Tag Archive for: Requirements & Requirements Management

Application of Systems Engineering in Healthcare

In this blog, we recap our webinar, “Application of Systems Engineering in Healthcare”. Click HERE to watch the entire webinar.

When it comes to healthcare, the first to market usually gains 80% of the market share, making development speed one of the most crucial aspects of success – or failure. That’s why many organizations are looking at systems engineering as a way of connecting needs to solutions.

In this webinar, Chris Unger of PracticalSE LLC and Vincent Balgos Director, Medical Device Solutions at Jama Software® have partnered up for an engaging webinar on the application of systems engineering in healthcare.

We invite you to join in as we delve into transformative role systems engineering is playing in the healthcare industry.

What to Expect:

1. The Power of Simplicity:

Discover how focusing on the basics, while maintaining world-class performance levels, can yield astonishing returns. We’ll show you how simplicity can be a game-changer in the complex world of healthcare systems engineering.

2. Market-Driven vs. Contract-Driven:

Intrigued by the difference between market-driven and contract-driven industries? We’ll explore how systems engineering varies in these two landscapes. Learn why “Market Driven” industries emphasize competitive value creation and use cases more than traditional requirements, and how this shift can redefine your approach in healthcare.

3. Striking the Perfect Balance:

Explore the ideal state of systems engineering in healthcare, often a harmonious blend of Agile, Lean Startup, and more traditional systems approaches. Uncover strategies to adapt, innovate, and succeed in this dynamic field.

Don’t miss this opportunity to gain a comprehensive understanding of how systems engineering can revolutionize healthcare. Whether you’re a seasoned professional or just beginning your journey in healthcare systems, this webinar promises valuable takeaways for all.

Below is an abbreviated transcript of our webinar.

Application of Systems Engineering in Healthcare

Chris Unger: We’re going to talk today about systems engineering in the medical industry, particularly medical device development. So the medical device industry faces several challenges. There’s clearly constant time pressure in developing and launching safe and effective products. We’ve got to be faster than the competition with better products. And as you can see from the statistics, this is a challenge. Part of the challenges in delivering things on time is the shifting regulatory landscape. I’m sure everyone’s aware of MDR. There’s software for medical devices. The FDA is going to think about redoing design controls next year. When we were at GE Healthcare, there were like 8,000 regulations we had to monitor. So it’s a very challenging and shifting regulatory landscape. Not only do you have to be compliant with regulations, but you have to ensure your device is safe. And so quality issues, safety and just keeping performance are key elements of delivering on time and that’s getting more and more expensive as you can see here, billions of dollars of financial risk of getting this wrong.

So to make all that harder, there’s a constant increase in complexity. When I first started, there were typical software development teams were 20 to 40 people. It’s now hundreds of people and lots of interactions. So additional things like AI, machine learning, or new technologies, really have to manage a lot of complexity inside of your devices. The organizational structure is getting more and more complex. There’s a heavy focus on acquisition, so you’re integrating new teams, new cultures, and geographically distributed development teams. So that makes it all challenging. So we’re going to talk about how systems engineering can help address some of these particular challenges.

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

Unger: As I mentioned, a key differentiator is getting to market faster. So the success of a program in a market-driven environment is basically profits. The first mover tends to collect the lion’s share of the profits. We typically have many customers. You don’t have a single customer marketing and product management tells you roughly what they think the competition will be and what differentiates versus in a contract-driven environment, success is satisfying the contract. So within GE Healthcare, the avionics and oil and gas businesses typically had a single customer. We would produce a floating city block to British Petroleum or Shell, go to the North Sea or the Caribbean and you had a contract and you delivered to that contract versus an engine, an aircraft engine, or a medical device, we deliver to the marketplace. We decide the timing, we decide the features.

So the stakeholders and market-driven are internal to the business and you can negotiate budget and time. If you get a really, really cool feature, you can take an extra month or quarter to develop it, versus in a contract-driven, it’s really fixed. So the challenges of market-driven and contract-driven are different. Contract-driven requirements are a key commitment. You’ve got to negotiate a formal design control versus within a market-driven environment they’re critical. You have to deliver validated requirements, but they’re definitely an internal business tool that helps communication across all the business functions.

So what’s the value of systems engineering in a market-driven industry? We basically turn the ambiguous needs that we get from product marketing or product management and turn them into clear and feasible solutions to be implemented by the hardware and software teams. The key value we produce is that those implementations seamlessly integrate into the customer’s workflow and work systems. So they work really well from day one, they reliably meet their needs. They work really well after five years and not just meet their needs, they delight the customer. We really want to deliver something that the customer enjoys using. So we have to make it work day one, we need to make it work day 50. We need to make it work for every single customer. So you have to deal with all the known variability of hardware and process. Every installation and every service event has to produce a uniform, high-quality, high-performing product.

