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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.


requirements traceability

Requirements Traceability – What are you missing? 

For systems engineers, business analysts, and product owners, requirements traceability (the ability to trace requirements to downstream development, test, verification, validation, and risk activities) is an unquestioned good and an unquestioned need. Traceability is required to demonstrate compliance to relevant standards in industries such as medical device, automotive, semiconductor, aerospace, and financial services. In addition to compliance requirements, traceability is quite helpful to assess the impact of change required on all relevant requirements and related downstream activities. But the largest potential value is missed by many organizations. 

After-the fact use cases 

The two main use cases for traceability noted above are both reactive to requests: the need to demonstrate standards compliance to third parties and the need to analyze the impact of a change request. Both use cases view requirements as static and passive. Requirements are documented and links created to downstream artifacts in software, hardware, and electrical development test and risk assessment — which are stored in a system. The system then waits until a request comes in from outside to document that a process has been followed or to identify which elements are impacted by a change. Both use cases reflect an after-the-fact mindset that limits the value that can be achieved from the effort put into establishing traceability. 

Analogies to other business-critical functions 

To view something we think we know well in a new light, it is often helpful to place it in a different context and look at it from a fresh perspective. So, let’s give it a try and compare traceability in the product development process to traceability in the new customer acquisition process.  

For engineers, these processes may at first appear to be too disparate for an apt analogy, but at a fundamental level, they are quite similar. Both start with a documented value (requirement vs. opportunity) that must transition through multiple phases and involve many other functions to reach the desired outcome (release vs. win) — and all sorts of things can go wrong along the way leading to delays, costs incurred, and failure. 

The aspect I want to focus on is how these two processes are managed. In the sales process, the element of value (the opportunity) is living — actively measured, analyzed, and tracked for exceptions on a daily basis. The key process metrics are defined with ranges for acceptable performance. Current process performance is automatically calculated based on the movement through stages of all opportunities. Alerts are raised for opportunities stuck in a process stage too long (relative to average dwell times) and predictions are made about future period performance based on the opportunities in the system.   

RELATED POST: Requirements Management – Living NOT Static

In contrast, for most product development organizations, requirement traceability is static and in after-the-fact analysis and not living — in the way opportunities are traced in sales as described above. To make requirement traceability living (like a sales opportunity) traceability would require software-enabled best practices in the following areas:  

  • Process metrics must be defined 
  • Actual performance against process metrics must be captured 
  • Once standard metric performance is defined, current performance must be compared to the standard 
  • Exceptions need to be defined 
  • Alerts need to be set up to notify when exceptions occur 
  • Learnings need to be incorporated into process improvement 

Once these steps are taken to improve requirements traceability, then requirements become living, not static, and performance improvement is possible: the risk of negative product outcomes is reduced, and process performance is improved; the product development process can then be data-driven, measured, and managed like all other business-critical processes. Without measurement, there is no way to benchmark performance against other organizations. There is no way to learn, no way to know, and no way to improve. 

Better to stay in the dark? 

There may be some that would prefer to keep the product development process shrouded in mystery and avoid data-driven analysis, measurement, and process performance improvement. There used to be chief revenue officers (CROs) that felt the same way. It is extremely hard to find any current CROs with that mindset. Those that can lead through data and drive performance improvements gain the support of leadership and elevate their careers. The same opportunity is now on the table for product leadership to turn requirements traceability into living requirements in order to reduce the risk of negative product outcomes and improve the performance of the end-to-end product development process. 

  To learn more on the topic of requirements traceability, we’ve curated some of our best resources for you here.

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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. 

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: 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.

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.

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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: How to Perform Better Impact Analysis on Upstream and Downstream Relationships

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.

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

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Impact AnalysisImpact analysis is the assessment of the implications of changes, in the specific context of product development. It is integral to requirements management, as it offers insights into dependencies and gaps in coverage, which help inform decisions about the product’s lifecycle.

Let’s say an organization is developing a medical device and must change some of its requirements along the way – something that happens all the time. By conducting an impact analysis of this requirement and its dependencies, the product development team could accomplish all of the following:

  • Determine the ripple effects of the change: How will it affect higher-level requirements upstream and links downstream? Are there are any conflicts to resolve? Proper impact analysis answers these questions and in turn reduces the risk of unexpected consequences requiring costly remediation later on in the lifecycle.
  • Connect people, not just requirements: The impact analysis process should go beyond flagging at-risk upstream and downstream items. It should also reveal who is affected by changes, plus notify those team members about the necessary next steps. This is where live traceability and real-time collaboration in one platform really matter.
  • Assess what is required going forward: Impact analysis is ultimately about gaining visibility into the future – almost like a crystal ball – and acting accordingly. In addition to showing potential risks to existing requirements, it can also identify new requirements and test cases that may be needed for keeping the project on track.

