Mergers and Acquisitions in MedTech: Positioning Your Company for Success

The MedTech Mergers and Acquisitions (M&A) scene is more active than ever. As global healthcare needs grow and regulatory landscapes shift, strategic acquisitions are becoming a key route to innovation, growth, and market expansion. For emerging MedTech companies, understanding this environment and positioning themselves smartly within it can shape their future.

Recent activity shows that opportunity is abundant for companies that are prepared. Strategic buyers are on the lookout for innovative technologies, strong product pipelines, and solid regulatory foundations. But having a breakthrough product is not enough. Success in M&A hinges on preparation, documentation, and systems that can stand up to intense due diligence.

The Current M&A Landscape: A Shifting Landscape

The MedTech M&A scene has evolved dramatically over the past year, marked by fewer deals but significantly larger transactions. While deal volume dropped by over 40%, the average deal size surged to $636 million, driven by strategic acquisitions like Stryker’s $4.9B purchase of Inari Medical and Thermo Fisher’s $4.1B buyout of Solventum’s filtration business.

Strategic Focus: Bigger Bets, Sharper Targets

Major players like Johnson & Johnson and Medtronic continue to lead the charge, but their strategies are shifting. J&J, for example, has spent over $30B on acquisitions since 2022, including Shockwave Medical ($13.1B) and Abiomed ($16.6B). These deals weren’t just about scale as they targeted technologies that redefine standards of care, particularly in cardiovascular intervention.

Medtronic, meanwhile, is leaning into tuck-in acquisitions to transform slower-growth units into innovation hubs. With 11+ deals in the past five years, the company is focused on strategic adjacencies and long-term portfolio optimization.

Trends Driving the Market

• Portfolio Shifts: Companies are divesting non-core assets and doubling down on high-growth areas like robotics, diabetes, and structural heart technologies.
• Private Equity’s Role: PE firms are increasingly active, both as buyers and partners in divestitures, helping streamline portfolios and unlock value.
• Cultural Fit Matters: Executives emphasize that successful deals go beyond financials. Shared values and aligned visions for patient impact are now critical to integration success.

What Strategic Buyers Seek: The Acquisition Criteria That Matter

To attract the right buyer, emerging MedTech companies need to align with what strategic acquirers value most. Here is what consistently matters:

Technology Differentiation & Market Position

Buyers want technologies that offer real clinical advantages such as better outcomes, simpler procedures, or cost savings. Proprietary tech backed by strong patents is especially attractive.

The best targets complement the buyer’s existing portfolio and address unmet clinical needs. Think AI diagnostics that plug into existing imaging platforms or minimally invasive tools that expand surgical options.

Regulatory Clarity

A clear regulatory strategy is a major plus. Companies that have engaged with the FDA, gathered solid clinical data, and understand approval pathways stand out.

Detailed documentation like pre-submission notes, trial protocols, and quality systems reduces risk and speeds up integration. It also boosts valuation.

Commercial Potential

Buyers assess market size, competition, and go-to-market strategy. Companies with clinical relationships, distribution channels, or early traction are more appealing.

Technologies that target large markets with clear reimbursement paths, and show signs of physician adoption, are especially valuable.

Financial Performance and Scalability

Even early-stage companies need to show a viable business model. Efficient use of capital, clear milestones, and scalable operations build credibility.

Detailed financials like cost breakdowns, revenue forecasts, and funding needs help buyers model ROI and integration scenarios.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Getting Acquisition-Ready: Preparing for Due Diligence

Due diligence represents the most critical phase of any acquisition process. Companies that invest in comprehensive documentation and systematic organization significantly improve their chances of successful transactions and favorable valuations.

Product Documentation

Keep everything up to date: design requirements, risk files, and testing protocols. Use document control systems to manage versions and changes.

Requirements management is key. Acquirers want to see how products were developed, validated, and maintained. Full traceability from concept to release builds trust.

Risk & Quality Systems

Risk documentation such as hazard analyses, mitigation controls, and post-market surveillance plans is essential. Quality systems should be fully implemented and certified (ISO 13485 is a big plus).

