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This image portrays two subject matter experts on the topic of Functional Safety in Robotics Development.

In this blog, we’ll recap our recent webinar, “Managing Functional Safety Development Efforts for Robotics Development” – Click HERE to watch it in its entirety.

Managing Functional Safety Development Efforts for Robotics Development

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 a preview of our webinar. Click HERE to watch it in its entirety.

The following is an abbreviated transcript 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 start off with a speech and company introductions. We’ll then look at functional safety and providing IEC 61508 overview, associated challenges, and 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 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 the 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 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, and automotive. And also, we can provide you with services regarding license compliances, processes, and 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.

Related: Jama Connect® for Robotics Datasheet

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 or 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, which means faults of a sense, or faults by the 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 the development, that happen during deployment, or maintenance of a product that is due to topics that are not covered, that are due to hazards you have not considered. This is 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, and other critical functions within your system. 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.

Related: FORT Robotics Selects Jama Connect® to Replace Google Sheets for Product Development 

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, and by deciding what kind of methods 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, and three-channel systems. How do you need to set them up? What are the minimum requirements regarding diagnosis you want to do 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 if is this sufficient for my use case. IEC 61508 also is very strong in the definition of 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 after deployment or during maintenance. It also guides you 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 the integration of your system into a bigger system.

This has been an abbreviated transcript of our webinar.

CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
Managing Functional Safety Development Efforts for Robotics Development

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 AECMagazine, titled “Cyberattacks: safeguarding contractors” – originally published on May 22, 2024, and written by Ben Wallbank.

Cyberattacks: Safeguarding Contractors

It’s every construction firm’s biggest nightmare: criminals taking control of their data and holding them to ransom. Ben Wallbank, Trimble, shares some best practices to mitigate cyberattacks

Cybersecurity and cybercrime often conjure up images of hackers in dark hoodies, sneaking in the digital back door. In reality, nearly 90% of corporate cybercrime, such as phishing or ransomware attacks, is a result of employee error.

The UK construction industry is no exception and could be an even greater target than other industries. Protecting massive amounts of data, including warranty and latent defect remediation periods, makes contractors attractive to cyber criminals. Cybersecurity is so crucial to construction that the National Cyber Security Centre produced a construction industry-specific guide, along with the Chartered Institute of Building (CIOB).

Cybercriminals who target the construction industry usually do so by accessing, copying, and sharing data illegally or by installing malware on a company’s computers and network, taking control of files, and holding them for ransom. It’s called ransomware, and it’s probably the most common and one of the most debilitating types of cybersecurity breaches in the construction world.

Each year, we hear of new cyberattacks, taking critical infrastructure offline and crippling construction businesses worldwide, including many here in Europe. These attacks cost billions of pounds a year and can cause whole cities, businesses, and services to grind to a halt.

UK contractors should follow these best practices to safeguard against cyberattacks and improve outcomes in case of an attack.

Create a business continuity plan

Preparing for the worst puts your business in the best position moving forward because you can act quickly and have more control of the outcome. A solid cyber security disaster plan can get quite detailed. It should be consistently reviewed, practiced, and updated to net the best results in case of an incident. At a minimum, a business continuity plan should include the following:

  • Name of a leader to act as a central resource to manage disaster recovery across multiple departments.
  • A communication plan for sharing key messages and managing crises with employees, clients, and additional project stakeholders.
  • A maintenance plan for a continually updated (and backed up) list of employee contact information and asset inventory.

RELATED: Six Key Challenges in the Architecture, Engineering, Construction, and Operations (AECO) Industry and How to Solve Them with Jama Connect®

Backup all data

A crucial aspect of any good cyber security plan is to make sure that everything is backed up, preferably on the cloud or physically on an offsite server that’s not on your network. Backups should be frequent and automated, so ask your IT provider to set them up so that they either happen in real-time (if you’re backing up to the cloud) or that they run daily after everyone has left the office.

Secure mobile devices

Mobile devices are more challenging to secure than other data systems, but just as critical. Utilizing an enterprise management platform, such as Cisco Meraki, allows you to maintain enterprise-level control over all of your devices. These kinds of platforms ensure that individual devices are still managed centrally, and contractors can limit software installation, track devices using GPS, disable devices, and more.

Protect software and servers

When it comes to software and security risks in construction, contractors should choose platforms and software providers that take security seriously. Granular permissions, user-friendly management systems, and multi-factor authentication, for instance, are all must-haves in any construction software.

By using cloud-based, connected construction software, contractors shift the responsibility of maintaining servers, ensuring SOC 2 Type II compliance, and data backup and storage. Project and business data backups happen automatically, providing daily protection, with costs often included or rolled into users’ subscription costs. New software features and security functionality are also rolled out automatically.

By coupling the backups with cybersecurity protections, cloud vendors use the latest technologies to thwart cybercriminals and provide an extra level of protection not otherwise achieved through in-house backups. When shopping for business software, make security one of your first discussion points.

Additionally, your web and email servers need to be properly protected to avoid online attacks. Physical network servers need to be secured, and you need to ensure that any cloud-based solutions you’re using also implement rigorous security protocols.

RELATED: Jama Connect® Amazon Web Service (AWS) GovCloud US Hosting

Assure employee buy-in

Cybersecurity protection in construction requires every employee at every level to be fully engaged and actively vigilant. There are several steps to take to make that happen:

  • Ensure all employees receive regular cybersecurity training, especially if online workflows or procedures change.
  • Welcome feedback from team members and update cybersecurity policies and processes as needed.
  • Counsel employees on everyday things to look for before opening email, like spelling and grammar errors, verifying sender’s email address, and never opening unexpected attachments.

Take the first step: get started

The most important step is the first one. The UK government offers two certifications – Cyber Essentials and Cyber Essentials Plus – that are crash courses in the basics to keep businesses safer from cybercrime. While they don’t replace a cybersecurity risk assessment, they will show you how to do one and how to select the security measures your business needs.

Anywhere your data is stored or used is a potential entry point into your company’s digital existence. It only takes one slip to allow malicious code or ransomware in, and once it’s there, it can cause millions of pounds worth of damage.

This image portrays a digital background with a banner reading, "SysML is Not Enough: Why You Still Need a Requirements Management Tool"

SysML is Not Enough: Why You Still Need a Requirements Management Tool

All engineering process models (Agile, waterfall, spiral development, V-model, concurrent engineering, iterative…) describe managing requirements as the most critical key to success. Well-understood requirements provide a single connection point for communication across the engineering teams. Using a Systems Modeling Language (SysML) tool alone to manage requirements instantly creates a silo between engineering teams.

Requirements, tests, architectures, and risks are utilized by every stakeholder when developing a new product or building or modernizing a new system. Customers generate needs and requirements and care what the development status of those are and whether the development team is following the necessary process especially if it requires contract adherence or must meet regulatory laws or industry standards.

