Tag Archive for: Product Development & Management

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

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 Spyrosoft, titled “CE marking for Medical Device Software: a step-by-step guide” – originally authored by MAŁGORZATA KAWAŁKOWSKA.

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

The recent introduction of EU MDR brought many changes to the CE marking certification process for medical devices. There are more requirements to fulfil, which makes the process more complex and much more time-consuming.

To avoid a scenario where the only thing that stops you from releasing your Medical Device Software to the market is the ongoing CE marking certification, you should know when to take the first steps in this process and how to include it in your overall business strategy.

From this blog post, prepared based on an interview with Krzysztof Minicki, Director of Healthcare and Life Sciences, you’ll get to know the steps of the CE marking process for Medical Device Software. You’ll also learn your responsibilities as a manufacturer, and thus get a better understanding of how to plan and optimise the process to avoid possible bottlenecks.

ToC:

  1. Does your software need a CE marking certification?
  2. How to get the CE marking certification for Medical Device Software in the EU?
  3. How to do CE marking self-certification?
  4. How long is the CE marking certification valid?
  5. How much does it cost to get CE marking certification?
  6. How long does the CE marking certification process take?
  7. Need support in the CE marking certification process?

Does your software need a CE marking certification?

Since the introduction of EU MDR in May 2021, the software is now classified as an active medical device. All Medical Device Software that is released to the EU market is required to have the CE marking. Otherwise, it cannot be sold within the EU.

CE MARKING AFTER BREXIT

As of January 1st, 2021, any type of business collaboration between the UK and EU countries got a lot more complicated. So did the CE marking process, which has gone into the transition period ending on January 1st, 2023 – medical companies operating on the British market will be obliged to receive UKCA certification instead of CE marking, with medical products sold in Northern Ireland still requiring the latter. Healthcare products that require to be assessed by a Notified Body will need to be check by an UK Notified Body rather than a EU one.

How to get the CE marking certification for Medical Device Software in the EU?

As a Medical Device Software manufacturer, regardless of whether or not you outsource the manufacturing process, you are responsible for acquiring the CE marking.

In general, the path towards obtaining the CE marking depends on the medical device’s class. Since, in the light of the EU MDR, Medical Device Software is considered as an active medical device, the majority will undergo the upclassification and will belong at least to class IIa.

As per the EU MDR rules, medical devices from classes IIa, IIb and III, have to go through the conformity assessment conducted by a Notified Body. A Notified Body is a third-party organisation, accredited by a European Competent Authority, that checks compliance with the MDR. As a medical device manufacturer, you can select which Notified Body you want to do the assessment for you.

Now, let’s move on now to what the CE marking process for Medical Device Software looks like step by step.

RELATED: 2023 Predictions for Medical Device Product Development

How to do CE marking via self-certification?

1: IMPLEMENT A QUALITY MANAGEMENT SYSTEM

As you determine the classification of your Medical Device Software and appoint a person responsible for regulatory compliance in your organisation, the next step is to create and implement a Quality Management System in accordance with Annex VIII of the MDR and ISO 13485. The compliance must be assessed and certified by a Notified Body. Moreover, the Quality Management System must include Clinical Evaluation, Post Market Surveillance and Post Market Clinical Follow-up plans.

2: PREPARE THE TECHNICAL FILE

In the Technical File you have to include the information about the Intended Use of your Medical Device Software, all the testing reports as well as the Clinical Evaluation Report, your risk management plan and other information specified in Annex II of the MDR.

3: REGISTER IN THE EUDAMED DATABASE

Register your Authorised Representative who will handle the regulatory matters as well as your company as a medical device manufacturer in the EUDAMED database. It’s important to note that the authorised representative is mandatory only for importers outside of the EU.

You don’t necessarily have to do it at this point. It can also be done earlier or later in the process.

4: PREPARE A DECLARATION OF CONFORMITY

The next step for you, the manufacturer, is to prepare a Declaration of Conformity. It’s a legally binding document in which you affirm that your Medical Device Software is compliant with the MDR. At this stage, your product becomes officially CE marked.

5: REGISTER THE MEDICAL DEVICE SOFTWARE IN THE EUDAMED DATABASE

Now it’s time to register your software in the EUDAMED database. Keep in mind, that the UDI number must be placed, for example, in the “footer” or “About” section or other visible and easy-to-access places.

That’s it – your Medical Device Software is ready to be sold on the EU market. Your duty as a manufacturer is now to keep it safe and effective. In this regard, the EU MDR requires that manufacturers conduct Post Market Surveillance Activities. Also, each year you will undergo a Notified Body surveillance audit to ensure continuous compliance with the EU MDR. If you fail to pass it, your CE marking may become invalid.

During the transitional period, the manufacturers are required to perform the Clinical Evaluation and Post Market Surveillance Activities required by MDR, even though their CE marking certification for class I is still valid.

How to CE mark your software if it falls into a higher risk class?

The certification of software that belongs to a higher risk class requires the involvement of a Notified Body. A Notified Body shall audit the quality management system to determine whether it meets all the regulatory and product requirements. If the quality management system conforms to the relevant regulatory provisions, the notified body shall issue an EU quality management system certificate. After that, the declaration of conformity can be signed. Then, the product can be registered in the Eudamed database and finally introduced into the market.

Specific requirements depend on the characteristics and the level of complexity of a product as well as the risk associated with using it, which directly translates into the scope and timeframe of the audit.

How long is the CE marking certification valid?

The CE marking certification for classes IIa, IIb and III is valid for up to five years. After the five-year period, the registration of the certification must be renewed. It’s key to have it on the radar and plan the process in advance. It’s recommended to start the registration renewal at least six months before the certification expires.

How much does it cost to get CE marking certification?

The total cost of the CE marking certification process is proportionate to a device’s class. The higher the class, the bigger the risk and the more complex the process. Hence, the cost is also higher. The CE Marking certification is the most expensive for class III devices and can reach even tens of thousands of dollars.

RELATED: Euro Roundup: MDCG Publishes Guidance on MDR, IVDR Authorized Representative Requirements

How long does the CE marking certification process take?

Since there are still very few Notified Bodies, conducting the conformity assessment may take quite a long time. The time to begin a Notified Body audit varies between half a year and a year. In comparison, under the MDD it was usually a quarter. The time between an audit and approval may take up from two to even seven months.

Why so long? The EU MDR brought in more requirements, especially for the QMS. This makes the whole process more complex and time-consuming.

One of the reasons why it takes so long is also that there are few Notified Bodies that got already accredited in compliance with the new MDR requirements.

Currently, the MDR requires Notified Bodies to make their price list public. However, it’s worth noting that it includes the hourly rates. It’s especially important to keep in mind when introducing a product to the market for the first time (also for the first time since the MDR came into force) as it requires more than one audit to be performed. Firstly, the Notified Body checks the readiness for certification and after a few months it conducts the certification audit. It significantly impacts the cost. The yearly surveillance or recertification audits are performed once per year.

