Tag Archive for: Product Development & Management

press release engineering USA and Jama Software

To read the complete press release, go to https://www.jamasoftware.com/press/a-new-partnership-for-digital-design-product-development-excellence/

Engineering Industries eXcellence Partners with Jama Software® to Drive Innovation in Digital Design and Product Development Across Industries

PORTLAND, Ore. and CHICAGO, September 21, 2023 – Jama Software®, the industry-leading requirements management and traceability solution provider, and Engineering Group’s Industries eXcellence division, a global leader in the field of engineering services, design automation solutions, and Industry 4.0 technologies, jointly announce a strategic consulting partnership to transform the way industrial organizations design, develop, and deliver innovative products to the market.

Jama Software’s requirements management platform, Jama Connect®, provides a collaborative environment for teams to define, design and develop their product visions. By maintaining Live Traceability™ across a best-of-breed ecosystem, Jama Connect enables organizations to navigate the intricacies of modern product development, leading to faster time-to-market and improved product quality. Engineering Industries eXcellence, with its rich experience in engineering services and global network of digital transformation experts, brings a wealth of knowledge in product design, systems engineering, and technology consulting.

 “We are excited to partner with the Engineering Group to deliver a holistic approach to intelligent engineering management that leverages Jama Software’s best-in-class technology with Industries eXcellence’s industrial sector expertise,” said Tom Tseki, CRO of Jama Software. “This collaboration represents our commitment to helping organizations bring innovative products to market faster, with higher quality and greater efficiency.”

Through this partnership, clients will benefit from the synergy between Jama Software’s innovative requirements management and traceability platform and Engineering Industries eXcellence’s deep industry insights, resulting in comprehensive solutions tailored to meet the unique challenges of their respective markets.

 

To read the complete press release, click here.

ABOUT JAMA SOFTWARE

Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries. For more information about Jama Connect services, please visit www.jamasoftware.com.

ABOUT THE ENGINEERING GROUP

The Engineering Group is a leading engineering services and solutions provider, offering a wide range of expertise in product design, system engineering, technology consulting, and more. With a track record of excellence, the Engineering Group partners with clients to drive innovation and achieve exceptional results. Learn more at Engineering Industries eXcellence (indx.com).

Media Contacts

Jama Software:
Karrie Sundbom
Senior Director, Corporate Marketing
[email protected]

Engineering Industries eXcellence:
[email protected]

Image for the blog, "EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights"

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 currency, meant to portray the importance of investing in a Requirements Management and Traceability Solutions as a wise financial choice.

A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn

In the realm of business, the economy is a dynamic force that ebbs and flows, much like the tide. Economic downturns, while challenging and sometimes scary, can also present unique opportunities for businesses to reevaluate their strategies, streamline their operations, and invest wisely for future growth. One such investment — that might not be immediately obvious but holds immense potential — is in requirements management and traceability solutions. In this blog post, we’ll explore why it makes sense to invest in these solutions during an economic downturn.

1. Enhanced Efficiency and Resource Optimization:

In times of economic uncertainty, operational efficiency becomes paramount. Requirements management and traceability solutions provide a structured framework for capturing, organizing, and tracking project requirements throughout their lifecycle. By optimizing requirements management processes, businesses can ensure that resources are allocated to the most critical aspects of a project. This reduces the risk of scope creep, minimizes wasted effort, and enhances overall project efficiency. With a clear understanding of project goals and dependencies, teams can work cohesively, to not only avoid both unnecessary and costly duplication of work but also enable organizations to allocate resources where they are most needed.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Software Development

2. Risk Mitigation:

Economic downturns often come with increased financial constraints, so allocating resources to any new software investments might seem counterintuitive. But investing in requirements management and traceability solutions can truly act as a risk mitigation strategy. The right requirements management and traceability solutions facilitate comprehensive end-to-end impact analysis, allowing businesses to understand how changes to requirements can affect other aspects of the project or organization. By foreseeing any potential pitfalls and addressing them proactively, companies can increase process efficiency, minimize costly errors, rework, and recalls, and streamline development to accelerate time to market — ultimately safeguarding their investments in both time and resources.

