Tag Archive for: Requirements & Requirements Management
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.
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.
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.
In this blog, we recap our eBook, “An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices” – Download the entire thing HERE.
An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices
In the world of modern medicine and healthcare, software plays an integral role in the functionality, monitoring, and management of medical devices. These software components can range from simple interfaces to complex algorithms that drive critical medical decisions.
Ensuring the safety and effectiveness of these software components is of paramount importance, leading to the creation of standards such as IEC 62304, which defines lifecycle requirements for medical device software.
Understanding the Importance of Software in Medical Devices
Medical devices have evolved significantly, integrating software into their core functionality. From pacemakers to diagnostic equipment and even mobile health applications, software contributes to accurate diagnoses, patient monitoring, and treatment delivery. This integration enhances the capabilities of medical devices but also introduces potential risks if not developed and maintained properly.
Overview of IEC 62304
IEC 62304, titled “Medical device software – Software lifecycle processes,” is an international standard that provides a framework for the development of quality medical device software. It establishes standards for managing software development, verification, validation, and maintenance within the context of medical device development.
This eBook delves into IEC 62304, its components, implementation strategies, and benefits, equipping readers with a comprehensive understanding of how to develop medical device software that adheres to rigorous quality and safety standards.
Scope and 2 Application of IEC 62304
What Medical Devices are Covered?
IEC 62304 applies to a wide range of medical devices that incorporate software – software that is a medical device on its own (SaMD) or an integral part of another medical device (SiMD). This includes both standalone software devices and software that is part of a larger medical device. These devices encompass everything from simple mobile health apps to complex medical imaging systems.
Examples include clinical decision support software, manufacturing software used to test the delivery volume of an insulin pump, software used to analyze genetic data, software in pacemaker, etc.
What Types of Software are Included?
The standard encompasses software used for medical device design, development, production, installation, and servicing. This encompasses not only the software that directly interfaces with the patient or provides a medical function but also the supporting software used in manufacturing and quality control.
Key Concepts and Terminology
Software Safety Classes
IEC 62304 introduces a classification system based on the potential harm caused by software failures. The requirements vary depending on the software safety classification There are three classes:
Class A: No injury or damage
Class B: Non-serious injury
Class C: Serious injury
These classes help determine the level of rigor required in the software development process.
Software Lifecycle Processes
The standard outlines processes that span the entire software lifecycle, including planning, requirements analysis, design, implementation, verification, validation, and maintenance. Requirements vary depending on the software safety classification.
Software Safety Requirements
Ensuring the safety of medical device software involves identifying and addressing potential hazards. IEC 62304 mandates an increase in rigor of design control processes and documentation based on the software safety classification.
Software Items
Software items are software components that make up medical device software. By decomposing software into discrete software items, the manufacturer can analyze
failure points and interfaces. It also allows the manufacturer to independently classify and document these subcomponents, thus facilitating the possibility of
reusing these subcomponents in future products.Properly managing these items ensures traceability and facilitates risk management.
Complying with IEC 62304 significantly enhances software quality by providing a
comprehensive framework that guides the development, maintenance, and validation of medical device software. By adhering to its guidelines, teams are compelled to follow a structured approach, resulting in improved software quality. The standard mandates clear documentation of requirements, architecture, design, and verification activities, which in turn fosters transparency and traceability throughout the software development lifecycle.
This meticulous documentation ensures that potential issues and deviations are identified and addressed early, reducing the likelihood of defects and vulnerabilities making their way into the final product. The standard forces manufacturers to consider not only how they will develop the software, but also considerations for maintenance and the end of life of the software. Consequently, software that complies with IEC 62304 exhibits higher reliability, safety, and overall quality, which are very important in the context of medical devices where patient safety is paramount.
Furthermore, IEC 62304 references rigorous risk management practices (such as ISO
14971 principles), leading to the identification and mitigation of potential hazards associated with the software. IEC 62304 concentrates on the software development lifecycle, process, and documentation. The standard necessitates the classification of software components based on their potential risks, facilitating a targeted approach to testing and validation efforts. This risk-driven approach helps allocate resources effectively, concentrating efforts on the most critical aspects of the software.
Additionally, IEC 62304 requires you to have a plan for verification and validation of software. Different regions may have slightly different requirements. For instance, FDA has published “General Principles of Software Validation” Guidance.” These verification and validation activities are vital for identifying and rectifying bugs, security vulnerabilities, and functional issues. By conducting thorough testing and verification activities, software developers can enhance the performance, reliability, and stability of their products, contributing to an overall elevation in software quality.
