Tag Archive for: Requirements & Requirements Management Page 19
Tag Archive for: Requirements & Requirements Management
Jama Connect® Features in Five: Risk Management for Medical Device
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.
We always want to be respectful of your valuable time, but in this Features in Five video, we do go beyond the promised five-minute format to include an information-packed session. Join Vincent Balgos, Director of Medical Solutions at Jama Software®, as he walks through how risk management is integrated into the Jama Connect for Medical Device framework and how our new Lookup Matrix feature can fit seamlessly with your organization’s risk processes
In this session, viewers will learn how:
Jama Connect for Medical Device framework helps organizations align with regulations such as ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019
How to set up and utilize our new Lookup Matrix feature
Follow along with this short video below to learn more – and find the full video transcript below!
VIDEO TRANSCRIPT:
Vincent Balgos: Hi, my name is Vincent Balgos, and I’m the director of Medical Solutions here at Jama Software. In this video, I’m going to provide an overview of how Risk Management is integrated as part of our medical device framework offering. In addition, I like to show you a new feature called Lookup Matrix that can fit seamlessly with your risk processes in a few easy steps.
So when developing complex products, integrating risk management activities can be a complicated process, usually requiring experts from various functional groups. Without a connected tool, there’s a potential for fragmented risk activities across the different siloed groups. This may lead to an impact on the product, its function, its safety, and its users.
In Jama Connects out of the box medical device framework, the risk management process is already integrated with other elements of key product development. These practices are aligned with ISO standards such as 13485, design controls 820.30, and also, of course, 14971. Seeing the relationship diagram of the medical device framework that’s readily available out of the box, hazards are a standalone item type that allows users to identify hazards that come directly from the product’s intended use, which is compliant with ISO 14971 section 5.4.
Related to the hazards is a risk evaluation item type that contains fields that also align with 14971 best practices, such as hazard situation, sequence of events, harm and severity, and probabilities, both pre mitigate and post mitigate. The risk evaluation is in trace downstream to risk control requirements and their verification activities. This continues to comply with the standard of practice as defined in 14971. Let’s dive into risk analysis. I’d like to talk to you about our new Lookup Matrix. Released in 8.75, this new feature allows the use of dedicated pick list inputs to automatically output desired content based on a pre-configured lookup table. The Lookup Matrix offers an easy-to-use interface, which allows for seamless analysis within the tool, which aligns with your organization’s process.
Vincent Balgos: As you can see here on the right, here is the general setup process, which I’m actually going to walk through right now. Here’s the out-of-the-box medical device framework. If you go into the admin section, one of the first steps is really to configure the Lookup Matrix. In the admin section, the first thing you have to do is define your pick list. So if I go here on the left, as you can see here, I’ve already set up an example for my Lookup Matrix, but this is an easy task to do to create your own that you want. So, for example, if I need to create a brand new pick list, all I have to do is hit the green button here. We’ll call this new pick list or lookup. And the key thing is here is instead of choosing the standard, we actually need to select the new Lookup Matrix.
And what this does is it’ll create a brand new pick list where then you can go ahead and define the different options as you have in your other standard pick lists. As you can see here, here are some options that, again, taking it straight from 14971, some good examples for probability. Some info tips and some color and stuff like that. So you can see here, I’ve created four different pick lists that will serve as input into my Lookup Matrix. That’s step one.
Step two is then to actually create your Lookup Matrix. Select on Lookup Matrix. You can actually see that here’s a new field where you can configure your Lookup Matrix. I’ve already pre-established this, but if I hit the view button, I can see that my probability P1 and P2 pick list is actually input on both my X and Y axes. And I can actually determine what is that total probability based off these two inputs. The second Lookup Matrix that we need to create is the risk lookup acceptability. Which actually takes input from the probability total Lookup Matrix that we just talked about and then compares it against the severity of it.
From here, this is where then you can do a lookup analysis based off your organization’s risk management process. This is pre-configured, but if you wanted to create your own, it’s as easy as hitting a couple buttons. All you have to do is add a new Lookup Matrix. Now we’ll call this new Lookup Matrix. And then from here I just have to pick what are my input pick list. So for my X axis let’s pick severity, like we did before. And then, for my Y-axis, we’ll go ahead and pick the total probability. As for the values of it, this is where the risk acceptability value is another input Lookup Matrix pick list that we have to create.
Once you’ve established that, you go ahead and hit generate matrix, and then the bottom screen here, you can actually then configure your matrix per your organization. So, for example, here, I can click that this is low, but maybe here, this is where I want to actually then increase the level of risk. As you can see here, this is quite easily configurable and easily managed. Now that you’ve established your Lookup Matrix, the last part is actually configuring your item type fields. So for this particular example, I created a brand new item type called the risk evaluation Lookup Matrix. And one of the key things you have to do is actually identify that this is a calculated logic field and that you’d like to use your Lookup Matrix.
