What makes Greyledge different?
-The field was driven and matured with a very low-quality control. For example, medical devices really were responsible for driving utilization in the early days of the field. In that situation, you would input a sample, the device would process it, a final product would come out the other end, and you had no idea what was in it. There was no measurement. There were no analytics. There was no quality control whatsoever. I started out using these devices a number of years ago, just like everyone else with no quality control, we were still seeing trends toward some reasonable and healthy outcomes.
-We were still within the range of what was legal or ethical to do, at the time, it was the best we had. Utilizing that, I just didn’t feel it was acceptable as a practitioner. The concepts of Greyledge came from feeling that that was inadequate. We had to do better. We had technology that could allow us to do better. Greyledge’s value proposition is that we provide the quality control and analytics.
-We have a quality management program that is set up based on something called “CLIA.” CLIA is a federal body that oversees hospital laboratories. And we started this there was no playbook. There was no one to oversee us. There was no one to regulate us. We had to go to what we felt was the closest model. We are a lab, so we went to the gold standard, which was CLIA.
-We wanted to create an analytical platform that would allow us ultimate to look at dose response relationships; measuring the numbers of cells and cell populations, that sort of dose, if you will. And response, how did the patients do?
-We went out and found elements of good laboratory prices and of good manufacturing practice. We melded it into this standard operating platform and quality management platform that satisfied elements of each, and then we invited the FDA to come and have a look, by registering.
-We wanted to set the bar as an industry leader in terms of quality, but we had no playbook, so we had to make it up. So, we cherry picked elements from what we felt were ideal to create that platform.
Get in contact with David C. Karli through his website, LinkedIn, and learn more about Greyledge Technologies here:
