In this blog, we preview our whitepaper “FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?” Download the entire whitepaper to learn more!
FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?
Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its “Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices” in 2005. Over the past 17 years, significant advancements have disrupted the market, including the advent of the smartphone, watches that monitor your sleep and snoring habits, and smartphone-connected pacemaker devices, just to name a few.
The medical device industry has also undergone a sizable transformation, which is why the FDA recently released the “Premarket Submissions for Device Software Functions” draft guidance to keep up with the changes. Please note that while this guidance is valuable to medical device developers to get a sense of what’s to come, it is not currently being enforced.
It’s also important to note this guidance applies to all premarket approval (PMA) and to some 510k’s, based on risk level.
The new draft guidance, which as of March 2022 has not yet gone into effect and therefore is currently non-binding, revises documentation standards that apply to the software development, design verification, and design validation processes.
As you work to adapt to the new guidance, you might have many questions, including “Who and what does the new guidance apply to? And what exactly has changed?” Answering these important questions will assist you with getting ready for the changes, which are set to finalize in spring 2022.
The New Guidance: Does It Apply To Your Device?
The new guidance applies to all premarket submissions that include at least one device software function. However, it’s not intended to provide recommendations on how a device’s software should be developed, verified, and validated. Software in a medical device (SiMD) and software as a medical device (SaMD) are both included in the guidance. The following are also included, according to the FDA:
Firmware and other means for software-based control of medical devices
Stand-alone software applications
Software intended to be operated on general-purpose computing platforms
Dedicated hardware/software medical devices
Accessories to medical devices when those accessories contain or are composed of software
Recent changes made to section 520 of the Federal Food, Drug, and Cosmetic Act under the 21st Century Cures Act excludes some types of software, including those that are lower-risk, support software, such as certain mobile applications for consumers, and software for administrator support to laboratories. Additionally, the guidance does not apply to automated manufacturing and quality system software or software that is not a device.
To learn more, download the entire whitepaper where we cover a summary of the draft guidance, plus:
The difference between the new and old guidance
Documentation levels: Basic vs. Enhanced
Software documentation elements
RELATED
In this blog, we preview our eBook IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing. Download the entire eBook to learn more!
IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing
Industrial manufacturing firms are undergoing rapid transformation as they navigate talent shortages, supply disruptions, digital adoption acceleration, and more. At the same time, they work diligently to accelerate time to market, streamline risk
management, and keep accuracy and safety at the forefront.
Eliminating 100% of risk is not always possible, but manufacturers continuously seek strategies to mitigate potential safety issues. That’s why industry experts in industrial manufacturing have created standards
such as IEC 61508 to reduce risk and support the development of safety-sensitive products.
However, if you haven’t implemented such standards in the past, you may have many questions. What is IEC 61508? What organizations need to adhere to it? And why does this standard matter?
Understanding the answers to these questions will assist you with implementing the necessary strategies and tools to mitigate potential safety issues and achieve IEC 61508 compliance for industrial product development.
What Is IEC 61508?
Industrial manufacturing firms need to prevent dangerous failures that may occur with the use of their system. The challenge is that oftentimes systems are incredibly complex with many interdependencies, making it difficult to fully identify every potential safety risk.
Systematic or random failure of hardware or software
Human error
Environmental interference, such as temperature, weather, and more
Loss of electrical supply or other system disturbance
Incorrect system specifications in hardware or software
IEC 61508 creates requirements to ensure that systems are designed, implemented, operated, and maintained at the safety level required to mitigate the most dangerous risks. The international standard is used by a wide range of manufacturers, system engineers, designers, industrial companies, and others that are audited based on compliance. The standard applies to safety-critical products including electrical, electronic, and programmable-related systems.
In this blog, we recap a webinar discussing Integrating Requirements Management with Planning and Checklist Processes for Aerospace Development.
Aerospace systems development requires provable requirements management and traceability. DO-178C (airborne software), DO-254 (airborne firmware/hardware), and ARP4754A (aircraft/systems) also require reviews, audits, and proof thereof. The best “proof” is detailed and complete DO-178C, DO-254, and ARP4754A checklists covering the primary software lifecycle activities and artifacts. And now that AFuzion’s compliance templates and checklists are integrated within Jama Connect, teams can automate your requirements management, planning, process, and review checklists in a single solution.
Using AFuzion’s DO-178C and DO-254 templates for plans, standards, and checklists ensures that you have an appropriate framework for successfully developing and certifying your system. These templates and checklists can also help in getting organizations to the goal of higher SEI CMM/CMMI ratings (preferably Level 3 – 4+). Usage of AFuzion process templates and checklists are intended to maximize the probability of project success and quality.
Learn how the partnership between Jama Software and AFuzion helps teams:
Reduce costs by using pre-built material from the most well-known industry experts instead of spending 2-3 person years typically necessary to develop these internally
Eliminate tools silos by keeping your process documents in line with your requirements data
Learn how to communicate process requirements to your engineering teams
Below is an abbreviated transcript and a recording of our webinar.
Requirements Management for Aerospace Development
Cary Bryczek: When we talk to our friends in the field, customers, our peers, and subject matter experts, we hear about increasing complexity required to design new products and systems and keep on track with their certification plan. The path to certification and in some cases, multiple certifications at a time spans multiple years sometimes beyond a decade. Development cycles are seeing increasing complexity driving the need for more and more automation and modern tools to support that. Across the plane collaboration, it’s not being achieved due to all of these different tools and the processes. New connected products and systems are not just complicated, they introduce significant risks into the certification process. Ensuring the compliance of safety-critical systems with faster iterations and evolving solutions is more difficult and time-consuming. Regulations themselves in are increasing due to things like automated flight components, urban air mobility, and other technology drivers. We’re seeing just huge, rapid changes in the market itself.