Teams may perform impact analysis using multiple tools. A dedicated requirements management platform, with integrated risk management and end-to-end traceability, is ideal for fully mapping out the effects of changes and identifying subsequent action items, along with the personnel responsible for them.  When manual tools are used, data gets kept in silos which can create misalignment, poor visibility, and difficulty to assess the impact of change.

Replacing those manual workflows, which often revolve around software like Microsoft Word and Excel, is crucial for optimizing impact analysis. That’s because informed analysis requires accurate traceability, something made much easier with a proactive and automated platform that serves as a single source of truth at every stage of product development. In this way, requirements management software addresses the biggest roadblocks to effective impact analysis.

Overcoming the Obstacles en Route to Better Impact Analysis

From the rapid pace of innovation in industries like medical device development and automotive manufacturing, to the need to coordinate increasingly distributed and remote engineering teams, there is no shortage of possible challenges when building a complex, modern product. When it comes to impact analysis in particular, the three primary issues include:

1. Manual Traceability

Impact analysis isn’t possible without effective traceability. But with so many evolving requirements to keep track of, accurately tracing everything can be difficult without truly scalable and automated tools.

To see why, consider a hypothetical case in which a critical requirement needs an immediate change. The time constraints mean all upstream and downstream effects must be quickly accounted for, with requirements and other artifacts (like test cases) properly traced forward and/or backward as needed.

But doing so is difficult when working with nothing more than a traditional traceability matrix  housed in Excel or Word. The amount of manual work required could result in something being missed due to human error and a lack of comprehensive traceability within the matrix itself. The team might not realize they’ve overlooked missing coverage until it’s too late.

Solution: Live traceability provides straightforward navigation of upstream and downstream relationships, along with automatic identification of risky links. It also updates items in real time so that team members are always looking at the most accurate assessment of test coverage.

2. Inefficient Modes of Collaboration

Email-oriented collaboration only compounds the above problem. When lengthy, complex documents – which might not even be up to date – are emailed between teams, confusion, and delay are almost inevitable.

Simply staying current with any changes to project requirements can mean searching through your crowded inbox and trying to reconcile various attachments. Is “RequirementsDoc_v2FINAL” really the final version, or is there something more recent circulating under a different name?

In order to effectively conduct impact analysis, everyone tied to the requirements needs to be notified in real-time when changes are made and provide their input. Centralizing this information creates a more systematic way for change management and enables accountability within the organization on how decisions are made past and present.

Solution: Instead of email, use a real-time platform with instant notifications and the ability to pull in internal and external collaborators as needed. On such a platform, everyone is looking at the same data, which helps expedite review and approvals.

3. Rework and Opportunity Costs

Impact analysis is supposed to reduce risk by letting you see how specific changes will play out and empowering you to take any corrective action as early as possible. But when impact analysis is built upon manual processes and limited traceability, it can do the opposite and actually make projects riskier.

For example, extensive rework may be required to ensure that all requirements are met. This work represents a major opportunity cost, as the time sunk into correcting process-related problems could have gone into more strategic initiatives.

However, teams can avoid getting bogged down in rework by upgrading their impact analysis and traceability tools. Leaving static documents behind for an automated platform with real-time collaboration built-in is both reliable and helps to ensure product quality.

Solution: Invest in a platform that enables proactive, rather than reactive, requirements management. Features like live traceability that connect requirements to tests make it easier to handle changes as they happen and avoid costlier actions later on.

Fueling the Engine for Superior Impact Analysis

A modern requirements management platform enables streamlined impact analysis while bringing teams closer together to work in real-time, even if they’re physically distributed. As a result, analyzing upstream and downstream relationships becomes more practical, as does the overall development of high-quality products within budget and on time.

More specifically, the right solution will be an engine for better impact analysis, propelling key advantages throughout product development, including:

  • Automatic identification of suspect links: If a requirement is modified, the platform will automatically flag its downstream links as “suspect” so that team members can review them before proceeding with development.
  • Easier relationship navigation: Users can efficiently navigate upstream and downstream relationships. A visual schematic lets team members save time in finding missing coverage and make sure that they’re not overlooking anything.
  • Enhanced collaboration: Team members get notified about relevant changes and can be pulled in right away to respond, on a shared platform offering a single source of truth. This real-time setup is much more efficient than relying on email alone.
Want to learn more about how Jama Connect can improve your impact analysis? Set up a free trial today to get started.