Vincent Balgos: As you can see here, here’s this has been predefined, but again, and if you wanted to add your own, it’s easy as adding your own field. So, for example, if we go ahead and hit add field, I go to customs, go ahead and hit calculate and logic. And we’ll say this is our new risk lookup. Once I come down to here, I establish that. For my calculation type, I actually just select Lookup Matrix. And then as my calculation source, I actually want to define my risk acceptability. And then here’s where then I define what are the fields to be used as input. So for this one here, it becomes pre-populated with the severity. But the next one is like, do I want to talk about pre-mitigated P-total or residual P-total? Why don’t we go ahead and pick residual. So that can establish your new field. Now that you configured your Lookup Matrix appropriately within your admin section, why don’t we jump to the project and see how that looks.
As you can see in this new project, I created this new item type called a risk evaluation Lookup Matrix. In the list view, as you can see, here are some pre-populated examples of this new item type with the Lookup Matrix functionality enabled. As you can see here, this follows the general standard best practice with 14971 in terms of identifying your hazards, sequence of events, hazardous situation. But more importantly, I identify what the severity is, the P1, P2, and P total. Again, based off your Lookup Matrix configuration, this is predetermined. But I can see here for this example, on my risk example five, that actually I have not identified what is my P1 mitigated. But this is really nice because with this view, you can take a look at seeing what has not been enabled, and then you can address it immediately right here on the screen. Let me show you how.
So for this particular example, I can see that my P1 hasn’t been defined yet. This is easily addressed by just go ahead and double click this. Let’s say with the, this is again, this is pre-mitigated, this is probably a more a probable type of event. I can go ahead and hit probable, and you can see that my “P total” is automatically updated again based off of my first Lookup Matrix. And then my risk level is also then determined based off that second Lookup Matrix that we’ve had here. If I further go down the list here, I can see I can go back and then see, hey, let’s define what our P1 mitigator looks like. So then with that, let’s say I put it in the risk controls and say, this is now improbable. I can go ahead and update based off of that. My “P total” has been reduced now to medium, but my risk level is still high. Again, this shows you can apply dynamic changes and analysis on your risk management activities on the fly.
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 Reviews, Dashboard Management, and more.
https://www.jamasoftware.com/media/2023/01/Karries-Copy-with-Edits-of-FIF-Risk-Management-5in5-intro.jpg10801920Vincent Balgos/media/jama-logo-primary.svgVincent Balgos2023-01-06 03:00:182025-04-18 13:57:58Jama Connect® Features in Five: Risk Management for Medical Device
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 final blog of this five-part series, we asked Steve Neemeh, CEO / CTO of LHP Engineering Solutions – Danny Beerens, Senior Consultant at Jama Software – and Richard Watson, Practice Director at Jama Software – to weigh in on automotive product and systems development trends they’re anticipating in 2023.
Read more about the authors at the end of this blog.
2023 Predictions for Automotive Product Development
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact automotive product, systems, and software development?
Steve Neemeh: A generation ago software was introduced in engine controls that changed the automotive industry and allowed for efficiency and emissions improvement that mechanical systems could not provide. In today’s world, software is entering a new stratosphere of complexity. Rather than focusing on emissions, the goal is the user experience. High-tech meeting transportation changes the paradigm for automotive companies.
Danny Beerens: I don’t see a lot has changed in this regard. What is changing is what’s being built, not how it is being built.
Richard Watson: Taking advantage of Live Traceability™ will become increasingly important.
Definition of Live Traceability: The ability for any engineer at any time to see the most up-to-date and complete up and downstream information for any requirement, no matter what stage of development it is in or how many siloed tools and teams it spans. This enables the engineering process to be managed through data, and its performance improved in real-time.
Biggest Challenges – What are some of the biggest challenges you think automotive companies will be working to overcome in 2023?
Neemeh: The commercialization of the zero-emissions vehicle is the biggest challenge for 2023. The price points are a challenge. The supply chains are limited and not optimized for worldwide expansion. And, the energy grids are outdated in many places, such as California.
In terms of product and systems development, what do you think will remain the same over the next decade? What will change?
Beerens: More and more brands will move to electric vehicles, making those vehicles and specifically their motor management components more software driven. The various other components (primary functions, driver assistance/automation, as well as onboard entertainment) will also become more electronically controlled and thus software driven.
[Side note] Autonomous driving vehicles even sparked new fields in Software Engineering, like Ethical Software Engineering (studies the interactions of human values and technical decisions involving computing).
Clearly the Automotive Industry is shifting from Hardware/Mechanical Engineering and Electo-Mechanical to Software Engineering, forcing Product Data Management, or Product Lifecycle Management, vendors to start including Application Lifecycle Management into their environments. Hence you see Siemens Teamcenter has acquired Polarion and PTC Windchill acquired Codebeamer recently.
The Holy Grail will be an ALM/PLM environment that truly embraces Configuration Management for all engineering disciplines involved, combined.
Anticipating a new player not hindered by their already existing PLM or ALM application, neither their customer base, to develop a truly all incorporating ‘Engineering Assets Configuration Management’ environment, platform or application.
For the next decade, next to fully autonomous driving vehicles, flying cars might be the new way to fight congestion and a more personalized way to get around.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2023?
