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Cytovale, a trailblazing medical diagnostics company, is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cleared by the U.S. Food and Drug Administration, Cytovale’s rapid sepsis diagnostic, IntelliSep®, leverages machine learning and advanced microfluidics to provide emergency department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep measures the dysregulated immune system response to infection that would indicate sepsis and generates results in about eight minutes using a standard blood draw.
Arena QMS and Onshape CAD
Centralizing product lifecycle management and quality processes in a single platform
Improved audit preparedness and collaboration across teams
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Arena QMS and Onshape CAD
Centralizing product lifecycle management and quality processes in a single platform
Improved audit preparedness and collaboration across teams
Streamlined documentation and revision control
Standardized processes for changes, nonconformances, CAPAs, and training
Arena-Onshape Connection enables real-time BOM synchronization
Accelerated new product development (NPD) processes
Helped Cytovale achieve ISO 13485 certification, positioning the company ahead of upcoming FDA standards and facilitating future market expansion
Cytovale was transitioning from a venture-backed startup to a commercially viable medical device company. As the company grew and advanced toward commercialization, so did the need to meet demanding regulatory standards and the pressure to do more with fewer resources.
Like many early-stage companies, Cytovale relied on common productivity tools such as Google Drive and SharePoint to manage product documentation and quality systems. This approach came with significant risks and limitations. “Our number one focus was addressing revision management and the security of documents,” explained Stephen Gerding, Quality Manager at Cytovale. “You can lock certain folders in Google but one of the things you can’t do is keep the quality team from mistakenly deleting something or moving it. It’s a huge undertaking to go find, look at the history, and move it back.”
To accelerate the delivery of medical technology to market safely, efficiently, and in compliance with strict regulatory requirements, Cytovale required a dynamic system to support controlled product lifecycle and quality processes.
The systems needed to support three critical needs:
To find the right solution, Cytovale conducted an extensive evaluation process led by a third-party consultant. The goal was to remain objective and identify a platform that checked all the boxes for compliance, usability, scalability, and cost-efficiency. “We had a contractor take as unbiased a look as possible,” Stephen shared. “Arena was one of about 10 platforms we looked at, specifically how they handled change management, BOM control, training, and how other applications like ERP and CAD could be integrated.”
The company chose Arena by PTC, a product-centric quality management system (QMS) to centralize product information, quality processes, and documentation control on a single platform.
Key goals of implementation included:
—Stephen Gerding, Quality Manager at Cytovale
Arena stood out not just for its robust capabilities but for its ability to act as a comprehensive, unified system for all teams. Cytovale had already adopted Onshape, PTC’s cloud-native computer-aided design (CAD) and product data management (PDM) platform, which made Arena’s seamless connection especially attractive. “The Onshape Connection was one of the big selling points for engineering,” Stephen added. “For the quality team, it was more about change management, training, and pricing. Arena continuously came out on top across all the areas we scored.”
The connection with Onshape allows engineers to automatically generate parts, drawings, and BOMs, eliminating redundant work and reducing risk. Jackie Marlin, Systems Team Manager at Cytovale, said,
“Before the connection with Onshape, document and part number requests were slow and error prone.” Stephen noted, “With the Arena-Onshape Connection, engineers get part numbers from Arena, and files are automatically generated in Onshape. Now that we’ve aligned our revision control, the entire process is synchronized and much more efficient.”
Since implementing Arena, Cytovale has realized transformative improvements in documentation control, engineering autonomy, and cross-functional collaboration. What used to be a time-consuming, manual effort to manage documents is now a streamlined, traceable process accessible to all relevant teams. “With Arena, we can independently create and update documents within engineering,” Jackie said. “We don’t have to rely on quality every step of the way. That has significantly sped things up.”
From a compliance perspective, Arena’s version control and change management capabilities have been pivotal. No longer does the quality team need to worry about accidental deletions or misplaced files. Everything is tracked, centralized, and audit ready. “Documentation history is all there at your fingertips,” Stephen emphasized. “We don’t have to dig through folders and wonder, ‘What did I name that again?’ That visibility and control are critical for quality assurance.”
The Arena-Onshape Connection has also unlocked new efficiencies in BOM management and engineering collaboration. Cytovale’s teams can now work from a single source of truth, reducing errors and ensuring alignment across departments.
Supplier collaboration capabilities within Arena, such as sharing release documents securely with partners and streamlining communication, are on the roadmap as Cytovale scales. While not yet active, Stephen acknowledged the long-term value: “If they [suppliers] could access the released documents directly in Arena instead of through email, that would be a major win. It’s part of our phased plan.”
Implementing Arena PLM and QMS has transformed the company’s approach to product lifecycle and quality management. The platform’s centralized environment is flexible, easy to use, and has helped accelerate workflows, improve audit preparedness, and foster greater confidence and collaboration across teams.
Since adopting Arena, the demand for Cytovale medical diagnostics continues to expand. A current customer at a medical center in Baton Rouge, LA, estimates that they’ve evaluated more than 25,000 patients and has reported that the implementation of Cytovale’s Intellisep test enables the hospital to achieve significant clinical improvements such as the following:
With ongoing plans to expand integrations and leverage new capabilities in Arena, Cytovale is well-positioned to support future growth across diverse populations and meet regulatory challenges.
—Stephen Gerding, Quality Manager at Cytovale
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