So with those constraints, we want to optimize the business value. So when we have multiple options, marketing will tell us the customer value of these options. The implementation teams will tell us the delivery and product cost of those functions. The role of systems engineering is to make trade-offs between those and really optimize the business impact based on the cost of implementation. So we want to make sure the work done by those implementation teams is tied to the maximum market impact. And associated with that is managing technical risks. If you go down a path and it turns out to be infeasible, while it might’ve been nice if it worked, you just wasted a lot of that work. So that cost has to be scaled by risk.

In doing all those first four bullets, our key value is making sure design decisions are identified and closed predictably, and that the team acts with one voice. So decisions are framed, the options are agreed to, the decision criteria are agreed to and the final decision is closed and stays closed as stakeholders change. So once you have a frozen design, do you want to make sure that actually integrates easily and when you have integration or quality problems, they’re found early and resolved early. When you have time to react, it’s a lot easier to adjust your design in the first half of your program. It’s really hard when you find severe quality issues with a month left before shipping.

RELATED: Embracing the Future of Healthcare: Exploring the Internet of Medical Things (IoMT)

Unger: And so really winning products happen when systems thinkers are effective. So clearly there’s going to be a need for some systems engineering process thinkers, but they’re system thinkers across the entire program. And so we want to make sure that everybody’s involved in systems and that the creativity of the entire program is maximized. So getting specific to GE Healthcare, what is systems engineering at GE Healthcare? Well, we have the essential customer-perceived performance. So a lot of our programs are imaging, so we have the image quality. Still, we also have things like maternal-infant care where we deliver the right humidity and temperature around the neonate. In delivering that essential performance, you’ve got to make sure it’s safe and you’ve got to make sure you have regulatory compliance. And I mentioned we really want products that are easy to use and delight the customer. So usability is a critical part of systems engineering. In doing that, we make sure we define the right implementation requirements and the right reliability strategy, and that it can be installed and serviced properly.

So with that being the overall goal, how do we organize? Well, there are a lot of things that are common across all of our product teams. We do have common program milestones. We do have a common systems’ lifecycle. It’s basically the V-cycle with iteration and agile built in. What differs is that different product teams at GE Healthcare have different levels of safety hazards, so FDA risk. We go from anesthesia where you can easily kill somebody down to ultrasound, where it’s non-ionizing equipment, that’s the light handheld probes. You can’t pinch or crush anybody to even service software that has zero patient impact. There are also almost no risks for anybody and we respond to that by adjusting the process rigor so that the higher-risk safety risk modalities have higher process rigor.

Additionally, things vary across the world or we have different locations with different cultures and different sizes of organizations. We have many systems engineers across the company, but the SE team sizes vary from less than 10. In fact, we had some sites with maybe 10 engineers and the systems engineer was half a person to teams that had over a hundred systems engineers. The scale of the programs we work on is less than 10 engineers and months-long programs to many hundred as engineers applied to a program that might last three years and were based on technology developed over the prior decade. And you want some systems engineering thinking even during that basic research decade.

RELATED: Understanding Integrated Risk Management for Medical Devices

Unger: The organization goes from product centralized, it’s like the SE GM for that hundred engineering group where they all reported to a dotted or solid line, to decentralized in where that team of 10 with one or half a systems engineer, there the manager was a general engineering manager and did not have a lot of systems engineering experience. So I joke that if there is a way of organizing systems engineering, we have one of those within our group somewhere.

But how did we think about tailoring? And so this is a page I put together that was generalized that you might be able to use. Obviously, as I mentioned, higher technical risks including safety risks. One way of measuring that is how many risks there are in your hazard analysis. For things that are a higher risk we looked for a higher level of functional excellence, more process documentation, more process compliance, and higher rigor of the technical design reviews, and maybe more independent reviewers. Team experience. This is subjective to measure, but Joel Goldstein did a very nice study, from Carnegie Mellon, that the value of systems engineering increases with program complexity, but it decreases with a more experienced team if you have a small team that is experiencing the technology and the application, they can get by with less process rigor and while systems engineering excellence delivers some value, it delivers less value.

To watch the entire webinar, visit:
Application of Systems Engineering in Healthcare


Image showing industry experts who speak about insurance product development.

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

Looking to bridge the gap in your insurance product development?

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

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

Gain insights into:

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

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

Below is an abbreviated transcript of our webinar.

Bridging the Gap in Insurance Product Development

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

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

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

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

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

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

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

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

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

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


jama software scalability

Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software

Jama Connect® 9.5 proven to scale to at least 10 million requirements in a single project to handle the largest product, systems, and software development efforts.