Software, hardware, and testing teams also access requirements to be able to analyze, develop, and test. Additionally, they are creating requirements at their given subsystem level too.

Systems Engineers work across all levels of requirements and coordinate the other engineering disciplines. NASA best describes it as, “Systems engineering is a holistic, integrative discipline, wherein the contributions of structural engineers, electrical engineers, mechanism designers, power engineers, human factors engineers, and many more disciplines are evaluated and balanced, one against another, to produce a coherent whole that is not dominated by the perspective of a single discipline.” – NASA

As you can imagine functionality such as configuration management of requirements, traceability between needs, requirements, tests, risks, and architecture are necessary. Systems engineers have been using various tools and even manual techniques for decades to do this.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

The Advertised Purpose of SysML

SysML is a graphical modeling language that is used within some systems modeling tools (such as Dassault’s Catia Nomagic) that enables systems engineers to perform “engineering” of the system. SysML “supports the specification, analysis, design, verification, and validation of a broad range of systems and systems-of-systems.” – Wikipedia

SysML is only a decade old; already a new, more complex version has recently been released; and SysML is yet to be widely adopted. It is widely thought to hold promise for the discipline of model-based systems engineering (MBSE). It is not the only language in use for MBSE though; LML and OPM are examples of modeling languages too, being used within other systems modeling tools.

However, a SysML model is difficult even for those trained in the language. Some indicate the learning curve is steep and the mechanics in the tools are difficult as cited in a recent article by Technology Strategy Partners. Additionally, the variety of tools that support SysML don’t consider themselves as a replacement for a true requirements management tool either. Capabilities from a dedicated requirements management tool such as Jama Connect have built-in collaboration, configuration management, baselines, managing traceability across multiple levels of objects, managing the verification and validation activities, controlling access and change to objects using role-based permissions, and showing real-time workflow states at the object level.

“What SysML lacks is its usage during key Systems Engineering (SE) phases like detail design or implementation phases wherein specific solutions like CAD, Software coding or network design for embedded systems are used,” said Kiran Jacob, Dassault Systems.

Also challenging is usage by software teams during later-stage design phases. Communication of the model (its requirements) becomes critical when needing to validate requirements with the customer, with product managers, and with other engineering disciplines outside of the SysML Scribe (tool jockey). The greater responsibility of the systems engineer as a cross-disciplined communicator requires the use of tools outside of the SysML tool to communicate. Effective communication of requirements is best represented in dedicated requirements management tools.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Conclusion

In conclusion, while SysML and other modeling languages offer significant promise for the discipline of model-based systems engineering, they are not without their challenges. The complexity of SysML, along with its steep learning curve and the limitations of the tools supporting it, often hinders its effectiveness in later stages of design and implementation. As such, relying solely on SysML can create silos within engineering teams, impeding the critical communication and coordination necessary for successful systems engineering.

Effective requirements management remains the cornerstone of any engineering process, ensuring all stakeholders — from customers to software and hardware teams — are aligned and informed. Dedicated requirements management tools, such as Jama Connect, offer robust features like collaboration, configuration management, and traceability, which are essential for managing the multifaceted aspects of modern engineering projects. These tools facilitate clear communication of requirements, verification, and validation activities across all engineering disciplines, thereby supporting the holistic, integrative approach championed by systems engineering.

Ultimately, the synergy between specialized requirements management tools and SysML can provide a comprehensive solution, leveraging the strengths of both to enhance the efficiency and success of engineering projects. As the field continues to evolve, adopting a balanced approach that incorporates the best practices and tools from both domains will be key to navigating the complexities of modern systems engineering.

In this blog, we recap our webinar, “Expert Perspectives: A Deep Dive Into Risk Management and Designing for Cybersecurity & Patient Safety” – Click HERE to watch it in its entirety.

Expert Perspectives: A Deep Dive Into Risk Management and Designing for Cybersecurity & Patient Safety

Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields.

With more than 30 years of experience and a mission to elevate knowledge and proficiency in medical device risk management, Bijan Elahi has worked with both startups, and some of the largest medical device companies worldwide.

In this presentation on Risk Management and Designing for Cybersecurity & Patient Safety, Bijan covers:

  • Significance of a comprehensive risk management approach, including safety & security, for medical devices
  • Interfaces between safety and security risk management processes, and how they interact/complement each other
  • Upcoming industry trends that impact risk management (safety, security) like AI/ML, rise in connected devices, wearables devices

Below is a preview of our webinar. Click HERE to watch it in its entirety.

The following is an abbreviated transcript of our webinar.

Kenzie Jonsson: Welcome to our Expert Perspective series where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields. I’m Kenzie your host, and today I’m excited to welcome Bijan Elahi, a world-renowned expert on safety risk management for medical technology. With more than 30 years of experience and the mission to elevate knowledge and proficiency in medical device risk management, Bijan has worked with both startups and some of the world’s largest medical device companies. Without further ado, I’d like to welcome Bijan who’ll be presenting on risk management and designing for cybersecurity and patient safety.

Bijan Elahi: Hello. My name is Bijan Elahi. I’m delighted to be speaking to you about cybersecurity and medical device risk management. Before I start, I’ll briefly introduce myself. I am a technical fellow, a professor, and the founder of MedTech Safety, an education and advisory company. To give you a little background about myself, I come from the industry and have been a medical device product developer for most of my career. Most of the products that I have developed have been class III implantable devices such as pacemakers, defibrillators, and deep brain simulators. Now I’ve also developed a kidney dialysis system, which includes disposables. I’m based in Florida, but I teach and advise worldwide. Risk management is my passion. I have trained over 10,000 individuals worldwide in the latest knowledge and best practices in risk management.

RELATED: Jama Connect® for Medical Device & Life Sciences Development Datasheet

Elahi: The companies that have benefited from my training range from small start-ups to the largest MedTech companies in the world. And here’s the sampling. I am also active in academia, for example, at Delft University of Technology and Eindhoven University of Technology in the Netherlands where I teach a graduate course to doctoral students in engineering. I am also an affiliate professor at Drexel University Graduate School of Biomedical Engineering and Health Science, where I teach safety risk management for medical devices. And lastly, I’m a contributor to the standard ISO 14971, and the author of two very popular books on medical device risk management published by Elsevier Publishing in the UK under the label of academic press. My publisher tells me that my books are bestsellers in the genre of medical books for them, and they’re available at all major booksellers such as Amazon.

So now let’s talk about cybersecurity and safety risk management. The threat of cybersecurity on medical devices is a rising concern as there’s an ever-increasing interconnectivity, interoperability, and reliance on digital technologies. Medical devices such as pacemakers, insulin pumps, and imaging systems often contain sensitive patient data and are integral to patient care. Cyber attacks on these devices can lead to severe consequences, including tampering with the device functions, unauthorized access to patient information, and destruction of critical healthcare services. The potential for harm is significant. For example, incorrect diagnosis, treatment delays, or even direct physical harm to patients. As cyber threats become more sophisticated, we need robust security measures, smart designs, and continuous monitoring to protect these vital components of modern healthcare systems. The safety impact of cybersecurity exploits must be considered in the overall residual safety risk of medical devices.

