Tag Archive for: Customer Spotlight

Robotics Industry
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Data Science Central, titled “Revolutionizing the Supply Chain: Developments in the Warehouse Robotics Industry” – originally authored by Nikita Godse on January 24, 2023.


Revolutionizing the Supply Chain: Developments in the Warehouse Robotics Industry

Warehouse robotics is witnessing steady growth, driven by the increasing adoption of automated solutions in storage for food and beverages, consumer goods, retail, and third-party logistics. The collaboration between the e-commerce sector and warehouse robotics is also a major driver of this market, as it allows for developing increasingly sophisticated warehouse automation systems. Additionally, the advent of autonomous mobile robots (AMRs) and the rising popularity of automated guided vehicles (AGVs) are also fueling the growth of this market.

Reforming Warehouse Operations: Increasing Adoption of AMRs and AGVs

One of the most notable trends in the warehouse robotics market is the increasing adoption of AMRs and AGVs. These robots are allowing for the development of more efficient and cost-effective warehouse operations, as they can automate tasks such as picking, packing, and transporting goods. Additionally, the use of AMRs and AGVs is also allowing for the development of more flexible and scalable warehouse operations, which can better meet the changing needs of businesses.

Efficient and Cost-effective: Rising Collaboration between eCommerce Sector and Warehouse Robotics

Another major trend in the warehouse robotics market is the increasing collaboration between the e-commerce sector and warehouse robotics. This is being driven by the growing demand for efficient and cost-effective warehouse operations, as e-commerce businesses look to keep pace with the rapid growth in online sales. Additionally, the use of warehouse robotics is also allowing e-commerce businesses to better meet the changing needs of their customers by providing faster and more accurate delivery of goods.

 


RELATED: Managing Functional Safety Development Efforts for Robotics Development


Advanced Automation: Increasing Preference for Advanced Robots in Warehouses

As the warehouse robotics market continues to evolve, it is clear that there will be a growing demand for advanced robots in warehouses. This is being driven by the surge in the adoption of robots during the COVID-19 outbreak, as businesses look to automate their operations and reduce their dependence on human labor. Additionally, the increasing adoption of industrial automation and control solutions is also contributing to the growth of this market.

Global Perspective: North America to Lead, Europe to hold Second Largest Share

The warehouse robotics market is a global industry, and it is clear that different regions are at different stages of development. Currently, North America is the largest market for warehouse robotics, driven by the rapid adoption of warehouse automation and the presence of major players in the market such as the United States. However, Europe is expected to hold the second-largest market share, driven by the rising adoption of industrial automation and control solutions in the region.

 


RELATED: 2023 Predictions for Industrial and Consumer Electronics Product Development


Innovations in Warehouse Automation: A Look at Leading Players’ Latest Developments

The warehouse robotics market is a highly competitive industry with several leading players. Some of the major players in the market include KUKA AG, FANUC Corporation, ABB, and Yaskawa Electric Corporation. These companies have made significant investments in the development of warehouse automation solutions and have a strong presence in the market.

Additionally, there are also several startups and smaller companies that are emerging in the market, such as Locus Robotics and GreyOrange, which are focusing on specific areas of warehouse automation. The competitive landscape is expected to become more intense with the entry of new players and increasing investments in the development of warehouse automation solutions.

In the warehouse robotics market, major players such as Kuka AG, FANUC Corporation, and ABB Limited have been focusing on developing advanced robots for warehouse automation. Recently, Kuka AG announced the launch of its new autonomous mobile robot, LBR iiwa, which is designed for use in the logistics and manufacturing sectors. Similarly, FANUC Corporation has introduced its new autonomous mobile robot, CRX-10iA, which is designed for use in the logistics and distribution sectors.

ABB Limited has also recently launched its new autonomous mobile robot, YuMi, which is designed for use in small parts assembly and other applications in the manufacturing sector. These advancements by leading players demonstrate the increasing focus on developing advanced warehouse automation solutions in the market.



CE Marking

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Spyrosoft, titled “CE marking for Medical Device Software: a step-by-step guide” – originally authored by MAŁGORZATA KAWAŁKOWSKA.


