Tag Archive for: Live Traceability

jama connect interchange

Jama Connect Interchange™: Live Traceability™ Realized

The #1 problem product engineering organizations face is complying with traceability requirements spanning siloed teams and tools. Organizations are often encumbered by the highly manual and time-consuming review of information across numerous spreadsheets.

What is Live Traceability?

Jama Software defines Live Traceability ™ as the ability to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans.

This enables engineering and product management processes to be managed through data and to improve performance in real-time.

How Can We Extend Live Traceability using Jama Connect Interchange?

Jama Connect Interchange™ is purpose-built to deliver Live Traceability across siloed teams and best-of-breed tools, including Microsoft Excel. By using Jama Connect Interchange, teams can simplify this process by linking data across multiple product development applications.


FREE Consultation: Requirements Traceability Diagnosis – Learn your current Traceability Score™


Best-of-Breed Tools That Plug into Jama Connect for Live Traceability

By utilizing Jama Connect Interchange, teams can now leverage the power of Jama Connect’s traceability model to continuously sync traceable information from other tools with no change required for engineering disciplines to continue using their chosen tools to maximize productivity.

To stay up-to-date on future integration tools available with Jama Connect Interchange, follow the Release Notes in our Community!

The Key Benefits of Jama Connect Interchange

Live Traceability

Overcome siloed information to support your product development lifecycle from user and market needs to verification and validation.

Data Integrity

Run complex calculations, logic statements, and other Excel operations from within Jama Connect. All standard Excel functions are supported, and values flow automatically, so you can utilize the full power of Excel without leaving Jama Connect.

Speed

Align teams, track decisions efficiently, and minimize rework to create high-quality products on time and on budget.

Adaptability

Easily adapt Jama Connect to your project and organizational workflows to create an intuitive experience so your teams can get up to speed quickly.

Requirements in a Single System of Record

Achieve and maintain alignment with real-time updates across teams and tools in a single location.

Common Jama Connect Interchange Use Case


Configurable Sync

One-way or bidirectional sync to match your workflows; set the sync frequency to match the speed of your business

Rich Data and Formatting

Supports text formatting, tables, bullets/ numbering, and text transformation

Simple Configuration

Quick setup wizard, control panel, and field mapping tools – all backed by auditable logs

Flexible Deployment Models

Available in cloud SaaS and on-premises


RELATED: Integrations for Live Traceability™


Conclusion

Unlike other solutions in the market, Jama Connect Interchange has been specifically designed and developed to work seamlessly with Jama Connect. It’s easy to deploy, configure, use, and expand – driving efficiency and further lowering your total cost of ownership.

To learn more about Jama Connect and the Jama Connect Interchange, download our Datasheet.


Live Traceability with Jama Connect

In this blog, we recap a webinar discussing Live Traceability™ with Jama Connect


In today’s world, successful organizations anchor their innovation and complex product development processes on interconnected data across numerous workstreams. This requires gathering stakeholder input to build system architecture, managing high-level requirements to create detailed user stories and implementing verification and validation to detect issues. Collaborating with various stakeholders while achieving standards compliance and competing in today’s marketplace requires a deeper level of traceability.

Organizations also must balance the needs of these various processes and teams with their continued use of best-of-breed tools – including Jira and Excel. While these purpose-build tools often bring efficiency and precision to specific work streams, spreading work across multiple tools makes maintaining and leveraging the benefits of traceability particularly challenging.

Ultimately, that’s why leading organizations leverage Live Traceability™, enabled by Jama Connect, in their product development process to eliminate delays, defects, cost overruns, and rework.

In this webinar, join our experts as they discuss:

  • The contrast between Live Traceability and after-the-fact traceability
  • How to achieve and benefit from Live Traceability
  • How the newly launched Jama Connect Interchange can help replace highly manual and time-consuming processes with an automated flow of information — even with Microsoft Excel

Below is an abbreviated transcript and a recording of our webinar.


Live Traceability™ with Jama Connect

Jeremy Johnson: We’re going to start with some of the common challenges that we see and hear from some of our customers and some of the companies and industries that we start working with around product development and requirements management.

