Tag Archive for: Requirements & Requirements Management
In this blog, learn how a Traceability Score™ can act as an empirical way to reduce the risk of late requirements.
Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements
Executive Summary
One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown to reduce this known risk?
Using our proprietary database of metadata from over 50,000 complex product development projects, we were able to determine that the Traceability Score™ is an empirical method to reduce late requirements. In fact, teams that maintain a high Traceability Score reduce the burden late requirements have on their project by 67% compared to teams with low traceability scores.
With this knowledge, our recommendation is that practitioners measure and monitor the Traceability Score™ of their projects to resolve issues early and ensure that the risk of late requirements is kept to a minimum.
Dataset Background
Jama Software® has the world’s largest, live dataset of engineering process performance with over 50,000 engineering projects updated and growing continuously. Leveraging this dataset, it is now possible to determine empirically which management practices improve the performance of the product development process. To learn more about our benchmarking, please review our Traceability Benchmarking Report.
The Empirical Questions
In this analysis we will explore three key questions:
What are late requirements?
How do late requirements negatively impact projects?
Does maintaining a high Traceability Score reduce the risk of late requirements?
What are late requirements?
For the purpose of this analysis, we define “late requirements” as those requirements created after the completion of a project’s requirement decomposition phase which we estimate as spanning the middle 50% of all requirement creation activity (creation and refinement). To illustrate what late requirements look like, we show two actual projects below with requirement activity plotted over time.
Requirement Creation Over Time
In the Timely Project, requirement creation occurs in a defined requirement decomposition phase to form a necessary and sufficient set of requirements, with very few requirements being added after the fact (e.g. in fig (a), only 1.3% of requirements created late). In the Late Project’, requirement creation bleeds into future phases of the project, leading to a significant amount of late requirements (e.g. in fig (b), 9.2% of requirements are created late).
How do late requirements negatively impact projects?
We can measure the outsized burden late requirements have on project teams, which we have illustrated for our two projects below. We define late requirement burden as the total number of requirement activities (creation and refinement) attributed to late requirements as a percentage of all requirement activity.
Impact of Late Requirements on Project Team Activity Burden
In the Timely Project, minimal late requirements enable better forecasting of project completion, and limits the rework and cost brought on by late requirements (e.g. in fig (c), late requirements only create an additional 8% burden).
In the Late Project, the high volume of late requirements makes it much harder to forecast project completion as the scope of the project is constantly changing, and project teams need to accommodate the late requirements (e.g. in fig (d), late requirements contribute an additional 31% burden).
Unsurprisingly, this additional burden of late requirements has an impact during testing for requirement validation. In our actual project examples, the Late Project has a test failure rate over 3x that of the Timely Project.
Does maintaining a high Traceability Score reduce the risk of late requirements?
A core theorem of Systems Engineering is that maintaining high requirement traceability from the start of a project reduces the risk of late requirements and negative product outcomes. With our project dataset we can now test this theorem empirically. We define traceability as a measure of a project’s ‘expected’ traceability that has actually been established and calculate the Traceability Score as follows:(1)
For our example projects, the Timely Project achieved a Traceability Score over 6X that of the Late Project; suggesting that maintaining a high Traceability Score throughout the project reduces the risk of late requirements.
To further determine if Traceability Score correlates to late requirements, we divided our dataset of projects into quartiles based on their Traceability Scores (Quartile 1 = bottom 25% traceability score, Quartile 4 = top 25% traceability score) and then compared the distribution of ‘Late Requirements Burden’ across these quartile groups. What we found is that projects within the bottom traceability quartile had a median Late Requirements Burden 3x greater than those in the top traceability quartile. In other words, the evidence supports that projects managed with higher traceability generally experience less risk from late requirements.
Recommendation
Our analysis has shown that late requirements negatively impact projects and that managing projects through a Traceability Score is the only empirical way to reduce the risk of late requirements. Below you can see how one can measure the Traceability Score over time as a project progresses to ensure system engineering best practices are being followed. A low or falling Traceability Score can quickly identify areas to address to reduce the risk of late requirements.
Here you can see how managing the Traceability Score directly as the project is underway would have identified the risk early in the Late Project.
