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In the light of the FDA's panel meeting in late summer on challenges and opportunities in the development of medical devices, Jeremy Kooyman MASc stresses usability and surgeon involvement in the design process.

There are a growing number of robotically-assisted surgery devices (RASD) and manufacturers entering the global market. However, an increase in the rate of adverse events related to these devices led to the FDA holding a panel meeting earlier this year to specifically address the challenges and opportunities associated with the rapidly evolving technology. Will the FDA’s involvement, with their upcoming Human Factors for Medical Guidance due to be issued soon, highlight the importance of usability in the development of these new devices?

Robotically-assisted surgical devices are considered by the FDA to be a subtype of computer-assisted surgery devices, typically consisting of several components which may include:

• A console which allows the surgeon to sit and view the surgical field through a 3D endoscope while remotely manipulating the surgical instruments;
• A bedside unit which houses the robotic arms that hold the surgical tools and endoscope, controlled by the surgeon through the console;
• A cart which houses supporting hardware and software components like suction/irrigation pumps and the endoscope light source.

The most well-known example is Intuitive Surgical’s da Vinci Surgical System, videos of which can be seen peeling a grape or folding a paper crane to demonstrate its dexterity and accuracy. The system was designed to facilitate complex minimally invasive surgery while being controlled remotely from a comfortable seated position. It can be argued that much of the initial commercial traction from the system was due to its ease of use and reduction of physical exertion combined with the obvious marketing appeal it might create in a privatised medicine system, rather than a clearly demonstrated superiority to traditional operational approaches. It is widely regarded as the most successful surgical robot and has indeed gone on to prove superior to traditional surgical approaches in a range of procedures, with more than nearly 600,000 procedures being performed in 2014 (up from 200,000 in 2009), paving the way for a number of other competing laparoscopic surgical robots to be commercialized.

Intuitive isn’t the only player in the field with hundreds of millions of US dollars being raised and spent by the likes of TransEnterix, Cambridge Medical Robotics, Magnetecs and Titan Medical, and even a partnership between Google and Johnson & Johnson has been announced.

With so many new devices arriving on the market, the FDA’s workshop was timely. But while it covered topics ranging from essential performance characteristics (stemming from risk management standards) to technical design considerations, there was little to no discussion on what I believe is the most important aspect of these machines: usability. Put simply, it is usability that determines whether or not the RASD can be used by a human operator. Focusing on safety and efficacy from a regulatory and design standpoint lends itself to cumbersome design solutions that can introduce use and misuse hazards that haven’t been accounted for, as the surgeon finds himself trying to figure out ways to outwit clumsy safety controls.

Usability for medical devices is moving to the forefront of many manufacturers’ design approaches, as it has changed from being viewed as just another ’regulatory hurdle’ to an integral process implemented throughout development. It can often take time, however, for such shifts to propagate backwards to academia and be adopted and supported throughout the hospital environment. Having learnt from incorrect design decisions that led to usability issues during my early academic career, I’ve been sensitive to the importance of user-centred design processes/thinking for some time. At two conferences I attended earlier this year - the AAMI Human Factors for Medical Devices course, London, UK, and the International Society for Computer Assisted Orthopaedic Surgery annual meeting, Vancouver, Canada - where the audiences couldn’t have been more different (industry and regulatory professionals versus a predominantly academic research crowd), I was reassured to perceive that both hinted that the current state of medical devices is changing for the better.

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Read the full article in MedSim magazine

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