Aras Briefing Note
Weaving Digital Threads into a Digital Fabric is key to achieving full product lifecycle traceability—allowing companies to track a product and its digital assets all the way from concept through design, manufacturing, quality, and service. Axendia was recently briefed by the executive team at Aras to learn more about its PLM functionality and business ready applications for the Medical Device industry.
After a long term partnership with the Minerva Group, Aras announced the merger of Minerva in January 2022. Minerva’s business-ready applications, built on the Aras platform, enable medical device companies to solve complex digitalization challenges across engineering, manufacturing, supply chains and post market activities.
Making Sense of the Digital Thread Chaos
PLM plays a critical role managing data, processes, decisions, and results across the product lifecycle. “Many medical device companies have a chaos of different databases and digital threads within their organizations,” explained Leon Lauritsen, VP Global Pre-Sales & Sales Enablement at Aras Corporation. Aras Innovator ® brings together the digital thread necessary to trace all the way from design input through design output to verification and validation in the lifecycle of the product.
Whether companies opt for waterfall or concurrent design models, Aras customers can weave their digital thread by connecting across information structures with proper change and release management. “We offer data connectivity and process alignment from user needs, through design process, output and the required validation and verification activities,” said Lauritsen.
Regulatory Structures on Projects
Many projects don’t go exactly as intended. With Aras, project change management and traceability of the change is also included in the platform. It also baselines all of the regulatory documentation structures, which is something its medical device customers have specifically asked for.
Parts and BOMs
Product structures can contain anything from software to mechanical parts. “Some of our clients that have challenges specifically for electronic components and for that, we offer integrations to electronic component databases such as HIS CAPS Universe, which manages 430 million parts,” said Lauritsen.
Today’s complex products often have many variants. The variant engine and the ability to set up different rules for engineering services is also available within the solution. Lauritsen explained this capability is critical for traceability. The solution also offers a 3D viewer of products and parts to visually navigate the product data as well. “We have data management capabilities within our solution, but we don’t have authoring or a simulation tool. However, we can manage the output of the simulation process and data and connect that to the actual test results and automate the simulation process,” explained Lauritsen.
Enabling Regulatory Compliance with PLM
An important aspect for change management is to understand the consequence of a change. The impact matrix within Aras’ change management module assists users to understand the potential impact of changes.
Integrated quality processes are also available with the Aras Innovator platform. “When you get to the final stage of a CAPA, you have to enter effectiveness. That is tracked on the CAPA for the entire duration of the effectiveness check. The platform creates an assignment to an end-user with what to do. Per the solution, the assignment must be completed before the CAPA is closed, “explained Thomas Skagen, Director of Sales Enablement at Aras.
Clients can also manage test specifications within a unified user interface, define the scenarios and steps to define the test specifications and reuse existing scenarios within the solution. This approach pulls the digital thread from intended use, through design input, design output, validation and verification into the traceability matrix.
In addition, risk management, training and learning management are also offered within the Aras platform.
Today, Medical Device Manufacturers are looking for preconfigured solutions for complex problems including business, technology, and regulatory challenges. Aras’s merger of Minerva offers medical device companies business ready applications built on the Aras platform that can support the Medical Device product lifecycle.
Aras Innovator can be deployed at any stage of the product lifecycle, and it can replace or overlay existing technology. The solution can be deployed in the cloud, on-prem or through a hybrid approach.
We will continue to provide updates on Aras as they become available.
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The opinions and analysis expressed in this Briefing Note reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this document is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This document is not intended to endorse any company or product and should not be attributed as such.