Increasing efficiency and reducing costs with smart factories
Modernizing medical device production with smart factories
Cerapedics, a medical device company from Colorado, was looking to modernize and automate their production process to improve cost-effectiveness, efficiency and analytics. By transitioning to a smart factory to utilize real-time data and insights, Onica helped Cerapedics enable predictive analytics and maintenance so that they could improve the yield of their manufacturing batches and minimize production losses.
Transition to a smart factory to utilize IoT, Machine Learning and Data Analytics to increase efficiency, cost effectiveness and analytics
Services & Tech
IoT, AI and Machine Learning, Smart Factory, Serverless
Medical device company and producer of FDA approved bone graft
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. The product is one of only two drug-device combination products approved by the U.S. 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 has been noted for its well-established mechanism of action and the level of clinical data that strongly supports its safety and efficacy. Since U.S. market launch in 2016, the company has generated more than $30M in annualized revenue. Cerapedics anticipates continued growth above 40% in the coming year, adding to its already impressive track record in a competitive bone grafting market.
As 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.
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. 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 Cerapedics production process involves a wider variety of equipment that generate a tremendous amount of data over the three week production process. 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. 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.
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. Another key consideration was the compliance requirements they had to adhere to being an FDA-regulated product. Along with FDA regulation, any changes made to production processes would have to undergo a rigorous approval process.
To mediate some of the concerns inherent with such a transformation, Cerapedics and Onica decided that first going through a pilot project to generate a Proof of Concept (PoC) would demonstrate the benefits of an IoT-enabled production process to share with their Quality, Operations, and Compliance teams the potential to use the system for compliant monitoring.
For the PoC, the Cerapedics team decided to focus on a single piece of equipment, the sterilizer. Part of this decision was based on the fact that with the current process, the sterilizer generates a large volume of data and is a key part of the production that can’t be easily outsourced. It has the potential to be a production bottleneck. As TC Thompson, Cerapedics’ Process Engineering Manager states, “Sterilization is one of the last steps in the process, prior to packaging, and failure during this step can cost us significantly. We thought this would be a good place to start, to see what data could be gathered.”
Onica crafted a PoC IoT solution that connected the digital and analog sensors on the sterilizer, extracted that data, and sent it to the AWS cloud where key data was displayed in a dashboard to enable real-time monitoring of the performance of the sterilizer.
Onica’s Data and Analytics experts worked with Cerapedics to define and optimize a data model, data types and connectors needed for Open Automation Software (OAS), which was responsible for local communication to the device, to send data to AWS IoT. At this phase, a particular challenge the team overcame was correlating multiple disparate pieces of data in order to present a cohesive message to the AWS backend.
Onica defined the authentication, device identification, MQTT topic hierarchy and a flexible payload format — allowing for future expansion — then built a hardware simulator in its lab environment. The serverless backend received data via AWS IoT, classified it, enriched it using Amazon Kinesis Data Streams and a series of AWS Lambda functions, then stored in both Amazon DynamoDB and Amazon Simple Storage Service (S3), for real-time and historical analysis use cases. By using AWS managed services, the pipeline scales automatically, is resilient to outage, and is cost-effective for any size workload. A series of Amazon QuickSight dashboards provides near-real time visibility into device performance. Additionally, Cerapedics can define threshold-based alerts to trigger notifications for anomalies or other interesting events.
With the new visibility and real-time flow of data, Cerapedics can now incorporate machine learning capabilities to assist in better calibration of the equipment, and anticipate failures.
While creating a smart factory connected to the AWS cloud will streamline the production process, it will not eliminate the need for their skilled staff on site. However, it will drastically reduce the time necessary for monitoring, optimizing the labor time spent on direct production activities. In addition, the value of the predictive maintenance, real-time alerts and analytics capabilities will greatly benefit Cerapedics in lowering the costs, mitigating potential risks and being able to react timely to issues. Armed with a deeper level of data, their team can focus on proactive monitoring and maintenance, anticipating problems before they result in lost productivity and costs.
While working with Onica, Cerapedics appreciated the use of an Agile methodology with sprint structures, and the team was receptive to their needs and requests during planning meetings.
Onica is one of the largest and fastest-growing Amazon Web Services (AWS) Premier Consulting Partners in the world, helping companies enable, operate, and innovate in the cloud. From migration strategy to operational excellence and immersive transformation, Onica is a full spectrum AWS integrator. Learn more at www.onica.com.