Tag Archive for: collaboration

Enabling Digital Transformation

In this blog post, experts from Cadence, OpsHub, and Jama Software talk about enabling digital transformation in the hardware and semiconductor industries.


The relentless pace of innovation, rapidly changing markets, and increasing product complexity are creating intense pressures on companies in the semiconductor and hardware space. Some of the biggest challenges relate to scaling effectively and efficiently within the context of digital transformations.

Organizations in all sectors are looking to support faster release cycles and accelerate innovation. Siloed and legacy tool chains create a major hurdle in accomplishing these goals.

Watch the webinar or read the recording to learn more about:

  • Rich collaboration
  • Complete traceability
  • Full transparency among all stakeholders
  • Faster releases
  • Improved quality and productivity

Below is an abbreviated transcript and a recording of our webinar.


 

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Jama Connect: the Leading Platform for Requirements

Matt Graham: Thanks everybody for joining. So today, before we get into the agenda just to introduce the three products that there are three subject matter experts about. First of all, something near and dear to my heart, the Cadence vManager, verification management platform which is a scalable, reliable and very feature rich verification planning and management solution from Cadence. That sits on top of a number of our verification and provides a sort of roll up capability. And we’ll describe it in a little more detail in a couple of slides. On the OpsHub opposite side, we’ll be looking at the OpsHub integration manager that enables enterprises to integrate their best of breed tools together that are best suited for the various teams and their various roles and connect those two together for integration and collaboration. And then Jama Connect, which is the leading platform for requirements, risk and test management to help provide that sort of end-to-end compliance solution.

Our agenda today. First we’ll look at some of the challenges of the semiconductor and hardware development ecosystem. This is obviously a very fast paced, highly competitive type of environment and there’s a lot of specific challenges that the integration of the tools I just mentioned can help address and solve. We’ll look at how engineers in this space can scale effectively and efficiently utilizing some of these, the tools to address some of the ongoing transformations in that space. And then specific to semiconductor domain, bridging the gap in what has historically been a very siloed development process. And bringing together for efficiency, quality and reliability all of the various tools that I mentioned and giving it a really nice integrated development and verification environment. We’ll then have a specific use case and demo showing how the three tools work in concert and then look at some key takeaways. And as Marie mentioned, some Q and A.

Standards for Requirements such as ISO 26262

Specifically to the semiconductor and hardware ecosystem, there are a developing set of challenges. And of course they’ve always been challenges in this area. First pass design success is critical for hardware development. Just because the tooling costs are so great. We don’t want to have to respurn hardware. It’s not like just releasing more software. It is it requires expense. But that has been the way of hardware development for some time. In the last several years we’ve seen a need creeping into that environment for even stricter compliance, particularly around mission critical domain such as aero and defense, automotive especially as self-driving and autonomous vehicles come in. And adherence to standards like ISO 26262 presents another layer of requirements and need for management and collaboration on top of an already strict set of sort of design parameters.

As I mentioned, this development environment tends to be very siloed in its nature because it is so specialist. You have specialist designers, specialists verification engineers to test the designs, specialists post silicon, specialists layout engineers and so on and so forth. And all of those silos, well somewhat required of the specialty of each of those tasks tends to hinder collaboration, compromise quality and just impact efficiency and velocity overall. In an area where efficiency and quality is critical. We can’t have bugs in semiconductors going to automotive and we need to be able to turn those new cell phones, those new mobile devices as quickly as possible. So turnaround time is just getting compressed and the requirement for quality is increasing at the same time.


RELATED: A Guide to Understanding ISO Standards


All of that sort of siloed nature of the specialties as well as the need for velocity and quality really ends up in poor traceability of results in terms of compliance and quality issues creeping in. Especially when it comes to doing things like audits for ISO and other similar standards that are becoming the requirement across again aero and defense type applications, automotive type applications and even down into the sort of consumer device applications. And really traceability is a watch word now in the ecosystem of hardware and semiconductor development.

So how does the offering from Cadence, vManager fit into and help provide a solution to those challenges that I just mentioned? Well, for a number of years now, in fact, vManager has been around for about 15 years and in that entire time it’s had the key capability of the verification plan. And the verification plan really exists to provide traceability between what is being executed during the testing or verification of your semiconductor or hardware design. And what were the goals of that or the requirements of that testing or verification project. Things like testing interfaces, both internal and external to the semiconductor, testing compliance with standards like ethernet and USB, such as that, things like that. As well as the internal requirements of the device, it must route packets this fast. It must answer phone calls in this manner or whatever it might be.

And the verification plan in vManager really allows the user to enter those requirements and then connect them to the real results that are occurring. We ran these tests, these tests were associated with a given requirement. Those tests passed therefore the requirement is satisfied. And so the V plan becomes a very natural place. And in fact the appropriate place to connect the rest of the ecosystem via OpsHub, two tool requirements coming from Jama Connect so that we can have traceability across the software development, the hardware development, whatever. The mechanical development et cetera ecosystems. And the vManager and the verification plan is really where that hardware verification, that hardware and semiconductor development information enters that ecosystem through the conduit of the verification plan. So let’s look a little bit more on, well what exactly is in that verification plan that vManager provides.

Enabling Digital Transformation: Static Documents Cause Challenges


RELATED: Reduce Project Risk in the Product Development Process: Bridge engineering silos with Living Requirements™ Management


And the V plan is really what we call, what we refer to in our vManager sort of pitch if you will as an executable verification specification or an executable verification contract. And what that means is that there’s data incoming to that during the creation, the authoring of that verification plan. Not only through connectivity to tools like Jama but also from say static documents like standards specifications, ethernet that I mentioned before, USB those are standard protocols that have very lengthy standards documents and needs to be a way to import, kind of gather the data from that and put it in the verification plan. Another input to the verification plan is other verification plans. So if you think about a system on a chip that is not a single piece of intellectual property, it’s built up of many, many different pieces, a USB piece, a central processing piece, a memory management piece and so on.