We’ll talk a little bit about what we see as best practices of what we call live traceability versus a more after-the-fact and reactive approach. We’ll talk a little bit about how you can achieve live traceability, and then we’ll dive a little bit more deeply into how Jama Connect can help. We’ll also introduce you to, as Marie mentioned in her intro, a new product from Jama Software, Jama Connect Interchange. We’ll talk about how Jama can help enable live traceability and help support best practices.

We’ll end with a recap of some of the benefits and the impact that we’ve seen from customers in various markets. As Marie mentioned, we’ll get into some Q&A at the end. Again, let’s start with some of the common pain points that we tend to see. Things like managing legacy systems, various Excel spreadsheets, no single version of the truth. You have maybe tedious manual effort, need to automate change management. Impact analysis is slow and manual.


Related Jama Connect Interchange Datasheet 


Jeremy Johnson: If you’re ultimately trying to do this traceability, trying to manage data across different points, looking at risk management, maybe even desktop applications, that stuff is out of date two minutes later, right? It’s not very timely. You have a lot of these challenges from a complex product development standpoint. What this typically goes back to, what it typically traces back to is something that tends to look like this, where companies are managing a very complex product development process, have multiple teams, different functions, and it creates silos. It creates teams and data that are fragmented across functions and across tools. May have things like hardware and software teams running in parallel, but not talking, or at least not talking enough or not talking at the right times.

You maybe have risk and quality and compliance teams that are engaged too late in the process, and maybe it’s more of a serial flow rather than an early engagement and a more collaborative and holistic process. Certainly, some of these teams may be loosely coupled, maybe some of the data points, they always seem to come together at the last moment. But do companies, and do people really want to rely on that? Do you really want to count on those things happening so late in the game? How confident does that make organizations feel with a product launch looming, with an audit schedule? That can be a very daunting and very disconcerting feeling that a lot of those things are happening just in time, rather than a more cohesive and coherent process.


Related: The Essential Guide to Requirements Management and Traceability


Jeremy Johnson: Another way to look at that this problem that we tend to see with companies that we start working with is in the context of the V model or the verification and validation model, which is fairly ubiquitous and complex product development. We’ll touch on it here a few times in this session, but companies have all of these points of intersections throughout this process, as this process flows. There’s all these points that you can see with Xs between where there’s a need for connected data, and these are points where barriers can exist potentially as companies work between siloed tools, again, maybe desktop applications, particularly Excel and things like that.

You have this myriad of tools, this myriad of best-of-breed tools to appropriately and efficiently execute this process. The reality is, to bring all of these pieces together, there really isn’t a single solution to this problem. It’s best of breed tools, and again, even in specific scenarios, maybe office apps like Excel, that’s really the norm and will continue to be. That’s the way people like to work. There are very bespoke solutions in certain parts of the product development life cycle, and that’s the way it’s going to continue to be.

Learn more by watching the entire webinar: Unlocking the Power of Live Traceability™ with Jama Connect

RELATED


Requirements Management and Traceability

This is a recap of our press release announcing The Essential Guide to Requirements Management and Traceability.


Jama Software®, the leading requirements management and requirements traceability solution provider has released The Essential Guide to Requirements Management and Traceability – a comprehensive microsite that helps engineers gain access to information on best practices related to requirements management and requirements traceability.

Requirements management is the process of gathering, analyzing, verifying, and validating the needs and requirements for the given product or system being developed. Successful requirements management ensures that completed deliverables meet the expectations of the stakeholders. Requirements can be managed using documents, however, complex systems or products in highly regulated industries mitigate risk by using trusted requirements management tools.

“Jama Software is committed to enabling system engineering excellence,” said Tom Tseki, Jama Software’s Chief Revenue Officer. “Practitioners can use this comprehensive nine-chapter guide to learn and follow best practices across all aspects of the systems development process.”