In total, the CE marking certification process may last more than a year. It’s important to take it into consideration when planning your business strategy. For example, you can optimise the process by creating an MVP first and start the CE marking Certification in the meantime, while at the same time developing your product further on.

Need support in the CE marking certification process?

We provide a technical file ready to be assessed for conformity by a Notified Body. Moreover, our specialists can conduct an independent conformity assessment before the official one to check what areas need improvement.

The software we create is compliant with all legal requirements, especially the IEC 62304 and ISO14971. In addition, we provide a Technical File and offer consultation and support with completing the CE marking certification process.

For more information, use the form at the bottom of this blog to contact Krzysztof Minicki, Director of Healthcare and Life Sciences.

TSMC is Building a Second Chip Plant to Meet US Semiconductor Demand – SUNSETTED

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 Engadget, titled “TSMC is building a second chip plant to meet US semiconductor demand” – originally published on December 6, 2022, and authored by Steve Dent.

TSMC is Building a Second Chip Plant to Meet US Semiconductor Demand

The expansion marks one of the largest direct foreign investments in the US.

The White House and Taiwan Semiconductor Manufacturing co. (TSMC) have announced plans to build a second chip plant in Arizona, AZCentral has reported. That will boost the company’s investment in the state from $12 billion to $40 billion, while heavily reducing US reliance on semiconductor imports.

Both TSMC factories combined will produce 600,000 wafers per year. “At scale, these two [plants] could meet the entire U.S. demand for U.S. chips when they’re completed,” the National Economic Council’s Ronnie Chatterji told CNBC. “That’s the definition of supply chain resilience. We won’t have to rely on anyone else to make the chips we need.”

The newly announced factory will produce cutting-edge 3-nanometer chips by 2026. The expansion marks one of the largest direct foreign investments in the US and the largest in Arizona. TSMC recently upgraded its plans at its first facility as well, announcing it will now manufacture 4-nanometer instead of 5-nanometer wafers. The first chips are set to be manufactured there starting in 2024, with Apple and NVIDIA reportedly among the first customers.

RELATED: Jama Connect® for Semiconductor Software: Modernize and Digitize the Requirements Management Process

The CHIPS and Science Act allotted $52.7 billion in loans and other incentives, plus billions more in tax credits, to encourage US semiconductor manufacturing investment. The legislation aims to boost private financing in chip manufacturing in the US.

President Joe Biden is set to visit the site of TSMC’s first plant later today, but the White House announced other related news yesterday. The US Department of Commerce and the European Commission are striking a deal to implement an “early warning mechanism” related to semiconductor chain disruptions following a pilot program last summer. The aim is to improve forecasting of semiconductor supply and demand to achieve a balance between the two.

RELATED: Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™

At the same time, the EU and US are implementing a “transparency” mechanism around public support provided to the chip sector. In other words, one side won’t blindside the other with unexpected semiconductor subsidies that could put either at a competitive disadvantage. A similar issue came up during a recent visit by French President Macron, as EU leaders complained that the US Inflation Reduction Act was unfair to non-American companies.

Collaboration

Jama Connect® Features in Five: Collaboration

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 Jama Connect®’s powerful features… in under five minutes.

In this Features in Five video, Carleda Wade, Senior Consultant at Jama Software, walks through how to collaborate with others users in Jama Connect.

In this session, viewers will learn how to:

  • Use the comment widget to @mention a user or group
  • Leverage action tags to designate high-priority comments
  • Use the Stream tab and the project dashboard stream view to see comments
  • Filter for comments that require action

Follow along with this short video below to learn more – and find the full video transcript below!

VIDEO TRANSCRIPT:

Carleda Wade: Hi, I’m Carleda Wade, Senior Consultant at Jama Software. By the end of this training, you’ll be familiar with how to collaborate in Jama Connect and have the confidence and basic skills to begin interacting with other users in the application. In this session, we will use the comment widget to @mention a user or group, leverage action tags to designate high-priority comments, use the stream tab and the project dashboard stream view to see comments, and we will filter for comments that require action.

RELATED: Carnegie Mellon University Software Engineering Program Teaches Modern Software Engineering Using Jama Connect®

Wade: So now let’s jump back into Jama Connect. As you can see, I’m back on the homepage. You can see bookmarks and recently viewed items on the left-hand side, and on the right-hand side, you’ll see active reviews and then stream activity in the bottom right-hand. If I click on the view all stream activity link here, it will bring me to this stream tab. From here, if I want to I can see all of the comments that are across the various projects within my Jama instance.

I also have the ability to apply a filter to, let’s say, look for any open questions, and when I do that, you’ll see any question that doesn’t have a resolution that’s being open. I can choose to reply to this or answer this question directly from here by clicking on answer question. And then when I answer this question, not only will you see it presented here in this stream, but if I go back to my project, this information, once I refresh this, will show up here in my activity stream. So here you can see both the comment as well as the response. From my dashboard, this activity stream will be a comprehensive viewing of not only changes made in the project but also comments that are made within the project. Here if ever I could choose to do a search for, let’s say, Joe, and anything that either was created by Joe or has Joe tagged will show up. Also, from this dashboard, I can click on the stream.

RELATED: Jama Connect® vs. IBM® DOORS®: Document Generation: A User Experience Roundtable Chat

Wade: This stream view will show me only comments that are made within my project. And once again, just like in the stream view for the full instance in the top header, I can apply filters if I like. Back to my project explorer, if I choose to, let’s say, look at my system requirements and maybe I want to look at climate monitoring, in this single-item view, I also have the ability to review comments. So if you have it enabled, you can click on review comments and see any comments that are made as part of the review module, or clicking on the comments will allow you to be able to interact directly with this particular requirement. So I could choose to create this comment, and maybe I want to have the person who owns this. So I want to have Joe, so I can @mention Joe to say, “Hey, can we clarify this?”

And then I can actually mark this action as a question. And when I do this, Joe will get an email notification that says that he needs to come into Jama and be able to reply to this. Joe would also have the ability to reply to his email, and that information will be added to this thread. But not only can I @mention a single user, but I also have the ability to @mention, let’s say, my risk team. And when I send this notification, every person who’s a part of that user group will get a notification, and once again, they can come in and start making comments directly. But let’s say, for whatever reason, after I make a comment that I decide that I need to delete it, or I inadvertently delete it.

So even though I just added this comment for the risk team, let’s say I choose to delete this, you’ll see the confirmation message that says to confirm, and let’s say I choose to delete it. But fear not because anything that happens in Jama stays in Jama. So now if I navigate out of the single item view back to the dashboard, when I… Let’s clear that. When I refresh my page you can see for the activity stream that this item is showing that it has been deleted. But if I want to, now I can click on restore, and all is well. Now you’ll see this comment is showing as un-deleted. So just to summarize, there are a number of different ways to be able to collaborate and comment on content within Jama. So just pick what works best for you, depending on where you are within the system at the time.

Thank you for watching.

To learn more about available features in Jama Connect, visit: Jama Connect Features

We hope you’ll join us for future Jama Connect Features in Five topics, including Risk Management, Reviews, and more.