Design controls should be complete and easy to navigate: planning, inputs/outputs, reviews, V&V protocols, and change logs. A well-organized design and development file makes due diligence smoother and less risky.

Testing and Validation Evidence

Strong testing documentation is essential to prove your product’s safety and performance. This includes everything from software testing protocols and biocompatibility studies to electrical safety tests and clinical evaluations.

To stand out, companies should maintain:

• Detailed test plans
• Clear procedures
• Organized results

This shows a systematic approach to validating product performance. When testing documentation is thorough and easy to navigate, acquirers can quickly assess technical risks and regulatory readiness.

Validation should not stop at product launch. Ongoing monitoring, post-market studies, and performance tracking signal a commitment to continuous improvement — something buyers value highly.

RELATED: Industry-leading Practices Modernize Legacy Public Health Software System, a Deloitte Customer Story

Intellectual Property and Regulatory Assets

Your IP and regulatory documentation are more than just paperwork — they are strategic assets. Patent portfolios, FDA submissions, and clinical data all play a key role in valuation and deal structure.

To prepare:

• Keep patent files current
• Document freedom-to-operate analyses
• Develop a clear IP strategy

On the regulatory side, maintain organized records of:

• FDA correspondence
• Clinical trial data
• Post-market surveillance reports

Well-managed documentation shows a strong compliance history and gives acquirers confidence in your ability to navigate future regulatory hurdles.

How Jama Connect^® Supports M&A Readiness

Requirements management and traceability are critical for M&A success and that’s where Jama Connect shines.

The platform helps companies maintain acquisition-ready documentation throughout the product lifecycle by:

• Connecting requirements to design decisions, tests, and regulatory submissions — giving acquirers full visibility into development processes.
• Organizing documents with version control — making it easy for due diligence teams to trace product history and compliance.
• Generating detailed reports — showcasing the maturity of your quality management system and development discipline.
• Supporting collaboration across teams and locations — ensuring documentation integrity even in distributed environments.

With Jama Connect, medical device and life sciences companies can confidently present their development story and proof of compliance, a major advantage during acquisition discussions.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Building Long-Term Value Through Strategic Preparation

The MedTech M&A landscape is evolving fast. As healthcare needs grow and technologies advance, new opportunities are emerging for companies that are ready.

Success isn’t just about having a great product. It’s about:

• Operational excellence
• Regulatory sophistication
• Systematic development processes

Investing early in documentation, requirements management, and quality systems pays off. These capabilities lead to faster development, lower regulatory risk, and better product quality.

If you’re looking to strengthen your M&A readiness, start by evaluating your documentation systems. Book a demo with Jama Software to see how structured requirements management can streamline your development and boost acquisition appeal.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish and Decoteau Wilkerson.

Tech Giants Turn to Nuclear Power for AI’s Energy Appetite

Artificial intelligence is revolutionizing industries at breakneck speed, with UBS CIO estimating global company spending $480 billion on AI infrastructure in 2026. This technological leap comes with an enormous energy cost. As AI workloads and data centers consume unprecedented amounts of electricity, tech giants are making a bold strategic pivot toward nuclear energy partnerships to meet their growing power demands while maintaining carbon-neutral commitments.

The energy requirements for training and running AI models have reached critical levels, forcing companies to seek reliable, preferably clean, power sources that can operate around the clock. Unlike solar and wind energy, nuclear power provides consistent baseline electricity that doesn’t fluctuate with weather conditions—a crucial advantage for data centers that require uninterrupted power supply.

AI’s Explosive Energy Demands Drive Infrastructure Crisis

The computational power required for artificial intelligence applications has created an energy consumption challenge that traditional power grids struggle to accommodate. Modern AI data centers consume significantly more electricity than conventional facilities, with some requiring the equivalent power of small cities to operate effectively.

Training large language models and maintaining AI inference capabilities demand continuous, high-intensity computing power. These operations cannot afford power interruptions or fluctuations that occur with renewable energy sources dependent on weather patterns. The reliability factor makes nuclear energy an attractive solution for sustained AI operations.

