Context:

While our customer, a company that created the #1 device for sleep equipment maintenance, had a successful shipping product, it was time for a product refresh to stay ahead of the competition. BCA was brought on as part of the team to provide the electronics and software support for this new effort. The device needed to comply with the home health care medical standards and hold up as an accessory to a class II medical device. One major short coming of the existing product which needed to be addressed was counterfeiting of the disposable element. Additionally, the design needed to support the potential for a product range with varying capabilities.

Solution:

BCA began leveraging our expertise in the medical design space for initial high level design phases. This included, helping define what standards needed to be complied to in order to ship worldwide, performing the electrical and firmware components of the risk analysis, and developing subsystem requirements for electronics and software. From this base the design began to take shape, architectures were evaluated to allow the full range of capabilities required for a possible product range, while keeping product cost as low as possible. Care was taken to address the counterfeit issues with the eventual solution leveraging BCA’s experience with RFID and knowledge of appropriate cryptographic technologies and techniques. BCA worked closely with the mechanical teams to overcome technical issues along the way ensuring the product was safe, intuitive to use, and consistently performed its disinfection task.

With a complete design BCA drove submission to the FCC as well as a full suite of electrical testing for IEC60601-1 and eventual regulatory approval. BCA worked to schedule lab time and monitor official testing ensuring testing was completed properly and efficiently.

BCA worked closely with the rest of the team and the manufacturing partner to ensure a smooth transition to production. In particular effort was put in to the software early working closely with manufacturing to ensure devices could be quickly and easily tested at a board level and at a full functional unit level. As any issues arose BCA successfully worked remotely to debug, driving to root cause and implementing appropriate fixes to be phased in as appropriate to the production process.

Throughout the entire development effort BCA followed our internal quality processes and produced high quality documentation to be included directly in a de novo submission to the FDA.