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

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

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

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

ToC:

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

Does your software need a CE marking certification?

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

CE MARKING AFTER BREXIT

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

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

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

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

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

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


RELATED: 2023 Predictions for Medical Device Product Development


How to do CE marking via self-certification?

1: IMPLEMENT A QUALITY MANAGEMENT SYSTEM

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

2: PREPARE THE TECHNICAL FILE

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

3: REGISTER IN THE EUDAMED DATABASE

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

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

4: PREPARE A DECLARATION OF CONFORMITY

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

5: REGISTER THE MEDICAL DEVICE SOFTWARE IN THE EUDAMED DATABASE

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

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

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

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

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

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

How long is the CE marking certification valid?

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

How much does it cost to get CE marking certification?

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


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


How long does the CE marking certification process take?

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

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

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

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

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

Need support in the CE marking certification process?

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

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

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

 

magniX

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 a press release, sourced from Cision Distribution by PR Newswire, about one of our customers, magniX titled “magniX Powers First Point-To-Point Flight of an All-Electric Helicopter” – originally published on November 4, 2022.


magniX Powers First Point-To-Point Flight of an All-Electric Helicopter

Flight of Battery-Powered Robinson 44 Helicopter Accelerates Path to Sustainable Delivery of Life-Saving Organs

EVERETT, Wash., Nov. 4, 2022 /PRNewswire/ — magniX, a manufacturer of electric propulsion solutions for aviation, is pleased to have powered the first fully-electric helicopter flight between airfields, in partnership with Tier 1 Engineering. The modified electric Robinson 44 (eR44) helicopter powered with a magniX magni250 electric propulsion unit (EPU) made its historic journey from Jacqueline Cochran Regional Airport to Palm Springs International Airport, arriving on 29 October 2022 at 11:00am PST, in a flight that lasted approximately 20 minutes.

Tier 1 Engineering is developing the magniX-powered eR44 for Lung Biotechnology PBC, a subsidiary of United Therapeutics Corporation, a biotechnology company dedicated to addressing the severe shortage of transplantable organs in the U.S. The magniX EPU was retrofitted into the helicopter together with a battery system developed by Tier 1 Engineering, specialists in the design and development of electric aircraft. The eR44 is designed to deliver human and manufactured organs for transplant with zero carbon emissions at the point of use.


RELATED: magniX, Selects Jama Connect® for Its Ease of Use and Quick Deployment


“Building from our first flight of the eR44 helicopter last June, the successfully completed point-to-point flight takes us a step closer to the sustainable transport of life-saving organs,” said Nuno Taborda, CEO of magniX. “magniX is excited to be part of an initiative that will positively affect those in need of urgent medical care. This is only the start of the applications for electric helicopters, which have a bright future as low-cost, carbon-free, reliable alternatives to combustion engine models.”

magniX Celebrates Another Industry First

Since December 2019, magniX has also provided the technology to power a number of first flights, including that of Harbour Air’s “eBeaver”, a Cessna “eCaravan” and, most recently in September 2022, Eviation’s all-electric commuter aircraft, Alice. This point-to-point flight of an electric rotary aircraft represents the latest first for the industry-leading electric solutions company. Tier 1 Engineering is currently working with the FAA on the eR44 project to obtain a Supplemental Type Certificate (STC). Lung Biotechnology PBC plans to acquire a fleet of sustainable aircraft to transport transplant organs.

“We are committed to charting a new path forward for the zero-carbon delivery of life-saving organs,” said Dr. Martine Rothblatt, one of the helicopter’s pilots and CEO of United Therapeutics Corporation. “Saturday’s point-to-point flight proves that the technology necessary for our mission is already here, as we actively work with the FAA to certify the eR44 helicopter.”


RELATED: Eight Ways Requirements Management Software Will Save You Significant Money


“Together we achieved an incredible outcome for the world’s first airport-to-airport cross-country all-electric helicopter flight,” said Glen Dromgoole, President of Tier 1 Engineering. “magniX has again demonstrated the reliability and power of its electric propulsion units, and we’re proud to continue this journey to create sustainable options for organ donation and, ultimately, help save lives.”