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Remote Workforce

Editor’s Note: This post on ways traceability has changed to support the remote workforce was originally published here on DevOps.com on June 24th, 2020, and was written by Josh Turpen, Chief Product Officer at Jama Software.

Traceability has always been a useful tool in the development process, but it has become especially important since the COVID-19 outbreak and the increased remote workforce.

Where developers and engineers were once working side-by-side, with the ability to discuss their process and keep their team informed, they are now navigating a remote collaboration landscape. According to a 2017 study done by Stack Overflow, there is a correlation for developers between remote work and job satisfaction, and the highest job satisfaction ratings are seen from developers who work remote full time. As technology has grown to make this process easier, remote working is expected to become a norm.

Advanced traceability has the potential to hold teams together by allowing increased visibility into each move throughout an entire project. Without traceability, it would be nearly impossible to keep remote teams aligned and on schedule.

Product development tools have continuously been forced to evolve to keep up with the multi-dimensional nature of requirement, test and risk management. For these processes to be successful, all related variables must work together continuously, at scale, and across teams.

We’ve only just started to see how traceability tools can use updated capabilities to streamline the product development process, but we know enough to discuss two things: what’s happening now and what the future may hold.

Traditionally, traceability could be compared to a map. While not limited to a single view, maps exist to help you navigate your way to a destination. Similarly, traceability leads product developers through every step of their processes, eventually helping them reach their goal. If your map was constantly changing you’d never be able to figure out where you were going, but what if people ahead of you could update it as they went along? This would keep you in the loop of the upcoming twists and turns, and no one would feel blindsided. Traceability makes it easy to share similar production changes with your entire team, all at once.

In the traceability process, links are built automatically which lets major decision points, reviews and approvals be captured in final documents and reports. This allows for faster and more informed decision making and these live references can exist across versions.

With the switch to remote work across the globe, and no immediate end in sight, developers don’t have the option of working side-by-side with their colleagues. Because of this, it is pertinent that they are able to streamline their work in every way possible, and increased traceability is expected to be a pillar of that transition.

At the end of the day, connecting the dots is all about making sense of everyone’s decisions. Why did they follow that process, and what factors led them to make the choices they made?

In the early days of traceability there wasn’t always room to include every piece of information that you might find relevant down the line. Legacy tools such as the act of manual reporting through Word documents left much to be desired. Today, that’s becoming less of an issue, as developers are allowed more meaningful accountability and insight into interconnections as they happen.

As we look ahead, we can expect to see these capabilities grow in five different ways.

Less Manual Effort

Updating your traceability reports with as little manual effort as possible will be essential to a streamlined, remote workforce. As traceability becomes more advanced, the work to create and maintain it should not become more difficult.

More Nuance Captured, Related and Parsed for Meaning

Improvements in software will make data gathering more precise, and increase the number of items a team can consider relevant, traceable information. This will take additional workloads off of the developers as more items are automatically traced and easily accessible.

More Attributes Can Define and Predict a Project’s Success

If you have a more data-rich, detailed record of activities, it is possible to understand the past with more context and less reliance on costly manual documentation or memory.

Dispersed Systems Holding Relevant Information Will Start to Feel Closer and More Interconnected

Through more dense integration and aligned processes, systems feel more controlled and connected, giving users a more seamless experience.

Expansion of Communication and Review Capabilities for Stakeholders Who May Be Impacted by Changes

The availability of a full audit trail of participation will make a big difference in the ease of the review process. The ability to easily see who is impacted by changes will allow teams to proactively manage the effects of said changes.

In response to the COVID-19 pandemic, and the number of companies who are maintaining their remote work policies, we can expect to see more innovations related to product development workflows. These innovations will enable easier remote collaboration between colleagues and across teams, overall streamlining the product development process.

Want more best practices and tips? Watch a recording of our webinar, “Ask Jama: Best Practices for Remote Collaboration with Jama Connect.”

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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

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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

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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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Product Development Lifecycle Management

Product development lifecycle management is the handling of the entire lifecycle of a product, from its earliest stages of concept development to its eventual production and use in the market. Effective strategy and execution across the lifecycle requires preserving quality while working within constraints on cost and time. A key component to successful product development is managing your requirements from start to finish within a system that allows for complete traceability and collaboration throughout the development process. A requirements management solution that enables live traceability, real-time collaboration, flexible development methodologies and hierarchical organization will ultimately lead to an improved product development lifecycle.

