Tag Archive for: Product Development & Management

Medical Device & Life Sciences

In part two of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect®. Click HERE for part 1 and  HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

Jama Connect Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2

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 under five minutes.

In part two of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, continues his demonstration of the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

Click HERE for part 1 and HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.

So the first thing I want to show is our Jama Connect Advisor™ example data. Released in 8.80, this new feature enables EARS and INCOSE rules for requirement quality authoring. Additional licenses are required, but wanted to share some of the capabilities examples right out of the box. So as you can see here, what we’ve shown, is, you know, the general use case description, but also an example requirement with the Jama Connect Advisor output. Again, this is a nonfunctional screenshot. We just wanted to share some of the information that you may see when having Jama Connect Advisor. Here’s, for example, for a green status, which means generally a good requirement, but let’s take a look at what a yellow requirement or maybe something that may need some rework and you can see which of the rules, particularly INCOSE, that is now flagged that is, you know, has some potential issues. And then the same is true with our red level of requirements.

So again this is potentially a useful tool to kind of share while authoring requirements for your project.

RELATED: The Top 5 Challenges in Digital Health Solution Development

Balgos: The next use case that we’d like to talk about is the industry standards trace. So in the standards use case, the first thing I want to share is this relationship rule diagram. As you can see here, we have user needs trace to system requirements, which is, you know, aligns with [21 CFR] 820.30, but also we have this new item type called standards reviewed is now traced to system requirements.

If you upload your standards into Jama Connect, what we can see for this particular item type is that we’ve identified now the standard, the clause number, the clause text, and identified does the standard apply for this particular project. What’s nice about once this is in Jama Connect, I can now actually do a trace downstream to the system requirement. Note, this project does not provide any standards due copyright issues, customers won’t need to vision their own standards for use and apply appropriately. The last thing we want to talk about is really the reports on this medical device framework update.

RELATED: Jama Connect® for Digital Health Solution Overview

Balgos: What I wanted to share is if I go into the admin area and I take a look at the reports, you can see now that we’ve now had the ability to upload and, you know, manage our own reports, but we’ve provided some additional categories and information to help organize the many reports that we have. As you can see here, we’ve identified some trace reports and some new SaMD reports. So if I go back to the project and let’s take a look at, let’s say, system requirements, I want to show you a new trace report that shows requirements to verification-only events. So for example, let’s say if we go on to, let’s say, our subsystem requirements that we have here I’m gonna pick this one.

I’m going ahead and go at export. Again, this is available now into the Medical Device Framework 2.0. What I want to show you is requirements to verification trace report. So if I go ahead and hit run, create a report, I’m gonna download it, and then what wanna share is this new trace report that we have, which now shows you the requirement, the verification test case associated with the requirement, But in addition, the latest test run and its test result status.

RELATED: Requirements Traceability Diagnostic

Balgos: So this helps clearly identify the requirement to verification traceability that’s may needed and they may be able to submit to your DHS. We have a similar one called the user needs to validation transport that falls the same above. The other thing we wanted to show is that we’ve added a couple popular and useful GitHub reports to this solution update. These are located up in our run reports area where we actually now included the test results report group by test case and the test result report grouped by test cycles, which are really, really helpful for understanding test management scenarios.

Okay. That’s for the general update for the the standard medical device framework. We have an additional updated solutions such as software as a medical device, research use only, and our new self-guided onboarding framework. So we definitely encourage you to look at that further.

Please contact your Jama success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

 

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


In this blog, we recap our webinar, “Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries”. Click HERE to watch the entire thing.

If you’re in the automotive or semiconductor industries – cybersecurity is likely top of mind.

During this informative session Effectively Managing Cybersecurity in Jama Connect for Automotive and Semiconductor Industries, Kevin Dibble, Principal Consultant at Reinnovate Consulting, and Matt Mickle, Director of Automotive Solutions at Jama Software®, offer insights on how the right tooling solution can make a difference in managing a cybersecurity case.

In this webinar, attendees will see exactly how to:

  • Define cybersecurity goals, requirements, and concepts
  • Conduct threat analysis and risk assessment
  • Establish traceability to the architecture design and verification/validation of cybersecurity measures
  • Document the cybersecurity case and manage changes
  • Identify and classify assets for the subject of the cybersecurity case
  • Discover how Jama Connect can help you optimize your cybersecurity processes and stay ahead in the Automotive and Semiconductor industries.

Below is an abbreviated transcript of our webinar.

Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries

Kevin Dibble: Well, first I’m going to talk about what we’re going to talk about, so these are the topics that we’re going to cover. And without reading this slide, really we’re going to cover the development life cycle of creating, the example we’re going to use is a 48-volt power assist system. You might also think of it as a battery management system. And so I’ll go over the agenda, but what you can see on the is we’re going to cover everything from the planning in the case through the TARA work and down through the left side of the V and some of the right side of the V activities as well. And here’s how we’re going to do it. First, to get everyone oriented to 21434, we’re going to talk about the standard itself briefly and highlight some of the benefits of implementing a cybersecurity case in a tool, in a requirement management tool.

Then we’ve got some workflows to look at, the steps of the development life cycle for 21434 from the perspective of an OEM and then again from the perspective of a tier one. And then Matt is going to show the work products, the traceability, and what we’ve talked about at the beginning actually in the tool in a built-out project for a 40 volt power assist system. And then we’ll finish with some takeaways. So that’s what’s on tap for today. And so I want to make the case for managing cybersecurity and the cybersecurity case and the work products in a requirements management tool. So I’m going to just look at each one of these points. The first item is to improve collaboration between OEMs, tier ones, and tier twos.

Jama Connect supports ReqIF, which can be used for bidirectional communication of requirements, item definitions, et cetera, as well as updates to those assets. And so it supports better collaboration. One thing that Jama promotes is this idea of trace as you go. So traceability is not an afterthought handled by a requirement engineer at the end of the project that takes weeks to implement on a complex project. It’s something that the engineers are doing as they’re creating the requirements tracing to parent requirements, design blocks for requirement allocation, et cetera. And so this tool supports that traces you go methodology along with some views of the progress of tracing.

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

Dibble: The impact analysis is a powerful tool when you trace as you go and the requirements left and right side V model assets are linked together. Then running impact analysis reports as changes come in midstream in programs, which they do in automotive for sure. You get that as a benefit. Like I mentioned earlier, requirements allocation. So allocating requirements to design blocks or interconnecting the requirement management system to design tools and doing allocation in those tools like Design Architect gives you some powerful analytics like test coverage reports automatically generated. Also connecting the tools through connectors gives you a toolchain view instead of disjointed tool. And finally, Jama Connect offers some analytics that we’ll see some of these in the demo that will give you a very clear indication of where you are in the project, especially in terms of requirements that are allocated, tests that have been covering requirements, and so on and so forth.

So with that, I’m going to orient everybody to 21434 in terms of the V model, which it’s centered on, and two other standards that you may be more familiar with. ISO 26262 and Automotive ASPICE. And so just a couple things here. If you are familiar with these other two standards, you’ll see that 21434 fits nicely alongside and that was intended by the ISO folks that did the standard. They very much aligned it with ISO 26262, and really even in nomenclature. So whereas in safety we have safety goals, in security we have security goals, in safety, we have the HARA, the hazard and risk assessment. In cybersecurity, we have the TARA, threat, and risk assessment, and so on and so forth. And also the common supporting processes like configuration management, change management, project management, document management, even confidence in use of software tools that all of these standards rely on are again repeated and required in 21434.

RELATED: A Guide to Road Vehicle Cybersecurity According to ISO 21434

Dibble: So just some basic organization of the standard in terms of the V model and then we’ll look at it in one more view in terms… this is directly out of ISO. And at Jama, we’ve added some color coding and I’m going to explain that. And so if you’re not familiar with this view, 21434 is oriented by clauses and sub-clauses. And so you can see the clause here like clause five is organizational, that’s policy and tool management and quality management and things. And then clause six, et cetera, and on down, that’s how this is organized. Jama has capabilities that support these sub-clauses. And so we’ve used a color system here to highlight that. The sub-clauses that are colored in green are fully supported and in fact, recommended to implement in Jama. The yellow are optional, they could be implemented in Jama.

And for most of these, we have customers that are implementing these types of things in Jama, but they also use other systems to implement them. And then this kind of yellow-green is partially supported. Jama can support some of the requirements but not all. And then of course red is not recommended for support in Jama and it’s usually house and other tools or things like production tools, et cetera. Okay, so what Jama brings to the table in terms of capabilities to support these green and yellow items are document building and generation. So the document management functionality as well as the exporting functionality. As you’ll see in the demo, you can export what has been entered in a requirements tree or in one view can be exported into a more of a document-style view that perhaps suppliers or other people might want to consume.

It has built-in collaboration tools for reviewing, which is very important because 21434, like 26262 requires review records, and all the work products are reviewed. Traceability and impact analysis, I already talked about. VNV verification and validation with the test manager tool as well as interconnections to other tools and analytics. There’s a nice support for the right side of the V activities. Using a common tool does bring alignment between different engineering disciplines, whether it’s hardware, software in systems, or if it’s QA tests and V&V activities versus development activities. Release planning and coverage through dashboards and status metrics and then of course baselining and reuse and whatnot.

