Tag Archive for: Jama Connect Platform

In this blog, we recap our eBook, “Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Aerospace” – To download the entire thing, click HERE.

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

Use a Single Platform to Accelerate Innovation in Aerospace Systems Development

Consistently meeting product security, reliability and safety requirements proves the top challenge for aerospace systems development lifecycles. Contract complexity, streams of new regulations and policies, in addition to the challenges presented by increasingly networked systems, add to the already onerous development processes. This can lead to unmet technical performance parameters or delayed airworthiness certification reviews which for commercial aviation today takes years, to possibly lengthen out even more.

Effective management of these shifting complexities impacts your ability to meet compliance and ultimately, critical timelines. As a result, your development teams could find themselves:

  • Mired in rework
  • Making trade-offs without context
  • Stuck in unproductive meetings

In this industry, aircraft and space systems development requires strict attention to safety and security requirements, as well as continuous innovation and fast paced development to remain competitive. Ineffective stakeholder collaboration and communication between suppliers, government customers, contractors, and vendors can lead to delivery delays and cost overruns.

Bottom Line: The accelerated development of safe, high-quality aerospace systems, coupled with a highly complex regulatory and contractual environment, create competing challenges, and make it difficult for teams to focus.

What if you didn’t have to compromise?

This Buyer’s Guide incorporates insights from Jama Software’s more than ten years of experience partnering with forward-thinking systems development teams. We’ve designed a platform to help aerospace systems development teams manage the systems engineering data and controls. This allows them to:

  • Align to industry regulations quickly
  • Simplify contract deliverables and certification preparations
  • Accelerate time to market and mission

Use these insights to better understand the challenges you’re up against and thoughtfully consider potential solutions. Plus, learn how to get the buy-in you need to undertake the kind of transformation necessary to succeed with complex systems development.

Making the Case for Change

Jama Connect for aerospace systems development helps organizations to manage systems complexity and replace documents or legacy tools with a single digital platform. When requirements, architecture, V&V, and safety analyses are managed in a centralized location, contract deliverables and certification preparations become a straightforward process and the business impact and value of the platform becomes clear across the organization. That makes executive buy-in easier.

Corrective actions can cost anywhere from $1.6 million for a small change (Gulfstream Model G–1159A and G–1159B airplanes and all Model G–IV and GIV–X airplanes to remediate the ground spoiler actuator installation) to a large corrective action that has indirect costs of lost revenue and diminished market cap at over $20 billion (Boeing 737 MAX). Those costs are especially significant considering the price tag of system development – $75 million in FAA compliance alone—and an average timeline of three to seven years for type certification alone. For a space system, a failure can mean the entire loss of a system or spacecraft; typically there is only a single system created.

Chart showing time-to-market competitive market costs.

If your company is not considering the importance of transitioning to a more streamlined development process, time is not on your side. Failing to act quickly can leave your organization even further behind. But to see the value a positive impact a system can have, stakeholders in an organization have to appreciate the challenges first.

This is where you come in. You can help quantify the problem within your organization and provide data to help make the case for change.

Go through the exercises in the next section using data from your organization to identify your current situation and the size of the potential opportunity.

RELATED: CIMdata: Digital Thread in Aerospace and Defense

Tools to Assess Four Development Pain Points

Throughout the past decade of working with organizations developing complex aerospace systems, four common systems development pain points continuously arise for those who have yet to transform their process.

We’ll provide context around the problems and share equations with examples to help you uncover the savings from a modern systems development solution. Remember to adjust the variables according to your company’s metrics to get a more precise estimate, and rethink how your team functions.

Improving any one of these four aspects of your development process produces real savings. While the calculations on the following pages aren’t cumulative, they impact one another and can add up to significant value for your organization.

This is the potential of using a modern systems development platform. If realized, it can radically change your business and be the competitive edge you need in today’s market.

The Four Common Development Pain Points

  • Unproductive Work Time
  • Lengthy Time-to-Market
  • Rework
  • Defects

Unproductive Work time

Are your days spent in inefficient meetings, sifting through emails and document versions for historical information or waiting for reviews and approvals? You’re not alone. Many teams suffer the repercussions of archaic, siloed development. A modern process maximizes efficiency by tackling the root causes of momentum-killing delays and holdups.

Calculate how much unproductive work time is costing your business and imagine the possibilities of getting that time back. What could you do with one extra hour each day?

PRO TIP: We’ve seen long status meetings shrink or vanish when teams have the right solutions in place. Think about your team’s schedule and adjust the average time saved per person based on the time spent in meetings each week.

Lengthy Time-to-Mark

Time to market or meeting a mission deadline and quality are usually seen as compounding challenges. Understanding the impact of change, capturing decisions, communicating feedback and reusing
existing intellectual property — all aspects that can help speed time-to-market — can be improved with a modern systems development solution.

PRO TIP: Cost savings can certainly be great and have an impact on your bottom line, but don’t forget the qualitative implications. Consider what it would mean for your systems line and brand to be first-to-market with game-changing systems.

RELATED: Tracing Your Way to Success: The Crucial Role of Traceability in Modern Product and Systems Development

Rework

In our experience, approximately 30-50% of a given project is rework. Rework is any time spent on extra work — including mid-development changes, incorrect testing or fixing defects — and it costs your company big time. Requirements errors cause the majority of rework. Improving the ability to track requirements from definition through testing to catch changes and adjust scope can ensure
you’re building the right thing and massively reducing overall lifecycle costs.

Complete the equation below to get an understanding of the number of hours your team spends in rework and the value of that in work hours alone.

PRO TIP: If your organization is working on more than one system at a time, repeat this calculation for each and add up the savings for a holistic view.

Defects

It’s common for requirements to have a defect at some point between definition and delivery. The important thing is to have a system in place that can quickly and accurately identify defects and
track their impact up and downstream. This provides visibility into the problem as early as possible when it’s less detrimental to fix.