Jama Software®, the industry-leading requirements management and traceability solution provider, has announced that Jama Connect® has set yet another scalability record with over 10 million requirements managed in a single project (within a standard cloud instance) with P75 user interface load times under three (3) seconds. 10 million requirements per project represents a new benchmark in the industry, clearly showing that Jama Connect is able to meet both the current and future scalability needs of our customers. It is also important to note that no project data storage limits were hit during this boundary condition test, so the actual limit has not yet been reached.

Engineering organizations are looking for software partners that can handle large-scale, collaborative projects that span engineering disciplines, customers, and suppliers. This performance benchmark demonstrates Jama Connect’s unique ability to handle the scale required within a single project. Today, our customers work with tens of millions of requirements across projects in a single instance of Jama Connect. This latest single project scalability milestone adds to Jama Connect’s market-leading standing for security, scalability, and performance in the cloud including:

  • Over 100,000 trailing 90-day active users
  • Daily users spanning 82 countries
  • 16ms First Input Delay (FID) response times
  • P75 response times of 2.7 seconds
  • The only requirements management application that is SOC 2 Type 2 certified at the environment AND application layers
  • The richest REST API with over 200 separate API functions
  • Over 600 million API cloud service requests per month

“Jama Software continues to lead the market in performance, security, and usability at scale,” said Josh Turpen, Chief Product Officer at Jama Software. “We are pushing beyond the 10 million threshold and will continue to deliver unmatched cloud capabilities to our customers.”

Related: Getting Started with Jama Connect REST API

About Jama Software
Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.

For more information about Jama Connect services, please visit www.jamasoftware.com

Read the official press release here:
Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software

What is DOORS


Image showing presenters of a webinar about Automotive and Semiconductor Development compliance

In this blog, we recap our webinar, “Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development”. Click HERE to watch the entire webinar.

Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software®

During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards.

Key takeaways from this webinar:

  • Learn about available diagnostic offerings in Jama Connect, such as: ASPICE, ISOS26262, and ISO21434
  • Learn about the benefits of diagnostic offerings, how they will expose risks to compliance, and which one is best for your organization
  • See firsthand how Jama Connect helps teams reduce unacceptable risks

Discover how Jama Connect can empower Automotive and Semiconductor development teams to evaluate and ensure compliance.

Below is an abbreviated transcript of our webinar.

Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development

Steve Rush: Hi everyone. I’m happy to be here today to take you through the presentation. I wanted to start with a high level agenda and an introduction. We’ll be discussing Automotive compliance in general. To start, we’ll be looking at specific service offerings that you can use to help leverage, to evaluate your compliance against certain Automotive standards.

There are two forces often related that I like to think about when it comes to compliance that really impact the organization as a whole, from engineers to executives and everybody really in between. And those are process and quality. And I like to think about compliance as the intersection of those two often related ideas. Meeting the objectives of these standards may achieve both process and quality, but developing a compliant process and system, this will speed up development by instituting good process and reducing rework. It will help catch and identify defects early in the development process. However, there’s many evolving regulations and standards in this Automotive sector that make the idea of compliance all the more challenging to understand, let alone demonstrate. Perhaps you don’t even know where to start when it comes to achieving compliance in an Automotive system. It might feel like you are building a car while it’s driving.

At the same time tasked with implementing the process and tools to support the process and unsure which should come first. And we want to talk a little bit about this through the lens of compliance and make the case that Jama Connect is a tool well suited to get you up and running quickly, optimized against popular Automotive standards. To assist with this, we’ll discuss the diagnostic that Jama Software offers as a service that’ll help you navigate these important compliance questions. But I fully believe that by meeting the objectives of some of these critical Automotive standards we will discuss today that you’ll balance both process and quality and achieve compliance.

RELATED: Global Industry Leading Automotive Application Developer dSPACE Migrates from Legacy Requirements Management Platform to Jama Connect®

Sam Yerramalla: Today we are highlighting some offerings that will help guide Automotive customers or prospects like you with your compliance process. We feel these diagnostics can be very helpful whether you are a customer of Jama Software or a prospect. If you’re a Jama Software prospect who’s not yet purchased Jama Connect, these diagnostics makes the case that Jama Connect can help you meet the objectives of the Automotive standards. And namely, there are three standards offerings that we provide. One is the ASPICE Diagnostics, the Automotive Functional Safety Diagnostics, and the Cybersecurity Diagnostics. Now these diagnostics can help you navigate the classic process versus tool conundrum. That is if you’re trying to understand whether you should build the process first or buy the tool first, you’ll first see firsthand how Jama Connect will help shape the process. If you’re a Jama Software customer, you can use these diagnostics as a baseline. Oftentimes, we get busy with our day-to-day work and we may drift away from the larger big picture.