Neemeh: With any new products in automotive, recalls will drive governments to regulate safety more closely. Functional safety is now a common term in automotive and most large OEMs are trying to find a way to comply and keep themselves from facing potential liability. The implementation of functional safety in the software development process will keep inching forward until a trigger makes it mandatory.
How do you foresee regulations shifting in Automotive Product and Systems Development over the next decade?
Beerens: Certainly, autonomous driving will introduce regulations to control not only functional safety and cybersecurity, but also for road safety (and legal responsibility) to interact with non-autonomous driven cars, until we’ve reached an era where none of us drive ourselves and all cars are controlled centrally to manage traffic flows.
Demands on alternative powertrains (e.g., hydrogen, or fuel cells) and existing electric driven cars’ necessity for fast charging and/or quick exchange of batteries, will spark off new technologies.
Apart from the obvious increase in data points and data exchange of the vehicle itself (sharing information for predictive maintenance, or usage of the car; tachograph in trucks) and its manufacturer and/or service station, G5 Connectivity of (autonomous driving) vehicles interacting with new traffic control instruments in, next to or on the road that assist with difficult traffic situations (automatically move to the side to allow emergency vehicles to pass), or location (purposely slow down at intersections that don’t have clear visibility of oncoming traffic) and react to traffic lights.
As a reaction to reduce CO2 emissions (cars sales are in a slow decline for a few years now already) new forms of mobility will arise where MaaS (Mobility as a Service) are being offered, sparking off disruptive newcomers to the traditional car sharing companies (renting: Hertz, and even taxi: Uber), like for example Lynk&Co, offering “memberships” for more flexible car usage and for car sharing with family and friends.
Tool Innovation – From an automotive 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?
Neemeh: Functional safety requires a strict development process and tools that support that process. Traditional tools only meet a small piece of that. They need to be integrated into an overall workflow and safety culture.
Any major disruptions to the Automotive Product and Systems Development industry you’re anticipating in 2023?
Watson: Political environment, supply chain issues, increased cost of specific items (such as chips). This increased cost is pushing the buyers into higher income areas, changing what kinds of cars will be successfully built.
Because of cost issues, refurbishing and retrofitting existing cars will become increasingly important. Similarly, car sharing will be increasingly wanted to control costs.
What role will cybersecurity play in automotive development in the coming year and beyond?
Neemeh: Safety can’t be achieved without cybersecurity. Assessment of your system’s vulnerability and its inclusion in your safety case is key to overall product acceptance. The more that cars become connected, the more this becomes important. Autonomous driving will be the pinnacle of connected cars. The more we move in that direction the more cybersecurity becomes a concern.
What sorts of process adjustments do you think development teams will need to make to be successful in 2023?
Watson: Automotive systems continue to have a stronger focus on software and this shift will continue. Different categories of software are provided in a vehicle from safety-critical to entertainment and this drives complexity sky-high.
With regulations continuing to get more stringent, development practices for non-safety-critical software systems must be tightened and this drives a focus to improve Agile practices. “Agile” is not an excuse to “throw something together” and must be supported by improved specification and verification techniques.
In your opinion, what are the biggest differences between an automotive company that survives to see 2030, and one that doesn’t?
Neemeh: Getting prototypes on the road and small-scale production with new technology (EV/Autonomous) is a monumental feat. The next step, however, is the commercialization of that technology into a transportation industry that is concerned about public safety. Those that consider that in the rollout and enable the scaling of safety-critical infrastructure will win, while the others will hit a brick wall of regulation.
Watson: A combination of sustainability with control of spiraling costs. There is a world shift in planetary awareness and the automotive market is at the forefront of reducing our consumption of fossil fuels. Car prices are increasing beyond inflationary rates and this increase will price out much of the lower market. Only organizations that can shuffle sustainability, quality and costs will survive this decade.
What role will cybersecurity play in automotive development in the coming year and beyond?
Watson: A shift towards Internet of Things (Iot) has exposed almost all aspects of automotive systems to the internet and social media. Cybersecurity will take a stronger focus, especially for those software systems that already interact with our social networking applications.
Beerens: Not only for our social networking applications; for long all systems utilizing the various onboard connections simply accepted instructions, without checking if that instruction was from a valid source. The infamous hack of a Landrover during Black Hack 2014 proved that. Encryption and intrusion detection are a good line of defense, but Zero-trust (or validating the source of the commands) Cybersecurity will be increasingly important for onboard systems from entertainment systems, connections like CAN, wifi, bluetooth or NFC, to motor management.
What advice would you give to new companies entering the automotive industry?
Neemeh: Get your workflows set up and your tools ready and optimized before you start throwing bodies at problems. Engineers are expensive. When they are set up properly, they can create miracles. But if they are burdened with administrative problems, they will get frustrated and leave.
Beerens: Look at established tool chains and industry templates to have a running start at the get-go. The European Union has an advisory board with such tool chains and templates. Concern yourself with compliancy from the beginning. Which compliancy standards you concern yourself with will depend on what parts of the auto you are working on.