PRO TIP: This calculation factors in personnel hours, but you should also think about the cost of parts, delays, and missed opportunities. Plus, should defects go undetected due to sub-par requirements or testing, releasing lower-quality systems could have devastating consequences.

“A document-centric approach often requires a gatekeeper and really limits collaboration – that creates a bottleneck. With Jama Connect, all our development teams can work together from anywhere with a shared collaboration hub.” – David Cubbage, Director, LEO Satellite Engineering and Production, Telesat

This is a preview of our eBOOK, “Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Aerospace”
– To download the entire thing, click HERE

In this blog, we recap our webinar, “Effective Strategies and Solutions for Successful SaMD Project Execution”. Click HERE to watch the entire webinar.

Empower your teams with insights and solutions that transcend the challenges of medical device software development.

Navigate the complex terrain of medical device software development and learn crucial insights and practical solutions to propel your projects forward.

In this webinar, Romer De Los Santos, Senior Consultant at Jama Software®, guides you through:

  • The new SaMD Framework, which features ISO-aligned document templates and customization capabilities
  • Variant Management in Jama Connect®, the key concepts required, and how it can revolutionize your workflow
  • Insights into the nuances of navigating complex medical device software projects
  • A brief exploration of the impact of US and EU regulations shaping the software landscape

Below is an abbreviated transcript of our webinar.

Effective Strategies and Solutions for Successful SaMD Project Execution

Romer De Los Santos: During this presentation, I’ll go over the challenges facing development teams working on medical device software, the key features of the Jama Connect SaMD Framework, and how you can use Jama Connect’s categories and reuse and sync features to manage releases and variants. A successful software development project in the medical device industry is a careful balancing act between documentation and development activities. Development teams have tight deadlines that are driven by market conditions. At the same time, they’re responsible for generating the required quality records according to each region where their device will be marketed. Since this isn’t a regulatory discussion, we’ll just focus on the EU and US as examples.

Medical device software development in the EU is governed by IVDR and MDR regulations. The risk classification in some software activities will differ depending on the regulation it falls under. Unlike in the US, there is no specific distinction between SiMD and SaMD software. It’s all considered medical device software. You’ll need to consider if the software you are developing is an accessory to a medical device or if is it a medical device on its own. If it is an accessory, it’ll need its own technical file. If it is sold as an integral part of the system, it should be included in the system’s technical file.

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

De Los Santos: In the US, there is a distinction between software in a medical device and software that is a medical device on its own. With the advent of AI, machine learning, cloud computing, and other innovations, the FDA has been drawing up new guidance to help modernize oversight on software development. The concept of device software functions are a key part of its modernization efforts. Each device software function has its own risk classification. The FDA has indicated that they intend to target their oversight over software that is an extension of one or more medical devices, software that transforms a mobile platform into a medical device by using attachments, displays, sensors, or including functions like a regulated medical device, software that performs patient-specific analysis and provides specific outputs or directives used in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition.

The Center for Devices and Radiological Health (CDRH) at the FDA created the Digital Health Policy Navigator to help manufacturers determine if their product’s software functions may be the focus of FDA oversight. This past September, the FDA released its new guidance on cybersecurity in medical devices. The guidance encourages the use of a secure product development framework when building software. It specifies some new deliverables such as a security risk analysis that is distinct from and in addition to the safety risk analysis specified in ISO14971.

Manufacturers will need to analyze security risks from the design and development phase through device maintenance and eventually to product end-of-life. Manufacturers are encouraged to use threat modeling to analyze security vulnerabilities in the environment where the device will be used. You’ll also need to consider all interfaces to and from the system and the Off-The-Shelf software (OTS) and Software of Unknown Provenance (SOUP) components that the system depends on. Software Bill of Materials (SBOMs) must be generated and analyzed for potential vulnerabilities. This represents more work for teams but is absolutely required in today’s interconnected world. In addition to all the required documentation for the design history file, developers also need to consider how to manage their fast development iterations, how to handle parallel development and variant and release management, how to properly triage and disposition defects, and how to manage third-party components that are part of their system.

RELATED: Jama Connect® for Digital Health Solution Overview

De Los Santos: The Jama Connect SaMD Framework is intended to alleviate some of the documentation burden while each company has its own procedures. The framework provides basic document templates that comply with requirements specified in IEC62304 and ISO14971. Furthermore, each document template includes a customizable export template for your convenience. It’s designed to keep things as simple as possible by minimizing the number of different item types and fields. The framework is versatile and includes the ability to trace to items outside of Jama Connect. This framework is designed to cover the most common use cases and is intended as a starting point for your own process. Jama Connect can easily be configured so that the tool adapts to your process rather than the other way around.

To watch the entire webinar, visit:
Effective Strategies and Solutions for Successful SaMD Project Execution

this image shows a graduation cap and a clock, indicating this pot will teach visitors quickly on the topic of space systems.

Jama Connect® Features in Five: Space Systems Framework

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Cary Bryczek – Director, Aerospace & Defense Solution at Jama Software® – we will explore the Space Systems Framework available for Aerospace & Defense teams in Jama Connect.

VIDEO TRANSCRIPT

Cary Bryczek: Hi. I’m Cary Bryczek, Director of Aerospace & Defense Solutions at Jama Software. In this video, I’m going to introduce you to our Space Systems Framework available in Jama Connect. In this video, we will explore the benefits of using our pre-built template to get started with managing requirements, test cases, and architecture using our best practices inspired by industry standards and guidance from organizations like NASA and the European Space Agency.

With space systems exponentially growing in complexity, shortening development timelines due to mission need and customer demand, and cost reductions influencing the capabilities able to be delivered with the final design. Programs need to be able to get started quickly and begin the real work of engineering the system. Development and engineering tools need to be robust enough to tackle that complexity easy enough to deploy and then not get in the way of the real work of engineering the system.