And each of those pieces can have their own verification plans for the verification at that sort of lower block level as well as then can sort of conglomerating or aggregating those verification plans into a single sort of system on a chip verification plan. And the vManager, V plan allows that through sort of parameterization and instantiation and really flexible set of sort of reuse capabilities for verification lands. And then of course just engineers authoring their verification plan. Literally writing, typing in here’s a specific requirement et cetera. And then we have the component of mapping those requirements to items that exist in the actual testing environment. Things like we have a test, did it pass or fail? What requirement is that test related to? So there’s mapping the test to a particular requirement and then did that test pass or fail. Those of you familiar with hardware verification know that tests passing and failing is not the only statistic or metric that we track.

There’s other metrics and statistics such as code coverage, functional coverage, assertion coverage, software coverage, all tracking what scenarios and what stimulus were driven to the specific device under test. And what was the reaction of the device under test? And then what percentage of the device has been exercised during that test? It is all basically statistics gathering from the testing effort. All that data can be mapped into the verification plan, directed to the specific requirement or multiple requirements that it may satisfy. And of course, this gives us the ability to not only specify a requirement, but then capture whether that requirement was met. Was it satisfied? And this is the place where I’ll hand over to Jeremy now to talk about what those requirements in those higher level requirements or system level requirements in the general world and how they’re going to connect into this hardware verification, hardware development world.

To learn more, watch the full webinar, “Enabling Digital Transformation in the Semiconductor and Hardware Space.

 



Medical Device Development

Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s Chief Product Officer.


In the fall, I wrote about how the medical technology industry has struggled to keep pace with other, similar industries. In the piece, I discuss how important it is for engineers designing those products to move gradually and carefully, even when under immense pressure, to reduce time-to-market. Now, a year on from the stay-at-home order issuance across the United States, it’s time to take stock on what temporary measures need to be made permanent to grow as an industry.

As we move forward into a post-pandemic world, it is important that companies are explicit with the lessons that they have learned from this past year. Executive staff, rightfully so, have been focused on keeping things going. Now the focus should shift to “how do we exit the pandemic in a better place than when we entered?” This is where it becomes important to create an open dialogue about what was successful and what could have been done better. This will assist in making those temporary adjustments a permanent fixture in medical device production.

Before we look towards a post-pandemic world, though, we need to evaluate where things went wrong and how to better address them moving forward.

What Have We Learned?

If COVID-19 taught us anything it is that we need to be more efficient at speed-to-market when creating products, especially when it comes to medical product production. Additionally, gone are the days of person-to-person-only collaboration. Organizations now have the capabilities for a hybrid environment consisting of remote and in-person teams.

The complexities of product development within health and life sciences should not be a surprise. What is more alarming is that, as the complexity of medical devices increases, we still have many engineering teams that are relying on decades-old technology such as Word documents and spreadsheets to manage requirements, risk assessment and testing. These legacy tools have a place in most of the professional world, however, they are not adequate for development teams who need to achieve alignment with massive amounts of data, regulations and standards to ensure device safety and quality.

As these device management teams face immense pressure to innovate while collaborating across software, hardware and quality teams, it is essential that their work is tracked and seamless to meet the increasing pace of market demand. That’s why we have seen traceability evolve to account for the complex, ever-changing nature of requirements, test and risk management. For a growing company to be successful, everything must be able to work simultaneously, at scale and across teams. Legacy tools do not provide the agile capabilities that modern traceability does.

It hasn’t been easy for engineering teams to adjust to their fully remote workplace. Even organizations that offered a hybrid working model previously are struggling to ensure their teams are aligned to meet delivery dates and project deadlines. The organizations that will have a distinct advantage over others are those focused on collaboration and context within their teams. These teams will be best set up to quickly build high-quality products, further ensuring better patient outcomes.


RELATED: How to Executive a Successful Design Review When Building Medical Devices

Where We Go from Here

As mentioned previously, the best course of action following this difficult year is to ensure company leaders are shifting their focus towards figuring out how to leave their companies in a better place following the pandemic, versus where they were when they entered. Based on my experiences as the chief product officer for a leading requirements, risk, and test management platform, I have noticed a few key ways that executives in the medtech industry can better prepare themselves moving forward.

1. Adaptability

In general, companies that have adaptability embedded in their DNA have already handled the peaks and valleys of the pandemic far better than those that remained rigid in their approach. Looking ahead, it will be immensely important to evaluate your process assumptions and determine how resilient you are to change.

Without a malleable business model, a company will constantly be scrambling any time it hits a road bump. However, with the right digital tools at your disposal, your company will be able to adapt quickly and effortlessly, allowing your employees and customers to remain calm in times of crisis.

2. Alignment

While companies in all industries adapt their business models to prepare for the new normal, innovative tech companies are transforming the devices and systems they build, and the technology and process they use to build them. Newer technologies in the medical field, like robotics nanotechnology and wearable health tech devices, bring added complexities for medical device companies. There is an additional risk for patients and consumers, which makes having the right product development solution in place even more important.

Medical device companies that embrace a proactive approach to quality will ultimately find fewer issues with their products, improve customer satisfaction, and stay competitive for the foreseeable future. To do this quickly and efficiently, though, teams must be aligned throughout the entire product development lifecycle. By leveraging an integrated platform for requirements management, teams can stay interconnected and deliver high-quality products that improve patient outcomes.