Watson: Don’t try and define and invent the wheel and get help. There are many development tools available, find which tools work best based on tool reviews. Once selected, ask the vendor for the best way of working and don’t force the tool to do inefficient practices.
What topic(s) do you wish companies were paying more attention to?
Watson: Understanding how to address complex problems without the systematic nature we have relied upon. This is the only way to keep control of costs.
Predictions – What do you think will remain the same in your industry throughout 2023?
Neemeh: The adoption of electric vehicles will continue. Governments are behind it and the adoption rate is increasing.
What do you predict for regulation in the Automotive industry in 2023?
Neemeh: Involvement in the design process and review of ADAS features will become more important. The NHTSA has already started putting frameworks in place for that in the USA. In Europe, functional safety is commonplace and regulated already.
Will those trends still be prevalent 5 years from now? 10 years?
Neemeh: Yes, and it will move as fast as ADAS features move forward. Any autonomous Level 5 applications will jump-start this trend.
Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2023 approaches?
Watson: Jama Software® is perfectly positioned to help the automotive industry allowing extended stakeholders to be directly involved with authoring and reviewing specification and verification activities rather than relying on tool super-users and PDF reports.
Beerens: Jama Connect® is a perfect fit for Product Design and collaboration with all its Stakeholders to refine, expand and improve Product Design, before any of these (proposed) changes are even visible in a PLM environment thereby preventing disruptions in Production before consensus has been reached.
——————————–
About the Authors:
Steve Neemeh joined LHP in 2015 to lead the expansion of the west coast operations. He is the leader of the strategy and solutions architects as well as president of the delivery consulting organization. Steve has over 25 years of Functional Safety experience prior to joining LHP. Steve has launched multiple start-up operations and has taken them to full production. Notably, a complete ground up electronics and software development group to service commercial aerospace electronics and military vehicle power electronics. For LHP, Steve pioneered the implementation of safety critical applications in California, launching functional safety for autonomous driving applications as well as air mobility.
Danny Beerens has 15 years of experience implementing, training, maintaining and supporting Application Lifecyle Management processes and their environments. Danny started in Software Configuration and Change & Defect Management (i.e., Workflows.) After joining Telelogic, he moved into Requirements and Test Management over the last decade, in roles as Support Engineer, Process Engineer, Consultant, and System Architect. Throughout his career Danny’s worked on projects and collaborated with customers in the Medical Devices, Aerospace & Defense, Automotive, and Semi-conductor industries. “The need to integrate ALM and PLM (and even beyond!) is apparent across all industries.”
Richard Watson is the Practice Director for horizontal solutions, engaged in identifying and creating services and assets spanning the Jama Software vertical solutions. Richard has a client first attitude and is passionate about Requirements and Systems Engineering. Based in the UK, Richard has been working in the systems and software industry for nearly 35 years and has been directly involved in most aspects of Systems Engineering from testing flight systems, through to software development of modeling tools, and Product management of IBM DOORS. Richard joined Jama Software as Practice Director in 2021.
https://www.jamasoftware.com/media/2022/12/2022-12-1-2023-predictions-automotive-1.jpg5121024Richard Watson/media/jama-logo-primary.svgRichard Watson2022-12-29 03:00:112024-01-18 09:33:402023 Predictions for Automotive 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 fourth part of our five-part series, we asked Shawnnah Monterrey, CEO at BeanStock Ventures – Romer De Los Santos, Senior Consultant at Jama Software – Vincent Balgos, Director of Medical Device Solutions at Jama Software – Michelle Wu, Medical Device Consultant at Wu Consulting – and Ivan Ma, Medical Device Program Leadership – to weigh in on medical device product development trends they’re anticipating in 2023.
Read more about the authors and their organizations at the end of this blog.
2023 Predictions for Medical Device Product Development
What are the biggest trends you’re seeing in the medical device and life sciences industry?
Shawnnah Monterrey: Biggest trends we are seeing include a rapid migration to the cloud this includes: IoMT, Digital Health, Digital Therapeutics and Big Data such as Genomics, Biotech, and Pharma.
We are seeing a rapid shift towards newly derived clinical insights using pre-existing data from existing medical devices, such as:
Companion diagnostics which combine a diagnosis outcome with a therapeutic and monitoring of that treatment
Digital therapeutics which use software ONLY to treat patients as opposed to a drug or instrument
Novel clinical insights where two or more measurements are combined to produce a clinical determination
AI based diagnostics which often consume numerous inputs that could be measured, demographical or even genetic to derive new clinical insights
Romer De Los Santos: Digital health continues to be a major source of growth as personalized medicine, wearable devices, and mobile health gain wider acceptance. Cloud computing, AI, and machine learning are improving patient outcomes by encouraging innovation and making personalized medicine possible. As these constantly evolving technologies continue to grow in complexity the regulatory framework around medical devices that incorporate them are also evolving to keep up.
