Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story
About Onera
Onera Health develops clinical-grade remote diagnostics and monitoring solutions, making home polysomnography broadly accessible and user-friendly for anyone who needs it, wherever they are.
Customer Story Overview
Onera Health has developed a sleep diagnostic system utilizing four patch-based sensors that patients could apply at home. Initially, the Onera STS 1 product development team conducted pilot studies and relied on Microsoft Excel and Word to manage requirements and create the necessary documentation for successful Medical Device Directive (MDD) and Food and Drug Administration (FDA) submissions.
With the development of the company’s second-generation commercial product, the Onera STS 2, and its integration into Onera’s enhanced end-to-end solution, Onera Health took an active approach in recognizing and acknowledging the increased complexity of its second product. The company began seeking a more structured procedure for managing requirements, tests, and risks.
The new solution needed to provide better access, efficiency, and collaboration for teams working in different disciplines so they could accelerate development with confidence. Onera Health chose Jama Connect because it enabled faster iterations, greater consistency of requirements after changes are made, and visibility into risks and related mitigations.
Faster iterations on requirements due to less time spent in alignment, review, and audit meetings
Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
Visibility into risk identifications and mitigations for internal and regulators’ teams
“We needed a more structured approach due to the complexity involved in maintaining consistency across our entire documentation set. With our first generation, tracking the impact of a design change or updates impacting multiple disciplines was time-consuming and came with its own challenges.” – PIETER ERMERS, FOUNDER AND VP QUALITY & REGULATORY, ONERA HEALTH
Challenges
Complexity of product design, regulations, and document strategy lacking efficiency, scalability, consistency, and accessibility.
Managing requirements and tests, while maintaining document consistency, was generally challenging due to product and regulatory complexity, as well as the limitations of an on-premises document database. Additionally, accessing the database required a VPN which can slow work or interrupt progress when the connection was down.
“We chose Jama Connect because of its intuitive user experience, cloud-based availability, and flexible output that our global team needed. Jama Software Consultants were very supportive in helping us understand how to set up Jama Connect to achieve our goals.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH
One cloud-based system, accessible and user-friendly, with integrated collaboration and reviews, automated test input, and flexible reporting.
The evaluation demonstrated that Jama Connect could easily be accessed and used to manage requirements, tests, and risk based on its intuitive user interface, authoring, collaboration, reviews, and verification. Automated input of test results and flexible output in generating reports provide a tailor-fit to the company’s needs.
“When making changes in a requirement used in multiple sensors, we must maintain consistency of requirements, tests, and documents across teams and disciplines. Jama Connect’s structured approach for automatically checking that everything is covered is very beneficial for us.” – PIETER ERMERS, FOUNDER AND VP, QUALITY AND REGULATORY, ONERA HEALTH
Outcomes
With Jama Connect, the Onera team has experienced the following benefits:
Faster iteration on requirements due to less time spent in alignment, review, and audit meetings
Consistency of requirements, terminology, configurations, and documents for all teams affected by design changes
Visibility into risk identifications and mitigations for internal and regulators’ teams
In this blog, we recap a preview of our recent webinar. Click HERE to watch it in its entirety.
Making Sense of ASQMS: A New Standard for Automotive Software Quality
The Next Automotive Software Standard Is Here. Are You Ready for ASQMS?
The shift toward software-defined, new energy, and intelligent vehicles is transforming the automotive industry. As vehicles become more reliant on complex software to power advanced features, autonomy, and connectivity, the need for robust quality management has never been greater. To meet this challenge, China’s CACPQSP introduced the Automotive Software Quality Management System (ASQMS).
An overview of ASQMS, who published it, and why it matters
Key differences between ASQMS, ASPICE, and IATF, including new lifecycle requirements
Why ASQMS complements, rather than replaces, ASPICE
Practical tips for risk-based software classification and lifecycle coverage
Actionable next steps to strengthen software quality and efficiency
The Above Video Is A Preview – Click HERE To Watch The Entire Webinar
VIDEO TRANSCRIPT PREVIEW
Ronald Melster: Thank you very much for the warm introduction and thank you very much also for inviting me to today’s webinar. I am excited to be here with all of you and to share with you the information about this new standard ASQMS. So let’s get started and explore what the standard means for the automotive world and how we can best adapt to it. For those of you who don’t know me yet, my name is Ronald Melster. In the automotive world, I’m simply known as Ron. As one of Europe’s most experienced Automotive SPICE principal assessors, I have spent nearly three decades helping organizations transform their development processes. Since 2005, I’ve been guiding teams not just to achieve higher capability levels, but to truly understand the why behind effective processes. My journey began in the 1990s when I studied computer science in Berlin and Edinburgh, but I quickly discovered my passion for software engineering and processes. What started as a love for coding evolved into a mission to help teams balance structure with pragmatism.
Over the years, I have had the privilege of working with industry leaders like Bosch, Audi, Porsche, and Here Technologies. One of my biggest achievements was leading a Bosch development division with 7,000 engineers worldwide to capability level 3, proving that even larger teams can embrace systematic improvements. But here’s what I’ve learned. Assessments are not just about ratings. They’re about empowering people, building confidence, and creating sustainable change. Whether it’s functional safety according to ISO 26262, cybersecurity, or process improvement initiatives, I’m here as your mentor, coach, and sparring partner. Maybe you have heard the rumors about this new China standard and you want to learn more about it. You have come to the right place. Let’s start with the name of ASQMS, Automotive Software Quality Management System. That’s the full name of the standard, and yes, it’s a Chinese standard.
We will take that apart piece by piece in this webinar. So the first question is which body exactly published this ASQMS standard? And the answer is the Chinese Association of Consumer Products Quality and Safety Promotion, short CACPQSP. Say this three times. This body is dedicated to consumer rights and their safety and regulates consumer products, including cars. To promote this, they created the ASQMS standard and demand that each OEM selling cars in China needs to be certified according to the standard. So naturally, it applies to Chinese OEMs selling in China, and it also applies to European OEMs wanting to sell cars in China as well. And there’s more. The OEMs are required to request the certificate from their suppliers as well, so it also applies to any supplier tier two or tier one if they want to be part of the supply chain for cars sold in China.
Let’s have a look at why they created the standard and why we need another standard if we have Automotive SPICE or ASPICE. The reason for that is the dependency on software in the car. The complexity is growing rapidly. The number of technical and organizational interfaces gets bigger every day, and the cars increasingly rely on data coming from the outside. Let me share an observation with companies trying to reach capability level 2, according to Automotive SPICE. At the beginning of the project, the capability level is at a stable level 0. Then it takes one, or two, or even three years to get to level 1 and then to level 2. Then the project delivers the result and is finished. And the next project start again at level 0. I call this cycle the chainsaw or zigzag, up and down and up and down. It’s a huge waste of time and effort, and might have led to the ASPICE frustration, which we observed in networks like LinkedIn.
