As per FDA design control regulations (Figure 1), medical device companies must ensure that the product effectively meets the needs of the user and that it is safe and reliable.
As shown in the video, we first tackled this challenge by developing a repeatable, reproducible, and accurate test fixture and test method for one of our recent clients. For the 1 out of 50 individuals whose lives depend on intrasaccular devices (Figure 2), it is essential to ensure that they are receiving the safest treatment there is by thoroughly testing medical devices prior to clinical implementation. See the results of our solution in the “Our Services” page.
With our COVID-19 pivot, we are developing an affordable, yet effective, controlled air-purifying respirator (CAPR) for local healthcare professionals. Currently, there are over 1.09 million cases of COVID-19 in the US alone, and over 2,250 cases in our own backyard here in Orange County. As the numbers only continue to rise and the supply chain falls short in providing the personal protective equipment (PPE) necessary to keep healthcare professionals safe, there is a need to produce effective PPE quickly and inexpensively. As seen in Figure 3, 61% of health care facilities across the U.S. had less than 1 week’s worth of N95 masks and 70% had less than 1 week’s worth of face shields as reported on April 20, 2020. Our CAPR system will help relieve the supply chain deficit by providing a cheaper and easily manufacturable alternative.