And so this slide shows all of the items from the previous slide that were recommended or are optional and just shows how they would look in a project tree format. Again, Matt’s going to go through most of these items for our 48-volt power assist item that we’ve built out. Okay, one of the important features of Jama Connect as well as any requirement management tool is the ability to develop traceability. Here we’re showing the traceability model, which is their traceability models come with the product, but they also can be customized. And then I’ve got a little animation here to show for cybersecurity, some of those standard parts and tying them back to the standard. So for instance, in the model, I don’t know, it’s small print, but you can probably see cybersecurity asset, attack path, damage scenario, threat scenario. Those all correspond to the TARA and here are the sections that those are discussed in.

To watch the entire webinar, visit:

Effectively Managing Cybersecurity in Jama Connect® for Automotive and Semiconductor Industries


Large Language Model (LLM) Image

How to Plan for Large Language Model (LLM) Adoption Within Your Engineering Organization

The initial free and unprotected access to ChatGPT (the most well-known Large Language Model) has led some individual engineers to try out the tool by using company owned trade secrets and intellectual property (IP) as prompts. The predictable result has been IP leakage with numerous high-profile examples, including at Samsung. As a result, many companies, including Apple, have banned internal use of the technology outright. Additional risks are just starting to be understood given the lack of consent provided by the actual owners of content that was used to train the LLMs. This leaves the concept of ownership of LLM output, and the ability to protect intellectual property that includes LLM output in question and legal experts are advising caution. Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that at properly allow for company level standards and governance of IP. Numerous lawsuits, such as Clarkson v OpenAI, are now underway alleging all of the data to train the LLMs was obtained without consent or renumeration and violates copyright law.

RELATED: Best Practices Guide to Requirements & Requirements Management

Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that properly allow for company level standards and governance of IP. Given the risks and unresolved legal questions LLMs pose for product development, how should an engineering organization plan an adoption path to achieve potential benefits from intelligent assistance for engineering tasks?

The guidance we provide our clients is to focus on the following three areas, ranked in order of greatest benefit from intelligent assistance:

  1. Improve requirements quality – Poorly specified requirements account for up to 64% of defects and are the costliest ones to correct. The International Council on Systems Engineering (INCOSE) and the Easy Approach to Requirements Syntax (EARS) have established best practices for requirements specification and unfortunately, LLMs are trained on publicly available requirements content that is rife with all the most common errors addressed by INCOSE and EARS. The best intelligent assistant to improve requirement quality is a Natural Language Processing (NLP) approach that analyzes requirements against INCOSE and EARS best practices and recommends improvements – which is exactly what Jama Connect Advisor™ does. Jama Connect Advisor protects all IP and engineers learn how to write better requirements through intelligent guidance.
  2. Manage by exception – The engineering function is one of the last in the enterprise to be managed through data. The engineering process is often fragmented across teams and tools which leads to late identification of cross-discipline issues that result in defects, delays, cost overruns, and recalls. Jama Connect® intelligently solves this problem through Live Traceability™ which automatically syncs data across best-of-breed tools and tracks engineering progress against the chosen development model (e.g., V-model) to identify issues as early as possible and thereby reduce the risk of defects, delays, cost overruns, and recalls.
  3. Increase engineer productivity – The biggest drains on engineering productivity are most commonly integration meetings and rework. Jama Connect’s Live Traceability intelligently alerts teams to impactful change from other engineering disciplines. Live Traceability eliminates the need for time-consuming and mind-numbing integration meetings and is proven to reduce rework based on our groundbreaking benchmarking study. Further productivity gains can be achieved by leveraging LLMs for requirement decomposition and we intend to be one of the first to market with an enterprise-class solution that protects IP and enables company standards.

RELATED: Best Practices Guide for Writing Requirements

To get started with intelligent assistance, learn how best to improve requirements quality across your engineering organization with the NLP application of EARS and INCOSE best practices.


In part one of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect. Click HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1

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 under five minutes.

In part one of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

We will share part two of this video series here once it’s published.

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device & Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.

So the first thing I want to show is the general organization and layout of our new Medical Device & Life Sciences Solution 2.0. The first thing I want to show is that this new folder that actually has our new Medical Device framework and our other additional popular frameworks such as SaMD and Consumables frameworks. The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our three hundred-plus customers and their practices using Jama Connect.

So now let’s go ahead and jump into the tool. We’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have.

