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 Reuters, titled “Canada investing C$350 million to boost drive for sustainable aerospace industry” – originally reported by David Ljunggren, edited by Jonathan Oatisand, and published on June 19, 2023.
Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace Industry
OTTAWA, June 19 (Reuters) – Canada is investing C$350 million ($265 million) to help fund efforts to make the aerospace industry more environmentally sustainable, Innovation Minister Francois-Philippe Champagne said on Monday.
The focus will be on hybrid and alternative propulsion, aircraft systems, the transition to alternative fuels, and aircraft support infrastructure, he said in a statement.
“(This) … will help drive and accelerate the green industrial transformation of Canada’s aerospace industry, generating high-value jobs while strengthening supply chains and supporting the transition to a net-zero economy,” he said.
Earlier this month, global airlines called for broad co-operation to reach “very tough” emission targets. Aviation, which produces around 2% of the world’s emissions, is considered one of the hardest sectors to decarbonise.
The C$350 million includes a C$49 million aerospace innovation investment announced in 2019.
Airbus said in 2021 it was working on hybrid-electric propulsion among the options for reducing jetliner emissions. It has pledged to introduce the first hydrogen-powered commercial plane in 2035.
In 2019, Vancouver-based seaplane operator Harbour Air carried out the world’s first fully electric, commercial flight.
($1 = 1.3202 Canadian dollars)
https://www.jamasoftware.com/media/2023/06/Canada-AD-Investment.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-06-27 03:00:142024-01-17 23:55:02Canada Investing C$350 Million to Boost Drive for Sustainable Aerospace 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 NPR, titled “After years of decline, the auto industry in Canada is making a comeback” – originally authored by H.J. Mai and published on March 12, 2023.
After Years of Decline, the Auto Industry in Canada is Making a Comeback
When most people think of Canada, they rarely think of cars. But the country, known for hockey, maple syrup and endless wilderness, is one of the largest car producers in North America. And with the growing importance of electric vehicles, Canada hopes to breathe new life into its automotive industry and maintain a more than 100-year-old tradition.
Canada’s automotive industry is primarily located in Ontario and Quebec, with Windsor, Ontario, claiming the title of Canada’s automotive capital.
“We’ve been the auto capital of Canada since about 1904, when the first auto plant opened in Canada,” said Windsor Mayor Drew Dilkins.
Windsor, just across the river from Detroit, has benefited from its proximity to the United States and the three major carmakers headquartered there.
Stellantis, formerly Fiat Chrysler, and South Korean battery maker LG Energy Solutions (LGES) announced last year that they will invest more than 5 billion Canadian dollars ($3.5 billion) in building a new large-scale battery manufacturing plant in Windsor. The plant is expected to be operational by 2024 and will create an estimated 2,500 jobs.
“It’s a massive, game-changing investment, and I’m not even sure these two words are big enough to describe how important it is for our community,” Dilkins says. “This will have a generational impact. [Companies] will look at the new world of automotive and will start looking at Windsor Essex as a place to do business.
Investment by Stellantis and LGES is part of a larger trend that has seen more than CA$17 billion in announced investment in Ontario’s automotive sector since the beginning of 2021.
“Ontario has had the greatest new investment in vehicle production in its history over the past two years,” says Flavio Volpe, president of the Canadian Automobile Parts Manufacturers’ Association.
Most of this investment, worth nearly CA$13 billion, is in electric and battery production. And by passing the Inflation Reduction Act, U.S. lawmakers have given Canada a further boost to its EV ambitions.
The law includes tax credits for EV buyers, but only if the car is largely made and assembled in North America, and its battery uses locally mined components. According to GM Canada’s David Paterson, this could give Canada an advantage over the U.S. and Mexico.
“What goes into our [sic] batteries are cathode active materials, which are mainly made of nickel and other critical minerals that we happen to have in abundance here in Canada,” he says.
“As we see less demand for gasoline, we see more demand for minerals, and Canada is an economy built on natural resources.”
In an effort to encourage the shift in the auto industry toward battery-powered EVs, Canada’s federal government along with Ontario’s provincial government have been investing billions of dollars.
“Our incentive is that you have a job because we invest about $2.5 billion in taxpayer money in these [car companies,” says Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade.
The recent investment streak is a welcome sign for an industry that has gone through many ups and downs. Increased automation and competition from lower-wage regions have led to plant closures and job losses over the past two decades.
“We have been coming from a whole generation since about 2000, watching this critical sector decline. We have seen disinvestment in the sector, we have seen job losses in the sector, we have seen plants closed and communities are basically disappearing,” says Angelo DiCaro, research director for Unifor, a union representing about 230,000 Canadian auto workers.
The North American Free Trade Agreement, or NAFTA for short, contributed to this downturn as car companies moved their assembly lines to places like Mexico or the U.S. Southeast to cut costs. The USMAC, which replaced NAFTA in 2020, has somewhat leveled the playing field by boosting regional content requirements and instituting a minimum wage of at least $16 an hour.
DiCaro says that despite the uncertainty surrounding certain jobs that could be lost in this transition to electric vehicles, Canada’s auto workers have a sense of optimism and hope.