About magniX

Headquartered in Everett, Washington State, U.S., magniX is dedicated to leading an era of environmentally-friendly and sustainable aviation. magniX has developed a family of flight-proven electric propulsion units (EPUs) and is fast maturing its energy storage systems (ESS) for commercial aviation. With high levels of reliability, unparalleled performance and operational practicality, magniX is leading the aviation industry into a sustainable future. magniX is a subsidiary of the Clermont Group, an international business group headquartered in Singapore. For further information, please visit www.magnix.aero.

Contact
FINN Partners for magniX
magniX@finnpartners.com

SOURCE magniX

Modern Software Engineering

In this blog, we’ll preview our customer story, “Carnegie Mellon University Software Engineering Program Teaches Modern Software Engineering Using Jama Connect®.” To read the entire customer story, click HERE.


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

Graduates enter the workforce better prepared to tackle real-world engineering problems with modern technology

About Carnegie Mellon University

  • Master of Science in Software Engineering (M.S.-SE) is a unique program offered exclusively at CMU’s Silicon Valley campus by the Department of Electrical and Computer Engineering
  • Emphasizes a rigorous foundation in the core disciplines of software engineering
  • Offers students fundamental knowledge, skills, and first-hand experience in software engineering by balancing theory and practice, engaging students in active learning, and encouraging collaboration on projects drawn from real-world contexts

CUSTOMER STORY OVERVIEW

As a co-founder of the Carnegie Mellon University Software Engineering Master’s Program, Dr. Cécile Péraire set out to prepare her students to enter the workforce by teaching modern software tools and processes with a hands-on approach. Prior to joining Carnegie Mellon as a professor, Péraire worked for a decade at Rational Software and then at IBM.

As part of this modern approach to software engineering, Péraire teaches her students how to use Jama Connect® as the single source of truth for software product definition and uses the platform as a way to review her student’s work.

Principles of the Software Engineering Course

As a professor of Software Engineering for master’s students at Carnegie Mellon, Cécile Péraire teaches with a hands-on approach. Each semester, students are asked to select one real world challenge, and to come up with a software product that could help address the challenge. In the past, students have selected challenges like wildfires, food waste, and homelessness.

Instead of teaching a traditional lecture-based course, Péraire takes a mixed approach that combines flipped-classroom delivery and project-based learning, with students implementing dual-track Agile during their project. As the name suggests, it’s a process that has two tracks of work – one track aims at discovering what functionality to build next, focusing on requirements engineering and interaction design, and the other track focuses on delivering new functionality. The two tracks run continuously and in parallel with a strong focus on understanding the needs of the stakeholders and validating that the team is building the right product from the technical perspective, the user perspective, and the business perspective.

“In order to ensure that my students are building the right product, they must remain with the stakeholders during the entire semester and welcome changes at any time, principle,” said Péraire.

Selection Process

Prior to Péraire joining CMU, the requirements engineering course was taught in a more traditional and outdated fashion.

“When I joined CMU, I inherited a requirements engineering course that was taught using Word and Excel. I’ve always tried to teach fairly lightweight processes but having to create and structure documents introduced a lot of overhead for the students and made the process quite heavy and old fashioned,” said Péraire. “I could immediately see that it wasn’t working. When I had a chance to create my own course, I decided to do it differently.”

When Péraire set out to find a requirements management solution for her requirements engineering and interaction design course, she had a set of very specific criteria.

The new solution must have the following characteristics:

  • Cloud-based
  • Robust requirements management capabilities
  • Customizable to support all development practices
  • Reliable – free from bugs and crashes
  • User-friendly interface that is easy to learn
  • Resources and e-learning for students
  • Responsive and helpful support team and account management

After evaluating all available solutions, Péraire determined that Jama Connect stood out as the leader and fit her needs the best.

“After reading many reviews about the leading requirements management solutions, I ended up with a short list of about five tools that I evaluated very thoroughly. Overall, Jama Connect was the one that performed the best and met all of the criteria on my list,” said Péraire.