The Importance of Live Traceability

From the early stages of a product’s development all the way through its go-to-market execution, product development teams need to understand how their different requirements and tests are traced to each other throughout the process, in order to effectively manage compliance, track changes, and ensure product quality. The right solution should enable visibility across the product development lifecycle, so that team members can:

  • See the impact of change before it happens and adjust as needed
  • Automatically trace your requirements as you create content, reducing non-value time
  • Keep track of test coverage one convenient place
  • Automatically have guardrails that alert you to any gaps in your product development
  • Easily view and navigate upstream and downstream relationships
  • Create a clear audit trail to support the development of complex, safety-driven products
  • Export your trace matrices easily to help with proof of compliance

So how do these types of features work in practice? Let’s examine how live traceability functions in specific ways within Jama Connect.

Navigating Change Management and Impact Analysis

Too often data in complex product development remains in siloes, creating misalignment, lack of visibility, and difficulty to assess the impact of change. With objects traced in Jama Connect, you have the ability to perform an impact analysis which enables you to review the impact of each change to a new or existing product before it’s actually made. Changes happen to requirements and other artifacts all the time, which is why it’s important to be able to create baselines.

Additionally, the platform can reactively and automatically mark items as “suspect” when they are downstream from a modified item. Teams can then review a running listing of items needing further evaluation that may need to be evaluated for impact.

Relationship rules also enable you to track items within the same project or across multiple projects, using a visual schematic for representing the different artifacts traced throughout your development process.

Jama Connect can take a snapshot that documents the detailed status of a project, or any subset of a project, at a designated point in time, also allowing you to maintain meaningful comparison and overall traceability.

Multiple versions of a product requirement can also be compared, side-by-side, to see what changed. Through such visualization, teams can easily see how requirements have iterated over time and what led to those changes.

Diving into Test Management and Traceability

QA teams need the power to trace test results back to their corresponding requirements. In Jama Connect, these teams can perform manual testing, create and organize test plans with groups of test cases, dashboards, and view test-related reports throughout the product development process. They can also:

  • Organize testing information to support an iterative verification process
  • Identify missing test coverage and take action to close gaps
  • Reuse validated requirements saving time when testing across multiple product versions or variants.
  • View real-time, consolidated data about test plans, associated test cycles, cases, and test runs to-date
  • Perform all of these actions from the same interface

The end result is reduced risk throughout the product development lifecycle, along with increased product quality. For example, the ability to log failures and defects allows for the creation of trace relationships that make it easier to resolve the issue in question.

Meanwhile, out of the box reports and dashboards provide straightforward visualizations of the progress of the test management process, including how tests trace back to their requirements. That helps simplify industry compliance, as it is easy to show auditors  the connections between requirements and tests along with associated results.

RELATED: Five Tips for Requirements Traceability

Adding Power Through Integrations

An RM, test, and risk platform ensures that no project-related stone is left unturned, not only through the test management capabilities above, but also through wide-reaching integrations.

In Jama Connect, you can integrate with industry leading solutions providing a flexible, scalable solution when automated testing is necessary in the product development lifecycle. Pull in automated test results from other sources using Jama Connect’s integrations with popular solutions such as Tricentis: qTest, LDRA, Vector, Testrail, and ANSYS, as well as its Open REST API.

The Role of Real-Time Collaboration

The product development lifecycle requires collaboration between multiple stakeholders and teams, along with the efficient capture of stakeholder feedback and other standardized data during the requirements review and approval processes. Teams must be able to share, confirm, and iterate on product requirements and specifications, determine acceptance criteria, and coordinate engineering responses in real time, including prioritization capturing electronic signatures for approvals – ideally from a common place.

In reality, real-time collaboration is hindered by disjointed processes and discrete documents.

Review Center within Jama Connect provides a streamlined alternative, allowing you to gather and incorporate feedback from the relevant project stakeholders, track a review’s overall progress and view team statistics to determine which requirements have the most issues to address.

Managing Approvals and Electronic Signatures

Reviewers can join in conversations and mark items as “Approved” or “Needs More Work.” Use electronic signatures to demarcate the different stages of the product development process, establish roles between “Reviewers” and “Approvers” and export approved reviews to more effectively prove compliance. Each signature captures the time and date for auditing purposes, making it very straightforward to tie them back to their corresponding individuals or stakeholders.