Jama Connect and our Space Framework come preconfigured with a ready-to-use template. The framework is comprised of a requirements data model that provides requirements leveling and decomposition, a verification of validation data model that provides traceability to those requirements, an architecture data model that provides mechanisms to support systems architecture system functions, and allocation of requirements, and a data organization method that follows industry guidance with the best practices of data organization in Jama Connect. Let’s see what this looks like in Jama Connect.

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

Bryczek: The Space Framework comes with two pre-built requirement data models. The one I’m showing now represents a full spacecraft product breakdown structure. The example shows how Jama Connect can handle the complexity of a full NASA or ESA space program. The requirements data model allows needs and requirements to be flowed down and fully traced from the stakeholder expectations, to the concept of operations, to system level requirements, down to segment element subsystem and component requirements.

This trace data model, what Jama calls the relationship model, provides a mechanism to enforce consistency and creation of data as well as a consistent method to trace that data. This allows you to do faster analysis, measurement of expected versus actual traceability, complex filtering, and easy trace matrix generation and reporting.

The left side of the screen is the exploratory and is where the data is organized. The Space Framework comes with this pre-built spec tree ready for users to start authoring content right away. You can see that it too is organized hierarchically from the highest level of abstraction at the mission level and then down to the component level. You can navigate this traceability in the tree as well.

We recognize that not every space system will be developed by a single entity that requires this combined breath of customer implementing requirements and those of the implementing organizations. Your organization might be merely developing only a component of a larger space system. For this, we have a second Space Framework for integrated systems. Let’s look at this one more closely.

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

Bryczek: In this CubeSat example that comes with the framework, it’s easy to see how the data is organized in the exploratory in a system, subsystem configuration. Inside each of the subsystems, you can see the specific requirements, their verifications, architecture, and design descriptions. Traceability throughout the entire project can easily be analyzed at any level.

What I’m showing is the traceability from the stakeholder expectations all the way down the decomposition tree. I can see the system requirements verification and validation test cases. I can see the architecture, the subsystem requirements, and even the test runs, these real-time trace views not only show requirements decomposition, but test covers as well as allocation to architecture.

The framework supports, as I said, not just requirements, but architectures, V & V, even risk management and security. We’ve preconfigured the way you organized that here in the tree. So if I wanted to see the system architecture, I am able to see all of the elements that are going into making up the system architecture of this CubeSat I can also see how I’ve organized by system subsystem within the tree itself. That enables me to reuse easily and do variant management in this particular CubeSat security.

So, if you need to have security requirements or if you need to do heavy cyber security and you wanna import things like NIST 800 you can easily do that kind of a thing. Risk management threats and risks moving the development cycle with security earlier in that life cycle is a big deal, or understanding how safety is influencing the design. We easily allow you to track risk management and threat analysis in Jama as well.

The intent of this is to provide ready-to-use solutions based on customer feedback, industry trends, and best practices, such as those of ESA and NASA. This enables engineers to tackle the complexity of space systems develop faster and collaborate at the speed of need. If you would like to learn more about how Jama Connect can optimize your product development processes, Please visit our website at www.jamasoftware.com. If you are already a Jama Connect customer and would like more information on the Space Framework, please contact your customer success manager or Jama Software consultant.

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

Co-workers portraying modern requirements management.

In this blog, we re-cap our eBook, “The Strategic Transition: From Word and Excel to Modern Requirements Management” – Download the entire thing HERE.

The Strategic Transition: From Word and Excel to Modern Requirements Management

Unless your organization’s business model is built on a foundation of inefficiency, you should not be using disparate documents for managing requirements. Whether it’s Microsoft Word, Excel, or a combination of both, trying to wrangle your product’s requirements soley in documents carries a lot of risk and will gradually eat away at your company’s bottom line.

There was a time when using disparate documents wasn’t such a problem for managing requirements, but as products grow in complexity, those days are fading. Many companies no longer produce products that contain just hardware or software; today it’s likely a combination of both, increasing development complexity exponentially.

Integrating hardware and software means teams spanning various engineering disciplines all need to stay aligned throughout development, especially when things like safety standards and regulations are involved.

Using documents alone, will simply not be up to the task of meeting today’s complex products, systems, and software development. When you need precision, context, and accountability for your requirements, a modern requirements management solution is really the only answer.

In this eBook, we’ll detail some of the reasons why you’ll want to leave disparate documents for managing requirements in your rearview. You’ll also get an overview of the benefits you’ll gain by moving to a purpose built software solution for requirements management.

What is requirements management?

To level set, requirements management is the process of gathering, analyzing, verifying, and validating the needs and requirements for a given product or system being developed.

Successful requirements management ensures that completed deliverables meet the expectations of the stakeholders.

Learn more

Five Drawbacks of Documents

Microsoft Word and Excel serve many purposes, and have done so for decades. And, in terms of requirements, for early-phase documentation and coordinating simple projects, they still remain effective tools.

As the complexity of product and systems development grows, so does your list of requirements. And teams need solutions that provide simple and streamlined collaboration, not jumbled — often quickly outdated — comments and suggested edits. Teams need to be able to instantly connect to globally distributed colleagues to facilitate real-time feedback and make smarter decisions with full context around requirements. Documents simply aren’t up to the challenge.

Here are some of the key limitations for a document-based approach for storing requirements:

1. Documents are tedious to maintain

Anyone who has ever managed requirements with documents and several collaborators is familiar with the unique pains of this approach. Whether it’s Word documents that are hundreds of pages long or Excel spreadsheets with thousands of lines, keeping them fresh with updates and free of errors is extremely cumbersome and time-consuming.

