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As medical device developers compete to push the boundaries on designing and building innovative, connected medical devices, the market continues to boom. It doesn’t look to be slowing down anytime soon, either. KPMG estimates that global annual sales of medical devices will rise by over 5 percent a year to reach nearly $800 billion by 2030.

Modern medical device makers are hyper focused on building innovative, connected solutions for the next generation of care. That continued innovation opens the door for new, lower cost technologies for early intervention and at-home care. But it also opens the door for more risk.

In the past, medical device software was generally used to control programs to simply switch the equipment on and off and display readings. Today, software and its functions dominate much of the features, making devices far more integrated, complex, and connected-and growing more so every year.

Growing Concern for the Security of Connected Medical Devices

While smart devices provide opportunities for instantaneous results and early medical intervention, connected medical devices are also more vulnerable to both deliberate attacks and undirected malware.

A survey released in October 2018 of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18 percent of provider organizations had connected medical devices impacted by malware or ransomware in the last 18 months.

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

Read this case study to see how RBC Medical Innovations leveraged Jama Connect to unify processes and enhance traceability.

Modernizing Requirements Management to Reduce Risk

The reliance on connected medical devices isn’t going to ebb, and the increased complexity will only make the management and reporting of interconnected information across product definition and verification more difficult and inefficient. This inefficiency is only exacerbated by the use of document-based requirements management, which introduces more risk into the process.

To achieve better results with projects of mounting complexity, teams must get a stronger handle on their process and avoid gaps in development. A better solution for requirements traceability can do just that.

Traceability, normally a sub-discipline of requirements management, ensures that engineering design aligns with the identified needs of users and patients; manages scope by ensuring alignment between engineering work and actual user needs; confirms that device needs are addressed at all levels through gap analysis; and connects the design of the device directly to the verification.

Requirements Traceability is No Longer Optional

Small teams building simple products may be able to get by initially with spreadsheets, documents, and emails, but with the rise of software-driven, connected medical devices and increasing system complexity, requirements traceability quickly becomes too convoluted to be handled manually.

The reality is that the more complicated or distributed the product development process becomes, the more opportunities for error are introduced. Excel just can’t account for the wide array of risks and requirements involved in medical device development.

In fact, according to Stericycle’s Recall Index, software issues were consistently one of the top causes of medical device recalls through 2017 and 2018.

Learn how Jama can help you better manage risk with ISO 14971 by downloading our white paper.

Today’s medical devices are so much more than metal and plastic – they’re incredibly complex, connected devices that require complete hardware and software traceability.

Medical device development contains too many scope changes, remote team members and reviewers, and requirements to be easily managed in documents and emails. Using Excel or an internally developed requirements management solution or system diverts scarce resources and availability away from the important tasks of product development. Instead, team members have to focus on attempting to assemble and maintain traceability, usually resulting in the trace being hastily thrown together in the end for the design history file (DHF).

Traceability increases efficiency, drives alignment, and mitigates organizational risk. And with Jama Connect, teams can link and decompose high-level requirements to more detailed system and sub-system requirements, including associated risks and hazards, to ensure proper verification and validation before release.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.

If you’re responsible for the requirements traceability of your complex product, do any of these scenarios sound familiar?

Scenario One: You just heard that a critical business requirement needs to change and be accounted for in the upcoming release. You need to know how this change will impact work downstream and how the system specification your engineers are working with will change. Immediately.

Scenario Two: Your QA team just found a critical bug in your most anticipated new feature and you’re two weeks away from launch. Do you ship with the known bug and hope to patch it later, or delay the launch? Will this impact your upcoming audit? You need to know who is working on this feature, who else needs to be notified and weigh in on the decision and know what other aspects of the product may be impacted. Immediately.

These scenarios, and countless others like them, affect engineering teams every day. And as software, embedded systems and external sensors contribute to product complexity (not to mention the complications that arise when you’re trying to unify multiple teams that contribute to a product) there is no chance that manual processes and static documentation can scale to support accurate impact analysis and quick decision-making. Requirements may be recorded, but if they’re not in a system of action, in situations like those above, you cannot effectively manage.