2023 Predictions for Industrial and Consumer Electronics Product Development

As we enter 2023, Jama Software® asked selected thought leaders – both internal Jama Software employees and our external partners – across various industries for the trends and events they foresee unfolding over the next year and beyond.

In the third part of our five-part series, we asked Beau-Colby Thomson – Associate Account Executive at Jama Software – Vlad Tanasescu – Global Industrial Sales Lead at Jama Software – and Steven Meadows – Principal Solutions Lead at Jama Software – to weigh in on Industrial and Consumer Electronics (ICE) product and systems development trends they’re anticipating in 2023.

Click the following links to visit part 1 – 2023 Predictions for Product & Systems Development Teams – and part 2 – 2023 Predictions for Aerospace & Defense Product Development. We will link the remaining 2023 Industry Predictions as they are published.

2023 Predictions for Industrial and Consumer Electronics Product Development

What product, systems, and software development trends are you expecting to take shape in 2023 as it pertains to the ICE industry?

Beau-Colby Thomson: Industrial robotics and automation adoption will continue to grow at a rapid pace to combat labor shortages and growing product demand.

Industrial Internet of Things (IIoT) + edge computing use cases are growing year over year. This will introduce complex software development to product lines that historically may have been mostly hardware + firmware. The addition of a new discipline into product development organizations may result in disruptions to existing processes.

Energy Storage continues to be an area of focus for the world. As more utility infrastructures fail and the cost of renewable energy decreases, the demand for energy storage systems will grow.

Fusion/Fission/Nuclear is becoming more widely accepted (more so in Europe than in North America). The development of these products takes many years at a time to complete, however the headcount of the engineering organizations for these companies continues to grow now.

Steven Meadows: The Internet of Things (IoT) continues to become more prevalent across all industries. Everyday consumer electronics like laptops, home appliances, and tablets are manufactured with an increasing number of sensors and inputs that transfer data to different networks and applications. Improved remote monitoring of these systems can also be enabled through IoT helping customers to maintain their products with ease.

Cloud computing also continues to grow across the software industry. Cloud is becoming the golden standard allowing for more flexible, cheaper, and sustainable solutions. Companies increasingly rely on cloud computing for projects and daily activities, without the need for managing system administration, upgrades, and security.

DevOps is constantly evolving with more companies utilizing a unified software development approach, allowing for code to be delivered faster with improved quality. This means there is less time spent on the integration of teams, infrastructure management, and the deployment of code. Product managers continue to push for the implementation of DevOps, finding it critical to deliver their products at a lower cost, and with better quality outcomes.

Vlad Tanasescu:

  • Robotics: autonomous factories, warehouse and delivery robots, AgriRobots (agriculture), humanoids.
  • IoT: smart homes/cities, connected devices, antennas, remote controlling.
  • Digitalization of the railway industry.
  • Smart energy solutions, especially given the current energy crisis.
  • Digitalized heavy machinery.

RELATED: ISO 26262 Second Edition Introduces Updates to Functional Safety in Road Vehicles

In terms of product and systems development, what do you think will remain the same over the next decade? What will change?

Thomson: The increasing level of connected products will drive more systems development maturity in organizations that fall under Industrial, Consumer Electronics, and Energy (ICE).

I believe over the next decade the struggle with writing ”good” requirements will not change.

Tanasescu: What will remain the same?

  • More software (SW) in systems, intelligence and autonomy in systems.
  • More autonomy.
  • Focus on smart / green energy (wind farms, etc.)
  • Innovation within roboticsand IoT.

What will change?

  • Functional Safety will become more important for industrial products.
  • New regulations will be introduced for robots as the technology evolves.

Meadows: Product development companies will continue to invest heavily in digital platforms which will help to streamline their processes, improve quality of their products, and improve team collaboration. Excel and Word are antiquated solutions that do not give product teams the necessary capabilities to handle complex development, so requirement solutions and Application Lifecycle Management (ALM) tools will continue to see an uptick in investment going forward.

There will continue to be an emphasis placed on functional safety with the functional safety devices market set to hit $10 billion by 2030. This means teams will need to prioritize functional safety throughout their development process to ensure that products are safe for industrial or private use. Development companies will continue to invest in the certification of their products, conforming to functional safety standards such as IEC 61508. This gives vendors and customers increased confidence in the overall quality of their manufactured systems.

RELATED: IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing

How do you foresee regulations shifting in ICE product and Systems Development over the next decade?

Thomson: We will definitely see more safety regulations imposed as products are introduced to the real world and unforeseen risks occur. I believe these will be both safety and cybersecurity related regulations.

This is mostly for automated technologies and energy products, potentially cybersecurity for connected consumer tech or IIOT applications.

Tanasescu: More dedicated FuSa (functional safety) standard will appear for robots, IoT devices, and autonomous systems as these technologies become more embedded in society.

Requirements engineering, traceability, risk analysis will become increasingly important.

Any major disruptions to the ICE product and systems development industry you’re anticipating in 2023?

Thomson: The predicted recession may have an impact on consumer spending therefore consumer technology development. Companies may also be reducing funding to innovative R&D or incubation projects.

Tanasescu: I’m not sure about 2023, but I believe that over the next 10 years the robotics sector will grow exponentially.

Over the next years the traditional home appliance manufacturers will need to become IoT companies and focus on connected devices.

What sorts of process adjustments do you think development teams will need to make to be successful in 2023?

Thomson: Standardization & maturity.

Tanasescu: Work as agile as possible, even in regulated fields, while maintaining engineering rigor. Embrace a best-of-breed tooling approach. Enable collaboration across many global stakeholders.

RELATED: Considering DOORS® for requirements management? There is a more modern solution.

What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?

Thomson: The ability to achieve executive initiatives to get products to market quicker while minimizing defects found after launch

Tanasescu: Investment in engineering. Understanding the value of structure and measurable product definition. Understanding of the future trends and the importance of software driven & connected devices, autonomous systems and digitalization.

Meadows: Development companies need to embrace a proactive approach to safety and quality when developing their systems. By incorporating functional safety throughout the product lifecycle, companies are much more likely to release safe and market leading products. These companies, and their customers, will experience greater long-term benefits than those companies that manage their safety and quality processes reactively.

By educating development teams on how to define requirements from the stakeholder level down to component, companies will have a better chance of building exactly what they intend to. By incorporating AI to help with requirements definition, teams can gain a competitive edge and author requirements in a concise and meaningful way.

What advice would you give to new companies entering the ICE industry?

Thomson: Build your house on bricks, not sticks. Leverage as much outside expertise/tools and focus your engineer’s efforts on innovation.

Tanasescu: Start with a structured, process driven approach when it comes to the use of development tools and traceability processes early on to best enable scale across the development programs, as the business will grow.

Meadows: When entering the industrial and consumers electronics industry, there are a lot of areas to consider when it comes to product development. Primarily, new companies should educate themselves on applicable standards and product development best practices. They should also consider certification in different areas including functional safety to make their products more marketable across a broader range of geographies and customer profiles.

