To live longer and better life is a big dream. Rising standards of living have helped in achieving this almost everywhere in the world. However, aging population brings many challenges into the healthcare sector for which the operators in this sector should prepare themselves.
“Aging population and inadequacy of beds in hospitals are both reflected in the trend, where homecare is becoming more and more common and the use of various homecare aids and devices is increasing. Thus, while life expectancy globally rises, the need of patient care naturally increases too, but the treatment methods are changing. All this should happen while still maintaining patient safety and control”, says Jenni Tuulos, Head of Innokas Medical’s engineering unit.
Patient safety is one of the most important aspects in the quality assurance process in the field of healthcare technology. In terms of patient safety, the regulatory requirements are strict and complicated as well as very controlled, both in Finland and in international markets. However, the necessary and continuous development of these strict regulations is understood without any difficulty by healthcare professionals and medical device manufacturers.
“In addition to nursing staff and healthcare technicians, the companies developing and manufacturing medical devices understand the need of discipline in the field very well; the device needs to be perfectly suitable for its intended use to ensure the safety of patients and to avoid the serious consequences it may otherwise cause in hospitals or home care. Therefore, one of the key elements in medical device development is that there cannot be any compromises made with the safety and effectiveness of the devices developed”, Tuulos continues.
The safety criticality, the regulatory requirements, as well as the changing methods of patient care reflect directly to companies selling their products and devices to hospitals – and thus to companies taking care of the design and manufacturing of those products and devices. This requires that companies in the field need to constantly keep up with the evolution.
“We’re working with some complex equations to solve nowadays. While the amount of patients to be treated is increasing and the patient care itself is getting more and more complicated, also the need for home and preventive care is increasing and the requirements for the medical devices constantly develop at the same pace. This creates totally new kind of challenges for medical device developers as even higher quality and user experience factors need to be taken care of – especially in terms of patient safety”, Tuulos argues.
Usability engineering as one recipe for solving the equation
In terms of patient safety, it is crucially important that the devices developed for the sector will not be exposed to unexpected user errors. In addition to ensuring the continuous development of the basic quality factors of medical device development and manufacturing, the authorities in the field have begun to pay even more attention on the usability factors of the devices. The prevention of user errors occurring when medical devices and medical software are already took in use is been raised as a major issue when promoting the safety culture in the field.
“Earlier, user trainings was underlined by the authorities, but it appeared to be not enough to ensure the patient safety by only stressing the importance of user trainings and quality of instructions. In consequence, nowadays standard that addresses usability for medical devices and IVD devices does exist: the development process need to follow the terms of IEC usability standard in order to reach the market authorizations”, tells Pekka Pohjosaho, Innokas Medical’s Senior Usability Engineer.
“According to the standard, the development process needs to follow the described path very strictly. It defines the ways how medical device developers need to be able to demonstrate that the incidents caused by user errors do not lead to any unacceptable safety risks. With requiring companies to be compliant with the IEC standard, the authorities want to emphasize the concrete effects of the design and development process of medical devices for usability, user experience and patient safety”, he continues.
When looking at this from the nursing point of view, the importance of usability engineering in improving patient safety cannot be stressed out too much. Nursing is often very hectic and in-depth user trainings for medical devices that are daily used in hospitals may not be necessarily arranged. In addition, rush can cause stress and fatigue to the nursing staff, which increases the need for clear usability of the devices. A totally new perspective is the abovementioned fact that homecare is becoming more popular as a treatment method: earlier the devices and software were mainly used in the hospital environment by professionals, today even more devices and software are used by patients themselves at home.
“Development of medical devices requires changing mindsets. Today it is not enough that the devices are developed according to ISO standards and FDA regulations or that the innovations meet the needs of the markets; in addition, the development process needs to follow the IEC usability standards and companies need to invest in user experience, too. The homecare generates some new challenges for usability engineers also, as when developing new devices the user environment needs to be taken into account, too. The condition of patient who is using the device at home can be varied; he may has e.g. used some medicine, he can suffer from tremendous pain or he may have some tensions of using the device”, Pohjosaho discusses.
Challenges are not often encountered until in practice
Taking all the quality and official regulations into consideration in medical device development and manufacturing may be time-consuming and requires considerable expertise. So it may seem with the usability standard, too. In addition to that the IEC standard may seem very complicated especially at a first sight, the rules and regulations are constantly changing and updated. However, the development process has to fulfill the certain criteria and the companies must also be able to verify that they operate according to these requirements.
“I’d say the usability engineering and the related standard is not a rocket science. The companies in the field are increasingly aware of the standard, but the implementation of its requirements as a natural part of the product development process has been kind of challenging for the companies. We’ve also noted that the authorities are paying even more attention to the appropriate documentation of usability engineering. Creating the documentation with high quality and proven traceability can be difficult, too”, says Pohjosaho.
Usually, the lack of knowledge becomes the biggest challenge for the companies. It's also too often overlooked that in order to create a high-quality and safety-oriented medical device, the usability engineering should be made user-driven.
“A device designer can become reasonably quickly “blind” with his own work; when designing new devices, some features that are self-evident for the designer itself, may be very tricky for the nurse using the device for the first time, or for the patient using the device at home. Engineers quite often have kind of technology-centered mindset, too, and they may not be able to have enough information about the requirements of the usage environment of the device”, ponders Pohjosaho.
Co-creating better usability
However, to ensure an agile path of new innovation from idea to market, the usability engineering should be integrated as a natural part of the product development process already when kick-offing the project. This requires some new kind of engineering expertise and creates a need for changing mindsets.
“According to our own experience, it is really important that usability engineering begins as soon as kick-offing the development project – preferably even already before that, because the user experience and other usability issues are more difficult and expensive to be redesigned when the product is already been designed and launched. In addition, when developing the device with an overall product development plan, it ensures that the user experience will be consistent and smooth”, Pohjosaho tells.
Ensuring a more compliant and safer user experience often requires the cooperation across the company borders where bringing together the robust technology-related knowhow and the knowledge of user environments in the field.
“When co-creating new devices with the experts in the field, every parties have a competitive edge, and time and money can be saved. Our customers have been able to experience that when bringing new products in the market by starting to cooperate with Innokas already in the very early idea phase. At Innokas, usability engineering and related usability studies are integrated as a natural part of our medical device development process. It is been great to utilize this knowledge when transforming our customers’ ideas into a high quality medical products – through the development projects implemented together with our customers”, Tuulos tells and continues:
“Through our +20 years of experience in the field we’ve been able to gather a robust knowledge in user environments and user profiles both in hospitals and homecare. Thus, we’ve been able to consult our customers already at a very early idea phase of what could and what shouldn’t work. Such an experience-based knowhow may not always be obtained e.g. through feasibility studies or preliminary interviews and surveys – the technology behind the idea need to be known well, also.”
Since through professional and user-oriented usability engineering the user errors and related critical consequences can be avoided, and the clearer user experience in different operative environments can be ensured and achieved, the usability engineering can be seen to be even more emphasized in future when developing user safety and promoting safety culture. By co-creating new devices together, the better usability can be achieved, which in turn generates the added value for the companies working in the field. And in terms of costs and time, this added value can be very significant.