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EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights

Are you grappling with the intricacies of the EU Medical Device Regulation (EU MDR) and searching for clear answers to your most pressing questions? Look no further!

In this blog post, we’ve teamed up with subject matter expert Saby Ágai, Senior Professional Services Consultant at Jama Software®, who will shed light on the complex world of medical device compliance.

Overview + General Information

Why was the MDD (Medical Devices Directive) updated?

Saby Ágai: MDD entered into force in 1993, 30 years ago. There have been many changes over these three decades. There have been technological changes since then, software for example has more attention now than it had 30 years ago.

Patient demographics characteristics have changed, now it is a more aging population than it was 30 years ago. Medical device safety should correspond to these changes.

MDD was primarily focused on medical device commercialization criteria rather than looking at patient safety from a holistic perspective.

What are the most important changes introduced by the EU Medical Device Regulation?
  • EU MDD was focused on commercialization guardrails and market clearance criteria first.
  • EU MDR accounts for the full technological landscape, establishing guardrails for the regulation, manufacturing, and commercialization of medical devices.
Given that timelines may continually change, what is the latest information regarding extensions?

Transition Timelines Chart

RELATED: What the New Medical Device Regulations (EU MDR) Mean for You

Implementation/Adaptation + Need for Process Improvement

The EU MDR has changed how medical devices are covered. What opportunities and challenges might this expansion present for manufacturers?

Opportunities:

  • Manufacturers can deliver to the market higher levels of safety for their medical devices.
  • Manufacturers can be more aware and in control of their medical device lifecycle.
  • Potentially this could result in less recalls and less rework, and fewer customer complaints. There is also an opportunity for an easier pathway to other markets like US, Canada, Japan, and others.

Challenges:

  • Steep learning curve to adopt to the new regulation
  • Lack of professional, lack of experiences how to adopt to the new regulations
  • Optimizing efforts and resources spent on the adoption of MDR
What strategic steps should medical device companies and regulatory experts take to ensure a successful transition in light of the changes brought on by the MDR and its effect on CE markings?

Manufacturers should have a plan for MDR transition

  • Expert panel of the EU could be involved to receive professional support
  • Regulatory professionals should be competent to the new regulations
  • Best practices across the medical industry should be utilized for the transition
How can medical device manufacturers improve their Quality Management Systems (QMS) to be better at compliance? What new approaches can be used to make business growth and product innovation possible?

New quality management processes should be developed to correspond to the requirements of the MDR. Manufacturers should also revisit their core processes including quality assurance, risk management, and post-market process to see if re-implementation needed to ensure compliance with new MDR.

Related: Learn about the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry:

Data & Documentation

What impact does the EU MDR’s demand for increased device traceability and technical documentation have on promoting patient safety and regulatory visibility? What potential advantages and obstacles might exist when attempting to reach these outcomes?

Patients will benefit from the increased focus on safety and regulatory visibility on medical devices that MDR demands. On the other hand, novel technologies in medical devices may suffer from delays to be available early for patients. It is a balance though between efficiency and safety that always was there. The increased volume of technical documentation can lead to higher levels of design awareness for the manufacturers, on the other hand the increased resources needed to get there need to be financed.

How can medical device manufacturers collaborate with notified bodies and competent authorities to ensure a streamlined and efficient certification process?

There is a conflict of interest that does not allow the Notified Body and Authorities to provide consulting on MDR compliance for the same manufacturer that registered for certification. Manufacturers can help the certification process by signing up for certification on time. Manufacturers also can streamline certification processes by involving competent and experienced professionals to fulfill the Person Responsible for Regulatory Compliance (aka PRRC) role.

RELATED: CE Marking for Medical Device Software: A Step-By-Step Guide

Innovation

Can you explain the new EU MDR’s structure and how it supports innovation and patient safety?

Here is a great resource for that: https://www.leanentries.com/wp-content/uploads/mdr-table-of-contents.pdf. MDR is taking a holistic view on patient safety by broadening its scope to the full lifecycle of medical devices.

What are some key differential requirements that organizations will need to comply with?

Chart showing 6 stages of the structure of the EU MDR Technical Documentation

Let’s investigate the products listed in Annex XVI of the MDR and discuss the effects this will have on both manufacturers and healthcare providers. How can stakeholders take advantage of this inclusion to create positive results?

Those products are subject to the MDR, even though those are without an intended medical purpose. These products previously were unregulated products and the MDR introduces new manufacturing and surveillance requirements. A positive result is the higher level of transparency of the design, manufacturing and post market activities of these products. Users of such products benefit from a higher level of safety when using these products.

Will the stricter regulatory requirements of the EU MDR hinder or promote innovation in the medical device industry?

There is always a balancing between introducing novel technologies to patient treatments that potentially can save or extend our life as a patient versus using only high level of safety assured medical devices. If the current MDR hinders or promotes innovation only time will tell.

How can manufacturers balance the need for compliance with the desire to bring innovative products to market in a timely manner?