Visit The Essential Guide to Requirements Management and Traceability to take a deep dive into the following topics and more:

  • Best practices for writing requirements
  • Requirements traceability – and why it matters
  • Requirements gathering and management processes
  • Evaluating requirements management tools and software
  • The requirements validation and verification process
  • Meeting regulatory compliance and industry standards
  • Key product development terms and definitions

The Essential Guide to Requirements Management and Traceability is live and can be found HERE


Read the entire press release here



Live Traceability with Jira


How to Achieve Live Traceability™ with Jira

For complex product development, the ability to trace through systems, hardware, electrical, risk, verification, and validation teams requires live requirements traceability.

To comply with industry standards, engineering teams in regulated industries must achieve requirements traceability across siloed teams and tools. Most software development teams have chosen Jira® as their preferred task management tool and refuse to switch to cumbersome legacy ALM tools that would negatively impact their productivity. Attempts to try and achieve Live Traceability™ with Jira or Jira plugins break down quickly as the complexity of approvals, versioning, change impact analysis, baselines and variant management overwhelm a task management approach.


Related Reading: Leveraging Jama Connect in a Multi-Tool Environment


The best practice approach implemented by hundreds of Fortune 1000 companies and startups alike, is to use Jama Connect to create Live Traceability across a best-of-breed toolchain including Jira or Azure DevOps for the software development team.


This approach simultaneously solves the need for Live Traceability AND causes no disruption to existing tools, processes, and even field names for the software development team in Jira.


Related Reading: Requirements Traceability – How to Go Live


Live Traceability™ Realized

Achieve Live Traceability across your best-of-breed toolchain. To make this continuous sync as easy as possible, Jama Connect Interchange is purpose-built to achieve Live Traceability between Jama Connect and Jira through a point and click interface.
Key Benefits of Integrating Jama Connect with Jira
Stay Aligned to Market and User Needs
Integrate upstream planning, requirements, and test plans into an iterative development process. Ensure what you build satisfies market, compliance, and user requirements.
Maintain Visibility into Downstream Development
Accurately capture and communicate requirements, goals, progress, and interdependencies to remove friction throughout the development process.
Eliminate Late-Stage Rework and Quality Gaps Due to Misalignment
Capture needs and maintain agreement on what you are building. Guarantee everyone is working off the most current spec, so the product/system ultimately delivers its intended value.
Support a Formal Change Management Process
Identify change impact implications of product requirements alterations and impacted owners so development teams make informed decisions as requirements evolve.

To Learn More About How to Achieve Live Traceability™ with Jira, Download The Full Datasheet.



Requirements Traceability Benchmark Report


Requirements Traceability Measured & Benchmarked for the First Time

The first large scale, empirical research to confirm higher levels of traceability correlate to cycle time and quality improvements

Jama Software, the leading requirements management solution provider, has released the Requirements Traceability Benchmark – the first-ever large-scale, empirical study to measure Traceability Scores™ and the impact different levels of requirement traceability have on quality and cycle times. The benchmark dataset includes over 40,000 projects spanning numerous industries. Requirements traceability across the entire systems development lifecycle is a core tenant of the systems engineering discipline and underpins industry standards to ensure higher quality, faster cycle times, and less costly rework.

“Process improvement requires measurement,” said Marc Osofsky, Jama Software’s CEO. “The engineering process needs to catch up to other business functions in terms of process measurement. Traceability Scores now provide a great way for companies to baseline current performance and measure improvement over time.”

The Requirements Traceability Benchmark is available for download today!


Read the entire press release here!



Traceability Alliance


Jama Software®, Tasktop, Intercax, LDRA, Vitech, and MID GmbH are founding members of the Requirements Traceability Alliance

Jama Software, the leading requirements management solution provider, today announced the formation of the Requirements Traceability Alliance with TasktopIntercaxLDRAVitech, and MID GmbH as founding members. The Requirements Traceability Alliance addresses the fundamental problem facing systems engineering organizations today – how to comply with Live Traceability across requirements that span siloed engineering disciplines and disparate tools. Live Traceability™ of system requirements is required by industry standards to ensure product safety and forms the foundation for digital engineering and model-based systems engineering. It delivers significant productivity improvements, and dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls resulting in faster time to market.