Data center operators face mounting pressure to expand capacity while meeting corporate sustainability goals. This dual challenge has accelerated interest in nuclear partnerships as a viable path forward for powering next-generation computing infrastructure.

RELATED: Accelerate Nuclear Design Assessments and Reduce Certifications and Engineering Costs with Jama Connect^® for Nuclear Reactor Design & I&C Development

Nuclear Renaissance Through Advanced Reactor Development

The nuclear energy sector is experiencing renewed momentum through innovative reactor technologies designed specifically for modern energy demands. Small modular reactors (SMRs) and advanced nuclear systems offer enhanced safety features, reduced construction timelines, and flexible deployment options that appeal to tech companies.

Dedicated next-generation nuclear facilities can be built closer to data centers, reducing transmission losses and improving grid reliability. Advanced reactor designs incorporate passive safety systems and simplified operations that address historical concerns about nuclear energy deployment.

Nuclear developers are actively pursuing projects that can deliver power within the next decade, aligning with tech companies’ aggressive expansion timelines. This convergence of technological advancement and market demand is creating unprecedented opportunities for SMR-powered nuclear energy growth.

Strategic Partnerships Transform Energy Landscape

Amazon, Microsoft, Alphabet/Google, and Meta, which contribute most of the global spending on AI infrastructure according to UBS CIO, have emerged as leaders in forging partnerships with nuclear energy developers, recognizing that traditional renewable sources cannot fully meet their expanding cloud and AI datacenter energy requirements. These collaborations represent billions of dollars in commitments toward nuclear power development.

Amazon’s approach includes investing in SMR technology and securing long-term power purchase agreements with nuclear developers. The company’s strategy focuses on deploying nuclear power near major data center clusters to ensure reliable electricity supply for cloud computing and AI services.

Microsoft has signed a 20-year nuclear power purchase agreement with Constellation Energy that will help restart the Crane Clean Energy Center’s Three Mile Island Unit by 2028.

Alphabet/Google has announced partnerships aimed at bringing gigawatts of nuclear capacity online by 2030, emphasizing the need for carbon-free energy that operates continuously. The company’s nuclear strategy complements its existing renewable energy portfolio while addressing the specific demands of AI workloads.

Meta’s nuclear initiatives focus on securing clean energy sources that can support the company’s ambitious AI research and deployment goals. These partnerships demonstrate how social media and technology platforms are adapting their energy strategies to accommodate next-generation computing requirements.

RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution

Nuclear Power’s Competitive Advantage for Data Centers

Nuclear energy offers unique advantages that align perfectly with data center operational requirements. The consistent power output eliminates concerns about energy storage systems and backup generation typically required with intermittent renewable sources.

Cost predictability represents another significant benefit, as nuclear fuel costs remain relatively stable compared to fossil fuel price volatility. Long-term power purchase agreements with nuclear facilities provide tech companies with budget certainty for their expanding operations.

The carbon-neutral profile of nuclear energy helps tech giants achieve environmental commitments without compromising operational reliability. This combination of sustainability and dependability positions nuclear power as an essential component of future data center strategies.

Powering Tomorrow’s Digital Infrastructure

The convergence of AI’s energy demands and nuclear power capabilities marks a transformative moment for both industries. Tech companies are demonstrating that meeting ambitious technological goals requires innovative approaches to energy procurement and infrastructure development.

These nuclear partnerships signal a fundamental shift in how major corporations approach energy planning for next-generation computing workloads. As AI continues expanding across industries, the demand for reliable, clean power will only intensify, making nuclear energy an increasingly critical component of digital infrastructure strategy.

The success of these early partnerships will influence broader industry adoption and accelerate nuclear energy development timelines. Organizations planning significant AI deployments should evaluate nuclear power options as part of their long-term energy strategies.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Mark Levitt and Vlad Tanasescu.

