Beyond standards

Human-machine relations: safety and usability.

A machine is a complex object, designed to extend people’s capabilities. In the healthcare sector, a technological device can improve doctors’ potential to make a diagnosis, by increasing their perception, organizing and synthesizing data, and making it easier to discuss experiences.

Each new product offers a new starting point; although much may have been achieved in research to date, we know that sooner or later the contexts and technological opportunities will change, as will users’ culture and expectations. There is a starting point for every brand to build client relations brick by brick: the point set by an international standard, requiring organizations to remain within specific boundaries, above all to ensure safety.

The updating of the standards for Esaote devices was presented to the project management team as a specific legal obligation, a regulatory request for adaptation, although it also brought about a virtuous process: experiments with new ways of listening to users and a return to the fundamental features of the product.

These are often taken for granted but require constant reassessment to adapt and harmonize decisions that are now consolidated by innovations. Conducted in conjunction with USE-ME-D, the Usability Risk Assessment project explored appropriate methods of human-machine interaction by assessing various levels of risk, from physical hazards to the operator and the environment in which they work to diagnostic risks of error and excessive personalization, the possibility of which has been raised by technologies known as “operator-dependent”.

The aim is to eliminate accidents; to do so, there must be alignment with the operator's cognitive processes, to follow their movements within facilities, to gain a full understanding of their everyday experience to improve their agility and to synthesize information when it is considered worthwhile. All this helps the operator to comply with standards, without preventing them from exploring new pathways in a focused way.

The stages of usability evaluation of Esaote devices resulted in an exploration of spaces for improvement, and in consolidation of design decisions taken previously, thus laying the foundations for future innovations.

"The study began with brainstorming between technical experts, followed by the prototype creation stage among a small core of users,” explained Marco Delpiano, Project Leader for ultrasound software and Head of Compliance. “Finally, soon before certification, a group of doctors (cardiologists, radiologists and gynecologists) tested the product in practice without receiving suggestions or explanations, so the product itself could demonstrate its accessibility with no contributions made by intermediaries. This is the only way to detect potential critical issues. Maintaining a neutral position as observers, we managed to obtain objective responses, gaining a 360° view of the ultrasound system via a profusion of perspectives from users with differing expertise. Every time we complete this type of analysis and feedback, focusing on individual aspects, we gain training experience that is invaluable for our work,” he continued.

Every doctor has their own style and specific requirements: some look for speed, others need time to adapt to a new workflow, still others are more interested in reliability and the possibility of personally harnessing the potential of imaging, plus those who prefer AI assistance and receive snapshots previously calculated as more effective.

“Knowing how to change perspective is a fundamental skill in Research and Development. This process has also enabled us to integrate our experience with the more specific design culture relating to the field of usability and ergonomics. We were once used to considering the user interface in the final design stage only, but this project strengthened our conviction that it is actually the synthesis of work that must be done at all stages in the design process, from the definition of customer needs and product requirements to development per se,” noted Ramona De Luca, the head of various projects for the Ultrasound Probes Design Technology group, from Human Factor Design to Reprocessing.

“We need to bear everything in mind, even factors that may seem unimportant such as cleaning: the topic of Reprocessing, which includes the cleaning, disinfection, and sterilization of devices, has proved to be very challenging. Simplicity is an aspect of usability: for example, we aim to remove from our probes any icons or embossed/recessed elements that could require time to be spent reconditioning the probe, i.e. preparing it for subsequent use.
It may seem trivial, but this is another aspect of design.”

Simplicity in understanding where to place cables or the trolley – a gentle and reassuring aesthetic feature, albeit modern enough to reassure all kinds of patients of the reliability of the technology – are only some of the details that cannot be ignored and must appear clearly in the user manual.

“Handling is one of the fundamental aspects of the probes, involving both ergonomics and usability. Discussions with USE-ME-D were doubly enriching for us: we benefited from their experience in risk reduction, gained in sectors other than ours, plus we had to spend time explaining the features and specificities of ultrasound devices,” stated Francesca Gelli, Project Leader for probes and CE certification, which requires compliance with usability standards.

“At the same time, we needed to interpret and translate, access new languages, and consider the basis for our way of communicating. This is always important; when we reanalyze things we often take for granted from a different perspective, we come across details that are worth reconsidering, or sidelined ideas that should be reawakened. We asked ourselves questions: how did we create these families of probes? Is this still the best way?
Teaching is the best way to learn.”

While international standards are designed to make it easier for operators to switch from one machine to another without concerning themselves with major differences in usability, a great deal of space remains within these regulations for personalization of the experience.

“Every doctor has their own approach and needs to use instruments as an accessory for their expertise: the challenge is to bring together all the options on offer,” concluded Marco Delpiano, referring to Easy Mode technology as a project that helps to differentiate the Esaote position from its competitors’, while still complying with the standards required in the sector.

"This new technology, used for example in MyLab^™, has enabled us to leverage the opportunities offered by 15 buttons to adjust image quality. It gives us the option to view just three slides processed by an algorithm, which combines all the parameters into a simple response to the most frequent image optimization needs of the majority of users. Under normal conditions that do not require further investigation, this proposal speeds up diagnosis and reduces the cost of the examination.”

Aspects of usability also form part of a list of priority objectives: improved reliability in diagnostics, higher productivity, avoidance of musculoskeletal stress, and a reduced number of image checks to be carried out by the operator.