For many years, medical device manufacturers secured their devices by disabling or designing out interconnectivity. The rise of electronic medical record keeping has forced manufacturers to support limited interconnectivity. They usually depended on security measures taken by their customer’s IT department as the primary risk control measure. That’s no longer acceptable in our interconnected world. The FDA requires manufacturers to consider cyber security threats and to design controls to reduce these risks as much as possible. This has led to developers having to learn more about threat modeling to limit touch points into their software and to creating plans on how to handle data breaches.
The 21st Century Cures Act amended the definition of a medical device to exclude certain software functions. The FDA intends to focus oversight on software functions that affect patient data and therefore pose the greatest threat to patient outcomes. Wise developers architect their software systems based on clearly defined software functions that can be individually evaluated for risk, leading to a reduction in the regulatory burden. Designing and documenting modular software facilitates re-use and therefore faster time to market for novel medical devices.
Michelle Wu: AI and Machine Learning: I continue to see AI and Machine Learning as a trend for 2023. Any pitch competition I attend includes multiple products that are incorporating AI or machine learning. There’s attention now on companies to look for and counteract bias in the data sets and algorithms.
Health equity: A spotlight on health inequities shines brighter since the pandemic and fortunately many companies are looking to do good and do well. Telehealth, remote patient monitoring, digital health apps, are the top areas of innovations that I see to address these disparities.
Vincent Balgos: The pandemic continues to drive the industry, regulators, and the market for COVID-19 related products and services, so I would expect continual development in these areas as new SARS-CoV-2 variants emerge, or other as other diseases arise.
Continual integration of medical life products, and interoperability amongst devices. As software to grows as a critical part of medical device industry, whether standalone SW or integrated with other components, there are many areas for 2023 innovation such as:
Software as a Medical Device (SaMD), Software in a Medical Device (SiMD)
Cybersecurity
Complex data analysis such as bioinformatics, genomic sequencing, imaging processing
Artificial Intelligence (AI) and Machine Learning (ML)
New or modified regulations (EU IVDR, EU MDR, and potential US VALID Act) continue to change the landscape in how medical device and life science organizations develop, manufacture, and maintain products.
The new FDA Computer Software Assurance (CSA) guidance that revisits validation in context of the current Computer System Validation (CSV) approach. Many medical companies are looking at this new risk-based approach to streamline their activities, documentation and outputs as the current standard practice can be complex and cumbersome.
Biggest Challenges – What are some of the biggest challenges you think medical device and life sciences companies will be working to overcome in 2023?
Monterrey: Two of the biggest challenges I see are: monetization and regulatory clearance.
Medical devices revenue models rely heavily on reimbursement from CMS which require a CPT code. Obtaining a new CPT code requires a significant investment and burden on the medical device manufacturer to provide clinical evidence which not only shows efficacy but also provides A reduced cost of care when compared to existing methods and treatments. We are seeing that digital therapeutics are struggling in this area. One strategy has been for digital therapeutics to partner with an existing reimbursed pharmaceutical via revenue sharing. But on the upside CMS has recently provided a new code which allows prescription digital behavioral therapy to be reimbursed as a medical benefit which is trailblazing the path for other digital therapeutics to follow.
While digital health applications that are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease are medical devices and have been regulated by the FDA for many years, there has been new entrants in the recent years that have gone under the radar. With the recently issued guidance from the FDA on Clinical Decision Support Software, FDA attempts to make it clear which products are regulated medical devices, and which are not. This will slow the reduction in the barrier to entry as many digital health applications begin to play catchup.
Ivan Ma: The supply chain for components and materials continues to remain constrained. With lead times stretching well past 6 months, and sometimes getting close to 12 months. Programs should plan for contingencies and with expectations that milestones that require physical materials will be impacted by the last part in. Be wary of strategies that start early but require more total effort to execute.
In terms of product and systems development, what do you think will remain the same over the next decade? What will change?
De Los Santos: The need to ensure traceability between requirements, testing, risk, and design will continue to be important in the next decade. Changes in what is considered medical device software will lead to revised regulatory strategies by companies agile enough to take advantage of these changes. Documentation must become more modular to match the software they describe.
Balgos: Based on my past 17 years in medical product development, the time pressures to launch safe and effective products quickly to the market has always been a constant theme.
Many attempt the “faster, better, cheaper” approach, but schedule has always been the driver when comes to the project’s managements iron triangle (scope, budget, schedule). While this “faster, better, cheaper” approach may work for other industries, the medical field is especially constrained in that a patient’s safety is non-negotiable.
What will change is how companies adapt to the complexities of the regulation landscape, innovative technologies, and ever growing knowledge of diseases, illnesses, etc. The adaption for advanced tools, processes, and digitization of information will continue to grow industry as scientists/engineers evolve their practices.
What changing regulatory guidelines do you anticipate having an impact on companies in 2023?
Monterrey: In addition to FDA’s guidance on Clinical Decision Support Software there are a few other draft guidance in the works such as Computer System Validation (CSA), Cybersecurity, and AI.