Enhanced Patient Safety
Compliance with IEC 62304 plays a pivotal role in elevating patient safety thanks to the rigorous guidelines that mandate a systematic and controlled approach to software development, emphasizing risk management and mitigation strategies. By requiring thorough assessment of potential hazards associated
with medical device software, IEC 62304 ensures that developers identify and address safety risks early in the development process. This proactive approach results in the implementation of appropriate controls and safeguards, minimizing the chances of software-related failures that could jeopardize patient well-being.
IEC 62304’s emphasis on documentation and traceability further bolsters patient safety. The standard mandates comprehensive documentation of software requirements, design specifications, and verification and validation activities. This level of transparency enables regulatory bodies, medical professionals, and device users to thoroughly assess the software’s functionality and safety features. In the event of an issue or concern,
standardized documentation facilitates swift identification of the problem’s root cause, enabling prompt resolution to prevent potential harm.
Additionally, by adhering to IEC 62304, developers create a foundation for ongoing software maintenance and updates, ensuring that any changes are managed
systematically and with patient safety in mind. Overall, IEC 62304’s structured approach to software development and its focus on risk management and
documentation significantly enhance patient safety by reducing software-related risks and facilitating effective issue resolution in medical device software.
Regulatory Compliance
Regulatory authorities worldwide, including the FDA and the European Medicines
Agency, recognize IEC 62304 as a reliable framework for the development of safe
and effective medical device software. By adhering to its standards, developers
align their practices with established industry standards, which simplifies the
process of obtaining regulatory approvals.
One of the key ways IEC 62304 aids regulatory compliance is through its emphasis
on risk- based development and design controls. The level of rigor depends on the
safety classification of the software. This aligns well with regulatory expectations, as authorities often require comprehensive risk analyses to assess the potential impact of software-related hazards on patient safety. IEC 62304’s risk-driven approach not only helps in identifying and mitigating risks but also provides the necessary documentation for regulatory submissions, demonstrating that thorough risk evaluations have been conducted and appropriate controls are in place.
IEC 62304’s structured development lifecycle, which includes phases for software
planning, development, verification, validation, and maintenance, aids regulatory
compliance by providing a clear and consistent roadmap. This ensures that essential development steps are followed and documented appropriately. Regulatory agencies often scrutinize these aspects during the approval process, and adherence to IEC 62304 greatly assists in demonstrating that all necessary
processes have been carried out systematically.
Software Development Planning: This phase involves creating a comprehensive plan for software development that outlines roles, responsibilities, and the overall approach.
Software Requirements Analysis: Identifying and documenting software requirements, including functional and non-functional aspects, lays the
foundation for development.
Software Architectural Design: Designing the software architecture defines
how components will interact and ensures that the software can meet its
intended purpose.
Software Detailed Design: In this phase, detailed design specifications are
created based on the architectural design, providing a roadmap for
implementation.
Software Unit Implementation and Verification: Developers write and test
individual software units, verifying that they meet the defined requirements.
Software Integration and Integration Testing: Units are integrated into a
cohesive whole, followed by testing to ensure they work together seamlessly.
Software System Testing: The entire software system undergoes rigorous
testing to identify and rectify defects.
Software Release: The software is prepared for release, including packaging,
documentation, and any necessary regulatory submissions.
Software Safety Classification
Class A: No Injury or Damage Class – A software failures are unlikely to cause any injury or damage to the patient or user. An example might be a display error that does not affect the device’s functionality.
Class B: Non-Serious Injury – Class B failures could potentially lead to non-serious injuries, discomfort, or inconvenience to the patient or user. An example
could be an incorrect alarm sound that causes temporary stress.
Class C: Serious Injury – Class C failures have the potential to cause serious injuries to patients or users. For instance, incorrect dosage calculations by a medical infusion pump fall under this class.
https://www.jamasoftware.com/media/2024/01/2024-01-25_iec-62304-ebook1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2024-01-25 03:00:462024-01-22 17:16:11An In-Depth Guide to IEC 62304: Software Lifecycle Processes for Medical Devices
G2® Once Again Names Jama Connect® the Overall Leader for Requirements Management Software
Jama Connect® was again named far and away the overall leader in the Winter 2024 G2 Grid® Report for Requirements Management Software!
In addition to the honor of being named the leader in requirements management software, we are proud to showcase that we were awarded several additional medals for Winter 2024 in requirements management, including:
Leader
Enterprise Leader
Momentum Leader
EMEA Leader
Small-Business Leader
Mid-Market Leader
Users Love Us
Download the full report to see why customers love using Jama Connect for product, systems, and software development.