What topic(s) do you wish companies were paying more attention to?

Thomson: It would be ideal if companies analyzed their engineering deficiencies and understood the amount of capital that gets wasted money in product development.

Tanasescu: Engineering predictability. Advantages of using a best –of-breed toolchain.

Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2023 approaches?

Thomson: Hopefully as an integral part of the best of breed landscape. The biggest expectation we can point our customers towards is our ability to measure project health through traceability and requirement scores.

Tanasescu: Jama Software will continue accelerating the time to market efforts of ICE companies, make development more predictable and measure product development efficiency. Jama Connect® will keep enabling ICE innovators to succeed globally. I see Jama Connect as an expert in complex requirements engineering, traceability in systems engineering which serves its customers as a trusted innovation partner.

Our customers can expect continuous investment in and commitment to our product and ICE industry solutions.

Meadows: As systems become more complex with increased connectivity between interfaces and networks, the need for a best-in-breed product development platform that enables Live Traceability™ is critical. Gone are the days when teams could get by documenting requirements, tests, and risks in Excel and Word.

To speed time to market, produce better and safer products, teams need to adopt digital solutions, giving them a competitive advantage. Jama Software continues to invest heavily in its core platform, Jama Connect. We have been incorporating AI capabilities to improve requirements authoring, enhancing integration options with other best in breed applications and always bringing out new capabilities to support the development of some of the most complex devices on the market today.

Migration & Data Mapping

Jama Connect® vs. IBM® DOORS®: Migration & Data Mapping: A User Experience Roundtable Chat

Increasing industry challenges and complexities are pushing innovative organizations to consider modernizing the tool(s) they use for requirements management (RM). In this blog series, Jama Connect® vs. IBM® DOORS®: A User Experience Roundtable Chat, we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.

In Episode 6 of our Roundtable Chat series, Richard Watson – Practice Director at Jama Software® – and Alisa Eikanas  – Senior Consultant at Jama Software® – discuss migration & data mapping, and how to migrate your DOORS® data to a new tool.

To watch other episodes in this series, click HERE.

Watch the full video and find the video transcript below to learn more!

VIDEO TRANSCRIPT:

Richard Watson: Hi everybody, I hope you’re all enjoying watching the vlog so far and that you take the time to watch some of the others. I’m Richard Watson, and I’m part of the solution management team at Jama Software. In this vlog, I’ll be giving the DOORS angle on things. I’ve been a systems engineer for about 35 years, 20 of which was as the product manager for DOORS and DOORS Next. I now spend much of my time advising clients on migration strategies to Jama Connect. Today I’m joined by Alisa, who’s going to give the Jama side of things.

Alisa Eikanas: Hello everyone, and good morning Richard. My name is Alisa Eikanas, and I’ve been a consultant here at Jama Software for just about five years. In that time, I’ve supported hundreds of successful implementations and have extensive experience supporting customers with complex migration needs, so I’m tickled to be here.

Richard Watson: Organizations are often black and white when it comes to migration. Either they believe migration is too risky to form, and so they’re stuck in their current tool, or they trivialize things, and they think it’s as simple as pressing a button and everything is done.
In my experience migration isn’t complex, but it does involve taking a lot of very small decisions and then repeatedly executing against those decisions when you’re migrating the data itself.

Alisa Eikanas: Mm-hmm, I couldn’t agree more. I often use the analogy of moving to help illustrate this very same point to customers. When you’re making the decision to move to a new house, the benefits are obvious. A bigger house, better schools, et cetera, and there’s things you can do to make that moving process more efficient. You can hire a mover and do all of that stuff, but there’s no shortcutting the fact that you still have to label the boxes, tell the movers where they have to go.

So again, we can take care of the heavy lifting, but that attention to detail is something that’s not ever going to be avoided. And it might seem tedious, but it’s so necessary in order to avoid unnecessary frustrations if not given the proper attention at the proper time. There are typically two blocking points regarding migrations.
So first, management would like to… The migration process itself to be predictable so that they can follow the progress and predict how long it will take. Ultimately, what they’re trying to avoid is disruption to work, additional costs, making sure that the proper resources are available during that process. And secondly, for end users themselves, they expect the migration to run smoothly and for us to be able to demonstrate that the migration task has been executed without error.

For example, I was recently working on a migration with a team and the data that we were migrating from DOORS Classic, they’ve been working on that data for 20 years and some of the original engineers are still involved in the project. And so, you can imagine for them how stressful it is to consider 20 years of their work being moved and just wanting to make sure and not have any fears or reservations.

That as the data was moved, that there would be no negative impacts to that data. So it’s completely understandable, but again, these are things that Jama Connect has found ways to address proactively to ensure that both of those concerns… Having the efficient be predictable so that it can be efficient and not overly expensive. As well as for end users, just ensuring again that data integrity is maintained from point A to point B.

RELATED: 2023 Predictions for Product & Systems Development Teams

Richard Watson: Generating a business case for migration is also often terribly difficult. In fact, it’s very difficult to justify moving from IBM DOORS to IBM DOORS Next because it’s more of an emotional decision. One reason to move away from DOORS is the aim to adopt more of a model-based systems engineering approach. If you have that, then it becomes consistent for your engineers, easier to create reports, and cheaper for integrations.
We all know that without DLX, it’s terribly difficult in DOORS to keep a consistent data model between your different modules. Thinking about consistent data types between modules, for example. DOORS Next, unfortunately, is very much the same as DOORS. While it has got shared information types within a component, those types are independent of other components and other projects. So you can very quickly have different data sets in DOORS Next that diverge apart exactly the same as you do inside DOORS.

Alisa Eikanas: Yeah, I would add that there’s typically always a great deal of desire to migrate, but defeating the perception that it’s an insurmountable obstacle can be tricky. This, as in many other cases, is where Jama Software really excels and exemplifies our customer-centric approach to solutions. We don’t treat or expect our customers or their data to be the same.

So, before we even begin a migration effort… Or for those of you that are considering looking into migration, Jama Software offers a free DOORS data model diagnostic service, providing a financial breakdown of the benefits, removing your DOORS data to an MBSE approach. And following that migration, your data, both old and new, we’ll consistently respect the data model defined by your organization within your Jama Connect instance.

Richard Watson: Another fallacy is that sticking to a single vendor for migration makes things simpler. Migration tools must be stronger between those tools from the same vendor. So DOORS, migration to DOORS Next is not the case, unfortunately. So DOORS Next is a wholly new requirement system, it’s just like moving to a different tool from a different vendor.

The data inside of DOORS Next is very different to DOORS, so it’s not a natural upgrade. You do have to do data migration. When adopting a new requirements tool, it’s really important to establish that data model so that you can exploit the benefits of the new tool with a consistent data model.

Migrating your data from DOORS to DOORS Next attempts to recreate your DOORS data in DOORS Next exactly as it used to look like in DOORS, and that leaves the reshaping of that data to the end user. We all know that the end user will typically not clean the data once he starts using DOORS Next, and so inefficient data in DOORS effectively becomes inefficient data inside of DOORS Next.