Safety risk management is distinguished from cybersecurity risk management. Safety risk management is primarily concerned with the safety of patients, users, and the performance of medical devices. This involves identifying, evaluating, and controlling the risks of harm to patients or users due to device malfunctions, use errors, or adverse interactions with the human body. The focus is on ensuring that the device functions safety and effectively under normal and fault conditions. On the other hand, cybersecurity risk management is focused on protecting the device and its data from malicious cyber-attacks and unauthorized access, which may have nothing to do with safety. Many hospital systems are currently under ransomware attacks with the intention of financial exploitation. Security risk management involves implementing measures to protect the data confidentiality, integrity, and availability of healthcare systems. Although these topics are distinct, there is an overlap between them.

RELATED: Mastering ISO/IEC 27001: A Guide to Information Security Management

Elahi: As mentioned before, there are different exploits that cyber attackers seek. Some are not safety-related. For example, private patient data, software codes or algorithms, financial data, money, et cetera. A famous example is the WannaCry cyber attack, which unfolded in May of 2017 causing widespread disruption across the globe. It all started on the 12th of May 2017 when many organizations began to notice that their computer systems were being encrypted and locked by ransomware demanding payment in Bitcoin to unlock them. The ransomware known as WannaCry exploited invulnerability in Microsoft Windows. The attack affected hundreds of thousands of computers in over 150 countries. Major organizations and institutions were hit, including the UK’s National Health Service, also known as NHS, FedEx, and many others. The impact on the NHS was particularly severe because medical staff were unable to access patient records leading to significant disruptions in healthcare services.

As you can see, this was a cyber attack with the intention of financial exploitation, but it ended up having a patient safety impact as well. A comprehensive risk management strategy for medical devices must integrate both safety and security measures. This ensures not only that devices are safe from operational risks, but also that they are protected against growing threats of cyber attacks, thereby safeguarding patient health and data integrity in a holistic manner. An interesting side note to the WannaCry story is that this vulnerability was known by Microsoft and they had released a security patch in March of 2017, two months before the cyber attack, but many hospitals and organizations have not applied the patch and remain vulnerable. This is a common issue even today, and many medical devices and healthcare systems remain vulnerable despite the available protections.

CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
Expert Perspectives: A Deep Dive Into Risk Management and Designing for Cybersecurity & Patient Safety

The Role of AI in Product Development: A Glimpse into the Near Future

Artificial intelligence (AI) is a topic that has infiltrated every aspect of society, causing a transformational shift (or the promise of one) in almost every landscape – and product development is no exception. AI has the potential to significantly improve productivity, innovation, and accuracy throughout the whole product development lifecycle, from ideation and defining requirements to commercialization.

In this blog post, we’ll look at some of the different ways AI and ML are (or will likely) influence product development.

Concept and Idea Generation

The ideation stage of product development is frequently very difficult. By employing data analytics and machine learning algorithms to recognize consumer preferences, market trends, and new demands, AI can significantly improve this stage. Large volumes of data from social media, customer evaluations, and sales statistics can be analyzed by AI systems to produce insights that support the development of new product concepts.

For instance, generative design algorithms can generate several design concepts according to predetermined standards, providing a range of possibilities that would be challenging for human designers to generate independently.

Great Products Start with Clear Requirements

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.

On such example of using AI and ML for creating product or systems requirements is Jama Connect Advisor™, a state-of-the-art requirements authoring guide and optimizer powered by natural language processing for engineering. Jama Connect Advisor was built to help 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.

Design and Prototyping

AI-powered technologies are transforming the phases of design and prototype. AI-powered generative design tools can explore every potential combination of a solution, testing and iterating solutions faster and more efficiently than humans could. This results in creative and well-optimized goods in addition to quickening the design process.

Furthermore, AI can improve prototyping by using sophisticated simulation methods. Before a real prototype is made, artificial intelligence (AI)-powered virtual prototyping can discover possible problems and areas for development by simulating how a product would behave under various scenarios. This lowers the time and expense involved in using conventional prototyping techniques.

Material Selection and Optimization

A product’s success can sometimes be contingent on the choice of materials. AI can assist in this process by predicting the qualities and performance of various materials through machine learning models. Through the examination of material qualities, usage patterns, and performance results, artificial intelligence may suggest the best materials for certain uses, guaranteeing longevity and economy.

AI can also optimize the use of materials, cutting waste and advancing sustainability, and can precisely forecast material requirements through predictive analytics, assisting businesses in minimizing excess inventory and minimizing environmental impact.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution

Manufacturing and Supply Chain Management

With the introduction of smart factories, AI is poised to completely transform the production process. These factories use AI to automate and optimize their production lines, which boosts productivity and decreases downtime. Predictive maintenance, enabled by AI, can forecast equipment breakdowns and arrange timely repairs, assuring smooth and ongoing operations.

In supply chain management, AI may boost logistics by forecasting demand, optimizing inventory levels, and managing supplier relationships. AI algorithms can examine historical data and market patterns to estimate demand more accurately, guaranteeing that products are accessible when and where they are needed, while preventing overstock and stockouts.

Quality Assurance and Testing

Ensuring product quality is paramount in product development. AI may complement quality assurance processes through automated testing and anomaly identification. Machine learning models can be trained to spot faults and anomalies in items, enhancing the accuracy and speed of quality checks.

AI may also undertake real-time monitoring during the manufacturing process, recognizing and correcting quality concerns as they develop. This proactive strategy not only promotes product quality but also decreases the expense associated with post-production adjustments and recalls.

Customer Feedback and Iterative Improvement

Post-launch, AI may continue to play a significant role in product development through the analysis of consumer feedback. Natural language processing (NLP) algorithms can sift through reviews, social media comments, and customer support conversations to derive important insights on product performance and consumer happiness. This data can inform iterative changes, ensuring that goods evolve to match consumer needs more effectively.

AI-driven sentiment analysis may also monitor client reactions in real-time, enabling organizations to respond promptly to any issues or trends. This responsiveness develops a better relationship with customers and improves brand loyalty.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

The Future of AI in Product Development

As AI technology continues to evolve, its impact on product development will only rise. Companies that leverage the power of AI will be better positioned to innovate, shorten time-to-market, and provide goods that resonate with consumers. The future of product development is clearly connected with AI and machine learning, offering a new era of innovation, efficiency, and precision.

In conclusion, the integration of AI in product development has great promise for revolutionizing how things are imagined, produced, manufactured, and polished. By integrating AI, firms can stay ahead of the curve, continuously adjust to market circumstances, and provide products and systems that not only meet but surpass client expectations. The future is bright for those who harness AI to drive product innovation and development.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Decoteau Wilkerson and Kenzie Jonsson.