Cary Bryczek: We see a number of market drivers that are changing the dynamics of system development. For example, the push to electric propulsion aircraft in components is rapidly occurring. Battery technology, as you know, as you know is kind of driving down the costs, and commercial hybrid-electric flight it really is going to be a reality and it’s insight. The development of UAM vehicles is expected to accelerate over the next decade. However, there are significant challenges that need to be worked out. Regulations are still in flux and need to be established for pilotless vehicles, airworthiness certifications, and even the use of the airspace itself. Are you ready for those new challenges? I’m just like me from the Jama side is your requirements and compliance platform and the associated processes ready? Vance, is this something that you see in your day-to-day life with your customers?
Vance Hilderman: Cary, it’s a fantastic question and I’m so pleased to be here. We want to welcome everybody this morning, afternoon, and evening. We’ve got hundreds of viewers here, it’s terrific. It is such a common question. And frankly, that provided the foundation eight years ago, when we began developing the content that you now have in Jama Connect and it’s just terrific. It takes so many hundreds of person-years of engineers to really create a great aircraft a system. And it only takes a few mistakes to cause mistakes. Well, we’re pleased to say that we you’ve got hundreds of years of experience into building what you now have in the Jama Connect content. These plans, standards, and templates and really the only way to go is by using something that’s been proven in the past.
Think about it. How many of our listeners today and viewers are designing an all-new aircraft with completely new technology, a material that’s never been used, an engine, a motor? No, no. That’s not how we progress in engineering or aviation, it’s incremental. Well, folks, the incremental is done with this content. It’s ready to be used and we’re really excited to show you how you can really optimize your daily efforts to not save hours or days once, years but decades of time. Cary, you’re absolutely right. Let’s dive in.
Download the Requirements Traceability Benchmark HERE
Cary Bryczek: Yeah, let’s just jump right in. I think legacy processes and digital paper really isn’t enough to handle the modern system. Legacy tools are siloed. If you store all of your content in SharePoint and documents, you really run a lot of risk for missing something. Who has the latest version? That’s not agile in any way. It doesn’t facilitate things like collaboration. It’s not scalable. And the expense for compliance, just using documents that are separate from your engineering tools is just time-consuming. Though one of the techniques that’s really hot out there is this notion of digital transformation. It’s really the goal today in all companies.
How are you going to get there with just a document-based legacy process and tools? You’re not. If you want to change the game, you need to bring your digital processes and data together to drive that innovation. When you capture your customer and regulatory requirements digitally, connect them to system architecture, design engineering, simulation, you’re bringing your teams together in the virtual world and creating your digital thread. This is what results in getting products to market faster with improved cost-effectiveness. This is what enables you to accelerate that path to certification. It also results in supporting the new reality of remote work and geographically distributed teams. Vans, are you seeing a lot of geographically distributed teams?
In this blog, we recap a webinar discussing Requirements Traceability Benchmarking.
Requirements traceability is a core systems engineering framework, has been around for decades, is required by industry standards for complex product development, and is deployed by thousands of companies — yet no one has ever measured it…until now.
In this industry-leading webinar, Jama Software’s CEO, Marc Osofsky, and Senior Manager, Business Intelligence, Kevin Pearson, review this groundbreaking, 1st ever benchmarking study of over 40,000 complex product development projects.
You will learn:
How to calculate a Traceability Score™
The impact requirements traceability has on quality and cycle time
The differences in performance among the top and bottom quartile performers
The top five best practices of top quartile performers
How to conduct a Traceability Diagnostic for your own organization
Below is an abbreviated transcript and a recording of our webinar.
Requirements Traceability Benchmarking
Marc Osofsky: We’re going to make this as practical as possible. So, here are the five takeaways we’re committing to offer. So, the first one is how to calculate a traceability score. So we’re going to introduce the concept of the traceability score, show you how to calculate it, then we’re going to talk about the impact traceability scores have on quality and cycle time. So, that’s the statistical work that we did. So we’ll go through that. We’ll help you understand the difference between top and bottom quartile performers on traceability score and how big that variance can be. Then we’ll dive deeper into those top performers, talk about the five best practices we found for companies that are in the top quartile for traceability score. And then lastly, we’ll talk specifically about how you can apply it at Company.
All right. So, the first question we should all be asking is why bother measuring requirements traceability at all? Why measure it? So to answer that question, let’s all try to get on the same page. We have hundreds of companies on the call right now across multiple industries, folks from very different engineering disciplines, but this diagram here generally represents what most of you are facing. So here you see the system development process and all of the different engineering disciplines that are involved. Many of you are probably experiencing some of the call outs here in terms of delays, errors, rework, a lack of visibility into what other teams are doing. This is the reality that we’re all living in.
So, most teams, most engineering disciplines have optimized the productivity of their own teams. They’ve chosen their own best breed tools within the software team or the hardware team, things work pretty you well, the challenges as you try to coordinate all of these engineering disciplines to get to positive outcomes, that’s the fundamental challenge. And so requirements traceability, if you’re not familiar with, it is the mechanism to help coordinate all of these engineering disciplines to achieve positive outcomes. And it’s also a mechanism for early detection of issues. If you can resolve issues early, they’re much less costly than finding them later.
Download the Requirements Traceability Benchmark HERE
Marc Osofsky: So if you look at this as just a typical process in the enterprise. The normal approach is to establish KPIs, try to manage this end-to-end process through data. Now, as most of that hasn’t happened. So, the question is, why? Why do we not measure the system development process?