And these diagnostics are meant to guide you to bring light into areas that you need improvement or any optimization of your current Jama Connect process. You can also be paired with a Jama Software consultant or a solutions architect who will take you through the diagnostics start to finish. The time commitment for each of these diagnostics is about two to three hours. We feel that’s reasonable considering the benefits you may get out of this. We focus on the outcomes and the objectives and how this will truly help meet your compliance needs by optimizing your Jama Connect usage. If you’re a customer or getting up and running in Jama Connect, if you’re a prospect who’s looking for purchasing Jama, you can see these diagnostics offerings along with other offerings that we provide on the Jama Software Success Program page at Jamasoftware.com/success. Here you’ll see details on the compliance offerings that we just mentioned and a lot more other offerings including offerings on onboarding Jama Connect, improving your process and requirements, quality, traceability, et cetera.

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

Yerramalla: You can also request an offering if you have a service program with no assigned consultant and our operations team will pair you up with someone. So as far as the Automotive standards and alignments are concerned, the diagnostics offerings that we provide are aligned to the three standards, the Automotive Spice, ISO 26262 and ISO 21434. Only certain areas of those standards are in scope. For example, things like part seven of the ISO 26262 for production and operation and decommissioning are not covered here. But you will see some of these sections here are covered by the diagnostics. So depending on which diagnostics is right for you, the risks that are identified will align to the different areas that you see on the screen. Now, it may be that you want to align to more than one standard. We certainly put you through multiple diagnostics to identify your risks pertaining to each of these standard.

The model which we use is the same, but the recommendation we provide and tailored solution that the diagnostics provides will be custom based on each scenario. And if you don’t know where to get started or you don’t know which of these diagnostics that you need to start first. Some things are obvious, again, that if you’re looking for cybersecurity compliance and that is of the greatest concern for you, then Cybersecurity Diagnostics, the 21434 is right.

And if you’re looking for developing any functional safety products that are used in the Automotive, then the ISO 26262 diagnostics is the correct one to start with. And if you’re looking for any software process improvements or quality management, then ASPICE is the place to start. But sometimes you need both APSICE and functional safety, for example, in which case we suggest the ASPICE Diagnostics first. And the reason is that we rank in the process ASPICE about the functional safety is that if you have a high level of ASPICE maturity or on the other side, if there are several risks that are flagged from the ASPICE Diagnostics, then those will impact your Functional Safety Diagnostics already.

So you would’ve covered those parts of it that as a prerequisite for the functional safety. And then the spirit of ASPICE is really the quality management. And this is important in every engineering organization. So if you’re unsure where to start, then ASPIE Diagnostics is one place. And if you don’t need to prove compliance to the latter, it’s really good because honoring it, the lead benefits in your process.

To watch the entire webinar, visit:
Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development


 

traceable agile development

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

Automotive, aerospace and defense, and industrial companies have largely adopted Agile within rapidly growing software factories to speed time to market in order to stay competitive. These software factories have largely succeeded in speeding up software development for companies within the industries that have adopted it, but maintaining quality is still a key concern. The inability to coordinate development across engineering disciplines has led to product recalls, quality complaints, and has created significant internal challenges to satisfy functional safety requirements from regulators and confidently deliver high-quality software. These challenges — and resulting outcomes — are often so severe that leadership of the software factories have been let go.

Fundamental Questions We Hear

When we ask software factory leaders, “what keeps them up at night?” We consistently hear the following five questions:

  • How do I know which product requirements have been missed?
  • How do I know which product requirements are not fully covered by test cases?
  • How do I know which product requirements have failed to pass tests?
  • How do I identify rogue development activity?
  • How do I know if changes have been made at the system and / or hardware level that impact the software team?

These are fundamental questions that should be answerable from leading Agile tooling, but they are not. The reason is that Agile tools focus on tasks (define, assign, status, complete, delete) and have no notion of the current and historical state of the project. Tasks are not tied to any state of the project which often leads to drift from the actual needs and requirements of your customer or end user. As a result, these questions are not answerable with Agile tools like Jira and Azure DevOps. Project management tools like Jira Align answer important questions around staffing, sprint planning, and cost allocation, but do not address the critical questions above focused on the real-time state of the software development effort against the approved requirements.

RELATED: What is a Scaled Agile Framework (SAFe) and How Does it Help with Complex Software Development?

The Answer? Traceable Agile.