Jama Software is always looking for news that will 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 the U.S. Food & Drug Administration, titled “Ramping Up Security to Meet Operational Resilience Rules” – originally published on April 29, 2024.

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests

Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years.

LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory that meets certain regulatory requirements. IVDs can play an important role in health care; they are used in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. They can be used to measure or detect substances or analytes, such as proteins, glucose, cholesterol or DNA, to provide information about a patient’s health, including to identify, monitor or determine treatment for diseases and conditions.

The FDA announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.

“LDTs are being used more widely than ever before – for use in newborn screening, to help predict a person’s risk of cancer, or aid in diagnosing heart disease and Alzheimer’s. The agency cannot stand by while Americans continue to rely on results of these tests without assurance that they work,” said FDA Commissioner Robert M. Califf, M.D. “The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust.”

RELATED: Jama Connect® for Medical Device & Life Sciences Development Datasheet

Although historically the FDA has generally exercised enforcement discretion for most LDTs, meaning that the agency generally has not enforced applicable requirements with respect to most LDTs, the risks associated with most modern LDTs are much greater than the risks associated with LDTs used when the FDA’s enforcement discretion approach was adopted many decades ago. At that time, many LDTs were lower risk, small volume and used for specialized needs of a local patient population. Now, many LDTs are used more widely, for a larger and more diverse population, with large laboratories accepting specimens from across the country. LDTs also increasingly rely on high-tech instrumentation and software, are performed in large volumes and are used more frequently to help guide critical health care decisions.

Moreover, there is a growing body of evidence that demonstrates that some IVDs offered as LDTs raise public health concerns; for example, they do not provide accurate test results or do not perform as well as FDA-authorized tests, including from published studies in the scientific literature, the FDA’s own experience in reviewing IVDs offered as LDTs, news articles and class-action lawsuits.

The FDA is aware of numerous examples of potentially inaccurate, unsafe, ineffective or poor quality IVDs offered as LDTs that caused or may have caused patient harm, including tests used to select cancer treatment, aid in the diagnosis of COVID-19, aid in the management of patients with rare diseases and identify a patient’s risk of cancer.

Without greater oversight of the safety and effectiveness of LDTs, patients may be more likely to initiate unnecessary treatment, or delay or forego proper treatment based on inaccurate test results or tests promoted with false or misleading claims. This could result in harm, including worsening illness or death, as well as unnecessarily increase health care costs.

Increased compliance with device requirements under the FD&C Act (such as premarket review, quality system (QS) requirements, adverse event reporting, establishment registration and device listing, labeling requirements and investigational use requirements) will put patients and health care providers in a better position to have confidence in IVDs regardless of where they are manufactured.

With increased oversight, the FDA will also be able to help promote adequate representation in validation studies, as well as transparency regarding potential differential performance and unknown performance in certain patient populations, which may ultimately help advance health equity.

“Today’s action is a critical step toward helping to ensure the safety and effectiveness of LDTs, while also taking into account other public health considerations, including continued access to critical tests patients rely upon,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Through targeted enforcement discretion policies for certain categories of tests manufactured by a laboratory, we expect patients and health care professionals will continue to have access to the tests they need while having greater confidence that the tests they rely on are accurate.”

The phaseout of the FDA’s general enforcement discretion approach for LDTs over a period of four years will protect the public health by helping to assure the safety and effectiveness of these tests, while avoiding undue disruption to patient care. Better assuring the safety and effectiveness of LDTs may also foster test innovation and facilitate the collective efforts of the scientific and medical communities to identify promising technologies, new therapies or areas worthy of future research.

Importantly, the FDA considered the large volume of comments received on the notice of proposed rulemaking, and in light of that input, has adjusted the phaseout policy in a manner that better serves the public health. After this phaseout, the FDA generally will expect IVDs made by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by laboratories may fall within one of the agency’s targeted enforcement discretion policies.

The FDA intends to exercise enforcement discretion with regard to premarket review and most quality system requirements for certain categories of IVDs, including but not limited to:

  • Currently marketed IVDs offered as LDTs that were first marketed prior to the date of issuance of the final rule. This enforcement discretion policy is intended to address the risk that the perceived costs of compliance with such requirements could lead to the widespread loss of access to beneficial IVDs on which patients currently rely.
  • LDTs manufactured and performed by a laboratory integrated within a health care system to meet an unmet need of patients receiving care within the same health care system when an FDA-authorized test is not available. This enforcement discretion policy is intended to help avoid patients being deprived of critically needed LDTs where certain risk mitigations exist that may help laboratories to identify any problems with their LDT and may help inform appropriate use and interpretation of such LDTs.

The FDA has also included additional enforcement discretion policies, such as for LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP), as described in the preamble to the final rule, where that program’s review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs.

RELATED: Buyer’s Guide: Selecting a Requirements Management and Traceability Solution for Medical Device & Life Sciences

Draft Guidance Documents

The agency also issued two draft guidances today. One provides the agency’s thinking about an enforcement discretion policy for certain laboratories offering certain unauthorized IVDs for immediate response to an emergent situation, such as an outbreak of an infectious disease, in the absence of a declaration applicable to IVDs under section 564 of the FD&C Act. The other provides insight into the FDA’s thinking about the factors the agency intends to consider when developing a policy regarding enforcement discretion for certain IVDs during a public health emergency declared under section 564 of the FD&C Act.

Inquiries
Media: James (Jim) McKinney, 240-328-7305
Consumer: 888-INFO-FDA

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 Scilife, titled “Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization” – written by Angel Buendia and originally published on March 31, 2023 and updated January 3, 2024.

Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization

The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US regulation on quality systems, the Quality System Regulation (QSR, described in the Code of Federal Regulations Title 21, part 820), with the international standard on quality management systems ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. On February 23rd, 2022, the FDA published a proposed rule in the Federal Register, declaring their intentions to replace the Quality System Regulation (QSR) with a new Quality Management System Regulation (QSMR). The FDA highlights that they first realized the “comprehensive and effective approach to establish a QMS for medical devices” in ISO 13485 through the Medical Device Single Audit Program (MDSAP), which allows inspections of medical device manufacturers based on ISO 13485 requirements.

US Quality System Regulation (QSR)

The US Quality System Regulation describes the requirements for quality management systems of medical device manufacturers based in the United States. It was launched in 1997, making it more than 25 years old. While the regulation originally shared many concepts with ISO13485:1996, it still needs to be updated sufficiently to encompass the changes in the industry.

Set to start work in 2018, the complexity of the update, paired with a global pandemic, has delayed the harmonization. However, we should be seeing the final rule soon.