Effective collaboration and engagement throughout the product development lifecycle has numerous benefits. With the right platform and setup, you can shorten milestone phases and development cycles, help teams better identify risks and opportunities and improve overall time to market.

RELATED: Streamlining Requirements Reviews: Best Practices for Moderators, Reviewers, and Approvers

Stream Discussions and Assign Responsibility

Jama Connect allows you to stream discussions bringing both internal and external stakeholders into the conversation easily without needing to navigate deep into the requirements management platform. A conversation can be easily expanded to encompass the necessary users and stakeholders and communicate key actions items to them. A user can respond to a conversation without even accessing the application proper, allowing them to add to a threaded and contextual exchange with ease.

Along similar lines, Jama Connect helps you see who authored, edited, commented on, or was mentioned in any given item. These details allow for quicker, more targeted action, for instance if a requirement changed and needs to be updated right away. The responsible parties, whether a developer or QA lead, can be notified and supplied with the relevant context.

Reusing Requirements to Save Time and Increase Consistency

Products often share requirements, so why not reuse them once approved? Efficient reuse requires the right platform for cataloging all the specific requirements in question and keeping them in sync across the organization.

Traditional document-based product development lifecycle management is an obstacle to reuse. Adding in a modern platform is a good step toward greater consistency in how you reuse your requirements and in turn shorten time-to-market by eliminating rework and manual processes.

To learn more on the topic of requirements management, we’ve curated some of our best resources for you here.

 SEE MORE RESOURCES

This post is the first in a three-part series on traceability. Keep an eye out for the second two posts on how requirements traceability will be different in the 2020s, and lessons learned from 2010s Agile product development.

There are new software capabilities being developed every day keeping us dazzled with trend-driven analytics and massive data analysis. At the end of the day though, it’s humans that are still accountable for the product development decisions being made with or without cutting-edge analysis tools. Even with the advancement of automated analytics, decision-makers must still demand good information so they can truly own their choices in complex product development.

Making good decisions depends on the ability to see comprehensible information as change happens in real time, both within your team and throughout the system your product exists in. That’s where modern traceability comes in – it makes it possible to manage and respond to change in a systematic, auditable, confidence-enhancing way.

Rather than trying to prevent change (still impossible with our current technology for now…), here are three ways traceability has evolved to support the dynamic job of decision makers.

Evolution 1: Modern traceability can capture when you actually make a decision, in multiple formats from both formal and informal situations.

Decisions have varying levels of durability, and it’s not always obvious at the time what that level is. Sometimes you know at the time you’re making a final, consequential decision. Other times you make what you think is a temporary choice and you’re living with it 5-10+ years later. Given that uncertainty, having mechanisms to see when decisions are made (throughout the development process) is essential when products are expected to be maintained for years. We may need to move on quickly in the development process, but the record can live on for future context.

In Action: Formal decision processes such as gate reviews can be managed in tools like Jama Connect™ Review Center, making it easier to mark versions of requirements as signed-off and complete. Decisions that arise from less formal activities like comment threads on requirements can be tagged and referenced later to piece together thinking from the past.

Electronically sign-off on formal reviews using Jama Connect Review Center.

“Catching these traceability gaps would’ve probably taken hours or days in our old system, while with Jama, it became obvious in a matter of minutes.” Read how Jama Connect improved Össur’s traceability process.

Evolution 2: Modern traceability connects people to the context of what they’re working on as they go – not just globally or in a matrix after the fact.

Traceability gives people a (specific) reason to care when asking for input. It helps everyone know why they’re there. Rather than rely on sharing lengthy Word documents or running general meetings, precise outreach is possible with precise mapping of work items (including their owners and contributors) to each other.

In Action: Figure out who to direct questions to or notify by looking at interconnected people, not just the work items. This list can be automatically generated with Jama Connect’s connected users feature – so knowing who to contact won’t slow anyone down from having timely conversations.

See who’s related to each item with connected users.

 

Evolution 3: Traceability can show past decisions, because they’ve been captured all along.

Can you follow any thread of a question or item to how it got there and why? Knowing who made a decision, and what information *they* had access to is as important as the information itself. Your traceability is incomplete if you can’t piece that together. The faster the better. The responsible thing to do: Make the task of keeping useful records low friction. It doesn’t need to be forced behavior if it’s captured along the way as a biproduct of doing your job.

In Action: Building technical requirements directly from primary source materials, like high level market requirements, has multiple benefits. It simplifies the authoring process by having the downstream requirements writing right next to the source materials, so the translation step is that much easier. It also ensures that when something changes downstream, features like Jama Connect’s suspect links can show where those changes impact other work in real time – no need to wait for an event to reconcile the original goals with what was built.