RELATED: Jama Connect® Customer Success Programs

Balgos: The most common example is associated with risk. Not all risk controls are requirements, so we still need a way to trace to these non-requirement risk controls. These controls may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.

Another thing that we’ve done is actually updated our hazards library to include general hazards identified in ISO 14971. So you have pretty much a starting place with your hazard library The next item that I like to talk about is the risk Lookup Matrix. Available in [Jama Connect] 8.74, this feature allows a new Lookup Matrix risk analysis approach that automatically outputs the desired content based on the preconfigured Lookup table. This really aligns with [ISO] 14971.

Let me show you a quick demo of this. We’ve now implemented this as part of our Medical Device & Life Sciences Solution 2.0. As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of again follows the general [ISO] 14971 schema of hazard sequence events, hazard situations, harms, but here is now where we’ve implemented this new Lookup Matrix feature. Where now I’ve identified the input pick list where I may be able to change this, and then that automatically updates my risk level based off that matrix.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Balgos: So for example here, if I went ahead and increased this to frequency and I increase my severity from here and this one as well. I can see that both my p total and risk analysis has been updated per the Lookup Matrix. We have an additional Features in Five video that shows cases a little bit more. So we definitely encourage you to look at that further.

The other thing that we wanted to share with particularly this Medical Device update is we have now included preconfigured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, when I look at my item type, I’ve now included preconfigured D FMEAs, Process FMEAs and, Use FMEAs that you may configure based on your organization.

RELATED: G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Summer 2023 Grid® Report

Balgos: The intent of this is really to continually improve and provide new solutions to our customers based on customer feedback, industry trends, and best practices.

The industry vertical solution updates expand new use cases and solutions to address complex challenges while continuing to comply with industry regulations. Please contact your Jama Connect success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

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


Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by Christine Fallabel and published on July 11, 2023.

Tandem’s Mobi Approved by the FDA

On Tuesday, July 11th, 2023, the Food and Drug Administration (FDA) announced the approval of Tandem’s newest insulin pump, called Mobi. This insulin pump is fully controllable from a mobile app and is now the world’s smallest durable automated insulin delivery system.

THE MOBI INSULIN PUMP

The Mobi will join a growing selection of Tandem products that support people with diabetes. Their human-centered approach to design, develop and support innovative products and services for people who use insulin is evident in this latest approval.

John Sheridan, president and chief executive officer for Tandem Diabetes Care said, “Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”

The San Diego-based company also manufactures the T:Slim X2 insulin pump with Control-IQ technology, a feature that is also part of this new release.

Control-IQ technology utilizes compatible continuous glucose monitor (CGM) sensor readings to predict blood sugar levels 30 minutes ahead of time. It then adjusts insulin delivery every five minutes to help prevent both high and low blood sugars levels. The system also delivers automatic correction boluses of insulin for up to an hour to help prevent high blood sugars.

The user can still manually bolus for snacks and meals.

The Mobi has been approved for people with diabetes aged six and older who require insulin.

RELATED: Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

MOBI FEATURES

The new Mobi has some great features that will make pumping not only easier for people, but more convenient and flexible too.

  • 200-unit insulin cartridge
  • Less than half the size of the T:Slim X2 pump
  • Detachable infusion sets that are compatible with all existing Tandem infusion sets, allowing users to mix and match infusion sites and tubing length combinations for greater flexibility
  • Control IQ technology designed for use as part of an automated insulin delivery system
  • Mobile app control with an on-pump button, providing an option for the user to utilize phone control for bolusing insulin
  • Inductive charging and capable of wireless remote software updates from a compatible smartphone

MORE CHOICES FOR PEOPLE WITH DIABETES

This new approval will greatly expand the choices people with diabetes who use insulin pumps will have, and it is the smallest and most convenient insulin pump yet.

According to the manufacturer, the Mobi is small enough to fit in a coin pocket, be clipped to clothing or fit into an adhesive sleeve—expanding where and how and insulin pump fits into your life and lifestyle.

Additionally, the Mobi insulin pump is completely controllable from a user’s mobile phone via an app, a feature many people with diabetes are looking for in newer tech releases.

People don’t want to always be juggling multiple devices, and having both blood sugar readings and insulin pumping capability from a smartphone just makes life with diabetes easier.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

MARKET AVAILABILITY COMING SOON

A limited release is expected to start in late 2023 with full commercial release planned for early 2024. To sign up for updates, please visit tandemdiabetes.com/mobi.

If you are interested in trying the Mobi insulin pump when it is available, start talking to your provider now about any necessary steps you may need to take like getting a prior authorization.