According to government data, the auto sector plays a key role in Canada’s economy, contributing CA$16 billion to its gross domestic product (GDP). With nearly 500,000 direct or indirect jobs, automotive is one of the country’s largest manufacturing sectors and one of its largest export industries.
Volkswagen and its battery company PowerCo announced Monday that they selected Ontario, Canada as the location of Volkswagen’s first cell manufacturing facility in North America.
The new battery plant in Canada will be the third group in the group, after Salzgitter, Germany and Valencia, Spain.
“Canada offers ideal conditions, including the local supply of raw materials and wide access to clean electricity,” the group said in a press release.
Production is expected to start in 2027.
Tesla is another company that publicly stated it is actively looking at Canada as a potential site for a new battery and / or assembly plant. The company would join Ford, General Motors, Honda, Stellantis and Toyota, which already have production facilities in Ontario.
“The success of the [Ontario] government and the federal government [sic] will not be defined by what we have landed at the moment. It will be whether we can lend a sixth automaker or a seventh,” Flavio Volpe says. “It will mean that our vision was worthy of the rhetoric and convince the best automakers in the world that the future runs through Ontario.”
https://www.jamasoftware.com/media/2023/05/Auto-Canada.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-05-16 03:00:042024-01-18 00:15:43After Years of Decline, the Auto Industry in Canada is Making a Comeback
FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld
Dive Brief:
The U.S. Food and Drug Administration is “moving forward with rulemaking” on laboratory developed tests (LDTs) without waiting for new powers from Congress, a senior FDA official said at an industry conference.
Elizabeth Hillebrenner said on a panel Wednesday that the agency cannot “just stand by” given the perceived public health problem created by LDTs and the failure of Congress to pass legislation.
The FDA has yet to set a timeline for LDT rulemaking or provide a close look at its plans, Hillebrenner said, noting that the agency will follow a three-tier risk framework, but giving few other details.
Lawmakers have been trying to pass LDT legislation for years. An earlier form of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act was introduced to Congress in 2018. Key aspects of the draft advanced as part of the FDA’s user fee package last year, only to be cut from the final version. A push to pass the VALID Act as standalone law fell short late last year.
The FDA identified a need to reconsider its policy of enforcement discretion for LDTs in 2010, reflecting the increasing complexity and risks of the tests, and shared a discussion paper in 2017. However, the paper is not enforceable.
Legislation would clarify the FDA’s authority to regulate LDTs and give the agency new powers, but in the ongoing absence of action from Congress, work is now advancing under the current statutory authority. Hillebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiological Health, outlined the situation at an American Clinical Laboratory Association event.
In comments reported by BioWorld, Hillebrenner noted that FDA Commissioner Robert Califf “has already said all options are on the table, including rulemaking, and we are moving forward.” The FDA continues to support legislation such as the VALID Act that provides a regulatory framework in line with modern diagnostics but is no longer willing to wait on Congress to address the problems posed by LDTs, she said.
https://www.jamasoftware.com/media/2023/04/BioWorld-1.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-04-26 03:00:592024-01-18 00:25:46FDA Moving Ahead with Rulemaking On Lab Developed Tests Without Waiting for Congress: BioWorld
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 MedTech Dive, titled “FDA Class I Recalls Hit 15-year High in 2022” – originally authored by Nick Paul Taylor and published on March 3, 2023.
FDA Class I Recalls Hit 15-year High in 2022
Dive Brief:
The number of Class I medical device recalls by the U.S. Food and Drug Administration hit a 15-year high in 2022, according to a report by Sedgwick.
In 2022, the FDA oversaw 70 Class I recalls, its highest risk classification, compared to an average of 47 over the previous five years. Eighteen of the Class I recalls happened in the fourth quarter.
Mislabeling was the most common reason for recalls in three of the past five quarters.
Last year, companies including Abbott, Baxter, GE HealthCare, Medtronic and Philips were the subject of Class I recalls, a category that the FDA reserves for problems with the potential to cause serious injury or death. The activity added up to a record year for Class I recalls.
Sedgwick reported the 15-year high for Class I recalls after tallying up the data for the fourth quarter. Over the final three months of the year, the total number of recalls of any type rose 8.1% sequentially, and the number of recalled units increased by around 10 million to 61.98 million.
Mislabeling was again the most common cause of recalls in the fourth quarter, as it has been for three of the past five quarters, followed by quality. There was a decline in the number of recalls related to software, the most common cause of recalls in the third quarter. Having been responsible for 46 events over that prior period, software accounted for 15 recalls in the final three months of the year.
Based on data for January, the increase in recalls between the third and fourth quarter may continue in 2023, the report said. Sedgwick counted 135 recalls in January, compared to a monthly average of 80 in the fourth quarter. The number of recalled units is also tracking above the rate seen in the fourth quarter.
Sedgwick identified the FDA’s use of Section 518 authority, which allows it to order manufacturers to notify patients and providers of risks, as one of the most significant developments in medical device recalls. The FDA used the power one year ago to order Philips to tell patients about its respiratory device recall because the company’s efforts to that point had been “inadequate,” the agency said.
https://www.jamasoftware.com/media/2023/04/FDA-Recalls-1.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-04-13 03:00:262024-01-18 00:31:35FDA Class I Recalls Hit 15-year High in 2022
Digital Transformation of Verification Process for Faster Aircraft Certification
The certification of new aircraft programs is expensive. Whether it is an advanced air mobility system, a (hybrid-) electric aircraft or a military aircraft with new weapon systems, new and innovative aircraft programs are very complex. The application of new materials, additive-manufactured structures, electrical propulsion systems and an increase in onboard software requires extensive virtual and physical testing to verify whether the aircraft is safe, reliable and cost-effective to fly.