Interested in learning more? Download the entire Research Notes: Traceability Score™ datasheetHERE.
https://www.jamasoftware.com/media/2023/02/2023-02-08-research-note-tracebility-score-1.jpg5121024Marc Osofsky/media/jama-logo-primary.svgMarc Osofsky2023-02-08 03:00:522024-01-18 01:22:23Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements
Jama Connect® Features in Five: Document View
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, Katie Huckett, Senior Product Managerat Jama Software®, walks viewers through Document View, a new feature offered in Jama Connect.
In this session, viewers will learn how Document View, now available alongside list and single-item views, allows users to:
Author, read, and edit items in line in a single view while maintaining an item-based structure within project hierarchies.
Improve consistency and accuracy of requirements quality by incorporating built-in support for Jama Connect Advisor™, an add-on to Jama Connect.
Jama Connects complete requirements authoring solutions supports different use cases and different preferred user work styles such as those previously performed in siloed tools like Microsoft Word or Excel.
With Document View, you can leverage all the functionality and toolbar actions of reading view, such as filtering and configuring items, reuse, batch transition, send for review, edit and more. Double-click on an item to open quick edit mode with the option to expand to full edit mode. Insert new items without losing your place in the document, add comments and lock or unlock items.
Follow along with this short video below to learn more – and find the full video transcript below!
VIDEO TRANSCRIPT:
Katie Huckett: Hi, my name is Katie Huckett and I’m a senior product manager here at Jama Software. In this video, I’m going to walk you through Jama Connects new feature Document View. Jama Connect now provides Document View, alongside list and single item view. Document view allows users to author, read and edit items in line in a single view while maintaining an item-based structure within project hierarchies. Document view improves consistency and accuracy of requirements quality by incorporating built-in support for Jama Connect Advisor™ and add-on to Jama Connect. Jama Connects complete requirements authoring solutions supports different use cases and different preferred user work styles such as those previously performed in siloed tools like Microsoft Word or Excel.
With Document View, you can leverage all the functionality and toolbar actions of reading view, such as filtering and configuring items, reuse, batch transition, send for review, edit and more. Double-click on an item to open quick edit mode with the option to expand to full edit mode. Insert new items without losing your place in the document, add comments and lock or unlock items.
Let’s see what this looks like in Jama Connect. Here in Jama Connect, I wanted to start on the current reading view so that you can see as I toggle over to our new Document View the transition to the new, clean, modern design. We’ve removed the horizontal lines between the items for a more seamless document experience. The item ID and current version are visible under the item name and comments and locking functionality have moved to the right of the item name so they don’t get lost within the content itself. Use the edit feature to quickly edit items without changing views or manually tracking your place in the document. I’ve opened what we call quick edit mode, which is a condensed form of fields only visible on the current view, as well as any additional required fields that you may have missed that need to be completed in order to save the item.
If you need to see the additional fields available for this item, expand to full edit mode and then you’ll be able to access any additional fields that you need. Quickly return to quick edit mode to complete any edits that you need before saving and completing your work. As I mentioned previously, Document View provide support for Jama Connect Advisor™. As you highlight text in a rich text field that you have enabled advisor for, you’ll notice an analyze button beneath the field. As you analyze the results, you’ll then see any recommendations that have been found. Click the view details button to see the information in more detail.
Huckett: Create new items and Document View with our new inline insert. I’m going to insert a new item between item one and two here, so I have a new requirement that needs to go in here. So you’ll see as you hover between the items, you have a plus button for inline insert form, and I’m going to go ahead and insert a new design description. You’ll notice that our inline insert form is very similar to the quick ad functionality that’s available in the ad dropdown in the content header. Only the name and description fields are visible, name being the only one that’s required. We are bypassing any additional required fields at this point so that you can quickly add as many items as you need to and then go back and edit in more detail and fill out the remaining required fields.
So you’ll notice I’ll add in a name and description into this item. You’ll note the Jama Connected Advisor analysis is also available in the inline insert functionality. We’re going to save this item. You’ll receive a toast message that lets you know your item’s been created, and you’ll see that new item appear in between items one and the previous item two that I had before. So as I mentioned, there is an additional required field on this item that I did not complete before. So I’ll go back in, edit this item, find that additional required field and assign someone to it so that we can then fully save and complete this item for the time being.
