On the last days of 2021 Ophiomics launched the fabrication of its first “production-scale” lot of the HepatoPredict kit, already in preparation for its anticipated commercial development in Q1 2022, and is now a registered manufacturer of medical devices.
It seems impossible that 6 months ago we were still entertaining a different business model, where we would operate a single reference laboratory and samples would be shipped from all over the world to Ophiomics. But in May 2021 we decided to work directly with the pathology laboratories associated with the hepatology and hepatobiliary transplant centres and to redesign our business model.
In six months we identified, adapted and equipped our manufacture facility, recruited specialised human resources, designed a kit to be used by the end user laboratory, tested, chose and sourced OEM-level reagents and packaging, registered our company and its manufacture facility as an official manufacturer of medical devices with the authorities and… we are now manufacturing the HepatoPredict kit!
It’s unbelievable what can go wrong in an IVD/biotech company, particularly if you trying to do this in the middle of a pandemic, particularly one that competes for the same reagents that you require for your work, and where the hospitals with whom you collaborate are overwhelmed with COVID cases. They say start ups are difficult to build, but we think that most people don’t understand how hard “difficult” means.
We prevailed because we have an amazing team, fantastic advisors and our suppliers have been instrumental partners. Thank you all!