2. Versioning difficulties

Collaborating on any kind of important documentation can be painstaking, especially when there’s an enormous amount of requirements involved. For instance, when reviewing requirements, it’s incredibly easy for two people to be looking at different versions of the same set of requirements, and not even know it. And even if it’s a cloud-based version of requirements, there are still plenty of opportunities for someone to unintentionally change something without getting prior approval, and that adjustment not being accounted for in future versions. Plus, online/cloud-based documents do not automatically create different IDs and versions for each requirement or highlight the changes between versions.

3. No traceability

There’s so much room for error through email chains and undisclosed updates. It’s incredibly simple, for example, to miss a tiny change that could have critical ramifications upstream or downstream.

4. Reviews are time consuming

Without traceability, review cycles with an enormous document of requirements are extremely long. You’re likely looking at scheduling lengthy meetings or passing around version after version, pulling team members away from other priorities, which is not ideal when you’re focused on getting to market quickly. And if you’re trying to manage reviews asynchronously, collaboration becomes tricky and timelines are likely to get pushed as people’s schedules shift.

5. Exhausting collaboration between teams

Sharing constantly evolving requirements files among multiple stakeholders and different teams throughout the development and testing process is risky, frustrating, and time-consuming. And with your customer demanding a perfect product, system, or software delivered ASAP, you can no longer afford that kind of inefficiency.

In this eBook, The Jama Software® Guide to Requirements Traceability, we’ll highlight the importance of tracing requirements without the headaches and risks of a traceability matrix in Excel, but also how to do so in a way that sets your organization up for future success. Learn how Live Traceability™ helps teams:

    • Reduce the risk of delays, cost overruns, rework, defects, and recalls
    • Comply with industry standards with no after-the-fact manual effort
    • Allows engineering teams that continue working in their chosen best-of-breed tools
    • Increase productivity and satisfaction of engineers

Get it here

Seven Benefits of Using a Requirements Management Solution

Despite rising product complexity and regulation, most development teams do not have a sophisticated requirement management system in place. In fact, according to a recent survey, almost one third of teams have no system in place and rely on formal processes with email, documents, and shared spreadsheets.

Another 52% manage their requirements with a system which is not meant for managing requirements, like Application Lifecycle Management (ALM) or Product Lifecycle Management (PLM) systems. And only 15% have chosen to invest in a formal dedicated requirement management solution.

Using a dedicated requirements management solution allows teams to stop getting bogged down on processes and start innovating. For example MediSync, reports that investing in Jama Connect® has saved 80% of the time that would have otherwise been spent on meetings, sorting through versions of Word documents and emails, and consolidating feedback in review cycles.

Grifols saved around 80 hours per project in medical device development when using the Jama Connect Review Center. And RBC Medical saved around $150,000 per project by improving team collaboration and workflow efficiencies using Jama Connect.

Here are some of the benefits you’ll get from investing in a solid requirements management solution:

1. Version and change management

A solid requirements management solution will maintain a history of each change made to every requirement. You’ll also be able to record the rationale behind each change, and refer back to a previous version of a requirement if necessary. Some solutions contain a change proposal system that links change requests directly to requirements. And, with a formal requirements management solution, you’ll always know you’re looking at the most recent version of the requirements.

2. Requirements attributes

With a strong requirements management solution, you should be able to record several descriptive attributes for each requirement. The right requirements management software should generate several system-defined attributes such as the date the requirement was created, its current version number, and the person on the requirements should be able to view these attributes, even if only a couple of individuals are allowed to update the attributes’ values.

3. Facilitate impact analysis

A requirements management solution enables requirements tracing by letting you define links between different types of requirements, requirements and different subsystems, and individual requirements and related system components (designs, modules, tests, and user documentation). These links help you analyze the impact that the proposed change will have on a specific requirement. It’s also very helpful to have the ability to trace each functional requirement back to its origin or parent so that you know exactly where every requirement came from. And some solutions use a traceability link to raise suspect flags to a linked item whenever a change is made, so you know exactly what needs to be reviewed after a change.

4. Track requirements status

Collecting requirements in a database lets you know how many discrete requirements you’ve specified for the product. And tracking the status of each requirement during development helps communicate how things are coming along to those across the organization. So, a project manager has good insights into prior states if he or she knows that, for example, 55% of the requirements committed to the next release have been verified, 28% have been implemented but not verified, and 70% have not yet been fully implemented. This type of information gives the project manager information to anticipate the project’s progress, and relay the message to stakeholders accordingly.

5. Control access

A requirements management solution should let you bring as many people into the system as possible, and grant them permission to access the specific parts they’re working on. This helps teams across the organization feel more invested in the product being developed and its progress.

What if you didn’t have to compromise? A growing number of organizations are exploring and adopting product development solutions that manage the complexity that comes with designing connected systems. This allows them to:

  • Build higher-quality products
  • Get to market more efficiently
  • Capitalize on opportunities faster

Download this Buyer’s Guide: Selecting a Requirements Management and Traceability Solution to better understand the challenges you’re up against and thoughtfully consider potential requirements and test management solutions. Plus, get tips on how to get the buy-in you need to undertake the kind of change necessary to succeed with complex product development.

Get it here

6. Facilitating communication with stakeholders

A requirements management solution should allow team members to discuss requirements issues electronically through a threaded conversation, in one central location, as opposed to having communication spread out across various platforms. It will automatically trigger email messages and notify effective individuals when a new discussion entry is made or when a specific requirement is modified. And it should allow team members to reach out to each other, but also contact non-project members and external users.

7. Recycling/reusing requirements

Storing requirements in a central database facilitates the reuse of them in multiple projects or sub-projects. And requirements that logically fit into multiple parts of the same product can be stored once and referenced whenever necessary to avoid duplicates. This saves a lot of time and reduces the chance of making errors.

Leveraging Jama Connect® for Effective Development of Combination Products

Developing combination devices, also called combination products, such as inhalers or injectables, is a complex and interdisciplinary endeavor that lies at the intersection of pharmaceuticals, biologics, engineering, and medical science. These innovative devices are designed to provide patients with a more convenient and effective way to administer medications.