3. Regulatory Compliance and Quality Assurance:

In certain industries, compliance with regulatory standards is non-negotiable. Implementing robust requirements management and traceability solutions can streamline the process of documenting and demonstrating compliance. These solutions enable clear documentation of how each requirement maps to relevant regulations, making audits smoother and reducing the risk of non-compliance penalties. Moreover, well-managed requirements also lead to improved quality assurance practices, ensuring that products or services meet the desired standards even during challenging economic periods.

4. Agility and Adaptability:

Economic downturns often require businesses to pivot their strategies quickly to address changing market dynamics. Requirements management and traceability solutions provide a foundation for agile decision-making. When requirements are well-documented and linked, it becomes easier to assess the impact of changes, make informed decisions, and adapt to shifting priorities without causing disruptions. This agility allows businesses to seize new opportunities and respond to market demands more effectively.

RELATED: Requirements Traceability Diagnostic

5. Long-Term Cost Savings:

While the initial investment in requirements management and traceability solutions might seem significant, it pales in comparison to the potential long-term cost savings. When requirements are managed efficiently, projects are less likely to overrun budgets or experience delays due to misunderstandings or miscommunications. The cost of fixing issues after they’ve occurred is far higher than preventing them in the first place. By investing in proper requirements management, businesses can avoid the financial strains that arise from project failures or inefficiencies.

Conclusion:

In the face of economic uncertainty, investing in requirements management and traceability solutions might not be the most obvious choice, but it’s certainly a strategic one. These solutions offer a structured approach to managing projects, reducing risks, enhancing efficiency, ensuring compliance, and promoting adaptability. By making this investment, businesses position themselves for not only surviving economic downturns but also thriving in the long run. As the tide of the economy inevitably turns, those who have laid a strong foundation in requirements management will be better equipped to ride the waves of change.

Download the complete eBook to access simple, interactive ROI calculators and learn the financial benefits of investing in a requirements management solution during an economic downturn >>
Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense


Image showing V Model for Validation and Verification

Best Practices for Verification and Validation in Product Development

In the competitive landscape of modern product development, ensuring the reliability and quality of the product is essential to meet customer – and stakeholder – expectations and regulatory requirements. Verification and validation (V&V) are two crucial processes that play a pivotal role in achieving these goals. V&V are systematic methods that assess a product’s adherence to specifications and its ability to perform as intended. In this article, we will delve into the best practices for verification and validation in product development, exploring the key steps, methodologies, and benefits of each process.

Understanding Verification & Validation

Before delving into the best practices, it is essential to clarify the distinction between verification and validation. Verification focuses on assessing whether a product meets its design specifications, ensuring that each component and feature works as intended. On the other hand, validation is concerned with evaluating whether the product fulfills its intended use and customer needs. In essence, verification confirms if the product is designed correctly, while validation confirms if it is the right product for the intended application.

RELATED: Five Key Design Control Practices that Improve Compliance and Help Develop Better Products

Incorporating V&V Early in the Development Lifecycle

To maximize the effectiveness of verification and validation, these processes must be integrated into the product development lifecycle from its early stages. By starting V&V activities early, potential issues can be identified and resolved before they escalate, reducing costs and time-to-market. Early involvement also allows for feedback to be incorporated into the design, leading to a more robust and reliable final product.

V Model image showing Verification and Validation in the Product Development Process

Clearly Defined Requirements

Well-defined requirements are the foundation of successful verification and validation. During the requirements gathering phase, it is vital to engage stakeholders and subject matter experts to create clear, measurable, and unambiguous specifications. These requirements serve as the baseline against which the product will be verified and validated. Proper documentation and version control are critical to ensure that changes to requirements are tracked effectively. Additionally, the later in the development process that requirements get changed, many times because they weren’t written well the first time, the more costly it is due to downstream impacts such as rework in verification and validation.

RELATED: Plutora: Verification vs Validation: Do You know the Difference?