How do you best speed software and overall product development and still achieve the quality expectations of customers and company leadership? The answer is Traceable Agile. Traceable Agile speeds the FLOW of software development but also maintains the current and historical STATE of the development effort and auto-detects issues early in the software development process. Traceable Agile recognizes that developer activity is best managed as a FLOW using tasks in a tool such as Jira. What is needed to achieve Traceable Agile is to pair a system with Jira that manages the STATE of the development effort at all times. By keeping STATE and FLOW tools separate but integrated, no change is required to software developer process and tools. This is significant. Software leadership can now answer their critical questions without having to undergo a major process and tool change with resistant developers which would slow down development and/or increase staff attrition.

RELATED: How to Achieve Live Traceability™ with Jira® for Software Development Teams

So how does Traceable Agile work in practice?

Here is an overview and diagram of Jama Connect® maintaining the STATE of development activity and Jira providing the FLOW.

  1. Task activity continues as normal in Jira and risk is auto-detected in Jama Connect by comparing all user stories and bugs in Jira to the expected development and test activity for each requirement in Jama Connect.
  2. All exceptions are identified —the ones that answer the questions that keep software factory leadership up at night — such as requirements with no user stories, user stories with no requirements, requirements with no test cases or test results, etc.
  3. After the exceptions are inspected in Jama Connect, management can take action and assign corrective tasks in Jira as just another task in the queue for a developer.

 

traceable agile software development

 

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

This is a fully automated process that leverages automated synchronization of meta data between Jira and Jama Connect via Jama Connect Interchange™. The only metadata that needs to be synchronized from Jira to make Traceable Agile possible is as follows: ID, Created Date, Creator (User), Modified Date, Modifier (User), Title, Status, Link (URL), Relationships. On inspection in Jama Connect of an issue, one simply clicks on the link to go to Jira if more information is required to diagnose.

Many of our leading clients have already implemented Traceable Agile and are significantly improving their Traceability Score™ which we have demonstrated leads to superior performance on quality metrics in our Traceability Benchmark Report.

Feel free to reach out to me to learn more and I will respond.


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 excerpts from an article, sourced from MedTech Dive, titled “UK regulators name 3 approved bodies to ease device certification bottleneck” – originally written by Nick Paul Taylor and published on August 31, 2023.

UK regulators name 3 approved bodies to ease device certification bottleneck

A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”

Dive Brief:

  • The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K.
  • As a result of Brexit, the U.K. is requiring manufacturers of all except the lowest-risk devices to apply for UK Conformity Assessment (UKCA) certification from an approved body. The approved bodies perform the same role as the notified bodies that issue CE marks to devices sold in the European Union.
  • MHRA’s designation of three approved bodies helps address a capacity shortage that led the government to stagger the transition from CE marks to UKCA certification.

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

Dive Insight:

MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.

Now, MHRA has designated TÜV SÜD, Intertek, and TÜV Rheinland UK. The designation clears the three bodies to certify general medical devices and empowers TÜV Rheinland UK to assess in vitro diagnostic (IVD) products. IVD capacity is lagging behind, with MHRA having designated four bodies in total.

In a statement, Laura Squire, chief healthcare quality and access officer at MHRA, hailed the addition of the three approved bodies as “almost doubling capacity for medical device assessment in the U.K.” It is unclear how many applications each approved body is capable of handling.

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

Even so, the designations go at least some way toward addressing a long-standing concern. The Regulatory Horizons Council identified the “lack of capacity in approved bodies within the U.K.” as a risk to patient safety and access to devices in a report two years ago.

Responding to the report early this year, the government accepted recommendations about addressing bottlenecks in device approval, notably the shortage of approved bodies, and taking mitigating steps to ensure the supply of products after the transition to UKCA. The concerns informed the decision to keep accepting devices with CE marks through 2028 or 2030, depending on the regulation.


press release engineering USA and Jama Software

To read the complete press release, go to https://www.jamasoftware.com/press/a-new-partnership-for-digital-design-product-development-excellence/

Engineering Industries eXcellence Partners with Jama Software® to Drive Innovation in Digital Design and Product Development Across Industries

PORTLAND, Ore. and CHICAGO, September 21, 2023 – Jama Software®, the industry-leading requirements management and traceability solution provider, and Engineering Group’s Industries eXcellence division, a global leader in the field of engineering services, design automation solutions, and Industry 4.0 technologies, jointly announce a strategic consulting partnership to transform the way industrial organizations design, develop, and deliver innovative products to the market.

Jama Software’s requirements management platform, Jama Connect®, provides a collaborative environment for teams to define, design and develop their product visions. By maintaining Live Traceability™ across a best-of-breed ecosystem, Jama Connect enables organizations to navigate the intricacies of modern product development, leading to faster time-to-market and improved product quality. Engineering Industries eXcellence, with its rich experience in engineering services and global network of digital transformation experts, brings a wealth of knowledge in product design, systems engineering, and technology consulting.