One of the primary objectives in developing combination products is to enhance treatment adherence, particularly in chronic conditions where consistent medication delivery is critical. By combining medication with a delivery system, patients can receive accurate doses, reducing the risk of errors and ensuring that the therapeutic benefits are maximized.

Image Showing a Combination Product Types Chart

Requirements management tools such as Jama Connect® have become indispensable assets in the product development process, helping streamline the complexities involved in producing safe and effective combination devices.

This article explores how Jama Connect can prove invaluable in areas such as reuse/variant management, hazard library maintenance, compliance standards, integrated risk management, and expeditious reviews, making it an essential tool for engineers and developers in the medical field.

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

Simplify Complex Traceability

  • The development of combination devices often involves integrating a complex hierarchy of requirements, from User Needs and System Requirements, down through Risk Evaluations, Subsystems, and Verifications and Validations. Maintaining proper traceability throughout the product development lifecycle is a vital component of developing safe and effective products. Jama Connect allows development teams to simplify this process by enabling Live Traceability™ between development artifacts. Product development team can establish traceability, ensuring that every design element, from the software components to physical hardware, aligns with the initial requirements. This robust traceability is essential for regulatory compliance and safety, particularly in the medical device industry.

Requirements Reuse

  • Combination product teams often face added levels of complexity in their development process as they work to adapt product designs to the specific requirements of multiple applications, and the diverse regulatory demands across markets. Jama Connect allows for the efficient reuse of requirements, hazards, risk assessments, and verification testing across projects, enabling development teams to take a platform approach to their development process, track the evolution of variants, assess the impact of change across all their systems, and ensure compliance with international standards is maintained. This significantly reduces redundancy, minimizes errors, and speeds up development cycles.

Compliance with Standards

  • Combination devices must adhere to stringent regulatory and quality standards, such as ISO 13485, ISO 14971, ISO 11608, and FDA requirements. Jama Connect aids in aligning the project with these standards by providing tools for document control, validation, and verification. It supports the creation of audit trails, which are essential for proving compliance. This streamlines the certification process and minimizes the risk of non-compliance.

Integrated Risk Management

  • Risk Management is a critical component of developing combination products, but development teams often struggle with highly disconnected risk management processes. Jama Connect’s integrated risk management capabilities allow teams to proactively identify, assess, and mitigate risks throughout the development process, and ensure Live Traceability between risk evaluations and controls. Risk matrices, failure mode and effects analysis (FMEA), and other risk management methodologies can be seamlessly integrated into the development workflow, ensuring that potential issues are addressed early and efficiently.

Hazard Library Management

  • Safety is of paramount importance in the development of combination products. Maintaining a comprehensive library of hazards, both known and potential, is crucial to mitigate risks effectively. Jama Connect facilitates the organization and accessibility of this critical information. It allows engineers to define, document, and classify hazards and their corresponding risk assessments. This central repository ensures that hazard management remains an integral part of the design process and that safety remains a top priority.

Efficient Reviews

  • Efficient and timely reviews are vital in the development of combination devices, as they help uncover issues, assess design tradeoffs, and ensure alignment with requirements. Jama Connect simplifies the review process by offering a collaborative platform for stakeholders to provide feedback, track changes, and sign off on design decisions. This collaborative approach fosters effective communication and reduces the time required for reviews, expediting the overall development cycle.

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

Developing combination products, which encompass a wide range of medical innovations, requires a multidisciplinary approach and careful management of various elements. Jama Connect is a powerful requirements management tool that streamlines the development process in multiple ways, from facilitating requirements reuse and variant management to managing hazard libraries, ensuring compliance, and integrating risk management.

By leveraging Jama Connect, product development teams can significantly improve their efficiency, reduce errors, enhance safety, and expedite the development of combination products while maintaining the highest standards of quality and regulatory compliance.


Image showing badges awarded by TrustRadius to Jama Connect.

Jama Connect® is Awarded the TrustRadius Triple Crown for Requirements Management Software!

Jama Connect® has gained recognition as an outstanding solution on TrustRadius, solidifying its position as a leading platform for requirements, risk, and test management.

With its intuitive interface, robust features, and exceptional customer support, Jama Connect has received the following prestigious awards in 2023: Best Of, Feature Set, Pricing, and Relationship.

Visit the full report to see why customers love using Jama Connect for product, systems, and software development.

This recognition underscores Jama Software’s unwavering commitment to delivering a reliable and efficient solution that empowers teams to drive innovation and achieve exceptional results.

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

As the leading provider of requirements management software, Jama Software is proud to receive recognition for our commitment to enabling multidisciplinary engineering organizations developing products, systems, and software to maximize their success. We value the feedback from our clients who have used Jama Connect and are committed to providing them with the best support, resources, and expertise to help them succeed.

“Jama Connect is a solid framework for systems engineering that can integrate many design processes into a single tool. At a fundamental level, it is a great tool for handling requirements management and traceability but offers a variety of other features such as risk management and verification and validation. For someone who works in the medical device industry, the tool also complies with CFR requirements for electronic approvals and can be validated for such use.”

-From review collected and hosted on TrustRadius – User in Engineering, Medical Devices Company

“I’m VERY likely to recommend Jama to a colleague because they’d struggle to get anything done without using it! That’s the tool we’re using for Req Management now, so I recommend to my colleagues that they get amongst it!”

-From review collected and hosted on TrustRadius – Ian Webb, Systems Engineering Technical Writer – Enphase EnergyElectrical & Electronic Manufacturing

From all of us at Jama Software® to all of you, thank you!


Image showing a graduation cap and clock, symbolizing that this content will teach someone about reuse & sync in a quick session.

In this video, we’ll discuss the reuse & sync capabilities in Jama Connect.