Market regulations are prescriptive to the given market. Manufacturers probably will deliver slightly different functionalities for essentially the same medical devices depending on how the market regulation allows for more open for novel technologies.

Patient Safety

How does the EU MDR change clinical evaluation requirements? And how can the industry adapt to these changes while continuing to prioritize patient well-being and efficacy?

The MDR has more rigorous clinical evaluation requirements, necessitating robust clinical data to support the safety and performance claims of the device. For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system that is proportionate to the risk class and appropriate for the type of device. The PMS system actively and systematically gathers, records and analyses data on the quality, performance and safety of a device throughout its entire lifetime. Post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation. It is conducted in accordance with a PMCF plan that is an element of the overall PMS plan.

What opportunities does the EU MDR present for enhancing patient safety through better data collection and analysis?

Clinical evaluation and post-market related information will be more transparent for the medical devices; therefore, manufacturers will have more opportunities to analyze device safety based on adverse events of similar types of devices.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Post-Market Surveillance

How does the increased emphasis on clinical data and post-market surveillance impact medical device manufacturers’ approach to product development and monitoring?

Clinical and post-market data collection should drive the design effort by transferring efficacy and safety related subjects back to development. Also, the analyses of similar products post market reporting enable manufacturers to enhance the safety of their medical device designs.

How can manufacturers leverage the new post-market surveillance requirements to proactively identify and address potential issues with their products?

MDR mandates and sets requirements for the post-market surveillance process. PMS process should be part of the manufacturer’s Quality Management System.

Manufacturers can use proactively the data gathered as part of the post-market activities for the following:

  • to update the benefit-risk determination and to improve the risk management;
  • to identify the need for preventive, corrective or field safety corrective action;
  • to identify options to improve the usability, performance and safety of the device;
  • to detect and report trends.

Conclusion

How will the EU MDR impact medical device companies operating outside the EU but wishing to access the European market?

For new arrivals, the new MDR is a demanding legislation to comply with in the European Union. Currently the conformity assessment bodies have limited bandwidth for new devices. Therefore, new manufacturers should assess the timing nature of their market access. For medical device companies operating outside the EU, there are further requirements set in the MDR in Article 11 on Authorized representatives.

How can Jama Software help organizations more easily comply with regulations like EU MDR?

Jama Software provides a solution for medical device manufacturers to adapt easily and to response quickly to the changes that the EU MDR demands. It’s achieved by providing best practices in medical device design in the context of the MDR.


Image showing Review Center features demonstration in Jama Connect

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

Jama Connect® Features in Five: Review Center

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

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

 

VIDEO TRANSCRIPT:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

RELATED: Requirements Traceability Diagnostic

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

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

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


Digital Thread

In this blog, we preview a section from the new eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download it.

Recent CIMdata research on behalf of the Aerospace and Defense PLM Action Group member companies in collaboration with PTC clearly indicates that digital thread investment within the ecosystem of industrial users, their customers, suppliers, and solution providers is poised for rapid growth. Initial implementations of targeted digital thread solutions have provided proof points of value and essential learnings. Now, rounds of investment are ramping up, guided by these early achievements and with expectations driven by the value potential revealed.

The concept of a digital thread providing automated linkage of multiple representations of a product, each tuned to the needs of various creators and consumers along the lifecycle, is very powerful. Until recently, tracing these linkages has been primarily a manual process, extracting product information from myriad heterogeneous systems and relating them in ad hoc reports. But now, with recent advances in commercial PLM solutions, the digital thread, with automated linkages and traceability, has become a practical possibility, even for industries with complex products, such as aerospace & defense.

In response, industry leaders have implemented targeted digital thread solutions and envision expanding these solutions throughout the product lifecycle. With the newness of this approach there is not much available in the way of lessons learned or value achieved. This lack of real data is a barrier to broader investment within industry. On the solution side, providers are constantly seeking additional insight into investment drivers within industry.

Future Digital Thread Investment Priorities

Looking to the future, industry leaders are taking a broader view of the digital thread’s value potential, with more investment in production and service use cases. They view the next stage as more complex and transformative to their companies. Fortunately, several have been successful in establishing programs that enjoy strong support from a well-informed and motivated senior management. However, many others have not.

All Top 5 pain points being targeted in future implementations relate to accessibility and traceability across data elements, especially traceability of requirements throughout the product lifecycle. Systems engineering is featured prominently in many responses, including ranking as the top new value opportunity being targeted in future digital thread implementations, which aligns with CIMdata’s view that systems engineering is a principal driver of the digital thread.

Digital Thread Investment Priorities

RELATED: Requirements Traceability Diagnostic

Strategies for Success

An area of divergence between industry leaders is in the focus of their implementations. For some, the focus is providing interfaces to source applications to extract and associate product data artifacts and attributes. For others, the key is the association and traceability of dependencies between artifacts in support of a use case. And for a few, the focus is on data governance, which they believe is foundational for enabling a richer and more extensive set of product lifecycle use cases.