Learn More About the Winter 2024 G2 Grid for the top Requirements Management Software productsHERE!
Jama Software® is honored to be acknowledged as the top requirements management solution. We’re grateful to our customers for sharing their valuable feedback on their experiences using Jama Connect. The “Users Love Us” category, in particular, is a testament to the value our industry-leading requirements management software brings to our customers, and especially for customers who have moved from a document-based approach to complex product, systems, or software developement.
“Product Design teams need a requirements management tool like Jama [Connect.] Using Jama Connect allows our software development team to have a well-organized and well-written set of requirements. It allows us to more easily maintain a baseline of features in our continuously evolving software.”
-From review collected and hosted on G2.com, Mark M. — Mid-Market
We strive to provide our customers with the best experience while using our platform. Being named as Leader in particular shows how much our users enjoy working within Jama Connect.
“Jama [Connect] is the final death blow to your grandfathers way of managing text based requirements.”
-From review collected and hosted on G2.com, Mark M. — Mid-Market
From all of us at Jama Software to all of you, thank you!
G2 scores products and sellers based on reviews, gathered from their user community, as well as data aggregated from online sources and social networks. Together, these scores are mapped on their proprietary G2 Grid®, which can be used to compare products, streamline the buying process, and quickly identify the best products based on the experiences of your peers.
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What is a Software Factory?
A software factory is not a physical factory; instead, it’s a metaphorical one, signifying a structured, systematic approach to software development. It’s based on the principles of manufacturing, where standardization, automation, efficiency, and quality control are paramount. In a software factory, software is produced in a manner akin to an assembly line, where each stage of development follows a well-defined process, ensuring consistency and scalability.
Standardization: Standardized procedures and equipment are the foundation of a software factory. Because of this standardization, the development process is more predictable and controllable since every piece of software is produced using the same set of procedures.
Automation: The software factory model’s foundation is automation. Automation tools are used to speed up development, minimize errors, and reduce manual labor from code generation to testing and deployment.
Modular Architecture: Software factories employ modular architecture in a similar way to physical factories that use interchangeable parts. Reusable components are made possible by this method, which speeds up and simplifies the development of new features or apps.
Quality Control: A software factory must employ continuous integration and deployment (CI/CD) techniques. By using these procedures, code modifications are automatically tested and released, upholding strict dependability and quality criteria.
Collaboration and Communication: Coordinating the efforts of the various teams participating in the development process requires the use of effective collaboration tools and processes. By doing this, it is made sure that everyone is in agreement and that the result meets the intended goals.
Benefits of a Software Factory
Increased Efficiency: By automating repetitive tasks and standardizing processes, a software factory significantly increases the efficiency of software development.
Consistency and Quality: Standardized processes and automated testing lead to more consistent and higher-quality software products.
Scalability: The modular approach and automation make it easier to scale the development process, accommodating more features or higher volumes of software production without a proportional increase in resources or time.
Faster Time-to-Market: With streamlined processes and automation, software factories can significantly reduce the time it takes to bring a software product from concept to market.
Cost-Effectiveness: Although set up requires an initial investment, the long-term benefits of increased efficiency and reduced manual effort result in significant cost savings.
Jama Connect® aids leaders by providing robust requirements and test management, ensuring clarity and alignment throughout the project. With Jama Connect’s Live Traceability™, teams can manage requirements and tests through the systems development process for proven reduction in cycle time and improved product quality.
With the advent of the software factory, software development has undergone a paradigm change from an artisanal, handcrafted approach to one that is more methodical, efficient, and scalable. Organizations can create software more effectively, more cheaply, and with higher quality by adopting the concepts of standardization, automation, modular architecture, quality control, and effective teamwork.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Steven Meadows, McKenzie Jonsson, and Decoteau Wilkerson.
https://www.jamasoftware.com/media/2024/01/2024-1-16-software-factory-2.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2024-01-16 03:00:592024-01-16 10:49:08The Software Factory: A Modern Approach to Software Development
2024 Predictions for Product and Engineering Teams
As Product and Engineering Teams move into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this industry are adapting to meet the challenges posed by these evolving complexities.
We like to stay on top of trends in other industries as well. Read our predictions for Automotive predictions HERE, Aerospace & Defense HERE, Industrial & Consumer Electronics (ICE) HERE, Medical Device & Life Sciences HERE, and SoftTech HERE.
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact product & engineering teams through product, systems, and software development?
Josh Turpen: Software continues to eat hardware. This trend is accelerating in the complex product space, particularly in automotive. This is driving companies to be “agile” but at the cost of quality.
