Enlil Paves the Way for Simplified Requirements Management at EMS

Founded in 2009 and headquartered in San Jose, California, Energy Medical Systems(EMS), specializes in the design, research, development, and manufacturing of medical devices. As an ISO 13485:2016 certified contract manufacturer, EMS supports its clients through every stage of the medical device lifecycle, from initial design and regulatory compliance to prototyping and low-volume production.

Erik Buchholtz, a Staff Software Engineer at EMS, leads the development and documentation of product and software/firmware requirement specifications. Recruited in early 2024, Erik’s initial task was to evaluate systems and select new technology to replace the manual requirements management process EMS had relied on for years. EMS was looking to transform its operations digitally to meet the demands of large medical device companies.

With over 20 years of experience in the medical device industry, Erik has worked with various QMS and requirements management tools, including Jama Connect, JIRA, Matrix Requirements, and X-ray Test Management. Leveraging this extensive knowledge, he shared his journey of implementing the Enlil platform at EMS, which began in June 2024.

Before adopting Enlil Trace and Risk, EMS tracked its requirements management and document revision processes through spreadsheets. This manual approach made it difficult to maintain clear traceability for Engineering Change Orders (ECOs) and to link interdependencies across the product development lifecycle. Additionally, validating final product specifications for client review was time-consuming and labor-intensive.

When implementing a new system, the biggest challenge is often the data migration. However, according to Erik the transition from EMS’s spreadsheet-based system to Enlil was seamless. “The import feature in Enlil Trace and Risk for transforming Word documents and table data into objects or 'snippets' is fantastic,” said Erik. “Not only does the snippets concept simplify data transformation, but it also allows EMS to establish a real-time traceability solution quickly.”

Once the data migration was complete, Erik tested Enlil’s functionality by linking snippets in Trace and Risk across various documents, such as product specifications, hardware and software requirements, design documentation, and Failure Modes and Effects Analysis (FMEA). “Enlil handled one-to-one, one-to-some, and some-to-many interdependencies perfectly,” Erik noted, “and the Enlil staff have been outrageously good in proposing solutions that fit our needs.” He particularly praised Ayah Al Buni, Product Management Business Analyst, and Arti Kamath, Customer Success Lead, for their quick responses and unwavering support.

EMS has already produced its first customer product specification document using Enlil’s collaborative requirements management tools, and the team is thrilled with the outcome. Erik described the entire process as “smooth as glass.”

With his background in QMS and requirements management systems, Erik is well-positioned to assess various solutions. When weighing Enlil’s Trace and Risk against Jama Connect, he likens the comparison in this way:

• Jama Connect: A comprehensive solution, though costly and with a steeper learning curve.
• Enlil Trace and Risk: A user-friendly, all-in-one platform that guides users through exactly what they need.

Next on the EMS roadmap is to provide clients with access to their own Enlil instances, enabling collaboration, review, and approval of documents. This move will not only strengthen existing customer partnerships but also open new doors for EMS to engage with larger enterprise-level medical device companies, fueling future growth.