Utilizing Various V&V Techniques

Product development teams should employ a mix of V&V techniques to comprehensively assess the product’s quality. Some commonly used methods include:

  • Testing: Conduct thorough testing, including unit testing, integration testing, system testing, and user acceptance testing, to verify that each component and the product as a whole performs as expected.
  • Simulation: Use computer simulations to evaluate the product’s behavior in various scenarios, particularly for complex systems or when physical testing is impractical or cost prohibitive.
  • Prototyping: Building prototypes early in the development process allows for real-world testing, uncovering potential design flaws and usability issues.
  • Peer Reviews: Encourage regular peer reviews of design documents, code, and other artifacts to catch errors and improve the overall quality of the product.
  • Model-based Design: Utilize model-based design approaches, such as Model-Driven Architecture (MDA), to create detailed models that can be verified before implementation.

Risk-Based Approach

Incorporate a risk-based approach into V&V activities to focus resources on critical areas. Identify potential risks associated with product failure and prioritize verification and validation efforts accordingly. This approach ensures that resources are allocated efficiently, concentrating on areas with the most significant impact on product performance and safety.

Independent Verification and Validation (IV&V)

Consider engaging external experts or teams for independent verification and validation. External parties can provide an unbiased assessment of the product, uncovering issues that internal teams might overlook due to familiarity or assumptions. Independent verification and validation bring additional expertise and ensure a higher level of confidence in the product’s quality.

RELATED: How to Achieve Higher Levels of the Capability Maturity Model Integration (CMMI)

Continuous Integration and Continuous Delivery (CI/CD)

Implementing CI/CD practices allows for continuous verification and validation throughout the development process. Automated testing and deployment pipelines can quickly detect regressions and integration issues, ensuring that the product remains stable and reliable throughout its evolution.

Documenting V&V Activities

Comprehensive documentation of all verification and validation activities is essential for compliance, knowledge retention, and continuous improvement. Properly documented V&V processes help maintain a historical record of changes, failures, and resolutions, facilitating future product iterations and troubleshooting.

V & V are integral to successful product development, ensuring that products meet the required specifications and perform as intended. By adopting best practices such as early integration, clear requirements, a mix of v&v techniques, risk-based approaches, and continuous verification, companies can create high-quality, reliable products that customers love and gain a competitive edge in the market. Moreover, investing in verification and validation from the outset of development can save time and resources, prevent costly delays, and lead to higher customer satisfaction and loyalty in the long run.


Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share excerpts from an article, sourced from MedTech Dive, titled “Q&A: How Monogram’s CEO Plans to Disrupt Robotic Joint Replacement Surgery” – originally written by Susan Kelly and published on August 4, 2023.

Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

Permission granted by Monogram Orthopedics

Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and Zimmer Biomet as well as smaller challengers in the growing market for robot-assisted joint replacement. CEO Benjamin Sexson, an engineer by training, sees a pressing need for personalized implants made to fit each patient’s specific anatomy.

This interview has been edited for length and clarity.

MEDTECH DIVE: What are some of the challenges in knee replacement that you are trying to solve with your surgical robot?

BENJAMIN SEXSON: The idea is to move away from what’s called mechanical alignment, which is how we’ve always done it with manual instruments. A lot of the robots on the market today are just basically helping surgeons put the knee into mechanical alignment – everybody gets the same knee, the joint line is basically restored to be parallel to the floor.

With functional, or more personalized, alignment approaches, surgeons are tweaking the plan based on, I have my patient’s specific data, I have the CT scan, and I can assess intraoperatively what do I think looks best? And they can make very, very precise and accurate tweaks to the surgical plan that, over time, we’re seeing are enhancing patient satisfaction.

Stryker and Zimmer both have the ability to use a CT scan or advanced imaging to preoperatively plan. Stryker has been driving this trend. Stryker is showing that patients are happier when you can do some degree of personalization of the surgery.

Other players in the space have been struggling [because] they are imageless. They made the bet that insurance companies would not be as accommodative in the future to reimbursing the cost of the CT scan, and so their surgeries correlate to generalized models. We think that over time, this is going to be increasingly problematic for those other players.

