Jama Connect® Features in Five: Jama Connect Advisor™
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, Joseph Pitarresi, Senior Product Manager at Jama Software, will introduce viewers to Jama Connect Advisor™, Jama Connect’s natural language processing (NLP) tool, designed to improve requirement quality.
In this session, we’ll explore the benefits of using Jama Connect Advisor™ to:
Reduce authoring errors
Increase clarity
Optimize foundational product needs and requirements managed in Jama Connect Cloud
Follow along with this short video below to learn more – and find the full video transcript below!
VIDEO TRANSCRIPT:
Joseph Pitarresi: Hello and welcome. Thanks for joining me today. I’m Joseph, Senior Product Manager at Jama Software. In this video, I’ll introduce Jama Connect Advisor, our new requirements authoring solution crafted with engineering-based natural language processing to help users write effective, efficient, and well-organized requirements. As a fully integrated add-on product for Jama Connect Cloud, it delivers extraordinary speed and accuracy in authoring advice. In this video, we’ll explore the benefits of using it in your daily product development to reduce authoring errors, increase clarity, and optimize the foundational product needs and requirements managed in Jama Connect Cloud.
Today, products of all types are rapidly becoming increasingly complex across every industry sector. Intelligent, connected products with rich software complexity are the new norm. Because of this, an exciting architectural evolution has emerged. The Systems-of-Systems architecture has become the new standard and brings with it the need to balance rigor and precision with agility and adaptability in the product development process. Success in this new form of product delivery starts by having accurate user requirements written clearly in natural language. Conversely, poorly written or ambiguous statements lead to development issues downstream.
Joseph Pitarresi: Efficient, precise, and professionally written requirements form the foundation of product development success. This is exactly what Jama Connect Advisor is crafted to help you and your team create. Our solution has been intentionally designed to help teams author intricate product requirements quickly and with precision. It’s been created to minimize the interruption of engineering and creative workflow processes. Jama Connect Advisor is a state-of-the-art authoring optimizer powered by engineering-focused natural language processing and artificial intelligence. Our use of engineering-focused natural language is different from that used by general-purpose digital assistance. It applies to special engineering terminology and engineering syntax expertise essential for successful product development.
So how does it work? It applies the globally proven industry principles of the International Council on Systems Engineering requirement’s rules and the easy approach to the requirement’s syntax. Authoring is a challenging task. Even experienced systems engineers and MBSEs need to consider the over 40 INCOSE rules and EARS notations six patterns while authoring even one requirement sentence. This is a daunting task. The challenge represents the perfect application of engineering-based natural language processing and artificial intelligence to speed up productivity and enhance quality. When you use Jama Connect Advisor, it reinforces and extends the authoring skills for everyone involved, regardless of their current skill level.
Joseph Pitarresi: Now let’s see how you and your team can use Jama Connect Advisor. Step one is to open a requirement in Jama Connect. Step two is to select the edit button. Step three is highlighting the rich text of a statement for analysis. You’ll notice a purple analyze button will appear on the lower right, select it. You’ll first see the quick analysis. This saves time, avoiding the need to review already well-written statements. You will see either a green, yellow or red indicator in the quick analysis. This is a rough initial gauge of quality. Next, if you see a yellow or red indicator, you’ll want to view the detailed analysis. Select the detailed analysis button.
Now you can consider detailed advice given by the INCOSE rules and EARS patterns assessments. Once you’ve considered advice, you can dismiss the detailed analysis, make your desired changes right in Jama Connect single-item view. If desired, you can repeat the analysis after you’ve made changes just to confirm your improvements were effective. This is all done in real-time with minimal interruption to your workflow and the creative thinking process.
In summary, Jama Connect Advisor enhances development team effectiveness by enabling teams to develop, refine, and adopt authoring skills faster. It speeds the creation of institutional knowledge, helping to develop an organization’s own unique approach to capturing customer value during the product development process. Thank you for joining today. We look forward to hearing from you and please ask your Jama software representative for a demo and more information about Jama Connect Advisor. Thank you.
CLICK HERE TO TRY OUT JAMA CONNECT ADVISOR FOR FREE!
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/2022/11/FIF-Req-Advisor-5in5-intro-22.jpg10801920Joseph Pitarresi/media/jama-logo-primary.svgJoseph Pitarresi2022-11-04 03:00:132023-07-26 12:37:44Jama Connect® Features in Five: Jama Connect Advisor™
In this blog, we overview Part 1 of our eBook, “A Guide to Good Systems Engineering Best Practices: The Basics and Beyond” in which we discuss the fundamentals of systems engineering best practices, the “V” model, the characteristics of good systems engineering, and lessons learned. To read the entire eBook, download it HERE.
A Guide to Good Systems Engineering Best Practices: The Basics and Beyond.
In the first part of this eBook, we discuss:
The fundamentals of systems engineering
The role of a systems engineer
Systems engineering process
The “V” Model of systems engineering
Part I: The Basics of Systems Engineering
What is systems engineering?
Systems engineering is an engineering field that takes an interdisciplinary approach to product development. Systems engineers analyze the collection of pieces to make sure when working together, they achieve the intended objectives or purpose of the product. For example, in automotive development, a propulsion system or braking system will involve mechanical engineers, electrical engineers, and a host of other specialized engineering disciplines. A systems engineer will focus on making each of the individual systems work together into an integrated whole that performs as expected across the lifecycle of the product.
What are the fundamentals of systems engineering?
In product development, systems engineering is the interdisciplinary field that focuses on designing, integrating, and managing the systems that work together to form a more complex system. Systems engineering is based around systems-thinking principles, and the goal of a systems engineer is to help a product team produce an engineered system that performs a useful function as defined by the requirements written at the beginning of the project. The final product should be one where the individual systems work together in a cohesive whole that meets the requirements of the product.
What is a system?
A system is a collection of different elements that produce results that individual elements cannot produce. Elements or parts can be wide-ranging and include people, hardware, software, facilities, policies, and documents. These elements interact with each other according to a set of rules that produce a unified whole with a purpose expressed by its functioning. An example of a system is the human auditory system; the system includes individual parts in the form of bones and tissue that interact in a way to produce sound waves, which are transferred to nerves that lead to the brain, which interprets the sounds and formulates a response. If any single part in the auditory system fails or experiences disruption, the entire system can fail to perform its function.
What is systems thinking?
Systems thinking is a way of thinking that looks at the overall function of a complex system rather than breaking it down into smaller parts. For example, systems thinking would consider an automobile a complex system that consists of smaller, specialized elements. While an electrical engineer might only be concerned with the electrical system of the automobile, someone looking at the entire complex system would consider how the electrical system would impact other systems in the automobile — and how those other systems might impact the electrical system. If one piece of the electrical system fails, for instance, how would that failure cascade to other systems to impact the operability of the automobile? Systems thinking will take a “big picture” approach to the overall product.
What is the role of a systems engineer?
A systems engineer is tasked with looking at the entire integrated system and evaluating it against its desired outcomes. In that role, the systems engineer must know a little bit about everything and have an ability to see the “big picture.” While specialists can focus on their specific disciplines, the systems engineer must evaluate the complex system — as a whole — against the initial requirements and desired outcomes. Systems engineers have multi-faceted roles to play, but primarily assist with:
Design compatibility
Definition of requirements
Management of projects
Cost analysis
Scheduling
Possible maintenance needs
Ease of operations
Future systems upgrades
Communication among engineers, managers, suppliers, and customers in regard to the system’s operations
How can systems engineers help improve traceability?