 “We are excited to partner with the Engineering Group to deliver a holistic approach to intelligent engineering management that leverages Jama Software’s best-in-class technology with Industries eXcellence’s industrial sector expertise,” said Tom Tseki, CRO of Jama Software. “This collaboration represents our commitment to helping organizations bring innovative products to market faster, with higher quality and greater efficiency.”

Through this partnership, clients will benefit from the synergy between Jama Software’s innovative requirements management and traceability platform and Engineering Industries eXcellence’s deep industry insights, resulting in comprehensive solutions tailored to meet the unique challenges of their respective markets.

 

To read the complete press release, click here.

ABOUT JAMA SOFTWARE

Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries. For more information about Jama Connect services, please visit www.jamasoftware.com.

ABOUT THE ENGINEERING GROUP

The Engineering Group is a leading engineering services and solutions provider, offering a wide range of expertise in product design, system engineering, technology consulting, and more. With a track record of excellence, the Engineering Group partners with clients to drive innovation and achieve exceptional results. Learn more at Engineering Industries eXcellence (indx.com).

Media Contacts

Jama Software:
Karrie Sundbom
Senior Director, Corporate Marketing
marketing@jamasoftware.com

Engineering Industries eXcellence:
info@indx.com

Diagram of a car rendering depicting the style of Software Defined Vehicles

Unlocking the Potential: The Importance of Software Defined Vehicles Explained

Introduction

The automotive industry is undergoing a massive transformation, driven by technology. One of the most exciting developments is the concept of Software Defined Vehicles (SDVs). In this blog post, we will explore the importance of SDVs and how they are revolutionizing the automotive landscape.

What is a Software Defined Vehicle?

Software Defined Vehicles are automobiles that rely on software and data to control major functions, such as propulsion, safety systems, and entertainment features.

Unlike traditional vehicles, which heavily rely on hardware, SDVs leverage advanced software algorithms and connectivity to enhance performance, functionality, and user experience.

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

Benefits of Software Defined Vehicles

1. Flexibility and Customization

SDVs offer tremendous flexibility and customization options. Software updates can be deployed remotely, allowing manufacturers to introduce new features or improve existing ones without physical modifications. This not only enhances the vehicle’s performance but also enables personalization according to user preferences.

2. Enhanced Safety and Autonomous Capabilities

SDVs play a crucial role in advancing vehicle safety and autonomy. With software-controlled systems, real-time data can be processed and analyzed more efficiently, enabling the vehicle to make instant decisions and react to various scenarios. From adaptive cruise control to automated emergency braking, SDVs are paving the way for a safer and more autonomous driving experience.

3. Improved User Experience

Software Defined Vehicles provide a seamless and intuitive user experience. Smart infotainment systems, integrated navigation, and connectivity features ensure drivers stay connected and informed on the road. Additionally, software updates can optimize vehicle performance and functionality, ensuring a consistently delightful driving experience throughout the ownership period.

4. Enhanced Sustainability

SDVs contribute to sustainability efforts in multiple ways. By optimizing energy consumption, software algorithms can improve fuel efficiency or increase the range of electric vehicles. Moreover, SDVs enable over-the-air updates, reducing the need for physical recalls and reducing waste associated with hardware replacements.

Challenges and Considerations

1. Cybersecurity

With increasing connectivity and reliance on software, cybersecurity becomes a critical concern. As Software Defined Vehicles become more commonplace, manufacturers and developers need to prioritize security measures to protect vehicles from hacking and unauthorized access.

2. Data Privacy

The extensive use of software in SDVs generates vast amounts of data. It’s crucial to develop robust privacy frameworks to ensure the responsible collection, storage, and use of data, protecting user privacy rights.

3. Regulatory Framework

The emergence of Software Defined Vehicles raises questions about legal and regulatory frameworks. Governments and authorities need to adapt and establish comprehensive regulations to ensure safe and responsible integration of SDVs into existing transportation systems.

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

Conclusion

Software Defined Vehicles represent a paradigm shift in the automotive industry. By harnessing the power of software and connectivity, SDVs offer unparalleled flexibility, improved safety, enhanced user experience, and sustainability benefits.

However, to fully unlock the potential of SDVs, we must address challenges related to cybersecurity, data privacy, and regulatory frameworks. Embracing this transformative technology will lead us into a future of smarter, safer, and more efficient transportation.

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

Stay tuned to our blog for future software defined vehicles content, including more in-depth explanations of how to adapt to these key challenges.

Stay tuned to our blog for future software defined vehicles content, including more in-depth explanations of how to adapt to these key challenges.