RELATED: Your Guide to Selecting a Medical Device Development Platform

3. Preparation

Benjamin Franklin once said, “by failing to prepare, you are preparing to fail.” As we look ahead into 2021, I believe it is unlikely we will see large regulatory changes in the medtech industry. However, over the next decade, a great increase in regulations for medical device development is definitely looming. So what can a company do in the meantime? Tighten up your risk management practices, before it’s too late.

The fact is, the medtech industry will always grow at a rapid pace, and regulations will follow. To avoid being left behind by events such as, finding regulatory issues in late-stage device development, and then having to implement confronting costly and time-consuming rework, your teams must align and future-proof the entire development lifecycle.

Future-proofing is the process of using digital tools to capture knowledge and ease accessibility for future employees, independent of the product development lifecycle stage. Employing future-proofing strategies helps company leaders and decision-makers ensure symbiosis throughout the entire process. Future-proofing is key in the age of digital transformation, as it helps address common concerns about collaborative environments, team efficiencies, and product integrations. A software that is up to this task will help you do this in three ways:

  • Comprehensively enables collaboration by giving users a single source of truth to track decisions, questions, and problems
  • Increase team efficiency by capturing knowledge within that single source—often without even realizing it—through feedback and team communication.
  • Seamlessly integrates digital tools that track development and with other information gathering and tracking solutions, knowledge is captured at multiple levels, streamlining future projects.

4. Harmony

Finally, to be successful, there will need to be harmonization on the development methodology across different devices, reducing the need to work off of different documents. Each product in development has its own particular set of customers, stakeholders and internal team members associated with it. Therefore, it is important that these individuals can be accurately connected to the items for which they are responsible. Enter traceability.

Traceability is all about relationships. To make informed choices, product development professionals need tools that allow them to see changes in real-time, within the team’s structure, and throughout the system where their product exists. Modern traceability makes it possible to manage and respond to change with confidence in a systematic and auditable way. When done correctly, traceability can be used as a key tool to allow for harmonious decision-making. Without it, accountability is incomplete and past decisions can’t easily be seen, learned from or built upon.

Overall, COVID-19 has been industry-defining as companies were made to quickly shift how their teams collaborated, now forced to have a remote workforce. As we see the light at the end of the tunnel it’s time to look towards the future of medical device development. Let’s take all that we’ve learned from this past year and use it to ensure that we’re putting out high-quality products, quickly and accurately.



Traceability

Editor’s Note: This post about how traceability improves collaboration and decision making was originally published here on DevOps.com on September 23rd, 2020, and was written by Josh Turpen, Jama Software’s Chief Product Officer. 


Jama Connect® creates Live Traceability™ through siloed development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning platform.

Minimize the risk of delays, defects, cost overruns, and the manual effort created by fragmented development processes and legacy solutions. Learn more!


New software is being developed at an incredible pace to help make our lives easier. This doesn’t change the fact that humans are still held accountable for product development decisions, whether these are made with or without advanced analysis tools. To make informed choices, product development professionals need tools that allow them to see comprehensible information in real-time as change is happening, both within the team’s structure and throughout the system in which their product exists.

Modern traceability makes it possible to both manage and respond to change in a systematic, auditable and confidence-enhancing way. Below, we will discuss three ways traceability has evolved to support key decision-makers in a number of industries.

Modern traceability captures when you make a decision

Decisions often have varying levels of durability. Sometimes, when you make a decision, you know then and there it’s final. Other times, you make what seems to be a minor choice and you end up dealing with the repercussions for years to come. With this level of uncertainty, it is essential to have mechanisms that allow you to see when decisions are made. As I discussed in a previous article, “5 Ways Traceability is Changing to Bolster the Remote Workforce,” this process can be compared to a map. By leading a team through every step of their processes, modern traceability helps product developers reach their goals without any surprises.

Often, products are expected to be maintained for years. This is significantly more challenging when you can’t properly track where a ruling originated or a change was made. While the team may move quickly in the development process, the record should always live on to provide future context where it’s needed.


RELATED POST: How to Realign Engineering Teams for Remote Work with Minimal Disruption


Modern traceability provides people the context of what they’re working on as they go, not after the fact

Rather than rely on sharing often lengthy and disparate documents or running time-consuming general meetings, traceability allows teams to streamline their collaboration. Mapping out work items, including owners and contributors, gives people a reason to care and to trace those items carefully. It helps everyone know why they’re there, what they are discussing and how to address it.

Many smaller companies are fortunate to get by using Word documents and other legacy tools for their traceability measures. However, as these companies grow, so do the complexities. That’s why traceability has been evolving to account for the multi-dimensional nature of requirement, test and risk management. For a company that is seeing major growth to be truly successful, all related variables must work together continuously, at scale and across teams. Legacy tools simply do not provide the agile capabilities that modern traceability does.


RELATED POST: Requirements Traceability – How To Go Live


Traceability captures and tracks past decisions and allows users to access them

Traceability is all about relationships. Each product in development has its own particular set of customers, stakeholders and internal team members associated with it. Therefore, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.

Knowing who made a decision and what information they accessed is equally as important as the information itself. If you can’t quickly piece that together, your traceability is incomplete. The responsible thing to do is to ease the process by keeping useful records. It doesn’t need to be forced behavior if it’s captured along the way as a byproduct of doing your job.

Overall, accountability is incomplete and past decisions can’t easily be seen, learned from or built upon without robust, modern traceability tools. It’s much harder to legitimately hold someone accountable when they’re working in the dark. However, when done correctly, traceability can be used as a key tool to support genuine liability and allow for a streamlined process of complex decision-making.


Download our eBook to learn how optimize product development with strategic team collaboration.

DOWNLOAD NOW



end-to-end traceability

Traceability is the ability to track upstream and downstream relationships between requirements and other artifacts, ranging from test cases to higher-level system or subsystem requirements. Through end-to-end traceability, teams can see if a product’s development process is currently on track, as well as view any and all of the history and context associated with it.