For many systems engineers, balancing the needs of the individual systems and their engineers against the system as a whole results in addressing problems after the fact, holding unwanted meetings, and trying to persuade others to change behavior. Many organizations may not adequately focus on requirements and traceability, resulting in a lack of data that would allow a systems engineer to better evaluate the product. To avoid constantly chasing problems and start streamlining processes, systems engineers can use three best practices:
Baseline the current traceability performance:
Traceability spans the product development process, and product team members understand the value of data management, especially as concerns meeting industry requirements. By establishing a baseline of traceability performance, the entire team will be able to see existing risks and potential savings and improvements. In addition, a baseline can give a foundation for a plan of action to move toward Live Traceability™.
Build the business case for Live Traceability:
With a baseline in hand, systems engineers can offer a case for moving to Live Traceability based on data. The data can establish the ROI, productivity improvements, and risk reduction of moving from static traceability to Live Traceability.
Create quick wins:
Once the advantages of Live Traceability are established, the systems engineer can set up continuous syncing between requirements and task management programs, thus automating traceability from requirements to user stories. This simple shift can help demonstrate the value of shifting from after-the-fact traceability to Live Traceability.
The systems engineering process can take a top-down approach, bottoms up, or middle out depending on the system being developed. The process encompasses all creative, manual, and technical activities necessary to define the ultimate outcomes and see that the development process results in a product that meets objectives. The process typically has four basic steps:
1. Task definition/analysis/conceptual: In this step, the systems engineer works with stakeholders to understand their needs and constraints. This stage could be considered a creative or idea stage where brainstorming takes place and market analysis and end user desires are included.
2. Design/requirements: In this phase, individual engineers and team members analyze the needs in step one and translate them into requirements that describe how the system needs to work. The systems engineer evaluates the systems as a whole and offers feedback to improve integration and overall design.
3. Create traceability: Although we’re listing traceability here as the third step, traceability is actually created throughout the lifecycle of development and is not an isolated activity taking place during one phase. Throughout the lifecycle of development, the team works together to design individual systems that will integrate into one cohesive whole. The systems engineer helps manage traceability and integration of the individual systems.
4. Implementation/market launch: When everyone has executed their roles properly, the final product is manufactured or launched with the assurance that it will operate as expected in a complex system throughout its anticipated lifecycle.
Developed in the 1980s, the “V” Diagram of Systems Engineering is a way of specifying the specific series of steps that make up a systems engineering approach. While it was originally employed in a pre-Agile environment, it still has relevance to product development today and can enable faster, less risky product development. The “V” diagram allows system engineers multiple viewpoints and opportunities to evaluate systems as they integrate with each other. This approach starts with the desired outcomes and objectives and then deconstructs them into individual systems and system components for the purpose of design. Once the requirements and design details are established, individual systems can be tested and evaluated, then integrated into the overall piece for testing and verification. As the systems are integrated and become closer to the final complex system, teams have multiple opportunities to validate and verify concepts, requirements, and design.
For the systems engineer, the “V” Model can give a clear roadmap that allows the breakdown of the complex system into smaller parts and then the reintegration and reassembly of the pieces into a cohesive whole. With systems broken down to individual components, traceability, requirements management, and testing and validation become more manageable. In addition, as the pieces are reintegrated into the whole system, the “V” Model allows for an iterative process that gives a clearer view into potential risks and helps troubleshoot problems. Systems engineering is a discipline that’s vital to the success of a complex system. By including systems engineers in all stages of product development and requirements management, teams can reduce risks, improve time to market, and produce better products that more adequately meet end user requirements.
Why is Live Traceability Essential? Given the complexity of products today, it takes multiple team members to weigh in on key decisions. And the number of decision points are only growing as products get more complex, making it even harder to adequately weigh all the options and trace their impacts. Learn more.
To read Part 2 of “A Guide to Good Systems Engineering Best Practices: The Basics and Beyond”, download the entire eBook HERE.
https://www.jamasoftware.com/media/2022/10/2022-11-03-sytems-engineering-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-11-03 03:00:272023-01-12 16:46:13A Guide to Good Systems Engineering Practices: The Basics and Beyond
Jama Connect® vs. DOORS®: Filters, Search, and Analysis: 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, A User Experience Roundtable Chat About Jama Connect® vs. DOORS®, we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.
In Episode 3 of our Roundtable Chat series, Richard Watson – Practice Director at Jama Software® – and Cary Bryczek – Director of Solutions Architecture, Jama Software® – walk us through filtering, searching, and analyzing content in Jama Connect® vs. DOORS®
To watch other episodes in this series, click HERE.
Watch the full video and find the video transcript below to learn more!
VIDEO TRANSCRIPT:
Richard Watson: Welcome to part three of our vlog series. I hope you’re enjoying the vlog so far. My name is Richard Watson and I’ll be representing DOORS today. In terms of experience, I’ve been using DOORS for just over 20 years and all of those was as the DOORS and DOORS Next product manager. I’m joined today by Cary.
Cary Bryczek: Hi everybody. I’m Cary. I haven’t had the pleasure of using DOORS for as many years as Richard. I’ve been blessed by not having to use it, but I have used Jama for a very long time and I’m the Director of Solutions Architecture here at Jama, and I’ve been in the requirements world for more than 25 years.
Richard Watson: Thank you. So in this vlog we’re going to be talking about requirements analysis, that’s filtering, searching, dashboards, etc.
Analysis is probably one of the most important reasons that we actually pick a requirements tool in the first place. The risk of life or the risk of lots of money gets organizations imposing compliance needs or their industry will give them regulations that they simply have to meet. And document-based systems just don’t give the relevant granularity to enable things like live traceability. So we need a tool.
Over time, the way we’ve engineered complex systems has changed and we find a much wider community of stakeholders are interested in direct access to the requirements. They want to actually go into the tool. And so usability of that tool becomes key. We also continue to get a wide dynamic set of users and new users, certainly younger users expect the tool to almost be like their social media apps that they’re using.
Cary Bryczek: Yeah, right but aren’t developing with the social media tools that the younger folks are used to. We’re doing real engineering.
Richard Watson: So how to persuade them to use an engineering tool?
Today’s tool engineers are being overwhelmed by data. Data can have, of course, huge value, but if you can’t find the data, it can sometimes even hinder your process, let alone give you any value.
Cary Bryczek: To do that analysis, we need to know how the information is stored, maybe even over multiple systems and how it’s all related to each other. We need to have different views of all of that trace data to ensure that really everything is being done as expected.
Richard Watson: So, okay, let’s start digging into the details. If we start with filters and search. Looking at DOORS, DOORS obviously has a world that’s wrapped around individual modules, and so trying to filter and search information across modules is next to impossible.
Initially, when we started out using DOORS years ago, that was okay. Today it’s not. Today we’re finding organizations have got thousands of DOORS modules and millions of requirements in those are total modules. It’s really difficult to find the data that you need. When you’re in a module, of course, DOORS has got quite sophisticated, complex filter definitions, but even they’re frustrating because if you want to modify them for some reason, perhaps you need to change them or maybe they’re even wrong, you have to start from scratch and normally, you need help to do that.
If we jump the fence DOORS Next, DOORS Next is DOORS next generation. It should be the next generation of DOORS, but it’s hampered by its history. DOORS Next actually was developed on top of an original tool requirements composer. And in order to introduce the DOORS, facilities, modules were added. And as a secondary fun function, modules actually confuse the situation. For example, when you add a requirement to a DOORS Next module, it also gets added to what’s called a base folder. And so when you’re searching for information, you need to know whether you’re looking for the requirement in a module or whether inadvertently you find that requirement in the folder. Sometimes you can even count these requirements twice because they’re in two separate places.