Alisa Eikanas: Absolutely, and what you’re talking about is a missed opportunity. That opportunity to recognize we can look at our data, see that perhaps we’re not treating it consistently or in a standardized way. And as we’re migrating that data, there is an opportunity to, again, apply a data model that’s going to be consistent and afford you so many benefits.

So, when approaching migrations here at Jama Software, firstly we identify. We work with organizations to identify and define the data model most appropriate for your development process, and then we migrate your DOORS data into that model. This doesn’t result in compromised data in any way, but it avoids the mass reshaping or cleaning of data after it’s been migrated.

Jama Software brings over 150 years of shared DOORS experience that we can bring to bear in helping clients migrate to Jama Connect. And in addition to that, we have extensive experience supporting customers going through that actual process of moving their data from DOORS or D&G into Jama Connect.

RELATED: When Evaluating Product Development Software Tools, Not All Cloud is Equal

Richard Watson: Alisa, perhaps the best thing to do next is simply to take a look at the tool. Should we take a look at Jama Connect?

Alisa Eikanas: Absolutely, let’s take a look at a project in Jama. But before we actually start poking around the project itself, let’s start with that data model we’ve been talking about. So, what we’re looking at here on this project dashboard is a rendering of that data model. So if we take a look at this example, we see that we have user needs, we have system requirements, system architecture, subsystem requirements, et cetera.

And in addition to showing each of those artifact types or item types, we also show the traceability paths between them. So for example, here we see our system requirements, and we see that we have those traceability lines established between the appropriate artifact types. We’re not ever going to see a user need directly connected to a subsystem requirement because through our data model, we’re just ensuring that that proper decomposition path is respected.

So again, that process of… As we’re migrating our data, taking the opportunity to identify and to establish a data model is just incredibly powerful and beneficial to our teams. Once we establish that model, and again, we’re going to migrate your data into that defined data model, we want to ensure that that transition is still comfortable for DOORS users. So again, this data model might be new, but the data is still the same.

It’s the same data that they had in DOORS. So that transition from DOORS to Jama is, for the most part… Or, it is a very comfortable one. Navigating around the project itself feels very similar for DOORS users, and I’ll give you an example of that. So, for example, if you’re looking at a DOORS project, you might see a folder with a number of modules located underneath that folder. And then of course, within our modules we’re going to have our individual objects.
So here we’re looking at a Jama project, and what we’re looking at is the project explorer. This will probably visually look similar enough to DOORS users, and what I’ve done is I’ve built out just a quick little example here. So, Jama has a different container name for this, but it’s essentially a DOORS folder. And then underneath that DOORS folder we’re going to see our individual modules listed out, and then if we open up one of our modules we’re going to see our individual objects.

Heading objects as well as our regular requirement or text objects. And that same hierarchical document structure that was established in DOORS, we’re able to carry that over seamlessly in Jama so that for DOORS users, again, it’s… Everything looks and is organized the same way that they’re used to seeing it, and it just makes it very comfortable.

But going back to that added benefit of having an established data model, for example, if I open up this system requirement, if I’m looking at the traceability information, here I can see that the system requirement has a parent, it has a child. But in this downstream bubble right here, I see that it’s red. That’s telling me that there’s a problem, it’s obviously not that it doesn’t have any children because I can see that, again, this user need has…
Or, that this system requirement has a parent user need and a downstream subsystem requirement. So, taking this example of a system requirement where Jama is telling me, “Hey, we’re missing some required coverage.” If I go back to that data model and I take a look at my system requirement, I can see that yes, I’ve satisfied that need to have a parent user need, and I’ve satisfied that need to have a child subsystem requirement. But I’ve yet to satisfy that need for a downstream architecture and a downstream verification.

So again, this is a very brief glimpse of the many benefits of having that established data model. But most, I would say the key takeaway again is that we can kill two birds with one stone. We’re migrating you to a more efficient system and tool as well as just ensuring that we’re able to also bring in efficiencies to your process by establishing that data model.

Richard Watson: That’s cool Alisa, thank you very much. So, that brings us to the end of this vlog for today. Hopefully, you’ve had some high-level overview of migration. Alisa, thank you very much for your discussion and perspective, that was super useful to actually see the tool.

I hope those listening to the vlog do have a reasonable starting point for migration, and I look forward to hearing about your successes in the future. We truly hope you’ve been enjoying this vlog series so far, stay tuned for the next entry in our series, it’ll be coming in a few weeks’ time. Thanks very much, Alisa.

Alisa Eikanas: Yep, thank you.

Is your data working for you? A consistent and scalable data model is instrumental for achieving Live Traceability™ and making data readily available across the development lifecycle.

Download our Jama Software® Data Model Diagnostic to learn more!

Thank you for watching our Episode 6, Jama Connect vs. IBM DOORS: Migration & Data Mapping. To watch other episodes in this series, click HERE.

To learn more about available features in Jama Connect, visit: Empower Your Team and Improve Your Requirements Management Process

We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.

2023 Predictions for Aerospace & Defense Product Development

As we enter 2023, Jama Software® asked selected thought leaders – both internal Jama Software employees and our external partners – across various industries for the trends and events they foresee unfolding over the next year and beyond.

In the second part of our five-part series, we asked Craig E. Miller, PhD – Principal Engineer at Ansys, to weigh in on product and systems development trends he’s anticipating in 2023.

Visit part 1 of this series, 2023 Predictions for Product & Systems Development Teams here. We will link the remaining 2023 Industry Predictions as they are published.

Read more about the author at the end of this blog. Note: The opinions expressed are those of Craig E. Miller, PhD.

2023 Predictions for Aerospace & Defense Product Development

Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact A&D product, systems, and software development?

Craig E. Miller: The most common design trend — one that will continue in the short and long term — is identifying how a digital transformation can enable a connected digital thread. A connected digital thread enables an organization to realize efficiencies encompassing all design teams, how these teams exchange data, and how enterprises will exchange data. A&D companies that can weave the design digital thread with business will become industry leaders. The digital thread can significantly improve efficiency relating to supply chain, energy, and safety. For example, virtually certifying subsystems — to quickly add suppliers to approved vendor lists — can add flexibility to supply chains. Coordinating digital hardware design, embedded software, and data (from T&E and/or the field) can enable trade studies to optimize energy efficiency of complex systems and can identify failure modes and expedite design modifications on existing (and future) platforms for continuous improvement.

Biggest Challenges – What are some of the biggest challenges you think A&D engineering firms will be working to overcome in 2023?

Miller: Probably the biggest problem that A&D firms need to solve is balancing resource allocation. How do you fulfill your future digital strategy without compromising short-term production work? Another significant challenge is managing supply chains, as global conflicts and inflation threaten to disrupt them. I would also add workforce enablement and cross-pollinating primary engineering efforts across aeronautics, space, and cyber as important challenges with respect to maintaining a competitive edge.

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

Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2023?