Melster: Why is that? Because the knowledge is not captured after the project in the company, nor is it standardized or rolled out. Only few companies have managed to establish a stable level 3 with a standard process according to ASPICE. Why can a project not start in a systematic way, aka level 2 or level 3, from the start of the project? This will also reduce the technical debt, which is built up every time a project starts from level 0. There are some of the reasons why this new standard was developed. We need a strong focus on software development. We need to include the software outside the vehicle, and we need to focus on the organization to provide standard process which is applied in each and every project in a similar way. And I might add that we need to take care of the software long after the initial development phase. In a world with rising cybersecurity issues, the software must be maintained and updated if new threats become known. Therefore, ASQMS includes the entire life cycle, including the termination of the software with a systematic deletion of all personal data.
Let’s talk about what’s inside the standard ASQMS and how it’s structured. The standard contains three kinds of requirements, which must be implemented by a company which wants to be certified according to ASQMS. The first one are basic practices, not base practices, but basic practices. They’re mandatory for all automotive development. The second kind of practices are advanced practices. They must be implemented by products which are safety or cybersecurity relevant. And the third type of requirements are recommended practices. They should be implemented by all software projects. The ASQMS standard follows a risk-based approach, which means that not all requirements, which are defined by the standard need to be implemented in each development program. For that, a classification is introduced, the two classes or types of software.
Type II is a software that carries a risk related to safety or cybersecurity, and type I is the rest of the software, which is not related to safety or cybersecurity. For type II software, the cybersecurity or safety-related, the basic practices are mandatory, and the advanced practices are mandatory. The recommended practices are recommended. For type I software, which are not as critical, only the basic practices are mandatory, and advanced and recommended practices are optional. ASQMS clusters the processes into three groups: operational processes, supporting processes, and system management processes. The operational processes include project management and the entire V-model with requirements engineering, architectural design, detailed design and implementation, unit verification, integration, and verification testing.
Apart from these well-known engineering processes, the following processes are defined as part of the operational processes: supplier management, software release, software deployment, software maintenance, user information management, and software termination. So there’s some overlap and some new processes. The supporting processes include some which we already know from Automotive SPICE like configuration management, problem resolution management, change request management, and of course, quality assurance. They even have the same process names. The basic practices may differ in some aspects. And some new supporting processes are introduced like documentation management, equipment and facilities, knowledge management, revenue management, and externally supplied products and services, which includes the management of free and open-source software.
Melster: With the system management processes, something completely new is introduced. They’re not to be confused with the system development processes, which we know from ASPICE. System here refers to the quality management system in the name of ASQMS. So it’s similar to ISO 9001, or ITF 16949, or an information security management system, which gets certified by TSACS. These processes include the scope and the context of the organization, the quality management system fundamentals like quality policies and roles, personnel management, performance evaluation, and the continuous improvement process. In this next section, I will highlight some of the key changes when we compare Automotive SPICE with ASQMS. The first one is the software, which is in the scope of the standard ASQMS. The requirements are not only mandatory for in-vehicle software, which many of us have known for a long time, but also for software outside the vehicle is in scope.
This includes any software in the cloud providing data to the vehicle or to an entire fleet. It furthermore includes any system along the roads, so-called roadside systems. Again, exchanging information with the car or even controlling the behavior of the vehicle. And it applies to the software tool chains which are used for software development and maintenance. The next important change is the lifecycle. Automotive SPICE development projects typically stop with the release of the finished software, whatever this means. The maintenance phase is usually left out or ignored, and really no one thinks about the termination of the software in an ASPICE project. This will change with ASQMS. The entire lifecycle of the software must be covered. This only starts with the initial development phase and must be continued with the ongoing maintenance of the software until the termination of the software. You might want to know, what is the termination more than switching off the software? Well, many software instances store data, oftentimes personal data, and this information must be securely deleted as part of the termination.
Many companies claim that they are ASPICE level 2 certified. However, this is not true. There is no such certification. What they have reached in most cases is a level 2 in one project at a certain time. So this does not apply to any other project in the same company without performing additional assessments, nor is the claim true in the future or after the assessment for the same project. So here’s the last key change I will talk about. ASPICE assessments are statements about projects at a certain point in time. This statement cannot be carried over to any other project in the company, nor is it valid in the future. ASQMS, on the other hand, focuses on the organization. This means that the organization must establish processes to fulfill the requirements and maintain them in each and every development project. This also includes internal auditing activities to make sure that all projects follow the defined rules and methods. And as I’ve mentioned earlier, it also includes processes to provide competence staff to the project. Only then will the company get the ASQMS certificate, which is published by an external auditor.
So what have we learned today about how ASPICE and ASQMS can work together? First, ASPICE integration. ASQMS will not replace Automotive SPICE. Instead, ASPICE can be used to show the conformance with the overall standard processes. And if you are already using ASPICE at the project level, these methods can be scaled to the entire organization using the approach of ASQMS. Second, both standards have shared goals. They’re built on the same fundamental principles, traceability, clear structure, and well-defined roles. Whether you’re working on a senior development project or managing quality across multiple teams, these core elements remain the same. And finally, ASQMS is extending the scope. Here’s where ASQMS goes beyond traditional ASPICE scopes. It adds organizational elements like leadership development, culture building, and personnel focus. The reality, ASPICE and ASQMS work as a partner, not competitors. Automotive SPICE gives you project-level excellence while ASQMS builds the organizational capability to sustain that excellence across all your software activities. Together, they create a comprehensive quality approach that works at every level.
Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect® for Nuclear Reactor Design and I&C Development
Designing and constructing nuclear systems and facilities, with instrumentation and control systems, is one of the most intricate and regulated endeavors any organization can undertake. The process of managing, defining, and tracing functional, safety, security, design, performance, independence, reliability, and special treatment requirements for complex nuclear reactors, along with their facilities, systems, subsystems, structures, and components, is compounded by strict, country-specific regulatory guidance and standards.
The design process is iterative and driven by continuous risk, safety, hazard, accident, and security analysis and mitigations. Revisions during and post-design and construction, based on safety/risk assessments and regulatory feedback lead to rework and reengineering, increasing costs and elongating timelines.
Effective requirements management, end-to-end traceability across the entire systems engineering process, continuous risk analysis and mitigations across the entire design cycle, and a single source of truth for systems engineering data aggregated across the digital thread are critical for project success. Failure to accurately categorize safety and security functions, classify structures, systems and components (SSCs), and assess the criticality of initiating events and hazards in compliance with the applicable regulations (IEAE,ONR, etc.) can delay certifications and project completion, dramatically increase costs, and jeopardize the safe state of the nuclear plant.
KEY BENEFITS
Streamline safety design assessments: Jama Connect offers a single source of truth for the digital safety assessment of a nuclear system, including qualitative hazard evaluations, probabilistic safety assessments, design failure, accident, and dose consequence analysis, FHA, security analysis, and combined risks mitigations.
Enhance collaboration across development teams and supply chain: Jama Connect natively enables co-development within the supply chain and external subcontractors, and improved communication and alignment between cross-functional teams and with external safety assessors.
Achieve end-to-end traceability across your development toolchain: Jama Connect’s Traceability Information Model™ outlines an end-to-end process for the requirements and design definition and decomposition, V&V, risk/safety/security analysis, and system implementation. With Live Traceability™, exchange system implementation specific data like models, architectures, parts/assemblies, tasks continuously with MBSE, PLM, work management, and P&ID tools.
