Even before the pandemic disrupted patients’ in-person interactions with their healthcare providers, visionary designers had made significant strides in developing new options for self-operated medical devices. Innovations in wearable technologies along with more streamlined and intuitive handheld options are gaining traction at a rapid pace. A Transparency Market Research analysis put the value of the global remote patient monitoring devices market at $8 billion in 2019, with a projected CAGR of 12.5 percent from 2020 to 2030.1
Along with the impact of the pandemic, other important factors are spurring the growth of the self-care medical devices market. Among them are a global aging population that brings with it the impact of lifestyle diseases like diabetes and cardiovascular issues. According to the World Health Organization, other factors affecting market growth include a lack of easy access to healthcare facilities, the rising cost of healthcare, and increasing interest by patients for more engagement and self-determination in their health.2
That said, the market is welcoming technology and digitization design teams that are making self-care devices easier and more functionally adaptable for people of all ages to exert more control over their health and well-being. One such organization is PreciHealth, a Swiss company founded in 2017 that offers creative engineering solutions in the fields of micromechanics and microfluidics.
Inspired by Nature
PreciHealth developed innovative intellectual property created around microfluidics, the technology of fluid manipulation in channels with dimensions of tens of microns. In nature, a microfluidics specialist is a mosquito. A mosquito can inject and draw blood at the same time, quickly and on a very small scale with a tiny injector. The question was whether the microfluidics intellectual property and nature’s inspiration could be adapted into a self-care auto-injector that would be safe and easy to use by patients in an at-home setting.
The answer was “yes.” The precision and repeatability of microfluidics technology were proven in commercialized tests. Once proven, however, the concept had to convert from technology to reality and be translated into a medical device design that would meet all regulatory requirements and, importantly, usability for the end-user. Human interaction throughout the design cycle is critical, particularly when the device needs to compensate for inexperienced users and digital technology is involved.
Design and Engineering Partnership
With usability being a primary driver in the device reality, PreciHealth partnered with a design and engineering team, BlackHägen Design, because of its approach to user-centered design and engineering techniques that are needed to appropriately develop a device.
The partner’s qualitative design approach looks to identify patterns to root out design issues early in the process. It also is able to define and optimize solutions with usability testing and methods to ensure that critical usability features can be quantifiably validated as safe to use. Safety criteria are also a focus to meet regulatory requirements. Ease-of-use features are necessary in order for the device to gain market acceptance.
Usability engineering requires several steps — research, confirmation, and validation through user studies. This approach provides an opportunity to identify potential end-user challenges, which may be demographic, i.e., the size of the user or economic variables, psychographic, or cultural.
It also considers patient safety if potential or actual comorbidities are involved. The environment in which the device will be used is also identified if, for instance, hygiene or hazardous situations cannot be predicted. The usability approach also looks at how the device can be designed to fit neatly into a home setting or, if a wearable, can be nonintrusive and perhaps worn under a patient’s clothing.
Device and Patent Success
PreciHealth and its design partners completed the specifications for the device and have recently received a multi-country medical device patent for its auto-injector design. Its design partners have been named contributors. This nature’s inspiration device is a solution for self-vaccination and remote medical treatment. It is a miniaturized auto-injector technology that permits different volumetric capabilities ranging from 25 to 2,500 mm3. Moreover, these smaller, user-friendly devices are easy to carry and have been developed for simple and safe administration. Their small size helps facilitate seamless integration with other platforms such as robotics, microsurgery tools, endoscopes, telemedicine IoT, and veterinary applications.
PreciHealth noted the power of user-centered design and engineering techniques as instrumental in developing the device. By applying principles used in the usability engineering, authentication, and workflow procedures during the design and development process, the device was able to meet the objectives for self-administration and regulatory requirements.
Their success with the auto-injector has evolved into two other PreciHealth projects. A one-handed device has been designed for in-home blood sampling, which offers an alternative to in-clinic procedures. The process guides users via an application that provides instructions, authenticates the user, and supports shipping the sample to a lab. The entire process meets the same standards as those required by automated blood laboratories.
The second design is for a self-vaccination platform that can support mass vaccination campaigns. The pandemic inspired the development when it became critical for millions of people to be vaccinated within a short period of time. This device ensures that the vaccine is safely and effectively delivered to the correct patient and prevents patient mix-ups with a verification system that is certified and recorded in the HMO database.
Both of these devices are verified via a mobile device with facial recognition that watches the insertion and then can validate the patient as well as the blood sample or vaccine. PreciHealth has applied for patents for each of these devices.
Empowering the Patient
While the pandemic has, and in some cases continues, to impact the way healthcare has been delivered, one upside is that it has encouraged consumers to be more engaged in their healthcare and lifestyle choices. Telemedicine has changed the way some patients are communicating with their doctors and healthcare systems.
By embracing in-home self-care devices, patients are also having a more convenient, less costly, and more private way to take a role in their medical decisions. These changing attitudes, along with the great strides made in technology, digitization, and design techniques, are certainly the driving forces for medical device developers and designers to pursue even more innovative alternatives for a market primed to embrace new ideas.
This article was written by Sean Hägen, Principal, Founder, Director of Research and Synthesis, BlackHägen Design, Dunedin, FL. For more information, visit here .
- “Remote Patient Monitoring Devices Market Forecast Report,” 2020–2030, TM-RGL401, Transparency Market Research.
- “Self-care interventions for health,” World Health Organization, Fact Sheet, June 30, 2022.