The number one inhibitor to formulating and executing a digital thread strategy is “lack of interoperability between different vendors’ tools and systems.” The number one proposed means for mitigation is to “increase support of standards.”

Images showing digital thread bar chart for strategies for success

Solution Technologies

Key Technical Considerations

Core to the value of digital thread is traceability across multidiscipline sources and derivative product-related artifacts along the product lifecycle and throughout the extended enterprise.

The digital thread value landscape is distributed across a heterogeneous value chain from customer to OEM to partners and multiple tiers of suppliers. This reality drives the need for data interoperability and elevates the importance of standards and openness of enabling solution architectures.

Proven technical solutions exist for enabling the digital thread, and leading solution providers are investing heavily in research guided strategies and roadmaps to further strengthen their offerings.

Data is the foundation of the digital thread. This reality elevates the importance of sound data governance and a cleansed repository, especially as use case implementations proliferate and must be interlinked into an extended thread.

Bar chart showing Product Lifecycle Data stats

Technologies in Use Today

The technologies used to link product lifecycle data segregate into three tiers as shown in Figure 16. The top tier, which has the longest history, includes PLM and PDM, followed by ERP, and custom applications. The middle tier consists of application and data integration tools. These are followed by the third tier of newer specialty technologies for combining data from multiple sources and establishing linkages and traceability. We can expect the ranking of these specialty technologies to rise significantly over the next few years.

Solution Capability and Provider Alignment

Attitudes on the topic of solution capability and provider alignment are mixed. Some industry leaders are quite critical, especially regarding data model accessibility and flexibility to comply with a corporate data governance strategy. Other interviewees are somewhat neutral or slightly positive. They feel that some providers are moving in the right direction; some are not. Several feel that solution capabilities have improved significantly overall in the last 5-10 years and that, despite some remaining gaps, are now fully capable. Some express satisfaction that “good partnering” is happening.

RELATED: Reduce Project Risk in the Product Development Process

Jama Software® Solutions

Jama Software®’s industry-leading platform, Jama Connect®, helps teams manage requirements with Live Traceability™ through the systems development process for proven cycle time reduction and quality improvement. The number-one problem product engineering organizations face is managing requirements traceability spanning siloed teams and tools (e.g., design, hardware, software, test, risk, quality) which creates an increased risk of negative outcomes such as extensive rework, delays, and cost overruns.

Jama Connect enables digital engineering for innovative organizations in aerospace, automotive, medical, and industrial verticals. The future of product development relies on agile and transformative digital engineering techniques. Jama Connect helps customers solve their toughest challenges and simplify complex mission-critical system development across complex partner and supplier ecosystems.

Jama Connect seamlessly integrates with the product development technology stack. Organizations can take advantage of Jama Connect’s integration solutions with market-leading tools for design and simulation, task management, lifecycle management, quality assurance, and testing. Teams can work in their preferred tools while ensuring all requirements are verified and validated to achieve complete traceability.

V Model image showing Jama Connect integrating with several additional platforms

Live Traceability with Jama Connect Delivers:
  • 1.8X faster time to defect detection
  • 2.1X faster time to execute test cases
  • 2.4X lower test case failure rates
  • 3.6X higher verification coverage

Jama Software’s benchmark study for monitoring and measuring traceability through its Traceability Score™ has shown that companies that have a higher traceability score in the digital thread have faster cycle times and defect detections. This allows companies to be nimble and be twice as fast in releasing products vs. companies that do not monitor and measure traceability in their product lifecycle. Requirements Traceability Benchmark

This has been an excerpt from the eBook, “CIMdata: Digital Thread in Aerospace and Defense”
Click HERE to download the full version.


In this video, we demonstrate the Baselines feature in Jama Connect®. 

Jama Connect Features in Five: Baselines

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

In this Features in Five video, Jama Software® subject matter expert Julie Goodner, Senior Product Manager, demonstrates Baseline capabilities in Jama Connect.

 

VIDEO TRANSCRIPT:

Julie Goodner: Hi. My name is Julie Goodner. I’m a Senior Product Manager here at Jama Software. In this video, I will walk you through Baselines in Jama Connect. I’ll cover what a Baseline source is, what Baselines are, when to create one, and some of our new Baseline features.

A Baseline source in Jama Connect is a collection of all versions of the requirements or other items that have been selected for a Baseline. A Baseline in Jama Connect is a snapshot in time and you can create a baseline to capture any milestone. In addition, a Baseline is also automatically captured when a review—or a revision to a review—is created.

A Baseline allows our users to capture the state of their content in alignment with key points in their product development cycle, such as during peer reviews, at key approval gates, or when generating documents from Jama Connect. In addition, utilizing Baselines allows our users to compare items as they change over time.

RELATED: Requirements Traceability Diagnostic

Goodner: With Baseline sources, you can see if the Baseline or Review contains signatures, see Baseline statuses, quickly navigate to a Review, or do a comparison summary between two Baselines and export the redlined report.

