Sterling Medical Devices participated in the development of a pressure sensing device. The pressure sensor of the device is required to target the correct area of the body when delivering supplements. In this case, the pressure sensor needed by physicians to be integrated into the device to target the non-atmospheric target area inside a joint. The pressure sensor connects directly to both the needle inserted into the patient and the syringe. By doing so, the sensor can safely administrate the supplements according to the determined navigation of the fluid flow path.
Sterling formulated a plan for feasibility testing of integrating a pressure sensor into the internal flow path of the device as it previously existed external from the device, contrary to its typical use in the field. Sterling researched pressure sensing extensively to determine how to apply it to the device optimally. Following this, Sterling aided in the development of specific functions of the device, such as materials of tubing, power output requirements, sterilization, and cost-effectiveness of the system. They then presented device designs with 3D beta prototypes and mock-ups for verification testing and design transfer. While doing so, Sterling cohesively outlined the requirements for user needs and ergonomic demands and optimized the device’s software accordingly.
Sterling also operated project management and resources, including the management of hazard and quality analysis reports that were documented regularly for record and reviewed weekly during meetings with the client. Upon completion of Sterling’s development services, compliant under ISO 31485 registration and IEC 62304, they transferred the product to the customer’s quality system. The customer, at their discretion and outside of Sterling’s services, had it manufactured.
January 15, 2021
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November 5, 2020