Background:
Diabetes affects people of all ages regardless of gender and geographical location. A diabetic patient unlike other diseases; may appear healthy and living a normal life under medication. Therefore a tendency of being
noncompliant with medicine especially insulin dosage is observed. One of the reasons of such behavior is that patients
find it irritating to use syringes or injections. It results into complications in other body functions such as heart, kidneys,
liver and loss of immunity.
Results:
Dimensional, performance and economic features were compared with existing devices. Device was designed to
use standard accessories of needles and insulin cartridges available in market. It was observed that the new device fared
well with current devices and provided additional benefits of convenience of use and portability of carrying along being
half the size of others. Its overall cost was also substantially reduced due to use of replaceable insulin cartridges as compared to syringes and pens that are discarded after use.
Conclusions:
A keychain held insulin administration device was successfully developed in this research. Patients could
use this device to administer insulin everywhere to ensure timely dosage. Patients are able to carry it along and develop
compliant behavior towards insulin usage. Its geometric as well as performance specifications were developed on the basis of syringes and typical insulin pens available in market. Final design fulfilled all the requirements provided by market
held devices besides being half the geometric size of regular pens. It uses insulin tubes which can be discarded and device
can be used again and again that makes it more economical. Both type 1 and 2 patients can use it because of simple assembly and operation. Prototype devices were used by two patients over a period of 12 weeks who confirmed its satisfac-tory performance. Addition of digital measurement scale was proposed for which further research is in process. Its small
size as compared to insulin pens and syringes provided possibility of carrying it in keychain.
Methods:
Present research was conducted to design and manufacture a keychain held insulin injectable device. Patients
requirements were collected through interviews regarding current devices such as syringes, insulin pens and insulin pump.
Its geometric features and possibility of carrying along everywhere was the primary focus of these interviews. Patients
ease of use, cost, dimensional and performance specifications of these devices were reviewed and considered as target
benchmarks for new device design. A set of parameters was established from the collected information that was considered as baseline for new device design. A detailed product design and development process was followed to arrive at final
design. Prototypes were developed and tested on few volunteer patients who confirmed its performance and usability advantages with reference to other devices.
The role of the user within the medical device design and development process: medical device manufacturers' perspectives