Well, the main reason is that we’ve all been in the dark. So nobody has visibility currently into end-to-end process data. And for each engineering discipline, as you look out from your own teams, it’s very hard to see what other teams are doing and to stay in sync with them. So, this lack of transparency, this lack of process data, this lack of ability to have a consistent traceability model and sync best breed tools has led to this feeling that we’re in the dark, and we keep getting surprised by issues.
So the approach that’s been taken to manage this world up until now, without end-to-end data, how do you get at all of these different teams to coordinate and work together, if you don’t have data to measure it and coordinate it? The answer has been methodology, and this is the entire field of system engineering. The V model that many of you are familiar with. There’s been wonderful work done here obviously, INCOSE as an associate to help drive that forward. But this was really the only approach. Without data without measurement, let’s see if we can get everybody agreed to a common methodology. A lot of this comes together through a lot of meetings and often you can get a clash of methodologies. So maybe the V model approach from system engineering may clash with Agile development software. So methodology doesn’t solve everything, but it’s certainly been the really the only approach you could take without data and visibility.
Marc Osofsky: So, now, this world is changing, and you can take a data-centric approach. The clouds are starting to lift. Each of you are likely at different stages in your evolution to more of a data-centric approach. Our clients are fortunate using our software that we’re able to create a common traceability model across the entire process and sync best breed tools from these various disciplines to give full visibility into end-to-end performance and actually do measurement. And so that’s what we’ll be talking about today.
So, in this world, you can measure the process, and it does reinforce the methodology that you’ve already been living. The measurement of requirements traceability is essentially measuring adherence to the traceability model that you’ve chosen to your methodology. So, they’re reinforcing for those of you who are not familiar with INCOSE or not involved, I’d certainly encourage you to get more engaged and check out these materials.
So, INCOSE is starting to shift towards more of a data-centric view now that the data’s available through systems like ours, there’s been some excellent work from the requirements working group, headed up by [Lou Wheatcraft 00:07:42], in terms of integrated data as a foundation for systems engineering and the recent handbook. And then also the measurement working group, with Paul, friends. There’s some great leading indicators and measurements here to go deeper and think about how should we measure the systems development process.
All right. So, hopefully that gives you some sense of why we’re measuring it. It’s now possible. And requirements traceability is really the only way to measure the actual end-to-end process, identify issues early, improve over time across projects and correlate to actual outcomes on quality and cycle time.
In this blog, we recap a webinar discussing Adopting EARS (Easy Approach to Requirements Syntax) to Improve Requirements Engineering.
Requirements are the foundation of a smooth-running process and are the essential inputs to your mission-critical projects. Yet writing requirements is also a practice that many underestimate and fumble.
The Easy Approach to Requirements Syntax (EARS) is a notation that “gently constrains” natural language requirements to help teams to easily achieve desired outcomes. Not only does adopting the EARS notation improve the quality of requirements, but it also enables cross team collaboration and synergy, improves product requirements, and reduces project risk. This webinar will introduce the EARS notation and walk through the benefits for both individuals and teams.
In our recent webinar, attendees got an exclusive look at the coming Jama Connect Requirements Advisor, a tool in development that allows you to check the quality and accuracy of your requirements by leveraging the power of natural language processing.
Watch this webinar recording to learn more about:
How to write better requirements with EARS, and the benefits for both teams and individuals
How EARS works alongside models and can help uncover what is not yet know
How Jama Connect Requirements Advisor will facilitate embedding EARS notation in your requirements engineering work.
Below is an abbreviated transcript, including a portion of the Q&A session at the end of the event, and a recording of our webinar.
Adopting EARS Notation to Improve Requirements Engineering
Alistair Mavin: What is this requirements engineering thing all about anyway? Well, in theory, you could say that requirements engineering is quite easy. What is requirements engineering? Well, you ask people what they want, you write it down, you build it and then you check that it does what they ask for. Like a lot of things, if you put it to a high level, it’s perhaps quite simple, but there’s obviously a lot more to requirements than that and they are in themselves quite slippery and difficult things.
But relevant to EARS, I think is the notion that asking people what they want and then writing them down, how you choose to write it down can guide what you ask them to tell you and can help them to tell you the useful things that you can then write down more effectively. The inherent nature of EARS, which I’ll explain in a little more detail helps a lot with elicitation because it identifies the things you need to know in order to write down a well-formed EARS-compliant requirement. There are certain things you need to know to be able to populate an EARS requirement effectively. That means you interrogate people, you ask people the right questions to be able to write a good question. From very early in your requirements elicitation, you are seeking the right information to get clearer requirements.
Alistair Mavin: I’ve said that in theory, requirements engineering is very easy. In practice, it’s not so easy. First of all, people don’t necessarily know what they want. If they don’t know what they want, they can’t tell you or maybe they do know what they want, but they don’t know quite how to express it, or if they’re an expert in something and after all many requirements are elicited from subject matter experts in various fields, it’s a well-known characteristic of experts that they don’t actually consciously know some of what their knowledge is. It’s so obvious to them and implicit. It’s tacit. They actually would struggle to articulate it because it’s so obvious to them, they don’t think of even mentioning it. That makes it quite a tricky discipline.
People want different things. If you’ve got a whole load of stakeholders, they’re going to want different things. They may be intention or in direct conflict. Who do you even ask anyway? Who are all the stakeholders? Almost always more than you first realize. Some of those stakeholders may not be available. You may literally not be able to get hold of them because they’re too busy or contractually or geographically or in time zones or for whatever reason, it might be hard to actually speak to those people. And of course, requirements also come from other places and people from documents and so on.
Below is an excerpt from the Questions and Answers portion of the webinar:
Question: “EARS notification seems beneficial for system requirements equals higher level requirements, but what about other low level requirements? What can you recommend using EARS for which level of requirements and for which requirement levels not using it?