With Baselines, you can add electronic signatures, compare two Baselines with redline edits from within Jama Connect, compare items in your Baseline items to their current state in the project, add a status, and navigate to the Baseline version in the project view.

So now let’s get into the demo.

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

Goodner: The Baseline can be manually created in many ways:

  • Right-clicking on a container, set, folder, or item, and adding a Baseline.
  • From the Filters tab, select any filter, and add a Baseline.
  • From the Baseline tab, you can select “Add a New Baseline” from the dropdown, or you can right-click on an existing source and add a Baseline.
  • From our new Baseline source header, you can add a Baseline from there.

Again, a Baseline is automatically created with any Review or revision of a Review.

RELATED: Reduce Project Risk in the Product Development Process

Goodner: From the Baseline source, you can see high-level information about its corresponding baselines that used to be hidden within a baseline details section. When selecting two Baselines, you can choose to do a comparison. This comparison summary model informs you have any updates that have been changed. You can also export that report and view the red line edit.

From a Baseline in the List View, you can see what relationships, categories, or other metadata were used to associate with the items at the time of the Baseline. When selecting the link in a Baseline, it will take you to the historical view from within the project.

From the Baseline Document View, you can choose to compare and see the differences in redline edit within Jama Connect, no longer needing to download reports.

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

Thank you.

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


Medical Device & Life Sciences

In part two of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect®. Click HERE for part 1 and  HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

Jama Connect Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 2

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

In part two of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, continues his demonstration of the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

Click HERE for part 1 and HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect.”

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.

So the first thing I want to show is our Jama Connect Advisor™ example data. Released in 8.80, this new feature enables EARS and INCOSE rules for requirement quality authoring. Additional licenses are required, but wanted to share some of the capabilities examples right out of the box. So as you can see here, what we’ve shown, is, you know, the general use case description, but also an example requirement with the Jama Connect Advisor output. Again, this is a nonfunctional screenshot. We just wanted to share some of the information that you may see when having Jama Connect Advisor. Here’s, for example, for a green status, which means generally a good requirement, but let’s take a look at what a yellow requirement or maybe something that may need some rework and you can see which of the rules, particularly INCOSE, that is now flagged that is, you know, has some potential issues. And then the same is true with our red level of requirements.

So again this is potentially a useful tool to kind of share while authoring requirements for your project.

RELATED: The Top 5 Challenges in Digital Health Solution Development

Balgos: The next use case that we’d like to talk about is the industry standards trace. So in the standards use case, the first thing I want to share is this relationship rule diagram. As you can see here, we have user needs trace to system requirements, which is, you know, aligns with [21 CFR] 820.30, but also we have this new item type called standards reviewed is now traced to system requirements.

If you upload your standards into Jama Connect, what we can see for this particular item type is that we’ve identified now the standard, the clause number, the clause text, and identified does the standard apply for this particular project. What’s nice about once this is in Jama Connect, I can now actually do a trace downstream to the system requirement. Note, this project does not provide any standards due copyright issues, customers won’t need to vision their own standards for use and apply appropriately. The last thing we want to talk about is really the reports on this medical device framework update.

RELATED: Jama Connect® for Digital Health Solution Overview

Balgos: What I wanted to share is if I go into the admin area and I take a look at the reports, you can see now that we’ve now had the ability to upload and, you know, manage our own reports, but we’ve provided some additional categories and information to help organize the many reports that we have. As you can see here, we’ve identified some trace reports and some new SaMD reports. So if I go back to the project and let’s take a look at, let’s say, system requirements, I want to show you a new trace report that shows requirements to verification-only events. So for example, let’s say if we go on to, let’s say, our subsystem requirements that we have here I’m gonna pick this one.

I’m going ahead and go at export. Again, this is available now into the Medical Device Framework 2.0. What I want to show you is requirements to verification trace report. So if I go ahead and hit run, create a report, I’m gonna download it, and then what wanna share is this new trace report that we have, which now shows you the requirement, the verification test case associated with the requirement, But in addition, the latest test run and its test result status.

RELATED: Requirements Traceability Diagnostic

Balgos: So this helps clearly identify the requirement to verification traceability that’s may needed and they may be able to submit to your DHS. We have a similar one called the user needs to validation transport that falls the same above. The other thing we wanted to show is that we’ve added a couple popular and useful GitHub reports to this solution update. These are located up in our run reports area where we actually now included the test results report group by test case and the test result report grouped by test cycles, which are really, really helpful for understanding test management scenarios.

Okay. That’s for the general update for the the standard medical device framework. We have an additional updated solutions such as software as a medical device, research use only, and our new self-guided onboarding framework. So we definitely encourage you to look at that further.