Cary Bryczek: Richard, that sounds complicated even listening to you describe it. Jama is a modern tool and we took a completely new approach with a web-based UI that’s designed for anybody to get up and running. And filters and searches is one of the prime areas that make it really super simple and easy to use for analysis.
Let me just show you what I mean. When we created Jama, we wanted it to be easy to use right away, and finding information should be just intuitive as possible. You don’t have to write any kind of DXL. I can see filters that I already have. I can see just things that I’ve bookmarked creating and searching. Again, I don’t have to write any DXL. It should just show me the particular type of requirements. I can even find things across. What are the ones that don’t have any downstream relationships.
Richard Watson: Yeah. This is so much different to DOORS, and also it’s an improvement over DOORS Next, Cary, because you can do filters on the information at the other side of the relationships and that’s quite difficult to do in DOORS Next and you just can’t do that in DOORS at all.
Cary Bryczek: Yeah. Filters are built into almost any view that you’re on. So if I’m right in a view that I’m looking at requirements, I’m able to filter it right there, filtered by keyword, filtered by the types of things that are in the view, even through traceability.
Richard Watson: Yeah. That’s really interesting, Cary. I particularly liked the way you were doing filters over relationships. I mean you consider it trying to do a filter in DOORS Next, which is impossible saying show me requirements related to defects that have been raised against failed test cases. You just can’t do that type of filtering inside of DOORS Next. So it’s pretty cool in Jama.
Richard Watson: Also, you’re showing the dashboard functionality. Dashboards in DOORS just don’t exist. So it’s got a welcome screen so you can sometimes see information on that welcome screen, but that was introduced so late in the process or the release schedule that not many organizations use it.
DOORS Next, of course, has dashboards, but again that’s hampered by history. DOORS Next dashboards are very much focused on requirements in folders. So for our DOORS user moving into DOORS Next, you’ll find that the maturity of dashboards around module information is pretty limited.
Cary Bryczek: With Jama, our dashboard technology is built right into the tool. You don’t need any extra add-on servers to make it work. And it’s something that is used as a launchpad for different stakeholders to get to the information. Let me show you what I mean.
We have dashboards that are built right in. The reporting engine is native inside of Jama itself, and then so you can take those filters that we were creating earlier and turn them into widgets, into pie charts, into bar charts, then you can download the information. You can download a picture of the things. You can see which requirements don’t have tests, what are the suspect ones, which are the recently viewed things, what’s the progress, which are the things that I’ve touched in the past few days. So if I need to pick up where I left off, launch that directly from a dashboard review.
Richard Watson: Yeah, that’s cool. I like the traceability map there as well. That’s really good. So let’s move on and talk about analysis of requirements. Analysis of requirements is where the fund is and we can start with DOORS.
DOORS has some analysis for capabilities, but mostly organizations are expected to develop DXL solutions. DXL it’s a cool thing to fill in gaps. I remember going around many of the software conferences and people will actually proudly come to me and say, “Hey, Richard. Our organization’s got hundreds of thousands of lines of DXL scripts,” sometimes over a million lines of DXL scripts.
Think about what we’re saying. A million lines of customization code where the organization’s core business is not developing requirements tools. That DXL hampers the performance of DOORS. Sometimes you lose sight of what’s making DOORS go slowly. Is it DOORS itself or is it a customization? And also, as time moved on, the number of people that have got skills in developing DXL is diminishing greatly. And so if you try to, you are exposing your organization to risk because you can’t maintain or extend your current environment.
Jumping the fence to DOORS Next, there’s a different problem entirely. DOORS Next, of course, doesn’t support front end customizations. It doesn’t support DXL. When you look at DOORS Next, actually you start to look at traceability. We want a system that can see an overall view of live traceability between data so that you can analyze that information. And the only way you can do that in DOORS Next is either with an additional tool, so Jazz reporting system, or you start looking at OSLC techniques. OSLC is okay if you’re looking at your Jazz-based products only. It’s got some very big constraints if you’re starting to get tools from different vendors. So you get tied into a single vendor solution simply because of the lack of maturity of OSLC implementations.
Cary Bryczek: Gosh, Richard. Again, that sounds really complicated. And one of the great things that Jama software did was build all of that workflow capability, all of the bits and pieces that you’d have to do with DXL into the software. So people just come in to Jama Connect and just start using it. And the live traceability aspect is probably my favorite aspect about the tool and it’s super powerful. Let me show you what I mean. One of the things that’s great is that live traceability enables pretty much anyone to find anything at the current moment across boundaries. And so, one of the ways that we start live traceability is through that relationship rule diagram. I can see the schema for what’s traced, and this information might be coming in live from other tools in the ecosystem.
We give you an easy way to organize. So if I’m starting to analyze a system just following this explore tree, and seeing how the information is organized by system and subsystem for this aircraft. Now once inside, just navigating to find that information is super simple. I even have live traceability here in the tools itself, so in the requirements, so I can see this particular function requirement, it traces to a system requirement.
Traceability is in almost every view that we look at. So if I’m in this one detail view of a requirement, I know it’s got upstream and downstream traces. If I’m in the live tracing view, my live tracing view, this is a multi-level view of requirements. So I can see if I’m following these requirements on down to the validation level or the system level. I can walk that traceability all the way down, multiple levels of requirements to look at test runs, to look at any defects along the way. It’s really powerful. And then I can start and filter right where I need to be. So if I want to have a filtered start from a filter view, which are the ones that are causing suspect?
Now, this shortens the amount of information that I have on the screen. It really makes the analysis much faster to do than having to work with DXL scripts or exporting stuff to spreadsheets and looking at the information.
Richard Watson: Thanks very much, Cary. That insight to Jama Connect is just reminding me of my last 18 months in Jama. I’ve really enjoyed picking up the Jama Connect product, really excited by it.
That brings us to the end of this particular vlog. I hope you all enjoyed it, and please feel free to take some time to look at some of the other vlogs in this series. Thanks very much, Cary.
Cary Bryczek: Thanks, Richard.
Thank you for watching our Episode 3, Jama Connect vs. DOORS: Filters, Search, and Analysis. To watch other episodes in this series, click HERE.
We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Review and Collaboration; Document Generation; Migration & Data Mapping; Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.
https://www.jamasoftware.com/media/2022/10/Doors-VLOG-Episode-3-intro-3-1.jpg10801920Richard Watson/media/jama-logo-primary.svgRichard Watson2022-11-02 03:00:142023-01-12 16:46:14Jama Connect® vs. DOORS®: Filters, Search, and Analysis: A User Experience Roundtable Chat
Jama Software is always looking for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from WIRED, about one of our customers, Illumina titled “The Era of Fast, Cheap Genome Sequencing Is Here” – originally published on September 29, 2022, by Emily Mullin.
The Era of Fast, Cheap Genome Sequencing Is Here
Illumina just announced a machine that can crack genomes twice as fast as its current version—and drive the cost down to $200 a pop.
THE HUMAN GENOME is made of more than 6 billion letters, and each person has a unique configuration of As, Cs, Gs, and Ts—the molecular building blocks that make up DNA. Determining the sequence of all those letters used to take vast amounts of money, time, and effort. The Human Genome Project took 13 years and thousands of researchers. The final cost: $2.7 billion.