In order to view comments, you’ll click on the comments icon next to the item name. After clicking on the icon, you’ll see the comments stream up here in a modal above Document View where you can interact with, comment and reply to any comments on the item. Next, I’ll take you over to the admin section for your Jama Connect administrators to customize and configure Document View and Jama Connect Advisor™ to your organization’s needs. For each item type, it can be configured for default Document View settings. You’ll find a new projects Document View option in the view dropdown where you can then place your default visible fields. Jama Connect Advisor™ can be turned on for any rich text field on any item type your organization chooses and left off for any item types that don’t need the analysis.
Huckett: When you open a rich text field on an item type, you’ll notice a brand new checkbox for Jama Connect Advisor™. Enable advisor for that particular item type field and save your configuration either before or after the individual item field configuration for Jama Connect Advisor™. Don’t forget to go into the dedicated admin section to enable the INCOSE rules in whole or selectively based on your needs and the EARS patterns.
For more information about Document View, please contact your customer success manager or Jama consultant. And if you would just like to learn more about how Jama Connect can optimize your product development processes, please visit our website at jamasoftware.com. Thank you.
https://www.jamasoftware.com/media/2023/02/FIF-Document-View-5in5-intro.png10801920Katie Huckett/media/jama-logo-primary.svgKatie Huckett2023-02-03 03:00:592024-01-18 01:26:01Jama Connect® Features in Five: Document View
Jama Connect® vs. IBM®DOORS®: Reuse and Variant Management: 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 8 of our Roundtable Chat series, Mario Maldari – Director of Solutions Architecture at Jama Software® – and Gary Hayes – Senior Solutions Architect at Jama Software® – discuss the importance of reuse and variant management for product teams.
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 everyone. Welcome to episode eight in our vlog series. Hope you’ve enjoying the series so far. Today, we’ll be discussing the important topic of requirements reuse, and I’m joined by my friend and colleague Gary Hayes today. Gary, would you like to introduce yourself?
Gary Hayes: Sure thing, Mario. Thank you. My name’s Gary Hayes. I am part of Mario’s team. I’ve been working with systems and software engineering teams for the last 25 plus years, just recently have joined Jama. Prior to that, I spent 18 years working with Rational Software and IBM, supporting their systems and software engineering tools suite. Got a lot of experience in the early days with Requisite Pro as part of Rational Software before being acquired by IBM and then, morphing into the Jazz-based tools and Requirements Composer, acquiring Telelogic and DOORS, and then, DOORS Next Generation. So, been around tools for a long time.
Mario Maldari:
Thanks Gary. You’re like me. We’ve been in Requirement Space for many years, so thanks for that, Gary. As both of us know, being in the requirement space for a while, requirements reuse is an extremely important concept. Whether you’re creating a common library set of requirements or you’re doing variant development, this is something that we experienced through many years of working with requirements tools. Very important concept, and curious as your perception working with other requirements tools regarding reuse and in particular, maybe the DOORS family of products. How has that been for you?
Gary Hayes: Yeah, it’s been an interesting journey. In the early days of Requisite Pro and actually, my first exposure to requirements tools were with Technology Builders and Calibre. Calibre version 1 as a matter of fact. Back in those days, they were client server tools that really didn’t have any kind of reuse features except copy and paste. Clone and own, if you will. And DOORS, my first exposure to DOORS was that same way. You could create linkages, you could copy modules and reuse those and different projects as they got spun up, but the real reuse didn’t come into play until you got to more modernly architected tools like DOORS Next Generation. DOORS Next Generation has a variety of ways in which they could reuse components or reuse different artifacts with the environment. For one, you could start off a project, and clone an existing project, and use everything that you had before.
But what they really started to do was use the change sets, which was really change sets with code development where you could branch and merge. You really started seeing a lot more sophisticated ways to do reuse within a project. It made it really interesting and it is fairly easy to understand for people using requirements. You really wanted to have a use case that matched up with one, what you needed in an environment. And then also, you wanted to match up with the maturity of your organization. You didn’t want to overwhelm them with a process that they couldn’t handle. DOORS Next Generation took that to the new level by Introducing Global Configuration Management or GCM for short. Very complex way to do business. And it was really a way to include not just requirements for reuse, but all of the artifacts across the software and systems engineering lifecycle.