Tools that are used to implement part of all the quality system require validation to ensure that the tool is fit for purpose and mitigates the risk of failures that could pose undetected harm in the medical product. We have seen many of our clients spend significantly more effort on validating tools that do not pose significant risk to their medical device than the medical device itself. FDA’s Computer Software Assurance for Production and Quality System Software draft (CSA) guidance provides great insight on how to take a risk-based approach when validating your tools.
Cybersecurity affects all products in development and on-market, regardless of if they are fully embedded or even connected. For medical devices manufactures that have many legacy devices on-market, this new guidance can pose a significant risk and cost.
Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan provides some additional insights into FDA’s current thinking behind AI. Although there is no current guidance from the FDA, AI devices continue to be cleared under existing guidance increasingly year or over.
Balgos: The US VALID ACT could have major disruption to lab developed tests (LDT’s) and how they are regulated in the US market. The additional restrictions may impact the growth of new tests, but provide additional oversight to help improve safety. This controversial topic has been a continual discussion point in industry, and that the new VALID ACT provides some additional clarification and guidance.
How do you foresee regulations shifting in medical device and life sciences over the next decade?
De Los Santos: There is a growing understanding among regulatory bodies that cloud computing companies are developing technology that will significantly improve patient outcomes.
Tool Innovation – From a medical device and life sciences 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?
Monterrey: From an engineering toolset perspective – finding automated tools that support the regulation and the team’s ability to be agile for the full development cycle will have a significant impact. Typically, we see our clients taking 6 to 18 months back tracking design activities in order to satisfy the FDA when the product is almost completed. If development is done in a more automated and iterative way – time to market can be significantly reduced, more predictable and lead to higher quality products.
Wu: Tools that make regulatory compliance more efficient. The best tools make it easy for companies to enhance, instead of hampering, their product development and business strategy.
Human centered design. While not a new concept, it is not universally practiced and incorporated. Those that do this well have medical devices that resonate with users and have better product adoption.
Ma: Requirements matter more than ever. Avoid building the wrong thing by keeping track of requirements and risks management using a tool like Jama Connect. If you are paper tracing, you’re operating in the 20th century.
Any major disruptions to the medical device and life sciences industry you’re anticipating in 2023?
De Los Santos: AI, machine learning, and cloud computing were instrumental in the response to the pandemic but have far bigger implications for improving patient health. As companies shift focus away from the pandemic, I expect more innovation around personalized medicine and clinical decision support software, both of which take advantage of these emerging technologies.
Balgos: The US VALID ACT could have major disruption to lab developed tests (LDT’s) and how they are regulated in the US market and industry.
What sorts of process adjustments do you think development teams will need to make to be successful in 2023?
De Los Santos: Development teams should take advantage of the guidance on software functions to improve the architecture of their code and their documentation. The sooner development teams create re-useable code and documentation building blocks, the better.
Balgos: Aligning with new regulations, such as the potential VALID ACT, and new FDA draft guidances such as CSA, Human Factors, and others
For the EU market, organizations need to start early. Notified Bodies engagement as the backlog continues to be longer than expected for re-certification for Medical Devices and IVD’s to the new regulations.
In your opinion, what are the biggest differences between a medical device or life sciences company that survives to see 2030, and one that doesn’t?
Monterrey: Companies that strive to maintain agility while being regulated leveraging tool automation as opposed to paper-based and stage gate processes will have a competitive advantage and higher chance of survival by having the ability to:
Address cybersecurity demands in an ever-changing eco-system
Derive new clinical insights using real-world data
Innovate by releasing product and features in more frequent cadences
Stay ahead of obsolesce issues
De Los Santos: The ability to organize software, hardware, and documentation into re-useable building blocks are key to winning in this kind of environment. You must be fast while maintaining a level of quality that ensures patient safety.
Ma: Products that bring true clinical value will win in the long run. The challenge is finding organizations and sources of capital that are methodical enough to identify true clinical value and have the grit and determination to stick with programs that take more than 5 years to reach human use.
Balgos: Adapting to the environment will be key for a company’s survival. Whether new regulations, innovative technologies, or another global event changes in how industry operates, companies that has the ability, resources, and willingness to pivot will likely survive.
What role will cybersecurity play in medical device development in the coming year and beyond?
De Los Santos: Cybersecurity is here to stay! The FDA requires device manufacturers to document how they handle cyber security threats and breaches. Companies can’t depend solely on risk control measures made by the customer’s IT department.
What advice would you give to new companies entering the medical device and life sciences industry?
Monterrey: Invest in tools, training, and infrastructure upfront and hire industry and technological experts to help you navigate the complexity of the cloud environment and regulated space.
De Los Santos: Take some time to define a simple design and development process. Don’t overdo it! You don’t get extra credit for adding extra process work. Use a risk-based approach to determine how much is too much.
Wu: Understand that the path to commercialization is much longer for a regulated medical device or therapeutic as compared to a consumer good.
Gain an appreciation for the regulations, what claims you want to make for your product, and how those two impact your timeline.
Human-centered design, including addressing diversity and inclusion, will differentiate your product from others.