Image showing V Model for Validation and Verification

Best Practices for Verification and Validation in Product Development

In the competitive landscape of modern product development, ensuring the reliability and quality of the product is essential to meet customer – and stakeholder – expectations and regulatory requirements. Verification and validation (V&V) are two crucial processes that play a pivotal role in achieving these goals. V&V are systematic methods that assess a product’s adherence to specifications and its ability to perform as intended. In this article, we will delve into the best practices for verification and validation in product development, exploring the key steps, methodologies, and benefits of each process.

Understanding Verification & Validation

Before delving into the best practices, it is essential to clarify the distinction between verification and validation. Verification focuses on assessing whether a product meets its design specifications, ensuring that each component and feature works as intended. On the other hand, validation is concerned with evaluating whether the product fulfills its intended use and customer needs. In essence, verification confirms if the product is designed correctly, while validation confirms if it is the right product for the intended application.

RELATED: Five Key Design Control Practices that Improve Compliance and Help Develop Better Products

Incorporating V&V Early in the Development Lifecycle

To maximize the effectiveness of verification and validation, these processes must be integrated into the product development lifecycle from its early stages. By starting V&V activities early, potential issues can be identified and resolved before they escalate, reducing costs and time-to-market. Early involvement also allows for feedback to be incorporated into the design, leading to a more robust and reliable final product.

V Model image showing Verification and Validation in the Product Development Process

Clearly Defined Requirements

Well-defined requirements are the foundation of successful verification and validation. During the requirements gathering phase, it is vital to engage stakeholders and subject matter experts to create clear, measurable, and unambiguous specifications. These requirements serve as the baseline against which the product will be verified and validated. Proper documentation and version control are critical to ensure that changes to requirements are tracked effectively. Additionally, the later in the development process that requirements get changed, many times because they weren’t written well the first time, the more costly it is due to downstream impacts such as rework in verification and validation.

RELATED: Plutora: Verification vs Validation: Do You know the Difference?

Utilizing Various V&V Techniques

Product development teams should employ a mix of V&V techniques to comprehensively assess the product’s quality. Some commonly used methods include:

  • Testing: Conduct thorough testing, including unit testing, integration testing, system testing, and user acceptance testing, to verify that each component and the product as a whole performs as expected.
  • Simulation: Use computer simulations to evaluate the product’s behavior in various scenarios, particularly for complex systems or when physical testing is impractical or cost prohibitive.
  • Prototyping: Building prototypes early in the development process allows for real-world testing, uncovering potential design flaws and usability issues.
  • Peer Reviews: Encourage regular peer reviews of design documents, code, and other artifacts to catch errors and improve the overall quality of the product.
  • Model-based Design: Utilize model-based design approaches, such as Model-Driven Architecture (MDA), to create detailed models that can be verified before implementation.

Risk-Based Approach

Incorporate a risk-based approach into V&V activities to focus resources on critical areas. Identify potential risks associated with product failure and prioritize verification and validation efforts accordingly. This approach ensures that resources are allocated efficiently, concentrating on areas with the most significant impact on product performance and safety.

Independent Verification and Validation (IV&V)

Consider engaging external experts or teams for independent verification and validation. External parties can provide an unbiased assessment of the product, uncovering issues that internal teams might overlook due to familiarity or assumptions. Independent verification and validation bring additional expertise and ensure a higher level of confidence in the product’s quality.

RELATED: How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI)

Continuous Integration and Continuous Delivery (CI/CD)

Implementing CI/CD practices allows for continuous verification and validation throughout the development process. Automated testing and deployment pipelines can quickly detect regressions and integration issues, ensuring that the product remains stable and reliable throughout its evolution.

Documenting V&V Activities

Comprehensive documentation of all verification and validation activities is essential for compliance, knowledge retention, and continuous improvement. Properly documented V&V processes help maintain a historical record of changes, failures, and resolutions, facilitating future product iterations and troubleshooting.

V & V are integral to successful product development, ensuring that products meet the required specifications and perform as intended. By adopting best practices such as early integration, clear requirements, a mix of v&v techniques, risk-based approaches, and continuous verification, companies can create high-quality, reliable products that customers love and gain a competitive edge in the market. Moreover, investing in verification and validation from the outset of development can save time and resources, prevent costly delays, and lead to higher customer satisfaction and loyalty in the long run.


Image showing Review Center features demonstration in Jama Connect

In this video, we demonstrate Review Center capabilities in Jama Connect®

Jama Connect® Features in Five: Review Center

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

In this Features in Five video, Jama Software® subject matter expert Mario Maldari, Director of Solution Architecture, will demonstrate Review Center capabilities in Jama Connect.