Please contact your Jama success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

 

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


Large Language Model (LLM) Image

How to Plan for Large Language Model (LLM) Adoption Within Your Engineering Organization

The initial free and unprotected access to ChatGPT (the most well-known Large Language Model) has led some individual engineers to try out the tool by using company owned trade secrets and intellectual property (IP) as prompts. The predictable result has been IP leakage with numerous high-profile examples, including at Samsung. As a result, many companies, including Apple, have banned internal use of the technology outright. Additional risks are just starting to be understood given the lack of consent provided by the actual owners of content that was used to train the LLMs. This leaves the concept of ownership of LLM output, and the ability to protect intellectual property that includes LLM output in question and legal experts are advising caution. Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that at properly allow for company level standards and governance of IP. Numerous lawsuits, such as Clarkson v OpenAI, are now underway alleging all of the data to train the LLMs was obtained without consent or renumeration and violates copyright law.

RELATED: Best Practices Guide to Requirements & Requirements Management

Clearly, it will take some time for legal frameworks and precedents to be established for the use of LLMs in product development and for enterprise-class integrations to be developed to LLMs that properly allow for company level standards and governance of IP. Given the risks and unresolved legal questions LLMs pose for product development, how should an engineering organization plan an adoption path to achieve potential benefits from intelligent assistance for engineering tasks?

The guidance we provide our clients is to focus on the following three areas, ranked in order of greatest benefit from intelligent assistance:

  1. Improve requirements quality – Poorly specified requirements account for up to 64% of defects and are the costliest ones to correct. The International Council on Systems Engineering (INCOSE) and the Easy Approach to Requirements Syntax (EARS) have established best practices for requirements specification and unfortunately, LLMs are trained on publicly available requirements content that is rife with all the most common errors addressed by INCOSE and EARS. The best intelligent assistant to improve requirement quality is a Natural Language Processing (NLP) approach that analyzes requirements against INCOSE and EARS best practices and recommends improvements – which is exactly what Jama Connect Advisor™ does. Jama Connect Advisor protects all IP and engineers learn how to write better requirements through intelligent guidance.
  2. Manage by exception – The engineering function is one of the last in the enterprise to be managed through data. The engineering process is often fragmented across teams and tools which leads to late identification of cross-discipline issues that result in defects, delays, cost overruns, and recalls. Jama Connect® intelligently solves this problem through Live Traceability™ which automatically syncs data across best-of-breed tools and tracks engineering progress against the chosen development model (e.g., V-model) to identify issues as early as possible and thereby reduce the risk of defects, delays, cost overruns, and recalls.
  3. Increase engineer productivity – The biggest drains on engineering productivity are most commonly integration meetings and rework. Jama Connect’s Live Traceability intelligently alerts teams to impactful change from other engineering disciplines. Live Traceability eliminates the need for time-consuming and mind-numbing integration meetings and is proven to reduce rework based on our groundbreaking benchmarking study. Further productivity gains can be achieved by leveraging LLMs for requirement decomposition and we intend to be one of the first to market with an enterprise-class solution that protects IP and enables company standards.

RELATED: Best Practices Guide for Writing Requirements

To get started with intelligent assistance, learn how best to improve requirements quality across your engineering organization with the NLP application of EARS and INCOSE best practices.


In part one of this two-part video series, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect. Click HERE to watch our related and full-length webinar, “Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

Jama Connect® Features in Five: Medical Device & Life Sciences Solution 2.0 – Part 1

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

In part one of this two-part Features in Five video series, Jama Software® subject matter expert Vincent Balgos, Director, Medical Device Solutions, will demonstrate the latest solution offerings for Medical Device & Life Sciences in Jama Connect.

We will share part two of this video series here once it’s published.

VIDEO TRANSCRIPT:

Vincent Balgos: Hi. My name is Vincent Balgos, and I’m the Director of Medical Solutions here at Jama Software. In this video, I’m going to talk about our updates to our Medical Device & Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today.

So the first thing I want to show is the general organization and layout of our new Medical Device & Life Sciences Solution 2.0. The first thing I want to show is that this new folder that actually has our new Medical Device framework and our other additional popular frameworks such as SaMD and Consumables frameworks. The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our three hundred-plus customers and their practices using Jama Connect.

So now let’s go ahead and jump into the tool. We’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have.

RELATED: Jama Connect® Customer Success Programs

Balgos: The most common example is associated with risk. Not all risk controls are requirements, so we still need a way to trace to these non-requirement risk controls. These controls may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.

Another thing that we’ve done is actually updated our hazards library to include general hazards identified in ISO 14971. So you have pretty much a starting place with your hazard library The next item that I like to talk about is the risk Lookup Matrix. Available in [Jama Connect] 8.74, this feature allows a new Lookup Matrix risk analysis approach that automatically outputs the desired content based on the preconfigured Lookup table. This really aligns with [ISO] 14971.

Let me show you a quick demo of this. We’ve now implemented this as part of our Medical Device & Life Sciences Solution 2.0. As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of again follows the general [ISO] 14971 schema of hazard sequence events, hazard situations, harms, but here is now where we’ve implemented this new Lookup Matrix feature. Where now I’ve identified the input pick list where I may be able to change this, and then that automatically updates my risk level based off that matrix.