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

Monogram Orthopedics plans to seek FDA clearance for its mBôs TKA System, a surgical robot that it aims to use for multiple orthopedic procedures, starting with knee replacements.
Permission granted by Monogram Orthopedics

What gives you confidence that there is room for another robot in the orthopedic marketplace?

Investors generally [say], “Well, everybody already has an orthopedic robot.” OK, but really only two companies are CT-based, and only one of those companies is actually [using surgeon-initiated] cutting. So there’s really only one navigated, efficient, cutting, CT-based robot, and that’s Stryker, and they have 90% of the market. And only 10% of knees today are robotic. So there’s a huge opportunity.

It’s inefficient for a small-footprint private clinic to be forced to buy five-plus different robots, one that’s good for the spine, one for the hips, one for the knees, one for the shoulders, one for the ankles, etc. The fundamental difference between our philosophy and our competitors is that Monogram seeks to develop one robot optimized for many applications.

Why did you decide to focus first on the knee market?

I’ll start by saying that our robot is not a knee robot. It’s an orthopedic robot. It just so happens that knees are our first application for a number of reasons. One is that we didn’t want to go on a missionary effort trying to convince people in, say, the shoulder space, to use an orthopedic robot and develop a whole new surgery. We wanted to come into a market that already had billing codes and an established market presence and some level of acceptance.

There are about a million knee replacements a year in the United States, and about 10% of those fail every year. And a lot of people are not satisfied with their knee replacement. We think we can make it a lot less scary and a lot less risky.

Where are you in the process toward gaining FDA approval?

We’ve had what’s called a pre-submission meeting with the FDA. This is a 510(k) submission, so we’re going to be claiming substantial equivalence to a system that’s already on the market. Where we are is, the FDA is accepting of our clinical pathway. They’re accepting of our predicate [Stryker’s robot] and intended use. The question that’s still outstanding is whether or not the technical differences with our predicate need to be tested with clinical data. Our plan is to take a defensive approach and submit to the FDA with clinical data. Our plan is to lean heavily on capturing that data outside the U.S.

RELATED: Revolutionary Surgical Robotics Company, Monogram Orthopedics, Selects Jama Connect® For Its Unique Cloud Based Services and Ease of Use


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


Image showing a lock for security in product development

“While the security of IT hardware and software has strengthened in recent years, the security of Internet of Things (IoT) … has not kept pace,” Microsoft’s Digital Defense Report 2022.

The Internet of Things (IoT) promises a flood of amazing new products, including autonomous cars, networked medical devices, home automation, and new devices in industrial applications. But data breaches affect millions annually, and there is real fear that hacked devices could be used for surveillance, fraud or even weaponization. With 17 billion IoT devices in the world the surface area for attack dwarfs that of traditional computer malware.

Make Security a First-Class Citizen During Development

Too often with IoT devices, security is an afterthought; sometimes it even gets scrapped due to time and resource constraints. But organizations cannot provide reliable security after the fact. Security must be addressed from day one, by both product development and leadership.

Consider architecture: There are many chipsets available that provide a security architecture for embedded devices, but less than 4% of new devices in 2018 include embedded security. The explanation for this oversight is obvious: Development begins without security in mind, leading to an architecture that omits it. And it’s not feasible to change the underlying architecture of a product after release to account for security.

RELATED: Four Key Considerations When Choosing a Cloud-Based Engineering Tool Provider

OtA Updates Should Be a Requirement

Many devices that are shipped to consumers have little to no update mechanism, or their update mechanism requires the customer to be aware of an update and go through a cumbersome process. This inevitably leads to out-of-date software that is an easy exploit for hackers.

Just like the PC industry, IoT developers must embrace secure, OTA updates to keep their customers safe. It is not enough just to offer updates; developers should push security updates to devices that are connected to their services. This is not just good business practice; it protects the service provider’s critical SaaS infrastructure as well.