Alistair Mavin: Good question. The first EARS paper, all we claimed was we’ve run it past some high level system requirements for a jet engine control system and it appears to work. That’s all we claimed. Subsequently, it was used by the team I was with within Rolls Royce and other people within Rolls Royce, and then once the paper was published, other people in other organizations for different sets of data in different domains and for systems at different levels. The short answer is it can be used pretty much at any level.
I mean, if you think about a system of… The thing about requirements engineering for me is you define your system to be built and you consider that as a block box. What are the inputs to it? What are things that it can detect that it’s going to react to? And what outputs does it produce in response to receiving those inputs? A system is a transfer function of inputs into outputs. Your system is whatever you define as a system. In that sense, you can do it pretty much at any level. The simple answer is it works at any level.
Interestingly, since we’ve talked about lower levels, one of the other questions, well, it’s not a question, but it’s a point put in the Q and A, Frederick Wolf, if I pronounce the correctly. Renault Software Factory is using EARS. There you go. Software people use EARS.
Question: “EARS notification seems to me to only be applicable to capture functional requirements. What about nonfunctional requirements, namely quality requirements and constraints?”
Alistair Mavin: Short answer, yes. EARS can handle nonfunctionals of all types. The way I recommend treating nonfunctionals within EARS is… It’s difficult to answer. This is a very short answer in the time we’ve got, but there are three distinct ways that you can handle nonfunctionals. Constraints can be handled with any EARS pattern. The system shall have a certain weight, maximum weight, shall comply with a standard, shall interface with some other system. Those sort of things can be specified just using any EARS pattern.
If you have a nonfunctional aspect that applies the one function, the system shall display a message within one second, that within one second is a quality of service. It’s called an EARS, is a little suffix you put on the end of an EARS requirement, which somehow gives a quality measure to how quickly, how accurately type of thing on the end of a functional requirement. Then the quality and performance requirements, which in a way are the purely nonfunctional requirements, if you like, quality and performance requirements, I recommend having three measures. A must, a plan, and a stretch, which is rather like Gilb’s Planguage, which handily, question four…
Question:“How does EARS compare to Gilb’s Planguage?”
Alistair Mavin: Well, in terms of how it handles nonfunctionals, it basically follows Gilb’s suggested notation for how to follow nonfunctionals. You would write a required following the general principles to make an EARS compliant requirement, but you would explicitly and specifically put in an imprecise word such as quickly, which in a normal requirement, you would not want a word like quickly. I would recommend tagging them as this is a QPR, this is a quality and performance requirement, so you know it has knowingly got an imprecise word such as quickly, and then you’d have metadata. Another attribute that says must, what’s the worst quickly will be? Within three seconds. The plan is within two seconds and the stretch is within one second. That maps exactly to Gilb’s Planguage… is taken from Gilb’s Planguage.
Question:“Is Jama Software the only provider of an EARS tool?”
Joseph Pitarresi: No, there are other suppliers in the market. Our approach, however, is to really provide this tool as a benefit to all Jama Connect users, many of the other solutions, and there are excellent solutions in the marketplace and we have partners that offer solutions as well, are created from a custom development process to where there’s either a special development tool and hands-on consulting required to develop a detailed approach to artificial intelligence. Again, we’re trying to provide the 80%, 90% of the value at a very high level across the INCOSE and the EARS patterns.
And so, we think that’s a huge value opportunity that we’re addressing, but we highly are happy to refer you to our partners who can build custom solutions for EARS analysis if you want to go into that kind of depth and you can contact me and I’m happy to refer you to our partners who want to go even deeper more than the Advisor, but just to be clear, Advisor will be integrated in our Connect platform. You’ll round trip your requirement statements that are in Jama Connect to the Advisor and back once you’ve decided if you want to make some changes. And so, it’ll be very quick and efficient right within our tool. You don’t have to be popping in and out of different tools.
The Limitations, Drawbacks, and Risks of Using Legacy Requirements Management Tools
Current market dynamics include disruptors that put innovation at the heart of your product development process. Organizations must be able to navigate these disruptions to remain competitive and sustain business growth.
Why organizations move away from legacy tools, the benefits of making the switch, and how to successfully migrate.
Requirements management (RM) tools started to evolve more than 25 years ago when it became clear that document-based tools such as Microsoft Office did not offer capabilities able to manage and analyze requirements traceability. Early requirements tools included QSS DOORS® (now IBM), Rational Requisite Pro (end of life), Borland Calibre RM (now Microfocus), and a couple of others. Legacy requirements solutions may have handled managing requirements in the past but are failing to keep pace over time due to increasing engineering complexity and the need for modern software to be far easier to use.
We will explore topics relevant to legacy requirements management tools, why organizations elect to move away from them, what benefits are realized after making the switch, and how to successfully migrate. We’ll also touch on how to navigate the data migration path from a legacy system to a new platform, and how innovation is realized in product development lifecycles with a modern requirements management solution.
There are a lot of solutions for requirements management on the market. Get a breakdown of what to consider when looking for requirements management tools and software, and what the top requirements management tools all have in common.
Every trade has its own sort of requirements — those items or processes necessary to produce products, systems, or software that meets certain standards for safety, use, reliability, and customer satisfaction. All of those requirements connect and build on each other in different ways. For example, in the development of a medical device, engineers, enterprise architects, designers, software developers, medical experts, and researchers all bring different requirements to the table. However, if those requirements don’t work together, the resulting medical device won’t function as it should or satisfy the end user.
In the realm of product development and software development, requirements can exist across a variety of boundaries and in a host of different places. Without a single place to capture all product requirements, team members can end up siloed and isolated from the big picture. The unintended negative outcomes of this fragmented process might include: significant delays, cost overruns, product defects, compliance gaps, safety recalls, omitted requirements, and lengthy rework.