Managing verification from the start of the program, as soon as the requirements have been defined and validated, is a good practice. As the verification job is huge, especially for start-up programs, a digital verification management platform can significantly reduce the risk and related over-budget costs of aircraft certification.
Challenge – Aircraft Complexity
There’s a reason why airplanes are the safest mode of transportation: certification. For aerospace manufacturers, aircraft certification is everything. No certificate means no product to market.
In addition to already strict EASA, FAA, and other regulations, companies face additional demands for advancements, including – but not limited to – sustainability targets and the ambition to fly autonomously, which require more integrated systems driven by software and electronics.
New technologies like this are exponentially complex. They impact all aspects of product development, including design, validation, and testing. Instead of a few components and hundreds of interfaces, there are now thousands of components with tens of thousands of interfaces. More and more functions are implemented through software.
Therefore, it’s no surprise that today, aircraft certification is more costly than design. This is a huge challenge. Many companies have great ambitions with new aircraft configurations. It is now technologically and financially feasible to build and fly prototypes and validate concepts. The big financial challenge and risks that a company faces are the costs of aircraft certification and industrialization. Indeed, Porsche Consulting estimated in 2018 that the series development and type certification of an eVTOL urban air mobility aircraft would cost between $500 million and $1 billion1, and Archer Aviation CEO Adam Goldstein says, “the price-tag for one aircraft design to reach certification could be up to $1 billion”.2
This represents a serious risk to many companies. As an aeronautical engineer, I cannot be more delighted when I see all the initiatives taken to exploit the possibilities of new propulsion systems into radical new aircraft configurations. In that sense, the last 5 to 10 years are comparable to the 1950s, when a lot of new aircraft configurations were explored. However, I’m worried that many companies with exciting new ideas will financially fail before getting aircraft certification.
One should not forget that many of these companies have to build the elements for proof of compliance from a blank sheet. They cannot count on data from previous programs to alleviate the verification process by comparison. This puts them at a competitive disadvantage against legacy companies, which might be less innovative but have an abundance of verification data at hand.
Because of the above, new organizations tend to postpone addressing the verification and certification aspects.
Opportunity – Certify During Development
Digitalization environments offer a lot of capabilities to pre-empt the aircraft certification aspects and associated risks.
Process-wise, companies should consider including the verification and certification process within the aircraft design, development production and quality process from the start of the program.
Different digital platform pillars are key in this.
It Starts with the Digital Twin
Throughout the development of aircraft, digital twin capabilities make it possible to design, engineer and optimize the aircraft and its systems. They provide engineering insight into how the aircraft is built and how it performs behaviorally. The use of a digital twin model enables manufacturers to become exponentially more accurate in all aircraft domains, covering all “engineering physics,” which define how well it operates.
Given good management and validation of the modeling assumptions, these digital twin models can be further exploited to verify the behavior of electro-mechanical systems, coupled to the software-based control functions. Indeed, once one gets confidence in how well the models represent reality, these models can be used to perform virtual testing and alleviate the burden and costs of physical testing.
The ability to author these virtual test models is dependent on having the necessary skill tools for generating the engineering analysis data.
An additional benefit of digital twin models is that they not only help with accelerating the verification based on virtual testing, but they also have an under-recognized value in preparing and de-risking the physical tests, which will be needed anyway.
Indeed, as long as innovation continues to occur in this industry, it will be necessary for companies to prove the accuracy of their modeling assumptions, methods, and processes to aircraft certification authorities and organizations.
Digital twin technology is essential when programs want to reduce the risks related to aircraft certification. However, there is a closed-loop process needed between virtual and physical testing in order to make this a viable strategy.
The amount of engineering analysis data a digital twin generates is enormous and requires a digital data and process management backbone to control it, keep it in configuration, manage the processes and make sure all data is traceable.
This backbone is also very important for the next programs. Indeed, stored data does not only serve current programs, but also can be reused in future programs to avoid verifying aspects multiple times on different programs. This drastically reduces verification costs of future programs, whether by simply re-using data or proving digital twin modeling assumptions were right and avoids physical verification on these aspects on the next program.
Digital Thread
The generation of engineering data using digital twin technology along with excellent data management is a start, but to be truly effective, the digital platform needs to keep all data generated and managed in the context of the aircraft program, as it assures the digital continuity of engineering data with the engineering decisions taken. As part of a model-based systems engineering (MBSE) approach, a verification management digital thread can provide a traceable link between the requirements and the artifacts that lead to the proof of compliance of that requirement, including all its intermediate data like the eBOM, test-BOM, etc.
Solution – Verification Management
A verification management digital thread should be a vital part of the digitalization strategy of all aerospace and/or defense companies. It can help make certification an integral part of the overall product development process and enable companies to have a robust certification execution plan and incorporates all the needed certification activities within the overall program plan.