Jama Connect^® Named #1 in G2 Fall 2025 Requirements Management Report

We are thrilled to announce that Jama Connect has once again been recognized as the undisputed #1 leader in G2’s Fall 2025 Grid^® Report for Requirements Management Software. This achievement marks our seventh consecutive quarter at the top, a direct result of the trust and feedback from our valued customers.

This continued leadership solidifies our standing ahead of competitors like Polarion, IBM^® DOORS^®, and Codebeamer. Your reviews and partnership have propelled us to the forefront of the industry, and for that, we are immensely grateful.

Explore the full G2 Fall 2025 Grid Report for Requirements Management Software!

A Testament to Customer Trust and Strong Relationships

G2 reports are a powerful reflection of the user experience, compiling authentic reviews and data to rank software solutions. Being named a leader is a significant honor because it comes directly from the people who use our platform every day to build the next generation of innovative products.

In the Fall 2025 report, Jama Connect’s performance was exceptional, earning accolades that highlight our strong customer partnerships and global reach. We didn’t just maintain our leadership position; we expanded our recognition across multiple new categories.

RELATED: Buyer’s Guide: How to Select the Right Requirements Management and Traceability Solution

Leading the Way: A Look at Our Fall 2025 Badges

Our success this quarter is a testament to the versatility and power of Jama Connect. We are proud to have earned badges across several key areas, demonstrating our strength for businesses of all sizes, worldwide.

Here are the accolades we received in the G2 Fall 2025 report:

• Overall Leader: For the seventh straight quarter, we are the #1 solution in Requirements Management. We also earned Leader badges for Enterprise, Mid-Market, and Small Business segments.
• Best Relationship: This new recognition underscores our commitment to partnership. We received this badge for Overall, Enterprise, and Mid-Market, reflecting the high-quality support and collaboration our customers experience.
• Regional Leader: Our global presence is stronger than ever. We were named a Regional Leader in Asia Pacific, EMEA, and Europe, showing our platform’s effectiveness across international markets.
• Momentum Leader: This badge recognizes our continued growth and innovation in the market, proving we are consistently evolving to meet modern development challenges.

Voices from Our Community

The praise and constructive feedback from our users on G2 are the driving force behind our innovation. Your insights help us refine our platform and better serve your needs. Here is what some of our users have been saying:

“Jama Connect is a powerful tool for requirements management and offers a wide range of features. Until now, the traceability of requirements was very difficult or even impossible. Jama Connect solves this problem 100%.” – Verified User, Renewables & Environment, Enterprise

“In the past, all requirement-related information was scattered across Jira, Confluence, Word, and Excel, making it difficult to know whether anything was truly up to date. With Jama Connect, we have centralized most of this information into a single, reliable source of truth. The transition is still ongoing, but the shift in mindset is already bringing greater clarity, consistency, and confidence to our work.” – Verified User in Manufacturing, Mid-Market

Driving Modern Requirements Management Forward

This G2 recognition reinforces our mission to help organizations move beyond outdated, document-centric processes. Jama Connect provides a modern platform designed for the complexities of today’s product development landscape.

With Jama Connect, teams can:

• Improve clarity and collaboration with a single source of truth.
• Ensure complete traceability across requirements, risks, and tests.
• Streamline compliance with industry-specific regulations and standards.
• Accelerate development cycles without compromising quality.

RELATED: The Benefits of Jama Connect: Supercharge Your Systems Development and Engineering Process

A Sincere Thank You to Our Customers

We could not have achieved this milestone without you. Your partnership, feedback, and trust are the cornerstones of our success. These G2 awards are not just for us; they are a shared victory for every team using Jama Connect to solve complex challenges and build amazing products.

Thank you for making us the #1 choice for requirements management. We are committed to continuing this journey of excellence with you.

Learn More

See for yourself how Jama Connect leads the competition. Explore the complete G2 Fall 2025 Grid Report for Requirements Management Software today.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Makenna Imholte.

How to Master Traceability in Medical Device Development

As an engineer in the medical device industry, you’re tasked with creating innovative products that are both safe and effective. However, this core mission is often overshadowed by the immense pressure of regulatory compliance and documentation. As technology advances and products get more complex, that task gets even more complicated. Managing traceability between thousands of requirements, risk items, and test activities can feel like a “paperwork” burden that pulls you away from what you’d rather be doing: designing and testing new products.

