Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect®
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In this blog, we recap our recent customer story, “Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect” – Click HERE to download it in its entirety!
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect®
Centralized requirements, Live Traceability™, and enhanced collaboration power Dexcom’s development of life-changing CGM technology.
About Dexcom:
- Develops, manufactures, produces, and distributes Continuous Glucose Monitoring (CGM) systems for diabetes management
- Headquartered in San Diego, California, USA
Dexcom was founded in 1999 to make diabetes management better with the world’s first real-time, integrated CGM system, the Short-Term Sensor (STS). This, and subsequent generations of the device now named the G series, combines hardware, software, and firmware to deliver an optimal user experience for making decisions about insulin and food intake.
After most of its history as a single product company, Dexcom developed Stelo, a wearable glucose biosensor available over-the-counter for people with type 2 diabetes who don’t require insulin.
RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences
CHALLENGES
- Siloed Tooling: A document-centric approach and legacy tools created barriers to adoption and collaboration across engineering disciplines.
- Traceability Gaps: Lack of a unified view of traceability made change management complex and created confusion across teams.
- Regulatory Overhead: Manual processes for generating regulatory document templates caused significant delays and administrative burden.
- System Complexity: Managing a complex set of interconnected hardware, software, and embedded requirements lacked a single source of truth.
- Disconnected Ecosystem: Poor connectivity between requirements management and other engineering tools hindered end-to-end visibility.
Dexcom’s products combine software, hardware, and firmware, each with their own requirements and tests that must be managed and traced for compliance. As the company scaled, the existing processes, which relied on a mix of legacy tools, spreadsheets, and documents created information silos. Teams were often uncertain if they were working with the latest requirements, leading to rework and inefficiencies.
Generating audit-ready documents for regulatory compliance was a time-consuming, manual effort. The engineering and quality organizations invested significant time in manual documentation to ensure their products were always safe, effective, and compliant.
“We have a lot of smart people who joined Dexcom with expectations about doing great things. Having them spend a significant amount of their time manually copying and pasting in spreadsheets and Word documents is not the best use of their talent and expertise,” says Sri Harsha Maramraju, Senior Manager, Systems Design Engineering at Dexcom
RELATED: Application of Risk Analysis Techniques in Jama Connect to Satisfy ISO 14971
EVALUATION CRITERIA
- A central repository to keep all stakeholders informed of requirements status and changes.
- An intuitive user experience to encourage broad adoption and cross- functional collaboration.
- Full end-to-end traceability of all requirements and tests to support design controls and compliance.
Dexcom identified the need for a modern, centralized platform to manage requirements, tests, reviews, and documentation. The goal was to find a system with an intuitive interface and clear traceability to improve efficiency, stakeholder engagement, and compliance readiness. After a thorough evaluation of several leading solutions, the stakeholders selected Jama Connect. The platform’s exceptional usability, robust traceability visualization, and deep-rooted acceptance in the medical device industry made it the clear choice.
Key evaluation areas where Jama Connect excelled were its ease of use and powerful document generation capabilities. Another critical factor was its ability to provide clear visibility into the end-to-end traceability of all hardware, software, and firmware requirements and tests.
“Other tools have traceability, but only Jama Connect has a visual, configurable model that shows exactly what traceability looks like and accommodates our product’s complex configuration.” Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom
For regulatory compliance, Jama Connect stood out with its out-of-the-box framework for medical device development, which simplifies alignment with stringent quality and safety standards.
“The built-in support for standards like ISO 14971 and the validated package included with Jama Connect give us the confidence to demonstrate that we are following industry best practices,” says Maramraju.
RELATED: Jama Connect for Medical Device Development
OUTCOMES
- Streamlined change management and reviews for monthly releases using Jama Connect’s Review Center.
- Achieved a 60% productivity boost for the systems engineering team, enabling faster project completion.
- Successfully migrated active projects to Jama Connect, ensuring a smooth transition to a modern platform.
- Driving reuse of requirements and tests across projects to support product line engineering (PLE) goals.
“If you’re building a centralized ecosystem for product development and design controls for the long term, you can rely on Jama Connect. Its usability, traceability, and industry-wide acceptance make it a cornerstone of our engineering process.” – Sri Harsha Maramraju – Senior Manager, Systems Design Engineering at Dexcom
Dexcom now depends on Jama Connect to efficiently manage requirements, changes, and reviews for its aggressive release cadence. Having one centralized place for these activities has improved systems engineering efficiency by 60%. The intuitive collaboration and review functionality in Jama Connect has increased stakeholder engagement. Quality and Regulatory teams now actively participate in the process within the tool, appreciating the structure and auditability it provides. “The conversation has shifted. Instead of discussing tool limitations, our teams now have productive, data-driven discussions about the work itself within Jama Connect. When other departments see what we are doing, they ask how they can get their projects onto the platform too,” says Maramraju.
Jama Connect’s Live Traceability™ has enabled Dexcom to track requirements through all stages of development, with integrations that sync requirements data to development activities in other tools like Jira. Looking forward, Dexcom is leveraging Jama Connect to drive reuse and synchronization of requirements across different platforms, a key step toward their product line engineering goals.
TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Dexcom Achieves 60% Systems Engineering Efficiency Improvement with Jama Connect
Senior Product Marketing Manager at Jama Software
Tom Rish is a biomedical engineer with over 15 years of experience developing medical devices. His work has spanned the entire MedTech product lifecycle, from initial concept through market launch. He is passionate about helping others navigate the complex journey of bringing a device to market so that patients around the world can benefit from life-changing technologies. Tom is currently a member of the Product Marketing team at Jama Software.
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