How many times have you lamented the poor design of a certain product, a poorly placed button or a floppy hinge? These ill thought-out features can alter our whole experience and attitude towards a product. There is a whole spectrum of consequences that can arise from such issues ranging from annoyance to harmful mistakes.
As a designer, it can be easy fall into the trap of focusing on and designing for the user. While this is all very good for the user, it’s not so great for the many other people who must interact with the product throughout its life. The intended user of a product is not the only user and there are a number of “stakeholders” in a product’s life.
A product’s life (in the physical sense) begins at manufacture. During this process there will be tool makers, production and assembly staff who all have to interact with the product during its various stages of infancy. If designers have thought about and designed for this process, it will make these individuals’ jobs easier, manufacturing implementation more efficient, and a better looking bottom line.
Testing is another necessary stage in a medical devices life. Designers of a product might place electrical connections to allow for the most compact PCB layout or behind a cover for aesthetic reasons. However, these decisions are often made with the requirements of only one stakeholder in mind. As part of our work we have to design and develop test methods and equipment to verify and validate device performance. Decisions such as these can have a profound effect on the complexity and cost of the equipment required to test these devices, impacting project funding and product reliability.
The world’s first pre-filled retractable syringe by Unilife developed with ide, is an example of a product that meets the needs of a number of key stakeholders. Doctors and patients required the syringe to be intuitive, employ a familiar usage technique and be safe and reliable. The pharmaceutical company requirements included drug compatibility, and utilizing existing production infrastructure, while the manufacturing and supply chain had entrenched, well known processes and were change averse. Our client themselves required a solution to differentiate themselves, gain market share, as well as having cost and time to market requirements. To be successful the solution had to tick all these boxes. In catering to the needs of all these stakeholders, requirements need to be developed and continually referred to throughout the development process. Think of these requirements as your development roadmap. They will help guide the design direction, decisions and make sure that no stakeholder is forgotten in the flurry of work to get to market. At the same time, maximizing the chance of the market truly embracing the product.
There is a growing trend in the healthcare industry towards devices and treatments that can be used at home. Where traditionally a person might go to the doctor or hospital to receive a test or treatment, they can now do this in the comfort of their home. This provides convenience for patients but also places huge importance on design for human factors. The experience of a medical professional will be totally different to that of a patient with no medical training. In a study done in Singapore on User Acceptability and Feasibility of Self-Testing With HIV Rapid Tests (Vernon et al. 2008), it was found that 61 percent of known HIV-positive participants and 92 percent of at-risk participants failed to perform all steps correctly, which in many cases resulted in invalid results. While participants preferred to perform the tests in private, the study concluded that implementation of HIV self tests should be reconsidered until kit design issues have been adequately addressed.
Since this study was performed, ide and Atomo Diagnostics have developed the world’s first integrated rapid test for blood collection. The MicroRapid solves many of the usability issues plaguing previous rapid tests by integrating many of the separate components into one device. It is also designed to address pressure from groups such as severely cost constrained government screening programs, so the device had to be inexpensive and easy to manufacture. This is another example of a product solution strongly driven by multiple stakeholder requirements.
Designing products and devices that are intuitive and easy to use can minimize costly mistakes and increase patient safety. If a device fits seamlessly into the clinician’s workflow, they don’t have to think about or struggle with the use of the device. The patient, not the device, becomes the focus of their attention. Ultimately this improves the experience for both the medical staff and patients and inherently reduces risks to all in its use, the goal of every good device.
The disposable medical device market is massive. Every year billions of disposable devices are thrown away. It can be easy to think that after a device has performed its function and thrown in the bin that its life is over. Think again. There is a whole industry involved in transporting, disposing and processing used devices. When these devices are thrown in the bin they begin another journey. By considering the stakeholders involved and understanding end of life issues, it is possible to recognize areas for improvement. Minimizing handling required, decreasing transportation volumes (don’t ship air!) or combining functions of separate devices into one are just some of the ways the disposal of the device as well as sustainability of the treatment it provides can be improved. People often associate sustainability with recycling, but sustainability can be improved through making careful materials decisions and by generally improving overall efficiency throughout the product’s life. This not only benefits the environment but also makes good business sense.
By thinking about the whole system that a medical device operates within, all individuals’ and groups involved, key insights can be gained about the way devices are used. This provides opportunities for innovation. We have found first hand time and time again, that the technology behind a device does not need to be revolutionary for a device to be disruptive and shake up the marketplace. It just has to offer real value to all its stakeholders.