A foundation of user research to guide the development process
Koru Medical Systems
Inserter
While there are several products available within this space, none of them provides two key features that Koru is interested in exploring: reusability, and the ability to deliver a drug to multiple infusion sites simultaneously. Competitive products are currently disposable, which can become a heavy financial burden to users, in addition to creating a great deal of waste. And the market tends to focus on drugs that require just a single infusion site, which cancels out any users whose therapies call for a higher volume of drug delivery, and therefore multiple infusion sites. This inserter fulfills both of these needs.
User Research
We built our own user group from scratch by joining diabetics support groups, who enthusiastically shared with us their experiences using competitive devices. This qualitative and quantitative data guided design and engineering decisions throughout the entire development process.
Concept Development
The inserter had to be intuitive, comfortable, and secure during infusion-set loading, placing the inserter on the skin (no risk of accidental triggering), and firing. These interface features could not interfere with each other, despite competing for space on a small device. The cap performs double-duty, as a protective dust cover during storage/transport, and as an infusion-set loading platform.
Engineering
At base, the device simply needed to pick up the infusion set, hold it during injection-site identification, and then insert it into the user’s skin. Easier said than does, as the infusion set provided little real estate for a secure grip. The injection force and duration required fine tuning to ensure patients’ fear of needles was not increased.
Ergonomic Modeling
Models were fabricated and evaluated by users of various capability in order to ensure proportions, features, and functional layout enabled intuitive and comfortable use.
Prototyping
Multiple iterations of functional prototypes were fabricated in order to make the infusion set pick-up and release mechanism reliable. Injector activation forces via the buttons were also fine tuned in order to make the actuator predictable and comfortable for all users.