ISO 13485

ISO 13485:2016 describes the requirements for a quality management system for medical device companies. The first version of ISO 13485, based on ISO 9001 Quality Management Systems, was issued in 1996. The standard is updated every five years.

Why harmonize?

Having harmonized regulatory systems in the major global markets significantly helps medical device manufacturers comply with international regulations. Furthermore, global harmonization work, such as the MDSAP, can more easily take steps to reach international regulatory alignment.

The FDA acknowledges the strength of the ISO 13485 approach to quality management and points to several ISO 13485 principles that are stronger than the FDA 21 CFR 820.

Medical device regulations aim to improve the safety and efficiency of medical devices on the market. The harmonization of standards helps medical device manufacturers streamline their processes and ensure the quality of their medical devices globally.

RELATED: The Complete Guide to ISO 13485 for Medical Devices

What will change?

While the two regulations have evolved to be substantially similar, there are some key differences that the FDA will need to address. In their communication from February 2023, FDA outlines the scope and proposed updates to the regulation. While most of the changes are about revising the regulation to mimic ISO 13485 closer, there are more extensive updates afoot:

  • Definitions: The FDA is planning to revise some of the definitions in the US regulation, such as “management with executive responsibility,” “Device Master Record (DMR),” “customer,” and others, to match ISO 13485. Likewise, the FDA is choosing to retain some of its definitions that do not match the international standard, such as “manufacturer,” “product,” and “device.”
  • Incorporate ISO 13485 by reference: The FDA will remove all Quality System Regulation (QSR) provisions substantially similar to ISO 13485 and directly reference the standard.
  • Quality system requirements: Currently, quality management systems in the US must comply with CFR 21 part 820. A proposed regulation modification will ensure that quality system requirements are standardized across regulations, highlighting compliance with FDA requirements where there are discrepancies.
  • Clarification of concepts: the FDA is clarifying the concepts of organization, safety and performance, and validation of processes to explain how ISO 13485 relates to the statutory and regulatory framework in the US.
  • Supplementary provisions: the FDA is looking to add additional requirements to ensure consistency and alignment with other regulations and laws in the US. These additional requirements fall within record control and controls for labeling and packaging.
  • Conforming amendments: The FDA will amend other parts of the CFR, such as part 4, to reflect the modifications made to part 820.
  • Language updates: The new Quality System Management Regulation (QSMR) also plans to update the language surrounding some concepts to adapt sections of ISO 13485 to existing FDA requirements. For example, to comply with the ISO 13485 section on the identification of medical devices, US manufacturers must label their devices with a Unique Device Identifier (UDI). Additionally, manufacturers must submit medical device reports (MDRs) to the FDA as described in 21 CFR 803 for compliance with the ISO 13485 section on reporting.

Impact on medical device manufacturers

So, how will this harmonization of regulations impact medical device manufacturers? The two regulations have evolved to resemble each other, and the day-to-day operations of medical device manufacturers will likely stay the same. However, quality departments will need to change their quality systems substantially.

Risk management activities must be increased. Several risk analyses are required in ISO 13485 to identify potential hazards in device design and hazards due to user errors. Essentially, US manufacturers must shift to a proactive risk management system instead of the reactive system of the past. A proactive risk management system actively monitors market behavior and trends to identify and mitigate risk, and it builds risk management plans that define how to handle any data that might impact the device’s benefit-risk profile.

Harmonization to ISO 13485 will not change the authority of the FDA. Medical device manufacturers with an ISO 13485 certification will not be exempt from FDA inspections, nor will they be granted certificates of conformance based on their ISO 13485. However, obtaining ISO 13485 certification will significantly help companies comply with the FDA regulations, as having formalized and effective processes are required for both certifications. Likewise, having FDA certification will help manufacturers obtain ISO 13485 due to the similarity in process requirements.

Regulatory compliance is expensive. By harmonizing regulations and standards, the FDA ensures that manufacturers can obtain compliance with both the FDA requirements and ISO 13485 relatively quickly, as the quality system processes will be similar. Once the initial implementation is complete, medical device manufacturers can save significant resources on quality system compliance due to the reduced need for quality management systems that comply with different regulations. The FDA estimates annualized net cost savings of approximately $439 million due to the reduction in compliance efforts of medical device manufacturers who currently comply with both standards. This includes reductions in personnel training, information technology needs, and documentation requirements.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

When will implementation be completed?

The big question is – when will this final rule be issued, and when will medical device manufacturers have to comply with it?

In February 2022, the FDA gave the public 90 days to comment on the proposed rule. They then suggested a one-year implementation time. A one-year implementation date is short for medical device manufacturers and the FDA; the industry has called for a more extended implementation period.

However, there has yet to be any news on the implementation date of the rule. The first anniversary of the proposed rule has come and gone and the QSR and QSMR were both missing from the FDAs semiannual regulatory agenda issued in February 2023. Based on that, it is unlikely we will see the harmonization rule published in 2023.

This image portrays an article about manufacturing technology predictions in 2024.

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 IndustryWeek, titled “AI, XR and Data: Manufacturing Technology Predictions for 2024” – written by Dennis Scimeca and originally published on January 3, 2024.

AI, XR and Data: Manufacturing Technology Predictions for 2024

If we’re finished with the hype cycle, we’re probably talking about a technology that’s here to stay. So, when IndustryWeek asks manufacturers and analysts for their predictions about manufacturing technology in the coming year, we’re looking for the most mature technologies with the widest adoption rates.

This year’s answers demonstrate the point yet again. Of the dozen technologies we asked about, artificial intelligence (AI), augmented/virtual/mixed reality (XR for short) and the use of data and analytics garnered the most response. Manufacturers next year really should keep their eyes on these three technologies in 2024.

AI’s 2024 Prospects

Artificial intelligence took center stage in 2023 with the arrival of generative AI, specifically ChatGPT and Microsoft’s Bing AI, sparking a slew of marketing campaigns and enthusiastic op-eds about what gen AI would do for manufacturers and the world.

Listening to our audiences (and IndustryWeek’s own analyses) the hype bubble for gen AI burst rather quickly but the topic of AI generally still holds great relevance for the manufacturing world.

“The current market zeitgeist around AI has bled significantly into manufacturing markets, but its deployment will be held back by a staunch lack of trust amongst operators and calls for comprehensive and provable use cases. This is particularly the case for functionality associated with quality management processes and QMS software, due to an entrenched resistance to change and concern around giving up control of processes,” says ABI research industry analyst James Prestwood.

“QMS software vendors are and will continue to take a slower approach to developing AI functionality for solutions, engaging in strong and consistent dialogue with key customers to ensure that the technology is meeting real plant floor challenges. … However, even as solutions are released, adoption will be slow, if in 2024 at all, and will most likely be focused on manufacturer’s lighthouse facilities, rather than being deployed organization wide,” Prestwood adds.

Paul Miller, vice president and principal analyst at Forrester, was a bit more blunt in his assessment.