Requirements Traceability Alliance members have already achieved hundreds of Live Traceability deployments across preferred best-of-breed software tools in the product development process. These tools include Jama Connect®, Tasktop Hub, TestRail, Microsoft Excel, Sparx Enterprise Architect, Jira, Azure DevOps, Slack, Cameo/MagicDraw, MATLAB & Simulink, Git, LDRA tool suite®, Syndeia, Smartfacts, Windchill, GENESYS, and many more.

“Companies enable each engineering discipline to choose best-of-breed tools to optimize their team’s work. Alliance members provide the interoperability to achieve Live Traceability across these best-of-breed tools.” – Marc Osofsky, Jama Software’s CEO

Best-of-breed technology partners can learn more about — and apply to join — the Alliance here.


Read the entire press release here!



Live Traceability™ for Airborne Systems Development


Live Traceability™ for Airborne Systems Development

Airborne systems are incorporating more cutting-edge technology and becoming more complex with advanced embedded computing technologies, electric propulsion systems, sensors and data, and airframes. A major percentage of this complexity is handled at the software level. Any error in the avionics software of safety-critical airborne electronics could be catastrophic to the aircraft, its occupants, or persons on the ground. 

Airborne systems development requires developers to adhere to the most rigorous safety standards in the world. These extremely rigorous, plan-driven, development processes are unimaginable to developers who have not done it before. Certification is expensive. Delays in certification due to lack of evidence of following mandated guidelines could spell the demise of a new startup. Mistakes in design and development could cost lives. Manual documentation or the use of legacy tools introduce risk. Achieving certification for safety-critical airborne software is costly and time consuming. Once certification is achieved, the deployed software cannot be modified without recertification. 

Airborne certification bodies such as the Federal Aviation Agency (FAA) and European Aviation Safety Agency (EASA) recognize international standards as “acceptable means, but not the only means, for showing compliance with the applicable airworthiness regulations for the software aspects of airborne systems and equipment certification.” The most common standards that are followed for airborne systems as a means of compliance are: RTC DO-178C (also published in Europe as EUROCAE ED-12C), DO-254 (also published in Europe as EUROCAE ED-80), and SAE 4754A (also published in Europe as EUROCAE ED-79) standards for Airborne systems.    


Related Reading: Better Product Development: Five Tips to Achieve Live Traceability™


Demonstration of traceability is fundamental to each of these standards as the evidence mechanism to demonstrate that safe design practices were followed.  Jama Connect provides an efficient way to capture traceability in a “Live” manner as artifacts (requirements, tests, risks etc…) are being created. Manual document methods and legacy tools will require engineers to create the trace relationships after the development has been done. This could introduce risk as well as lengthen development times.  

Traceability models assist users to create consistent traces between data, then query that data, and provide consistent trace nomenclature between different tools in the ecosystem. The standards are where to begin when defining a traceability model for airborne systems. For example, ARP4754A/ED-79 describes the identification of requirements at the aircraft level, system level, and at an item design level. These requirements interact and are “traced” to various safety related data as well as verification tests. In Jama Connect data artifacts called item types are defined to capture this data and a relationship ruleset is put in place to govern the traces and provide the facility to analyze and report on the traces. 

ARP4754A process interactions between safety and development.

In Jama Connect data artifacts called item types are defined to capture this data and a relationship model is put in place to govern the traces and provide the facility to analyze and report on the traces. In the figure below the relationship model that Jama Connect automatically draws for you, the item types are: Function, Failure Analysis, System Architecture, System Requirement etc. The traces relationships are depicted as the lines between the items types. 

The airborne systems software standard DO-178C/ED-12C requires a “documented connection” (called a trace) between the certification artifacts. In the figure below from DO-178C, users must document traces between system requirements and high level software requirements (HLR). HLRs must be traced to software low level requirements (LLR) as well as test cases and software architecture. LLRs must be traced to test cases and source code. 

For example, a Low Level Requirement (LLR) traces up to a High Level Requirement (HLR). A traceability analysis is then used to ensure that each requirement is fulfilled by the source code, that each requirement is tested, that each line of source code has a purpose (is connected to a requirement), and so forth. Traceability ensures the system is complete. The rigor and detail of the certification artifacts is related to the software level. 