The Argument for Security in IoT Devices

Security is often seen as a cost, but if you understand it correctly, you can turn it into a value proposition or a competitive advantage that customers are willing to pay a premium for. For instance:

  • Today’s customers are increasingly concerned with security and privacy. Companies like Apple can charge a premium because they address these concerns.
  • Insufficient security can lead to counterfeiting.
  • Good security increases brand value and decreases the risk of brand erosion.
  • Security is required by law, and failure to comply can result in heavy fines.

RELATED: What is DevSecOps? A Guide to Building Secure Software

Security as an Integral Part of Product Development

Once you recognize the importance of security, it’s logical to make it an integral part of your product development process. This means, amongst other things:

  • Security is part of the stakeholder needs and therefore must be part of the core requirements. This also applies to regulatory requirements, such as those derived from legislation like GDPR.
  • Make sure your architecture fits your security requirements, since architecture is one of the most difficult (and expensive) things to change after the fact.
  • Ensure your security requirements are tested. You achieve this by maintaining correct end-to-end traceability from requirements to test results.
  • Collaborate on all levels. If you want to prevent security from being patched on an ad-hoc basis, make sure that all teams communicate properly. For instance, an engineer might be tempted to write custom code to detect a Denial of Service (DoS) attack, but this might be addressed more efficiently on the architecture level.
  • Implement a product line strategy and perform systematic reuse. Security extends to the complete lifecycle of products, so you must be prepared to provide security updates for years to come. Also, reuse allows teams to use previously tested elements, improve quality and accelerate development.

Embracing security today provides more than just a competitive advantage – it may be crucial for survival. While a product development platform alone is not enough to address security, it is an integral component for implementing security policies and frameworks.


In this blog, we recap our webinar, “Accelerate Your ECSS Standards Compliance with Jama Connect®“. Click HERE to watch the entire thing.

Streamline your systems engineering efforts and ensure your products meet all the necessary industry standards.

Jama Connect® enables digital transformation with a more efficient and user-friendly approach to managing space systems development. It can optimize your systems engineering efforts and ensure your products meet all the necessary industry standards.

Learn how to incorporate regulations governing European space systems development into your Jama Connect solution. In this webinar, we discuss how customers can leverage a library of the European Cooperation for Space Standardization (ECSS) standards right inside their Jama Connect instance.

Cary Bryczek, Director of Aerospace & Defense (A&D) Solutions at Jama Software® along with fellow A&D experts Alisa Eikanas and Martijn Janssen, provide a high-level overview of the ECSS standards, along with best practices for leveraging them within Jama Connect, including:

  • ECSS Process workflows and how they align with processes managed within Jama Connect
  • Establishing an ECSS Library in Jama Connect to provide a Single Source of Truth
  • Explanation on how to tailor the ECSS requirements and leverage Jama Connect’s Reuse capability

Below is an abbreviated transcript of our webinar.

Accelerate Your ECSS Standards Compliance with Jama Connect®

Cary Bryczek: So welcome to today’s webinar. I am Cary Bryczek, the Director of Aerospace and Defense Solutions. I lead up a global team of industry and Jama Connect experts. For today’s webinar, two esteemed members of the team will be speaking. First to speak is Martijn Janssen. Martijn is a senior consultant at Jama Software. He has been working with PLM and requirements management solutions for over 15 years and is very proficient in not only Jama Connect but the Siemens industry software solutions as well as PTC Windchill. He currently works on implementing space-related systems such as satellites, launchers, and space-related components in the European Union for our Jama Connect partners. Martijn is a specialist in both systems engineering and information technologies.

We are also joined by Alisa Eikanas. Alisa is a senior consultant at Jama Software. She has over 15 years of experience supporting multi-discipline engineering teams and brings more than 10 years of experience as a business analyst to Jama’s customers. She works with our largest US government and commercial space customers in the US and she’s an expert at helping customers migrate data from legacy requirements tools such as Doors to Jama Connect. And with that, I’ll pass it over to you Martijn.

RELATED: Jama Connect® for Space Systems Datasheet

Martijn Janssen: Well, thank you for the introduction there, Cary. So welcome everybody to our webinar on ECSS. I’m very excited today to introduce you to the way we manage ECSS standards within Jama Connect. Over the past couple of years, we’ve been working with a lot of customers on managing ECSS standards within our solutions, and today we’re going to show you some examples of how we manage to do that.