That 1990 project kicked off the age of genomics, helping scientists unravel genetic drivers of cancer and many inherited diseases while spurring the development of at-home DNA tests, among other advances. Next, researchers started sequencing more genomes: from animals, plants, bacteria, and viruses. Ten years ago, it cost about $10,000 for researchers to sequence a human genome. A few years ago, that fell to $1,000. Today, it’s about $600.
Now, sequencing is about to get even cheaper. At an industry event in San Diego today, genomics behemoth Illumina unveiled what it calls its fastest, most cost-efficient sequencing machines yet, the NovaSeq X series. The company, which controls around 80 percent of the DNA sequencing market globally, believes its new technology will slash the cost to just $200 per human genome while providing a readout at twice the speed. Francis deSouza, Illumina’s CEO, says the more powerful model will be able to sequence 20,000 genomes per year; its current machines can do about 7,500. Illumina will start selling the new machines today and ship them next year.
“As we look to the next decade, we believe we’re entering the era of genomic medicine going mainstream. To do that requires the next generation of sequencers,” deSouza says. “We need price points to keep coming down to make genomic medicine and genomic tests available much more broadly.”
Sequencing has led to genetically targeted drugs, blood tests that can detect cancer early, and diagnoses for people with rare diseases who have long sought answers. We can also thank sequencing for the Covid-19 vaccines, which scientists started developing in January 2020 as soon as the first blueprint of the virus’s genome was produced. In research labs, the technology has become essential for better understanding pathogens and human evolution. But it still isn’t ubiquitous in medicine. That’s in part because of the price tag. While it costs around $600 for scientists to perform sequencing, clinical interpretation and genetic counseling can drive the price to a few thousand dollars for patients—and insurance doesn’t always cover it.
Another reason is that for healthy people, there’s not yet enough evidence of benefits to prove that genome sequencing will be worth the cost. Currently, the test is mostly limited to people with certain cancers or undiagnosed illnesses—although in two recent studies, around 12 to 15 percent of healthy people whose genomes were sequenced ended up having a genetic variation that showed they had an elevated risk of a treatable or preventable disease, indicating that sequencing may provide an early warning.
For now, researchers—not patients—will likely benefit most from cheap sequencing. “We’ve been waiting for this for a long time,” says Stacey Gabriel, chief genomics officer at the Broad Institute of MIT and Harvard, of the new improvements. “With greatly reduced costs and greatly increased speed of sequencing, we can sequence way more samples.” Gabriel is not affiliated with Illumina, but the Broad Institute is something of an Illumina power user. The institute has 32 of the company’s existing machines and has sequenced more than 486,000 genomes since it was established in 2004.
Gabriel says there are a number of ways that researchers will be able to apply added sequencing power. One is to increase the diversity of genomic datasets, given that the vast majority of DNA data has come from people of European descent. That’s a problem for medicine, because different populations might have different disease-causing genetic variations that are more or less prevalent. “There’s really an incomplete picture and a hampered ability to translate and apply those learnings to the full population diversity in the world,” Gabriel says.
Another is to boost the size of genetic datasets. In the early 2000s, when the Broad Institute started a project to search for genes related to schizophrenia, researchers had 10,000 genomes from people with the condition, which didn’t yield many insights, Gabriel says. Now, they have amassed more than 150,000.
Comparing those genomes to those of people without schizophrenia has allowed investigators to uncover multiple genes that have a profound impact on a person’s risk of developing it. By being able to sequence more genomes faster and more cheaply, Gabriel says they’ll be able to find additional genes that have a more subtle effect on the condition. “Once you have bigger data, the signal becomes clearer,” she says.
“This is the kind of thing that shakes up everything you’re working on,” agrees Jeremy Schmutz, a faculty investigator at HudsonAlpha Institute for Biotechnology, of new sequencing technology. “This reduction in sequencing cost allows you to scale up and do more of those large research studies.” For Schmutz, who studies plants, cheaper sequencing will allow him to generate more reference genomes to better study how genetics influence a plant’s physical characteristics, or phenotype. Large genomic studies can help improve agriculture by accelerating the breeding of certain desirable crops, he says.
Illumina’s sequencers use a method called “sequencing by synthesis” to decipher DNA. This process first requires that DNA strands, which are usually in double-helix form, be split into single strands. The DNA is then broken into short fragments that are spread onto a flow cell—a glass surface about the size of a smartphone. When a flow cell is loaded into the sequencer, the machine attaches color-coded fluorescent tags to each base: A, C, G, and T. For instance, blue might correspond to the letter A. Each of the DNA fragments gets copied one base at a time, and a matching strand of DNA is gradually made, or synthesized. A laser scans the bases one by one while a camera records the color coding for each letter. The process is repeated until every fragment is sequenced.
For its latest machines, Illumina invented denser flow cells to increase data yield and new chemical reagents, which enable faster reads of bases. “The molecules in that sequencing chemistry are much stronger. They can resist heat, they can resist water, and because they’re so much tougher, we can subject them to more laser power and can scan them faster. That’s the heart of the engine that allows us to get so much more data faster and at lower costs,” says Alex Aravanis, Illumina’s chief technology officer.
That said, while the cost per genome is dropping, for now, the startup cost for a machine itself is steep. Illumina’s new system will cost around $1 million, about the same as its existing machines. The high price tag is a key reason they’re not yet common in smaller labs and hospitals, or in rural regions.
Another is that they also require experts to run the machines and process the data. But Illumina’s sequencers are completely automated and produce a report comparing each sample against a reference genome. Aravanis says this automation could democratize sequencing, so that facilities without large teams of scientists and engineers can run the machines with few resources.
Illumina isn’t the only company promising cheaper, faster sequencing. While the San Diego-based company currently dominates the marketplace, some of the patents protecting its technology expire this year, opening the door for more competition. Ultima Genomics of Newark, California, emerged from stealth mode earlier this year promising a $100 genome with its new sequencing machine, which it will begin selling in 2023. Meanwhile, a Chinese company, MGI, began selling its sequencers in the United States this summer. Element Biosciences and Singular Genomics, both based in San Diego, have also developed smaller, benchtop sequencing machines that could shake up the marketplace.
Ultima’s machine design has replaced the traditional flow cell with a round silicon wafer just under seven inches in diameter. Josh Lauer, the company’s chief commercial officer, says the disc is cheaper to manufacture and has a bigger surface area than a flow cell, allowing more DNA to be read at once. Because the disc rotates like a record under a camera instead of moving back and forth like flow cells do, Lauer says it requires smaller volumes of reagents and speeds up imaging. “We think this will enable scientists and clinicians to do more breadth, depth and frequency of genome sequencing,” he says. “Instead of just looking at tiny parts of the genome, we want to look at the whole genome.”
Ultima’s machine isn’t widely available yet, and the company hasn’t released the price, though Lauer says it will be comparable to other sequencers on the market.
The increased competition could be a boon to the genomics field, but research is often slow to translate to health improvements in real people. It will likely take time before patients see a direct benefit from cheaper sequencing. “We’re at the very, very beginning,” deSouza says.
https://www.jamasoftware.com/media/2022/10/Illumnia-Customer-Spotlight.png5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-10-27 03:00:042023-10-25 12:32:09The Era of Fast, Cheap Genome Sequencing Is Here
A User Experience Roundtable Chat About Jama Connect® vs. DOORS®: Adoptability for All Stakeholders
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, A User Experience Roundtable Chat About Jama Connect® vs. DOORS®, we’ll present several information-packed video blogs covering the challenges that teams face in their project management process.
In Episode 2 of our Roundtable Chat series, Cary Bryczek – Director of Solutions Architecture, Jama Software® and Susan Manupelli – Senior Solutions Architect, Jama Software® – walk us through the importance of adaptability, and ease of use, for all stakeholders in a requirements management tool.