It is vital that companies embrace not only a verification management digital thread, but also a full digitalization strategy. Digitalization enables aerospace manufacturers and their supply chain partners to make better-informed decisions based on extensive data and analysis as well as full traceability. It is the only way to turn the increased level of complexity and integration inherent in new programs into a competitive advantage.
The aerospace and defense industry is going through a time of immense innovation, and I’m excited to see what the future holds as A&D companies and teams of all sizes adopt digitalization to deliver on the promise of this innovation.
References
1. The Future of Vertical Mobility, Sizing the market for passenger, inspection, and goods services until 2035, A Porsche Consulting study, 2018
2. Can UAM developers turn their electric dreams into a reality? Pilar Wolfsteller, 2022
About the Author
Thierry Olbrechts is the Director of Simcenter Aerospace Industries Solutions, Siemens Digital Industries Software. In 1996, he joined Siemens Digital Industries Software. Since 2000, Thierry has been responsible for Siemens simulation and test business development and go-to-market strategies for the aviation, space and defense industry segments.
https://www.jamasoftware.com/media/2023/03/Digital-Transformation-of-Verification-Process-for-Faster-Aircraft-Certification.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-04-04 03:00:212024-01-18 00:35:25Digital Transformation of Verification Process for Faster Aircraft Certification
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 MedTech Dive, titled “Medtech industry relieved as Europe’s MDR extension nears final approval” – originally authored by Susan Kelly and published on March 6, 2023.
Medtech Industry Relieved as Europe’s MDR Extension Nears Final Approval
The Council of the EU is expected to vote Tuesday on an extension of deadlines for complying with Europe’s Medical Device Regulation (MDR), in a move to keep critical treatments on the market during the transition period.
The revised timeline would give notified bodies that certify devices in the European Union longer to prepare for the new regulatory framework.
Companies that operate in the European market were expected to have devices recertified by May 2024 under the regulation, but with the deadline approaching, notified bodies faced a backlog, prompting the European Commission to propose extending the time frame.
“Industry is relieved that these amendments have been introduced – they are the culmination of many warning signs about a potential shortage of medical devices in the EU,” Brussels-based life sciences lawyer Josefine Sommer, a partner at Sidley Austin, wrote in an email.
The extension would stagger deadlines until 2027 or 2028, based on device risk classification, allowing manufacturers and notified bodies more time to complete conformity assessments. Products placed on the market under the predecessor Medical Devices Directive (MDD) could remain, under certain conditions.
“Once the amendments have been adopted, it will be interesting to see how the conditions for benefiting from the additional transitional periods are to be interpreted and implemented in practice,” Sommer said.
The upcoming European Council vote follows the European Parliament’s approval last month of the new timetable. EU procedure calls for both branches of the legislature to approve the plan.
“This will be the final step in the process,” an EU official said in an email.
Member state health ministers in the EU’s Employment, Social Policy, Health and Consumer Affairs Council backed the plan in December, after European medical societies called for urgent action to address device supply shortages reported by physicians.
“The Health Council supported the European Commission’s proposal to delay the transitional deadlines to avoid causing harm to EU health systems and, most critically, patient care,” London-based attorney Lincoln Tsang, partner and head of Ropes & Gray’s European life sciences practice, wrote in an email.
The MDR was adopted in 2017 following the recalls of breast implants and metal hip replacements due to safety problems. The regulation tightens controls for the safety and performance of medical devices and includes stricter monitoring and certification procedures to ensure compliance and traceability. The new rules also are intended to reflect technological and scientific advancements in the sector.
With the extended deadlines, higher-risk devices such as implants must transition to the new requirements by December 2027, and medium- to lower-risk devices such as syringes or reusable surgical instruments have until December 2028.
But Erik Vollebregt, a founding partner of Axon Lawyers in Amsterdam, said the timeline still requires manufacturers to be MDR-ready, “with an MDR application in the door at a notified body” no later than May 26, 2024.
“The current state of the market is that everybody is still figuring out what the proposal will mean for them specifically, both industry and notified bodies. Some manufacturers have seen 2027 and 2028 as dates and do not understand that these are dates for notified bodies and not for manufacturers,” Vollebregt said in an email.
Reuters reported in December that medical device manufacturers were dropping products from their European portfolios because of the cost of complying with the new regulations.
Although six new notified bodies received MDR designation in the second half of last year, it created a pool of 36 organizations to process around 23,000 certificates of current devices on the market, prompting EU Health Commissioner Stella Kyriakides to propose delaying enforcement of the MDR.
https://www.jamasoftware.com/media/2023/03/new-new-medtech-1.png5121024Jama Software/media/jama-logo-primary.svgJama Software2023-03-23 03:00:592024-01-18 00:44:49Medtech Industry Relieved as Europe’s MDR Extension Nears Final Approval
In this blog, we recap the “Managing Functional Safety in Development Efforts for Robotics Development” webinar.
Industrial manufacturing firms are undergoing rapid transformation as they navigate talent shortages, supply disruptions, digital adoption acceleration, and more. At the same time, they work diligently to accelerate time to market, streamline risk management, and keep accuracy and safety at the forefront.
