Tag Archive for: Product Development & Management

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

Aerospace

Canada’s Minister of Innovation, Science and Industry Francois-Philippe Champagne speaks during Question Period in the House of Commons on Parliament Hill in Ottawa, Ontario, Canada April 25, 2022. REUTERS/Blair Gable/File Photo

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.


Solving Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry with Jama Connect®: Part 1

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

Introduction

The AECO (Architecture, Engineering, Construction, and Operations) industry faces various challenges and opportunities as it adapts to changing market trends and technological advancements.

AECO is the largest industry in the world, according to McKinsey, and makes up 13% of global GDP. The industry has seen a steady increase in demand for sustainable and energy-efficient designs, as well as for innovative building materials and construction techniques. Additionally, digital technologies such as Building Information Modeling (BIM), cloud-based collaboration, and requirements management tools have become more prevalent, enabling better communication and project management across different stakeholders.

However, the industry is also grappling with issues such as a shortage of skilled labor, rising material costs, and increasing regulatory requirements. As such, the AECO industry is undergoing a transformation as it seeks to meet the evolving needs of clients and society while navigating a rapidly changing business landscape.

One of the challenges in adapting to changes in AECO is that a typical project involves many stakeholders, including architects, engineers, contractors, owners, and regulators, often with different business models and goals. These stakeholders must work together to design, build, and maintain the built environment, but structural and contractual agreements often make it difficult to communicate with each other to deliver projects on time and budget.

In this whitepaper, we will explore some of these challenges and how a requirements management solution like Jama Connect® can help solve them.

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Six Key Challenges

CHALLENGE #1 – Lack of Collaboration and Poor Communication

Collaboration and communication are essential in the AECO industry but can be difficult to achieve. With dozens, if not hundreds of individual firms involved in any given project, each stakeholder brings their own expertise, agenda, and perspective, which can lead to misunderstandings and communication breakdowns. This can result in rework, delays, and increased costs throughout the development process.

A requirements management solution like Jama Connect can help facilitate collaboration by providing a central repository for all project requirements. For example, the owner could post their original requirements into a Jama Connect environment allowing all stakeholders, project managers, and contracted firms access to the same information to jointly verify that their work is aligned to achieve project goals. Using Jama Connect to manage this process goes beyond just document sharing, by creating a record of verification that the requirements are met, or if there are changes, that those modifications are also tracked and validated back to the source.

CHALLENGE #2 – Scope Creep

Scope creep is a common issue in the AECO industry, where projects can become more complex and costly than initially planned. Scope creep occurs when project requirements expand beyond the original scope, leading to additional work, time, and costs that were not anticipated in the project plan. Broadly, this is referred to as the ‘change order’ process and results in project delays in addition to cost increases. Sometimes the changes result from a lack of clear communication and project management, where changes or additions to the project scope are not properly documented or approved. Additionally, external factors such as changes in regulations, client requirements, or unexpected site conditions can also contribute to scope creep. Managing scope creep in the AECO industry requires a proactive approach, including regular communication and documentation of changes, proper project planning and risk management, and stakeholder engagement to ensure that project expectations are aligned with project scope.

Jama Connect can help prevent scope creep by providing a platform for managing project requirements. This includes defining the scope of the project and ensuring that all stakeholders are aligned on project objectives and their plans are validated against the owner’s project requirements documents. Any changes to the project scope can be easily tracked and managed — in real time — within Jama Connect.

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CHALLENGE #3: – Redoing Similar Work Across Multiple Projects

Requirements reuse is a practice in the AECO industry that involves leveraging existing design requirements to develop new projects. By reusing requirements, designers and engineers can save time and resources while improving project quality and consistency. This can be particularly useful for large-scale projects or projects with similar design requirements, where requirements can be adapted and refined to fit new project contexts. Reuse of requirements can also help to ensure compliance with regulations and standards, as existing requirements can be used as a baseline for new projects.

While reuse can save an incredible about of time and money for all stakeholders involved, there needs to be an upfront investment in both tools and processes. To facilitate reuse of requirements, effective requirements management processes and tools are needed to capture, store, and manage requirements. Additionally, collaboration across different stakeholders is important to ensure that requirements are applicable and relevant to new projects.