Miller: Enabling virtual certification and coordinating virtual hardware design with software and data both require standards and regulations on virtual engineering. Such standards and regulations need to be coordinated among government, academia, and industry, and consortiums should start as soon as possible.

Tool Innovation – From an A&D engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process, and why?

Miller: Aerospace and defense firms recognize that making the right choices, early, is the only way to succeed against the dual problems of increasing complexity and decreasing timelines. And one of the best ways to improve decision making is through engineering simulation standards, some of which are being developed right now. These standards should capture contextual metadata, facilitate collaboration, and make it easier to share knowledge within an organization — all of which contributes to faster, better-informed decisions.

It will be vital for the industry to support and adopt effective standards in the years ahead. And the challenge goes beyond development and adoption, because you have to manage the transition, too. In other words, if you adopt a standard without defining a clear path from “here” to “there,” you risk your teams developing ad hoc approaches, and that leaves you once again without a standard.

In your opinion, what are the biggest differences between an A&D company that survives to see 2030, and one that doesn’t?

Miller: The biggest discriminator has to be the ability to adapt to increasing complexity on shorter time-scales. These two pressures are everywhere, and they compound each other.

What advice would you give to new companies entering the A&D industry?

Miller: Take advantage of hard-earned wisdom and start with the right approach. Common traits of successful digital transformation initiatives are an open ecosystem, mission-centric alignment across teams, and a connected digital thread to facilitate and maintain that alignment. This is the what established firms are trying to achieve, but to get there they must contend with their legacy data and processes, as well as promoting a cultural transformation to enable this journey.

RELATED: Integrating Requirements Management with Planning and Checklist Processes for Aerospace Development

Predictions –

What do you predict for regulation in the A&D industry in 2023?

Miller: Certification for process and people. Regulation of training standards for people supporting a digital transformation. What coursework, certifications, etc. are required when matriculating from traditional design and manufacturing into modern environments? And this isn’t a question just for design and manufacturing engineers — it applies equally to management, to track that change process.

Will those trends still be prevalent 5 years from now? 10 years?

Miller: The trend of digital transformation will evolve for the next 5-10 years. There are many aspects of an A&D business that digital transformation will affect, and each will have its own prioritization that dictates the short- and long-term tasks to enable their digital strategy.

About the Author:

Craig E. Miller, PhD – Principal Engineer at Ansys

Craig Miller is a Principal Application Engineer with ANSYS Inc, where he leads several multiphysics simulation efforts for the Aerospace & Defense industry. Prior to ANSYS, he designed and analyzed a range of products, from nuclear reactors to fiber optic devices. Craig was a Graduate Research Fellow while earning his Ph.D. at the University of Maryland and earned his BS in Engineering Science at Penn State.

Jama Software® Partners with Sterling PLM (Now Vantage Medtech): Expands Lifecycle Management and Live Traceability™ Expertise OfferingsIn this blog, we recap our press release on Jama Software® partnering with Sterling PLM.

Jama Software® Partners with Sterling PLM (Now Vantage Medtech)

Expands Lifecycle Management and Live Traceability™ Expertise Offerings

Jama Software®, the industry-leading requirements management and traceability solution provider and Sterling PLM (now Vantage Medtech), an industry leader in engineering management problem-solving, have partnered together to expand expertise and offerings across requirements management and Live Traceability™ solutions.

“Jama Software’s world-class consulting organization — that spans across multiple verticals including medical device development — will be greatly complemented by this partnership with Sterling PLM. Sterling PLM expands on our already comprehensive services that drive measured improvements across product development processes that result in faster time to market and higher product quality.”

Tom Tseki, Chief Revenue Officer at Jama Software®

Jama Connect® is the only platform that delivers Live Traceability™ across engineering disciplines through the entire product development process to reduce defects, delays, rework, and cost overruns. Sterling PLM‘s team has decades of combined experience consulting in highly regulated industries for a variety of medical device manufacturers. By partnering with Jama Software, Sterling PLM (now Vantage Medtech) will collaborate and support lifecycle management services around configuration, training, and process development.

“At Sterling PLM, we have years of experience cultivating superior technical and lifecycle management know-how. We pride ourselves on our ability to anticipate problems before they become apparent to our clients. We are excited to add Jama Connect to our arsenal of technology solutions, adding to our capability to apply our specialized expertise and customized approach to solving problems for our clients.”

Dan Sterling, President, Chief Executive Officer, and Founder at Sterling PLM

Jama Software has consistently been listed as the leader in Requirements Management software tools by G2® for the fourth consecutive reporting period. By combining Sterling PLM’s customized solutions and seasoned expertise in lifecycle management technologies and Jama Software’s industry-leading requirements management and traceability offerings, Jama Software and Sterling PLM will continue to accelerate transformation to serve the needs of medical device developers.

“We’re especially excited to leverage the expertise and experience of the Sterling PLM (now Vantage Medtech) team with our Medical Device customers. They’ll be a great addition to our out-of-the-box solutions for medical device developers and provide specialty services such as computer systems validation and legacy tool data migration.”

Vincent Balgos, Director, Medical Solution at Jama Software

About Sterling PLM
Sterling PLM helps engineering companies across the globe implement proven processes that govern the design and development of their engineered products while leveraging software that tracks processes with greater visibility across the enterprise. Our team has decades of combined experience consulting in highly regulated industries for a variety of manufacturers—from small start-ups to large global organizations—and we’ve spent years cultivating unique skills and concentrated expertise in the business of engineering. We specialize in regulatory-compliant software programs that help customers track the project artifacts that they care about—across the entire project lifecycle.

About Jama Software
Jama Software is focused on maximizing innovation success. Numerous firsts for humanity in fields such as fuel cells, electrification, space, autonomous vehicles, surgical robotics, and more all rely on Jama Connect® to minimize the risk of product failure, delays, cost overruns, compliance gaps, defects, and rework. Jama Connect uniquely creates Live Traceability™ through siloed development, test, and risk activities to provide end-to-end compliance, risk mitigation, and process improvement. Our rapidly growing customer base of more than 12.5 million users across 30 countries spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, financial services, and insurance industries. For more information about Jama Connect services, please visit www.jamasoftware.com

Read the entire press release here:
Jama Software® Partners with Sterling PLM: Expands Lifecycle Management and Live Traceability™ Expertise Offerings

View Synonyms and Definitions

2023 Predictions for Product & Systems Development Teams

As we enter 2023, Jama Software® asked selected thought leaders – both internal Jama Software employees and our external partners – across various industries for the trends and events they foresee unfolding over the next year and beyond.

In the first part of our five-part series, we ask Josh Turpen, Chief Product Officer at Jama Software, to weigh in on product and systems development trends he’s anticipating in 2023.

We will link the remaining 2023 Industry Predictions as they are published. Read more about the author at end of this blog.

2023 Predictions for Product & Systems Development Teams

What product, systems, and software development trends are you expecting to take shape in 2023?