So without further ado, I’m going to go over some of the ECSS standards, which include,  the use cases our customers face, and then afterward Alisa will dive into the system and show you some of those use cases in action in Jama Connect. Let’s dive into the presentation.

When we talk about ECSS, and I presume many of you here already are aware, but for those of you that are not aware of ECSS, ECSS is a European Cooperation and it’s a collaboration between the ESA, the European Space Agency, and many different other space agencies across the world to make sure that we have a single set of standards that we can use across companies working in the European space activities. Many of our customers around the world are looking to those standards, making sure they’re compliant with them, and working with those standards in different projects and at different levels.

So ECSS is a standard. You can find a lot of information on the website for ESA about the standards. They’re all there to be found if you’re not aware of them already. The way that ECSS is organized and set up is something you will see in the standards on the website itself, but we also have the organization within our Jama Connect application. So once Alisa’s going to show the demo, you will recognize a lot of those structures in Jama Connect.

RELATED: CIMdata: Digital Thread in Aerospace and Defense

Janssen: So when we talk about the standards, the standards are divided into branches and disciplines. So you will find, for example, the different branches on the top level there. So for example, the space project management branch or the engineering branch. Below those branches, you will find a lot of disciplines detailed per section. They are numbered in a specific way. Again, when we look into the demo, you will see a lot of those specific annotations come back and we maintained that same structure within Jama. So many of our customers use a subset or a number of these standards in their Jama Connect application to make sure they are compliant and they are working towards the standards that ESA has set for these specific projects. So the main structure in here is recognizable towards what is on the websites and in the organization of ECSS.

Outside of the actual organization of the disciplines and the branches, the disciplines themselves are even further, let’s say detailed in documents. All these documents fall into one of those disciplines. So for example, when we look at the discipline of system engineering, you can see a large number of documents below that, talk about different topics. So for example, on testing, on verification, on referencing coordinate systems, all kinds of documents describing the standard, what you need to do to be compliant towards those standards.

Now these documents are pulled into Jama Connect. And as you will see later on, we have all these documents available for you to start tracking and tracing compliance. So the structure from a branch to a discipline to all the documents is something that you will recognize in the demo later on by Alisa and where you can find and filter and search for certain topics that are numbered and maintained by the ESA.

To watch the entire webinar, visit:

Accelerate Your ECSS Standards Compliance with Jama Connect®


MDR/IVDR

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Regulatory Focus™, titled “MDR/IVDR Survey Shows NBs Have Increased Capacity” – originally written by Ferdous Al-Faruque and published on July 31, 2023.

MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity

A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.

The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.

Between 22 October 2022 and 31 Marodiech 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951.

The survey found that in October 2022 there were 22,793 products on the market with valid certificates under the Medical Device Directive and Active Implantable Device Directive (MDD/AIMDD) which means that applications for about half of those products have been submitted for transition by March 2023, and about 35% of MDD/AIMDD products submitted for transition to MDR were submitted since October 2022.

Similarly, the data shows the number of IVDR applications received by NBs has gone up more than 15% from 822 in October 2022 to 950 in March 2023, and the number of certificates they have issued for the products has gone up 24% from 268 to 331 during the same period.

“This progress is good news, [but] the survey results should be interpreted with some caution,” Sabina Hoekstra-van den Bosch, global director for regulatory strategy at TÜV SÜD GmbH and vice-president of Team-NB, told Focus.

RELATED: An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)

While the survey takes into consideration data through 31 March 2023, Hoekstra-van den Bosch says it doesn’t take into account any potential effect of the MDR extension that went into effect on 23 March 2023. She says it is likely the effects of the delay are only now showing up in the data and notes NBs have shared new data through the end of June with the European Commission which may offer a clearer picture. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

“Everyone hopes and expects, that the number of applications will increase rapidly,” said Hoekstra-van den Bosch. “[But] another expectation is that the number of certificates will rise much more slowly than the number of applications, as Regulation 2023/607 gives time until 2027/2028 to finalize certification, while in the meantime manufacturers are allowed to keep the legacy device on the EU market.”