Automate risk categorization and classification: Replace manual, error-prone categorization of risks and classes by letting Jama Connect automatically assess and calculate the criticality, categorization and classification of events, functions, and SSCs.
Jama Connect for Nuclear Reactor Design and I&C Development is purpose-built to guide engineers through the systems development and digital safety assessment of a nuclear system, automatically measure the completeness and quality of traceability across the entire digital thread, and enable the automated creation of digital safety reports.
Jama Software’s nuclear framework is oriented towards and based on the guidance of the NRIC for the usage of digital engineering tools for nuclear DSAs (digital safety assessments), the guidance of IAEA and ONR for the Categorization and Classification of Functions and SSCs, and IEC 61513, and IEC 61508 for the development of I&C systems.
Here’s how Jama Connect can help your team streamline processes, improve safety outcomes, and meet regulatory requirements:
End-to-End Traceability Across All Levels
With Jama Connect, you can ensure complete traceability across the design and engineering process – from product definition and design to V&V, safety and security classifications, categorizations and analysis, and product implementation. Our platform connects every design element — from mission-level objectives down to individual components, assemblies, and parts. Live Traceability not only satisfies regulatory demands but also provides critical insights into how changes at any level and any stage impact the entire system.
Traceability at every level: From mission needs and platform designs, to systems, subsystems to individual components, Jama Connect traces risks, requirements, V&V, and implementation elements are connected in an iterative, risk-driven process.
Event-function-SSC traceability: Map initiating events, safety, and security functions, and SSCs seamlessly, helping ensure safety-critical events are covered at every level.
Dynamic risk-response integration: Feed critical information like initiating events, identified hazards, safety, security and reliability requirements, and special treatments directly into the design, ensuring risks are evaluated and mitigated throughout the lifecycle.
Streamlined Safety Design Assessments
Regulatory requirements for nuclear reactor certification differ from country to country, but the principles of risk/safety/security analysis, safety and security classification, and categorization remain universal. Jama Connect simplifies this process by guiding teams through compliance-specific workflows.
Safety and security classification and categorization: Automate initial and final classification of safety/security functions, SSCs, and events. Automatically assign safety categories using calculated fields and lookup metrics based on global or country-specific nuclear standards.
Iterative compliance support: Conduct preliminary safety assessments early and refine security functions as the design evolves. Ensure that every regulatory stage is met with precision, from early safety categorizations to final licensing approvals.
Digital export for documentation: Generate detailed certification-ready documentation of classification assignments, risk analyses, and hazard outcomes for key documentation items like safety and security cases or preliminary and final design safety reports.
Seamless Integration Across Digital Engineering Tools
To ensure every aspect of the development process stays connected and enable the DSA (Digital Safety Assessment), Jama Connect integrates with industry-standard tools used for model-based systems engineering (MBSE), product lifecycle management (PLM), and after simulation:
MBSE: Collaborate effectively by connecting Jama Connect with tools like Cameo Systems Modeler (aka CATIA Magic) or Enterprise Architect to exchange architecture, models, and design data.
PLM: Sync parts, assemblies, and change requests with PLM tools like PTC Windchill, Aras PLM, or Siemens Teamcenter to manage parts and mechanical implementations efficiently.
P&ID: Diagram synchronization (either direct or via PLM) with tools like PTC Creo or Siemens NX.
Software development and work management: Easily sync tasks, stories, and epics with tools like Jira or Azure DevOps to ensure software requirements are implemented.
Digital threads: Create and manage a fully integrated digital thread that ties all relevant data from requirements and designs, V&V, MBSE, PLM, simulation and visualization, safety assessment, and risk management, enabling end-to-end traceability, completion measurements, change impact analysis, and the automatic detection of gaps and risks.
Risk Analysis and Hazard Management
Risk analysis is the backbone of safety in nuclear reactor design. Jama Connect supports rigorous risk, safety, and security analysis throughout the iterative design lifecycle, from the initial qualitative hazard evaluation to the analysis of initiative events, classification and categorization of functions and SSC, DID analysis to the probabilistic safety assessments, SSA, and DCA.
Initiating events from qualitative hazard evaluation: Identify events that could jeopardize the safe state of the nuclear power plant. operation, including those rooted in design, external hazards, or past regulatory findings.
Hazard analysis and mitigation – probabilistic safety assessment: Collect and analyze identified hazards, assess severity, and create safety requirements that feed directly into system updates. Out of the box HARA and HAZOP data models.
SAA, FHA, DQA, and combined risks: Conduct severe accident analysis, fire hazard analysis, dose consequence analysis, combine/enveloped risk assessments, and derive mitigations and special treatments as part of Jama Connect’s end-to-end traceability.
By centralizing all information within a single source of truth, Jama Connect eliminates inefficiencies, reduces rework, and fosters alignment between teams.
Agile-compatible iterations: Adapt requirements and designs iteratively as new risks or design details emerge.
Collaborative team environment: Share updates and insights in real time, ensuring stakeholders, engineers, and regulators remain aligned at every stage. Easy to initiate and complete reviews and approvals.
Automated workflows: Save time by automating time-intensive, repetitive tasks like hazard categorization and safety classification.
AI-enabled Intelligent Engineering
AI analysis and automation with Jama Connect Advisor™ improves productivity and product development outcomes.
Requirements quality intelligence: Enhance the quality and clarity of requirement language to significantly reduce a major cause of defects.
Test case intelligence: Streamline verification by automatically generating test cases derived from requirements.
Organizations at the forefront of nuclear innovations — including those overseeing and developing small modular reactors (SMRs) — recognize Jama Connect as a transformative tool in navigating the unique challenges of the industry.
From guiding teams through compliance workflows to empowering iterative risk analysis, Jama Connect for Nuclear Reactor Design and I&C Development is reshaping how the nuclear industry approaches design and certification. Its ability to combine traditional systems engineering approaches with modern digital iterative processes and digital safety assessments are redefining what’s possible in a nuclear reactor development.
To learn more about managing your nuclear requirements, tests, and risks with Jama Connect, visit jamasoftware.com
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.
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
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
“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.
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.
AI in MedTech: Transforming Device Innovation and Quality
No matter where you turn these days, it is nearly impossible to escape the influence of AI. The MedTech industry is no different and stands at the brink of an AI revolution. From smarter devices to streamlined quality systems and even regulatory reviews, AI is poised to become a powerful tool across the product lifecycle.
Despite the potential, MedTech companies are lagging a little behind other industries when it comes to the use of AI. Recent industry surveys reveal that while 51% of high-tech companies have successfully integrated AI into their operations, only 24% of medical device organizations have achieved similar adoption rates. This gap represents an unprecedented opportunity for forward-thinking MedTech companies to gain competitive advantage through responsible, intelligent use of AI.