Jama Connect® Features in Five: Reuse & Sync

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Zeb Geary – Principal Professional Services Consultant at Jama Software® – will go over the reuse & sync capabilities for requirements management in Jama Connect.

VIDEO TRANSCRIPT

Zeb Geary: Welcome to this segment of Features in Five. I’m Zeb Geary, a Principal Consultant at Jama Software. In this video, I’ll explain how your team can reduce time to market and improve quality by reusing and synchronizing requirements and other content in Jama Connect.

Teams often struggle to build on existing work when requirements and tests are spread across documents and systems. Lacking a live trace, they must manually identify and copy related content, increasing the risk of rework and gaps. Additionally, teams tend to lack visibility across efforts, causing necessary changes to not propagate across reuse content, potentially impacting quality and disconnected product design efforts.

Jama Connect simplifies and enhances the process of reusing requirements and verifications by allowing you to copy selected content with its containers and its traced items. Synchronization ensures visibility and enables key use cases such as parallel product definition, common content libraries, and product variance. Let’s look at reuse and synchronization in Jama Connect.

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

Geary: Here in Jama Connect, I’m looking at a project that we would consider a library or potentially a platform of 150% of our requirements. For this example, I’ve started building out the requirements and verifications for a new Jama Connect project, but I’ll be incorporating some standard or common requirements from this project. And through reuse, I’ll save time and ensure consistency with the platform.

I want to bring these common display requirements into my project from the platform. I see that these requirements have related verifications, and I want to bring these into my project as well. I’ll go ahead and select to reuse this folder. The reuse window shows me what I’ve selected for reuse and provides me with important options that reveal the significance of this capability. The first option determines if I will enable synchronization. If enabled, Jama Connect will establish a connection between the result of my reuse and its source so that I can monitor them for differences. I have options to include or exclude tags, attachments, and links, and to form a relationship to my source item from the resulting copy.

The final section of options determines how I will handle related content outside of my selection. Recall that the selective requirements have downstream verifications that I want to make sure I bring into my project. I will select the option to include related content and to mirror the relationships in my project. This saves me a lot of time since I will not have to recreate these relationships in the new project and removes the risk of missing verifications related to my selected requirements.

Finally, I indicate where I want to reuse the content to. I’ll select my project and I can have Jama Connect copy the project hierarchy as well into my target project, or I can select an existing location in my project. I selected my location and I will reuse with Sync.

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

Geary: In my project, the common display requirements have been reused with their related verifications. Here in my project, I can use Sync View to see how my reused items may differ from the library or any other project using these common requirements. Let’s check out this folder called “Scheduling.”

I can see from our sync items view that I’m in sync with the platform, meaning there’s no difference there, but we have a parallel effort that I am out of sync with. In Compare View, I can see exactly how we differ and bring those differences, if necessary, into my project. Sync View provides me with the visibility I need to make sure I’m working with the latest applicable requirements in my project. Here I will update the requirement text and I’ll create the missing requirement in my project. Now my project and this parallel effort are in sync.

As we have seen, reuse and synchronization is a key feature supporting critical requirements and verification activities. A Jama Software consultant can help you properly support your process with reuse and sync. If you have a Success Program with Jama Software, see our offerings under Improving Your Process to request assistance from a consultant. Your customer success manager can help you learn more about Jama Software Success Programs. If you would like to learn more about how Jama Connect can optimize your product development process, please visit our website at www.jamasoftware.com.


This image shows a lightbulb lit with a money sign, symbolizing saving money on requirements management software.

Economic Climate Have You Rethinking Your Software Spend? Five Reasons to KEEP Your Requirements Management Software

It’s a conversation in every news cycle, boardroom conversation, and dinner table right now – the economy. And while the economy is a dynamic force that ebbs and flows, much like the tide, the state of our current economy has most of us on edge.

In the world of product, software, and systems development, cost-cutting measures are often at the forefront of organizational decision-making. When times get tough, the temptation to trim budgets and eliminate seemingly non-essential tools and processes becomes more pronounced.

For organizations developing complex products, one such area that might be under the cost-cutting axe is requirements management solutions. While it may seem like an easy way to save money, ditching your requirements management solution could have unintended and detrimental consequences on your bottom line.

In this post, we will explore five compelling reasons why eliminating your requirements management solution may not be in the short- or long-term best interest of your organization — or your bottom line. Without a formal requirements management solution, you open your organization up to:

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

1. Increased Revisions and Rework

Requirements management solutions are designed to streamline the process of capturing, analyzing, and managing project requirements. Without a dedicated tool for this crucial task, the likelihood of misunderstandings and miscommunications regarding project requirements increases. This can lead to more frequent revisions and rework, consuming valuable time and resources that could be better utilized elsewhere. The iterative nature of resolving requirements without a structured system often results in delayed project timelines and increased costs, offsetting any initial savings resulting from cutting your purpose-built requirements management solution.

2. Communication Breakdowns

Clear and effective communication is the backbone of any successful project. A requirements management solution provides a centralized platform for stakeholders to collaborate, document, and discuss project requirements. When this system is removed, communication can become fragmented and disorganized. Critical details may be lost or misinterpreted, leading to confusion among team members. Efficient collaboration is compromised increasing the risk of errors, hindering productivity, and negatively affecting overall project success.

3. Difficulty in Requirement Traceability

Traceability is a fundamental aspect of requirements management, ensuring that each requirement is linked to its source and can be traced throughout the product or software lifecycle. Without a dedicated solution, maintaining this traceability becomes a laborious and error-prone manual task. This lack of traceability can result in gaps, inconsistencies, and the inability to ensure that all requirements are met, potentially leading to very costly project failures, recalls, or compliance issues.

4. Compliance and Audit Risks

For organizations operating in regulated industries, compliance with industry standards and regulations is essential. A requirements management solution often offers features that help in maintaining compliance by documenting and tracking adherence to specific guidelines. Eliminating this tool may expose your organization to increased compliance and audit risks, potentially resulting in fines, legal complications, and damage to your reputation.