RELATED: The Complete Guide to the Systems Engineering Body of Knowledge (SEBoK)


Using Jama Connect for Teaching Software Engineering

“…from interview notes to storyboards, prototypes, user stories, all the way down to working software. Every artifact that relates to the project is available in or accessible from Jama Connect. It’s the hub for all of the information we need.” CÉCILE PÉRAIRE, Professor of Software Engineering Carnegie Mellon

Now, with Jama Connect deeply ingrained in her software engineering course, students use the platform as their single source of truth for all software product definition activities.

Using Jama Connect for software product definition has been key to supporting her students in order to build the right product for their stakeholders. They use Jama Connect as a hub for all the artifacts that are created during the project, “…from interview notes to storyboards, prototypes, user stories, all the way down to working software. Every artifact that relates to the project is available in or accessible from Jama Connect. It’s the hub for all of the information we need,” said Péraire.

“My students use Jama Connect first to structure the information effectively, and then to share the information within their teams and with other stakeholders. They are required to stay in contact with their stakeholders throughout the semester and Jama Connect helps to facilitate that communication when they aren’t able to meet in person. Remote communication can happen synchronously or asynchronously as Jama Connect supports all those different ways of sharing information and getting feedback on the work done,” said Péraire.

Using Jama Connect to Review Work Provides Students with Real-World Project Management Experience

In addition to using Jama Connect to help students learn how to properly organize software development projects’ artifacts, Péraire also uses the platform to review, grade, and give feedback on her students’ work.

Improved Review Processes

“I use Jama Connect Review Center to grade and provide feedback on all deliverables. The process in itself is a learning experience for students because it actually mimics the real-world industry review. It provides me with the ability to very easily comment on any element of the project, ask questions, request changes, or have discussions related to a specific section of a deliverable,” said Péraire.

Enhanced Visibility into Revision History

“Jama Connect gives me visibility into the students’ work. At any point I can log into Jama Connect and see what is going on, who is doing what, and I can see the different discussion streams. I can see the revision history and who is contributing to what. Compared to Word and Excel, this gives me an improved ability to evaluate students individually while letting them work in teams,” said Péraire.

Effective Collaboration

“With Jama Connect, I not only have improved visibility into the students’ work, but I have the ability to effectively collaborate with students outside of the classroom for both mentoring and evaluation purposes. We can have a conversation around any project item,” said Péraire.


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


Preparing Students for Engineering Careers

Because Péraire’s courses are hands-on and not lecture-based, her students learn by doing. By taking a project-based approach to learning, she’s able to mimic what happens in the industry, and her students get firsthand experience working through those challenges and interacting with stakeholders.

“Software product definition is a highly creative process supported by a combination of interactive design and requirements engineering practices. As students learn to apply those practices on their products during the course project, they document the outcome of their work in Jama Connect.” said Péraire.

“Jama Connect is really an effective way of teaching by example. The platform is fully customizable, so I created a structure for the students that nicely supports software product definition in the context of course projects. Students can use that as a good example of how to structure and share information in the future. That can be used as a starting point for a project and be customized to adapt to a different context,” said Péraire.

With Jama Connect, Péraire shares that her students can focus on content creation instead of building a complex document structure, which results in better learning outcomes and increased student productivity. Even if a student graduates and goes on to work at an organization that chooses not to use a requirements management platform like Jama Connect, Péraire believes her students are still more prepared to enter the workforce than those taught traditional, outdated software engineering tools and processes.

“Learning with Jama Connect gives my students a model of how to organize and structure artifacts related to software product definition. Even if they do not have a requirements management tool and have to go back to Word and Excel on their next project, they will have a good idea about how to organize and structure the information. While in that case they would lose the power of the tool, being exposed to an effective way of working should benefit my students greatly,” said Péraire

“Learning with Jama Connect gives my students a model of how to organize and structure artifacts related to software product definition. Even if they do not have a requirements management tool and have to go back to Word and Excel on their next project, they will have a good idea about how to organize and structure the information.”

How Jama Software® Supports CCMI

The Software Engineering Institute (SEI) at Carnegie Mellon University is the birthplace of the Capability Maturity Model Integration (CMMI), a framework used to evaluate the maturity of an organization’s software development process. The model describes a five-level evolutionary path of increasingly organized and systematically more mature processes.

