Design & Development Services for Diagnostic Instruments
DeviceLab has a long track record of developing in-vitro diagnostic instruments, designing leading-edge clinical laboratory systems for immunoassays and blood chemistry. Such systems employ disposable cartridges, optics, and fluidics, driven by advanced control systems.
At the point of care, our customers seek to acquire patient data in minimally invasive ways while reducing caregiver workloads. Devices are often in constant use, so reliability and durability rank high in user needs. Users may be well-trained in this setting, but face high cognitive demands – physical and software user interfaces that ensure proper operation are essential.
In the laboratory setting, the focus is usually on throughput, accuracy, and per-test costs. Systems are often automated to achieve these goals. Managing large volumes of patient data is important as well, including secure data storage and transmission protocols. Diagnostic instrument technologies rely heavily on micro optics, lasers, and machine vision techniques (color, turbidity, particle counting, etc.).
Cybersecurity & HIPPA
In any setting, the protection of patient data is paramount and legally required under HIPPA. Systems must be able to ensure that data is shielded from unauthorized access and protected from tampering. Cybersecurity techniques such as encrypted transmission protocols are employed, and validation testing must demonstrate that the system is secure.
Disposable Components in a Diagnostic Instrument
Many diagnostic instruments incorporate a disposable component as a sample container or patient interface. Some of these are sold sterile, and all are produced in large volumes relative to the instrument itself. These system parts can be a significant project in of themselves, incorporating optical components, reagents, and even electronics and RFID. DeviceLab can ensure both the instrument and the disposable are properly design and work properly together.
DeviceLab’s Areas of Expertise with Diagnostic Instruments
DeviceLab’s success in these areas is based on expertise in systems engineering, analog electronics, wireless, sensors, optics, software, human factors, industrial and graphic design, sterile disposables, and cybersecurity.
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