Gartner highlights one of the main reasons why companies struggle to achieve the benefits of traceability:

“The most widely adopted tools for requirements continue to be general document software such as Microsoft Office or Google Docs (40% to 50% of the market) due to cost, availability and familiarity. Yet these often lead to poorly managed requirements, thus eliminating and exceeding any cost benefit the tools themselves have. Requirements end up captured in a variety of documents and spreadsheets supplemented by post-it notes in unmanaged versions with no traceability or reuse. This creates a more costly user acceptance testing cycle, both in the time to execute as well as remediation of issues found late in the process, where they are far more costly to address.”

Read more about the Gartner Market Guide for Software Requirements Definition and Management Solutions.

Software and hardware teams must work together in tight collaboration throughout the development process to define market requirements, functional requirements, test cases and other artifacts that define the scope of what you’re building are related in some fashion, either directly or indirectly. This becomes difficult when the teams use different tools and terminology, and work in different cadences with difference methodologies.

Adopting these four best practices around modern requirements management and requirements traceability will help your team ensure product quality, decrease time-to-market, and achieve regulatory compliance.

Four Best Practices for Requirements Traceability

1. Connect stakeholders and contributors to the requirements they care about to ensure the right people can weigh in on important decisions at the right time.

Traceable relationships are as much about connecting the people as they are about connecting the requirements themselves. Each requirement in the system has members of the team associated with it — analysts, architects, development, verification and quality assurance among them — and stakeholders and customers who care about its status. With connected relationships built into your project you can quickly get interested parties involved in decision making.

2. Automate bi-directional requirements traceability to minimize risk and ensure quality.

Manually updating an old-style traceability matrix is not only cumbersome and time consuming, it leaves open the risk for human error. In the development of safety-critical products like medical devices and airplanes, this risk isn’t acceptable. And it’s difficult to prove to an auditor that you got it right.

Key to managing requirements traceability is the ability to view source requirements and their related items downstream to lower-level requirements and then back to the source, and know the status of those items at each step of the product development process. Because this data may be stored in multiple systems, it’s key to be able to connect tools via open APIs and automatically pull data into a single actionable system with visualized coverage of these trace relationships.

Learn more about the limitations of a document-based requirements management approach, and how to get the most out of your requirements management by downloading our whitepaper.

3. Connect data, conversations, and decisions in a single system in the product development process.

Being able to visualize coverage of trace relationships is imperative. But what happens when you find a gap, or a test is failing? The ability to confer and collaborate with the people connected to the requirement right in the system allows you to capture decisions and actions and keep that information associated with the requirement. Down the road, if you need to revisit decisions, all data is stored and easy to find.

With this information managers can, for example, verify that their requirements are connected to downstream test cases and see what percentage of those tests have passed. In a system of action, every test case has a comment and activity stream accessible to all users. Testers and contributors can capture decisions, answer questions, and resolve issues transparently and responsively.

4. Conduct formal reviews in compliance with internal controls or industry regulations with built-in reporting.

In the case of proving compliance with a set of rules and regulations, you need to show your requirements, their traceable connections to test plans, and verification that all test have passed. Using a requirements management solution that has built-in formal reviews and reporting for auditors makes this process less cumbersome and more reliable.

Teams facing increasing complexity and pressure to comply with industry regulations must be able to search, track, and connect interdependent requirements. Achieving a faster time to market demands that teams collaborate quickly and effectively while they work on traceable requirements.

To learn more about traceability best practices, download our whitepaper, “Better Product Development: 5 Tips for Traceability”

When our customers move from managing requirements in isolated documents to using a collaborative requirements management solution, they’re better-equipped to conduct impact analysis and ensure full test coverage and traceability throughout the development process.

Managing complex requirements necessitates that information be visible and accessible to all team members at all times. You also have to make sure that all this information is connected in a way that is relevant and comprehensible to your teams. This helps ensure that you’re building what you set out to build, that it fulfills your customers’ expectations, and that it’s safe and compliant.

In order to get a full picture of what’s been built and if it’s on track, it’s crucial to build connections between data, as well as to map the conversations and decisions associated with each requirement.

In this post, we’ll explore how some of our customers have realized these results using Jama Connect™.