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

Balgos: So for example here, if I went ahead and increased this to frequency and I increase my severity from here and this one as well. I can see that both my p total and risk analysis has been updated per the Lookup Matrix. We have an additional Features in Five video that shows cases a little bit more. So we definitely encourage you to look at that further.

The other thing that we wanted to share with particularly this Medical Device update is we have now included preconfigured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, when I look at my item type, I’ve now included preconfigured D FMEAs, Process FMEAs and, Use FMEAs that you may configure based on your organization.

RELATED: G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Summer 2023 Grid® Report

Balgos: The intent of this is really to continually improve and provide new solutions to our customers based on customer feedback, industry trends, and best practices.

The industry vertical solution updates expand new use cases and solutions to address complex challenges while continuing to comply with industry regulations. Please contact your Jama Connect success manager or consultant to learn how to implement these new solutions at your organization.

Thank you.

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


Curious to learn how the Medical Device Framework in Jama Connect® can help streamline your compliance efforts and ensure your products meet necessary regulatory requirements?

During this informative session, Vincent Balgos, Director of Medical Device Solutions at Jama Software® discusses the latest solution offerings for Medical Device and Life Sciences in Jama Connect, including:

  • Updated Software as Medical Device (SaMD) framework incorporating readily available off-the-shelf elements for workflow and efficiency
  • Newly developed Research Use Only (RUO) and In-Vitro Diagnostics (IVD) frameworks
  • Refined solution enhancements, including new and updated report templates
  • Self-guided onboarding framework to assist new users in Jama Connect

Discover how Jama Connect can help you optimize compliance and regulatory processes, helping you stay ahead in the constantly evolving medical device industry.

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

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

Vincent Balgos: For today’s webinar, I’d like to talk about our updates to our Medical Device and Life Sciences Solution 2.0. For the agenda, there are quite a few improvements I’d like to share with you today. The first one is really just kind of talking about general overview and general improvements in terms of risk, some new features that we’ve enabled with Jama Connect, but also some new and updated solutions such as Software as a Medical Device, Research Use Only, and our new self-guided onboarding framework.

So the intent of the update is to continually improve Jama solution to the medical device and life sciences industries based on a variety of factors, including new Jama Connect features and abilities that help streamline general product development processes and industry best practices. Also adapts to the ever-evolving regulations such as MDR, IVDR, and potential changes to the lab developed test area. We’ll talk about more of this in the ROU space. We’ve also included internal research and internal experience with over 80 years of industry experience from the internal Jama team. And lastly, we’ve also incorporated some feedback from customers like yourselves on best practices, innovative solutions, and new use cases. So thank you ahead of time and please continue to contribute via the Jama Community Ideation page or discussion with Jama folks.

These solutions that are presented are compatible and available with Jama Connect for both our cloud customers, both the standard and validated, and our self-hosted environments. Some highlighted features may require version updates, and this is really particular to our self-hosted customers with legacy versions.

RELATED: The Top 5 Challenges in Digital Health Solution Development

Balgos: So what I’d like to first talk about is the general organization and layout. So what I’m going to do is come back between screens, between the PowerPoint and the actual, the demo itself.

So the first thing I want to show is the general organization and layout of our new Medical Device Framework 2.0. The first thing I want to show is when we go ahead and take a look, you’ll see here in this new folder we have something enumerated Medical Device Framework 2.0, that actually has our new Medical Device Framework and our other additional popular framework such as SAMD and Consumables Framework.

The other folder to mention is really kind of our new use case library that highlights additional use cases that we’ve seen across our 300 plus customers and their practices using Jama Connect. We’ll deep dive into each one of these very shortly. We’ve also archived the current… sorry, the previous Medical Device Framework 1.0 for your reference only.

So now let’s go ahead and dive into the overview of the MDF 2.0. So I’m going to jump into the tool. And as you can see here right on the screen, we’ve updated the relationship rule diagram with some minor improvements. The first thing we’ve done is really streamline the risk stream where we remove the validation trace and trace this now to an external resource item type. The purpose of this item type is a general documentation catch call for a lot of various traces that you may have. The most common example is associated with risk. So as many of you may know, not all risk controls are requirements. So we still need a way to trace to these non-requirement risk controls. These controls could be IFUs or instructions for use, training, labeling, or labeling and packaging, et cetera, and may vary depending on your risk management procedures. This provides additional risk coverage traceability that provides flexibility for your organization.

RELATED: Jama Connect® for Digital Health Solution Overview

Balgos: Another thing that we’ve done is actually updated our hazards library to include general hazards identified in 14971. As you can see here on the screen, we’ve now populated the general hazards identified in 14971 based on the information that you have. So you have pretty much a starting place with your hazard library that you have here.

The next item that I’d like to talk about is actually this new feature called the Risk Lookup Matrix. Available in 8.754, this features allows a new lookup matrix risk analysis approach that automatically outputs the desired content based on a pre-configured lookup table. This really aligns with 14971. Let me show you a quick demo of this because we’ve now implemented this as part of our Medical Device Framework 2.0.