NASA Systems Engineering Handbook Rev2

Unveiling the NASA Systems Engineering Handbook Rev2: A Comprehensive Guide for Space Exploration

NASA, the National Aeronautics and Space Administration, has been at the international forefront of space exploration for decades, pushing the boundaries of human knowledge and expanding our understanding of the universe. Behind every successful NASA mission lies a robust framework of engineering practices and principles, which are meticulously documented and compiled in the NASA Systems Engineering Handbook Rev2. In this blog post, we will delve into the key aspects of this handbook, exploring its purpose, contents, and the diverse range of professionals who rely on it.

Understanding the NASA Systems Engineering Handbook Rev2

The NASA Systems Engineering Handbook Rev2, also known as NASA/SP-2007-6105 Rev2, is a comprehensive guide that provides detailed insights into the principles, practices, and processes of systems engineering as applied to space missions. It serves as a valuable resource for engineers, scientists, project managers, and other professionals involved in the planning, development, and execution of NASA missions.

In comparison to NASA Systems Engineering Handbook Rev1, which was published in 1995, Rev2 is a modernized version that aligns with current practices, incorporates lessons learned from recent NASA missions, and integrates more current technologies and tools to enhance system development and management.

RELATED: [Webinar Recap] Launch Your Aerospace & Defense Product Development Processes with Jama Connect®

Purpose and Objectives

The primary objective of the handbook is to promote effective systems engineering practices within NASA and its associated programs. It outlines a standardized approach to managing complex projects and ensures that all aspects of engineering are considered throughout the lifecycle of a mission. By adhering to the guidelines presented in the handbook, NASA aims to enhance mission success rates, mitigate risks, and optimize resource utilization.

Contents and Key Topics

The NASA Systems Engineering Handbook Rev2 covers a wide range of topics, providing a holistic view of the systems engineering discipline. Some of the key areas addressed in the handbook include:

  • Introduction to Systems Engineering: This section provides an overview of systems engineering principles, concepts, and the overall engineering process. It lays the foundation for understanding the subsequent chapters and their relevance to space missions.
  • Systems Engineering Processes: Here, the handbook outlines the various processes involved in systems engineering, such as requirements development, design, verification, validation, and risk management. It emphasizes the importance of a structured and iterative approach to achieve mission objectives.
  • Systems Engineering Management: This chapter focuses on the management aspects of systems engineering, including organization structures, roles and responsibilities, and project planning and control. It provides guidance on effectively managing interdisciplinary teams and fostering collaboration.
  • Systems Engineering Tools and Techniques: The handbook explores the tools and techniques commonly employed in systems engineering. It covers areas like modeling and simulation, trade studies, configuration management, and system integration and testing. These tools facilitate informed decision-making and ensure the successful integration of complex systems.
  • Systems Engineering and NASA Programs: This section discusses the application of systems engineering within various NASA programs, highlighting the specific challenges and considerations associated with each program. It encompasses areas such as human spaceflight, robotic exploration, Earth science missions, and astrophysics.

RELATED: Aerospace & Defense PLM Action Group Digital Thread Collaborative Research Report

Users of the NASA Systems Engineering Handbook Rev2

The NASA Systems Engineering Handbook Rev2 is an invaluable resource for a wide range of organizations involved in space exploration system development. The following are some key users of this handbook:

  • Engineers and Scientists: Systems engineers, aerospace engineers, and scientists working on NASA projects rely on the handbook for guidance on best practices, processes, and techniques. It provides them with a standardized approach to system development, ensuring consistency across missions.
  • Project Managers: The handbook offers project managers a comprehensive understanding of systems engineering principles. It assists them in establishing project plans, managing risks, and coordinating activities across multidisciplinary teams.
  • Academia and Research Institutions: The NASA Systems Engineering Handbook Rev2 is widely used as a reference in academic and research institutions. It serves as a guide for students, researchers, and professors involved in space-related studies and projects.
  • Industry Professionals: Engineers and professionals working in the aerospace industry often refer to the handbook as a benchmark for best practices. It helps them align their methodologies with NASA’s standards, enabling seamless collaboration with the agency on joint projects.

Conclusion

The NASA Systems Engineering Handbook Rev2 stands as a testament to NASA’s commitment to excellence in space exploration. By encapsulating the best practices and experiences from numerous successful missions, this updated comprehensive guide empowers engineers, scientists, project managers, and other professionals involved in NASA programs. With its emphasis on a structured approach to system development, risk management, and interdisciplinary collaboration, the handbook plays a pivotal role in ensuring the success and safety of future space missions.