“Generative AI will not transform the business of manufacturing in 2024,” Miller says. “There are clear opportunities to add ChatGPT-like interfaces in front of complex sets of product documentation and operational data, lending a helping hand to experienced engineers. The human remains in charge, and they must still be responsible for the actions that they take: We’re not yet in a position where these generative AI tools can be relied upon to support inexperienced users in situations where mistakes can be both costly and dangerous.”

RELATED: 2024 Predictions for Product and Engineering Teams

Tim Gaus, smart manufacturing leader and principal at Deloitte, is more optimistic in the long term, but sees few applications right now.

“GenAI holds the potential to create closed-loop manufacturing systems that can automatically make real-time adjustments and self-optimize based on data. This can bring new levels of efficiency to the industry – but as the capabilities of GenAI continue to be explored and mature, organizations will be best served to start testing the technology in areas like maintenance and repair.” .

Of the technology leaders and experts we interviewed, Anu Khare , senior vice president and chief information officer at Oshkosh Corp., sounded the most optimistic about AI’s potential.

“We are entering into the most exciting period of technological evolution since the advent of the Internet. The most impactful and broadest application of technology will be AI (artificial intelligence). Every aspect of business will be infused with and augmented by various AI tools,” Khare says.

According to Khare, predictive insight, task automation, human machine engagement and content generation are the four areas that will most benefit from new AI technology.

“All these technological advances and adoption will create a new relationship between humans and AI, where AI becomes an augmentation tool, just like we use industrial tools in our manufacturing plants,” Khare adds.

AR/VR

XR technology, initially pitched as the next, best thing in gaming instead found its home within the manufacturing world. That’s not to say no one uses VR for entertainment, but we cannot deny the utility of manufacturers blowing up product designs in augmented reality to allow operators to see how their parts fit into the final product, or virtually training operators on dangerous equipment to increase safety or collaborating with colleagues across continents.

Somehow this morphed into discussions of the metaverse, a term borrowed from Neal Stephenson’s 1992 dystopian science fiction novel Snow Crash, but according to our experts XR discussion came down to earth again quickly.

“We see a bit of a resurgence of interest in AR and VR in 2024, as everyone moves away from talking about the industrial metaverse. … . Both AR and VR got caught up in broader hype around the metaverse, and they and other enabling technologies like digital twin and even IoT now risk losing credibility (and project funding) as part of the backlash against that deflating hype bubble. Forrester predicts that over 75% of industrial metaverse projects will rebrand to survive the metaverse winter: project teams will go back to talking about the enabling technologies – and the very real problems they address – and quietly hope that everyone forgets any association with the metaverse,” says Miller.

ABI Research director Eric Abbruzzese expects 2024 will be an important year for the AR/VR/MR market because Apple releases its Vision Pro hardware, the company’s first truly new device in a long time. He there expects an influx of mixed reality content to hit the market next year, both for the Pro and its competitors.

“While mixed reality may have a strong 2024, smart glasses will not. OEMs continue to struggle to create a full smart glasses package that delivers quality of experience alongside acceptable design, form factor, and price. Devices have either been too niche and focused—such as glasses specifically targeting cyclists—or too expensive and bulky for broad use (e.g. Magic Leap),” said Abbruzzese.

“Even if smart glasses from major tech names like Samsung and Meta hit the market in 2024 (which is possible, but releases have traditionally been delayed), these will be first generation smart glass devices mostly targeting developers and early adopters,” he adds.

Dale Tutt, vice president of industry strategy at Siemens Digital Industries Software, adds, “The computing and visualization graphics power that are available makes augmented and virtual reality much more accessible and I think in 2024 there is going to be even greater use of AR/VR.” .

“When I think back to the transition from 2-dimensional drawings on the shop floor to when we started printing 3D pictures with colors to help the technicians install equipment, that had a massive impact and reduced the learning curve. AR/VR provides an even more intuitive environment, so the more that companies can present in virtual and augmented reality, the more effective they are going to make technicians and engineers,” Tutt says.

RELATED: Traceable Agile™ – Speed AND Quality Are Possible for Software Factories in Safety-critical Industries

Data and Digitization

Of all the technologies highlighting this year’s predictions, data digitization and analysis represent the most mature of the trio. Plant-wide lattices of IIoT devices can capture information on vibration, temperature, humidity, quality check results, cycle times, just about anything you can register and quantify with a sensor.

Even the simplest IIoT system, that only tracks products passing in front of photoeyes or logs when and why machines go down can have profound results in increasing OEE and productivity. At the other end of the spectrum, dense IIoT meshes feeding rich data into AI algorithms enable prediction, process tracking and simulation. That’s also a much more complicated proposition.

“In 2024, we’ll continue to see industrial data management evolve and become a priority for organizations if it is not already at the top of the list. Most manufacturers continue to cite industrial data as one of the biggest challenges to innovation due to complexity and accessibility issues,” says Gaus.

Miller adds, “Industrial IoT software platforms do important work, connecting to, managing and extracting data from large fleets of connected devices in production environments. But that’s only part of the picture. Manufacturers need analytics to make sense of the data. They need AI and machine learning to build models and predictions based on the data. They need job scheduling systems and work order management systems, tasking field service engineers to repair machines when machine learning models trained on IoT data spot a problem ahead.”

“IoT platforms are very good at managing and extracting insight from connected devices, but it may not make sense continuing to extend IoT software much further beyond that. Instead, we should be working to effectively surface IoT data inside these more comprehensive enterprise systems,” Miller adds.

Sean Spees, CPG market segment leader for Bosch Rexroth, says in 2024, the emphasis will be “data retrieval and remote assistance. How the data is used and finding a partner with expertise in the digital space to evaluate it to help with predictive maintenance and line conditioning to move towards a lights out factory will be critical.”

This image shows someone taking a picture of damage to a damaged vehicle, indicating that the use of a smart phone and technology helps bridge the gap in insurance product development.

In this blog, we recap our whitepaper, “Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management” – Download the entire thing HERE

Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management

In an industry as longstanding, complex, and regulated as insurance, it’s easy for inefficiencies to creep in. Companies use the same old systems and processes that others have used for decades, and in the crunch to manage the day-to-day business, the drive to update and streamline can get lost in the shuffle.

But in the modern business world, where everything moves at the speed of the Internet and consumers expect new and improved products constantly, insurance companies can’t afford to fall behind on product upgrades and new product development. Old systems and processes keep products from getting to market in a timely manner. How can insurance product developers keep up with demand while meeting business needs and regulatory requirements?

The right requirements management solution can help bridge the gap between product development and the marketplace.