Preston Mitchell: The big trend will be how to focus using the emergent Artificial Intelligence (AI)/ Large Language Models (LLM) solutions so they actually help the team be more efficient or profitable. Plenty of emerging tech in the AI space but remains to be seen how “useful” it will be. There is a huge opportunity to leverage this in ways that are beneficial for teams with the right focus. For example, we’re just starting down this path at Jama Software® with Jama Connect Advisor™, which helps train business analysts/product managers / engineers on how to write their requirements in more concise fashion with less ambiguity.
Biggest Challenges – What are some of the biggest challenges you think product & engineering teams will be working to overcome in 2024?
Turpen: Quality at scale and speed will continue to be a problem. This is exacerbated by the increasing complexity in software.
Opportunities – What are some of the biggest opportunities you think product & engineering teams should be considering in 2024?
Mitchell: Automation. Consider where automation can reduce the complexity and time needed to deliver large scale products. I’ve worked with hundreds of companies that build very complex products and I’m still amazed at how many of their internal processes are manual. AI will certainly be the 2024 buzzword – but currently most AI tools are still beta and rely on a human to prompt for an answer – not exactly automating a repeatable process. When I mean automation opportunity I’m talking about the low-hanging fruit of manual business processes – for example, automating task links between multiple engineering tools.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Turpen: Companies that seek to identify risks (not just in products, but in process) will come out on top. Anti-fragile product development pipelines are the logistical super-power for the next phase of product development.
Tool Innovation – From a product & engineering toolset perspective, what are some of the processes you think forward-thinking organizations will be working to leverage or incorporate into their process and why?
Turpen: Moving from the individual engineer to the team/product pipeline will give management the opportunity to intervene early to reduce risk. Products that are focused on a best-of-breed world will give companies a leg up on legacy vendors and their suite approaches.
Mitchell: Forward-thinking orgs will adopt data-driven assessment of the product development lifecycle. Today there are no generally accepted measurements of Research and Development (R&D) efficiency. It’s hard for organizations to predict if a product will be delivered on time and without defects. Launch delays and regressions are common and almost generally accepted. Organizations commonly measure a product’s performance after it is launched (revenue, profit, adoption.) Why don’t we measure what happens before it is launched? Why don’t we measure the R&D lifecycle? Forward thinking orgs will adopt ways to measure their development lifecycle to they can better predict success or failure…and some may not like what they find.
Cybersecurity – What role will cybersecurity play in product & engineering development in the coming year and beyond?
Turpen: Cybersecurity will be baked into requirements and, therefore, products for everything from thermostats to ADAS.
Survival Factors – In your opinion, what are the biggest differences between product & engineering companies that will survive to see 2030, and ones that don’t?
Turpen: Agility tempered with quality will be the common trait of survivors. We’re already seeing companies get slapped with criminal charges based on their inability to see and manage risk.
Mitchell: With the hot economy and low interest rates before recent inflation there was a lot of investment in new startups and emerging technologies — think self-driving cars and AI. The economy is still doing well, but tempered with higher interest rates, so the investors of years past are looking for a return on their prior investment and will be more tempered with any new bets they place. The companies that survive to see 2030 will be the ones that find clear use cases that people are willing to pay for in these emerging technologies. New products and tech just “because it’s cool!” will not survive without a commercialization path.
Advice – What advice would you give to new product & engineering teams entering the market?
Turpen: Move fast and KNOW what you’re going to break.
Mitchell: Ask questions and seek advice from your peers or mentors who have built something before in your industry. Determine who your ideal “first customer” would be and work hard to speak with them, show them your early prototypes, and validate your assumptions about what they need.
Emerging Topics – What topic(s) do you wish companies were paying more attention to?
Turpen: Management of the engineering process.
Mitchell: Solving very easy efficiency problems in the engineering process like automating flow of data between disparate systems. I just spoke with a customer whose testers were redundantly logging defects in two different systems! Come on! Set aside some time to automate that process!
Identifying Mistakes – What is the biggest mistake you see product and engineering teams making right now?
Turpen: Throwing money at hard problems with little understanding of success and no management of the outcome.
Mitchell: Assuming a tool will solve their problems. Process first, then tool.
Innovation – What is the most innovative thing you’ve seen with product and engineering teams this year that you anticipate other companies following suit in coming years?
Turpen: Moving away from the “big meeting” to an asynchronous, stateful collaboration process.
Predictions – What do you think will remain the same in your industry throughout 2024?
Turpen: Companies who think the answer to their engineering process problems is a monolithic tool will continue to lose ground and engineers to their competitors.