That’s the ideal, at least.

Where Traceability Can Come Up Short – And How to Fix It

Traditionally, traceability has been performed using document-based workflows involving applications such as Microsoft Word and Excel. A team member creates a traceability matrix in a text document or spreadsheet and updates it manually throughout the product development lifecycle. Unfortunately, this approach has distinct limitations and is prone to error.

When teams trace requirements within discrete and static documents, they often create extra work for themselves, while also running the risk of missing out on critical updates or making mistakes.

Let’s say someone updates a matrix in Excel with the latest statuses of test cases related to a medical device that’s in development. It might seem like everything is proceeding smoothly on the surface, but multiple problems could be lurking underneath:

Human Error

Since everything is done by hand, this individual must regularly revisit the matrix to keep it in sync and up to date with product development activities across the whole organization. The complexity of the traceability matrix in question – with its numerous tables showing how requirements and test cases connect to one another – makes such work inherently complicated and error-prone.

Email-Centric Collaboration

Meanwhile, these updates to the matrix are primarily communicated via email. Between the normal flow of messages into everyone’s inboxes, people being out of the office, and other complications -like poor version control – and mishandling of incorporating everyone’s comments, it is likely that errors will occur and misunderstanding will necessitate rework down the line.

No Built-In Compliance

Finally, even if everything goes according to plan, there’s no guarantee that the traceability workflows in use will account for all relevant requirements and risks. For instance, in the case of a medical device, a matrix created within Excel won’t come with frameworks aligned with industry standards like ISO 14971, making it more difficult to ensure coordinated traceability and ensure successful proof of compliance.

Fortunately, these types of issues don’t have to hold your teams back and expose your product development processes to undue risk. End-to-end traceability is possible by upgrading from document-oriented workflows to a comprehensive requirements management platform that enables real-time collaboration, bidirectional traceability, and integrated risk management.

Let’s look at four central benefits of implementing end-to-end traceability with a solution like Jama Connect®.

1. Holistic, Actionable Visibility into Requirements and Stakeholders

Traceability is ultimately about relationships, not just between requirements and other artifacts, but between all of those items and the people responsible for managing them. With end-to-end traceability in place, teams can see:

  • How requirements trace forward to their implementations within work products, along with how those products trace back to original requirements and designs.
  • How all requirements were tested – i.e., the test cases linked to them, whether the tests passed or failed, and any associated defects identified along the way.
  • Who was involved in the development of specific requirements and test runs, so that they can be notified right away about necessary next steps or actions required.

This comprehensive visibility creates a system of action – one that teams can use to not only trace the life of each artifact but to initiate the appropriate activities to sustain product development and ensure coverage. Is a medical device safe to use? Does it comply with applicable standards? Can the processes used for building it stand up under an audit? A full-fledged traceability solution provides clear answers to these questions and others.

2. Better Impact Analysis of Changes

Truly informed impact analysis isn’t possible without end-to-end traceability. That’s because such analysis is rooted in being able to see how specific changes to an artifact will affect other items connected to it. Knowing those impacts requires traceability.

In traditional document-based workflows, it can be difficult to know how different items are affected by change. But in a platform with end-to-end traceability, much of this work is automated and becomes a byproduct of your daily work. The solution will instantly flag downstream links as “suspect” so that teams can attend to them as needed.

For example, teams can see if an altered requirement has test cases downstream and what share of them have passed – all in real time. This setup saves immense time and effort compared to manual processes.


RELATED POST: What is Requirements Traceability and Why Does It Matter for Product Teams


3. Easier Identification of Gaps in Test Coverage

Speaking of tests, a requirement is typically only considered “covered” if it has corresponding test cases against it, as well as test engineers assigned to it. But too often, gaps in coverage only become apparent after the fact, when a product issue reveals how a key flaw was overlooked during development.

In fields with rapid change and innovation, such as medical device development and automotive manufacturing, any unidentified coverage gaps are risky to end users and costly to remediate. Improved tracking of test coverage in a platform with end-to-end traceability helps eliminate these blind spots and ensure quality.

More specifically, this level of traceability within a requirements management solution helps test engineers and project managers visualize where gaps exist and whether tests have been approved, completed, rejected, or drafted. As a result, product development becomes less risky overall.

4. Simplified, More Accurate Audit Passage

“Show your work” is a familiar adage to anyone who’s completed a mathematics assignment, and it is crucial advice when tracing requirements, too. Passing an audit will require presenting specific information about those requirements, in formats acceptable to reviewers and regulators.

A platform like Jama Connect simplifies this process by letting teams show clear supporting evidence of comprehensive traceability. It provides export templates like trace reports to provide this evidence, simplifying regulatory submissions and the audit process.

Jama Connect’s Requirements Management Enables Live Traceability™ Across Your Development Process.

Bridge engineering siloes across development, test, and risk activities. Provide end-to-end compliance, risk mitigation, and process improvement with our intuitive, award-winning requirements management platform. Learn more! 


Download our eBook to learn how to optimize product development with strategic team collaboration.

DOWNLOAD NOW



Optimize Product DevelopmentEditor’s Note: This post about how to optimize product development was originally published here on DevOps.com on July 31st, 2020, and was written by Josh Turpen, Jama Software’s Chief Product Officer. 


Systems engineers have faced complexity since the dawn of time. And while bringing complicated projects to market under old rules, methods and technologies was never a walk in the park, today’s highly competitive market presents new challenges to prove the old rules of product development are defunct. In fact, a recent report from Machina Research, now part of Gartner, estimates the number of connected machine-to-machine devices will increase to 27 billion by 2024, up from 5 billion in 2014. The sheer increase in machine devices alone provides a clear picture of the importance placed on systems engineers to stay the course when navigating product development’s complex nature.