This article offers a practical guide to transform traceability from a time-consuming chore into a strategic advantage. We’ll explore how to build a robust traceability model that not only satisfies regulators but also helps you build better, safer products faster.

TL;DR: Stop treating traceability as an end-of-project scramble. By implementing a single source of truth with Live Traceability™, you can connect requirements, risks, and tests in real-time. A modern platform like Jama Connect^® automates this process, helping you identify gaps early, reduce rework, and free up your team for more efficient product development.

The High Cost of Inefficient Traceability

When traceability is managed with disconnected documents and spreadsheets, it becomes a significant bottleneck. This manual approach is not just inefficient; it introduces substantial risks that can derail a project and kill the team’s morale. For complex medical devices, the consequences of poor traceability are severe:

• Project Delays: Manually creating and updating traceability matrices consumes hundreds of hours, often at the end of a project that results in pushing back launch dates.
• Compliance Risks: Incomplete or inaccurate traceability is a common reason for audit findings and can jeopardize FDA submissions and technical file reviews under the EU MDR.
• Increased Rework: Without a clear line of sight between requirements and tests, design changes can have unforeseen impacts, leading to costly rework late in the development cycle.
• Reduced Innovation: Engineers spend valuable time on administrative tasks instead of focusing on design, testing, and innovation.

The key takeaway: Treating traceability as a final-step documentation exercise is a high-risk strategy. The true cost isn’t just the time spent on paperwork, but the project delays, compliance failures, and missed opportunities that result from it. You can assess your own risk by taking a Requirements Traceability Diagnostic.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

How-To: Best Practices for Ensuring Medical Device Traceability

To move from a reactive to a proactive approach, you need to integrate traceability into the fabric of your development process. Here are four actionable steps to make that happen.

Step 1: Establish a Single Source of Truth

The foundation of effective traceability is a centralized platform where all product development data resides. When requirements, risk analysis, and test cases live in a single system, you eliminate the confusion and errors caused by separate documents.

A single source of truth ensures that every team member—from systems engineering to quality assurance—is working with the most current and approved information.

• Benefit: Creates consistency and provides a complete, auditable record of your design history.
• Impact: Reduces miscommunication and errors, ensuring all teams are aligned.

Step 2: Implement Live Traceability™

A static, manually created traceability matrix is outdated the moment it’s finished. Live Traceability, in contrast, creates a dynamic, real-time map connecting every requirement to its corresponding risks and test cases.

With Live Traceability, you gain instant visibility into the health of your project. If a requirement changes, you can immediately perform an impact analysis to see which downstream requirements, risk mitigations, and test items are affected.

• Benefit: Allows you to identify and address gaps in coverage early in the process.
• Impact: Drastically reduces audit preparation time and minimizes the risk of missing critical connections.

Step 3: Integrate Risk Management into Your Workflow

For medical devices, traceability isn’t just about connecting requirements to tests; it’s about proving that every potential hazard has been identified, analyzed, and mitigated. This is a core expectation of standards like ISO 14971.

By managing risk within the same platform as your requirements, you can directly link risk control measures to the design requirements that implement them. This creates a closed-loop process that demonstrates comprehensive risk management.

• Benefit: Ensures product safety is a continuous focus that woven into all project milestones, not a separate, check-box activity.
• Impact: Builds a safer, more reliable product and provides clear evidence of compliance for regulators.

Step 4: Streamline Collaborative Reviews and Approvals

Formal design reviews are a critical part of the development process, but they can be slowed down by manual feedback cycles via email or comments in disjointed documents. A modern platform streamlines this with a dedicated review center.

This allows stakeholders to comment, vote, and approve items in a structured, collaborative environment. All feedback is captured in one place, creating a clear and permanent audit trail of every decision.

• Benefit: Accelerates feedback loops and decision-making.
• Impact: Ensures that all approvals are documented and traceable, strengthening your Design and Development File.