Watch this short video below to learn more and find the full video transcript below!
VIDEO TRANSCRIPT:
Cary Bryczek: Hi everybody. Welcome to part two of our vlog series. I hope you’re enjoying the series so far. My name is Cary Bryczek, and I’ll be representing Jama software today. In terms of experience, I’ve been using Jama for nine years, but have used DOORS and numerous other requirements tools for the past 20 years. I’m joined today by Susan.
Susan Manupelli: Hi there. My name is Susan Manupelli. I’m a solutions architect here at Jama Software. Prior to joining Jama, I was a test architect working on the engineering lifecycle management suite of products, particularly on Rational DOORS Next Generation and the Global Configuration Manager. So I’m happy to be here with you today to talk requirements management adoptability
Cary Bryczek: Thank you Susan. In this vlog, we’re going to be talking about the adoptability for all stakeholders. Adoptability, it might be the most important aspect for a requirements tool and sometimes it’s the most overlooked. Adoptability isn’t just about being able to get users to actually use the software, but it’s about how well it fits into the IT ecosystem. How hard or easy it is to maintain, or even whether or not the organization recognizes its benefits.
UI, Ease of Use, and Adoptability
Susan Manupelli: Right. Let’s talk… One of the first challenges in the adoption of DOORS Classic is that many dev teams are distributed globally. DOORS is a legacy client server application, which doesn’t scale well over the WAM, so DWA, DOORS Web Access, was released as the answer to that problem, but it lacks significant functionality only available in the desktop client.
Another challenge with DOORS Classic is that the UI look and feel is very dated. Modern engineering teams are energized by utilizing the very latest technologies for developing state-of-the-art products for the future, and then they’re asked to use a requirements tool that was designed some 30 years ago. So that just doesn’t fly very well.
Let’s talk a little bit about DOORS Next Generation. It was marketed as a new modern alternative to DOORS Classic. Unfortunately, it’s very hard to use. There are too many different options for use and a lack of direction on best practices. So we’ll go through some of these challenges in the vlog.
The first place where users struggle to adopt DOORS Next Generation is a very basic question; whether to use modules or not. DNG originally only allowed you to organize requirements in a tree view hierarchy of folders. And later, to accommodate users that were more familiar with DOORS Classic, modules were added to DNG. Modules provide a document-like view for requirements, but these same artifacts outside of the module view show up in alpha numeric order in the true view, it makes organization of artifacts outside of the module very confusing.
Cary Bryczek: Wow. Yeah, that does sound complicated to comprehend. Jama was developed as a web-based solution from scratch. We wanted to fulfill the lowest common denominator stakeholder so anybody could come in and use our software. Our UI is modern and intuitive. Let me show you what I mean.
This is what I mean about our UI. It’s very streamlined. There’s hardly any button clicks or menus to learn how to use. There’s four main menus. And then the rest of them are kind of like right click kinds of options. We have the dashboard built right in. Our views are super simple. The explorer tree matches exactly what you see in our list view. And our views are very simple to navigate. So if this is the list view, and I wanted to see a document or a reading kind of view, I can just toggle the buttons to show those different types of views.
Teaching someone how to use this is really super simple, and it doesn’t take that much time at all. In fact, analysts have even recognized Jama Software as being the easiest user tool in the marketplace. You can go out there and see something like from G2, which queries users without us even knowing about it to get their direct feedback on the tools.
Link Relationship Rules and Traceability
Susan Manupelli: Well thanks, Cary. That was great. Another area that’s confusing in DNG has to do with linking. Linking behavior is different between module artifacts and non-module artifacts. A lack of understanding leads to incorrect or incomplete traceability analysis. In DNG, if you link to artifacts that are outside of a module, the link is placed on the core artifact. If you link to artifacts within a module, the link only appears in that particular module. If you then print a traceability report, you’ll only see links made in the module context. So links to core artifacts won’t be displayed. So as a user, that behavior is very confusing.
Another gate to adoptability has to do with enforcing link relationships. Enforcing relationship rules in DNG it’s just hard to do. Either all links are allowed, which means that users can kind of willy-nilly apply link rules that don’t make sense really for relationship, or allowed link rules are specified in a list form for a given component, and then they must be recreated across all components in the project. There’s also no visual representation of link rules in DNG, and there’s no notion of enforcement of required link rules, so compliance is hard to maintain.
Cary Bryczek: Gosh, just listening to that sounds really confusing to me, and I’ve even used DOORS. In Jama, linking is just straightforward. If an item is linked to another item, that link relationship will be visible wherever you are in the UI. We also have the capability to see what our relationship schema looks like and enforce a consistent way to apply traceability. Let me show you what I mean.
There’s a couple of different ways to look at the traceability. I can see that traceability right away. So I know that this standard aircraft platform requirement is traced to another object downstream. I can see the traceability numbers, so this one in this list view. I can see that this one requirement has five different traceability things. I can see it also in the trace view. We’ll tee up a live real-time version of what’s currently traceable out there. It’s very easy to see where there’s gaps in traceability because there’s just no information there.
We have our traceability rule set. Think of this picture as being the schema for what types of objects are allowed to be traced to one another. So I might have four levels of requirements traceability. I might have test cases in there. And so this set of rules would enforce the users to create consistent traces. And then I can follow those rules down in the live trace view as well. So if I’m following this aircraft level requirement, I can see the system requirements, and any kind of lower level objects, whether those are high level software requirements. Here I see some verification tests and agency test runs. Traceability is really made to be super intuitive, real-time, live, to allow anybody to understand and analyze the current situation.
Susan Manupelli: Another common issue is that DOORS Next is hard to administer and maintain. Upgrades are often a challenge. As major architectural changes have occurred in recent releases of the DNG, the time and effort and ultimately the cost to upgrade has been daunting.
Another area of maintenance in DNG has to do with the type system. The type system, that’s the part of DNG that keeps track of your artifact types, your attributes and your values and their relationships. And that needs to be consistent from project to project for cross component and cross project reporting. And there’s no global way to keep these items in sync from project to project or component to component.
Cary Bryczek: Cool. That’s really different than the experience here at Jama. Our host of solutions get updates just about every 60 days. Middleware and security updates are handled as necessary. And sometimes the middlewares might take six months to a year or so. Very stable releases and changes to the ecosystem. We have self-hosted solutions and even customers that have air gap, we can satisfy those sort of ecosystem environments. Very easy to set up and deploy.
Now, it was interesting that you talked about, Susan, though the type rules. In Jama, we’re a little bit different for item types and attributes. We define those globally. Here’s an example.
Our type rules are defined globally, like I said. Here’s an example of schema for the types that are relevant to this particular achiever one project. When we define them globally, it’s all point and click kinds of experience of dealing with that. These attributes are now consistent from project to project to project. And that way you can have really easy reuse scenarios. If you’re doing complex scenarios like product line engineering or if you have complex libraries of data that you use from one project to the next, having that consistent type definition really makes it easier for you to do analysis, leverage reuse, have shorter project startup times.
Susan Manupelli: Yeah, sure. I can definitely see that. One other area that I wanted to talk about has to do with reporting. For all the effort that’s put into DNG to maintain the projects, to build up the requirement specs, the reporting needed to meet certifications is hard or sometimes impossible to create. Mistakes or inconsistencies in the type system that we just talked about, those often manifest as issues once you try to do some traceability reporting. Keeping data consistent between DNG in the reporting data stores has proven to be a challenge, so we’re talking about the data warehouse and LQE. And basically robust reporting out of DNG requires the use of additional IBM tooling, either Jazz Reporting Service, or RPE, the Rational Publishing Engine, and those products are outside of DNG.