Do you think there will be any major disruptors for product & engineering teams in the coming year? How do you think it will impact the industry?
Turpen: We’ll see the first set of major Intellectual Property (IP) lawsuits based on uncontrolled LLM. This will force companies to think about security and IP protections in their own AI development.
Mitchell: This will not happen in one year, but I foresee AI solutions replacing the need for traditional learning assets like static help guides, training videos, and maybe even support sites. Users don’t need to read a help guide, watch a tutorial, or submit a support ticket if an AI assistant is guiding them in the process and available for quick questions. Effort to build those types of traditional learning assets will be redirected to investments in AI assisted “on the job” learning while using the product.
What do you predict for product & engineering regulations in 2024?
Turpen: A continued increase in the importance of security/safety regulations in the automotive/medical industries with more penalties for poor performance.
Will those trends still be prevalent 5 years from now? 10 years?
Turpen: Yes, this is an area that will only grow in complexity and impact.
https://www.jamasoftware.com/media/2024/01/2024-1-11-2024-product-and-engineering-predictions-2.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2024-01-11 03:00:472024-01-12 18:27:472024 Predictions for Product and Engineering Teams
In this blog, we recap our webinar, “Critical Alignment for Security, Safety & Product Development Team” – Click HERE to watch it in its entirety.
Critical Alignment for Security, Safety & Product Development Teams
Break down silos to unite teams for the future of vehicle technology!
Safety, security, and development teams tend to work in silos due to differing objectives, tooling, and methodologies; historical contexts; educational backgrounds; and even fundamental terminology.
The increasing interconnectivity of vehicles makes it hard to separate safety and security from development. In the complex world of software, teams must break down silos, foster collaboration, and streamline documentation to ensure agile development and adapt to evolving demands.
In this webinar you will learn:
Why it’s important to have compliance teams speaking the same language
What we’re seeing and expecting from the industry to bring these specialized teams closer
How to keep security, safety, and development teams aligned using Live Traceability™
How to avoid rogue development and keep track of progress with Traceable Agile™ practices
Discover how Jama Connect® can empower Automotive and Semiconductor development teams to improve their end-to-end lifecycle and avoid costly rework.
Below is an abbreviated transcript of our webinar.
Kevin Dibble: I’d like to talk about the agenda for today and focus on the word alignment because that’s where we’re going to cover how we bring together cybersecurity teams, safety teams, product development teams, and even project management.
There’s a lot of siloing and opportunities in organizations for these specialized groups to work separately. But we’re going to talk about the importance of bringing these teams together and show some enabling technologies around live traceability and traceable Agile practices. So that’s the focus for today. But first, let’s start with the problem, and I want to isolate safety and security to begin with. So how are teams working today in these two functional areas?
With the puzzle piece in the middle, I’m trying to communicate that these teams want to work together, but the puzzle doesn’t quite fit yet. So let’s look at some of the underlying reasons why.
First, with functional safety, the standards for functional safety in automotive, ISO 26262, has been around since 2011, and the safety work’s been around even longer than that. So for OEMs, tier ones, and even some tier twos, the organizational competency, processes tool, the culture of safety are quite mature.
But on the right side, we have cybersecurity, which in automotive is a new discipline, with new standards, new audits, and assessment requirements, and requirements coming very rapidly from OEMs and tier ones worldwide.
Dibble: These teams are going through training. The processes for doing product development according to standards like ISO 21434 are new or in development still. The discipline itself is new and transforming out of IT security. And so this helps to understand perhaps some of the underlying factors of why these teams might be working separately or not working exactly on the same page.
Which leads to a silo situation. And I’ve got functional safety on the right and cybersecurity on the left. Both of those standards and both of those disciplines require automotive V-Model development, with strict requirements for documentation, quality, and compliance with the V-Model.
And so what’s happening is that the organizations pulling together these disciplines along with product development are doing some sharing in risk analysis, and basically handing requirements to product development teams, and not yet in a stage where they’re fully collaborating. And that presents some problems. And it adds some risk.
A couple of examples here are both safety and security risk-based standards for understanding how we mitigate the risk of something wearing out like hardware or defects that could cause safety issues on the one. And then on the cybersecurity side, how do we mitigate the risk of an attacker using a threat to infect or change the behavior of a system?
The controls or the mitigations for those two types of risks might result in conflicting requirements. For example, how to handle a communication channel, and I’ve given you an example right here.
Those two teams have to work together along with product to solve those differences, as well as to build an integrated system that at the end of the product release cycle we’re not finding surprises in terms of conflicting requirements and implementations that don’t work together cohesively. And so that’s one of the areas cyber and safety silos can cause problems.