Worldwide CMMI plays a key role in software development organizations that must showcase their development maturity. Teams are working hard to move their current CMM level to the next level and hence demonstrate their ability to deliver quality software.

Being CMMI certified is a common requirement for the Department of Defense (DoD) and U.S. Government software development contracts.

“While I am not a CMMI expert, my understanding is that during a CMMI appraisal, the organization must show evidence of implementation for each practice in the scope of the appraisal. For organizations that have a good process in place, Jama Connect can make this process visible. This can be beneficial during the CMMI appraisal in order to quickly identify evidence that the required practices are being implemented by the organization. Jama Connect can be leveraged to support demonstrating the alignment between CMMI and the practices adopted by the organizations needing certification,” said Péraire.

To read about the predicted future of Carnegie Mellon University and Jama Connect, download the full customer story HERE

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.


RELATED: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


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.


RELATED: Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA


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.


RELATED: The Benefits of Jama Connect Datasheet


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.



Electric Transportation

In this blog, we partially recap this customer story, “Electric Transportation Startup, REGENT, Speeds Time to Market with Jama Connect®” Read the entire story HERE.


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

RELATED: Certification and the Role It Plays in the eVTOL Aircraft Market


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

RELATED: Innovative Aerospace Manufacturer Chooses Jama Connect® to Help Revolutionize Space Transportation


OBJECTIVES

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.”


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


EVALUATION

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.

To read the outcome from REGENT’s choice of Jama Connect, read the entire customer story here: Electric Transportation Startup, REGENT, Speeds Time to Market with Jama Connect®


Convergent Dental

In this blog, we partially recap this customer story, “Convergent Dental Selects Jama Connect,® For Its Live Requirements Traceability” Read the entire story HERE.


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

RELATED: Certification and the Role It Plays in the eVTOL Aircraft Market


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

RELATED: Eight Ways Requirements Management Software Will Save You Significant Money


CHALLENGES

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.


RELATED: A Guide to Good Systems Engineering Best Practices: The Basics and Beyond


EVALUATION

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

To read the outcome from Convergent Dental’s choice of Jama Connect, read the entire customer story here: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


Surgalign

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.”


RELATED: Convergent Dental Selects Jama Connect® For Its Live Requirements Traceability


More about Cotera

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.


RELATED: Jama Connect® and FDA 21 CFR Part 11


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.”


Are you a Jama Software customer looking to fill open positions at your organization with prospects who have Jama Connect experience? We’d love to help! Tag us on LinkedIn (@jamasoftware) with your job posting and we’ll share it!


RELATED


 

SITA

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 Times Aerospace, about one of our customers, SITA titled “SITA unveils eVISA and ETA to transform borders” – which was originally published on July 28, 2022.


SITA unveils eVISA and ETA to transform borders

SITA has launched SITA eVisa and SITA Electronic Travel Authorisation to meet the growing demand from governments for digital visa systems to stimulate national economies after COVID-19.


RELATED: Customer Story: How SITA Manages Complex Product Development with Globally Distributed Teams


Governments globally are shifting to modern travel authorization solutions, like electronic visas and Electronic Travel Authorisations (ETAs). According to the World Travel & Tourism Council (WTTC), traditional visas – applications made via a consulate or embassy – decreased from 77% in 2008 to 53% in 2018. There is a growing demand for digital travel solutions.

The advantages of digital authorization solutions include improved security, reduced administrative burden, easier travel, and increased visitor flows, promoting spending that benefits local economies and creates employment. For example, one government’s introduction of an eVisa scheme covering 40 plus countries in 2014-2015 led to a 21% increase in international visitor arrivals and the creation of 800,000 jobs accounted for around 20% of the growth seen in the country’s travel and tourism over the period.

The mobile capability of SITA’s new eVisa and ETA capability allows travelers to make applications and provide their biometric information using their personal devices before they travel.

SITA’s eVisa and ETA solutions provide visas containing ICAO’s Visible Digital Seal (VDS), an encrypted bar code that enables visas and ETAs, paper or electronic, to be digitally verified for authenticity, offering enhanced security and fraud prevention.