DO-178 mandates requirements-based testing. Each requirement must have associated tests exercising both normal processing and error handling, to demonstrate that the requirement is met and that the invalid inputs are properly handled. The testing is focused on what the system is supposed to do, not the overall functionality of each module. In figure X the Jama Connect traceability model demonstrates this end to end traces from aircraft functions, to system level, and lower level software as well as the verifications covered in all of the standards 

In addition to requirements to test coverage demonstration, the airborne systems standards call for bi-directional traceability between code and requirements. The source code must also be completely covered by the requirements-based tests. “Dead code” (code that is not executed by tests and does not correspond to a requirement) is not permitted. Jama Connect’s Live Traceability allows for connections to other tools in the ecosystem that engineers are using to perform these activities such as testing tools such as LDRA Tool Suite and SW configuration management tools such as Git. The LDRA tool suite is a flexible platform for producing safety, security, and mission-critical software in an accelerated, cost effective and requirements driven process. The tool suite’s open and extensible architecture integrates software life-cycle traceability, static and dynamic analysis, unit test and system-level testing on virtually any host or target platform.  Finding the dead code using LDRA makes this an easy task. The figure below describes an example of a best of breed tool ecosystem facilitated by Live Traceability. 

Jama Connect’s Live Traceability supports capabilities to both continuously sync data between tools in the ecosystem or display the live linked data within the UI. Organizations may require one or both use cases to support their digital transformation efforts. Tools like Syndeia from Intercax can easily make use of Jama’s Live Traceability to perform synchronizations as well as provide services to author, query, visualize, and curate open digital threads. 

Live Traceability performs a crucial role when it comes to review. DO –178 calls for, and is required for the higher DAL levels, what is called “transition criteria.” Essentially this means that reviews of the traceability itself must be demonstrated. Jama’s Review Center streamlines this by displaying the up and downstream traces right in the context of the review. 

Airborne systems have far more onerous governance and compliance hurdles than other industries such as automotive, finance, or medical. The standards require evidence that traceability evaluations were performed. Traceability evaluations must also be independently assessed by four successive levels of traceability assessments:  1) engineering author, 2) an independent engineering reviewer, 3) a software quality assurance auditor, and lastly, 4) a certification liaison reviewer from FAA or EASA. 


Related Reading: [Webinar Recap] Lessons Learned for Reducing Risk in Product Development


At the end of the day, Airborne Systems developers must provide evidence of compliance to the certifiers. Live Traceability provides the ability, for the first time, to manage by exception the end-to-end airborne design assurance process across all engineering disciplines. The traceability model defines required data traces called for by the standards that can be compared to actual activity to generate exceptions. These exceptions are the early warning indicators of issues that most often lead to delays, cost overruns, rework, defects, and certification deficiencies.  

 

The benefits of using Live Traceability in airborne systems development within Jama Connect and across a tool ecosystem are as follows: 

  •  Proves Airborne Systems compliance articulated in the industry standards in real time without the need to create traces after the fact and enhances the visibility that the defined process is being followed. 
  • Provides simplified project estimates, reduces the risk of delays, cost overruns, rework, defects, and recalls with early detection of issues through exception management, and saves 40 to 110 times the cost of issues identified late in the process. 
  • No disruption to engineering teams that continue working in their chosen best-of-breed tools with no need to change tools, fields, values, or processes. 
  • Increase productivity and satisfaction of engineers with the confidence that they are always working on the latest version, reflective of all changes and comments. 

Click here to learn more about Live Traceability™ and get your free Traceability Diagnostic!

