Improving the safety of patients with adrenal inefficiencies in emergency situations
University / Individual Project / 8 months
Iuvo
/ˈyu.vo/
Verb: I help, aid; save
Iuvo is the first-ever multi-use autoinjector aimed at patients with adrenal and pituitary conditions, delivering 100mg of Solu-cortef. The device replaces the current manual syringe solution on offer with a simple, fully self-contained unit.
My role
As an individual university project, I was responsible for everything, from organisation to output, throughout the duration of the project.
In just three months, a problem had to be identified, researched, and a design proposed for the first submission. We had another four months from here to re-evaluate our design, build prototypes, and undergo thorough testing with users to finish with a robust and realistic proposal to fit our design brief.
I wanted to bring a user experience focus to what was, primarily, a product design project, giving the end product an advantage of a well-defined interaction and experience for the user.
Responsibilities
Discovery, research, ideation, prototyping, user testing, speculative design, visual design & UX design.
Timeline & output
8 months to research & design an IM injector, with the output including reports, development folios, presentations and physical artefacts.
Team
This was an individual project from start to finish, although assistance was provided by my personal tutor and Design School support staff.
High-level goals
01 / Widely accessible
These conditions are incurable and for life, meaning users could be well over 65+. With older people more susceptible to breaking bones from falls, it's important that the device is usable for people who may have limited dexterity.
03 / Immediately understandable
If the device's owner is for some reason incapacitated and unable to use the device themselves, a member of the public may need to carry out the injection. They should be able to pick up and understand the device immediately.
02 / Simple to use single-handedly
As it's very possible that users may be carrying out the injection due to a broken hand or wrist, being able to use the device one-handedly is imperative. Currently, users have to swap vials and draw up liquids, requiring two hands.
04 / Easy, safe disposal after use
To counter the threat of 'needle stick injuries', the device should cover the needle immediately following use. The empty vial and needle should be disposable, allowing fresh replacements to be attached for another injection.
Research & investigations
Early research focussed on injection methods, injector powering and existing solutions, all in an effort to find a potential innovation that may have been missed.
Part of this process involved speaking to experts in various related fields and potential users - both with the condition and without, given it could end up being used by anyone.
“The problem is the fact it needs to be prepared. When in an emergency, you may not be as lucid as when you learned.”
“Medical approval is the biggest hurdle, it’s a 3-5 year process…”
“There are cases where people die because they put off the injection.”
Dr Alessandro Prete, QEHB
Steve Martin, Owen Mumford Ltd
Sallyann Blackett, The CAH Support Group
The problem
1/3 have never had to use their injector
Despite the condition being for life, the fact a third of respondents have never used their injector warns of the distinct possibility that they would be unable to use it if the need to ever arose.
"It's too complicated to draw up an injection when you may not have needed to do it for a few years"
As alluded to by Dr Prete, a trained Endocrinologist, you're not as aware of the process as when you were taught. With a number of steps required - often needing both hands - it's quite possible that mistakes might be made and the injection being unsuccessful - which, of course, could be life-threatening.
“I know I need to use it to prevent my son dying”
This simple statement was perhaps the hardest hitting in all the answers to my questionnaire. It just shows what is on the line when using the injector, and why it has to be near enough perfect, and easily usable in any situation.
Proposal
A fully self-contained autoinjector using replaceable & disposable needle and drug cartridges that;
( 01 )
Eliminates manual medicine mixing
by automating the mixing process and taking responsibility away from the user.
( 02 )
Mitigates needle-stick injuries
with a spring-loaded protector that covers the needle at all times.
( 03 )
Addresses injection fear
by simplifying the process and supporting the user through every step.
Design development
In the early stages of the project, I defined the problem and opportunity following research into adrenal insufficiencies, treatments and current injection solutions - as seen in the sections above.
This led to a user specification and technical specification and market plan that I would aim to meet. As I transitioned from rough sketches to higher fidelity designs, diagrams and low-fidelity models, a number of different designs were developed both for the inner mechanism and outer casing.
One of the primary problems faced was how to optimise the inner mechanism. It had to fit into the smallest possible volume, to keep the device easily handleable and carryable. It also had to automate the mixing and injecting processes to simplify the whole sequence for the user.
The medication vial is split by a seal between the water and the Solu-Cortef powder. To mix them, the piercing tool is pushed down, breaking the seal and forcing the liquid into the lower chamber. This reduces the device preparation to just two steps; piercing the seal and mixing the solution.
The user is guided through the entire process with clear, informative illustrations of each of the three steps on a sticker on the front of the device. This is further aided by the use of lights on the top of the device, which will either flash or remain a solid colour depending on the stage the user is at. Again, these are referenced at every stage of the process.
The instructions and lights feedback were well received during user testing; over 80% of participants said they would be able to use the device without prior training, in part due to the instructions.
Although the entire device is designed to be instantly recognisable as a medical device, more specific information is provided on the top of the device.
Children with adrenal insufficiencies only require about 50mg of hydrocortisone, so printing the size of the medication is a necessary addition to allow smaller volume injectors to be produced and differentiated. Storage information is, of course, important for any medication. To ensure users actions don't affect the efficacy of the drug, it's clearly printed and always available for reference. Finally, the expiration date of the Solu-Cortef is also printed on the device.
As shown in the above picture, on the opposite side is a QR code. This links the user to online help videos and instructions to provide further guidance.
In an effort to reduce the risk of needle-stick injuries, a simple protective cap was designed. Using a spring, the cap is pushed back automatically when the injector is jabbed against the thigh. When the injection is finished and the user pulls the injector back from the leg, the spring pushes the cap back over the needle again.