Hoekstra-van den Bosch says calculating the transition rate for products getting MDR certified is complicated and can be interpreted differently.

She notes that the current number of AIMDD/MDD products that need to be recertified is probably being underestimated since under MDR certificates will need to be given out for products such as class IIb implantable devices that require separate certificates. On the other hand, grouping basic UDI-DI products under MDR may also mean an increase in the number of certificates.

Hoekstra-van den Bosch says the MDR extension and publication of a Medical Device Coordination Group (MDCG) guidance encouraging manufacturers to not wait until the last minute are all good signs and if left unheeded may still result in bottlenecks for products getting recertified. (RELATED: Euro Roundup: EU answers questions about the extension of MDR transition, removal of ‘sell off’ periods, Regulatory Focus 30 March 2023)

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

“The [Austrian National Public Health Institute] survey shows some hopeful signs, but the ‘proof in the pudding is the eating,’” Hoekstra-van den Bosch said. “We are eagerly anticipating the publication of the next editions of the European Commission’s survey results.”

Gert Bos, executive director of the Qserve Group, says his main concern about products transitioning to MDR/IVDR has to do with communication between NBs and manufacturers.

“On the one hand many notified bodies indicate they can handle more applications, whereas manufacturers are not all speeding up their processes to get to the application phase,” he told Focus. “Meanwhile, companies on their second and third dossier may currently be waiting for 12 to 18 months to get feedback on their responses to the previous rounds of questions.”

Bos says there is plenty of guidance on how the new MDR system should work but there is still not enough guidance on what is considered sufficient evidence regarding clinical support, toxicity, biocompatibility testing, and general performance testing.

“The good news is that the structured dialogues between manufacturers and notified bodies are starting to bring clearer expectations,” he added. “So, we are going slowly in the right direction.”

Bos is also concerned that when applications do get feedback from NBs, they may contain deficiencies that could have been addressed in the first review round.

The survey sheds some light on the topic and lists the key reasons for why an MDR application was refused and shows some interesting trends.

In October 2022, the top two reasons were insufficient NB resources or because the application was outside the scope of the NB’s designation, with 61 and 66 applications being refused for those reasons, respectively. However, the top three reasons given for an application refusal in March 2023 were the wrong qualification or classification of a product with 74 refusals, the application was not complete with 80 refusals and the application was outside the NB’s designation with 208 refusals.

RELATED: European Union Medical Device Regulation (EU MDR): What You Need to Know

The number of refusals due to insufficient NB resources dropped to 31 which shows that NBs have started to significantly increase their capacity to handle incoming applications.

Bos is also worried that while global production processes have significantly improved in the past three decades, it has come to a halt due to delays in the MDR transition process.

“The problems rise to the level that such reviews on supply chain and production change approvals are starting to take priority over the more lengthy full MDR review processes,” he said. “This might in the coming 12 months fill the spare notified body capacity, in which case we’ll be walking straight into a further bottleneck when too many MDR and IVDR applications come in the second half of next year.

“Again the message is clear: Don’t delay your MDR and IVDR applications, but talk with your notified body about having the elements of the continued improvement reviewed in parallel,” he added. “It might free up the blocked production processes and will be useful in the full application as part of the new production has already been reviewed by the notified body.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Survey

© 2023 Regulatory Affairs Professionals Society.


Blog image for MIL-STD-810 showing engineer holding a clipboard.

MIL-STD-810: Ensuring Quality and Reliability in Challenging Defense Environments

From the desert to swamps to the frozen tundra, the United States Department of Defense (DoD) created the Military Standard 810 (MIL-STD-810) to enforce manufacturers deliver a product that will not fail in operational environments. This compliance regulation outlines environmental engineering considerations for testing equipment’s durability, performance, and quality in challenging and harsh environments. The blog will explain the significance of MIL-STD-810, its purpose, and how it impacts industries and consumers worldwide

Understanding MIL-STD-810

MIL-STD-810, widely used by commercial, non-military entities as well, prescribes a series of tests and procedures that have been created to measure the durability of equipment and its ability to survive in tough conditions.