The FDA’s recent appointment of Jeremy Walsh as Chief AI Officer signals a clear regulatory shift toward embracing AI technologies that can accelerate device development while maintaining rigorous safety standards. Organizations that strategically implement AI across their device development, quality management systems, and regulatory processes will be positioned to deliver safer products faster while reducing operational costs.
AI-Enabled Medical Devices: The Next Generation
AI is increasingly embedded directly into medical devices, enabling real-time diagnostics, predictive analytics, and enhanced imaging. In fact, the FDA authorized 235 AI-enabled devices in 2024 alone, the most in its history.
Despite the success of an increasing number of devices being launched, much still needs to be done to ensure the devices are safe and meet their intended purposes.
The Validation Imperative
Recent research published in JAMA Health Forum analyzed 950 AI-enabled medical devices and found a concerning trend; devices without proper clinical validation were significantly more likely to be recalled. The study revealed that 43% of all recalls occurred within one year of FDA authorization, with diagnostic errors and functionality delays being the most common causes.
This data highlights a critical responsibility for manufacturers; robust clinical validation must be built into your AI device development process from day one. Companies that prioritize validation studies demonstrate measurably better post-market performance and reduced recall risk.
Practical Implementation Strategies for AI-enabled Devices
Start with Data Quality: AI algorithms require clean, structured datasets to function effectively. Implement data governance protocols that ensure your training data meets the highest quality standards.
Design for Continuous Learning: Modern AI-enabled devices benefit from continuous monitoring and improvement. Build infrastructure that supports ongoing data collection and algorithm refinement while maintaining regulatory compliance.
Plan for Regulatory Pathways: The FDA’s 510(k) process for AI devices is evolving rapidly. Stay informed about emerging guidance documents and consider engaging with FDA early in your development process through pre-submission meetings.
Implement Robust Testing: Beyond clinical validation, establish comprehensive testing protocols that evaluate your AI systems under real-world conditions, including edge cases and unexpected inputs.
AI in Quality Management Systems: Efficiency Through Intelligence
AI is not just for use within a device; it can transform operations too. From document generation to requirements management to supplier evaluation, AI can dramatically reduce manual effort and improve accuracy. Yet, only 10% of Medtech companies report measurable value from AI so far, compared to 24% across other industries. Quality management represents one of the most promising applications for AI in MedTech, where document-intensive processes create natural opportunities for automation and optimization.
Document Intelligence and Process Automation
AI-powered quality management systems can transform time-consuming manual processes into streamlined, automated workflows. Leading organizations report 60-70% reductions in initial document drafting time and weeks of improvement in overall review cycles when implementing AI solutions for regulatory document generation.
The key to success lies in establishing proper document management infrastructure before deploying AI tools. When quality teams maintain organized, structured document systems, AI can effectively analyze historical deviation reports to identify emerging patterns, generate compliance documentation that aligns with current specifications, and automate routine quality review processes.
Strategic Implementation Approach
Assess Your Document Infrastructure: Evaluate whether your team can rapidly locate current versions of critical documents and whether workflows are standardized across departments. These capabilities directly determine AI implementation success.
Start with High-Volume, Low-Risk Processes: Begin AI implementation with routine documentation tasks like generating standard operating procedures or compiling reports. This approach allows teams to build confidence while minimizing regulatory risk.
Maintain Human Oversight: Position AI as a capability enhancement rather than human replacement. Quality professionals should conduct comprehensive reviews and maintain final approval authority for all AI-generated content.
Establish Clear Governance: Create company-wide guidelines that specify which quality processes can utilize AI assistance, and which require traditional human-driven approaches. This clarity ensures regulatory compliance while capturing efficiency gains.
Regulatory Bodies Embrace AI: The FDA’s Digital Transformation
The FDA’s AI implementation aims to reduce non-productive busywork and accelerate review times for new therapies and devices. This regulatory modernization creates opportunities for companies that align their submission strategies with the FDA’s digital capabilities.
Prepare for AI-Assisted Reviews: Structure your regulatory submissions to work effectively with AI-powered analysis tools. This includes using standardized formats, clear section headings, and consistent terminology throughout your documentation.
Leverage Data-Driven Insights: The FDA’s AI systems will likely identify patterns across submissions that can inform your development strategy. Companies that maintain robust data collection and analysis capabilities will be better positioned to benefit from these insights.
Stay Informed on Evolving Guidance: The FDA has indicated that more details on their AI initiative will continue to be released. Monitor these developments closely and consider how they might impact your regulatory strategy.
Building Regulatory-Ready AI Systems
When developing AI-enabled devices, design your systems to generate the comprehensive documentation that regulatory bodies require. This includes maintaining detailed training data records, algorithm performance metrics, and clinical validation evidence that demonstrates real-world effectiveness.
How Jama Connect® Can Accelerate Your AI Journey
Requirements management plays a critical role in successful AI implementation for MedTech companies. Jama Connect provides the structured foundation necessary for AI-enabled development processes.
Jama Connect Advisor™ leverages natural language processing to help teams author requirements quickly and accurately, ensuring that AI system specifications meet the highest quality standards from the outset. This AI-powered feature analyzes requirements against industry best practices such as INCOSE and EARS, providing immediate feedback that improves requirement quality and reduces development risks.
The platform’s comprehensive Live Traceability™ capabilities ensure that AI system requirements remain connected to design decisions, test results, and regulatory submissions throughout the development lifecycle. This end-to-end visibility is essential for demonstrating compliance and supporting regulatory submissions for AI-enabled devices.
The intersection of AI and MedTech presents unprecedented opportunities for organizations willing to invest in the proper foundation and strategic approach. Companies that begin building their AI capabilities now will be positioned to lead the industry as regulatory frameworks mature and competitive pressures intensify.
The key to success lies not just in adopting AI technology, but in implementing it thoughtfully within robust quality management and regulatory compliance frameworks. Organizations that prioritize data quality, maintain human oversight, and align their AI strategies with evolving regulatory expectations will realize the greatest benefits from this transformational technology.
Ready to explore how AI can enhance your MedTech development processes? Book a demo with Jama Software to discover how our AI-powered requirements management solutions can help you build safer, more effective medical devices while streamlining your path to market.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.
Jama Software Launches Jama Connect® Availability in AWS Marketplace
Jama Software, the industry-leading requirements management and traceability solution provider, announced today that Jama Connect, and its add-ons, Jama Connect Interchange™, and Jama Connect Advisor™ are now available in AWS Marketplace, a digital catalog with thousands of software listings from independent software vendors that make it easy to find, test, buy, and deploy software that runs on Amazon Web Services (AWS).
Jama Connect, designed for teams prioritizing precision and collaboration, streamlines requirements gathering, management, and validation with unmatched efficiency. Now available in AWS Marketplace, customers can easily access Jama Connect, along with Jama Connect Interchange and Jama Connect Advisor—simplifying purchase, management, and integration while enhancing traceability, reducing risks, and accelerating time to market.