The right modern requirements management tool can help.
What is a requirements management tool?
Put simply, a requirements management tool is a central repository for product development teams that ensures all team members can see requirements as they evolve and properly evaluate where they are — at any given time — in the product development process. With a requirements management tool that captures everything from soft knowledge to regulatory compliance standards in real-time, product development teams can realize benefits such as faster speed of delivery, lower costs, and improved productivity.
Selecting the Right Requirements Management Tools and Software
As products, software, and regulatory guidelines have become increasingly complex, so has requirements management and project management. Methods that worked in the past, such as tracking requirements in static MS Word or Excel documents or using Atlassian Jira alone, may no longer be adequate for development teams. With teams scattered across geographic boundaries and a trend toward remote work, key members may work anywhere around the world from any time of day. Moreover, the convergence of technology means that products may need multidisciplinary teams across a complex hardware and software ecosystem. A product that used to require mainly mechanical experts now requires experts on mechanics, electronics, software, hardware, and even new technologies such as green energy and artificial intelligence.
And it’s not just the hard knowledge that needs to be captured. As the workforce ages, it’s vital that teams find ways to capture the soft knowledge and experience of workers who are preparing to retire. Not only that, but younger workers, especially Millennials and Generation Z, tend to change jobs more often than their predecessors. With workers moving in and out of the workforce and shifting jobs more often, teams need to preserve knowledge as much as possible. In addition, as enterprise companies move to Agile to stay competitive in a start-up world, they increasingly need collaborative tools to streamline processes and move past old ways of doing business and ineffective static requirements documents.
In this environment, the need for requirements management solutions has never been greater. With the right requirements management tool, teams will streamline product development and get better products to market faster.
What is the best tool to manage requirements for complex products in regulated industries?
In general, the more complex the product, the more robust the solution needs to be. Highly regulated industries need requirements management tools that allow them to trace compliance-related requirements in real-time.
If your requirements management tool or system fails to address a fragmented development life cycle, and you are still operating with static requirements, the likelihood and risk of negative outcomes increases.
Are we stuck, unproductive, or frequently bogged down in a way that delays the release of products?
The right requirements management tool can streamline your processes and get the team moving in the right direction.
Do we need our requirements management tool to connect with other tools?
Many cloud-based requirements management solutions offer integrations with other cloud-based tools to further streamline your product development process and allow better collaboration across ecosystems.
What is the difference between using a spreadsheet and requirements management tools to manage requirements?
Using an Microsoft Word document or a spreadsheet for requirements management isn’t necessarily wrong. For simple products with small, in-house development teams and few governing regulatory guidelines, a spreadsheet may suffice. Historically, requirements have been captured using spreadsheets or simple processing documents.
What are the pros and cons of using an MS Word document or spreadsheets for managing requirements?
· Pros: Simple; cost-effective with free or open-source spreadsheet apps; few barriers to adoption.
· Cons: Prone to errors; tracking change is difficult; may not be easy to collaborate.
But as products and regulations become more complex, the spreadsheet approach presents challenges and hinders traceability. Teams increasingly work across a variety of geographies, disciplines, functions, and even companies. As the importance of cross-boundary collaboration rises and teams work in-person less frequently, trying to maintain one spreadsheet becomes increasingly difficult. Even a shared document on a cloud drive is inadequate; it may be infrequently updated, saved on multiple drives, or full of insufficient information. In addition, especially on multi-disciplinary teams, members may find a spreadsheet cumbersome as they try to determine which requirements they are directly responsible to address. Finally, creating a requirements trace matrix from a spreadsheet can be cumbersome and prone to incomplete information.
At the point where a spreadsheet is no longer adequate to trace and track requirements, organizations and teams need to consider what type of dedicated requirements management solution will work for them. A dedicated tool should allow the product development team to collaborate across boundaries, easily trace requirements, and produce requirements documentation with ease.
What are the best requirements management tools?
Of course, because teams and products have unique needs, defining the “best” requirements management tool is dependent on a number of factors.
For small teams or start-ups with few stakeholders, simple products, and tight budgets, there are a variety of free and open source requirements management tools available, including spreadsheets.
For SMBs who typically have fewer stakeholders and users, cost may be an important consideration. SMBs may want to look for a tool that has a lower priced edition or a per-user pricing model. Those options can still provide the important functions of requirements traceability, integrated discussion boards, and collaboration while remaining cost-effective.
For highly regulated industries, a robust RM tool can significantly reduce the risk of product failures, recalls, and reprimands from regulatory agencies. With a requirements tool that captures everything in one place, teams operate with more complete information and generate more accurate reports, which reduces the risk of product failure.
For the enterprise, a requirements management software that offers full integration and collaboration options can help keep teams agile in a start-up world. In addition, the right requirements solution makes integrating market research and user stories better, improving the chances of successful product release.
Your requirements management system should, at the very least, do these things:
Simplify the effort it takes to achieve compliance with regulatory standards
Reduce risk and the probability of negative outcomes and the impact of change
Enable alignment and collaboration across teams and activities
Provide end-to-end visibility and control with a single source of truth
What are the pros and cons of requirements management tools?
For teams working on complex products in a regulated industry (especially those with a widely distributed team), there are many pros to adopting a dedicated requirements management tool. With the right tool, teams can realize several advantages:
Improved productivity:With one dedicated solution, team members have a single source of truth. As members write requirements, add user stories, trace progress, link to other layers of knowledge, and create relationships with other requirements, everyone on the team can see how decisions and progress ripple across the product development lifecycle.
Reduced time to market: With improved productivity comes reduced time to market. With true collaboration inside a requirements management solution, traceability improves, and all stakeholders can see connections in real-time.