 



Jama Connect® 8.71 Exceeds Benchmarks

In this blog, we recap our press release covering the new performance and scale benchmarks set with the release of Jama Connect® 8.71


Jama Connect® 8.71 Exceeds Benchmarks

#1 in scale, concurrent users, response times, global usage, and interoperability

Jama Software, the leading requirements management solution provider, has announced performance benchmarks that set a new standard for Software-as-a-Service (SaaS) used by engineering teams for complex product development. Specifically, Jama Connect® 8.71 exceeds benchmarks for published performance and scale metrics for SaaS in the Requirements Management (RM) /Product Lifecycle Management (PLM) space. SaaS adoption among complex product engineering teams has historically lagged other areas of the enterprise due to the security and technical immaturity of hosted products from legacy vendors. Jama Connect is the first enterprise-grade SaaS product in the RM/PLM space and outperforms other SaaS solutions as well as legacy desktop and client-server offerings in use today.

“The poor performance of legacy attempts at ‘hosted’ solutions has led to SaaS hesitancy. The continued, market leading SaaS scale and performance of Jama Connect has broken through this hesitancy and led to rapid global adoption and usage.” – Josh Turpen, Chief Product Officer, Jama Software

Jama Connect 8.71 was released on March 4th, 2022, and all cloud customers and users were seamlessly upgraded as part of our regular SaaS deployment.


Read the entire press release here! Jama Connect® 8.71 Exceeds Benchmarks for Published SaaS Performance and Scale


For more details on how your team can experience Jama Connect’s user-oriented performance and scale, request a trial here.



reduce risk product development

In this blog, we will recap a webinar on reducing risk in product development


Over the last 20 years, product development complexity has expanded exponentially, creating innovations in areas such as space tourism, autonomous vehicles, satellite communications, and more. In this webinar, Kemi Lewis, Senior Consultant at Jama Software, will demonstrate how Jama Connect© creates Live Traceability™ through siloed development, test, and risk activities to effectively reduce risk in the product development process.

In addition to a walkthrough of the platform and our Live Traceability dashboard, we’ll cover:

  • The critical challenges to reducing risk in product development
  • Why deeming requirements “good enough” to allow teams to proceed with an acceptable level of risk culminates in static requirements, unplanned rework, and compounded product risk
  • How “Project management” activity is a fallacy — it is the management of requirements, people, risks, change, opportunities, expectations, resources, commitment, and suppliers

Below is an abbreviated transcript and a recording of our webinar.


Reducing Risk in Product Development

Kemi Lewis: Today’s agenda covers a deep dive into the critical challenges to reduce the risk in product development, what are the viable solutions to this problem, key takeaways, and wrapping up with a question and answer session at the end of the webinar

Let’s get right into it. What are the main critical challenges that product development teams are facing? In my experience, the main factors that lead to adverse product outcomes and risk are, number one, no upfront and iterative collaboration during requirements and design creation and review stages due to limited customer and cross-functional team involvement in the review and approval of requirements. This lack of cooperation results in missed and misunderstood requirements driving the product design into severely costly errors later on.

Second factor, no digital thread connecting the product and team to the end to end product life cycle process. What do I mean by the digital thread? A digital thread is a data driven architecture that links together information generated from across the product life cycle and is envisioned to be the primary and authoritative data and communication platform for a company’s product at any instance in time. Without this digital thread, there’s no ability to track the life of a requirement through development, test and release.


Related Reading: What Is the Definition of a Digital Thread


Kemi Lewis: This missing digital thread results in static requirement documents rarely viewed by critical stakeholders maintained in Word, Excel or standalone tool used only by a few as a repository. I’ve personally experienced this at companies where only the systems engineers were accessing the repository and the rest of the product development team from product managers down to testing and integration engineers never accessed it.

You can only imagine how this turned out. Countless rework during testing and integration in addition to postlaunch rework this early, which was severely costly to the customer and left them very unhappy. So lacking this digital thread leads to no management visibility into crucial metrics for the end to end process and no identification of process risk patterns, such as delays in development, multiple test failures, rework cycles, etc.

Third main factor is having a low level of requirements management maturity. Let’s discuss this in more detail. Level zero: There are no formal requirements. So no documentation exists for user or system requirements. Instead, development operates off of user stories with no clear distinction between the functionality of the system being built and expected user experience. Level one: Document based requirements. Static requirement documents are created and most often maintained by each author on their desktop with various emails, slack comments containing more information. This especially gets fun when you have to merge 10 different versions of the same document from 10 different people from 10 different timeframes, none of which have visibility to each other’s feedback in real time. I’ve seen this at several companies where they lose technical product proposals due to this inefficiency of being able to get a proposal out in time representing the right design specifications of their product.