Josh Turpen: Natural Language Processing (NLP) is coming to the engineering space in a big way. Far from the “robot overlords” that have been feared, this technology is revolutionizing quality by spotting poor writing and anti-patterns as engineers are working, instead of late in the process during Root Cause Analysis (RCA) for test failures.

RELATED: Jama Connect Advisor™

In terms of product and systems development, what do you think will remain the same over the next decade? What will change?

Josh Turpen: Development will continue to struggle with the changing regulatory and security landscape. This has been a perennial problem in software and hardware is feeling it more and more with an increasingly connected ecosystem. I’m excited for tools that offer easy traceability to regulatory requirements. It makes it so much easier to validate everything from tests to requirements to regulations, ensuring that you’ve met the mark. This level of discipline should become the norm.

How do you foresee regulations shifting in product and systems development over the next decade? Or maybe just engineering, or systems engineering, in general.

Josh Turpen: Security and safety regulations for advanced technology will start coming with severe financial, and potentially criminal penalties. We’re starting to see the beginning of this, and it is high time the industry paid close attention. We’re moving beyond a point where security vulnerabilities are annoying and into a time where they will become casualty events.

Any major disruptions in product and systems development you’re anticipating in 2023?

Josh Turpen: I don’t think NLP quality linters will be a “major disruption” but more of a leading trend in quality focus in the systems engineering space.

What sorts of process adjustments do you think development teams will need to make to be successful in 2023?

Josh Turpen: The delta between those companies that have embraced a distributed workforce and those that haven’t will continue to grow. Those that still insist on collocated teams and “big meetings” for process control are going the way of the Dodo.

What do you think will be some of the differentiators between a company surviving to see 2030, and those that do not?

Josh Turpen: Embracing distributed teams and the technology that helps them be productive.

Organizations that define, measure, and improve processes are always going to outperform those that do not.

Josh Turpen: Companies that codify change into their process will dominate. They can absorb change, measure the impact, adjust accordingly and iterate. If your product development process can’t do this, it is what needs to change.

RELATED: How to Streamline Reviews and Collaborate with Remote Teams, Customers, and Suppliers with Jama Connect®

What advice would you give to new companies developing products or systems from scratch?

Josh Turpen: Define your outcomes! These can change as new information becomes available, but don’t underestimate the power of clearly stating your objective.

What topic(s) do you wish companies were paying more attention to?

Josh Turpen: Process measurement and improvement. It shocks me the number of companies that have a product failure and their “RCA” is a big meeting without data. As an industry we are awash in data and those companies that are using this data to improve will dominate.

Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2023 approaches?

Josh Turpen: We are the recognized industry leader and have the largest repository of systems engineering data on the planet. New capabilities built on that data, like the Jama Connect Advisor™
and our Industry Benchmarks are just the beginning of the journey. New capabilities to spot process issues and anti-patterns are on the horizon.

About the Author:
Josh Turpen, Chief Product Officer, Jama Software

With a deep background in software development and consulting, Josh oversees the ongoing innovation and refinement of Jama Software’s core product offerings. Beginning as an engineer, Josh’s career has taken him from Indiana to Germany, Colorado, and Portland. His work with the U.S. Department of Defense solidified his knowledge of safety-critical systems, and the vital role requirements and risk management plays within them. Having led product and engineering organizations, with teams distributed across the globe, Josh understands the daily challenges our customers face in a constantly changing marketplace and the tools they need to be successful.

DOORS

Jama Connect® vs. IBM® DOORS®: Document Generation: A User Experience Roundtable Chat

Increasing industry challenges and complexities are pushing innovative organizations to consider modernizing the tool(s) they use for requirements management (RM). In this blog series, Jama Connect® vs. IBM® DOORS®: A User Experience Roundtable Chat we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.

In Episode 5 of our Roundtable Chat series, Mario Maldari – Director of Solutions Architecture at Jama Software® – and Susan Manupelli – Senior Solutions Architect at Jama Software® – walk us through document generation and reporting in Jama Connect vs. IBM DOORS.

To watch other episodes in this series, click HERE.

Watch the full video and find the video transcript below to learn more!

VIDEO TRANSCRIPT:

Mario Maldari: Hello, welcome to part five of our vlog series. I hope you guys are enjoying the series so far. My name is Mario Maldari, director of Solution Architecture here at Jama. I manage a team of solution architects. Spent about the last 20 years working with requirements software tools and watching them evolve over time. Happy to have landed here at Jama where we’re working with the Jama Connect product, which is great tool as well as a great company culture. Joined by my friend and colleague, Susan Manupelli. Susan, would you like to introduce yourself?

Susan Manupelli: Sure. Thank you, Mario. So my name is Susan Manupelli. I’m a solution architect here at Jama Software. Prior to joining Jama, I was over at IBM where I worked on their engineering lifecycle management suite, primarily on the requirements management products. So Doors and Doors Next Generation. And I’m also happy to be here at Jama.

Mario Maldari: Thank you, Susan. And this vlog episode will be discussing document generation from requirements tools. And so we often encourage our clients to stay within the requirements tool for the purpose of versioning and tracking change on requirements. But there are valid reasons why you’d want to get your documents out. And that could be something from sharing your requirements with suppliers or customers, long term archival, submitting documentation to a formal documentation system. So many reasons why you’d want to get them out. And I guess the difference would be between the tools is how easy is that to do and how seamless can that transition to a document generation be. So Sue, I know you’ve worked with requirements tools in the past and specifically Doors Classic. And how is that experience for you?

RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense

Susan Manupelli: So, sure. So first for Doors Classic, you can print Doors modules using a standard print window and there is some control over what the printed output is going to look like through something called page setups. However, the challenge there is that it doesn’t actually export it to a common format like Word or PDF. So in order to actually generate a word or PDF document, you have to use another tool from IBM called Pub, it was renamed from Rational Publishing Engine. So that’s another tool outside of Doors.

Mario Maldari: I see. And is it the same for Doors Next?

Susan Manupelli: Yeah, so with DNG, the situation’s a little bit better. Out of the box, DNG does allow you to export certain documents to Word or PDF, but the challenge there is that there are very few customizations that can be done. There’s a few trivial settings that you can make when you’re doing your exports. But in order to actually customize the output, you have to use again Rational Publishing Engine. And there’s a few challenges with that. So first of all, it’s a separately licensed tool, so you have to pay extra for that. Second of all, using RPE requires a knowledge of the rest APIs. So you basically end up meeting a programmer to customize the reports for you and create that template. And then the third thing is in order to take the template from RPE and upload it into DNG, you have to have administrative privileges to be able to do that. So the users are really limited in what they can do from DNG.

Mario Maldari: Yeah. And how is that received by the customer base?

Susan Manupelli: I think it’s fair to say they would prefer a lot more flexibility for the users to be able to make some simple adjustments to the reports.