Ma: A mentor told me that medical devices are a hard but worthwhile sport. Play the sport with the intent to bring positive clinical value to people everywhere. The rest, as they say, will take care of itself.
Balgos: Understand the market, regulations, and intended use of products/services and the associated risks.
Encourage good documentation practices early and consistently, as documentation is the lifeblood of the industry. Because if it wasn’t documented, it never happened.
What topic(s) do you wish companies were paying more attention to?
Monterrey:
FDA requirements pre-development – implementing a QMS and following a design process.
Customer needs – developing with the end user in mind.
Software as a profit center – focused on the revenue opportunity software can bring.
Tool validation – focus on value-add activities, if you’re spending more time and money validating tools that verifying your medical device you should revisit your QMS for inefficiencies.
De Los Santos: I wish companies would take a little more time cleaning up their processes. Where are you wasting effort? Putting band-aids on your development process costs you more in the long run. What is a working medical product with a poor or non-existent design history file? It’s a brick. It’s a very expensive brick that will require months of remediation work. Design documentation created after the fact is always poor and you’ll also have trouble retaining great engineers if they must spend months remediating documents.
Wu: Women’s Health: While women make up 51% of the population, less than 1% of VC funding is going to FemTech. With an estimated market size of $1.186 Trillion by 2027, the medical device industry is slowly taking notice of the unmet need and market potential of innovation focused on women. Consumer product goods, digital health, and diagnostics are top three product addressing issues unique to women, including menstruation, maternal health, and menopause1. It’s an under tapped area that continues to be prime for disruption.
What do you think will remain the same in this industry throughout 2023?
Monterrey: I think we will continue to see slow economic recovery as a result of the side-effects of COVID as it relates to supply chain, pivots, and lower year end earnings. The businesses that end up striving will be those who are focused on long term strategy as opposed to short term reactions to the economy. Reinvestment and patience will be essential to staying ahead competitively.
What do you predict for regulation in the medical device and life sciences industry in 2023?
Monterrey: There will be a watchful eye on cybersecurity, additional thinking around AI and significantly longer wait times for approval.
Wu: While not significant changes in regulation, the change to MDR and IVDR in the EU continues its impact to the industry, especially as companies’ previous MDD certifications lapse, but have yet to obtain their MDR certifications. As of a July 2022 MedTech Europe Survey Report, >85% of existing medical devices that had MDD certification have received MDR. And unfortunately, it is the patients and public that live in the EU that will be affected when they no longer have access to the same medical devices and diagnostics that they had previously. With the 13–18-month time-to-certification with MDR-designated Notified Bodies, nearly double the time historically needed, this influences the worldwide go-to-market strategy of companies.
Will those trends still be prevalent 5 years from now? 10 years?
Monterrey: Digital health applications will begin to dominate the market over traditional hardware devices with new and innovative, diagnostics treatments and therapies leveraging cloud, AI and real-world data. FDA trends over the next 5 to 10 years will move towards harmonization to reduce complexity and improve ease of use. The reduce wait times the FDA will continue to extend devices in the break-through designation and rely on the use certification bodies or 3rd party FDA reviewers like BeanStock Ventures.
Where do you see Jama Software fitting in as the product development landscape evolves, and what can our customers expect as 2023 approaches?
De Los Santos: When properly configured and coupled with a simple design control process, Jama Connect significantly reduces the documentation burden for our customers. In the same way that a good source code management system facilitates code reuse, Jama Connect facilitates re-use of requirements, test cases, and risk documentation. There have been some recent improvements to the Jama Connect that I’ve been requesting since I was a Jama Software customer. I hope people take time to take advantage of them.
Shawnnah Monterrey – CEO, Beanstock Ventures
20+ years’ experience in the medical industry, Shawnnah Monterrey knows a thing or two about guiding innovative products to market.
Prior to founding BeanStock Ventures, she obtained a bachelor’s degree in computer science from the University of California, San Diego and an executive MBA from San Diego State University, then went on to hold product development management positions across numerous global firms, including Illumina, Invetech, Medtronic and Carl Zeiss Meditec. Through this work, she continued to develop a passion for innovation in medical devices, life sciences, and biotechnology.
BeanStock Ventures
BeanStock Ventures is 1 of 9 FDA-accredited Third Party Review Organizations globally which provides software development and regulatory compliance products and services to minimize complexity, and reduce cost and time to market of innovative medical devices.
BeanStock Ventures has over 140 years of combined experience in software development for the healthcare and life science space.
833.688.BEAN (2326)
marketing@beanstockventures.com
Michelle Wu – Principal Consultant at Michelle Wu Consulting
Michelle Wu is a senior leader with 20 years of experience in the medical device and life sciences industries with roles in executive leadership, product and process development, manufacturing, and quality. Michelle has a history of successful medical device product development, strategic planning and execution, building teams, process evolution, and managing organizational change. She values a collaborative and diverse, equitable, and inclusive environment, believing that diverse perspectives lead to the best ideas, more cohesive teams, and better results.