“Jama Software’s partnership with AWS highlights our commitment to cloud native and scalable cloud technology. Our collaboration with AWS allows us to work hand in hand with their consultancy services to deliver best of breed cloud native and scalable cloud solutions to our clients. AWS is committed to providing leading edge AI technologies in a ubiquitous manner to their client base. Jama Software leverages this to deliver secure, ethical, and reliable AI technology at the speed of market. Our recent public listing on the AWS marketplace furthers our commitment to this partnership and the success of our clients.” – Jim Davidson, Chief Technology Officer at Jama Software
Jama Connect and its add-ons, Jama Connect Interchange and Jama Connect Advisor are now generally available in AWS Marketplace. For more information on Jama Software and its offerings, please visit https://www.jamasoftware.com/.
Jama Software is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
For more information about Jama Connect services, please visit jamasoftware.com
Data-Driven Reports Show Jama Connect® Outperforms Key Competitors Polarion and Codebeamer
These head-to-head comparisons pit Jama Connect against two major competitors: Polarion ALM and Codebeamer. Based on verified user feedback from the July 2025 Data Quadrant Award, the results paint a clear picture of industry leadership that might surprise you.
The Data Behind the Decisions
SoftwareReviews, a division of Info-Tech Research Group with over two decades of research experience, doesn’t rely on vendor claims or marketing materials. Their methodology digs deep into real user experiences, collecting over 130 data points on each product across the entire software lifecycle.
Every review undergoes rigorous quality assurance to ensure authenticity. Only verified users with legitimate credentials can participate, creating a trustworthy foundation for decision-making. This approach reveals insights you won’t find in traditional product comparisons or vendor demonstrations.
The reports examine both quantitative metrics and qualitative feedback, measuring everything from technical capabilities to emotional satisfaction. This comprehensive view helps you understand not just what the software can do, but how it feels to work with it daily.
Your requirements management platform needs to evolve with your business. The reports evaluate how well each vendor demonstrates forward-thinking innovation and supports customer growth initiatives. Jama Connect shows particularly strong performance in helping customers innovate and continually improving their platform.
Users consistently report that Jama Connect inspires innovation within their organizations, while competitors struggle to maintain the same level of strategic vision. This matters because today’s software purchase becomes tomorrow’s competitive advantage — or disadvantage.
Service Experience
Technical support can make or break your software experience. When critical projects hang in the balance, you need responsive, effective support that treats your business with respect. The data reveals significant differences in how vendors handle customer relationships.
Jama Connect users report notably higher satisfaction with service quality, describing interactions as respectful, efficient, and time-saving. This translates to faster problem resolution and less downtime for your team.
Product Experience
Features matter, but user experience determines adoption success. The reports examine how well each platform enhances performance, maintains reliability, and protects organizational data. These factors directly impact productivity and user satisfaction across your entire team.
The comparison reveals substantial gaps in product experience metrics, with Jama Connect consistently outperforming competitors in reliability and productivity enhancement. Users describe the platform as performance-enhancing rather than burdensome.
Negotiation and Contract
Software procurement involves complex negotiations that set the tone for your entire vendor relationship. The reports evaluate how vendors handle contract discussions, pricing transparency, and initial relationship building.
Data shows marked differences in negotiation approaches, with some vendors prioritizing client interests while others focus primarily on their own objectives. These patterns often predict long-term satisfaction levels.
Conflict Resolution
Disputes and disagreements inevitably arise during software relationships. How vendors handle these situations reveals their true character and commitment to customer success. The reports examine trustworthiness, fairness, and integrity under pressure.
Results show significant variation in conflict resolution approaches, with some vendors maintaining professionalism while others become adversarial. Understanding these tendencies helps you choose partners who will support your success even when challenges arise.
Traditional software evaluations focus on feature checklists and pricing tables. These reports dig deeper into the human elements that determine real-world success. They examine emotional footprints, measuring user sentiment across multiple dimensions of vendor relationships.
The Net Emotional Footprint Score captures user feelings about vendor trustworthiness, respect, and fairness. These emotional responses predict long-term satisfaction better than technical specifications alone. The data reveals substantial differences between vendors in building positive user relationships.
Users don’t just evaluate software — they evaluate the entire experience of working with a vendor. This includes everything from initial sales interactions through ongoing support relationships. The reports capture these nuanced experiences that traditional product reviews miss.
The reports examine 11 core product features specific to requirements management, including:
Agile Work Management: Sprint planning, backlog management, and artifact hierarchy
ALM Integration: Cross-phase artifact integration through APIs and internal systems
Analytics and Reporting: Real-time dashboards and data extraction capabilities
Artifact Management: Creation, reuse, and audit capabilities for project artifacts
Collaboration: Real-time work sharing and communication features
Each feature receives detailed evaluation based on actual user experiences rather than vendor specifications. This reveals gaps between promised functionality and delivered value.
The analysis shows consistent patterns of performance across feature sets, helping you identify vendors who excel broadly rather than in isolated areas. This comprehensive view prevents costly surprises after implementation.
Vendor Capability Deep Dive
Beyond product features, the reports evaluate 11 essential vendor capabilities that determine long-term partnership success:
Business Value Creation: Ability to generate organizational value
Vendor Support: Quality and timeliness of customer assistance
Usability and Intuitiveness: Learning curves and adoption barriers
Implementation Ease: Deployment complexity and timeline predictability
Data Integration: Compatibility with existing systems
These capabilities often matter more than individual features because they affect every aspect of your software experience. Vendor support quality, for instance, impacts how quickly you resolve issues and implement new functionality.
The data reveals significant performance variations across these capabilities, with some vendors excelling consistently while others show uneven performance. This information helps you avoid vendors who might excel in sales presentations but struggle with execution.
Requirements management software represents a significant investment in both financial and organizational terms. The wrong choice creates cascading problems that affect project timelines, team productivity, and business outcomes. These reports provide the evidence needed to make confident decisions.
User feedback reveals real-world performance under actual business conditions. You’ll learn how software performs during high-stress periods, how vendors respond to urgent support requests, and how well platforms scale with growing requirements.
The comparative format lets you evaluate trade-offs between different approaches. Some vendors prioritize feature breadth while others focus on user experience. Understanding these strategic differences helps you align vendor strengths with your organizational priorities.
Your Next Steps
Don’t let requirements management software decisions rest on vendor demonstrations and marketing materials alone. These comprehensive reports provide verified user insights that reveal true performance patterns and vendor capabilities.
The data shows clear performance leaders across multiple evaluation categories, but your specific needs might prioritize different factors. Download both reports to understand the complete competitive landscape and identify the best fit for your organization.
Each report includes detailed breakdowns of user satisfaction metrics, feature comparisons, and vendor capability assessments. You’ll gain access to insights from verified users who’ve implemented these platforms in real business environments.
Requirements management affects every aspect of product development. Choose your platform based on comprehensive data rather than surface-level impressions. These reports provide the evidence you need to make decisions that drive long-term success.
Download the comprehensive head-to-head comparison reports against Polarion, Codebeamer, and IBM® DOORS Next® today and discover why users consistently choose Jama Connect for their requirements management needs.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mario Maldari, Makenna Imholte, McKenzie Jonsson, and Decoteau Wilkerson.
Managing product development across complex teams and toolchains can result in incomplete traceability, delayed deliveries, and costly rework. But it doesn’t have to.