Really interesting, sounds really great, but like I said, very complex, and once you turned it on to use in your environment, you couldn’t turn it off, so it did not lend itself to a lot of flexibility. It was flexible from the point of view that yeah, I can make components in different disciplines and mix and match them as I chose to, but you really had to have a mature organization and a mature administration group to keep it under control, and make sure everything stayed on track.
Mario Maldari: Yeah, the complexity, I think it’s a challenge for adoption. And I think targeting some of the very large, big customers and modeling their use case, I think that becomes very difficult for smaller customers when they try to use some simple use cases and take them forward. So, I think that that complexity is a challenge. Well, let me show you something. I want to talk a little bit about how reuse is done in Jama, and I’d like to show it to you. Some of the common reuse scenarios that I’ve seen here at Jama, but as well as an industry is developing common libraries of requirements where you’re wanting to develop once and be able to reuse these requirements across the board in different projects, even within the same project. Parallel development. Very common to reuse requirements for your parallel development as well as variant reuse, being able to use them across your variants. These are very common scenarios that we see in industry today.
Jama has a very simple implementation for reuse, but it’s quite powerful. Anything in Jama can be reused, whether it’s a set of requirements or an individual requirement. And to do so, you simply will click on the requirement, and you can say reuse item. And here, you can share this requirement. Within the same project, you can reuse it, or you can reuse it in a different project. And you have a few different options here as well. You can add a relationship from the original item, so you have a link back to it. You can include all tags, attachments, and links. You also have the ability to include the relationships from the source item, include related items as well in minor relationships. A lot of different options when you go to reuse the requirement. And once it’s reused, you can take a look at the requirement itself, and see where it’s been reused. You can see in this case, the current item I have here I’m looking at, but then this requirement’s also shared across and reused in two different projects.
And you’ll see it’s out of sync. That means the requirement’s been evolving and changing in these different projects, which is what you’d expect in this case. Now, if I wanted to get a little bit more information and see okay, well, how are those requirements evolving and changing? I can take a look at the synced items here across the whole project. And if I want to take a look at this particular requirement and see how it’s been evolving and changing, I can take a look at it and I say, “It’s out of sync.” And I can say, “Well, let’s compare.” And here, I can get a side by side comparison of how the requirements he has evolved in this project. You can see the source project, I have the name with a global impact. And in the project that I’ve reused it in, I can see easily that this requirement has changed to a North America scope only. A really nice side-by-side comparison in terms of how the requirements are evolving.
Even more to that, there’s a nice UI here where if I decide that the requirement, that’s evolving, I want to override it with the source, I can do that easily. Or perhaps this requirement that’s evolving should be the new standard. I can overwrite the original with the evolved requirement. A lot of options in terms of managing your reused requirements. But I think the key for me, from my perspective with the Jama implementation, it’s very simple, very easy to use. You can build from a very simple case to a very complex case as you go incrementally, so you’re not overwhelmed instantly with the reuse scenario itself. A nice supporting UI to deal with reuse within Jama. Let me just stop there, Gary, and see if you had any perceptions. You’re relatively new to Jama, so just curious to your thoughts.
Gary Hayes: Yeah, what I really like about this is that it’s easy to enable. It’s really kind of straightforward. It has a variety of use cases that it supports. Got some basic features, but it also supports some advanced features, so you can turn on as much or as little as you need to be effective. Also, the people that are part of the project, the common users, they get that visual cue. I noticed that in the interface, anything that was in a reuse state had the little dot next to it. If I was curious about the reused state of it, I could drill down on that and do some comparisons myself to see how it evolved over time. I think that one, it’s important that it’s easy to use and people aren’t afraid of using it. They can investigate it and it’s very simple. Simple, yet powerful in my estimation.
Mario Maldari: Yeah, I think that’s a good way of saying it. And of course, you and I have been in requirements for 20 years plus, we know that reuse is such an important concept, but it’s really about striking the balance between features and functionality and ease of use. It’s something that every requirement tool needs to have and needs to support. But the question is how easy is it to adopt? And how easy is it to use? You want to find yourself being productive and not wasting a lot of time and energy out of the box.