Ivan Ma
Ivan Ma has nearly two decades of experience in the medical device industry holding leadership and design positions spanning a wide range of medical devices; from single use devices and active implantables to complex surgical robotic systems. Ivan specializes in bringing early phase projects through development in preparation for FDA submission and human use by introducing balanced discipline to an inherently chaotic process.
Vincent Balgos
Vincent Balgos currently leads the Medical Solution at Jama Software. Prior to joining Jama Software, he worked in the medical device / IVD industry for over 17 years with roles in systems engineering, product development and project management. Vincent has successful history in launching new products to the global regulated market, and is experienced in product development, risk management, quality systems, and medical device regulations.
Romer De Los Santos
Romer De Los Santos has been developing software and firmware in the medical device industry since 1999. He is proud to have been involved in the development of a wide variety of medical devices including insulin infusion pumps, continuous glucose sensors, solid state mobile SPECT cameras, sequencers, liquid handling robots, and various IVD assays. He’s served in the roles of software developer, product owner, scrum master, internal auditor, systems engineer, software project lead, core team leader, and technical product manager before joining Jama Software as a senior consultant this past February.
https://www.jamasoftware.com/media/2022/12/2022-12-22-2023-predictions-medical-product-development-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-12-22 03:00:052024-01-18 09:39:142023 Predictions for Medical Device Product Development
In this blog, we announce Jama Connect® for Robotics, which leverages functional safety and best practices for robotics product development.
Jama Connect® for Robotics
Reduce deployment time, ensure best practice adoption, and increase the success rate of innovation in robotics development
Leveraging functional safety and best practices for robotics product development based on the IEC 61508 industrial standard.
Jama Software®, the industry-leading requirements management and traceability solution provider, has announced the launch of Jama Connect for Robotics, which incorporates product development and functional safety best practices based on the IEC 61508 industrial standard for robotics product development.
Jama Connect for Robotics is a complete set of frameworks, example projects, and procedural, export, and configuration documentation that helps teams reduce deployment time, ensure best practice adoption, and increase the success rate of innovation. This solution comes with a fully equipped package that contains a robotics dataset, a procedural guide to functional safety based on IEC 61508, and other relevant guides. All these items help companies accelerate robotics product development with comprehensive reporting to document the process and improve compliance.
”Jama Software is proud to release a first-of-its-kind solution to the market that caters to all companies innovating and developing robotics applications,” said Tom Tseki, Chief Revenue Officer of Jama Software. “Jama Connect for Robotics enables companies to rapidly innovate, reduce risk, implement Live Traceability™, and optimize their systems development process.”
“Jama Connect for Robotics provides a consistent and comprehensible way to specify, analyze, and create critical products in compliance with IEC 61508,” stated Nicole Pappler, Senior Functional Safety Expert, AlektoMetis. “This solution allows for a structured approach to assigning functionality and safety functions to components. In addition, the solution provides a framework to accumulate the relevant and necessary documentation and evidence needed for getting the functional safety capabilities of the final product confirmed by the certification bodies.
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® Launches Jama Connect® for Robotics
https://www.jamasoftware.com/media/2022/12/2022-12-21-robitics-release-2-1.jpg5121024Steven Meadows/media/jama-logo-primary.svgSteven Meadows2022-12-21 06:30:392024-10-03 09:52:09Introducing Jama Connect for Robotics
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 Consultantat 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.
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.
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.
https://www.jamasoftware.com/media/2022/12/FIF-Collaboration-5in5-intro-1.jpg10801920Carleda Wade/media/jama-logo-primary.svgCarleda Wade2022-12-16 03:00:112025-04-18 13:57:24Jama Connect® Features in Five: Collaboration
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.
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.
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.
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.
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.
https://www.jamasoftware.com/media/2022/12/2022-12-15-2023-v2-predictions-industrial-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-12-15 03:00:472024-01-18 09:52:302023 Predictions for Industrial and Consumer Electronics Product Development
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.
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.
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.
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.
https://www.jamasoftware.com/media/2022/12/Doors-VLOG-Episode-6-intro.jpg10801920Richard Watson/media/jama-logo-primary.svgRichard Watson2022-12-14 03:00:062025-04-18 14:05:26Jama Connect® vs. IBM® DOORS®: Migration & Data Mapping: A User Experience Roundtable Chat
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.
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.
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.
https://www.jamasoftware.com/media/2022/12/2022-12-08-2023-predictions-aerospace-and-defense-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-12-08 03:00:032025-04-18 14:03:052023 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 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.
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.
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.
https://www.jamasoftware.com/media/2022/11/2022-12-01-2023-predictions-product-systems-development-teams-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-12-01 03:00:232024-01-18 10:49:142023 Predictions for Product & Systems Development Teams
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?
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.
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.
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.
https://www.jamasoftware.com/media/2022/11/Doors-VLOG-Episode-5-intro.jpg10801920Mario Maldari/media/jama-logo-primary.svgMario Maldari2022-11-30 03:00:522024-01-18 10:51:51Jama Connect® vs. IBM® DOORS®: Document Generation: A User Experience Roundtable Chat