RELATED: The Importance of Benefit-Risk Analysis in Medical Device Development

Balgos: As you can see here on the screen, I have a new item type called Risk Evaluation 2.0 that kind of, again, follows the general 14971 schema of hazardous sequence of events, hazardous situations harmed. But here is now where we’ve implemented this new lookup matrix feature where now I’ve now identified the input pick lists where I may be able to change this, and then that automatically updates my risk level based off that matrix. So for example here, if I went ahead and increases the frequency and I increase my severity from here over here, and this one as well, I can see that both my P total and risk analysis has been updated per the lookup matrix. We have an additional features [inaudible 00:07:27] video that showcases a little bit more. So we definitely encourage you to look at that further.

The other thing that we wanted to share with particularly this medical device update is we have now included pre-configured FMEA item types for ease of implementation for your risk processes. If I go ahead and look into my admin area, what I mean by this is when I look at my item type, I’ve now included pre-configured DFMEAs, process FMEAs, and use FMEAs that you may configure based on your organization. This just allows for streamlining of your risk measures processing quickly to Jama Connect.

To watch the entire webinar, visit
Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®


G2 Summer Report

 

G2 Again Names Jama Connect® the Standout Leader in Requirements Management Software in their Summer 2023 Grid® Report

Thank You to Our Customers!

Jama Connect® was again named far above all others as the overall leader in the Summer 2023 G2 Grid Report for Requirements Management Software!

Alongside the honor of being named the only leader in requirements management software, we are proud to showcase that we were awarded several additional medals for Summer 2023 in both Requirements Management Software and Application Lifecycle Management (ALM) Software, including:

    • Users Love Us: For products that have collected 20 reviews with an average rating of 4.0 stars.
    • Enterprise Leader: For products rated highly by G2 users and have substantial Satisfaction and Market Presence scores
    • Momentum Leader: Products in the Leader tier in the Momentum Grid® rank in the top 25% of their category’s products by their users.
    • Easiest to Use: The product in the Usability Index earned the highest Ease of Admin rating in its category
    • Best Relationship: The Best Relationship product in the Relationship Index earned the highest Relationship rating in its category
    • Easiest To Do Business With: The Easiest Doing Business With product in the Relationship Index earned the highest Ease of Doing Business With rating in its category
    • Easiest Admin: For products that earn the highest Ease of Admin rating in their category
    • Best Usability: The Best Usability product in the Usability Index earned the highest Usability rating in its category
    • Fastest Implementation: For product that had the shortest go-live time in its category
    • Easiest Setup: The product that earned the highest Ease of Setup rating in its category
    • Users Most Likely to Recommend: The Users Most Likely to Recommend product in the Results Index earned the highest Likely to Recommend rating in its category

Download the full report to see why customers love using Jama Connect for product, systems, and software development.

Learn More About the Summer 2023 G2 Grid for the top Requirements Management Software products HERE!

DOWNLOAD

At Jama Software®, we’re proud to be recognized as the leader in requirements management software. We’re grateful to our customers for their invaluable feedback on their experiences using Jama Connect for requirements management. We remain committed to providing them with the expert knowledge, attention, and resources they need to help them achieve their goals.

The “Users Love Us” category, in particular, is a testament to the value our industry-leading requirements management software brings to our customers, and especially for customers who have moved from a document-based approach to complex product, systems, or software developement.

“Jama [Connect] is the final death blow to your grandfathers way of managing text based requirements.”

-From review collected and hosted on G2.com, Mark M. — Mid-Market

Read Jama Connect reviews on G2

We strive to provide our customers with the best experience while using our platform. Categories such as “Easiest to Use”, “Easiest Admin”, “Users Most Likely to Recommend”, and “Best Usability” in particular show how much our users enjoy working within Jama Connect.

“Product Design teams need a requirements management tool like Jama [Connect.] Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.”

-From review collected and hosted on G2.com, Verified User, Retail — Mid-Market

Review Jama Connect on G2

From all of us at Jama Software to all of you, thank you!

G2 scores products and sellers based on reviews, gathered from their user community, as well as data aggregated from online sources and social networks. Together, these scores are mapped on their proprietary G2 Grid®, which can be used to compare products, streamline the buying process, and quickly identify the best products based on the experiences of your peers.


Traceability Matrix

Traceability Matrix 101: Why It’s Not the Ultimate Solution for Managing Requirements

In this post, we cover the definition of a traceability matrix and discuss the limitations of using a trace matrix for requirements management and provide an alternate, superior option.

Trace matrices, also known as traceability matrices, are frequently used in complex product, system, and software development to keep track of the connections between specifications, design components, and test cases. They provide an organized way to make sure that the system’s planning, execution, and testing satisfy each requirement. When utilizing trace matrices in challenging development projects, however, it is important to consider a number of their known drawbacks.