5. Impaired Decision-Making

The right requirements management solution will provide valuable insights and analytics that aid in informed decision-making. These tools can offer data-driven metrics, progress tracking, and performance indicators. Without this data-driven approach, decision-making becomes subjective and less efficient, potentially leading to costly errors and suboptimal project outcomes.

One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown to reduce this known risk?

Using our proprietary database of metadata from over 50,000 complex product development projects, we were able to determine that the Traceability Score™ is an empirical method to reduce late requirements. In fact, teams that maintain a high Traceability Score reduce the burden late requirements have on their project by 67% compared to teams with low traceability scores.

With this knowledge, our recommendation is that practitioners measure and monitor the Traceability Score™ of their projects to resolve issues early and ensure that the risk of late requirements is kept to a minimum.

RELATED: The Strategic Transition: From Word and Excel to Modern Requirements Management

 

While the prospect of cutting costs by eliminating a requirements management solution may seem appealing initially, it’s clear that the long-term consequences outweigh the short-term benefits.

It’s important to carefully consider the potential risks associated with such a decision and evaluate the true cost savings against the potential detrimental impact on project success, compliance, and overall organizational efficiency. Balancing cost-saving initiatives with maintaining essential project management tools is crucial for achieving sustained success in today’s competitive business landscape.

Download our eBook to access easy-to-use, interactive ROI calculators and to learn more about the value of requirements management. These calculators will help you argue for the financial advantages of continuing to invest in a requirements management solution even in uncertain economic times. >> Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense.


Image showing a clock with a graduation had, symbolizing that the viewer will be learning about SaMD.

In this video, we’ll discuss the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

Jama Connect® Features in Five: SaMD Framework

Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.

In this Features in Five video, Romer De Los Santos – Senior Consultant at Jama Software® – will go over some highlights of the Software as a Medical Device (also known as SaMD) framework in Jama Connect.

VIDEO TRANSCRIPT

Romer De Los Santos: Hello. My name is Romer De Los Santos and I’m a senior consultant here at Jama Software. In this video, we’ll go over some highlights around Jama Connect’s new Software as a Medical Device (also known as SaMD) framework.

Anyone who has worked developing medical device software has struggled with balancing the creation and maintenance of the required documentation with the day-to-day struggle of developing and testing software. And because software cycles are highly iterative, they are incompatible with traditional waterfall development.

Jama Connect’s new SaMD framework is designed to help alleviate the burden of documentation so that your team can focus on development. This purpose-built framework allows users working on both simple and complex software projects to use Jama Connect right out of the box. Its design was born from over 20 years of hands-on experience developing medical device software.

Some highlights of this framework include:

  • Templates like Software Development Plans that are designed to be compliant with IEC62304. These documents come with a customizable report that you can modify with your own branding.
  • Built-in risk analysis designed to be compliant with ISO14971 that takes advantage of Jama Connect’s built-in look-up table feature.
  • A new SOUP/OTS item type is designed to capture information about third-party developed software components in compliance with the FDA’s guidance on Off the Shelf, (or OTS)Software Use In Medical Devices.
  • A new External Resource item type to capture and trace items tracked outside of Jama Connect.

Let’s take a closer look.

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

De Los Santos: The SaMD framework gives new medical device manufacturers a great starting point. It has been designed to with regulations like IEC 62304 and ISO 14971 in mind. However, manufacturers are still required to define their own quality management system.

Although regulations specify what needs to be documented, there’s no universally accepted document name or format. Jama Connect can be configured to use your company’s own jargon and the document templates required by your own quality management system.

The framework is organized into four major components in a document-centric structure. This means that items are organized into documents rather than by function.

This structure is easier for new users to recognize and work on. It also facilitates the generation of documents that will be submitted to the system of record of your choice.

For your convenience, the framework includes customizable export templates for multiple documents. You can change the logo, headers, footers, fonts, and style of your document to match your company’s branding requirements.

Project-level documentation includes planning documentation such as the Software Development Plan and Software Verification Validation Plan.

IEC 62304 has specific requirements for software development plans that have been incorporated into the template for your convenience.

RELATED: Jama Connect® Customer Validated Cloud Package for Medical Device and Life Sciences

De Los Santos: While IEC 62304 does not require a separate Software Verification or Validation Plan, it does require specific information about how verification and validation will be performed. This document template includes sections for the required information.

System-Level Documentation includes documents that define the requirements, testing, and design of the whole system. It can include items like User or Stakeholder Needs, Design input documents, Product Requirements Specifications, and Software Architecture documents.

Sub-System Level Documentation can be organized into individual components, software or otherwise. Each component includes the requirements, test cases, and design documentation.

The Risk Management Plan, FMEAs, and risk analysis are centralized in the Risk component. By default, the FMEA and risk analysis are organized as you would see them in Excel. It also takes advantage of Jama Connect’s built-in look-up matrix feature to do your risk calculations.

Of course, not all medical device software projects are multi-component projects. A software project that consists of a single software component doesn’t need to have system and subsystem-level requirements. In this case, remove the System Requirement and System Architecture item types from the relationship diagram to create a single-level structure.

OTS/SOUP components are documented through a new item type that is specifically designed to capture the information specified in the FDA’s guidance on OTS Software Use in Medical Devices.

RELATED: EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights

De Los Santos: Jama Connect allows you to trace the specific sections of your design documentation that utilize third-party components to this item type. This makes tracking where these software components are used easy.

Finally, we’ve added a catch-all item called External Resource. External Resource items allow you to trace items that may be tracked outside of Jama Connect. This can be items like instructions for use, labeling, package inserts, specifications, schematics, and pretty much anything else you need to trace.

