Instead of ice-packed coolers like the kind you might take on a camping trip, Tucson, Arizona-based Delta Development’s APRU refrigerates fresh whole blood and vaccines with a built-in battery that lasts for days on a single charge. The APRU also constantly monitors the temperature and can withstand outdoor elements such as water and ice, dust, UV rays and extreme temperatures.
As part of the Medical Design & Outsourcing cloud conversation series with medtech innovators and leaders, Delta Development Chief Technology Officer Robert Futch shared his team’s experience using web-based CAD software Onshape and other cloud tools to design, manufacture and sell the device. This conversation has been edited for space and clarity.MDO: Is your device regulated by the FDA?
FUTCH: The APRU is an FDA Class II device and we had to list it with the FDA to be a medical manufacturer. We always warn customers who use non-listed products that they may be subject to FDA penalties.
We also are nearing the release of a new companion product, which we are currently working with the FDA on since it requires FDA clearance. Designed in Onshape like the APRU, it will be the world’s first product of its kind that doesn’t require disposable parts.
Note that the FDA is picky about the terms here. FDA approval usually refers to medicine. Our Class II exempt refrigerator required FDA listing and the new companion product requires Class II FDA clearance.
MDO: What did the cloud allow your team to do?
FUTCH: Cloud-based design had a bunch of benefits for my team. No. 1 on the list is that it didn’t slow down our development when everybody went to work from home at the beginning of the pandemic. Since everything we do was already online, it was as if there was no disruption to development, which is super important for a small company like us with a fixed amount of time to start manufacturing and selling our product before we run out of runway. Onshape was a big part of this, but a few other tools like Greenlight, Dozuki, Github and good old Google Docs were also important.
Some other benefits we saw were: built-in version control of all these cloud-based systems, quickly scaling our workforce with remote contractors, faster turnaround on solving software bugs and updating manufacturing procedures, way faster collaborative reports (which means more time designing and building), and super easy customer support/call management and directing phone calls.MDO: And you saw positive results from your team’s ability to work together?
FUTCH: They’re happier employees — they have flexibility and also had more time to go back to school. It is easier to keep track of productivity as well. There’s no tribal knowledge and less supervision required. Everyone is aware of what they have to do and where to find the right information.
MDO: Do you have more plans for the cloud in the future?
FUTCH: We’re constantly moving things to the cloud. A recent one is our shipping software.