In this session, you’ll learn how Jama Connect® enables engineering teams to achieve Live Traceability™ as a natural part of their daily workflows — unlocking faster, more efficient product development.
What You’ll Learn:
Experience Live Trace Explorer™: Visualize and investigate the full impact of changes across your entire product lifecycle.
Built-In Traceability: Learn how everyday engineering works within Jama Connect to builds and maintain end-to-end traceability.
Speed Up Change Impact Analysis: See how structured data supports faster, more informed decisions.
Boost Quality and Coverage: Ensure complete test coverage, mitigate risk, and improve delivery timelines
The Above Video Is A Preview – Click HERE To Watch The Entire Webinar
VIDEO TRANSCRIPT PREVIEW
Jakob Khazanovich: Good morning, good afternoon, and good evening to everyone joining us. Today, we’re going to explore Live Traceability, what it is, why it matters, and how you can achieve it with Jama Connect. My name is Jakob, and I’m a Senior Solutions Consultant at Jama Software. My job is to help customers be successful in their product development goals by using Jama Connect. My expertise is in systems engineering for the medical device industry, and I’ve also had roles in test and quality engineering. My goal today is to give you clear, practical insights into how traceability works within Jama Connect to help you meet regulatory compliance requirements, ensure complete development and testing coverage, and streamline Change Impact Analysis. We’ll start with a brief introduction to Jama Connect, and then I’ll walk you through what complete traceability looks like in action. We’ll see how this ideal state strengthens development and sustaining engineering practices, and I’ll share the steps to get there. We’ll wrap up with a short Q&A so you can get your questions answered.
So when we talk about capturing data for complex product development, we all know that data in our organizations exists in many different forms. We have documents, we have Excel sheets, those Excel sheets contain rows, and all of those rows have data around a certain requirement or a certain artifact. Now, that’s all fine, but usually, documents or requirements are not so useful in and of themselves. What we actually are after is complete information for our system. Where did our requirements come from? What elements in the design implement that requirement? Did we test to make sure the requirement is met? And so on. When information is fragmented, whether that is requirements, testing, work management items, system architecture, risk management, product management, regulatory, or any other commonly siloed function, this increases risks to the product and end user, increases time to develop, and increases development costs.
What we are looking at here is a typical V-model of development. We have design inputs down the left side, design outputs on the bottom, and testing up the right-hand side. These are typically the steps in a product development effort. Now, this slide highlights a study finding that many will find intuitive. The earlier in the development process the changes are implemented, the less costly it will be to implement that change. But I still found the number staggering. On average, it costs 110 times more to make a change once you are in the design validation phase of your development compared to early on in the requirements definition phase. This hammers home the importance of thorough requirements identification, traceability from requirements to every downstream element in the development, and the need for a streamlined way to evaluate and to implement changes when necessary.
Khazanovich: This is a typical development ecosystem. This structure often leads to negative outcomes, as described in the previous slides. When teams develop documents and designs and siloed tools, then identification of coverage gaps, inadequate change management, failure to assess and manage risk proactively, and countless hours and days building trace matrices are practically expected. Jama Connect solves these challenges and more. Complete information is created by building trace relationships and structure around individual artifacts in the system. When you do that, you basically empower your users to find any information and context to complete their work in the most accurate and efficient way possible. This is done in real-time, creating full traceability as a byproduct of engineering work rather than as a retrospective effort. We call it Live Traceability.
Now, you can go a step further than just traceability, and that would be understanding where decisions come from. You want to capture the why of a change. Why did we change the requirement or the occurrence estimate for a particular risk evaluation? This is invaluable information when changes are being considered or implemented in the product in the future. We will briefly discuss how Jama Connect supports documenting decisions and ensuring that institutional knowledge is minimized as much as possible.
Of course, teams do not develop complex systems in their own specific habitats. They are connected to a greater ecosystem, the many, many connections around them that have input on decisions and have input on those connections. So, engineering partners, customers, and other departments within the company can be invited to take part in that process and must be considered in development and change management processes. In the latter half of this presentation, we will show how we can actually relate information and what is involved in building those relationships. And once we have those relationships, what leverage, what value, and benefit can we get out of those relationships? What kind of higher-level perspective do they give us?
Traceability helps us confirm that we actually built the product we intended to and that every identified risk has been addressed and controlled. Second, embracing change. Products and requirements evolve. Traceability lets us quickly see what parts of the system are impacted by change so we can manage it without introducing new risks or gaps. Next, validation and verification. We need objective evidence that our product meets requirements and user needs. Traceability also lets us confirm that the risk control measures we put in place are truly effective. Live Traceability is the gold standard in product development. It allows you to see the status of your development effort in real-time and enables many benefits that we will later discuss. In Jama Connect, the easiest way to visualize your live traceability is with the Live Trace Explorer, so let’s jump into the tool and see what our gold standard looks like.
Khazanovich: Now, we are in Jama Connect, and we can see the Live Trace Explorer in action. The first thing we can see in the upper right corner is the overall traceability score, which is the number of relationships created, divided by the total expected relationships, based on your defined Traceability Information Model (TIM). This has been filtered down to only consider the relevant and expected trace relationships for this particular project. I can see a nice green symbol in the upper right corner, which, as I remember from my business school days, means that things are going well in my product development. Throughout the development of the product, I saw this score increase from red to yellow to green, with the percentage associated as the traceability was created and completed. Going through the various tiles, here we can see the different sections of the explorer tree and have a more detailed view of which relationships have been created.
For example, I can see that all of my user needs are traced to system requirements, and all of my user needs are traced to validations. Additionally, I can see what percentage of my relationships are valid relationships, meaning that they’re not suspect links. We will discuss suspect links a bit more later. The Live Trace Explorer mirrors the traditional V-model layout, with design inputs on the left-hand side, testing on the right-hand side. I can see that 100% of my user needs are traced to validation test cases, and all of those test cases are included in test plans. I can see a summary as well of any open conversations, which will clue me in to why traceability may be missing or any outstanding questions that the team is trying to align on. If I want to get any additional details on a specific tile, I can click on the desired trace pair, for example, from user needs to requirements, and a new window will open showing my Trace View for the relationship pairing. Within the Trace View, I can then navigate one-by-one and get a preview of my items, like user needs and system requirements.
So, in the Live Trace Explorer, we mentioned the Trace Score™, and you’re probably wondering, how can we compare or calculate a trace score when there are many different ways to create Traceability Information Models, depending on your project and industry? As mentioned previously, the Trace Score is calculated by taking the number of established relationships among model elements, divided by the number of expected relationships among model elements, as specified by the project’s traceability model. Looking at the left diagram here, we can understand that for a single requirement, in this example, there are three expected relationships: one relationship to the user need, one to the subsystem requirement, and one to a verification. In this example, we are missing the trace to verification, so out of the three total traces that we’re expecting, we only have two of those created, resulting in a 66% Traceability Score.