Within the constantly evolving modern product development system comes an increasingly intricate development process. Today’s system engineers are fighting to fit a square peg into a round hole by using old tactics to solve new challenges. This includes an accelerated rate of innovation, increasingly complex end user asks, tighter deadlines and ever-changing regulations. Alongside these challenges, Forrester Consulting found that product development is facing five main obstacles in keeping teams from true optimization:

  • The confusing and constantly changing nature of requirements and a lack of quick development for solutions.
  • Stakeholders providing conflicting priorities, assumptions and unclear objectives.
  • Difficulty collaborating across globally distributed teams.
  • Unnecessary handoffs and delayed decisions.
  • The increased need for collaboration across diverse roles.

So what is the solution to these problems, you ask? One could argue strategic team collaboration is the best way to address both the challenges of the modern product development landscape and the obstacles systems engineers are facing. Let’s dig into that a bit deeper.


RELATED: How to Realign Engineering Teams for Remote Work with Minimal Disruption


Team Collaboration: An Enabler of Innovation

Teams that are still operating with outdated strategies and systems find themselves unable to adapt and adjust quickly when the market changes. With rapid growth predicted to stay at a steady rate, strategic collaboration allows companies to build partnerships and seek solutions that are adaptable and specialized. This includes sharing data throughout your whole business, including distributed teams and partner organizations, which allows transparency to reach the entire supply chain. With the COVID-19 pandemic causing supply chain halts and the backup of product releases, it is now more important than ever to ensure communication throughout the entire development process.

With the country leaning on a remote workforce more heavily this year, virtual meetings and emails are not sufficient enough as communication tools for a team that has to coordinate across departments, roles, companies and geographic boundaries. As a first step to meet these demands, system engineers should consider the following strategies:

  1. Ask your team the question, what does success look like? If each member has a different end goal, you will end up wasting valuable time. By defining what success looks like, you can align your teams on what you are building and clarify expectations upfront. This saves time and allows for better communication across teams.
  2. Support better decision-making through situational awareness. When you have communication upfront about a team’s end goal, they are far more likely to make decisions that work toward achieving that. Without situational awareness, employees are unable to comprehend the impact of their decisions or clearly define their roles and responsibilities. This makes it difficult to settle on the right choice when faced with a bump in the road.
  3. Ensure you’re up-to-date with your traceability practices. Especially for those who need to adhere to regulations, traceability analysis allows you to ensure your system holds up under regulatory demands. Further, it meets contractual terms before you encounter a problem.
  4. Create collaboration with a purpose. Ensure relevant data is accessible to everyone to whom it may be relevant, and keep them in the loop on decisions that happen outside the process as much as possible. When you keep your teams in the know, they are able to work collaboratively and with greater situational analysis.

At the end of the day, your goal should be to empower your whole team through data sharing, transparency and a clear definition of success. When you are able to do this, your team will be better positioned to make decisions that benefit the project and work symbiotically across diverse roles.

We may not be able to predict exactly where the product development industry is going, but know that there will be rapid innovation. It’s best to prepare your teams now; otherwise, it will be a bumpy ride.


Download our eBook to learn how optimize product development with strategic team collaboration.

DOWNLOAD NOW

Jama Deminar SeriesWith over 12.5 million active users, organizations around the globe rely on Jama Connect to help bring complex products to life. Innovative companies choose Jama Connect to improve quality, reduce rework, prove compliance, and get to market faster.

That’s why we’re excited to announce a six-part series of deminars (yes, you read that right – it’s a demonstration webinar!) where we’ll be giving you an inside look at the leading platform for requirements, risk, and test management. In this deminar series, we’ll cover key features and capabilities, seamless integrations, best practices, and more.

Below is a snapshot of when each deminar will happen, what will be covered, and how you can save your spot.


Product Essentials: A Quick Tour of Jama Connect for Modern Requirements Management

Thursday, September 10 – 8:00 a.m. PT | 17:00 CEST

Jama Connect enables consistency, collaboration, and alignment across the enterprise by providing a continuous flow of accurate requirements information. This webinar demonstration tour provides an overview of the Jama Connect platform.

In this demonstration session, you’ll learn how to:

    • Establish alignment across people, process, and technology to establish a single source of truth around digital requirements management
    • Collaborate across both internal and external teams using Review Center
    • Use traceability views to provide visibility across the entire product development cycle
    • Utilize our common integrations to extend the solution capabilities — including JIRA
    • Use Jama Connect to support testing, change management and impact analysis

Product Essentials: How to Streamline Reviews and Collaborate with Remote Teams, Customers, and Suppliers with Jama Connect.   

Thursday, September 24 – 8:00 a.m. PT | 17:00 CEST

Through structured collaboration in Jama connect, teams can source feedback from distributed teams and collect side-conversations in an actionable way to gain cross-team visibility.

In this demonstration session, you’ll learn how to:

  • Easily establish communication and document decisions across virtual teams
  • Immediately notify and prioritize critical decisions and pull in required contributors throughout the development process
  • Hold formal reviews and document those decisions in Review Center
  • Exchange requirements with remote teams, customers, and suppliers to extend the development process beyond your core team

REGISTER NOW


Product Essentials: Unpacking Requirements Traceability Capabilities of Jama Connect

Thursday, October 8 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect capabilities provide requirements traceability which improves product development accuracy and/or quality and ensures the ability to provide trace reports for audits. Learn how various options are used to track relationships to/from/between requirements and understand the full impact across the project.