Where The Insurance Industry Needs Requirements Management: Two Scenarios

There are two main scenarios where requirements are needed in the insurance industry. The first is in the policy administration systems that automate the day-to-day operations of an insurance company. While every insurance company is unique, most share processes for day-to-day operations and have some kind of policy administration system. It may be a unique proprietary system, designed specifically for that company, or it may be provided by an outside software vendor. This policy administration system manages the day-to-day operations of the insurance company in three areas:

  1. Policy Administration: To administer an insurance policy, the company must quote, bind, and issue the policy and process endorsements, cancellations, reinstatements, and renewals.
  2. Billing/Accounting Administration: The policy administration system must also manage the financial side of each policy. This administration involves processing initial down payments and providing payment plan options; processing cancellations or reinstatements around non-payment of premiums; processing refunds and collections; and producing an annual statement and statistical reporting.
  3. Claims Administration: Finally, the policy administration system must process insurance claims, including first notice of loss, claims payments, and reinsurance.

Even listing the basic types of information that must be processed doesn’t capture the complexity of the details that have to be managed by the policy administration system. For example, while there is one set of requirements related to insured risk and coverages, there is an entirely different set of requirements for the output to describe both static and variable data that must be printed. In addition, every policy needs to have changes at some point, which are processed as endorsements. There are different rules for different types of endorsements, which will be captured as separate requirements. At each stage and level of the policy there are different requirements that must be applied.

The list of requirements across different functions and processes in the insurance industry is almost endless; managing these requirements according to the massive number of variables across products, risks, jurisdictions, and so on can quickly become overwhelming and cumbersome. In addition, when the requirements aren’t managed or applied properly, gaps and errors can easily arise, leading to administrative challenges at best, legal challenges at worst.

The second area where the insurance industry needs requirements management is in the new and enhanced insurance products and services that insurance companies want to develop and roll out to customers. Designing and introducing new products and services involves new states or geographies with different rules and regulations. Enhancing existing products can involve rate changes or additional coverages. In addition, with new or enhanced products, the policy administration system will need new or upgraded interfaces and other upgrades to the system. Introducing even one new or enhanced product can cause system-wide ripples that can impact everyone from the corporate office to the local agent.

In a world this complex, with this many details, insurance companies need a purpose-built requirements management system to allow them to effectively and efficiently respond to change.

RELATED: How to Solve the Top Five Challenges for Insurance Product Development

Gathering, Documenting, and Reusing Requirements

The common thread to implementing a robust and comprehensive policy administration system is understanding the requirements of the core business processes.

  • Business requirements are the needs of the company, regardless of whether there’s a system to process the work.
  • Stakeholder requirements are the requirements needed for a specific user to be able to process that information in a specific type of system, but they do not need to be specific to the system. These requirements are the ones that a user (such as an agent or claims adjustor) would need to accomplish the business requirements.
  • Solution requirements (functional and non-functional) are the technical requirements that each software solution must have to accomplish stakeholder requirements.

The big key to gathering requirements in all three areas is that the requirements must be reusable. While each software company may have a preference on the format used for the implementation, the business and stakeholder requirements should be reusable within any system so that software requirements can be tailored to the specific implementation strategy.

The Four Main Challenges for Insurance Requirements Management

There are currently four main challenges facing the insurance industry when it comes to requirements management.

1. Introduction of Agile Methodology

The move to agile methodology created a mindset in the insurance industry that requirements weren’t necessary for software development and upgrades. Shortly after the agile revolution began, the IIBA, International Institute of Business Analysis, which is the governing body for business analysts, suggested that business analysts had to adjust to this methodology by evolving to support these new ways of working—not just in software development, but in any area of business analysis where changes happen rapidly. Since then, business analysts often say, “requirements are in the code,” suggesting that requirements are just an extra step that takes too much time.

The reality is that not everyone is a developer who can read and interpret code. Business analysts know the requirements of the business and stakeholders, but they don’t necessarily know how to gauge whether the software meets those requirements. Likewise, software developers may not know the needs of the insurance business without someone who can communicate requirements.

Requirements and requirements management are essential for project success, in part because they reduce the risk of project failure or cost overrun. The solution is not to eliminate requirements to work faster; rather, it’s to manage requirements more efficiently to meet the demands of the market.

2. Unwillingness to Change Outdated Requirements Processes

Change is difficult for a lot of reasons, and it’s not uncommon to hear “we’ve always done it this way” or “if it’s not broken, we don’t need to fix it.”

However, outdated methods of requirements management cannot keep pace with modern needs, and relying on old processes inhibits new product development and innovation. Business analysts should be catalysts for change and demonstrate the efficiencies of new processes throughout the organization.

Another obstacle to change is summed up by the statement, “we’ve managed without requirements management all this time—why is it so important that we do this now?” This attitude represents a misunderstanding about requirements in general. They have always been necessary, and they’ve always been around, whether documented in a specific way or simply discussed in general terms.

Unfortunately, adding new processes to consistently use and reuse requirements can sometimes mean extra work that nobody has time for. Again, this is where business analysts can step
into the fray and be catalysts for change.

3. Reliance on Document-Based Requirements Management Tools

Too many insurance companies rely on document-based tools such as Microsoft Excel spreadsheets and Word documents to manage requirements. These tools are just too time-consuming to manage and can become quickly obsolete if they’re not consistently and constantly updated. It’s also very cumbersome to provide appropriate traceability for testing and test planning using these types of tools. Imagine trying to sit down with four or five different Excel documents and trace the requirements all the way through!

4. Complex Collaboration Across Teams, Departments, and Stakeholders

There is often a great deal of difficulty collaborating within teams, departments, and various stakeholders involved on a project. When it comes to developing and launching new insurance products, collaboration is vital to success, but coordinating schedules and sharing documents can often result in confusion. Fragmented collaboration also introduces the risk of siloed activities and tools; when teams and tools exist independently of one another in different formats and processes, coordination and collaboration become cumbersome at best, impossible at worst. Old tools and processes introduce risk, whereas modern requirements management systems allow people to collaborate at their own pace and provide documentation necessary to clarify and approve requirements.

To solve these challenges, any requirements management system adopted by insurance companies should address four main issues:

  • Maintenance and Traceability: The system must allow requirements to be easily maintained and traced across all teams, stakeholders, and functions throughout the development process. Having the ability to quickly identify requirements and their related functionality is essential for making informed decisions quickly. Lack of maintenance and traceability can lead to major product delays and make it difficult to shift resources from core business tasks to breakthrough innovation initiatives.
  • Easily Adapt for Future Innovation: A requirements management solution for insurance should allow current state requirements to always be ready for future state innovations, drastically reducing the time to market for new and improved products. Having the ability to integrate existing requirements with new functionality is essential to quickly move breakthrough innovative initiatives from development to market.

The traceability functionality really drew Farm Bureau Insurance to Jama Connect because it is easy to identify within the workflow.