Dibble: Now, we’ve heard about safety issues, recalls, and unfortunately crashes and fatalities for years. But I want to highlight some of the things that are being written in the press even recently about the threats that cybersecurity is now trying to address. From taking control of fleets of vehicles to shutting down production lines to causing safety-related hazards potentially, these are very real threats, and this is why the industry is moving so quickly to adopt the new cybersecurity standard.
To be able to tie together the disciplines of safety and security as well as product development, communication is critical. These safety analysis and threat analysis can’t happen in a vacuum. The teams have to work together, and this is where that alignment concept becomes so important.
Also, both these standards, 21434 and ISO 26262 require the establishment of communication channels between safety, security, and other disciplines like quality. So the developers of these standards certainly were aware of the need for these teams to talk and to achieve alignment.
https://www.jamasoftware.com/media/2024/01/Copy-of-compliance-made-easy.png5121024Jama Software/media/jama-logo-primary.svgJama Software2024-01-10 03:00:332024-04-05 13:30:52[Webinar Recap] Critical Alignment for Security, Safety & Product Development Teams
2024 Predictions for Soft-Tech Product, Systems, and Software Development
As the SoftTech sector moves into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this industry are adapting to meet the challenges posed by these evolving complexities.
In part five of this six-part series, we asked our own industry experts Patrick Garman – Principal Solutions Consultant, and Steven Meadows – Principal Solutions Lead, to weigh in on the SoftTech trends they’re anticipating in the coming year and beyond.
We like to stay on top of trends in other industries as well. Read our Automotive predictions HERE, Aerospace & Defense HERE, Industrial & Consumer Electronics (ICE) HERE, Medical Device & Life Sciences HERE, and Product & Engineering Teams HERE.
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact SoftTech development?
Patrick Garman: With the increased awareness and popularity of tools like ChatGPT, Generative AI and its potential applications in product development and requirements management has come up often in conversations with customers. Common questions include: can AI suggest ‘missing’ requirements, suggest relationship links for existing requirements, or even generate a full set of requirements based on similar products or projects? These are interesting questions, and I can certainly see the potential value that AI could add, but softtech companies should be wary of automating too much of their requirements management and product development processes. Generative AI might be able to provide suggestions or at least a starting point for requirements, but it cannot and should not replace human review and insights.
Steven Meadows: Artificial Intelligence (AI) is evolving at an unprecedented rate and the continuation of the application of AI in software development is no exception. More tools and libraries are being built to help support the automation of development tasks, including coding and test automation. Developers are now able to create more intelligent and user-centric systems, which ultimately improves the stakeholder experience. Over the next few years, I anticipate that we’ll start to see more AI-based applications that will help teams debug code and fix bugs in real-time.
In terms of requirements management in the software world, we’re seeing AI and machine learning assist with tasks such as requirement generation. This will continue to help shape better-quality systems with fewer issues for users. Models in this area are still being improved, but we are already seeing the benefits of AI bringing better-quality systems to market.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Garman: Data privacy still looms large in SoftTech and is top of mind for consumers. A 2020 Pew Research study indicated that half of U.S. consumers have not used a product because of privacy concerns. While the European Union acted several years ago by introducing GDRP, the United States has shied away from federal regulation – focusing on specific classes of data (health and financial) and users (children). Traction for data privacy regulation at the state level is gaining speed, though. California introduced the California Privacy Rights Act in 2019, laws are being enacted in Virginia, Colorado, Utah, and Connecticut this year, and eight more states have signed data privacy legislation, with another six currently debating the issue. With the continued growth of connected devices and cloud services, and the emergence of advanced AI, I predict even more attention will be directed to how tech companies collect and use consumer data. To prepare, forward-looking tech companies will take a cue from companies like Apple and take a more proactive ‘self-regulating’ approach to data privacy in their product design.
Meadows: Keeping with the theme of AI, I anticipate that there will be new regulations coming out affecting the application and use of AI in software. Governments and state entities have made it clear that further regulation of AI is coming, so it’s only a matter of time.
It’s clear to see that there have been instances of biased results being produced by AI systems. For example, credit card algorithms that discriminate based on sex and other factors. Algorithms have also been developed that target people based on race, religion, and gender.
It’s unclear if there will be mandates on the particular use of training data as part of a model’s learning phase or whether limitations will be placed on the types of models used. One thing is for certain though – further regulation of AI in software is coming!
Tool Innovation – From a SoftTech industry engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process, and why?