In this demonstration session, you’ll learn how to:

  • Create relationship guardrails to ensure traceability rules will guide users and prevent dependency chaos
  • Right click to build relationship dependencies as you perform everyday work activities
  • Use trace view to:
    • Identify relationship dependencies between data
    • Track progress and identify missing work items
    • Analyze potential impact of changes
    • Gain visibility needed for prioritizing lower level work items against higher level requirements
  • Use item widgets to:
    • View impact analysis to understand the potential impact of change
    • Initiate conversations between connected users
    • Export relationship dependencies to support compliance audits

REGISTER NOW


Product Essentials: Using Jama Connect and JIRA to Manage Requirements for Software Development Teams

Thursday, October 22 – 8:00 a.m. PT | 17:00 CEST

In this session you’ll learn how Jama Connect provides the ability to link JIRA tasks and defects to requirements for full transparency, traceability, and change management throughout the software development process. Product and engineering teams can connect product planning to execution and stay in sync to ensure accuracy and quality of work.

In this demonstration session, you’ll learn how:

  • Link issues and defects from JIRA to Jama Connect
  • Support conversations across the team between the requirements and epics throughout the software development process
  • Analyze—at a dashboard level—the state of the tests, stories, and epics related to a project
  • Use the two-way integration between Jama and JIRA to allow the flow of information back and forth across the teams with synchronization, providing a single source repository and full traceability

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Product Essentials: Sharing How Jama Connect Allows for Earlier Testing in the Lifecycle to Increase Quality and Efficiency.

Thursday, November 5 – 8:00 a.m. PT | 17:00 CET

Through testing in Jama connect, teams can achieve value by incorporating the results of the test strategy into the product strategy and identify potential defects earlier in the product development lifecycle, which prevents late stage changes leading to costly rework.  Learn how Jama Connect provides full manual testing capabilities tied into the product development process ensuring that you release a best-quality product that meets customer expectations.

In this demonstration session, you’ll learn how to:

  • Create a test case and configure filters to quickly access requirements that have no test coverage
  • View test cases, the tests associated, and test run results to analyze test coverage and easily view any gaps
  • Log defects from the testing interface and view automatic trace relationships
  • Export reports to support compliance activities

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Product Essentials: Working with baselines in Jama Connect to Facilitate Compliance and Reuse in Product Development.

Thursday, November 19 – 8:00 a.m. PT | 17:00 CET

Learn how to view and create a baseline to capture and preserve the project at a single point in time. This supports compliance and enables reuse in product development projects.

In this demonstration session, you’ll learn how to:

  • Coordinate product releases across teams and projects
  • Easily create a baseline release and track it effectively throughout the development of the product
  • Navigate the workflow across teams to support release schedules
  • Use baselines to fulfill regulatory requirements (with respect to record keeping) by producing a clear and readable audit trail.

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To view the full series, watch recordings of the deminars after they happen, or register for individual deminars, visit our Product Essentials page.

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Documents-Based Design Control

Medical device companies are on the cutting-edge of advancing health care. Along with facing relentless pressures to innovate and release quality products, they also must comply with regulations and standards to remain competitive. And a big part of that is design control and risk management in medical device development.  

We recently held a webinar specifically designed for product and engineering teams building medical devices, demonstrating how to move beyond the frustrations of disconnected, document-based requirement systems, streamlining your design and development and risk management processes while maintaining compliance with applicable regulations and standards. 

Below you’ll find an abbreviated transcript and the webinar recording.  

 

Move from a Documents-Based Design Control and Risk Management in Medical Device 

If we consider two aspects of your work, the first being the processes and tools that define your methodology and support your work, and the second being the documentation generated to show compliance with applicable regulations and standards, what tends to drive your team? Although it is true that both are necessary, you may find that one carries more weight than the other. For many medical device manufacturers, the answer has been to prioritize the documentation needs of the quality system, especially when considering regulated design control and risk management activities.  

This is understandable given that the documentation serves as the evidence that’s needed to get a product cleared and into the market. But as we’ll see, there are challenges teams face when documentation starts to tip the scale. Our assertion here at Jama Software is that having to prioritize the documentation needs over the product definition and development process and tools is unnecessary. In fact, many times what feels like a prioritization of the documents over all else, is really just a symptom of using documentation tools like Word or Excel to manage product development activities.  

What tends to happen is the quality management system requires specific documents as evidence of proper design and development activities and to show alignment with regulatory requirements. And working backwards from those quality needs results in the use of documentation tools to support the product development life cycle. This may work for a while, but often does not scale.  

The problem here is that the opportunity to improve processes and to increase efficiency and quality is not found in the documentation improvements. There isn’t a better Word template or an Excel macro that can help. The opportunities to improve are in the product development processes and tools. And this is where teams gained value.  

The Challenge Medical Device Development Teams Face in Design Control  

The challenge, as we see it, is that teams are trying to balance the needs of meeting design control regulatory requirements with how they desire to work. And I call it specifically this idea of how teams desire to do work, because our customers are, more often than not, looking to modernize and see a lot of opportunities in new solutions and becoming more collaborative, really improving how they work.  

Design control and risk management activities and the resulting required artifacts are, many times, supported by existing document-centric processes and tools. And although they are difficult to work with, sometimes the confidence and the comfort in having them and not changing, outweighs the benefits of modernizing through supporting tools and introducing change. However, though, we would argue that this comfort and confidence is really in perception only. Behind that perception is the reality of teams struggling with the need to align to market and user needs, deliver quickly to market, and build efficiencies into how they work together. All thwhile working to produce and maintain the necessary design control and risk related artifacts. 

The issue is that how teams work, and the documentation needs are being at odds with one another. When, in fact, that doesn’t have to be the case. Beyond team members simply struggling to keep up with the documentation needs and create the trace matrix, there is real risk to quality and gaining clearance, especially as product complexity only increases. And while it may seem that the documents that go into submission, as long as they are polished in the end, should continue to be the focus, even more so, as the docs and spreadsheets need to manage more information. There is clearly a tipping point.  