RELATED: 15 Digital Twin Applications and Use Cases by Industry in 2022


Jeremy Springall, Head of SITA AT BORDERS, said: “Adopting eVisa and ETA supports national prosperity. We’ve productized our proven and robust travel authorization systems to benefit more nations around the world as they shift to digitalize and future-proof their borders. The solutions help countries to cope with growing passenger volumes, improve security and efficiency, and deliver a more seamless travel experience that travelers demand, removing the complexities of applying for traditional visas”.

Springall added: “The adaptability of these two solutions means that they are fully interoperable with existing border control and airline systems. And, they comply with international standards and best practices.”

RELATED


aerospace

In this blog, we recap this customer story, “Innovative Aerospace Manufacturer Chooses Jama Connect® to Help Revolutionize Space Transportation.” Read the entire story HERE.


Launching spacecraft and satellites into orbit are highly complicated endeavors and like many large organizations, this rocket and spacecraft manufacturer was struggling to provide visibility, manage, changes to requirements, and meet aggressive schedules.

In 2010, this industry-leading space exploration technology company selected Jama Connect to help its team develop new ways of working to simplify requirements management, improve visibility, and customer communication, and create an efficient, paperless product delivery process.

They saw significant improvements to its requirements management process with Jama Connect, including:

  • Reducing meeting times, simplifying cumbersome specification docs, and improving overall communication to ensure all requirements were accounted for accurately
  • Better traceability from requirements to derived requirements to verification events
  • Improved customer relations with shared project visibility and enhanced communications

RELATED: Certification and the Role It Plays in the eVTOL Aircraft Market


Jama Connect® helps an innovative aerospace company keep track of thousands of requirements by providing a platform for greater visibility and collaboration with its team and customers

This innovative aerospace launch company designs, manufactures, and launches the world’s most advanced rockets and spacecraft. In just ten years, the company has emerged as one of the fastest growing aerospace companies in the world working toward their vision to revolutionize space travel.

CHALLENGES

• Providing visibility and managing customer expectations

• Managing inevitable change to requirements and other important details

• Eliminating rework in order to meet aggressive schedules

EVALUATION

• Utilize Jama Connect’s Review Center for open customer and internal communication

• Track requirements for faster change management

• Maintain common requirements in one place to prevent repeats

RESULTS

• Helped reduce meeting times, simplify cumbersome specification docs, and improve overall communication to ensure all requirements were accounted for accurately

• Provided a method for traceability from requirements to derived requirements to verification events

• Improved customer relations with shared project visibility and enhanced communications

• Accounted for contract milestones and ensured timely payments


RELATED: 15 Digital Twin Applications and Use Cases by Industry in 2022


Challenge: This is Rocket Science

Launching spacecraft and satellites into space is a highly complicated endeavor. Like many other large organizations tackling complex projects, the company initially faced a few critical business challenges that Jama Connect could help them address:

• Providing visibility and managing customer expectations

• Managing inevitable change to requirements and other important details

• Eliminating rework in order to meet aggressive schedules

As a customer, NASA needed visibility into the company’s progress to ensure key requirements were being met. Prior to using Jama Connect, the company did not have an easy way to share quick status reports on requirements verification. As a result, many hours were spent compiling status and change-control reports.

This process, although effective, took too much time. Hours were spent in meetings reviewing large cumbersome spreadsheets – going line by line to review thousands of details. The company had to implement complex macros to pull information from Microsoft Excel into Word documents to create specific reports. This was time-consuming for everyone involved. The company wanted to share real-time information with NASA for their review and approval, but they did not have an easy way to accomplish this level of collaboration prior to using Jama Connect.

Solution: One Small Step for the Company, One Giant Leap for Efficiency

The company implemented Jama Connect in 2010, wanting to develop new ways of working to simplify requirements management, improve visibility and customer communication, and create an efficient, paperless product delivery process.

To read the entire customer story, visit “Innovative Aerospace Manufacturer Chooses Jama Connect® to Help Revolutionize Space Transportation.”