We played a crucial role in the development and validation of an advanced auto-injector designed for diabetes treatment.
Our team was responsible for ensuring the device met regulatory standards (the device is in compliance with FDA and ISO 11608-1 regulations), performed reliably under different conditions, and provided an optimal user experience.
Through extensive testing and analysis, Kaira contributed to enhancing patient autonomy and medication compliance.
The project focused on an auto-injector developed for drug administration in diabetes management. This medical device is designed to facilitate self-injection, ensuring accurate and consistent delivery of medication.
By automating the injection process, the device minimizes human error and improves adherence to prescribed treatment regimens.
The auto-injector operates by delivering a precise dose of medication at controlled pressure and timing.
Its mechanism ensures optimal injection depth and reliability across various patient conditions. Functional performance testing verified parameters such as injection pressure and release time, while mechanical robustness analysis validated the structural integrity of components under stress conditions, including fatigue and vibration.
Development and validation testing:
Rigorous testing protocols are essential for ensuring that auto-injectors perform reliably under various conditions, thereby safeguarding patient adherence to medication regimens.
Compliance with FDA and ISO standards:
Meeting regulatory guidelines is paramount for market approval, ensuring both safety and effectiveness of medical devices before they reach patients.
Functional and performance testing:
Thorough evaluation of the device’s operational capabilities provides insights into user experience and device reliability, ensuring that it meets clinical needs effectively.
Usability simulation and ergonomic assessment:
In-depth usability studies focus on user interaction, ensuring that the design accommodates diverse patient needs and reduces the risk of administration errors.
Kaira Engineering, the perfect partner for all MedTech companies that need professional consultancy services to keep up to date with the latest trends and requirements of the medical industry.