At some point, the ineffective and inefficient use of tools to manage everything becomes a risk in itself. Things get missed, precious time gets consumed, rework overwhelms innovation. Now, this is not to say that compliance related design control and risk documentation is not important. It definitely is important. Especially considering the regulations and requirements behind them. The intention here is not to suggest that the documentation is not significant. It’s actually…we suggest that because of the significance, a keen focus on the work and the product development approaches from where these materials are generated, will increase the confidence in the content in those materials, while, at the same time, opening the organization up to opportunities for efficiency and process improvements.  

The Complexity of Design Control of Medical Device is Real  

To take just a couple of examples, here you can see that the median number of years to reach the initial 510(k) clearance has increased from three and a half years to just over five years. And that’s between 2007 and 2013. And if that’s not sign enough of increasing complexity, look to the increase in the number of pages in a 510(k) submission from 1983 to 2017. That is over a 2,000 percent increase. And consider this, that chart starts at 1983, and Microsoft Word, which many of the customers I work with are transitioning away from, was launched in 1983. And that’s when the 510(k) averaged about 50 pages.  

You may consider increasing complexity against productivity, or metrics around time to market, or even your organizations willingness to change and to adopt new tools. These might be places you find where the challenge manifests for your teams.  

Balancing the Requirements of the Quality System with Your Approach 

The shift, we see it, is not to eliminate or downplay the importance of the documentation supporting your regulated, auditable, design control and risk management activities. We see the shift as balancing the requirements of the quality system with your approach to product development. And this balance is found by constructing an approach to how you work, so that the needs of the quality system and the required documentation are actually byproducts of your work, not in themselves defining, or the constraining factor.  

By shifting or balancing, really, the focus toward your product development approach, we suggest that organizations can then look to improve their processes and modernize their tools without negatively impacting or neglecting the regulatory requirements driving documentation today. And the key to making the shift, one that balances product development and documentation needs, is Systems Thinking. And the shift and implementation of Systems Thinking, with it manufacturers can really begin to take advantage of systems engineering principles for developing complex products and find efficiencies in how they work, both cross functionally and in the solutions and tools they use to support their work. 


Watch the full webinar recording to learn more about implementing a design control and risk management approach informed by System Thinking, how Jama Connect for Medical Device Development can help, and more.  

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Team Collaboration

In an environment where modern systems are getting “smarter” and more complex every day, the product development process required to build them is also growing increasingly complicated. 

Today’s engineers face new challenges such as: 

  • Tight operational margins 
  • Accelerating rate of innovation 
  • Increasingly complicated end-user demands 
  • Heightened focus on getting to market faster 
  • Increased and changing regulations

RELATED: A Project Manager’s Guide to Negotiating Stakeholder Priorities like a Pro


For early-phase documentation and for coordinating small, simple projects, Word and Excel remain effective tools. But as product development grows more complex, teams need solutions that provide purposeful, structured team collaboration; connect globally-distributed team members; and accurately capture and facilitate feedback, decision making, and context for requirements under review. 

Increasingly, teams are augmented with many different types of players through contract manufactures or acquisitions or even strategic alliances. The benefits of team collaboration are rarely lost on industry leaders. Bringing together innovators to create a new way of doing things can revolutionize a sector, but without the correct support and infrastructure, collaborations often fail. 

Support Structured Collaboration with Modern Requirements Management   

Research conducted by Forrester Consulting on behalf of Jama Software identified five obstacles to optimized product development: 

  • Unclear or changing requirements coupled with lack of timely feedback for solutions 
  • Lack of focus caused by conflicting stakeholder priorities, assumptions, and unclear objectives 
  • Difficulty collaborating across globally distributed teams 
  • Unnecessary handoffs and delayed decisions 
  • Increased collaboration across diverse roles, including executives, operations, marketing, and quality assurance 

Companies with teams spread across the world, increasingly complex products, and expanding product lines require a centralized system to manage requirements. These teams must be able to trace requirements from concept through design and implementation. Plus, given the disparate locations for teams, ease of use around a shared solution is a critical factor. 

When it needed a collaborative software solution for managing requirements within its Border Management portfolio, SITA (Société Internationale de Télécommunications Aéronautiques), a multinational company providing IT and telecom services to the air transport industry, selected Jama Connect™ because their expanding portfolio of products brought added complexity.  

SITA makes a suite of products, and while individual releases can work on their own, they also must effortlessly integrate together. This, in turn, makes SITA’s products more complicated, and they grow even more so as customers request new customizations to fit their individual needs. “Keeping track of what customizations every customer uses on an already expanding portfolio was proving extremely complex,” says Alistair McBain, Sr. Business Consultant, SITA.  

[Jama Connect] has allowed us to get more people from our other offices involved in the collaboration process because we’re not all having to sit on a conference call at awkward times. People can come into the system at a time that suits them and review things. And we know their comments will be seen by everybody else.” 
Alistair McBain, Sr. Business Consultant, SITA 

Jama Connect provides SITA’s Border Management portfolio team with a centralized, accessible repository for all its requirements. As the team’s single source of truth, Jama Connect ensures everyone from business analysts to developers and testers — no matter where they are located in the world — are all working off the same set of current requirements.  

In an environment that introduces so much complexity into the product development process, a more strategic approach to team collaboration offers one of the best ways to address the challenges and obstacles of the modern product development landscape. 


Download the full eBook to learn how optimize team collaboration to streamline product development processes.

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jama connect for medical device development

Infographic: Jama Connect™ for Medical Device Development

We’re excited to share our latest infographic for the Jama Connect for Medical Device Development solution which explains how Jama Connect can help accelerate innovation, maintain product quality, and manage the ever-changing complex regulations in medical device development. This is a single powerful platform for medical device teams to manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.