Cary Bryczek: That sounds complicated. Again, one of the great things that we have at Jama is our reporting engine is built right into Jama itself. And Jama is a single application, so there’s no deploying 11 different servers of applications that are sort of cobbled together through an integration under the covers. Jama is just a single application. And exporting is super easy. Let me show you what I mean.
We have lots of built in reports. Lots of different kinds of reports that you can add in. We have the capability to export directly to Excel, Word, right there. All a user has to do is configure the view that they’re looking at, whether that’s the reading view or the list view that’s customized to match what they need to have. And then they can have the built in export templates that are just creatable via Microsoft Word templates, so there’s no custom coding in most cases that a user has to do to run these kinds of reports. Doesn’t that sound much easier, Susan?
Susan Manupelli: It sure does.
Cary Bryczek: That brings us to the end of this particular vlog. I hope you all have enjoyed it. Please, I hope you also take some time out to look at some of the other vlogs in this series. Thank you so much, Susan, for your perspective on DOORS and DNG as well.
Susan Manupelli: Thank you Cary. Happy to be here.
Thank you for watching our Episode 2, Jama Connect vs. DOORS: Adoptability for All Stakeholders. To watch Episode 1 of this video series, click HERE.
We hope you’ll join us for future Jama Connect Jama Connect vs. DOORS topics, including: Adoptability for All Stakeholders; Filters, Search and Analysis; Review and Collaboration; Document Generation; Migration & Data Mapping; Industry Templates; Reuse and Variant Management; Requirements-Driven Testing; Total Cost of Ownership; and Why Did We Move to Jama Connect? A Customer’s Story.
https://www.jamasoftware.com/media/2022/10/Doors-VLOG-Episode-2-Blog-Image.jpg10801920Cary Bryczek/media/jama-logo-primary.svgCary Bryczek2022-10-19 03:00:362023-01-12 16:46:16A User Experience Roundtable Chat About Jama Connect® vs. DOORS®: Adoptability for All Stakeholders
As the developer of a coastal transportation vehicle, REGENT must adhere to rigorous safety standards for both aviation and maritime travel, and they take that process very seriously. And in order to create the safest, highest quality vehicle, they know that they must implement a world-class development process. With that in mind, REGENT implemented Jama Connect.
After implementing Jama Connect®, the REGENT team has realized the following outcomes:
Ability to complete an entire design review in three weeks
Reuse library of compliance with more than 25 sets of external regulations and standards
Documenting verification and collecting artifacts for compliance is a simple, automated process
Electric Transportation Startup, REGENT, Speeds Time to Market by Choosing Jama Connect to Simplify and Prove Compliance for Complex Safety-Critical Product Development with Strict Regulatory Oversight
ABOUT | REGENT
Founded in 2020 by MIT-trained, ex-Boeing engineers
Building their flagship product, the seaglider, a wing-in-ground-effect craft
Sub-scale prototype built and a goal of having paying passengers on their 12-passenger seaglider Viceroy by 2025
Headquartered in the Boston area
With a mission to drastically reduce the cost and headache of regional transportation between coastal cities, REGENT is building a revolutionary new category of electric vehicle called a seaglider that will service routes up to 180 miles with existing battery technology, and routes up to 500 miles with next-gen batteries. The vehicles will be as safe as aircraft and have better wave and wind tolerance than existing seaplanes and WIGs.
By coupling the high speed of an airplane and the lower operating cost of a boat, REGENT is revolutionizing regional coastal travel.
Founded in late 2020, REGENT has already built a sub-scale prototype of the seaglider and will have a full-scale prototype by 2023.
Backed by many big-name investors, including Mark Cuban Companies, Hawaiian Airlines, and Founders Fund, REGENT aims to safely transport commercial passengers by 2025.
REGENT CUSTOMER STORY OVERVIEW
As the developer of a coastal transportation vehicle, REGENT must adhere to rigorous safety standards for both aviation and maritime travel, and they take that process very seriously. And in order to create the safest, highest quality vehicle, they know that they must implement a world-class development process. With that in mind, REGENT implemented Jama Connect®.
OBJECTIVES
Demonstrating compliance with stringent aviation and maritime safety standards
Meeting aggressive development timelines in order to safely transport commercial passengers by 2025
Building an inclusive, efficient review process
EVALUATION
Cloud-based solution
Easy-to-use platform with a modern, intuitive interface
Ability to scale multiple projects
Industry experience and aviation market presence
OUTCOME
Ability to complete an entire design review in three weeks
Reuse library of compliance with more than 25 sets of external regulations and standards
Collecting artifacts for compliance is a simple, automated process
As a new company, REGENT knew that they needed to get things right the first time around. With little wiggle room for error, the team set out to find a requirements solution that could help the team turn their ideas into reality.
The main objectives that REGENT needed their requirements management platform to support were:
Demonstrating compliance with stringent aviation and maritime safety standards
Meeting aggressive development timelines in order to safely transport commercial passengers by 2025
Building an inclusive, efficient review process
“As a developer of seagliders which are essentially flying boats, REGENT connects the aviation and maritime domains. In the future we will also need to comply with international maritime regulations as well. Because of this, we knew we needed to take a rigorous approach to safety and vehicle development. It was important for us to find a solution that could track requirements and be used to generate the artifacts necessary to certify a flying boat,” said Ted Lester, Vice President, Certification at REGENT. “We wanted to lay the groundwork for the kind of safety-critical development that’s used in the aviation industry. Ultimately, we knew that if you’re developing a new aerospace vehicle from scratch, a good requirements management tool is key.”
From the start, REGENT knew they needed the best available requirements management platform available.
As part of their evaluation process, they began searching for a solution that met the following criteria:
Cloud-based solution
Easy-to-use platform with a modern, intuitive interface
Ability to scale multiple projects
Industry experience and aviation market presence
REGENT evaluated a number of solutions, including IBM® DOORS® and Intland codebeamer, but Jama Connect was the only platform that met all of their needs.
“As a startup, we were working with a very small, agile team. We knew that we couldn’t stand up a hosted solution, so it was important to us that we find a solution that could be Software as a Service (SaaS). And with Jama Connect, we were able to stand the platform up very quickly with very little IT work” said Ted Lester, VP, Certification.
“It was also very important to us that our team could easily use the platform. We knew we needed a solution that allowed us to easily trace requirements from design all the way through verification and validation,” said Lester. “Between the more than 25 sets of external regulations and standards we need to follow, our requirements, and our sub-system requirements, we knew were going to have an extensive number. The ability to scale and do traceability easily was key to our selection process, and nobody did that better than Jama Connect.”
Another factor that played into REGENT’s decision was Jama Software®’s deep knowledge of the aviation industry, extensive resources, and industry templates that help teams build the infrastructure for regulatory
compliance with aviation standards.
“Although IBM DOORS and IBM Telelogic probably have the largest market penetration in aviation, we had many people on our team who had worked in the tool in the past and did not have good experiences. With
Jama Software, we had templates available for DO178 and ARP4754 available to help us get up to speed faster.” said Lester.
https://www.jamasoftware.com/media/2022/10/2022-09-22-regent-customer-story-1-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-10-13 03:00:462023-01-12 16:46:16Electric Transportation Startup, REGENT, Speeds Time to Market with Jama Connect®
Jama Connect® Features in Five: Jama Connect Interchange™
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, Debbie Mitchell, Product Manager at Jama Software, will introduce viewers to Jama Connect®’s dedicated integration platform, Jama Connect Interchange™.