RELATED: Why Investing in Requirements Management During an Economic Downturn Makes Good Business Sense

Mario Maldari: Yeah, that makes sense. Okay. Well I’d like to show you how this is done in Jama. And let me share my screen and show you some options here. So in Jama, most views when you’re looking at your requirements, most of the views can be exported into either Word, Excel, PDF, or even a customized template. And so this is kind of interesting here and key. So customers often, if they’re exchanging requirements with stakeholders, they’ll want to put their requirements in a particular format with some branding or logos. And so you can do that easily in Jama by just modifying a Word document, uploading the template, and then once you have that template available, you can have your exports go into that format very easily.

So there’s a few different options here in terms of custom templates. You can create your own, which is great. And so when you’re looking at a view of requirements like this reading view, it’s easy to export it into Word. And let’s see if I have that up. And so you can take a look, and this is a customized template that I’ve created and you can see that the very basic one with just a logo, table of contents and then you see your requirements. The pictures in terms of the description as well as the name and some other information as well that comes in. So really easy to do that in Jama in terms of customizing your export template.
And if that’s not enough, we also have reports available out of the box canned reports with a number of different options that can be set down to Word or PDF. So a lot of different options in terms of pre-canned reports. But if the out of the box reports aren’t giving you what you need, then we also have a velocity engine where a lot of our customers create their own reports as well. And if they don’t have a skill set in that they can come to our services team and we can do that for you, which we do often all the time.

So a lot of different options in terms of getting your requirements out. And I think the key, you know, had mentioned flexibility, and I think that’s the key differentiator with Jama is to be able to have that flexibility, not only in terms of tools to get it out and export it into, but also to be able to customize.

Susan Manupelli: I agree, definitely for the end users to be able to do the kinds of changes that they need, straight Word is really a huge benefit.

Mario Maldari: Yeah, I agree. So just to summarize with Document Generation. We encourage you to work within your requirements tool, do everything you can, your reviews, your approvals changes your requirements. But of course there are cases where you want to get your requirements exported and I feel as though Jama does a really good job supporting that and providing the flexibility as well.

Susan Manupelli: I agree. Sounds great. Thanks Mario.

Mario Maldari: Yeah, Sue, I’d like to thank you so much for your time today and looking forward to having more of these vlog series. And yeah, take care and we’ll talk soon.

Susan Manupelli: Thanks. Bye guys.

Thank you for watching our Episode 5, Jama Connect vs. IBM DOORS: Review and Collaboration. To watch other episodes in this series, click HERE.

To learn more about available features in Jama Connect, visit: Empower Your Team and Improve Your Requirements Management Process

We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Migration & Data Mapping; Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.

Jama Connect® for Semiconductor Software: Modernize and Digitize the Requirements Management Process

In this blog, we’ll break down key elements of our Jama Connect for Semiconductor Software. 

Jama Connect® for Semiconductor Software

It can take months or even years to complete the development of a new chip. To avoid costly mistakes, semiconductor requirements need to be clearly communicated to the entire team across the development lifecycle. While most teams acknowledge their communication challenges, the risk of process change or adopting a new tool can be daunting. Jama Connect for Semiconductor provides an intuitive, leading-edge semiconductor requirements management solution for complex chip development with methods in use today by top manufacturers.

Supercharge Your Systems Development and Engineering Process

Jama Connect® is a solution for managing product requirements from idea through development, launch, and iteration. It brings people and data together in one place, providing visibility and actionable insights into the product development lifecycle. Jama Connect equips teams to analyze impacts, track decisions, and ensure quality of the product you set out to build.

Simplify Complex Product Development With Jama Connect

Jama Connect is a hub for understanding your complete product development lifecycle, enabling product managers and engineers to track requirements, decisions, and relationships on multiple levels to deliver compliant, market-driven products effectively. Jama Connect helps teams deliver high-quality products on time and on budget by aligning stakeholders, identifying risks early on and visualizing connections between regulations, requirements, and test cases throughout the development process.

Key Benefits

In the increasingly complex semiconductor industry, market forces are creating new challenges for semiconductor product developers. Jama Connect was designed to help teams:

  • Confidence – Trace requirements throughout the development process, illuminate risk, and proceed with confidence that you are building what you set out to build.
  • Visibility – Gain visibility into the product development process by monitoring relationships and dependencies between systems, teams, activities, and results.
  • Speed – Align teams, track decisions efficiently, and minimize rework to create high-quality products on time and on budget.
  • Adaptability – Easily adapt Jama Connect to your project and organizational workflows to create an intuitive experience so your teams can get up to speed quickly.
  • Performance – Benchmark and monitor team performance over time to understand the benefits of retooling your product development process. Store and reuse existing intellectual property and best practices from multiple product lines.
Download the entire Datasheet – Benefits of Jama Connect®: Supercharge Your Systems Development and Engineering Process 

RELATED: 3 Semiconductor Procurement Pitfalls To Avoid

How Jama Connect Helps Our Customers

Infineon Transitions From a Document-Centric to Data-Centric Development Flow with Jama Connect

Founded in 1999 as a spin-off of Siemens AG, German semiconductor manufacturer, Infineon Technologies AG is a world leader in semiconductor solutions that make life easier, safer, and greener. Ranking among the 10% most sustainable companies in the world, Infineon is a leading player in automotive, digital security systems, power and sensor systems, and industrial power control.

In our Infineon customer story, we examine how Jama Software helps Infineon manage complex product development subject to regulatory compliance and increase efficiency. Read the full customer story to find out how Infineon’s shift from a document-based approach to a more modern requirements management solution resulted in:

  • Better management of product complexities throughout the development cycle
  • Systematic handling of requirements from product definition to product development and verification
  • Improved collaboration with distributed teams both inside and outside of their organization
  • More effective exchange of requirements to ensure functional safety standards are met

RELATED: Enabling Digital Transformation in the Semiconductor and Hardware Space

INFINEON CUSTOMER STORY OVERVIEW

Database-centric approach increases the efficiency of Infineon product development

Jama Connect helped Infineon shift from a document-based approach to a more modern requirements management solution enabling newfound product development efficiencies around complexities, communication, reviews, and compliance.

CHALLENGES

• Keep the overview on ever-increasing product complexities and avoid requirements misunderstandings
• Provide compliance without compromising time-to-market goals
• Manual document versioning makes review cycles and alignment difficult
• Improve the review & sign-off process, making it an integral part of the requirement management system
• Need for enhanced reuse capabilities • Exchange requirements information with customers and suppliers
• Overcome the scaling limits of a document-centric approach

SOLUTIONS

• Jama Connect’s scalability supports complex projects
• Easier to show compliance to industry regulations
• Jama Connect Review Center supports an efficient process
• Provide requirements-accurate versioning to backtrace decisions
• Reuse requirements to shorten development cycles
• Digital exchange of requirements between customers and suppliers

RESULTS

• Better management of product complexities throughout the development cycle
• Systematic handling of requirements from product definition to product development and verification
• The traceability of requirements enables functional safety standards compliance
• Improved collaboration with distributed teams both inside and outside of their organization
• More effective exchange of requirements to ensure functional safety standards are met

Download the Customer Story – Infineon Transitions From a Document-Centric to Data-Centric Development Flow with Jama Connect