In this webinar, learn about functional safety challenges during the development of complex robotics systems, and how to conform to IEC 61508. Also, learn about how Jama Software’s new robotics solution allows developers to quickly leverage a template and documentation to kickstart development efforts ensuring quicker time to market, and higher quality and safer products.
You’ll learn more about:
Functional safety development challenges
IEC 61508 best practices
Tips and tricks on certification
Jama Software’s new robotics solution offering and benefits
Below is an abbreviated transcript and a recording of our webinar.
Managing Functional Safety in Development Efforts for Robotics Development
Steven Meadows: Hi everyone, and welcome to the webinar on Managing Functional Safety and Development Efforts for Robotics Development. In terms of the agenda today, this is what we’re going to be covering. We’re going to be starting off with speaker and company introductions. We’ll then look at functional safety and providing IEC 61508 overview, associated challenges, associated best practices. We’ll then switch gears and talk a little bit around live traceability followed by robotics development best practices. And then we’ll finally wrap up with Jama Software’s Robotics Solution. So let’s start with some speaker introductions. Go ahead, Nicole.
Nicole Pappler: Okay. Hey everybody. My name’s Nicole Pappler. I am a Senior Functional Safety Expert at AlektoMetis. I started working with safety critical systems more than 20 years ago, working with automation, working with automotive and other domains, and always moving around in the safety critical projects with safety critical systems, being a developer, being a tester, being on the complete system side. About 10 years ago, I started then to work as an assessor of for functional safety at TÜV SÜD. And about three years ago, started together with my business partner, AlektoMetis to provide independent consulting and assessment services using all our experiences that we had up to now. If you want to Google me, I’m also active in several open source for functional safety, so you should be able to follow me around. If you want to contact me, my social media handle is nicpappler, so you can find me on GitHub Discord and usually wherever you want want to look.
As AlektoMetis, our company, together we have more than 20 years of experience. We provide a network of experts for functional safety, for cybersecurity, for multiple domains, so automation, railway, automotive. And also, we can provide you with services regarding license compliances, processes, quality management. We have a set of trainings and workshops available for functional safety, for security, or with our network, also for other topics that you need to cover for critical systems and to keep up to date and to drive topics forward, we participate actively in international committees for standard digitization like the IEC, ISO or DIN or also industry networks like the Bitkom, or the Industry Business Network 4.0.
Steven Meadows: Great. Thanks for that, Nicole. So hi, everyone. Thanks again for joining the webinar. My name is Steven Meadows and I’m a Principal Solutions Lead here at Jama Software, primarily working with our customers in the industrial space, including robotics teams. So I’ve been at Jama for around about three years. I’m an expert in requirements management and before Jama, I worked extensively with the Atlassian tool stack as well as in various implementation functions. Excuse me. I do want to briefly provide some context on Jama Software and what we do. So our main purpose is to ensure that innovators succeeds with client success at the forefront of pretty much everything that we do.
For years of industry specific experience and thousands of client engagements, we bring best practices to bear to maximize the success rate of the product development process. So we work in a number of verticals that you can see at the bottom of the slide here, including medical device, automotive and semiconductor, aerospace and defense, software development. And last but certainly not least, industrial manufacturing and robotics automation. So we’re the largest requirements platform on the market today, and our Jama Connect platform is the number one requirements management software according to independent user reviews on G2 Crowd. We’re also the market share leader of all products, including those from bigger companies and the leader in user adoption and success. So with that, I will hand over to Nicole who’s going to be talking about functional safety and IEC 61508 in terms of an overview as well as challenges.
Nicole Pappler: So first of all, I’d like to give you an overview of what’s all this about with functional safety and with IEC 61508. So I’m sure you are here because you already heard about functional safety. Maybe you’re a pro, beginner with functional safety. So first of all, functional safety is the topic that’s associated with reducing risks that are associated with products that can be caused either by random faults, that means fault of a sense or faults by controller, just random things stop working or start working in a very inconsistent way. So one of the big topics in functional safety is really avoiding random faults, avoiding faults due to hardware components just dying on you. And the other big topic in functional safety is the avoidance of risk due to systematic faults.
So systematic faults are usually faults that happen during development, that happen during deployment or maintenance of a product that are due to topics that are not covered, that are due to hazards you have not considered. That are due to functions you haven’t implemented correctly or that haven’t been tested if they are correctly implemented, and then go into the field in an inconsistent or insufficient way. So functional safety can be achieved then by the methods of engineering and of process application. It means the random faults you avoid by systematically identifying what are the critical components, what are critical parts, what other critical functions within your system. And to then choose suitable and robust system architectures suitable and robust components and hardware parts to be integrated into your system.
Nicole Pappler: So first of all, I’d like to give you an overview of what’s all this about with functional safety and with IEC 61508. So I’m sure you are here because you already heard about functional safety. Maybe you’re a pro, beginner with functional safety. So first of all, functional safety is the topic that’s associated with reducing risks that are associated with products that can be caused either by random faults, that means fault of a sense or faults by controller, just random things stop working or start working in a very inconsistent way. So one of the big topics in functional safety is really avoiding random faults, avoiding faults due to hardware components just dying on you. And the other big topic in functional safety is the avoidance of risk due to systematic faults.