Related Reading: Bridge Engineering Silos with Living Requirements Management in Jama Connect


Kemi Lewis: Level two: Siloed requirements tool. A standalone tool in place to draft review, track comments, version and store static requirements documents, compliance steps, limited reuse, defects and recalls. Level three: System based compliance. Compliance is the forcing function to shift from static to live traceability to meet standards for requirement validation, verification and traceability into a single end to end system. Level four: Product risk reduction. A process centric focus to reduce the likelihood of all forms of product risk via a system enabled live traceability. This requires detection and alerts for specification and functional changes, process exceptions and test failures with resulting impact analysis. The risks mitigated include failure to meet the needs of the customer, failure to perform specific functions, delays, cost overruns, defects, compliance and regulatory gaps, delays and fines in addition to recalls.

And the last level of maturity, level five: Development process improvement. Moving past compliance and risk into the spirit of standard based on quality management and process control. These stages place focus on measuring, managing and improving the product development process. The unintended result of this fragmented process is that critical function such of requirement, traceability, verification, validation, risk mitigation, product integration and compliance are often fraught with information gaps, defects, delays, reworks, recalls, missed requirements and significant manual effort. This includes all areas of the complex product system and software delivery life cycle that can experience negative outcomes and should be actively managed to reduce the likelihood of appearance, such as performance.

Watch the full webinar to learn more about Lessons Learned for Reducing Risk in Product Development

Risk Management


Medical Device Risk Management

Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a reactive way, is not sufficient to create a safe product. Implementing an effectively proactive process and achieving live traceability throughout development, while adhering to the standard will result in a higher quality and safer product fit for market use.

In this blog, I will share how proactive risk management along with Live Traceability™ are two key areas that every medical device developer should focus on when it comes to risk management.

Reactive vs. Proactive

A lot of medical device developers do not prioritize risk evaluation throughout the different design stages, but instead, consider risk a checkbox activity at the end of development. With important prototype deadlines, limited funding, and resource constraints, it’s very easy to make excuses for not running risk evaluations of initial user needs but waiting until entire subsystems have been designed. This may seem like a minor hiccup, but the lack of ongoing risk assessment from an early stage can be very risky for FDA approval, future patients as well as your business’s bottom line and reputation. The later that risk is addressed, the more expensive changes are to incorporate. Delays become the norm as well as budget overruns.


Jama Connect Enables Live Traceability™ Across Your Development Process: Learn more!


Live Traceability

The number one cause of inspectional observations, product recalls & delays, increased CAPAs, and cost overruns is the lack of live traceability throughout different development stages. With complex medical devices, there can be thousands of user needs, product requirements, risks, mitigating requirements, tests being executed, and defects logged. At Jama Software, we’ve noticed that a lot of medical device developers are using different technologies and applications to store this information including Excel, Jira, Word, and others. The below image depicts that and shows the siloed world a lot of engineering teams are living in:

 

 

Unless you have a real-time system that can interface with spreadsheets, tools like Jira and other applications, it’s impossible to get a holistic view of development. This can cause several issues, some of the most critical being:

  • Late identification of defects/coverage gaps due to lack of visibility throughout the development process​
  • Lack of requirement coordination and change management between hardware/software​
  • Lack of ongoing risk assessment and change management​
  • Cumbersome and risky effort to produce trace reports and other DHF artifacts

RELATED POST: Avoid the Most Common Challenges of the Design History File


Without Live Traceability, risk teams can’t be effective in mitigating potential failures or hazards. Outdated and manually updated trace reports and spreadsheets can’t be relied upon. What if there was a way to get a real-time view of traceability throughout development?

At Jama Software, we’ve created the capability for our product development platform to integrate seamlessly with tools like Excel, Jira, and others straight out of the box, and we are proud to be the only vendor on the market that can help engineering teams realize Live Traceability. Risk should be a priority, not a checkbox item!

Get in touch with us to see how we can help you.