Now, if we look at multiple requirements, let’s say there are three requirements and each of them have a trace to a subsystem requirement, but maybe only one of them is traced to a user need and only two are traced to verification items, now we can see that overall, for those three requirements, we have six of the traces created out of the nine that we’re expecting based on our model. On the right side, you can see how this would be scaled up to the entire project level. We’re going to look at every item that’s created, how many items are expected to trace to it, and then how many items are actually traced to it, and we’re going to look at that as a total for all items. Here, we see 101 expected relationships, 73 of which are established, and that leads to a 72.3% Traceability Score.
Jama Connect® Features in Five: Consumer Electronics Development Solution
We value your time, but this Features in Five video goes beyond the five-minute mark to deliver an information-packed session, hosted by Vlad Tanasescu, GM, Industrial & Consumer Electronics, Jama Software.
Developing consumer electronics is complex, but Jama Connect’s new out-of-the-box solution simplifies the process. Discover how Jama Connect helps teams bring products to market faster while ensuring safety, cybersecurity, and seamless collaboration.
With AI-driven automation, real-time gap detection, and integrations with tools like Jira and GitHub, Jama Connect delivers end-to-end traceability and reduces risks. Whether managing product lines or collaborating with subcontractors, this solution is designed to help you work smarter.
VIDEO TRANSCRIPT
Vlad Tanasescu: Hi, this is Vlad from Jama Software, and today I will walk you through a brief live demonstration of our new out-of-the-box consumer electronics development solution. In this video, we will cover how Jama Connect’s intelligent, guided, and measurable product development approach enables us to launch products to market faster, reduce product recalls and re-engineering, how we can leverage Jama Connect’s engineering AI to automate manual day-to-day engineering tasks, how we can natively co-develop with external subcontractors and contract manufacturers in Jama Connect so that we achieve a central source of truth across our entire engineering data, as well as external traceability, and how we can better leverage product cybersecurity, safety, and risk management in the context of our integrated consumer electronics development.
In Jama Connect, we use process models to define end-to-end product development processes, starting from the ideation definition and design of our products, all the way to the manufacturing, software development, and testing. Jama Connect will use these models to guide engineers through the end-to-end development, automatically measure system and process completion, and automatically detect gaps and risks so that organizations know where to take action. Our out-of-the-box consumer electronics solution contains process guidance for the development of integrated consumer electronics products like laptops, phones, computers, or tablets, as well as for the development of consumer electronics app systems like battery systems, displays, or systems on chips, as well as for the development of standalone software consumer applications.
Within Jama Connect, we can measure and manage the end-to-end traceability from the definition of the product from the highest level of the stakeholder need, all the way down to the part and line of code. As part of the development of end-to-end consumer electronics products, practitioners are integrating Jama Connect with multiple other tools for task management, source code management, and product lifecycle management. Jama Connect will exchange data bidirectionally and continuously with these tools, so that in Jama Connect, we can manage the impact of changes across the end-to-end engineering data, and so that in Jama Connect, we can measure completion and detect gaps programmatically across the digital trend.
Tanasescu: For example, here on the left, we can see a project tree. This project tree will enable findability across the entire engineering data and will enable us to display our product structure, including the components, subsystems, and disciplines that are part of those subsystems and components. The project is entirely customizable. For example, within my software component, I can find the software user story that is linked in traceability with the software functional requirement. This software user still exists in Jama Connect and is bidirectionally and continuously synchronized with tools like Jira, Azure DevOps, as well as with manufacturing tools for parts or design tools for models and architectures.
The developers, the mechanical engineers, the designers, they will not make any change to their way of working, and Jama Connect will manage the end-to-end traceability from the highest level of the requirement all the way down to the implementation. Jama Connect will then measure product completion and detect gaps as mentioned before, across the entire product data. Here we can see to what extent the decomposition of our requirements, the testing against the requirements, or the allocations to architectures is complete, and due to the integrations with other software development, task management, or mechanical tools, we can also measure the completion of the implementation and development of our system. This capability enables organizations to know where they have their biggest gaps and product risks so that they know where to take action, and this type of intelligent product measurement hasn’t been possible historically.
For teams developing standalone consumer electronics software applications, Jama Connect can exchange data bidirectionally and continuously with source code management tools like GitHub and GitLab to enable end-to-end life traceability and the understanding of the impact of changes from the requirements all the way to the lines of code.
Product line engineering is a very important part of our consumer electronics framework. In this project, for example, I’m working on the development of a laptop. This laptop has multiple other variants our engineering teams are working on in parallel, and with a couple of clicks, we can get an overview of all of our variants as well as understand the delta between variants with respect to requirements or designs that are only part of one variant or with regards to shared requirements which are part of both variants one and two but slightly different in each products to fulfill the needs of the variants.
Tanasescu: Once we’ve identified the differences, Jama Connect will allow us to synchronize changes between variants or across our entire product library. These capabilities enable product modularization and help reduce the time needed to start the development of new generations. In Jama Connect, we can also maintain libraries of subsystems, systems, or standard requirements. In this example, I’m maintaining multiple battery versions, multiple versions of a subsystem, and whenever appropriate, I can reuse the respective subsystem version in a new development project.
Jama Connect enables multiple product line engineering approaches, which our customers find very useful. The first one is the approach of the library. From the library, we will be reusing content in different product projects. The second one is the approach of a technology platform where we would be setting up a 150% product containing all the data that we could ever use in a variant, and then when a new release starts or when a new generation product starts, we can branch up the necessary content from the technology platform in the variant.
Jama Connect also enables us to work on multiple releases in parallel and bring over changes from one release to another, and the product line engineering approach in Jama Connect is entirely customizable. Another very important component of our consumer electronics solution is native code development. Consumer electronics companies very often work with external subcontractors and contract manufacturers for the development of subsystem technologies. Contract manufacturers can create engineering content natively in the same environment with the OEM so that the OEM can manage end-to-end traceability and detect gaps externally towards the data provided by the subcontractor. Here as an example, we can use Jama Connect to measure the external traceability.
We can see that only 20% of the specifications that we’ve defined internally have been implemented with designs or parts from our external subcontractors. Functional safety as well as cybersecurity are becoming more and more important for consumer electronics companies. The consumer electronics framework contains out-of-the-box safety, cybersecurity, and failure modes and effects analysis data models, which will enable companies to manage risks and the mitigation of those risks as part of one integrated process with the other functional and non-functional elements of the consumer electronics products. The out-of-the-box data models will enable the automatic calculation and classification of the cybersecurity threats, definition and analysis of the safety risks, as well as the failure modes.
Tanasescu: We believe that artificial intelligence is crucial to reducing time to market. In Jama Connect, we are able to automate key day-to-day engineering tasks. For example, I will manually create a requirement that the laptop shall maintain Wi-Fi connectivity, and then, historically, to test against this requirement, engineers would’ve needed to define the test manually. They would’ve described the parameters and the objectives and then defined the steps that the executor would need to go through. Jama Connect’s engineering AI will derive tests automatically and massively reduce the time needed for test generation and validation. The QA engineer can choose to take over one of multiple tests created by AI, and Jama Connect’s AI* will link the test in traceability with the requirements automatically. Jama Connect’s engineering AI can help automate multiple day-to-day engineering tasks like the generation of requirements, the refinement of requirements, or the creation of traceability across the end-to-end process.