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


Traceability Cluster

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

Traceability is a crucial aspect of product, system, and software development that enables organizations to maintain a record of the components and activities involved in the design, production, testing, and delivery of their products. In essence, traceability means being able to show documentation of the “trace” of a product or system, from its inception to its final state, in order to ensure quality, compliance, and accountability.

What is Traceability?

In its simplest definition, traceability refers to the ability to track and document the lineage or history of an item, process, or system. It involves keeping track of the various components, parts, materials, and processes involved in the creation of a product, as well as the different stages of testing and inspection that the product undergoes. In this way, traceability provides a way to verify that a product meets the required specifications and standards, and that any defects or problems can be quickly identified and resolved.

Why is Traceability Important?

Traceability is particularly important in industries such as aerospace, automotive, and medical devices, where safety, quality, and compliance are critical. In these industries, traceability systems are often mandated by regulatory bodies to ensure that products are safe, reliable, and comply with applicable standards and regulations.

What is a Traceable System?

A traceable product or system is one that has a documented history or record of its development, production, and testing. This record provides a complete picture of the product or system, including its design, components, and any modifications or changes made throughout its development. A traceability system also enables organizations to quickly identify the source of any issues or problems that arise during production or testing, and to take corrective action as needed.

RELATED: [Webinar Recap] New Research Findings: The Impact of Live Traceability™ on the Digital Thread

What Are the Benefits of Traceability?

The benefits of traceability are many. First, it ensures product quality by enabling organizations to track and verify that all components and processes meet the required standards and specifications. This helps to reduce the risk of defects and recalls, which can be costly in terms of both financial loss and damage to a company’s reputation.

Second, traceability helps to ensure compliance with regulatory requirements. In many industries, organizations are required to maintain detailed records of their products and processes, and to demonstrate that they are meeting all applicable standards and regulations. A traceability system provides a way to easily produce these records and demonstrate compliance.

Third, traceability promotes accountability and transparency. By maintaining a complete record of a product’s development and testing, organizations can demonstrate that they are taking steps to ensure quality and safety. This can help to build trust with customers and stakeholders and enhance a company’s reputation.

How Do You Enable Traceability?

In practice, traceability involves the use of tools and systems to track and document the various components and processes involved in product development and testing. These tools can range from simple spreadsheets and databases to modern requirements management platforms that enable Live Traceability™  and integrate with other product development tools such as product lifecycle management (PLM) systems, test management tools, and task management tools like Atlassian Jira and Azure DevOps.

RELATED: Extending Live Traceability™ to Product Lifecycle Management (PLM) with Jama Connect®

Challenges in Implementing Traceability

One of the key challenges in implementing traceability is ensuring that all relevant data is captured and documented. This can be particularly difficult in complex product, systems, and software development processes involving multiple teams, suppliers, and partners. However, by establishing clear processes and standards for data capture and documentation, organizations can overcome these challenges and reap the benefits of traceability.

In conclusion, traceability is a critical aspect of product and system development that enables organizations to ensure product quality, compliance, and accountability. By maintaining a complete record of a product’s development and testing, organizations can reduce the risk of defects and recalls, demonstrate compliance with regulatory requirements, and build trust with customers and stakeholders. While implementing a traceability system manually is very challenging, using a modern platform like Jama Connect® automatically creates Live Traceability throughout the development process.


Aerospace

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Reuters, titled “Canada investing C$350 million to boost drive for sustainable aerospace industry” – originally reported by David Ljunggren, edited by Jonathan Oatisand, and published on June 19, 2023.

Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace Industry

OTTAWA, June 19 (Reuters) – Canada is investing C$350 million ($265 million) to help fund efforts to make the aerospace industry more environmentally sustainable, Innovation Minister Francois-Philippe Champagne said on Monday.

The focus will be on hybrid and alternative propulsion, aircraft systems, the transition to alternative fuels, and aircraft support infrastructure, he said in a statement.

RELATED: New Research Findings: The Impact of Live Traceability™ on the Digital Thread

“(This) … will help drive and accelerate the green industrial transformation of Canada’s aerospace industry, generating high-value jobs while strengthening supply chains and supporting the transition to a net-zero economy,” he said.

Earlier this month, global airlines called for broad co-operation to reach “very tough” emission targets. Aviation, which produces around 2% of the world’s emissions, is considered one of the hardest sectors to decarbonise.

RELATED: Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety

The C$350 million includes a C$49 million aerospace innovation investment announced in 2019.

Airbus said in 2021 it was working on hybrid-electric propulsion among the options for reducing jetliner emissions. It has pledged to introduce the first hydrogen-powered commercial plane in 2035.

In 2019, Vancouver-based seaplane operator Harbour Air carried out the world’s first fully electric, commercial flight.