Traceability is Essential to Requirements Management

With everything you’re managing day-to-day, the last thing you need is a tool that takes just as much time and effort to learn and use as writing and managing the requirements themselves. A requirements management solution should make your life easier, and it should be easy to roll out to your team. Moreover, the solution should help you step back and look at your entire product or system as it’s being built, see all of the connections, and easily identify where work is needed.

Our Jama Professional Services consultants often hear from customers facing the inherent challenges of complex systems that establishing and managing traceability in Jama Connect is much easier than in any other solution they’ve tried.

Here are five ways to create relationships, account for full test coverage, and manage traceability throughout the development process in Jama Connect

1. Build a framework for properly linking artifacts with relationship rules

Creating meaningful connections between artifacts is vital to having that all-important big picture view. With relationship rules, you specify the proper relationships and how to implement them, while also freeing up your team’s time to focus on building and managing requirements.

2. Find out who is connected to an item and easily communicate with connected users in the Collaboration Stream

Let’s say you notice that something is wrong with the way a requirement is written, and it needs to be adjusted. Jama makes it easy to identify not only everyone who is involved with that requirement, but also everyone involved with impacted requirements. Using the Collaboration Stream, you can quickly post the issue for these connected users, who then receive a notification and can respond quickly —without anyone needing to book a conference room.

3. Determine gaps in your test coverage quickly and easily with Trace View

A critical piece of assuring quality is being able to see where gaps lie in your test coverage. Jama Connect’s Trace View identifies those gaps by leveraging the relationships your team has created to give you a holistic view of where work is still needed.

4. Identify high-level impact across your project using suspect links

If a system-level requirement changes, it could dramatically impact the quality of your product. By using the suspect links feature in Jama Connect, you can see at a glance what other items are impacted by changes and quickly assess whether additional changes need to be made downstream.

5. Understand how product features are connected or share IP using Reuse and Sync

Complex systems make for complicated connections between individual systems and products. Jama Connect allows you to share crucial pieces of information across product lines, compare these connections at a glance, and align them with the click of a button using the Reuse and Sync feature.

Managing traceability in complex product and systems development is challenging, but it’s essential for ensuring product quality, on-time and on-budget delivery, and alignment between customer expectations and the final deliverable. That’s why you need the right product development platform to help you achieve traceability and reap the benefits.

For more strategies for establishing traceability in product development, download the whitepaper “Better Product Development: 5 Tips for Traceability.”

The popularity of Agile methodology, along with the increasing trend toward automation in software development, has pushed requirements management solutions to evolve. The misconception that Agile methodology doesn’t work in regulated industries is outdated, but regulated industries have, justifiably enough, specific expectations of their requirements management (RM) solutions, and those expectations continue to drive change in the market.

A recent report from Forrester Research, “Now Tech: Agile Requirements Management Tools, Q2 2018,” outlines the state of the market for Agile RM solutions and lays out the questions customers should ask when selecting the right requirements solution for their space.

Why invest in requirements management?

According to Forrester, it’s not just highly regulated industries and organizations involved in complex product development that can benefit from a requirements solution.

In spite of the “a coalition of Agile aficionados arguing that it’s unnecessary to formally collect and manage requirements,” the report suggests that best-in-class RM solutions can significantly improve product design and delivery for Agile development teams: “In the face of increasing regulations, connected products for the internet of things (IoT), and scaling Agile practices, AD&D [application development and delivery] leaders long for something to bring traceability and auditability to their processes without sacrificing speed.”

Why do you need traceability?

The right RM solution enhances development transparency through traceability. Traceability is a roadmap that shows you where in the product development lifecycle each requirement or business rule was implemented. With traceability, teams are better-equipped to perform impact analysis – i.e., to assess the consequences of proposed changes. This is crucial in complex product development, where simple changes can have far-reaching impacts, and it’s tough to isolate every system component that might be affected by a change in requirements.

Teams facing increasing complexity, pressure to comply with industry regulations, and the need to measure customer value must be able to search, track, and connect interdependent requirements. Achieving a faster time to market demands that teams collaborate quickly and effectively while they work on building out traceable requirements and test cases.

Why is it important to reduce tech debt?

Forrester reports that RM solutions can also help Agile teams reduce technical debt. Agile teams are focused on moving quickly, so they sometimes fall back on fixes that are easy to implement right now, but that will require rework down the line. Basically, tech debt refers to the work you’ll have to do tomorrow because you cut corners today.

