Medical Design Briefs - August 2022 - 23

Validate
Affordable
Safe
User-friendly
Securely
assigned
Scalable
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. (Credit: PreciHealth)
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
Medical Design Briefs, August 2022
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.
References
1. " Remote Patient Monitoring Devices Market Forecast Report, " 2020-2030, TMRGL401,Transparency
Market Research, https://www.transparencymarketresearch.com/remote-patient-monitoring-devices-market.html
2.
" Self-care interventions for health, " World Health Organization, Fact Sheet, June
30, 2022, https://www.who.int/news-room/fact-sheets/detail/self-care-healthinterventions
This
article was written by Sean Hägen, Principal, Founder,
Director of Research and Synthesis, BlackHägen Design,
Dunedin, FL. For more information, visit http://info.hotims.
com/82324-347.
www.medicaldesignbriefs.com
23

https://www.transparencymarketresearch.com/remote-patient-monitoring-devices-market.html https://www.transparencymarketresearch.com/remote-patient-monitoring-devices-market.html https://www.who.int/news-room/fact-sheets/detail/self-care-health-interventions https://www.who.int/news-room/fact-sheets/detail/self-care-health-interventions http://info.hotims.com/82324-347 http://www.medicaldesignbriefs.com

Medical Design Briefs - August 2022

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