Mediomics, LLC in St. Louis is a leading innovator and provider of assay kits and biosensors for the medical field. Their patented technology allows for the quick detection of biomolecules, which will revolutionize the ability of medical facilities and physician’s offices to do onsite testing for their patients faster and more cost effectively. These quick and simple test kits are used to quantify many biologically and therapeutically important macromolecules, including DNA, biomarkers, hormones, antibodies, intracellular signaling molecules, protein-protein complexes, cell receptors, bacteria, fungi and viruses. In simplest terms, Mediomics’ technologies can do a wide variety of common medical tests faster and cheaper than conventional testing methods.
Very soon after Mediomics’ inception in 2001, the company realized it needed help with certain technological capabilities and operational efficiency issues. They contacted Missouri Enterprise, and found exactly the expertise they needed to get their company on a path to profitable growth.
“Missouri Enterprise visited us with a group of their engineers,” says Dr. Yie-Hwa Chang, founder of Mediomics. They quickly set to work helping us build a prototype for our automated analyzer. It was a great success. As we continued to grow the company, we saw that our manufacturing processes were not as efficient as they needed to be. We needed a structure for our operations, a framework…and Missouri Enterprise was there to help us again.”
The Project Managers at Missouri Enterprise set to work guiding Mediomics through the process of ISO 9001 implementation. “Their project managers were extremely knowledgeable, highly organized, and incredibly patient as they helped us bring the company into compliance with the ISO standards,” Dr. Chang tells us. “We are very proud to announce that we just received our ISO 9001 certification. Missouri Enterprise helped us streamline our manufacturing processes and standardize our procedures, so now we’re much more organized and efficient, and we’re able to grow sustainably.”
Mediomics next steps include ISO 13485 certification, the standard for medical devices, and the incorporation of Current Good Manufacturing Practices (CGMP) to get the company ready for compliance with the Food and Drug Association’s (FDA) regulations for medical devices. “The people at Missouri Enterprise are very professional, very nice and very easy to work with, a combination you don’t find too often. So we’ll be partnering with them for our needs for years to come,” concludes Dr. Chang.