Jul 5
Five Critical Considerations in Designing Microfluidic Cartridges
Developing microfluidic devices can be a daunting task not unlike the development of other medical or in-vitro diagnostic devices. Development typically arises from the need to miniaturize and automate existing assays for microbiological applications such as ELISA, PCR, flow cytometry, etc. This blog covers key considerations which we have found increase the chances of success during the early phases of microfluidic cartridge development.
Continue reading »
Commercializing your medical device in the US market requires submitting marketing applications to the FDA to become an FDA Approved or Cleared Medical Device. The content of your FDA submission is determined by how your medical device is 
This blog provides a context for designers to streamline their development process using 3D printed parts as a part of their market-ready medical devices. 3D printing is disruptive. It challenges the way that designers consider product development. Contrasted with traditional fabrication methods, 3D printing offers several benefits along with certain limitations. Regulatory agencies are providing guidance to 3D printed component testing and process control, which allows for 3D printed parts to be included in medical devices once they are defined by the manufacturer.
This blog covers the optical safety limits and maximum exposure limits of wavelengths in the IR, UV and visible light spectrum for ophthalmic instruments. Optical safety for ophthalmic instruments focuses on ocular exposure limits because the eyes are the most light-sensitive part of the body and ophthalmic instruments are intended to interface directly with the eyes during diagnosis and treatments.
A common challenge when designing medical devices that make optical measurements is ensuring the optical system state remains correlated with sensor measurements in order to maximize medical device optical signals.
Moulded plastic light guides are an inexpensive means to “pipe” light around inside a medical device. Their design process makes light guides amenable to a variety of shapes and sizes. Applications include delivering light to an indicator, a switch, or a peripheral diagnostic attachment, thus, these optical guides are an attractive technology for solving a light-transport problem in a medical device.