($1 = 1.3202 Canadian dollars)


AECO

In this blog series, we’ll recap the “Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®” whitepaper. To read part 1 of this two-part series, click HERE.

Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 2

Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®

Six Key AECO Challenges Continued…

CHALLENGE #4 – Inability to Track and Manage Owner Changes

The AECO industry is a complex and dynamic industry that involves many stakeholders and moving parts. One critical aspect of managing AECO projects is conducting change impact analysis, which involves evaluating the potential effects of proposed changes to a project’s design, scope, schedule, and cost. The inability to effectively track and manage change can lead to significant negative impacts on project outcomes.

For example, without a proper analysis, changes may be implemented without understanding their full downstream consequences, resulting in unexpected delays, cost overruns, safety hazards, and quality issues. Furthermore, failing to conduct a change impact analysis can undermine project team collaboration, trust, and communication, leading to increased conflicts and disputes. Therefore, incorporating change impact analysis into AECO projects is crucial for ensuring project success and minimizing risks.

A real-world example might be: One contractor decides to make a window larger. This change might impact the structure of the building, air conditioning needs, electrical placement, the roof, and even violate building codes. While a simple change like this may seem insignificant, it will often have ripple effects throughout the development process. Without proper visibility, collaboration, and consideration, this can result in rework, delays, and increased costs across the board.

Jama Connect is a powerful tool that can help the AECO industry effectively manage change by providing a centralized platform for capturing, tracking, and analyzing changes across the end-to-end project development lifecycle. Jama Connect’s change management capabilities enable project teams to quickly assess the impact of proposed changes and make informed decisions about their implementation. With Jama Connect, project teams can easily collaborate and communicate about change requests, ensuring that all stakeholders are aware of the potential impacts and can provide input. Additionally, Jama Connect provides real-time visibility into the status of changes, allowing project teams to proactively identify and address any issues that arise. This level of transparency and control helps to reduce the risk of errors and delays, ensuring that projects are delivered on time and within budget. Overall, Jama Connect is an essential tool for the AECO industry to effectively manage change and ensure project success.

RELATED: Best Practices Guide for Writing Requirements

CHALLENGE #5 – Inefficient Design Review Process

In the AECO industry, design review processes are critical to ensure the quality and compliance of construction plans. However, inefficient design review processes can lead to significant delays, cost overruns, and mistakes in the final product. One common issue is the lack of clear communication and coordination between different stakeholders, such as architects, engineers, contractors, and clients. This can result in conflicting feedback, revisions, and approvals that prolong the design review process. Additionally, outdated or manual review methods, such as paper-based markups and physical meetings, can further slow down the process and increase the likelihood of errors. Overall, improving the efficiency of design review processes in the AECO industry requires better collaboration tools, streamlined workflows, and clear communication channels.

Jama Connect can play a significant role in streamlining the design review (and design verification) process in the AECO industry by enabling collaboration, improving communication, and reducing errors. It is required that engineering firms provide specific validation of how their proposed design meets the original owner’s requirements, and with Jama Connect, that process is simple.

Here are some specific ways Jama Connect can help with the design review process:

  • Centralized platform for design review: Jama Connect provides a centralized platform for design review, allowing all stakeholders to access the latest designs, review comments, and feedback in real-time. This eliminates the need for stakeholders to send design documents back and forth via email, which can be time-consuming and result in errors.
  • Collaborative review process: Jama Connect enables collaboration between all stakeholders during the design review process and documents the history of every change, who made it, and why. Stakeholders can provide feedback and comments on designs, and other stakeholders can respond to those comments, creating a collaborative feedback loop. The ability to trace designs back to the original requirements is a key component of moving smoothly through the design process, and with Live Traceability™ within Jama Connect, this traceability is automatically created as you go through the design and review process and gives an owner a complete record for their project. This helps to ensure that all stakeholders are on the same page, reducing errors and misunderstandings.
  • Version control and tracking: Jama Connect provides version control and tracking features that allow stakeholders to see the history of design changes, track who made each change, and ensure that everyone is working with the latest version of the design. This helps to avoid errors that can occur when stakeholders work with outdated or incorrect design documents.
  • Approval workflows: Jama Connect allows organizations to define and enforce approval workflows for design reviews. This ensures that designs are reviewed and approved by the appropriate stakeholders before being finalized, reducing the risk of errors and ensuring compliance with industry standards and regulations.
  • Reporting and analytics: Jama Connect provides reporting and analytics features that allow organizations to track the progress of design reviews, identify bottlenecks, and analyze review data. This helps organizations to continuously improve their design review process, reducing errors and improving efficiency over time.