You can’t avoid tech debt entirely, and you shouldn’t even try; you can’t move quickly without accumulating a little. But as the Agile methodology becomes even more widespread and project complexity continues to grow, RM tools will help development teams understand what has been done, what will be affected in the next sprint, and how to improve collaboration within distributed teams.

Finally, the report suggests, development teams can use RM solutions to embed visual modeling, design, and prototyping into their product development process. By modeling customer journeys, business processes, system designs, and user-interface components, teams can ensure that the final deliverable meets stakeholder expectations.

How has Agile changed requirements management?

Agile teams expect to move fast, so RM solutions looking to penetrate this market must meet developers’ need for speed. Transparency is another priority for Agile teams, and the transparency and traceability offered by an RM platform empowers teams to move beyond what the report dubs “static, text-based requirements.” As we noted above, traceability enables more effective and timely impact analysis, a critical consideration for rapidly evolving requirements.

Even though plenty of Agile teams see the value of a requirements solution, Forrester notes that “vendors have shied away from the term [requirements management] and evolved their offerings to fit new product niches.” Part of this avoidance of the term is because people tend to associate “requirements management” with clunky, tedious processes that lacked the efficiency and ease of use that current solutions offer. In contrast, the requirements solutions favored by Agile teams are less highly specialized; they have different capabilities and focus on different segments of the development lifecycle. As such, the Forrester report suggests that Agile teams consider whether the best solution for them is not one solution but a combination.

How do you choose the right requirements solution?

To maximize success in requirements management, the report found, teams should choose a platform that works for their discipline (product management, engineering) and their industry (medical, automotive).

As we wrote in our recent post, “Systems Thinking for Complex Product Development,” collaboration is easier and delivers better results when teams are encouraged to find approaches that are effective for them within their disciplines.

Before investing in a RM solution, Forrester suggests that Agile leaders engage in some strategic thinking to determine which RM platform will deliver the most value in concert with other tools and solutions. Decision-makers should:

Audit the tools already in use. Company and industry requirements drive investment, so understanding the existing ecosystem of tools already in place at your organization is essential in choosing the best RM solution for your particular needs. Take a close look at your Agile planning/project management, design, testing, and continuous integration tools to determine the best solution for your organization.
Identify where requirements fall apart. If you have issues uncovering requirements to begin with, consider a tool with more advanced collaboration, design, and modeling capabilities to help you define exactly what you want to build. If your challenge is understanding the impact of requirements, passing tests, or avoiding bugs in production, you need a tool with greater traceability and robust reporting capabilities that can integrate with automated testing tools.
Anticipate change. What changes are ahead for your industry? How will you be affected by new or evolving government regulations? Will your products be integrated with sensitive customer information? Now is the time to start laying the foundations for compliance with these future requirements.
Right-size the need for documentation. What’s the future of Agile at your organization? Are you looking to scale Agile companywide? Even if you don’t need a super-robust RM solution now, you’ll need to implement some governance early unless you want to be drowning in technical debt.

To learn more about how Jama Connect® stacks up against other requirements solutions, download our eBook, “Selecting the Right Product Development Platform.”

Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units. This makes it easier to evaluate the system holistically as well as in terms of its individual components.

A high-level, interconnected view of the product development process can yield new insights into how products are defined, built, released and maintained. Product managers sit at the center of the product development system, so they’re primarily responsible for understanding and directing the system.

You can think of systems thinking as a diagnostic tool: a disciplined approach to examining problems more completely and accurately before taking action. Systems thinking encourages teams to ask the right questions before charging ahead under the assumption that they already know the answers.

For product teams grappling with exceptionally complex design specs and requirements, systems thinking opens the door to procedure-level improvements and the ability to take full advantage of solutions that support them.

In this post, following up on our recent piece about systems thinking for medical device development, we talk about how product managers can leverage systems thinking to improve their processes.

The Iceberg Model: How to Put Systems Thinking Into Action

The Iceberg Model is a practical way to put systems thinking into action. We borrowed the following excellent example from the smart folks at the Northwest Earth Institute.