Gary Hayes: Exactly. Yep, absolutely.
Mario Maldari: Well, Gary, I want to thank you very much for your time today, and want to thank everyone watching this vlog series, and look forward to seeing you on the next one.
Gary Hayes: 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 Requirements-Driven Testing and Total Cost of Ownership.
https://www.jamasoftware.com/media/2023/01/Doors-VLOG-Episode-5-intro-2.jpg10801920Mario Maldari/media/jama-logo-primary.svgMario Maldari2023-02-01 03:00:272024-01-18 01:29:46Jama Connect® vs. IBM® DOORS®: Reuse and Variant Management: A User Experience Roundtable Chat
Jama Connect® vs. IBM®DOORS®: Industry Templates: 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 7 of our Roundtable Chat series, Cary Bryczek – Director of Solutions Architecture at Jama Software®– and Danny Beerens – Senior Consultant at Jama Software®– discuss the importance of industry templates in requirements management.
To watch other episodes in this series, click HERE.
Watch the full video and find the video transcript below to learn more!
VIDEO TRANSCRIPT:
Cary Bryczek: Welcome to part seven of our vlog series. I hope you’re enjoying the series so far. My name is Cary Bryczek, and I’m from Jama Software. I’ve been working here at Jama for over nine years, and I’m the director of aerospace and defense solutions. You’re in for a really special treat today. And I’m excited to be joined by my colleague Danny Beerens, who is a longtime IBM expert. Danny, tell the audience a little bit about yourself.
Danny Beerens: Hi, Cary. Thanks for this introduction. Yes, my name is Danny Beerens. And within Jama, I am both a solution architect for pre-sales and a senior consultant for post-sales. So I’m not going to sell you anything I can’t deliver myself. I’ve been in the requirements management field for the last 15 years, starting with DOORS Telelogic, and after the acquisition by IBM, I moved to IBM Jazz, the ELM Suite, and I actually started out with implementing Rational Requirements Composer. It was the prelude to DOORS Next.
Cary Bryczek: Oh wow. That’s awesome. So today’s topic of industry templates, I think, is a really interesting one. Requirements tools have been around for decades and were originally designed to be just a database. They had some rudimentary capability to control versions and add attributes, and that was about it. There were very few concepts, and still today there are very few concepts of a pre-configured template that were specific to the processes of a particular industry such as automotive or medical devices. When there are no templates and organizations start adopting a new tool, they’re forced to then configure the requirements management system to match the processes to be able to generate reporting information and documentation. Now, this just takes a lot of time, and it forces organizations, in many cases, to have teams of workers whose job it was to just engineer and maintain the tool itself. Danny, what’s been your experience with IBM tools with regards to templates?
Danny Beerens: Well, in general, IBM does offer some industry templates, what they call solution process assets. And for those, there is not a lot of templates available. So you have system software engineering templates. You have a template to support DO 178B and ASPICE ISO 26262.
Cary Bryczek: So in your experience in using DOORS, is there even the concept of creating a template? Is that hard?
Danny Beerens: Yeah, you can create your own templates, but yes, like you mentioned in your introduction, it takes a lot of time and effort from your own organization to implement your own templates to support your own industry. So setting up everything to get ready to start using the application, it takes a lot of effort for your own organization to be set up.
Cary Bryczek: Oh gosh. Well, it’s so easy in Jama. I think maybe I should let the tool talk for itself. Our templates come right out of the box pre-configured. Let me show you maybe what the building blocks look like. In Jama, totally web-based, our pre-configured industry templates come with item types that represent the nomenclature very specific to the industry. So in A&D and space defense, you’re looking at different types of element requirements, different failure analyses, functional requirements, high-level and low-level requirements for avionic systems, parts. All of these are pre-configured with the most common types of attributes ready for you to use right out of the box. And then where we start talking about how to interconnect all of that kind of data is where we have, in Jama, our relationship rules. And our relationship rules, we have relationship rules for the NASA product breakdown structure.
So if you are following the NASA systems engineering handbook and you’re going all the way from stakeholder expectations to component level requirements, we have this pre-configured for you with all of the correct relationship types. We have one for avionics development that matches all of the DO 178 and ARP 4754. We have templates for MBSE. We have templates for defense system V. We have templates for automotive as well. So all of those are basic automotive framework. If you’re having to do ASPICE or ISO 26262 or both of them together, we have these pre-configured data models for you to start just creating and authoring the requirements right away.