 

VIDEO TRANSCRIPT:

Mario Maldari: Hi. My name is Mario Maldari, and I’m the Director of Solution Architecture here at Jama Software. In this video, we will demonstrate a powerful and easy-to-use feature in Jama Connect, the Review Center.

Reviews play a key role in successful product development. In this video, you will learn how to initiate a review, how to invite participants to a review, how users can complete tasks, provide feedback, and finish a review. You also see how moderators can view review activity, interact with feedback, publish revisions, compare review versions, and more. Now let’s get to the demo.

Anything in Jama Connect can be sent to the review center, individual requirements, or a set of requirements, simply right-click and send for review. This will put you into our, Review Center dialogue where you’ll have a few options to choose from, give the requirement to review a name, a deadline, and a time. You can include related items. Perhaps you want the test cases that are associated with the requirements to be reviewed as well and select those. You have a few additional options.

You can choose to have an electronic signature. You can enable time tracking, and notify when a participant finishes a review. I like that one. In this dialogue, you can add your users and assign them various roles, review approver.
And we’ll have a couple of reviewers here.

RELATED: Leading Quantum Computing Company, IonQ, Selects Jama Connect® to Decrease Review Cycles, Reduce Rework

Maldari: A very nice feature of our review and approval is the ability to invite users by email. This allows you to invite, participants in your review, that aren’t part of your project, your job or project, or aren’t even part of your company. Perhaps you have, vendors that have given you requirements that you want their feedback on, stakeholders. So you can add them.

They can participate in the review, and you don’t have to add them to the project. So let’s continue on here. This final dialogue is in the details of the email that’ll be sent out to the participants. Customize this as you see fit. And let’s initiate that. Alrighty.

Essentially, the email that your participants will see will look very, very similar to this. It’ll have some instructions. It’ll have the link to the review. Their role and what the deadline is. As soon as they click on this link from their email, it’ll send them into the review. Where they’ll be able to go through and accept or reject, each item as they go through the review. You’ll be able to see the related items here in this case, the test cases because we included that in the review. So very nice to be able to include that as well. So I’ll go through and I will accept.

And perhaps there’s a case where I disagree with something or I’d like to see a change. I can get very granular in terms of my commenting ability. I can select over text. And I can say and I could even @ mention users here as well as an FYI, and I could further qualify the comment. Perhaps, say, I have an issue with it, I can enter my comment. When I’m done with the review, I simply click complete review.

And it gives me a nice summary of what has changed in my review. And at this point, I could either be done, you know, assuming maybe I accepted all the requirements. I was happy with it. In this case, since I rejected one, I’d like to request a new revision after the update is made. So the moderator at this point would get a notification that someone has completed the review. They’d be able to come in and see all of the passing, requirements, but then they could also see the comments on the ones that I would like, to have updated so they could say, okay. It should be more specific. So they can simply go into the requirement. They could edit it.

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

Maldari: And I can get a little more detail in this case. They could resolve the comment right from here. And they can resolve that comment right on the fly. It could say, save and close, commit, ok. And now at this point, the moderator could publish a new revision, and they could let the reviewers know that there’s a new version of that particular requirement. So let’s publish that after the change that was made.

And now they can actually see that there are two versions. Of the review. You can compare version one to version two, and you can see what’s changed in the requirements between the two versions. So a really nice way of seeing how the requirements evolve over time by virtue of the reviews.

The moderator also has some really nice views here in terms of statistics of the ability to see where the team is in terms of, you know, how far along they are in their review, how many they’ve approved, rejected, the time spent, on the reviews, They can email the participants, send reminders, email the approvers only. A lot of different information and statistics here. They can look at the types of comments that were put as part of the review so they can get a sense of how many changes they may need to make. Maybe there are just some questions and general comments, but if there are proposed changes or issues, you know, that’s that translates to work, the moderator may have to do.

So it’s really good information in terms of statistics here. All of the reviews that are in progress, completed, are stored in the review tab, all the Jama Connect, And so that at any given time, you can go back. You could take a look at your reviews, you know, see how the requirements evolved over time. Maybe a year later, you need to produce an audit report.

RELATED: Requirements Traceability Diagnostic

Maldari: Jama Connect allows you to create reports off on these reviews with all the comments and the states of the requirements. So very useful, for seeing how your requirements have evolved over time. A very powerful feature of the Review Center, but also as you can see, very easy to use and and very collaborative.

If you would like to learn more about how Jama Connect can optimize your product development processes, please visit our website at www.jamasoftware.com. If you’re already a Jama Connect customer and would like more information on the Review Center, please contact your customer success manager or Jama Software consultant.

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