In this session, we will explore:
Benefits of integrating Jama Connect
Features of Jama Connect Interchange
Common Jira and Excel Functions integration workflows
Follow along with this short video below to learn more, and you can find the full video transcript below!
VIDEO TRANSCRIPT:
Debbie Mitchell: Welcome. I’m Debbie, a Product Manager here at Jama Software. In this video, I’m going to introduce you to Jama Connect’s dedicated integration platform, Jama Connect Interchange. In this video, we will explore the benefits of integrating Jama Connect to other best-of-breed tools, the features offered by Jama Connect Interchange, and some common workflows using our Jira and Excel Functions integrations.
When developing new products, organizations typically employ an entire suite of best-of-breed tools. Requirements management tools like Jama Connect, task management tools like Jira and Microsoft Azure DevOps, and charting and spreadsheet tools like Microsoft Excel.
Working across disconnected tools can present a problem, though. Information quickly becomes out of date, and teams get out of sync with one another, leading to product delays, defects, cost overruns, rework and recalls. This is why we built Jama Connect Interchange, a new integration platform that delivers seamless integration between Jama Connect and other best-of-breed tools.
Unlike other integration tools in the marketplace, Interchange is built, supported, and continually enhanced by dedicated teams at Jama Software. This means Interchange is deeply integrated with Jama Connect configurations and workflows, providing you with a smart and seamless sync while you continue to work in your tool of choice.
Let’s take a common example. Suppose my company is building a new product that includes a software component. Using Jama Connect, I finalize a list of software requirements which will now be decomposed into individual user stories. Those stories will be sent to Jira, the software development team’s tool of choice, for the software engineers to complete.
Debbie Mitchell: Let’s see what this looks like in Jama Connect. Using Interchange, I have set up an integration that allows the user stories that I’ve created in this set to automatically flow to a specific project in Jira. In Jira, the software development team can then refine the stories and create additional tasks and subtasks as needed to complete the development work.
In the Interchange admin hub, I’ve specified exactly how information should flow between Jama Connect and Jira for this particular project. I can specify whether each field flows one way or bi-directionally, and the frequency with which changes are synced. Updates can flow as fast as every 15 seconds, so both systems always have the latest information.
For this particular scenario, I’ve configured Interchange so that when development work is complete in Jira, the user story status is automatically synced back to Jama Connect to a field called Development Status. Now I can use the trace view in Jama Connect to easily identify when all user stories associated with a particular requirement have been completed.
To further automate this workflow, I can use the Interchange Excel Functions module to apply additional logical transformations to my data in Jama Connect. You can think of Excel Functions as a calculator that runs in the background while you continue to work in Jama Connect. A Jama Connect administrator maintains the formulas and calculations in an Excel template, and those formulas are then applied to fields in Jama Connect based on the settings and rules the administrator sets up in Interchange.
In this simple example, I’ve set up a rule in my Excel template stating that when all downstream user stories have a status of Development Done, I want the upstream software requirement in Jama Connect to also be marked as Done. Now, this is just one example of how Interchange Excel Functions can be used.
Debbie Mitchell: Jama Connect clients today derive much deeper value from Interchange for scenarios like complex risk calculations, automated field inheritance or data population between related items, customized test case status rollups, and more. You can find out more about Excel functions, use cases, and capabilities by joining the Jama Connect interchange sub-community on the Jama Software community website.
Jama Connect customers can now leverage the power of Interchange to continuously sync information between Jama Connect and other best-of-breed tools. This means teams can continue using their tool of choice to maximize productivity while ensuring that critical project requirements stay in sync. Unlike other solutions in the market, Interchange has been specifically designed and developed to work seamlessly with Jama Connect. It’s easy to deploy, configure, use, and expand, driving efficiency and further lowering your total cost of ownership.
For more information about Interchange, contact your Customer Success Manager today, and thanks.
In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.
In this customer story, we examine how Jama Connect helps Convergent Dental increase efficiency and manage complex product development subject to regulatory compliance. Read the full customer story to find out how Convergent Dental has shifted from cumbersome document-based processes to a more modern requirements management solution, resulting in:
Audit preparation decreased from three weeks to one day
Streamlined review cycles
Plans for leveraging Jama Connect for test management
Convergent Dental chooses Jama Connect to manage compliance through in-depth reviews and to save valuable engineering time.
ABOUT | Convergent Dental
Headquartered in Needham, MA
Expertise: Creating breakthrough laser technology that completely changes how people think of dentistry.
Awards: The Company’s flagship product, Solea®, was voted a Gold Winner for innovation at Edison Awards 2016.
Headquartered in Needham, MA, Convergent Dental, Inc., is the creator of Solea, the world’s first computer-aided hard, soft, and osseous tissue dental laser.
With an isotopic CO2 beam of 9.3 µm, Solea cuts significantly finer and faster than any other dental laser, with virtually no noise or need for anesthesia. Their unique system, with patented technologies and controls, nearly eliminates the need for the drill – the thing that many dread about going to the dentist.
CONVERGENT DENTAL CUSTOMER STORY OVERVIEW
CHALLENGES
Manual, cumbersome processes were slowing teams down significantly
Difficulty compiling necessary documentation for compliance
Proving all requirements are tested
EVALUATION CRITERIA
Easy-to-use platform with a low barrier to entry
Out-of-the-box configurations
Automated traceability
THE OUTCOME AND THE FUTURE
Audit preparation decreased from three weeks to one day
Streamlined review cycles
Plans for leveraging Jama Connect for test management
Manual, cumbersome processes were slowing teams down significantly
As a small team, the development team’s motto is that no one has the option to be “dead weight.” So, when their engineers were forced to spend hours manually editing requirements and tracking traceability using Word and Excel documents, it wasn’t great for team morale, or for their pace of development.
While using Word and Excel, they found themselves tracking across multiple documents, all with their own trace matrix tables relating to different requirements. The fallout from this process is that even a single word or letter change in a low-level subsystem requirement led to updating the corresponding requirements documents and their trace matrix tables. So, a single letter turns into not one change but potentially six changes across five different documents.
This manual method of digging through Word documents led to cumbersome requirements management and traceability tracking from engineers whose time should be devoted to systems engineering for product development.
We have a small team with a large amount of features and updates to perform on an ongoing basis. We all work really hard here, and there’s no option to be dead weight. Getting rid of that wasted time in Word and Excel, and getting our test engineers back to work, is the ultimate goal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent
Difficulty compiling necessary documentation for compliance
In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they began to seriously consider the challenges of their documents-based requirements management process.
They knew their requirements were tested, but in order to show proof, they had to go through hundreds and hundreds of pages. They tediously combed through all their records, which took weeks, significantly impacted productivity, and slowed time to market.
“So instead of just being able to reference the reports and say, ‘Look, they’re here,’ I had to put together the list and then ask a team member to go dig down those. And that took him a couple of days to dig up all that testing. So that was the loss, time from our test engineers.” – Craig Woodmansee, Electrical Systems Engineer, Convergent
Preparing for the De Novo Submission was a catalyst for this in-depth review of their requirements. If they continued down the path of Word and Excel, an auditor — if they decided to pull on any small little string — would have resulted in more time trying to track down the requirements. This experience was the deciding factor that led them to understand that the Convergent team needed a better tool.
To solve the above challenges, and in order to save valuable time in the development process, the Convergent team knew they needed to move to a modern and proactive requirements management tool.