If you’re doing automotive development within the semiconductor industry, we have a template that is developed by industry experts. So we at Jama have hired people that have worked in these industries and know what are the types of compliance reporting that you have to do and then put together these just easy and ready-to-go templates that allow you to get started right away. If you need to do functional safety in automotive or cybersecurity, our templates are built right in, letting you do the safety and cybersecurity right away along with your design development of your requirements. Danny, doesn’t that look like it’ll save organizations time to get started and eliminate the army of DOORS admins?
Danny Beerens: Oh, definitely. If I look at that, your type system is already there. Your relationships are already defined. It saves a world of work there.
Cary Bryczek: So what, Danny, about DOORS NG? What’s the state of industry templates with that tool?
Danny Beerens: If you look at the entire IBM ELM suite, the main focus nowadays is automotive, ASPICE ISO 26262, cybersecurity. And although there are many other multiple templates for different industries like aerospace, medical devices, rail end, they mostly seem to focus on EWM or RTC, as it was called previously. So there is hardly any good templates to support industries endorsing NextGen.
There is an additional application that would allow you to have specific templates or to configure your templates and migrate those to DOORS Next. It’s called Method Composer, but then you also need to know how Method Composer works because you get your templates out of the box. You need to adapt those templates in Method Composer to suit your business processes, and then from there, export it to DOORS Next. So you need an additional application. You need to know how that additional application works to customize it to your processes. Then you need to make sure that DOORS Next gets those templates.
So you need another application, additional infrastructure, and there’s a lot of knowledge in Method Composer. So you need either an IBM expert like I was, an IBM business partner to help you out with that. And in my experience, there is hardly any company that also acquires Method Composer. So you are stuck with setting up your templates in DOORS Next Gen yourself, again.
Cary Bryczek: Wow. God, that just sounds so complicated. So there really aren’t any really ready-to-go templates made for an industry. You still have to do a lot of work.
Danny Beerens: You need a lot of hand work yourself, so you take time away from your own engineering team, from your own process engineers implementing everything in DOORS Next Gen or, like I mentioned previously, in traditional DOORS. So it takes a lot of time away and costs a lot of effort to get you started.
Cary Bryczek: Wow. Is there any process documentation that the end users would use? Anything like that? Or you just have to make that yourself too?
Danny Beerens: Well, you look at your own process or the customer’s process documents, and you try to translate that into a configuration of DOORS or DOORS Next Gen. So there’s really not an easy way to set things up for your industry.
Cary Bryczek: Jama Software, we’ve hired, like I said before, industry experts to put together, not just the templates themselves, but also put together the process manuals that guide users to follow their required industry standards such as the automotive ASPICE and ARP 4754 or IC 6304. Maybe we can take a look at and look at that from a user’s perspective. Let me share my screen here.
Our templates are not just pre-configured in Jama itself, which is very nice. It also comes with a user guide. How do you use Jama itself to follow? This one is a airborne systems process guide. How do I make sure that I really am following ARP 4754 and DL 178? How do I use the system from a high-level process standpoint? So we have these process guides that make it really easy. And then from a user’s perspective, I jump in, I really like the automotive project, we have fantastic sample projects that you can look at, as well as a bare bones skeleton template that you can just start filling in. We have places where you can implement your planning documents in addition to the requirements. We have the dashboards that show you processes that are taking place within your requirements. It’s very easy to follow from the user’s perspective at all.
So I can see what are the different types of requirements, what are the different types of validation testing, or what are the risks that you’re following, and even how the particular system that you are engineering is subdivided from a systems engineering standpoint. So if I want to define the mechanical engineering or the software, I can dig right down in. And this configuration of how the information is organized, how the information is related to one another, it’s all part of the solution, so users don’t have to spend time studying the standards that you have to adhere to or the organization’s process. That’s already built for you. You can just start using it right away, which I think is really cool and a huge time saver and what really differentiates Jama Software from IBM itself.