So systematic faults are usually faults that happen during development, that happen during deployment or maintenance of a product that are due to topics that are not covered, that are due to hazards you have not considered. That are due to functions you haven’t implemented correctly or that haven’t been tested if they are correctly implemented, and then go into the field in an inconsistent or insufficient way. So functional safety can be achieved then by the methods of engineering and of process application. It means the random faults you avoid by systematically identifying what are the critical components, what are critical parts, what other critical functions within your system. And to then choose suitable and robust system architectures suitable and robust components and hardware parts to be integrated into your system.
And then to avoid systematic fault by applying a suitable development process, by applying suitable verification measures, by using a suitable deployment and maintenance process. And then also going into a suitable change management process for your system, so that you don’t add bugs and sufficiencies to your system that wouldn’t be there by definition. So easily, you don’t need to start thinking about how to do this on your own. So there are standards around. And the main functional safety standard is the IEC 61508. It’s a standard that talks about functional safety for electrical and electronic and in any kind of ways programmable safety related systems. And although there are a lot of other safety standards around, IEC 61508 is still not only the most generic, but also the most used and most applied standard, not only in other industries but specifically also in the automation industry.
Nicole Pappler: So what will IEC 61508 help you with? So what is defined there? Most of it really consists of methods and definitions and explanations, how to do engineering and how to do the planning of your engineering, of the safety relevant systems and equipment. Then with the process, how to reduce your development issues by planning ahead, by planning your resources, by deciding what kind of methods that are suitable for your kind of development. There are standard planning methods defined. You need to have a safety plan that’s more or less the project management plan thingy for your safety relevant tasks. You have the definition of processes, so everything will be done in a consistent and traceable way. You will have templates though that you won’t have to invent the structure of a document that invents the structure of your definitions every time. Again, the standard also talks, let’s say on a very high level, but on a very important level about safety architectural requirements.
It walks you through a few basic architectural topics like one channel systems, two channel systems, three channel systems. How do you need to set them up? What are the minimum requirements regarding diagnosis you want to do on live on these channels? So that already gives you a lot of help with the basic setup. What is the minimum requirement? And then you can go from there really deciding is this sufficient for my use case. IEC 61508 also is very strong in the definition on verification activities, be this on the one hand side for inspections, for analyzers, for reviews of your plant concept, of your requirements of your specifications. And also on how to do testing on multiple stages of your development or after deployment or during maintenance. It also gives you guidance then after development, after production of your system, how to mitigate the issues or to avoid issues that might be introduced during installation or during integration of your system into a bigger system.
https://www.jamasoftware.com/media/2023/02/Copy-of-WB-2022-01-12_Managing-Product-Development-Complexities_Social-Image-1.png5121024Steven Meadows/media/jama-logo-primary.svgSteven Meadows2023-02-07 03:00:312024-01-18 01:24:08[Webinar Recap] Managing Functional Safety in Development Efforts for Robotics Development
In this blog, we recap the “Write Better Requirements with Jama Connect Advisor™” webinar.
Successful product delivery starts with having the right user needs and requirements. Efficient, precise, and professionally written requirements form the foundation of the product development process so that various teams (design, software, and hardware systems) can all work together with a shared and clear understanding of the project goals.
Jama Connect Advisor™ is a state-of-the-art requirements authoring guide and optimizer powered by natural language processing for engineering that helps a system engineer or a product developer write effective, well-organized requirement specifications based on industry-accepted INCOSE (International Council on Systems Engineering) rules and the EARS (Easy Approach to Requirements Syntax) notation.
Learn more about leveraging Jama Connect Advisor to:
Improve the quality and usability of your requirements
Save time authoring, reviewing, and updating requirement statements
Continuously enhance team requirement authoring skills with regular use
Deliver programs and projects on time and on budget with long-term success
Plus, hear from Rockwell Automation on their experience with Jama Connect Advisor
Below is an abbreviated transcript and a recording of our webinar.
Write Better Requirements with Jama Connect Advisor™
Jeremy Johnson: Great, thank you so much Juliet, and thank you so much to everybody that’s joining us today. This is a pretty special time for us, to be able to take a new capability to market from a product management and product development standpoint is just, it’s an extremely exciting time for us, so again, appreciate everybody’s time in joining us here today.
Before we transition into the main portion of the session here, I did want to provide a short introduction and short overview of our agenda. We’ll talk a little bit, for those that aren’t familiar with us, a little bit about Jama Software. We’ll talk a little bit about the trends in product development, some of the challenges that we see in requirements authoring. We’ll also, of course, introduce you to Jama Connect Advisor, who it’s for, how it works, we’ll get into a demonstration. We’ll also talk a little bit about our customer success program, specifically our customer success authoring workshop, and how we are now including and embedding the technology and the capabilities around Jama Connect Advisor into that consulting offering.
And then, as Juliet mentioned, our special guest, Sheila King, will go into the requirements quality focus that she’s helping implement at Rockwell Automation, and we’re super excited and happy to have her. And then we should have some time at the end of the session for some questions as well. But again, starting with and moving into Jama Software’s role in the product development ecosystem, our vision and our purpose, as an organization, is to ensure that innovators succeed. And as you’ll see from today’s discussion and demonstration, that’s really at the core of what drove our introduction of Jama Connect Advisor.
