies, different surgeons didn’t need to twist the device. A relatively simple modification to allow the handle of the device to rotate (if required) offered a more versatile and adaptable surgical device. It wasn’t essential for the critical function of the device, but it aided those surgeons who benefited from it. What’s more, this feature could then be used by the client’s marketing team as a differentiator to other similar devices.

Why we need to continue learning from surgeons

Over the years, I have developed numerous medical devices used by surgeons and other clinical professionals. I have worked with multi-national MedTech companies with multi-billion dollar revenues. I have also worked with practicing clinicians who, in between their busy daily surgeries, are conceiving and developing their own ideas, hoping that one day, it might improve patient safety or provide a better working practice. As part of what I do, I have worked with and observed different surgeons demonstrating their craft, including orthopaedic, cardio-vascular, ENT, ophthalmic, dental, obstetrics-gynaecology, urology and general. Each has their own specialty, skillsets and priorities, but they all possess the attributes I have grown to admire and deeply respect.

As medical device designers, we must continue to strive to improve the lives of clinicians and patients alike. What JFK said is true: “The greater our knowledge increases, the more our ignorance unfolds.” In this way, we must not allow ourselves to become complacent. We must instead continue to work as closely as possible with surgeons and other clinicians, to observe what they do, better understand their needs and consider what they might need from surgical instrument design in the future.