Reduced rework:A 2018 Engineering.com study (sponsored by Jama Software) revealed that 83% of design teams experienced some kind of production outcome failure due to poor requirements management. Improving requirements management along the way will reduce potential rework, thereby improving outcomes.
Reduced defects:Defects in the development process are common, but they don’t have to result in long-term problems if caught early. Proper requirements management can help quickly identify defects and track their impact. By giving visibility into the problem early, teams can address and correct defects before they result in product failure or regulatory problems.
Of course, there are downsides to some requirements management tools. Some solutions may be cost-prohibitive, and if the solution is cumbersome or not user friendly, teams may be reluctant to implement and adopt it, especially if the customer support isn’t outstanding. Additionally, cross-boundary teams may use different apps or solutions that lack integration capabilities, creating barriers to productivity, collaboration, and, ultimately, product releases.
What features are important for requirements management software?
Jama Software breaks down some of the key features of various requirements management solutions on the market, and shows what top requirements management tools have in common.
There is a wide range of features offered across requirements management solutions. The features highlighted focus on the core functionality that any solution must offer to effectively fulfill the function of requirements management.
Top Requirements Management Tools Have These Things in Common
Ease of Use – installation and implementation must not take a lot of time and must quickly integrate with other systems and workflows to ensure adoption of the solution across teams.
Requirements Management – includes the ability to define requirements, model relationships, link requirements, reuse requirements, and export/import requirements data.
Collaboration and Reviews – includes the functionality for interaction between users, as well as some basic task management functionalities to allow for collaboration on tasks. This includes the ability to review, approve, provide electronic signatures, gather input, maintain version control, and receive notifications about other users’ activity within the software. This may extend to include collaboration with external teams and suppliers.
Full Traceability and Impact Analysis – able to establish an automatic relationship across requirements is key to effective requirements management. This includes test management and the ability to run test cases and mitigate risks through change management across the lifecycle of a project.
Flexible, Scalable Architecture – customers are searching for flexible, scalable and secure deployment models with simplified, yet flexible license types for uses to support role-based deployment. These options should include availability as a SaaS solution in the Cloud or offered on-premises.
Integrations – the ability to integrate easily with other systems that are being used by the company. Additionally, the solution should include an API built for customization and integrations to best-of-breed solutions across the customer’s tool ecosystem. Some integrations to look for are for software development tools, automated testing tools, and design and modeling tools.
Reporting and Analytics – graphical tools and reports, interactive flows and simulations, dashboards, storyboards, and functionality for graphical models.
Tools on the market to fill the function of requirements management vary from MS Word to those that focus on a specific industry use case (e.g. Greenlight Guru), all the way to full-scale Application Lifecycle Management (ALM) tools (e.g. Modern Requirements4DevOps, Intland Software codeBeamer ALM) and Product Lifecycle Management (PLM) tools that serve multiple lifecycle needs (e.g. Siemens Polarion and PolarionX, IBM Engineering Lifecycle Management, IBM Rational, IBM DOORS Family and IBM Next, Rational DOORS, PTC Windchill, Dassault Systems Reqtify) to fit-for-purpose requirements management tools, focusing on the discipline of requirements management (e.g. Jama Connect).
Learn from customers directly how the products compare on leading customer review sites like G2 and TrustRadius.
Team Culture and the Right RM Solution: Paired for Success
Finally, it should be noted that the right software can only do so much. Ultimately, a requirements management tool is just that — a tool. The right tool, however, can go a long way toward encouraging team cohesion and success, especially in an agile project. Look for a requirements management solution that:
Captures a full range of knowledge from all users:With an increasingly mobile workforce, it’s more important than ever to capture knowledge and hold onto it when workers move on. The right requirements management tool can help. As users enter and track requirements, knowledge is saved in one central location, allowing future users to access that knowledge for future projects.
Encourages collaboration and allows all users visibility:While it may be necessary to limit who can actually make changes to requirements, the right tool should give all team members the ability to see up-to-date information. This gives everyone a sense of connection to the project and allows users to see the impact of requirements and changes to all steps of the design process.
Provides a top-notch customer experience:A solution that gives you a full range of training options and ongoing support will help all members of your team adopt your solution. An added bonus is a strong user community that can offer support and advice from colleagues.
The right requirements management solution can give your product design team a way to manage, change, and track requirements through the full development life cycle and improve your chances of a successful product launch. To learn more about how Jama Connect can streamline your requirements management, contact us.
Selecting a Requirements Management Tool
Requirements engineering is critical to the success of a project because it tells everyone involved with the project what needs to be done. A project manager, who schedules tasks, can do so based on more accurate requirements. A requirements management software tool can greatly support successful teams, as it enables more efficient and optimized product and system development.
This type of tool can provide:
Clarity and visibility. Get broader visibility into what you’re building and why.
Live traceability. Ensure product quality and improve change management with complete traceability.
Decision tracking and fast reviews. Conduct virtual reviews of requirements, test cases, user needs and more.
Real-time collaboration. Immediately note and prioritize important decisions, pull in the required stakeholders and reference historical context to eliminate communication errors.
Editors note: In this two-part blog post, we’ll cover the top challenges of requirements management and how to solve them.
Every year, the complexity of projects increases. Requirements documents can be more than 100 pages and change 20 times during the development process. That means you likely spend hours circulating, editing, and tracking changes to a hefty requirements document with the hope that your team reads it and stays engaged.
The problem isn’t the requirements document itself. The problem is in using the document as the place to manage requirements. It’s no longer realistic to use documents to set expectations, communicate project details, and track changes throughout the process of developing today’s complex products.
