Medical Device Maker benefits from Custom Cactus Product

While performing a needs analysis at a US based medical device maker, we found several requirements that needed custom features to create a solution.

The device was battery operated and needed a storage solution that met high shock and vibration specification while using very low power. Performance was not very important since the data rate was quite low.

For the shock and vibration requirements, flash storage is a no brainer. The 3000G operational shock and 30G vibration of the Cactus CompactFlash cards easily covered this criteria.

The device is used by the health practitioner or their patient for extended monitoring periods relying solely on battery power. The smaller flash cards inherently use less power than rotating disk alternatives, but in this application, even lower power was required.

After some investigation, the Cactus engineering team was able to create a custom product which lowered overall power usage by a significant amount by lowering performance of the card, which was not needed in this application. This allowed the overall device monitoring period to increase 2-3 times.

Since this system uses the popular industry standard CompactFlash form factor, the medical device is subject to having a non-qualified generic CompactFlash card inserted by the end user.

In order to prevent this from occurring, a custom manufacturer's ID only available to this medical OEM is set at time of manufacture. This ID cannot be changed in the field by the OEM or others. When the system initializes it first checks for this custom ID, if not found it prompts the user to install an "authorized" memory card.

To further customize the product, a label with the OEMs name, artwork, branding and part number is applied to each card from the factory.

Finally, each medical device built by this OEM has to go through rigorous testing to get FDA certified for use. Any subsequent changes to the BOM (Bill-Of-Material), must undergo stringent testing to ensure they are equal to or greater than the part they are replacing. If too many changes are being made, the entire system needs to be completely recertified.

To mitigate this effort, Cactus has been able to hold the same BOM of this custom design for over 5 years for this customer, thereby alleviating a significant amount of test and qualification expenses.

If your company also requires some specially designed flash storage solutions to meet a need in your market segment, please contact Cactus for a needs analysis.