Picture an iceberg (doomed ship optional). The tip sticking out of the water represents the event level. Problems detected at the event level are often simple fixes: You wake up in the morning with a cold, so you take a couple of ibuprofen to feel better. However, the Iceberg Model encourages us not to assume that every issue at the event level can be quickly resolved by treating the symptom.

Just below the event level is the pattern level. As the name suggests, this is where you detect patterns: You catch more colds when you skimp on sleep. Observing patterns helps product managers forecast events and identify roadblocks before they rear their ugly heads.

Below the pattern level is the structure level. If you ask, “What’s causing this pattern?” the answer is likely to be structural. You catch more colds when you skimp on sleep, and you skimp on sleep when you’re under pressure at work or when your personal life is causing you stress.

The mental model level is where you find the attitudes, beliefs, expectations and values that allow structures to function as they do. These attitudes are often learned subconsciously: from our parents, our peers, our society. If “I’ll sleep when I’m dead” is part of your mental model, you’ll have trouble making the attitude and behavior adjustments that could help you avoid another cold.

The Iceberg Model encourages you to stop putting out fires and start addressing deeper issues. Using this model can align your team members through shared thinking and reveal opportunities to make small changes to the process that will yield big benefits.

More Visibility, Superior Collaboration

With a systems-thinking approach, complex product development teams can improve their processes by enhancing visibility and enabling more seamless collaboration and coordination between stakeholders.

Complex product development requires that the right people have visibility into the right parts of the system at the right time. Systems thinking drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more productive when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.

Compliance & Traceability

Simple changes to requirements can have far-reaching impacts, and it’s hard to isolate every system component that could be affected by a requirement modification. It’s easier to assess the impact of proposed changes – that is, to perform valuable impact analysis – when you have a roadmap that shows you precisely where each requirement or business rule was implemented in the software. Traceability gives you that roadmap.

By helping identify all the areas you may have to modify to implement a proposed change to a requirement, traceability enables impact analysis. With proper traceability, you can follow the life of a requirement both forward and backward, from origin through to implementation.

Traceability is difficult to establish after the fact, so teams can use a tool like Jama Connect from the beginning to track tasks, keep tabs on evolving requirements and contextualize test results. Traceability gives teams confidence in the safety and quality of their products, and helps them demonstrate compliance with national and international standards for highly regulated industries.

Since lower-level requirements and outputs are defined within the context of a specific system need, traceability allows teams to understand that context and the downstream impacts of any change made.

Customized Solutions for Complex Product Development

Organizations across a huge range of industries are engaged in complex product development. Systems thinking encourages teams to work through a common system need, while still employing the approaches that work best within their disciplines. To assist, Jama Connect provides visibility throughout the product development cycle and keeps stakeholders connected to minimize miscommunication and unnecessary rework.

And our Jama Professional Services consultants work with you to understand your objectives and configure the platform to support your process in the optimal way. As your process, people and data change, our experts help you realign development methodologies to best practices, elevate your requirements management skills and reinforce your process. For larger teams that want ongoing deployment and optimization assistance, our adoption services give you a team of experts at your fingertips.

Learn more about some of the ways systems thinking helps overcome complex product development with our whitepaper, “Systems Engineering and Development.”

The Jama Support Community is a forum for Jama Software users to interact and collaborate with other users and with Jama support engineers. It’s full of resources for everyone from novices to masters, including tutorials and webinars, help guides and FAQs, feature requests and announcements and a robust knowledge base. For today’s post, we spoke with one of our Jama Support Community power users — frequent contributors with great questions and powerful insights into using Jama — about how their organization uses Jama and the value they’ve seen from the Support Community.

Srilatha Kolla works on the DevOps team at at Hill-Rom Cary in the Raleigh, North Carolina area. Hill-Rom’s Clinical Workflow Solutions team develops medical devices that protect patients by anticipating the care they will need and communicating that information to their healthcare providers.

The process of developing these Class II and Class III medical devices is heavily regulated by the FDA, and Kolla’s team needed to achieve full traceability in order to satisfy these requirements. Hill-Rom was using IBM Rational DOORS for their requirements and test case management prior to 2012, but it didn’t meet their traceability needs, among other shortcomings.

Kolla, who started her career as a developer at IBM, was on the Quality Engineering team at Hill-Rom when they began looking for a superior solution. Her QE team evaluated several options before choosing Jama Connect™ in 2012.