RELATED: Your Guide to Selecting a Medical Device Development Platform


Bringing a medical device to market requires navigating a sea of complex and ever-changing regulations, not to mention bearing significant costs along the way. A device recall can cost $600 million, while the indirect costs of lost revenue and diminished market cap are even higher at $1-3 billion per company. Those costs are especially significant considering the price tag of product development—$75 million in FDA compliance alone, and an average timeline of three to seven years.

Jama Connect customers have been able to reduce planning time as much as 80%, thanks to consolidated feedback replacing emails and a document-based approach to project management.

Better quality products get out the door faster. By understanding the impact of change, capturing decisions and feedback in real-time and reusing existing IP, Jama Connect reduces medical device development time by an average of 130 days per project.

Jama Software reduces rework, which accounts for approximately 30-50% of a given project and arises from issues such as requirements errors. Improving the ability to track requirements from design through verification and validation ensures teams build the right medical devices with the lowest possible lifecycle costs.

In this infographic, we share how, with the right requirements management solution, you can accelerate the development of cost-effective products that also comply with both safety and quality standards.
You’ll learn: 
  • How to overcome the biggest challenges in medical device development 
  • The ways Jama Connect for Medical Device Development can help 
  • Keys to unlocking a better customer experience 

 

Editor’s Note:  In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we’re proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by Jama‘s VP of Customer Success, Clay Moore.

Medical device

How Effective Collaboration Can Expedite Medical Device Design

Medical device companies are committing significant resources to the fight against Covid-19. Collaboration tools can help expedite product design while supporting evolving compliance standards.

Weeks after the COVID-19 lockdown, medical device companies continue to face challenges as they manage remote engineering teams working rapidly to keep up with a changing environment. Now that the initial shock has passed, companies are becoming more well-versed in their new workplaces and identifying how to keep remote engineering teams working successfully.

Teams are under pressure to meet quality and compliance standards while staying on pace to hit delivery dates, and optimizing the efficiency of remote engineering teams as they develop complex devices can be difficult. Normally, products can undergo multi-month-long review cycles, which tie up valuable resources. Technology, when properly leveraged, can reduce that review cycle by as much as 75%—a vast improvement.1

Effectively streamlining collaboration is key to expedite design reviews and medical device product launches. The following is how companies can use collaborative technology to maximize output while meeting critical health standards.

Reduce Dependency on Documents

Medical device companies have been forced to come to terms with their current processes to see if they work for remote engineers. Most know that helpful technology exists, but platforms that promise to streamline lengthy processes can be intimidating. Companies that delayed digital adoption are especially disadvantaged.

The document-based requirements management approach often used by medical device companies limits visibility into the design process across teams. This makes it difficult to scale across multiple product lines and versions, especially with teams working remotely, and it increases expenses.

Collaborative requirements management software can help engineers easily communicate and smoothly define, review and validate information digitally to ensure projects are tracking and a clear path to compliance and launch is visible. Effective software reduces manual processes that limit innovation and add time to development.

Medical device companies should seek collaboration tools that help their engineers clearly communicate the path to launch, tasks and ownership, and current status and action items needed. Remote work on complex processes requires seamless communication and understanding where work is being bottlenecked so teams know how to direct their attention.

Stay On Top of Compliance

In the medical device industry, understanding current product regulations is key to shape the product development process. In recent weeks, the FDA has issued changes to its 510(k) program, and the European Parliament voted to delay the EU Medical Device Regulation.2,3 Companies who have a centralized approach and real-time access to requirements and design can minimize the added overhead of regulatory requirements, streamline development, and minimize risk.

When companies lack resources to efficiently locate regulatory standards and swiftly communicate them to engineers, they’re wasting time and limiting the ability to mitigate risk. Using traditional collaboration tools or Word documents to manage the product development process isn’t effective, leading to teams spending days or weeks to pull together documentation in preparation for an audit. Ensuring compliance requires context and visibility throughout the design process, and innovative tools that structure collaboration and put compliance and regulation at the forefront can provide both.

Good requirements management software uses a lifecycle approach to make sure compliance is integrated into the design process. Team members are held accountable, and workstreams keep track of when signoffs occurred.

Getting compliance right can be a challenge with engineers working remotely—but it is too important and too costly to get wrong. It can cost $600 million to recall a product.4

Remote Collaboration Sets Medical Device Companies Up for Success

Companies forced to embark on their digital transformation journey during this pandemic can save valuable time and money on product launches by embracing requirements management software to help streamline communication, structure collaboration, and ensure compliance.

This level of collaboration is more prevalent than ever, especially considering the state of work may change as we know it. In fact, a Gartner, Inc. survey revealed that 74% of CFOs and finance leaders will move at least five percent of their previously on-site workforce to permanently remote positions post-pandemic.5 Engineering teams need to make remote collaboration an effective part of their normal operating routines, starting now.

By embracing the right technologies, medical device companies are not only investing in supporting their teams at this crucial time but also they are investing in the success of taking products to market, as the world conducts more and more business online.

References
  1. Case Study: Healthcare Leader Grifols Uses Jama Connect to Cut Costs and Speed Development”. (June 2019). Jama Software.
  2. FDA Relaxes Rules on Ventilators for COVID-19”. (April 2020). The Regulation Review.
  3. EU MDR: Parliament Overwhelmingly Backs One-Year Delay”. Regulatory Affairs Professionals Society.
  4. The Business Case for Medical Device Quality”. (October 2013). McKinsey & Company.
  5. Gartner CFO Survey Reveals 74% Intend to Shift Some Employees to Remote Work Permanently” Gartner, April 2020

Take a look at some of our other resources around collaboration that we’ve compiled for easy review here:
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