From Burden to Benefit with Jama Connect

Implementing these best practices is far simpler with a purpose-built tool. Jama Connect is designed to help medical device teams master traceability and accelerate efficient product development.

By providing a single platform with Live Traceability, integrated risk management, and collaborative review workflows, Jama Connect helps you build your traceability matrix as you work. This transforms it from a document you create at the end of a project into a powerful, real-time tool you use throughout the project.

Customer success stories highlight the impact. For example, Dexcom achieved a 60% improvement in systems engineering efficiency by using Jama Connect to manage its complex requirements. Similarly, Vave Health significantly reduced the time spent on traceability matrices, accelerating its development and path to FDA clearance.

The most important benefit: Jama Connect empowers engineers to focus on what they do best—designing and building life-changing medical devices—by turning the “paperwork” of traceability into an automated, value-adding process.

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

FAQs: Medical Device Traceability

Q: What is a traceability matrix in medical device development?
A: A traceability matrix is a document or table that demonstrates the relationships between user needs, design inputs (requirements), design outputs (specifications), risk control measures, and verification and validation activities (tests). While traditionally created in spreadsheets, modern solutions like Jama Connect provide Live Traceability, which is a dynamic, real-time view of these connections, making it far more accurate and less time-consuming to manage.

Q: How does traceability help with FDA and EUMDR compliance?
A: Regulatory bodies like the FDA (under the new QMSR) and the EU (under MDR) require manufacturers to prove that their device is safe and meets all specified requirements. A complete traceability record is the primary evidence used to demonstrate this. It shows auditors that every requirement has been tested, every risk has been mitigated, and the entire development process was conducted under a state of control.

Q: Can we integrate Jama Connect with our existing engineering tools?
A: Yes. Jama Connect is designed to serve as the central hub for requirements and risk management while integrating with other best-of-breed tools in your ecosystem, such as Jira, Azure DevOps, and various testing suites. This creates a connected toolchain that provides end-to-end traceability without forcing your teams to abandon the specialized tools they rely on.

Take Control of Your Traceability Process

Stop letting manual traceability processes create bottlenecks and introduce risk. By adopting an integrated approach, you can pass audits with confidence, accelerate your time-to-market, and empower your engineers to focus on innovation.

Ready to see how you can transform your product development process? Schedule a personalized demo to learn more about Jama Connect for Medical Device Development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Tom Rish.

In this blog, we preview a section of our recent customer story. To download the entire story, visit “Onera Health Chooses Jama Connect® to Provide Flexibility and Consistency for Sleep Diagnostic System Development Customer Story”

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.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

With Jama Connect, Users Experience:

• 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

RELATED: Jama Connect for Medical Device & Life Sciences Development Datasheet

Evaluation

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

Learn how Jama Connect helps medical device companies succeed with higher quality and faster time to market.

TO DOWNLOAD THE ENTIRE CUSTOMER STORY, VISIT:
Onera Health Chooses Jama Connect to Provide Flexibility and Consistency for Sleep Diagnostic System Development

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

To read the entire Press Release, visit “Jama Software Launches Jama Connect Availability in AWS Marketplace”

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/.

To read the complete press release, click here.

About Jama Software

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

In this blog, we recap a section of our recent webinar, “Best Practices for Live Traceability™” – Click HERE to watch it in its entirety.

Drive Better Outcomes Using Live Traceability™

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.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

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.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

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.

To Watch the Entire Webinar, Visit:
Best Practices for Live Traceability

In this video, learn about the Consumer Electronics Development Solution in Jama Connect.

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.

RELATED: Empowering Complex Development with Responsible AI

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.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

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.

RELATED: In Sync: Harmonizing Development on a Diverse Line of Audio Equipment, a Shure Customer Story

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™

To view more Jama Connect Features in Five topics, visit:
Jama Connect Features in Five Video Series

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.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

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.

RELATED: Accelerate the Development of Safe and Effective Medical Devices & Life Science Products with Jama Connect

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.

Ready to see how you can transform your quality management process? Request a personalized demo of Jama Connect today.

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.