Since then, Kolla has moved to the DevOps team, where she’s responsible for deploying and managing processes to help development, requirements and quality engineering teams build, test and release products that are safer and more reliable. Her team is closely involved from the requirements stage to coding, testing and verification of the product, and she’s responsible for managing the solutions, including Jama Connect, that her team depends on.

Kolla’s DevOps team serves as the Jama administrator at Hill-Rom, but the development, requirements and quality engineering teams, she says, also “live in Jama Connect day in and day out.” Among the organization-specific best practices her team has developed is a multi-project structure, which works better for them than a single, more complex project structure.

As an FDA-regulated company, Kolla says, Hill-Rom values Jama Connect for its traceable requirements and test case management: “That’s what we depend on highly.” She’s also a fan of the Review Center in Jama Connect. The Review Center enables teams to collaborate without hunkering down in the same room or emailing a Word document back and forth. Stakeholders can also review and sign off on requirements within the Review Center, which comes in handy when you need to reach consensus between team members quickly.

Kolla began using the Jama Support Community to get her questions answered. She wanted to see how other people were using Jama to address the same product development challenges her team was facing. As Kolla says, “We’re definitely not the only ones using this platform.”

Like many Jama customers, Kolla’s team uses Jama Connect in conjunction with Jira, so she turns to the Support Community to ask relevant questions about Jama’s functionality and interconnectivity with Jira, Microsoft Office and other tool suites. Given her team’s focus on traceability, Kolla has often sought Jama-related input from other users on things like item management, defects, Test Center, Trace View, Coverage Explorer, Reuse and Filters.

Stay tuned for more posts on how Jama users are leveraging the Jama Support Community to get the most out of the platform. In the meantime, connect with Sri and other fellow Jama users on the Jama Support Community.

Systems are only becoming more complex. When mapping out system requirements, relationships diagrams can quickly start looking messy and confusing.

And the deeper down you go in the relationship tree, the more items branch from the trunk and the interconnections become countless. However, the information contained within these diagrams is critical. An accidental alteration to a relationship could lead to catastrophic failure.

This is one area where Jama Connect’s Trace View is providing an increasing amount of value for our customers. Trace View allows product development teams to maintain Live Traceability, view how items link together and trace them as they change at any point in time.

Instead of retracing your steps to find gaps in coverage or wasting time managing multiple documents to update requirements, you can always keep your teams moving forward with Trace View. It is easy to manage upstream and downstream relationship impacts, see missing relationships and analyze item relationships.

And now, we’ve made Trace View even better. The latest enhancement to Trace View — Trace View Filtering — allows product development teams to quickly filter through items and analyze data that is pertinent to their search criteria.

To understand why Trace View Filtering is so important, let’s take a typical scenario where you only want to see item test cases and not be distracted by text, stories or defects.

Filtering allows users to quickly shed item types from the views that do not apply to the current situation.

Each column filters independently, because item types may appear at more than one level in Trace View. And the filter panel allows users to see all item types found in a column and filter them out.

With Trace View Filtering, you can also save and share your filters across teams.

An effective traceability system is important to the success of any product development. With Trace View, you can increase visibility, save time and eliminate risk throughout your product development lifecycle.

To learn more about how Trace View Filtering can help you find item types quickly in Trace View, email your Jama Connect account manager or contact us directly.

Once your team uses traceability for medical device development, you’ll wonder how you managed any other way.

Building traceability into the process is a critical step to ensure regulatory needs are met, requirements hit and changes managed along the way.

When brought to market, the margin of error for medical devices is near zero. Any defects not discovered and corrected during development can result in patient injury or death, not to mention devastating legal consequences for the company that released the product. With the stakes so high, every step of the development process must be traceable.

Traceability ensures a collaborative and unified timeline from conception to market, meticulously documenting everything in between. It also allows stakeholders to continually monitor timelines, and view how changes affect the team and the necessary response needed.

In essence, traceability lets teams map out interdependencies at each phase of development, ensure all compliance regulations are continually met and changes conform accordingly.

A Unified System of Record for Medical Devices

Heavily regulated products like medical devices require comprehensive audit trails of changes during development.