Jama Connect is a powerful platform that can help the AECO industry with reuse in a number of ways.

Here are some examples:

  • Requirements reuse: In the AECO industry, many projects have similar requirements. By using Jama Connect, organizations can create reusable templates and structures to reuse requirements across projects, saving time and effort. This can be especially useful for organizations that work on multiple projects simultaneously or for those that have a large number of projects with similar requirements.
  • Design reuse: Just like with requirements, many projects in the AECO industry require similar designs. Imagine a wind farm project for example, where each of the turbine structures are identical in design. By reusing designs, organizations can reduce design time, improve consistency, and minimize errors. Jama Connect allows organizations to easily store and retrieve design artifacts, making it easy to reuse them across projects.
  • Knowledge reuse: Over time, organizations in the AECO industry accumulate a lot of knowledge about their projects, including best practices and lessons learned from experience. Jama Connect provides a central repository for this knowledge, making it easy to share and reuse across projects.
  • Process reuse: Many organizations in the AECO industry have well-established processes for managing projects, for example processes like issue resolution and design-change tracking. By using Jama Connect, organizations can capture these processes and reuse them across projects, improving consistency and efficiency.
Stay tuned for part 2 of this two-part series. Click 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®“


DevSecOps

What is DevSecOps? A Guide to Building Secure Software

DevSecOps has gained popularity as a secure and dependable software development methodology in the fast-paced world of software development. But what is DevSecOps really, and why is it so crucial?

DevOps is a set of techniques that stresses collaboration and automation between development and operations teams. DevSecOps is the integration of security practices into this methodology. DevSecOps seeks to establish a security culture that guarantees the software is secure and complies with compliance standards by integrating security into every phase of the software development lifecycle, from planning through deployment.

DevSecOps

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What are the advantages of DevSecOps?

The ability to identify and address security risks earlier in the development process is one of the main advantages of DevSecOps. This means that security is incorporated into the software at the outset instead of being added later, which can be expensive and time-consuming. Also, DevSecOps plays a big role in decreased risk of security breaches and data leaks by identifying vulnerabilities earlier.

The fact that DevSecOps helps to ensure compliance with laws and standards is another crucial feature of the practice. In many businesses, especially those that deal with sensitive or private data, including healthcare and banking, compliance is becoming more and more crucial. DevSecOps aids in ensuring that the software complies with requirements by incorporating compliance into the development process.

How does DevSecOps work?

What does DevSecOps look like in practice? DevSecOps is fundamentally about cooperation and communication between teams working on development, security, and operations. This implies that everyone bears some kind of responsibility for security, not just the security team. Instead of adding security features later, development teams collaborate with security and operations teams to incorporate security into the software from the start.

The automation of DevSecOps is a crucial element. Automation makes the development process more efficient, reduces errors, and ensures consistency. DevSecOps can aid in the quicker and more precise detection of vulnerabilities and threats by automating security testing and other security operations.

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

Ongoing Monitoring with DevSecOps

Continuous monitoring is a key component of DevSecOps. This means that maintaining security involves ongoing monitoring and improvement rather than being a one-time action. DevSecOps can assist in identifying and mitigating risks before they turn into significant concerns by continuously monitoring the program for security threats and vulnerabilities.

DevSecOps also depends on a culture that values security. As a result, security is more than just a collection of guidelines; it’s also a way of thinking and conducting business. Organizations may ensure that security is always a top priority and that everyone is aware of the significance of security in their work by developing a culture of security.

DevSecOps is a vital method of software development that places an emphasis on teamwork, automation, and constant monitoring. DevSecOps contributes to the creation of a security culture that guarantees the software is secure and complies with regulatory standards by integrating security into every phase of the software development lifecycle. Organizations that implement DevSecOps are well-positioned to produce secure and dependable software that satisfies the needs of their stakeholders and customers given the growing relevance of security in today’s society.

There are numerous online resources, like blogs, podcasts, and online courses, that you may use to learn more about DevSecOps. In the world of DevSecOps, there is something for everyone, whether you are a developer, security expert, or operations specialist.

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