“Traceability in Jama Connect® makes it easier to assess the impact of a proposed change,” says Blundy. “It helps identify all areas we have to modify and then gives us the ability to route the change for review and approval with ease. A single source of truth also improves consistency, for example, having templates built into Jama Connect — with all templates located in a single spot — means we’re all using the same template. And we’re following the same processes when writing, sending, and closing requirements.” – HEIDI BLUNDY, BUSINESS AND TECHNICAL ANALYST AT FARM BUREAU INSURANCE

Read the complete story here »

  • Standardization of Reusable Requirements: Having a standard way to reuse existing requirements reduces the risk of project failure, achieves cost savings, and ultimately increases customer satisfaction and return on investment. With standardized requirements, team members who need to review and respond to the requirements can perform their roles more effectively and efficiently.
  • Centralization of Requirements: Effective collaboration in the development of insurance products is vital to successful product development, and having your requirements in a central place to quickly find and use is key to effective collaboration.

DOWNLOAD THIS ENTIRE WHITEPAPER HERE:
Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management

This image portrays a news article asking "How Can Technology Advance Our Lean Effort?"

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 IndustryWeek, titled “How Can Technology Advance Our Lean Effort?” – written by Doug Berger and Conrad Leiva originally published on November 20, 2023.

How Can Technology Advance Our Lean Effort?

Lean has played a significant role for the past few decades in driving efficiency across manufacturing organizations by providing people with the data and methods for eliminating waste, improving factory flow, and focusing on customer value. Lean techniques have promoted simple, intuitive visual and analytical approaches to decision-making, problem-solving, and continuous improvement.

The “digital lean” movement stays true to lean principles while taking advantage of the real-time and data-centric techniques from smart manufacturing and Industry 4.0.

Digital lean amplifies the core strengths of both methodologies. It works best when the operations improvement team pulls in technology to add value for specific process improvements and avoids pushing technology because there is good buzz about it. When deployed to support people and process gains, digital lean unlocks even greater levels of efficiency, quality, velocity, and adaptability in operations.

Extending Value

Digital lean achieves gains with technologies like automated data collection, analytics platforms, digital dashboards, artificial intelligence, and integrated workflow systems. It amplifies both the measurable performance and qualitative employee engagement gains.
The following illustrates the added value that well-placed digital technology can bring to a lean effort in three key areas:

1. Reducing Waste

Reducing downtime through predictive maintenance: Unplanned downtime is wasted time and disruptive. Planned maintenance on a fixed schedule, regardless of equipment condition, is also wasteful. Instead, advanced sensors for conditions such as vibration, force, and temperature can be installed on machines, monitored in real-time, and analyzed by AI-based predictive maintenance algorithms to trigger maintenance when needed based on machine usage and monitored conditions.

Reducing defects with real-time detection: Lean has always had a focus on the waste from out-of-spec quality, material scrap, and rework. Automated in-process quality monitoring through sensors, computer vision, and artificial intelligence (AI) can detect small deviations, including deviations not visible through traditional methods. It can spot in real-time when a process is trending out of its control range, triggering warnings and corrective action.

Reducing waste through enhanced value stream mapping (VSM): The typical VSM is infrequently conducted and based on estimated processing times. Digital process monitoring allows the enterprise to perform VSM with precision processing times, error rates, variations, and other statistics that are not readily available with more traditional manual tracking.

RELATED: Best Practices Guide to Requirements & Requirements Management

2. Reducing Inventory

Minimizing inventory waste through automated material tracking: Auto-ID technology such as radio-frequency identification (RFID) sensors and advanced analytics make it easier to accurately track raw materials, work-in-progress and finished inventory location and levels. The consumption of raw materials is monitored in real-time and triggers replenishment automatically. This reduces unnecessary purchases and out-of-stock due to data errors or not locating inventory. Replenishment levels can be lowered with confidence.

Improving flow with automated movement and handling: Lean has long recognized that any movement of material is less than ideal. Practical considerations often limit the ability to rearrange equipment at a production site. Automated guided vehicles (AGVs) and cobots make it practical to move smaller production batch sizes to achieve continual flow of material, lessening the labor wasted in manual movement. With sensors, routing instructions, and AI, the AGV is automatically placed at the work center in anticipation of completion. From the perspective of the part, it is continuously moving from workstation to workstation with no wait time.

3. Improving People Utilization

Improving work rhythm with real-time digital dashboards: Smart dashboards are configured to automatically use collected data to generate charts, diagrams, and other displays that support everyday decision-making processes. Digital and on-displays mounted in hallways around the plant are updated in real-time. Accurate, timely data is key to improving flow and using people effectively.

Reducing errors with digital work instructions: Operators review the latest standard operating procedures (SOPs), work instructions, and checklists on monitors or mobile devices. This can improve consistency and reduce waste due to operator error.

Eliminating clerical steps with a paperless factory: “Pushing paper” is a form of wasted worker time and expertise. Every instance of a person transcribing information or data entry is non-value-added. The paperless factory eliminates this waste as well as errors introduced through manual data collection.

Improving talent use with online training: Workers are better utilized when they learn to perform a wider range of tasks. Tablets, augmented reality (AR), and virtual reality (VR) are becoming more popular to train workers on new tasks, without risking the impact of learner mistakes on the actual product, especially when the potential mistakes would be a safety concern or costly scrap.

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Where Do I Start?

Perform a variant of the typical value-stream mapping technique and include the steps involved with handling the paperwork. Review the wasted time and errors in your paper-based processes. Consider the improved productivity through eliminating manual steps.

Better data will give you more visibility into the value stream and areas of waste, constraints, and bottlenecks.

In a ‘What if’ mode of thinking, prioritize your areas of opportunity. Over the past several years, commercial technology solutions have reduced the need for custom solutions. This is making digital lean more available and cost-effective for all-size operations.

Do a use-case search on available technology and identify solutions that are relevant to your business.
Debrief with other companies that have deployed similar solutions.
Go into the selection process with a clear understanding of what your business needs and stick to that plan.
It can be tempting to envision a big transformation by having a long-term end state in mind. Take into consideration that technology is rapidly evolving, and your end state will inevitably change. The key is for each step in your journey to build on the prior one and lay a good foundation for expanding future capabilities. Keep your options open.

Do not underestimate the change management effort. The team will need to develop competence in smart manufacturing technology. Throughout this process, engage those employees who will be most affected. You will make better decisions and have less friction during implementation.

Digital lean harnesses advanced technologies to supercharge traditional lean manufacturing. It provides real-time insights to drive faster, more informed decision-making. It identifies and corrects inefficiencies and waste with higher velocity. Embracing digital lean equips businesses with the agility and adaptability needed to thrive in today’s rapidly evolving market landscape.

Based in the New York City area, Doug Berger is founder and president of the non-profit Industry Reimagined 2030, which is on a mission to revitalize U.S. manufacturing at a national scale.

Based in the Los Angeles area, Conrad Leiva is vice president of ecosystem and workforce development at CESMII–the Smart Manufacturing Institute.