Traceability enables teams to view and analyze all changes made during development — including who made the change, what it was, when it was made and why it occurred in the first place. Since a traceable development project is kept in a unified system of record, it allows you to revert back to an earlier version of the changes.

Traceability also saves time and effort by communicating requirement modifications directly to the relevant group or individuals responsible in real-time, instead of forcing various team members to pore over the spec to determine if the latest change affects them.

Streamlining Communication for Medical Devices

Collaboration has become a central component of product development teams, and it’s the core of modern traceability.

Bringing all stakeholders together ensures compliance as well as productivity. With everyone on the same page, any potential questions an auditor could raise about process or a development decision can be easily answered. Traceability also makes a product lifecycle and its surrounding processes a living, ongoing entity as opposed to an afterthought. This is vital with the increasing complexity of today’s market.

Bringing Globally Distributed Teams Together

Multidiscipline teams working with different processes and systems must be able to see and understand what their fellow collaborators are doing.

This is especially true in complex spaces like medical device development, and traceability lets remote teams move faster and work together in a more cohesive way. This empowers them to independently make important decisions, based on correct and current data.

Anyone pulled into the conversation during development can be quickly brought up to speed without impeding on the momentum teams have already built.

Adopting Traceability for Medical Devices

Today’s medical devices are so much more than metal and plastic. Software plays a big part in communicating data to patients and doctors. This means the software component must be as traceable as the hardware, since a single instance of incorrect code can become a major liability.

All risk must be considered throughout the product design and implementation. Proper traceability establishes consistent, accurate links between each step of work to ensure the framework protects the user and organization.

Traceability isn’t just about information tracking, it’s about being able to call up that data in the correct format to share with customers and auditors. With Jama, you can track your design and verification within the solution.

Some of our customers complete their risk management analysis around why specific severity was assigned or why a mitigation was applied in a certain way. A single spot for modern traceability around the product you’re developing makes it simple to find the information you need about why decisions were made, as well as understanding their upstream and downstream impacts.

Learn how Jama uses live traceability to let medical device developers locate the source of any decision, manage risk and reference similar past projects in our webinar, “Live Traceability: The Golden Key to Proof of Compliance.”

During a keynote at CES 2018 in Las Vegas Nevada, NVIDIA’s Founder and CEO, Jensen Huang, took the stage in his iconic black leather bomber jacket. As expected, he touched on all things NVIDIA: from new gaming technology to their recently announced autonomous driving platform, DRIVE.

Amongst the powerful processors waving about onstage and videos projected on the walls of driverless cars navigating the streets of New Jersey, Jensen took pause in his address to put an emphasis on a word and concept not often used in the semiconductor industry: traceability.

The Tip of the Iceberg

To begin his segment on automotive functional safety, Jensen makes use of a common metaphor; saying, “Functionality is plenty challenging. The performance of these computers, the algorithms that have never been done before, the large-scale system integration with all different configurations of sensors is so complex, it is the most complex development we’ve ever done.

“And yet…”

In Jensen’s own words: “That’s just the tip of the iceberg.”

Beyond functionality, Jensen explains, “the most important feature of a self-driving car is not that it drives by itself; the most important feature is actually safety.” That is, how do you make a system respond safely, when the system itself fails?

This is clearly no easy achievement. In fact, Jensen argues it is so “extraordinarily complex” that it is literally easier to make a car drive by itself in the crowded streets of New Jersey than it is to ensure a system is functionally safe. After all, functionality is just the beginning.

From Culture, to Technology, to Tools

So, in the face of an engineering feat so “extraordinarily complex,” what do you do?

For NVIDIA, Jensen says, “it requires a holistic system approach, from culture, to technology, to tools.” This point is rather straightforward: to manage something so “extraordinarily complex” your entire organization needs be in unison, from the company culture to the tools by which your engineers use.

However, the next step in Jensen’s progression isn’t quite so black and white. With his own personal flair, Jensen announces, “We have the ability to achieve traceability for as long as we shall live.”

Hidden beneath this grandiose verbiage is a slightly ambiguous concept: traceability. Thankfully he continues, “If something were to happen, we can trace it all the way back to its source to improve and mitigate risk in the future.” Now we’re talking.