Many team members had shared their past experience with Perforce Helix, however, when they began evaluating new solutions, they realized they needed more robust configurations and a more intuitive interface than what those could offer.
“When comparing Jama Connect and Helix, ease of use and the interface played a large role in that decision. While Perforce has many strong applications, this specific area is one where Helix fell short.” – Craig Woodmansee, Electrical Systems Engineer, Convergent
The evaluation process for selecting a modern requirements and test management solution ultimately came down to Intland codebeamer and Jama Connect®.
The following capabilities and features were ultimately why Convergent selected Jama Connect:
Easy-to-use platform with a low barrier to entry
Throughout the evaluation process, it was important to the Convergent team that they found a platform that was easy to use, allowing all team members to easily get started without spending significant time learning a complex platform.
As a small team, Convergent needed a platform that would allow them to move quickly and be agile. They didn’t have time to waste when looking for the requirement management tool that would solve their challenges. After completing trials of both Jama Connect and codebeamer, they knew they needed to make a timely decision. They gathered as a team for an internal review where they asked each other questions such as, “How easy was it to learn?”, “How good and intuitive did it feel to use?”, and “How fast can we be onboarded?”
During their evaluation, Jama Connect’s online training videos demonstrated just how easy the platform was to use. After watching tutorials, critical team members felt they already knew how to use the platform and that Jama Connect would provide a good level of support. After their trial, they discovered that the low barrier to entry and quick adoption helped Jama Connect stand out from other platforms and made their team excited when they received approval to start using Jama Connect.
Out-of-the-box configurations
Implementing a new system is a big deal for any company, and while the team knew onboarding a modern requirements management solution would greatly improve the team’s efficiency, they knew that they were facing a relatively significant change. To save time for their quality team, they prioritized finding a solution with out-of-the-box configurations aimed at the design control process.
While evaluating Jama Connect, they found preconfigured design rules that closely matched what they currently used.
“You can’t beat it. It’s too easy. Using the out-of-box configurations, I can just click and view the trace matrix. That was phenomenal.” – Craig Woodmansee, Electrical Systems Engineer, Convergent
Automated traceability
When evaluating solutions, Convergent knew that a key component of their search revolved around a platform’s ability to automatically — and proactively rather than reactively — create traceability from design, all the way through to verification and validation.
What they found was that Jama Connect was the only platform that could create Live Traceability™, the ability to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans.
The Convergent team knew that this level of traceability would allow the team to work faster, simplify their process, and improve the quality of their project management.
After importing user needs and requirements, creating relationships, and running tests in Jama Connect, the Convergent team realized that traceability became semiautomatic.
“We don’t have to manually maintain traceability because Jama Connect does it for us. Once requirements are in place, Jama Connect just says ‘if you make a change, then here are all the things it affects.’” – Craig Woodmansee, Electrical Systems Engineer, Convergent
https://www.jamasoftware.com/media/2022/10/2022-09-customer-story-convergent-1-1.jpg5121024Decoteau Wilkerson/media/jama-logo-primary.svgDecoteau Wilkerson2022-10-04 03:00:042023-01-12 16:46:18Innovative Dental Equipment and Technology Company, Convergent Dental, Selects Jama Connect® For Its Quick Adoption and Live Requirements Traceability
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Security – 5 FBI Recommendations for Medical Device Cybersecurity – which was originally published on September 16, 2022, by Madeline Lauver.
5 FBI Recommendations for Medical Device Cybersecurity
While medical devices are often designed for decades of use in hospitals, the software needed to run them becomes outdated more quickly. This results in devices running vulnerable software on healthcare networks, which can expose patients to physical and cyber threats.
In response to the threats facing medical devices, the Federal Bureau of Investigation (FBI) has released recommendations for the healthcare sector to bolster the cybersecurity of medical devices.
Consequences of medical device cyberattacks
Cybersecurity threats to medical devices can initiate a range of adverse effects. “On the extreme side, you have the scenario where a medical device compromise could directly impact patient safety and potentially be life-threatening,” said Ben Denkers, Chief Innovation Officer at CynergisTek. “What could an attacker do if they took control of an insulin pump or pacemaker?”
While medical device takeovers have the potential to cause life-threatening consequences, many cyberattacks on medical devices lead to system downtime, rather than complete control of devices. “The most common consequence is healthcare organizations must deny service to the individual because the device no longer works or requires supporting infrastructure, which has also been compromised. Where time becomes a critical success factor in many medical emergencies, this can also have severe patient impacts,” said Denkers.
To prevent cyberattacks on medical devices, the FBI released a list of recommended security strategies and technologies for healthcare cybersecurity leaders to adopt, including:
Endpoint protection: Encrypt medical device data, use antivirus protection where able in medical devices, and monitor for cyber threats to the hospital network.
Identity and access management: Use complex passwords and limit the amount of users with accessibility to medical device credentials. If possible, change medical device passwords on a regular basis.
Asset management: Maintain an inventory of all medical devices and track their software lifecycle to replace devices when necessary.
Vulnerability management: Scan devices for vulnerabilities and work with medical device manufacturers to update software.
This FBI guidance aims to provide the foundation of a robust healthcare security program that reduces medical device cyber risk. “Reducing risk is not a static, one-time process,” said Denkers. “Organizations need to have a program in place to identify ongoing risk and ensure safeguards are performing as designed. Doing so can allow organizations to have an upper hand when dealing with the ever-evolving threat landscape.”
For more medical device security information, read the full FBI recommendations.
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Jama Software is always on the lookout for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from Mass Device, about one of our customers, Surgalign titled “FDA Clears Surgalign’s Cortera Spinal Fixation System” – which was originally published on August 24, 2022, by Sean Whooley.
FDA Clears Surgalign’s Cortera Spinal Fixation System
Surgalign (Nasdaq:SRGA) has announced that it received FDA 510(k) clearance for its Cortera spinal fixation system.
Deerfield, Illinois-based Surgalign said in a news release that the new flagship Cortera product represents a key product portfolio piece. Surgalign officials see Cotera driving the company’s future growth. It could ensure market gains in the posterior fixation market.
“The Cortera system is a testament to the spine engineering talent and expertise we’ve assembled in very short order, as we moved from zero engineers in the United States following the RTI divestiture two years ago, to approximately 30 today,” said Terry Rich, president and CEO of Surgalign. “Thanks to our team and incredible surgeon partners, we progressed from company inception to FDA 510(k) clearance with a very polished system in approximately 16 months. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”
Cortera, a 5.5/6mm rod pedicle screw system, offers both open and minimally invasive surgery (MIS) modules, plus a feature-rich screw design with a comparatively low profile and newly designed locking mechanism.
Surgalign designed Cortera to maximize adoption in the spine market, both today and in the future with evolving techniques and technologies. The company added that Cortera demonstrates the ways in which spinal implants will be deployed with technologies like its own HOLO Portal surgical guidance platform.
The company plans to integrate Cortera with HOLO Portal to create what it labeled “an unrivaled user experience for pedicle screw navigation.” Surgalign also has plans for additional implants and instruments to add to the system over the next few years to expand applications into a majority of posterior fixation spinal procedures.
Surgalign will offer Cortera in a limited market release, which it expects to positively contribute to its 2022 fourth-quarter results and in the coming years.
“The system is hands down the most precise, elegant and comprehensive screw that currently exists in my opinion,” said Dr. Jeremy Smith, chief of spine, Hoag Orthopedic Institute. “I find the system has an evolved sophistication that provides a high-quality user experience and enhanced clinical performance in challenging pathologies.”
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