AECO Projects Must Move Quickly While Balancing Budget and Quality:
Learn More: Buyer’s Guide- Selecting a Requirements Management and Traceability Solution eBook

CHALLENGE #6 – Lack of Accountability

Accountability is essential in the AECO industry, as it ensures that all stakeholders are responsible for their actions and decisions. This includes ensuring that project requirements are met, timelines are followed, and budgets are managed effectively.

Jama Connect can help solve this challenge by providing a platform for managing project requirements. This includes defining responsibilities and tracking progress against milestones. This helps ensure that all stakeholders are accountable for their actions and decisions.

Conclusion

In conclusion, while the AECO industry is facing many unique challenges, there is also an opportunity for process improvement that will allow stakeholders to reduce delays, project risk, and overspending. Jama Connect can help facilitate collaboration, prevent scope creep, reuse requirements, designs, knowledge, and components, and improve the design review process. By leveraging Jama Connect, AECO organizations can overcome many of the challenges they face and meet the evolving needs of clients and society while navigating a rapidly changing business landscape.

Click HERE for part 1 of this series and HERE to download the entire whitepaper,
“Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®“

Want to Get Your Budget Back and Simplify Your AECO Projects?
Get Started By Trying Out Our Award-Winning Requirements Management Software Platform!


FMEDA

Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

As a product development team working in the medical device sector, assuring the dependability and safety of your products is crucial. FMEDA, or failure modes, effects, and diagnostic analysis, is a method frequently used to assess potential failure modes and their consequences on the entire system.

What is FMEDA?

FMEDA is a rigorous and structured analysis technique used to predict the potential failure rates, failure modes, diagnostic capabilities, and their impact on a system or product. It is a quantitative approach that helps in understanding the failure rates and probabilities of different components, the suitability of the diagnostic functions of the design for subsystems of a product.

FMEDA is an essential step in the product development process since it aids in the detection of probable faults and their effects on the performance of the system as a whole. It also evaluates the potential efficacy of the implemented diagnostic functions in the subsystem or product design. It is used to assess a product’s dependability and safety and aids in the detection of any possible system failures.

FMEDA is frequently applied to complicated systems with numerous components and subsystems. It is commonly used in the medical device sector to assess the product’s safety characteristics, and to confirm that the design is suitable and safe to be used in the medical device industry.

RELATED: Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System

How does FMEDA work?

There are various steps in the FMEDA process. The system or the subsystem is first divided into all of its component designs. The impact of each failure mode on the safety related functions of the design, as well as the diagnostic functionality coverage to identify the failure modes and to prevent occurring those, are then taken into consideration while evaluating the safety characteristics of the system or subsystem design.

The severity, frequency, and detectability of the failure modes are all taken into account while rating them. The impact of the failure on the system’s or product’s overall performance is referred to as severity. The terms “occurrence” and “detectability” describe the possibility that a failure will occur and the capacity to identify the failure mechanism, respectively.

Based on the system’s capacity to identify the failure mechanism and take appropriate action to lessen the effects of the failure, the diagnostic coverage is assessed.

The data is then utilized to determine the system or product’s overall failure rate and probability after each component’s failure modes, their consequences, and diagnostic coverage have been assessed for each one.

What makes FMEDA crucial?

FMEDA is significant for a number of reasons. It is beneficial to first recognize probable failure modes and how they may affect a system or product. The evaluation of the efficiency and suitability of the diagnostic coverage of the design provides further insights for developers on system or product safety. This information is essential for identifying any hazards the product can have and making sure it complies with all applicable regulations.

Secondly, FMEDA contributes to ensuring the product’s dependability and safety. Product development teams can take the necessary steps to reduce the consequences of probable failure modes and enhance the product’s overall performance and dependability by identifying potential failure modes and assessing their influence on the system or product.

Finally, FMEDA decreases the overall cost of product development. Early in the development process, teams can identify potential failure modes and take the necessary steps to mitigate those failures before they become significantly more expensive and time-consuming to fix.

RELATED: Functional Safety (FuSA) Explained: The Vital Role of Standards and Compliance in Ensuring Critical Systems’ Safety

Conclusion

The bottom line is, FMEDA is a crucial step in the creation of new products for the medical device sector. It helps organizations ensure product’s safety and dependability, the identification of probable failure modes and their effects on the system or product, and the reduction of the overall cost of the product development process.

Understanding the FMEDA method and how it’s applied to improve the safety and dependability of your products is crucial for the product development team. You can make sure that your products comply with regulations, are trustworthy and safe, and satisfy the demands of your customers by incorporating FMEDA into the development process.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by McKenzie Jonsson and Vincent Balgos.