I hope you got a lot out of this quick look at the new SaMD framework in Jama Connect. If you want to learn more about Jama Connect and how it can optimize your product development process, please visit our website at jamasoftware.com – If you’re already a Jama Connect customer and would like more information about Medical Device Software, please contact your customer success manager or a Jama Software consultant.

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


Image showing industry experts who speak about insurance product development.

In this blog, we recap our webinar, “Bridging the Gap in Insurance Product Development”. Click HERE to watch the entire webinar.

Looking to bridge the gap in your insurance product development?

Learn how carriers can utilize Jama Connect® to increase efficiency across the development process and more effectively deliver high quality products on time and on budget.

During this informative session, Lianne Warford, Senior Business Analyst at LHW Consulting, and Steven Meadows, Principal Solutions Lead at Jama Software®, discuss how this newly available insurance framework and dataset streamlines and simplifies product development for the insurance industry.

Gain insights into:

  • Overcoming common insurance industry challenges
  • Leveraging the benefits of a modern requirements management solution
  • The new insurance framework available in Jama Connect, with off-the-shelf elements for enhanced workflow and efficiency

Discover how Jama Connect allows carriers to innovate, bring products to market quicker, and ultimately better serve their customers.

Below is an abbreviated transcript of our webinar.

Bridging the Gap in Insurance Product Development

Steven Meadows: Okay, so today, we have a pretty packed agenda. We’re going to be starting off or Lianne’s going to be talking about legacy insurance requirements management. Following that, we’ll be talking about how you can overcome some of the common insurance industry challenges, some of the important considerations for streamlined insurance product development. After that, I’ll be talking about the problem with legacy tools and insurance product development, followed by best practices for an effective development strategy. I’ll then be providing a brief introduction to Jama Connect for Insurance, very high level overview. And then finally, we’ll end with a solution key takeaways and questions. And with that, Lianne, go ahead.

Lianne Watford: All right, thanks Steven so much. I appreciate this opportunity to work with Jama Software. I want to get started today with talking about different scenarios, two main scenarios where requirements are needed in the insurance industry. So we have the policy administration systems that automate the day-to-day operations of an insurance company. And the second area is the new and enhanced insurance products and services that insurance companies want to undertake. So let’s just dive right in. It has a lot of information, so let’s get started. So from the policy administration system, while every insurance company’s unique, processes that all insurance companies share for the day-to-day operations are quite common. And I’d venture to say that you would have to look long and hard to find an insurance company today that doesn’t have some type of policy admin system, whether it be a homegrown system that they’ve done themselves or utilizing some other type of software vendor.

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

Watford: So if you take a look at the areas that are common, you have your policy administration. So every insurance policy starts with a quote and there’s quite a bit of information that needs to be captured. You’ve got your insured name, address, and contact information among others. You have information about the risk that’s being insured, whether it’s a house, a car, or business. And there are specific details for each types of risks that have to be captured to provide an accurate rate for the policy. You’ve got your coverages that are needed for each of the specific types of risks like property damage and liability coverage, and there’s lots of information that needs to be captured around that as well. And then once the policy is bound and issued, there’s several different types of documents such as declaration pages, rating sheets, etc, that have to be generated and are dependent on specific policy details.

And while those requirements are related to the insured risk and coverages, there’ll be an entirely different set of requirements for the output that describe the information about both the static and the variable data that’s needed to be printed. So that’s a ton of information right there. If you haven’t really captured it, we’ve just hit one bullet point under the policy admin. And then you’re always going to have the need to make a change to the policy at some point. And those are processed as endorsements. And while some of these requirements can be reused from the quote bind and issue process, there’ll also be certain rules for different types of endorsements that’ll need to be captured as separate requirements. And then you also have the output that’s specific to those related endorsements. Again, more stuff. And then you also have the processes around your cancellations and reinstatements for underwriting reasons, and you’re going to have documents that go along with that as well.

RELATED: A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn

Watford: All of those have to have requirements for the related output and downstream effects as well. And then hopefully the insured’s going to be happy with your service at your company and they’ll want to renew the policy for another term. So yep, there goes another set of specific requirements that are associated with the processing of the renewal as well as the output that’s associated. That’s a big mouthful of information. But then the next step you’ve got to do is collect the money for the premium that’s generated on the policy. So you gather requirements for down payments if you require them. You also provide payment plan options to allow them to pay, and installments are all at one time, so there’s lots of requirements around that. Then you also have special rules for nonpayment of premium cancellations and reinstatements that are different from your underwriting cancellations and reinstatements, different set of requirements.

And then you have to process refunds and collections. Again, and there’s all types of outputs that go along with these processes as well that have to be documented. And then of course, the big thing for an insurance company is your annual statement. That’s your accounting for what insurance companies do. And so, there’s all kinds of requirements for your annual statement, annual statement lines, and statistical reporting. Again, a ton of requirements. And then last but not least is your claims administration, which is the reason that you actually have insurance, right? So that if you need to make a claim, so you have your requirements around first notice of loss and then there’s a ton of information that they have to capture, lots of things that they have to do in that area as well. Come out and inspect, assign agents, all different types of processes for your claims.

And then you ultimately want to make a payment to the insured when it’s needed and processing of reinsurance if your company handles reinsurance. So that’s a mouthful of information and lots of requirements that maybe a lot of people don’t think about when it comes to insurance day-to-day operations. And then when you move on to thinking about the company wants to have new and enhanced insurance products and services. So you’ve got new products that you want to offer, you have new states and lines of business and coverages that you want to move into. And then if you want to enhance existing products, you’ve got rate changes, additional coverages you want to provide. And then there’s all kinds of interfaces, imager, quick rater, all types of interfaces into insurance policy admin systems that help integrate your business. And then not to mention, you’ve got to upgrade those existing interfaces because softwares are continuously evolving.

To watch the entire webinar, visit:
Bridging the Gap in Insurance Product Development