From a broader solution standpoint, Jama’s the number one requirements management provider in the marketplace, we help teams with requirement management and product development through Live Traceability that also spans not only requirements, but the verification and validation components on the test side, risk management, and other key data that drives those processes forward.
The value that we hope these innovative organizations our customers derive is really focused around things like cycle time reduction, helping speed time to market, enabling through Live Traceability the ability to gain visibility and control over the organization’s product development processes and really drive streamlining, really drive a tremendous amount of value, and ultimately ensure compliance and manage risk.
As far as organizations that we work with, we span medical device, automotive, industrial machinery, software, and this is just a sampling of the customers that we have the pleasure to partner with. We have over 800 customers globally, these organizations span from smaller startup organizations to large global enterprises. So with that very short intro to Jama Software, I now would like to bring in Joseph Pitarresi to review some of the complexity and challenges that we see today in product development, and of course to introduce you to Jama Connect Advisor. Joseph?
Joseph Pitarresi: I’m really excited to talk about Jama Connect Advisor today, and some of the things that are happening in the environment that led us to the development of this solution is that today’s systems have become much more complex, and the emergence of the Systems of Systems architecture has become the dominant approach for devices in all sectors, whether it’s aerospace, automotive, medical, and even consumer products now.
The Systems of Systems is obviously a collection of independent subsystems that are integrated into larger systems and deliver the unique capabilities required by users. The challenge is that it’s difficult to produce accurate predictive models of all emergent behaviors, so global Systems of Systems performance is difficult to design. And that leads to testing and verification, verifying upgrades to existing Systems of Systems is difficult and expensive as well, so it’s hard to scale. So these are some of the factors that have led us to think about how can we help.
Another question we ask ourselves is why is requirements authoring so hard? So if we look at the industry approaches for requirements authoring, we looked at the International Council on Systems Engineering and their guide for requirements, there’s the need to exercise a core subset of over 40 rules in the INCOSE rules for writing requirements, and in addition to that, assess 49 requirement attributes. So just following INCOSE alone requires a substantial amount of training and understanding and then applying it, and that can take a lot of time.
And in addition, we’ve also found that the EARS, the Easy Approach to Requirements Syntax, is being adopted by many organizations developing complex Systems of Systems. That includes Airbus, Bosch, Dyson, Honeywell, Intel, NASA, Siemens, and others, and what EARS does is gently constrains the textual requirements, the EARS patterns provide guidance while you’re writing a requirements sentence, and it provides syntax structure with an underlying rule set. Now, as I said, even these industry preferred approaches are challenging to apply, so we’re looking at how we might address that.
Joseph Pitarresi: So today, just as a brief example, product requirements quality drive fidelity and efficiency in the product development cycle, and if you just look at this automotive example, there’s many systems, it’s a complex System of Systems that are dependent on each other, and any of these systems can either lead to confusing the operator, or systems not operating optimally. And if you look at the traditional V model of approaching systems engineering, the requirements are fundamental at the very early phase. So immediately after your needs analysis you need to have really clear, crisp, accurate requirements definitions.
Now the negative outcomes of poorly written requirements have been well documented. It often leads to delayed time to market, late stage errors in the product, inaccurate translation of stakeholder needs into product attributes, and the lack of development team synergy, as teams are very organic today and the requirements need to be documented clearly and in an understandable way so that the team can execute with high performance. And then ultimately failure to verification and validation can happen without the high quality requirements.
A secondary challenge is the training and reinforcement of requirements offering skills. The lack of proper requirements can lead to product issues, and it’s a significant challenge in today’s environment. So 30% of engineering degree holders are nearing retirement, that’s globally, and in the US 79% of American workers agree that to retain or increase their future employability they need to continue their learning and development. So computer scientists, 47.5% participate in work related training to maintain and extend their skills, and engineers, almost 60% participate in work related training. So onboarding, retraining, and training system engineers remains a significant challenge.
So with those items as a background I’d like to introduce Jama Connect Advisor. Jama Connect Advisor is an add-on for Jama Connect Cloud. It’s an intelligent natural language advisor that improves the quality of requirements. It allows you to author intricate product requirements quickly, easily, and with precision. It’s powered by engineering-based natural language processing, so this is not a general purpose aid, it’s engineering language-based, and the advice is based on the recommended practice, as I mentioned before, the INCOSE rules and the EARS notation. It has a very significant side benefit that while you use it, it augments skills and reinforces organizational preferences while authoring. So not only is it doing the pragmatic work of improving requirements quality, you learn how to do that more quickly and efficiently over time with its use.
So when we look at Jama Connect Advisor’s capabilities, its features are the analysis from industry leading practices, as we’d mentioned in INCOSE, the International Council on Systems Engineering, the EARS notation, and also the unique thing is that the application is designed to work, it’s crafted to use INCOSE rules and EARS notation together to increase the quality and accuracy, and the efficacy of requirement statements, and that’s really its unique value, it’s very quick and efficient, and combines both those attributes. And we’ll talk about that more in a minute. The guidance is provided seamlessly while you’re editing in Jama Connect single item view, and we’ll demonstrate that.
In this blog, we recap the “Driving Business Outcomes with Jama Software’s Success Programs” webinar.