Initially published in 1962, the standard has been regularly updated to keep up with technological developments and the varying environmental conditions. MIL-STD-810 thus serves as a useful tool for manufacturers, guaranteeing that their products can withstand the toughest circumstances.

The Purpose of MIL-STD-810

Defense contractors and manufacturers are required to meet the requirements outlined in this standard to sell their equipment to the U.S. military. MIL-STD-810 is used to ensure operability of equipment in conditions it may come across during its service life. The standard provides a broad selection of environmental factors and tests to go with them, allowing companies to find any weak points and make the necessary changes. By following this standard, it will help to improve the reliability and robustness of their product, resulting in successful harsh environment operation and a longer life in the field.

RELATED: Jama Connect® Airborne Systems Solution Overview

Key Environmental Factors Tested under MIL-STD-810

  • Temperature: Equipment is exposed to a broad range of temperatures, from frigid cold to blazing hot, to make sure its performance and security are up to the task in different climates.
  • Humidity: Checking the humidity level helps to guard the device from harm and ensure it functions properly in areas with high levels of moisture.
  • Shock: Devices are tested by subjecting them to mechanical shocks, such as drops and vibrations, to replicate real-world conditions and to evaluate their structural soundness and operation.
  • Vibration: The MIL-STD-810 outlines a variety of different vibration tests to simulate any transportation or operational movements that may affect the performance or parts of a device.
  • Sand and Dust: The capability of the equipment to resist being exposed to tiny particles such as sand and dust that are commonly seen in desert and arid areas is appraised.
  • Altitude: Checking the equipment’s operation at various altitudes determines its capacity in different air pressures, guaranteeing its dependability in high-altitude zones.
  • Solar Radiation: Evaluating the equipment’s response to solar radiation helps manufacturers understand its performance in outdoor environments with direct sunlight exposure.
  • Rain: Devices are tested to withstand exposure to rain and water, preventing water intrusion and potential short circuits.

Impact on Industries

    • Military and Defense: MIL-STD-810 is mandatory for military and defense contractors. Ensuring equipment works well in harsh conditions is vital for military operations. Compliance reduces the risk of equipment failure in critical situations.
    • Aerospace and Aviation: The aerospace industry uses MIL-STD-810 to make equipment for aircraft and space missions. The standard makes sure that equipment can handle extremes in flight and space conditions.
    • Consumer Electronics: MIL-STD-810, originally intended for military use, has been embraced by consumer electronics producers. This has resulted in the production of rugged smartphones, tablets, and laptops for those with a fast-paced lifestyle or who do their work in demanding settings.
    • Industrial Equipment: Industrial equipment and machinery often must endure difficult conditions, such as those found at construction sites and mining operations. By following MIL-STD-810 guidelines, manufacturers are able to produce sturdy and resilient machinery that can endure these types of settings, reducing the need for maintenance and repairs.

RELATED: Requirements Traceability Diagnostic

Conclusion

The MIL-STD-810 is of major importance in the assurance of the quality and dependability of equipment across myriads of industries. By undergoing multiple environmental examinations, companies can notice and tackle possible problems before their equipment is delivered to customers and stakeholders. This guideline has not only ensured reliability of military devices but has also played a role in the construction and production of commercial electronics and industrial machines.

In a world where technology is more and more ubiquitous, MIL-STD-810 remains a fundamental point of reference in managing the difficulties of hostile and unpredictable environmental conditions. Its impact will remain, prompting manufacturers to construct reliable and rugged devices that meet the requirements of the DoD and commercial customers across the world.

How Can Jama Connect® Help?

Jama Connect®‘s digital engineering strategy is essential for any organization seeking to increase efficiency and reliability. It serves as an essential bridge between teams, optimizing design and engineering processes. With its comprehensive system view and dependable source of information, it is an invaluable asset for achieving success.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Cary Bryczek.