Here are five key limitations of using a traditional traceability matrix for requirements management:

1. Limited Visibility: In projects with a lot of requirements and design components, trace matrices can grow significantly in size and complexity. As a result, it can be difficult for teams and stakeholders to get a comprehensive understanding of the complete system — and to understand how each requirement relates to the other components. This often results in mistakes and gaps in the trace matrix, which lowers the system’s quality and introduces risk to both the project and the product.

2. Maintenance Overhead: Trace matrices require constant maintenance throughout the development process. As new requirements are added or changed, the trace matrix needs to be updated to reflect these changes. This can be time-consuming and can take away from other important development tasks. Additionally, it can be challenging to keep track of every change, which can result in mistakes in the trace matrix.

3. Limited Scope: Trace matrices are typically limited to the scope of the specific project they were designed for. They are insufficient for tracing issues that span across various disciplines, such as security or efficiency, which may require a different, more robust, traceability strategy. Additionally, trace matrices might not fully account for a system’s complexity, such as sudden changes or relationships between components, which can result in unforeseen issues.

4. Lack of Context: Trace matrices only provide a static view of the system and do not capture the dynamic context in which the system operates. For example, a requirement may be met by a design element, but the design element may have unintended consequences when combined with other elements in the system. Trace matrices may not capture these interactions, which can lead to bugs or other issues in the final system.

5. Limited Support for Agile Development: Trace matrices are typically associated with traditional, waterfall-style development processes, which do not align well with Agile development methodologies. Agile development processes emphasize collaboration, iterative development, and quick feedback cycles, which can be difficult to reconcile with the strict traceability requirements of a trace matrix. As a result, trace matrices may not be well-suited for Agile development projects.

RELATED: The Jama Software® Guide to Requirements Traceability

Five Advantages of Using a Robust Requirements Management and Traceability Solution, Like Jama Connect®, Over a Static Traceability Matrix

Jama Connect®’s powerful, yet easy-to-use, requirements management and traceability platform bring people and data together in one place, providing visibility and actionable insight into the complete product development lifecycle. Teams and stakeholders — regardless of their location — can easily share updates in seconds, discover issues weeks sooner, and have one place to collaborate with key stakeholders — in real time. As a result, Jama Connect offers many advantages over using a traditional traceability matrix.

Here are five advantages of Jama Connect:

1. Automation: Jama Connect automates many tasks that would be tedious and time-consuming to do manually. For example, it can automatically generate traceability matrices, link requirements to test cases, and track changes to requirements. And, because testing is built into Jama Connect, users can take advantage of our trace view to navigate from high level requirements, all the way down to test cases and defects. This allows users to view any failed tests or open defects that are associated with their upstream requirements. Because traditional trace matrices are static, they are unable to benefit from this type of automation.

2. Visibility: Jama Connect provides a more comprehensive view of the requirements and their relationships than a static traceability matrix by automatically generating Live Traceability™ which allows you to navigate levels of traceability both upstream AND downstream. With Jama Connect, you can see the entire requirements hierarchy, including parent-child relationships, dependencies, and impact analysis.

3. Collaboration: Jama Connect makes it easy for teams to collaborate on requirements. With features like comments, reviews, and notifications, team members and stakeholders can discuss and iterate on requirements in real-time.

4: Customization: Jama Connect is highly customizable, allowing it to be tailored to your specific needs. You can create custom fields, workflows, and reports to match your organization’s processes and requirements.

5. Scalability: Jama Connect is designed to handle large and complex projects with thousands of requirements. It can support multiple teams, projects, and stakeholders, and can integrate with other best-of-breed tools in your ecosystem.

Additionally, with Jama Connect, teams can implement live requirements traceability and measure it to continuously improve end-to-end systems development process performance, even through siloed development, test, and risk activities.

RELATED: Requirements Traceability: Links in the Requirements Chain

What is Live Traceability™?

Live requirements traceability is the ability for any engineer at any time to see the most up to date and complete upstream and downstream information for any requirement—no matter the stage of systems development or how many siloed tools and teams it spans. This enables the engineering process to be managed through data, and its performance improved in real time.

Conclusion

Even though trace matrices can be a helpful tool for keeping track of requirements, design components, and test cases in some development projects, there are several drawbacks to be cognizant of, especially as projects become increasingly complex. These limitations include limited visibility, lack of context, narrow scope, maintenance overhead, and inadequate support for Agile development. So, it might be time to consider other, more modern, and robust approaches to traceability for complex product, systems, and software development projects.

Jama Connect, the leading requirements management and proven traceability software platform, enables a digital thread that ties tools and metadata together across the end-to-end product lifecycle. This provides real-time insights that allow for streamlined product development that is less prone to overall risk, rework, or recalls. Overall, Jama Connect offers more automation, visibility, collaboration, customization, and scalability than a traditional traceability matrix — and provides a more modern and efficient way of managing requirements in complex product, system, and software development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom and Mario Maldari.