Along with FDA regulation, any changes made to production processes would have to undergo a rigorous approval process. Another key consideration was the compliance requirements they had to adhere to being an FDA-regulated product. One of the challenges they faced with this project was that they didn’t have the in-house expertise across several cloud disciplines required to envision and execute a smart factory transformation. Cerapedics understood that their transition to a smart factory would enable them to better manage the vast amount of data collected and use it to maintain and enhance their production. Given the length of the process and the volume of product lost if a batch were to fail, having real-time data and insight to develop the ability to do predictive analytics and maintenance to improve yield and minimize production losses was mission-critical. The Cerapedics production process involves a wider variety of equipment that generate a tremendous amount of data over the three week production process. As an AWS Premier Partner with extensive expertise in IoT, Machine Learning and Advance Data Analytics, as well as the Healthcare industry, Onica was recommended as a partner who could help them achieve their vision. The company had already begun utilizing AWS, and early into their journey they decided they wanted to envision the possibilities of creating a smart factory to streamline and modernize their fabrication process. Cerapedics anticipates continued growth above 40% in the coming year, adding to its already impressive track record in a competitive bone grafting market.Īs their FDA approved production process has multiple steps, with a large amount of data that has to be tracked and recorded for compliance and production purposes, Cerapedics was interested in automating the process in order to ease their operations, with the goal being to improve the costs, efficiency, analytics capabilities, and the ability to monitor all steps in their production process in real-time. market launch in 2016, the company has generated more than $30M in annualized revenue. The product has been noted for its well-established mechanism of action and the level of clinical data that strongly supports its safety and efficacy. Food and Drug Administration (FDA) through the Premarket Approval process and supported by level 1 clinical data for use in spinal fusion surgeries. The product is one of only two drug-device combination products approved by the U.S. Cerapedics is a novel medical device company based in Colorado that makes a bone graft biologic, i-FACTOR for patients with spinal issues including patients who suffer from degenerative disk disease that requires surgery.
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