Garman: While it might seem like a step back for some, I think there is a strong movement in software development to find a better balance between planning and implementation activities. Many companies take Agile to mean ‘just go do’ — start writing code as quickly as possible, release to customers early and often, learn lessons on the fly, and incorporate feedback rapidly. That’s certainly part of Agile and a great ideal to strive for, but in practice, it is very difficult to incorporate customer feedback into iterative releases quickly enough. In other words, it’s easy to ‘fail fast’ but very hard to ‘course correct fast.’ That’s not the fault of software teams; there is a lot of pressure to deliver an ever-growing backlog of features and stories, and prioritization is difficult to manage when business objectives and market demands can change overnight! Applying more diligence to the planning activities – defining and getting agreement on requirements before ‘just going and doing’ – goes a long way towards improving software teams’ ability to actively prioritize their backlogs, feel confident that what they are doing is the right thing to be doing, and reduces the amount of rework or technical debt that must be addressed post-release. Adopting a requirements management tool that supports an agile approach will add tremendous value in SoftTech development.
Meadows: Software companies continue to adopt, and rightly so, an Agile work culture and methodology. Forward-thinking Agile teams must be prepared to adapt to challenges that can hinder quality development for their customers. Task management tools like Jira and Azure DevOps (ADO) have become standard ways to manage work including the prioritization of activities, project management, and resource allocation. One aspect of development that is very much neglected is requirements management. Development teams need to be able to effectively communicate with business analysts, product owners, architects, and their own customers, as well as understand whether requirements have been satisfied in real time.
Without a dedicated and purpose-built requirements management system, silos are created in terms of data and teams, leading to systems produced with more defects and lower quality. Forward-thinking- teams should be adopting a requirements tool tightly coupled with their task management applications for effective end-to-end visibility throughout the development cycle, catching issues and mitigating risk earlier in the development lifecycle.
What role will cybersecurity play in soft-tech industry development in the coming year and beyond?
Garman: Cybersecurity is perhaps the most important consideration for product development in SoftTech. The convenience of connected devices will continue to drive consumer demand – even my dishwasher connects to the internet! However, this convenience comes with the risk of data breaches and network vulnerabilities. Encrypting data during transmission and storage is just table stakes now. SoftTech companies must be ready to move much faster than in the past to push software and firmware updates in response to new vulnerabilities. The ability to quickly generate impact analyses and trace- identified risks and vulnerabilities to the mitigating requirements is more important than ever in taking a proactive stance toward cybersecurity.
In your opinion, what are the biggest differences between SoftTech companies that will survive to see 2030, and ones that don’t?
Garman: Technical debt is becoming a much larger liability for SoftTech companies as the rate of innovation continues to accelerate – the more technical debt a SoftTech company builds, the harder it will become to quickly respond to emerging trends and innovations. We see it more and more often – once the better mouse trap is available, it becomes the expectation, not the nice to have. Of course, decisions must be made to address near-term or immediate needs and there will always be trade-offs to consider to optimize ROI. SoftTech companies that design and develop their products to not only to fulfill the near-term needs while maintaining the architectural flexibility to adopt future trends will be the ones to keep pace with consumer expectations and win in the long term.
What advice would you give to new companies entering the SoftTech industry?
Garman: Embrace design thinking and avoid jumping too quickly to a solution. This applies if you are a new company or an established company entering a new market. SoftTech products can become commodities very quickly – it’s easier than ever to just copy/paste an existing solution – but that will ultimately only drive prices down as more options are available to consumers. Design thinking is a great framework for requirements management. Start by really defining the problem or needs that your product intends to resolve and also defining the user needs for your target market. User needs are the foundation for good requirements, and good requirements are the foundation for successful products.
What topic(s) do you wish companies were paying more attention to?
Garman: Refocus on user experience. MVP is commonly defined as “Minimum Viable Product,” but I strongly prefer “Minimum Valuable Product”– in other words, instead of designing through the lens of ‘what is the least we can deliver so that a user can accomplish this task or goal,’ adopt a mindset of ‘what is the least we can deliver so that a user has a good experience in accomplishing this task or goal.’ Designing for good user experience does not limit the return on investment (ROI) – in fact, it leads to higher lifetime value through customer loyalty and goodwill.
What is the biggest mistake you see companies in the soft-tech industry making right now?
Garman: I mentioned earlier that I see the trend of software teams re-prioritizing requirements management and planning activities in advance of development activities, and that is in direct response to the issues and pain points that SoftTech companies have experienced as they adopt a ‘just go do’ approach to product development. One of my grad school professors claimed that an 80/20 ratio of planning to doing was the ideal. Every company will need to find its own balance, but the data is clear – companies that apply diligence in requirements management are faster to market, expend less time and resources in the actual development phase, and experience fewer defects after release.