As the person responsible for ensuring everyone understands what we’re building and why (a.k.a. requirements), you must evolve how you work. You must embrace new techniques and tools to find a better way to communicate requirements and deliver the right solutions while making the process as enjoyable as possible.
Based on our own experience and that of our customers, we compiled the five biggest challenges of requirements management, as well as expert insight into how to conquer each one.
The Top Challenges of Requirements Management
Challenge #1: The 11th Hour Swoop-In
An executive comes to you last minute with feedback that you needed three weeks ago.
We’ve been on both sides of this frustration, and it’s not pleasant for either party. The reality is that managers are busy dealing with a variety of issues and are often forced to focus on what’s most urgent. Also, ideas might be generated after leaders or stakeholders see prototypes and realize that what was specified in the initial requirements document is no longer the best solution.
Expert Tip: Be Open
To prevent the 11th hour swoop-in, you must be transparent and open to feedback at all phases of the project. Give management better visibility and a continuous feedback loop throughout the development process to address issues before it’s too late. Frequent check-ins can help get reactions early. If your team and executive staff are in the same office, this is easier to accomplish. Have a white board or dedicated wall sharing the latest designs in a prominent location. Every day, folks walk by and have an opportunity to react to what they see. Most people respond better to visuals versus written words to understand the user experience.
If you’re a distributed team in multiple locations, as is common today, then a specialized solution that provides everyone a central hub for the project’s requirements, related designs, and real-time feedback will help. Anyone, no matter where they are, can see what’s happening as the project evolves and you’ll be able to see any disagreements or potential hang ups before they cause costly rework.
Meetings are spent revisiting old decisions or bringing others up to speed.
Decisions may be overturned as new information becomes available during the development process. However, there are better—and more cost-effective—ways to work through these changes than hashing it out in team-wide meetings.
Expert Tip: Be Clear
To manage change well, the whole team needs full context of the decisions made to understand why things are changing and how those changes impact the project’s scope. People need clarity and understanding to execute at their best.
This applies upstream to your stakeholders and customers so they understand what they’re getting. It also applies downstream to your design, development, and QA teams so they know exactly what to build and test properly.
Modern collaborative solutions exist that can help you capture the healthy debates and ongoing discussions that naturally take place around requirements, without the need for more meetings. People can see what others are saying and add their feedback anytime to agree or disagree, approve or reject, or propose edits to refine the solution.
Also, decisions made in meetings aren’t easily tracked in documents and people’s memories fade as time goes on. If this is an issue for your organization, adopt a new technique to capture decisions in line with requirements, and make them easy for the team to view anytime. This will eliminate ambiguity and ensure that decisions about the project are crystal clear.
Manually sending updates to everyone when something changes.
When executing complex projects, change is going to happen. And, often for good reasons. As you get deeper into the design and development of a project, you know more than you did at the beginning. Thus, you and your team will think of better ways to build the desired product and iterate on the requirements along the way. If you try to manage versions and maintain visibility by tracking changes in Word documents, you’ll experience a huge tax on your time.
Expert Tip: Be Iterative
Embrace changes intelligently by connecting the dots, quickly assessing the impact, and automatically communicating changes to the right people involved. You want your entire organization to feel empowered to propose a change if they find a better solution.
The number one reason to adopt Agile within your organization is to create a culture that is nimble so your team can respond quickly and effectively to changing requirements. Thus, iterating as you go.
Don’t get hung up on the labels or the debate of whether scrum or kanban is superior. There is no definitive, one-size-fits all process. Agile first and foremost is a cultural mindset, not a prescriptive development process.
If you’re coming from a more traditional waterfall approach, your challenge with adopting agile is to avoid going from one extreme to the next. There is a myth that Agile doesn’t require a plan, but that isn’t the case for most organizations.
Smart Agile teams maintain requirements best practices such as traceability, impact analysis, and change management, which are borrowed from traditional methods so they can understand the ripple effect a change has on the rest of the project.
It’s a balancing act between agility and formal control. Some call it a hybrid approach. Again, the labels don’t matter. The key is to find the mix of techniques that works best for your team so you can execute projects without friction.
Stay tuned for next week when we cover the rest of the top challenges for requirements management and continue to give expert tips on how to conquer them.
Download our eBook to learn how optimize product development with strategic team collaboration.
With a top requirements management tool, your teams can better navigate complex product development cycles while adapting to evolving business demands and regulatory environments. Instead of legacy requirements management solutions or document-based processes, harness the power of Jama Connect to centralize your requirements in one solution and reduce risks and inefficiencies at every stage of the product lifecycle.
Centralize Your Requirements
Jama Connect is a modern requirements management tool, built for handling today’s demanding workflows and navigating all the complexity that comes with them.
Jama Connect provides:
Ease of Use
Benefit from an intuitive browser-based interface that creates and exceptional user experience because fast team adoption and ease of collaboration between users means faster time-to-market.
Single Source of Truth
Increase cross-team visibility, and structure real-time collaboration, formal reviews and sign-off to build consensus and support informed decision-making across the entire product lifecycle.
Live, Actionable Traceability
Experience an end-to-end live view of connected people, data, and processes within your organization, to reduce risk and achieve an easier path to compliance than possible with a manual process.
Reuse Functionality
Reuse existing content, templates, and relationships so you can manage complex product lifecycles through multiple versions and iterations, in turn dramatically reducing your typical design cycle time.
Open Architecture
Utilize our best-in-class solution with an ecosystem of industry-leading integrations with preferred tools such as Jira, along with a REST API for making your own custom integrations.
Culture of Customer Success
See time-to-value with our adoption-oriented services team and comprehensive customer care which includes online tutorials, the Jama community, and exceptional tech support to ensure your success.