Danny Beerens: And if you look at your type system and then the documentation that comes along, I must say in my 15 years, I’ve learned that having industry templates is a really great stepping stone to getting a customer quick up and running and achieving their industry compliancy goals. They don’t have to figure it out themselves. It’s already there. You will have guiding documents that explain to you why those templates are set up like they are, what the purpose is, and it comes fully guided with Jama experts. They are experts in the industry, so they can also talk you through the templates if you have any questions. It just simply helps you adjust the framework that comes out of the box to your specific situation within your industry. So you’re already there. You just need to apply rough tweaks to make it your own, and that’s it. And that’s what I love about Jama, working for Jama. How about you?
Cary Bryczek: I love that too. If I’m an end user, I just install Jama, tweak it a little bit here and there and give a minimal amount of training to my users, and then they’re ready to use it. And working at Jama in the aerospace and defense, I really enjoy putting together these solutions and seeing the companies not have to work so hard at using the tool, but actually spending more time innovating on the products and the systems that they’re building. Thanks so much, Danny, for your perspective on the IBM side. That was really insightful. I learned a lot.
Danny Beerens: You’re welcome.
Cary Bryczek: This concludes our vlog on the industry templates and its significance within the requirements management domain. We truly hope you’ve been enjoying the series so far. Stay tuned for our next entry in our series. We look forward to seeing you then.
Danny Beerens: Thanks for having me.
Cary Bryczek: See you next time.
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/2023/01/Doors-VLOG-Episode-7-intro-1.jpg10801920Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2023-01-19 03:00:082024-01-18 08:50:49Jama Connect® vs. IBM® DOORS®: Industry Templates: A User Experience Roundtable Chat
In this blog, we recap our press release, “Jama Software® Is the First to Deliver a Complete Requirements Authoring Solution” – To read the entire thing, click HERE
Jama Software® Is the First to Deliver a Complete Requirements Authoring Solution
Requirements can now be authored in free text form, natural language analyzed, and managed as distinct items
Jama Software®, the industry-leading requirements management and traceability solution provider, has announced enhancements to Jama Connect®’s user experience. As part of the update, Jama Connect now includes a Document View, which allows users to author, read, and edit items in-line in a single view while maintaining an item-based structure within project hierarchies. This enables the streamlined authoring of requirements leading to material efficiencies gained and time saved.
The new Document View augments Jama Software’s atomic, item-based requirements approach. It allows users to easily learn and adopt Jama Connect whether moving from a documents-based approach or a legacy requirements tool. The seamless user experience combines the best of model-based requirements engineering with an enhanced, quick-editing Document View functionality. This improves time-to-adoption for Jama Connect users.
In addition, the enhancements also improve consistency and accuracy of requirements quality by incorporating built-in support for Jama Connect Advisor™ (add-on to Jama Connect). With this, users can seamlessly see EARS (Easy Approach to Requirements Syntax) and INCOSE (International Council for Systems Engineering) rules suggestions while actively authoring and editing requirements.
Jama Connect is the only comprehensive requirements management and traceability solution that allows:
Requirements authoring in free text form;
Analysis in natural language to maintain quality; and
Management of requirements as distinct items.
These capabilities make Jama Connect an incredibly powerful platform that delivers immense value for optimizing and accelerating systems development across various industry verticals.
“Jama Software is committed to continuously improving the adoptability and useability of Jama Connect. These powerful enhancements strengthen Jama Connect’s best-of-breed requirements authoring and Live Traceability™ offering, which continues to make Jama Connect the highest-rated solution for ease of use and adoptability in the industry, “said Josh Turpen, Chief Product Officer of Jama Software.
To learn more about Jama Connect’s features, please visit our product features page. If you would like to speak with one of our industry experts and/or book a free Jama Connect trial, click here.
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, please visit www.jamasoftware.com.
https://www.jamasoftware.com/media/2023/01/2023-01-18-document-view-release-1.jpg5121024Josh Turpen/media/jama-logo-primary.svgJosh Turpen2023-01-18 03:00:372024-01-18 08:58:52Jama Software® Is the First to Deliver a Complete Requirements Authoring Solution
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 03:00:182024-01-18 09:07:43Jama 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.
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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 06:30:392024-01-18 09:41:46Introducing 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 03:00:112024-01-18 09:42:49Jama Connect® Features in Five: Collaboration