Achieving traceability means that everything throughout development — whether it be meeting minutes, email exchanges, specification tradeoffs, data sheets, management approvals, verification tests, you name it — is recorded, tracked in real-time and put to use to ensure that “if something were to happen,” or an error were to occur, you have the ability to immediately flag it, trace it to its source and fix the problem.

The question I then pose to you is, if something goes awry in your next highly complicated project, as you’re barreling a million miles an hour in the pursuit of your deadline, will your traceability help?

I know Jensen’s will.

To see how Jama’s solution helps companies achieve traceability, read our paper, “How Traceability Makes Semiconductor Development Easier” or get in touch.

A product development team’s success or failure hinges on the many decisions it makes throughout a development cycle. Those choices are influenced by a myriad of factors, including balancing timing, regulations, production costs, customer feedback and benefits to the end user.

Given the complexity of products today, it takes multiple team members to weigh-in on key decisions. And the number of decision points are only growing as products get more complex, making it even tougher to adequately weigh all the options and trace their impacts.

Decisions under pressure: Making an already complex process even tougher

Those who have been through crunch time know the volatile element hanging over all decisions throughout development is pressure — whether it’s related to deadlines, complexity or the organization. Here are some examples.

Decision Pressure = Not Enough Time

Depending on the number of stakeholders, their schedules, and level of involvement in the development process, receiving input on key changes or milestones can be an extremely tedious and time-consuming endeavor.

Getting multiple parties to sign off on a plan traditionally takes time, and it becomes nearly impossible if circumstances change while working through an especially sluggish sign-off process.

Decision Pressure = Not Enough Data

When debating decisions with team members — whether they’re executives, engineers or interns — good data strengthens the argument.

Running on instincts works for certain things, but if you’re constantly making tough calls without solid data, there’s a high probability of hitting problems— such as rework, delays and failures— later on.

Having visibility into the data used to define original requirements, as well as any new information causing requirements to change, is essential.

Decision Pressure = No Visibility Into Impact

Any new decisions must also take into account how they will impact the original requirements. One tweak to a requirement may cause ripple effects that impact the product in unintended ways.

Issues may be uncovered in the testing stage, but if one tiny change means a complete redesign, you’re going to miss market opportunities and blow past your budget.

Modern Traceability Relieves Decision Pressure

The practice of traceability was created to demonstrate that good decisions were made throughout development. While it’s a concept that has been around a while, it has had to evolve to keep up with a transforming, increasingly complex and time-sensitive product development process.

Building off the gains of the past, modern traceability is a new way of handling the process that’s built to support how people think and work.

Critically, it’s focused not just on the actions of an individual person, but entire teams over time. And this provides many benefits.

Less Pressure from Connected Data = Saved Time

Having a platform to power modern traceability is crucial. At a minimum, it needs to record, share and display data.

Crucially though, it also must be easy to use — so anyone on your team, from any experience level, can take advantage of it immediately with only a small learning curve.

Using modern traceability tools allows you to quickly show how the work being done is related to the company’s overall goals, which speeds up review cycles.

Less Pressure from Connected Data = On-Demand Context

Instead of data only being available at the end of a project or during major milestones (when people have the time), modern traceability’s data is continuously updated by the entire team and it’s always live and accessible.

For example, if all requirements have direct links to the original intent of the organization for a project, it’s easy to see whether a change is in alignment or deviating from that goal.

Simply look upstream from a requirement (or test, or design, etc.) to see why that piece of work existed. This provides valuable context ahead of any decisions to make a change. Have questions about why? Ask the person who added that upstream content directly.

Less Pressure from Connected Data = Clarity on Impacts to Requirements and People

While traceability practices have always connected test data to requirements, modern traceability delivers visibility into how people are connected to, and impacted by, changes to ongoing development work.

When a test fails, not only is it possible to see what requirements are impacted, modern traceability also offers the ability for affected parties to be notified immediately. No waiting for a major milestone review when pivots are costly. It amplifies the effectiveness of collaborative work already being done, and works best when you’ve got the right tool to utilize it.

The benefits of modern traceability are increasingly becoming essential for teams serious about creating better products with less waste and timelier cycles.

With modern traceability, you can connect data to make informed decisions faster and do your job better.

To learn more, check out our webinar, “Products Under Pressure: How to Leverage Traceability to Power Better Decisions.”

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