View the context of how decisions were made with commenting in single-item view.

Traceability can be used to support more genuine accountability. Without robust, modern traceability tools accountability is incomplete — past decisions can’t easily be seen, learned from, or built upon when new choices are made. It’s much harder to legitimately hold someone accountable when they’re working in the dark.

To go deeper on the topic of traceability, and how Jama Connect helps fast track the process, check out our eBook, “The Jama Software Guide to Requirements Traceability.”

Ossur uses Jama for Medical Device Development

In medical device development, control of quality and risk is heavily driven by regulatory requirements. Compliance with international medical device standards like ISO 13485 and ISO 14971 can drain resources and reduce operational agility if the means of demonstrating compliance are not agile themselves.

The more complex the project, the higher the risk. And the higher the risk, the more stringent the medical device compliance procedures. Managing hundreds of requirements in a document-based system without traceability becomes a major chore.

Össur, a global leader in non-invasive orthopedics, had for several years been relying on an internally developed document-based process to manage its product requirements. While their system had been working as intended, they felt there was an opportunity to streamline procedures and compliance tasks.

Read our eBook to learn more about risk management for Class II and Class III medical device development.

The Costs of a Rigid Requirements System in Medical Device Development

Continually evolving its processes has always been a key to success for Össur, whose cutting-edge prosthetics technologies have been showcased in publications like Popular Science and have been worn in competition in the Olympic Games. They examined their development cycle for inefficiencies and noted their requirements process unfolded in a sequential manner that was costing them an enormous amount of time and effort.

In specifying a highly complex Össur medical device, several engineers would collaborate on drafting requirements and compiling the requirements document. The document would then be circulated for review. Once approved, the requirements would be verified. If any requirement needed to be added or changed, however, the entire review and approval cycle had to be repeated.

“Our old system was very rigid,” said David Langlois, Director of R&D for Bionic Solutions at Össur. “The minimum effort was always quite high, which means the overhead was also high.”

Össur knew it was time for a change. They wanted something that was as close to a turn-key solution as possible — one that would provide traceability and dynamic content management, and would be scalable across their organization. Plus, it needed to be capable of handling the complete development chain — from requirements through verification and validation, along with easing the path to compliance to ISO standards like ISO 13485 and ISO 14971 — for a diverse product line.

After evaluating several alternatives, including some designed specifically for medical device development, Össur chose Jama Connect™.

 Learn more about how Jama Connect helps teams improve medical device development.

Replacing Process Rigidity with Speed and Agility

Össur began using Jama Connect in 2018, starting with a small group of developers working on bionic lower-limb prosthetics. They immediately began seeing dramatic improvements in their process, especially in the areas of traceability, impact analysis, and test management.

As soon as they began importing their data into Jama Connect, Össur’s engineers saw they had traceability gaps. “Catching these gaps would probably have taken hours or days in our old system,” says Langlois. “With Jama, it became obvious in a matter of minutes.”

With Jama Connect’s impact analysis, teams can quickly gain an accurate understanding of the implications of a proposed change. So, in turn, they can make better informed business decisions. “That brings a lot of value when you’re trying to run a review, and you want to know whether you have gaps in your test coverage,” says Langlois. “With Jama, it’s a five-minute question instead of one that takes hours.”

In addition, Össur feels Jama Connect’s test coverage and built-in metrics are making its testing process far more predictable and efficient. “One thing that’s very powerful about Jama Connect is that, after a few test runs, you can actually quantify pretty accurately what sort of effort is required,” Langlois says. “Jama provides all these metrics that allow you to identify where your bottlenecks are, giving you a better understanding of where the time is going and where you’re losing money.”

Leveraging Jama Connect’s Flexibility for a Faster, More Flexible Future

As Össur branches Jama out into other areas of its organization, it plans to allow individual teams to configure Jama Connect in a way that best suits how they work. And Össur is already thinking about ways to integrate with some of the other solutions it’s currently using.

“As a software developer, I think Jama Connect’s integration with Jira is going to be very useful for me,” says Matthías Kristjánsson, Product Lead Designer at Össur. “Today, we actually make duplicates of our requirements into the Jira system. Being able to connect them straight to Jama and remove that step — so they’re directly connected to a requirement or specification — will be valuable.”

Read the full case study to learn more about how Össur is using Jama Connect to grow more agile and efficient and assure compliance with relevant regulatory standards.

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