Document-based workflows and legacy requirements management tools sharply increase risk across the product development process. They create time-consuming extra work, put pressure on budgets, and result in poor overall requirements management, which dooms many projects.
Jama Connect is designed to deliver a more streamlined experience that will help you seize opportunities and eliminate all of these sources of friction.
Reduce Rework by Understanding and Responding to Change
With full traceability in Jama Connect, teams can accurately monitor their progress and connect individual requirements to key stakeholders. This allows for superior communication about the implications of all changes, along with improved capacity to respond to them. Teams gain access to the most up-to-date information reducing the amount of costly rework and late-stage changes.
Gain Visibility and Enable More Productive Collaboration
Jama Connect’s detailed dashboards and multiple integrations across the ALM-PLM landscape make it easier to keep track of what’s being built and why. For example, you can combine Jama Connect’s requirements management capabilities with Jira’s task management features to increase visibility and alignment throughout the development process, resulting in more effective collaboration.
Improve Efficiency and Optimize Product Development Processes
Best-of-breed requirements management tools replace the siloed activities and data sources of document-based processes. From one interface, it’s possible to manage all requirements tests and create the traceability that supports more efficient product development. And Jama Connect’s many integrations deliver more flexibility than legacy requirements management platforms, which weren’t built for integrated systems or modern methodologies.
Gain Visibility and Collaborate Better
Jama Connect helps you accelerate product development. It’s a requirements management tool that not only reduces manual rework and integrates with a wide variety of solutions, but also provides a single source of truth and a common point of control.
Requirements can be created, reviewed, validated, and verified on the same platform, thanks to features that let your team:
Gain clear insights across the definition, design, build, and test phases.
See relationships and dependencies between systems, teams, actions, and results.
Conduct real-time virtual reviews of comments, revisions, and approvals.
Work within multiple methodologies, including lean and Agile software development.
Use templates and configurations to comply with industry best practices and regulations.
Visualize how each test traces back to a requirement, for better compliance and quality.
Reuse requirements so that important features can be replicated across products.
Simplify Change Management
A seemingly minor project change can have major ripple effects across your development process. What is the potential impact of making even bigger changes to a project? Jama Connect gives you the answers you need to these questions and others that arise during the product lifecycle.
Live Traceability
With Jama Connect as your requirements management tool, you can navigate upstream and downstream relationships, quickly identify gaps in test coverage, and filter and export views specific to your products. People and items impacted by any change are also automatically highlighted for easier review.
Real-Time Collaboration
Prioritize your most important decisions, flag risks and opportunities, and shorten development cycles with Jama Connect’s collaboration capabilities. Stakeholders can be easily identified and pulled in as needed, gain visibility into all connected users on each project, as well as stream discussions and notifications.
Accelerated Decision Tracking and Reviews
With Jama Connect, stakeholders (on-site or distributed) can conduct comprehensive virtual reviews, share requirements and feedback, approve or reject items, identify priorities, and even add electronic signatures to projects. It’s the ideal tool to help accelerate tests and requirements and keep your development process on target.
Seamlessly Integrate with Your Development Tech Stack
Jama Connects lets you get even more value from your existing testing and quality assurance setup. Many integrations between Jama Connect and other ALM-PLM solutions are available, so that your team can continue to use its preferred tools while ensuring complete traceability. A REST API is also available for crafting custom integrations with Jama Connect.
Get Started With Jama Connect
Ready to learn more about how Jama Connect delivers an all-in-one requirements management solution to transform your processes and see more effective cross-team collaboration, reduced rework, simplified compliance, and faster time to market?
Learn more about how Jama Connect streamlines development process and speeds time to market.
Looking for a new way to manage your requirements in 2021 but not sure where to start? Selecting a modern requirements management tool might be the right next step. A growing number of organizations are exploring and adopting product development solutions that manage the complexity that comes with designing connected systems.
Requirements are the foundation of a smooth-running process and are the essential inputs to your mission-critical projects. Effectively managing the flow of changes and refinements early in your lifecycle will significantly reduce both quality issues downstream and the volatility that plagues so many projects – and the right requirements management solution can make all the difference.
The right requirements management solution can help manage the complexity of product, systems, and software development, but it also allows teams to:
Build higher-quality products with fewer defects and rework
Get to market more efficiently with fewer people and spending less money
Capitalize on opportunity faster through earlier launch dates and a prolonged market window
Another thing to consider when selecting a requirements management solution, is whether it allows for living requirements. Living requirements are becoming a competitive advantage in the innovation economy. If your requirements management solution doesn’t allow for living requirements, it’s like that your team will fall behind.
Differences between static and living requirements
Living requirements address the root causes to deliver increased productivity, faster speed of delivery, and risk reduction. This includes all areas of the complex product, systems, and software delivery lifecycle that can experience negative outcomes and should be actively managed to reduce the likelihood of occurrence.
Performance | Product fails to perform specified functions
Quality | Product defects are discovered by customers post-launch
Delays | Product release deadlines are missed
Fit to Requirements | Product fails to meet the needs of customers
Compliance Gap | Gap identified late and extreme cost to rework and fix
Regulatory Action | Product is not approved for launch or recalled post-launch
Whether you’re building products, systems, or software, check out this handy checklist to make sure you’re getting everything you need in a requirements management solution in order to improve efficiencies, cut down on costly rework, and mitigate negative product development outcomes.
Have confidence that you’re selecting the right requirements management solution by downloading our checklist for essential features and functionality.
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With a top requirements management tool, your teams can better navigate complex product development cycles while adapting to evolving business demands and regulatory environments. Instead of legacy requirements management solutions or document-based processes, harness the power of Jama Connect to centralize your requirements in one solution and reduce risks and inefficiencies at every stage of the product lifecycle.