Our AI Relationship Discovery** will enable the user to define what relationship suggestions they’d like to receive. For example, I can choose to ask Jama Connect to show me subsystem requirements and system architecture traceability suggestions for my system requirements, and then Jama Connect will query our product library and display multiple objects that we can choose to relate in traceability with our source objects. The user will have the ability to visualize the content of the suggested relationship, and then will be able to intuitively create a traceability link between the source object and the suggested object.
Thank you very much for your time. If you’d like to find out more about our consumer electronics solution, please visit our website. Thank you.
*Test Case Generation available through our add-on product, Jama Connect Advisor™
**Relationship Discovery coming soon as part of Jama Connect Advisor™
A Quality Leader’s Guide: How to Improve Quality Metrics in Medical Device Development
As a Quality leader in the medical device industry, you face constant pressure to not only ensure products are safe and effective, but to make sure your team is staying compliant with all applicable regulations. Passing audits, hitting project deadlines, and achieving first-time regulatory approval are always at the top of your mind. However, these important goals are often undermined by inefficient processes, disjointed systems that hinder collaboration, and teams not following your quality system procedures. The result? Delays, compliance risks, and, at the very worst, potential product issues.
This article provides a practical guide on how to overcome these challenges. We’ll explore how a modern, collaborative solution can help you improve key quality metrics, foster a true culture of quality, and turn compliance from a burden into a competitive advantage.
TL;DR: Discover how to improve your organization’s quality metrics by implementing a single source of truth for requirements, risk, and test management. With Jama Connect®, you can leverage live traceability, out-of-the-box workflows that are compliant to medical device regulations, and powerful reuse capabilities to reduce risk and streamline product development.
The Challenge: Why Traditional Quality Management Falls Short
If your teams are still relying on a mix of documents, spreadsheets, and siloed tools, you’re likely all too familiar with the pain points. Disconnected systems make it very difficult to maintain a clear, up-to-date view of the entire product development lifecycle. This leads to common problems that directly impact your quality metrics:
Inconsistent Processes: When information is scattered, it’s difficult to enforce standardized procedures, leading to deviations and errors.
Lack of Collaboration: Functional groups struggle to work together effectively, causing misalignments between design requirements, risk analysis, and testing.
Inefficient Workflows: Manual tracking and excessive paperwork consume valuable time, slowing down innovation and delaying time-to-market.
Audit & Compliance Risks: Without a clear, traceable line from requirements to verification, proving compliance during an audit becomes a stressful, time-consuming scramble.
The key takeaway: Disjointed systems don’t just create inefficiency; they actively increase risk and make it harder to deliver high-quality, compliant products on schedule.
How to Improve Quality Metrics with a Modern Solution
Transitioning to a modern requirements management platform like Jama Connect provides a structured path to enhancing your quality metrics. It’s not just about new software; it’s about adopting a more integrated and transparent approach to product development.
Step 1: Establish a Single Source of Truth to Foster a Quality Culture
The foundation of any high-performing quality system is a single source of truth. When all functional groups, including engineering, quality, manufacturing, and more, collaborate within one platform, you eliminate confusion and create consistency.
Jama Connect provides this centralized environment where design requirements, risk management, test management, and design reviews are all interconnected. This ensures that everyone is working from the most current and approved information.
Benefit: Teams follow procedures correctly because the system guides them through structured workflows.
Impact on Metrics: Reduces errors, rework, and inconsistencies, allowing you to hit project deadlines.
Step 2: Leverage Live Traceability™ to Reduce Risk and Ensure Completeness
Passing an audit requires demonstrating that every requirement has been addressed from a risk management perspective, verified and/or validated, and properly reviewed., Manually creating and maintaining traceability matrices is prone to error and incredibly time-consuming.
Live Traceability in Jama Connect automates this process. It creates a real-time, dynamic map that links every requirement to its corresponding tests, risks, and design reviews. If a requirement changes, you can instantly see the downstream impact on testing and risk mitigation.
Benefit: You gain complete visibility into your project’s health and can prove compliance with a few clicks.
Impact on Metrics: Drastically reduces audit preparation time and minimizes the risk of findings. It ensures 100% test coverage, directly improving product quality and safety.
Step 3: Streamline Product Development with Out-of-the-Box Compliance
Meeting medical device regulations like ISO 13485, FDA QSR (soon to be QMSR), ISO 14971, and IEC 62304 demands meticulous documentation and adherence to specific processes. Jama Connect helps you streamline this with pre-configured frameworks and workflows designed specifically for medical device compliance.
Instead of building your compliance structure from scratch, you can use these out-of-the-box solutions to get a head start, ensuring your Medical Device File is built correctly from day one. All information can be easily exported into submission-ready documentation for your Quality Management System (QMS).
Benefit: You can reduce paperwork and focus your team’s efforts on innovation rather than administrative tasks.
Impact on Metrics: Accelerates project timelines and increases the likelihood of achieving regulatory approval on the initial submission.
Step 4: Boost Efficiency and Consistency with Reuse
Do your teams develop multiple versions of a similar product or use common components across different devices? Rewriting and re-verifying or re-validating the same requirements and test cases is a major source of inefficiency.
Jama Connect features powerful libraries that allow you to store, manage, and reuse requirements, risk analyses, and test cases across multiple projects. When an item in the library is updated, the changes can be synced to all projects that use it, ensuring consistency.
Benefit: Saves significant time, reduces the risk of inconsistencies, and frees up engineers to focus on innovation.
Impact on Metrics: Improves development efficiency, reduces costs, and ensures a standardized level of quality across your entire product portfolio.
FAQs: Improving Quality Metrics with Jama Connect
Q: How does Jama Connect specifically help with FDA compliance?
A: Jama Connect helps you adhere to FDA design control regulations like 21 CFR 820.30 by enforcing design controls within a structured environment. Its Live Traceability feature is critical for demonstrating the link between design inputs, outputs, verification, and validation. The platform also simplifies the creation and management of your Design History File (DHF), making it audit-ready at all times. For more details, see our guide on FDA Design Controls.
Q: Can we use Jama Connect without completely overhauling our existing toolchain?
A: Absolutely. Jama Connect is designed to integrate with popular engineering tools (e.g., Jira, Azure DevOps, TestRail). It acts as the central hub for requirements and risk management while allowing your teams to continue using the specialized tools they know best, creating a connected, best-of-breed toolchain.
Q: How does this platform help us use quality as a competitive advantage?
A: By streamlining compliance and improving process efficiency, Jama Connect allows you to get safe, effective products to market faster. This speed, combined with reduced development costs and lower compliance risk, gives you a significant edge over competitors who are still bogged down by manual processes.
Take Control of Your Quality Metrics
Stop letting disjointed systems and manual processes slow down your projects. By embracing a modern, integrated approach, you can improve your quality metrics, pass audits with confidence, and empower your teams to deliver innovative medical devices safely and efficiently.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish, McKenzie Jonsson, and Mark Levitt.
