To live longer and a better life is a big dream. Rising standards of living have helped in achieving this today almost everywhere in the world.
However, this brings many challenges into the healthcare sector: aging population and inadequacy of beds in hospitals are both reflected in the trend where home care is becoming more and more common. Logically, also the use of various home care aids and devices is increasing. Thus, while life expectancy globally rises, the need of patient care naturally increases too, but the treatment methods and tools are changing. All this should happen while still maintaining patient safety and control.
Therefore, in the medical field the patient safety and safety control are one of the most important aspects in the quality assurance process. In terms of patient safety, the regulatory requirements are strict and complicated as well as very controlled, both in Finland and in international markets. To ensure the safety of patients and to avoid the serious consequences the device may otherwise cause in hospitals or home care, the device needs to be perfectly suitable for its intended use.
Applying human factors and usability engineering to medical devices
Nowadays, usability and usability engineering are becoming more of a science and less of an art in the medical device field.
As an example, it’s been recognized that the use errors can be significantly reduced if there’s a process in place to manage the usability properties of a device. In addition, the increasing complexity of medical device field as well as the change of the environment where the devices are used have resulted that a well-defined usability program is necessary to protect both the users and the patients from accidents.
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 standards (IEC 60601-1-6 and IEC 62366) to reach the market authorizations. These standards define the processes how medical device developers need to demonstrate that the incidents caused by use errors do not lead to any unacceptable risks.
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.
A totally new perspective is the above-mentioned fact that home care is becoming more popular as a treatment method: today even more devices and software are used by patients themselves at home. The home care generates some new challenges for usability engineers also, as when developing new devices, this new trend in user environment as well as in users, needs to be taken into account.
It is therefore very important to understand the context of use when designing medical devices. Medical device standards define detailed basic safety requirements for e.g. electrical safety and radio emissions due to which devices are technically interoperable and thus, safe. Setting up acceptable current limits is somewhat straight forward. However, surgery rooms are packed with equipment which looks the same but have completely different purpose. How can manufacturer assure that devices are safe after use error such as mixing up cables of two life-supporting devices?
One of the everyday tasks of a usability engineer is to address such usability risks and communicate testable requirements for the design team. On the other hand, also narrow the scope to those that actually poses a risk so that the workload remains tolerable. Adequacy of usability is proven by validation testing.
The most common challenges faced in medical device usability engineering
The usability engineering and the related standard is not rocket science – it’s just one mandatory thing among the others that need to be considered in medical device design and development.
However, even if the companies in the medtech field are increasingly aware of the standard, the implementation of its requirements as a natural part of the product development process can be challenging for the companies. The authorities are paying more attention to the appropriate documentation of usability engineering as well. Creating the documentation with high quality and proven traceability can be difficult.
But the biggest challenge for the companies is usually the lack of knowledge. It's too often overlooked that in order to create a high-quality and safety-oriented medical device, the usability engineering should be executed user-driven. One very common challenge is that the device designer can become reasonably quickly “blind” with his own work; 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, and they may not have enough information about the requirements of the use environment of the device.
Co-creating better usability
To ensure an agile path for new innovations 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. Actually - 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 designed and launched. When developing the device with an overall product development plan, it ensures that the user experience will be consistent and smooth.
In addition to that, ensuring higher user experience often requires the cooperation across the company borders. In co-creation of better usability, the idea is to bring together the robust technology-related know-how and the knowledge of user environments and users in the field.
When combining the needed knowledge of user environments and user profiles both in hospitals and home care with the robust know-how of the technology behind the idea, the best possible outcomes can be expected to be achieved. This 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.
This blog post was one writing in a blog post series of creating next generation medical devices in more agile way. In addition to the importance of taking human factors and usability into account, the whole medical device development process should follow certain rules and best practices to achieve more agile medical device development cycle. According to our studies, the commonly known three methodologies of product development - Design Thinking, Lean Start-Up and Agile methodologies - are something that can be successfully applied to the design and development of medical devices. When done properly, they reduce the time to market of the device by ensuring that right and well specified customer problem will be solved with a feasible solution, which is going to be incrementally developed.
In our brand new, free White Paper we describe in a detailed level how to get high-quality medical product to the market as quickly as possible by using these three methodologies. Please, download yours below!