When you buy Jama Connect, you’re not just buying the #1 requirements management solution on the market. Our Customer Success team stands behind you, delivering the expertise, guidance, and resources you need to see a quick return on your investment and achieve your business goals.
Our adoption-oriented approach balances industry best practices with the practicalities of how you plan, build, and test your products.
In this webinar, we discuss how Jama Software has created specific diagnostic tools and customer success offerings to achieve higher value with Jama Connect. We also explore how Jama Connect can enable transformational value to positively impact your business, and how our specific customer success offerings can help your team increase traceability compliance and requirement quality.
Learn more about our new customer success programs, and how they lead to better outcomes such as:
Higher percentage of passing tests
Lower product defect rates
Faster time to market
Below is an abbreviated transcript and a recording of our webinar.
Driving Business Outcomes with Jama Software’s Success Programs
John D’Addario: Good morning. Good afternoon. Good evening. I’m John D’Addario, senior director of customer success here at Jama Software. I’m responsible for our global customer success team here, and we are so excited to share with you some of insights around how our new success program can help you and your company drive business outcomes with Jama Connect. I’ve asked my colleague Preston to join me today. Preston, can you give a brief introduction of yourself?
Preston Mitchell: Yeah. Thanks John. Hey everybody. It’s great to be here. As John mentioned, I’m really excited to share with you some of the things we’ve been working on here to make the success programs even better. For those of you that don’t know me, I am the director of the global solutions team. I’ve been with Jama for about 10 years. My background is kind of in requirements management. I’ve been a business analyst, I’ve been an Agile program manager. So I’m really excited about all of the best practices when it comes to system development and requirements authoring. So yeah, I’ll pass it back to John and we’ll dive in.
John D’Addario: Thanks Preston. So as the number one in requirements management software, our purpose is to ensure that innovators succeed with customer success at the forefront of everything we do. Through years of industry specific experience and thousands of customer engagements, we bring the best practices to bear, to maximize the success rate of the product development process. There are six core business outcomes we focus on helping you drive with Jama Connect. They are reduced cycle time, increased process efficiency, streamline and accelerate reviews, speed time to market, gain visibility and control, ensure compliance and manage risk. We do this across our five key verticals, medical device, automotives and semiconductor, space, airborne and defense systems, software development, and industrial manufacturing.
We have a really exciting agenda for you today. We’re going to go through four topics. We’re going to give an overview of our success program. Preston’s going to go on and talk about measurements and outcomes. We’re going to do a double click on the success programs and then leave some time at the end for some Q and A. So let’s get into it. We are the experts when it comes to requirements management and traceability. We have years of experience between our customer success managers, solution consultants, and technical support engineers. Through our success program, we help our customers achieve faster time to value with Jama Connect.
Preston Mitchell: Hey John, maybe for some of the folks we could give a breakdown of the different team roles here. I’m not sure if everyone has actually interacted with their entire success team at Jama Software. So maybe we could give a background of each of the roles and what their goals are at Jama.
John D’Addario: Sure, sure. So starting with our customer success manager, really think of your customer success manager as you’re trusted advisor, focusing on understanding your business outcomes. We work together to build what we call a success plan. We use that success plan to help marshal resources across the genre enterprise. We also help you with all your commercial needs, like renewals, buying more licenses, adding a success program subscription, adding services, things like that. Our technical support engineers are there to help you with any technical questions that come up during your time with Jama Connect. They are well versed in the ins and outs of all things technical. Preston, why don’t you give a little bit more detail around the solution consultants?
Preston Mitchell: Yeah, definitely. The solution consultants are part of my team. They really bring a lot of industry experience to bear. So a lot of them have been product managers, system engineers, quality managers in their prior roles. So they bring industry experience like requirements authoring experience, quality management, specific industry experience. Then they also of course have a lot of deep practical experience using Jama Connect the product. So they combine those to really recommend best practice uses of the tool. They very much understand the pain points and the outcomes that you all are trying to drive with your products every day. So any kind of deep product questions, or asks of how to use Jama Connect in order to achieve their goals, that’s really what their purpose is.
John D’Addario: Great. Great. When I look at this team and the resources we have here at Jama, I’m a little partial to think that, not only do we have the best team and the requirements management industry, I think we have the best team of any team that I’ve worked in over the last 10, 15 years. It’s really exciting to have this level of engagement between these three teams with this one mission of driving customer success. Let’s do a little bit of a deep dive into our success program. So through this continual engagement with your teams, we really focus on measurable improvements to your process. We do that by forming focus areas, helping you drive adoption and usage of Jama Connect, helping eliminate trace debt, and increasing your Traceability Score™, improving requirements quality score, increasing verification compliance. When you think about the success program, one of the main benefits of the success program is what we call the success catalog.
John D’Addario: This success catalog brings together four great resources for our customers to use. The first one being training resources. The second one being benchmark assessments. The third one being solution consulting. And lastly, fourth, our technical services. When you think about your journey with Jama Connect, think about it in three stages, implement, measure, and optimize. The success program is at the foundation of helping you achieve those business outcomes. We do that by mixing different services in our success catalog together, and what we call a success path. In these three examples, you can see here, we have three different success path that brings this prescriptive use of these services in the catalog to help you achieve business outcomes during the different phases of your journey with Jama Connect.