Do you think there will be any major disruptors in the SoftTech industry in the coming year? How do you think it will impact the industry?
Garman: At the risk of sounding like a broken record, advancements in artificial intelligence. The potential applications are tremendous! I’ve mentioned the potential for using AI to develop products. In the short term, we’ll likely see more soft-tech companies employing generative AI for product support and predictive process automation. Conversational AI will also change the way we interact with software and connected devices. The market for voice assistants has a projected CAGR of nearly 27% over the next eight years and hands-free devices are projected to have a 7% CAGR over the next five years – and that is based on the current task-based commands that are supported. As consumers continue to adopt smart home devices, the expectations for hands-free control will only increase.
What do you predict for regulation in the SoftTech industry in 2024?
Will those trends still be prevalent five years from now? 10 years?
Garman: I’ve already discussed data privacy regulation, and I do think that the federal regulations will be expanded in the United States in the coming years. Regulation for AI – specifically generative AI – is likely next, but what will be enacted and how is still an open question. The two topics are linked in that generative AI produces content based on existing inputs, generally user data and public-facing IP. AI and advanced machine learning have tremendous potential, but aside from data privacy concerns, AI also introduces safety risks. We are already seeing the implementation of functional safety standards in robotics, and as autonomous robots continue to advance, we will likely see increased regulatory oversight. No one wants the rise of Skynet!
https://www.jamasoftware.com/media/2023/12/ae4b613d-2906-40d0-b83f-71f65f854007.jpeg512986Jama Software/media/jama-logo-primary.svgJama Software2024-01-04 03:00:202024-01-17 17:12:392024 Predictions for SoftTech Product, Systems, and Software Development
2024 Predictions for Medical Device & Life Sciences Product, Systems, and Software Development
As the medical device & life sciences industry transitions into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this sector are adapting to meet the challenges posed by these evolving complexities.
In part four of this six-part series, we asked the following industry experts to weigh in on the medical device & life sciences product, systems, and software trends they are anticipating in the coming year:
We like to stay on top of trends in other industries as well. Read our Automotive predictions HERE, Aerospace & Defense HERE, Industrial & Consumer Electronics (ICE) HERE, SoftTech HERE, and Product & Engineering Teams HERE.
2024 Predictions for Medical Device & Life Sciences Development
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact medical device & life sciences development?
Shawnnah Monterrey: We are seeing a significant increase in healthcare innovations, especially with in-vitro diagnostics, and clinical decision support software.
The ability to connect medical devices to share medical device data through emergence, evolution of cloud computing, and the increase in data storage capability has led to the derivation of new clinical insights, in diagnostics, and clinical decision support. Artificial Intelligence (AI) and Machine Learning (ML) are being applied to clinical and patient data in unique and novel ways, such as in-vitro fertilization, cancer treatment recommendations, and the automation of status-quo manual clinical processes.
The increase in research allocated to understanding our DNA, and its relationship on our health, has led to the rapid adoption of DNA-based clinical tools utilizing next-generation sequencing and other DNA detection technologies such as DNA nanotechnology tools, chip-based digital Polymerase Chain Reaction (PCR) detection, Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) diagnostic technology, etc. to aid in the diagnosis and treatment of complex diseases such as cancer, neurodegenerative diseases and dementia and even behavioral, and psychiatric disorders.
Vincent Balgos: As we’re seeing in other industries, a common trend in the medical industry is that organizations are refreshing their internal processes to scale, integrate, and increase efficiency. With extrinsic pressures (market, financial, and regulatory), there is continual effort to optimize organization activities, specifically around product development processes, and leverage previous work as much as possible.
Biggest Challenges – What are some of the biggest challenges you think medical device & life sciences companies will be working to overcome in 2024?
Monterrey: A few of the biggest challenges companies will face in 2024 include but are not limited to:
Being competitive and innovative in a highly regulated environment
Understanding regulatory requirements in new or less mature regulated areas
Obtaining funding to support regulatory and development efforts
Companies who are focused on aligning their product roadmap with a sound regulatory strategy will not only unlock funding but obtain revenue faster, which will allow them to leap ahead of the competition.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Monterrey:U.S. Food & Drug Administration (FDA) is not known to be fast, but within recent years, the FDA has released a record number of guidances and have even changed the medical device regulation in a few areas. While the industry is playing catchup on hundreds of new guidances in areas such as:
Software as a Medical Device (SaMD)
Cybersecurity
Clinical Decision Support Software
Mobile Applications
The FDA is working on furthering the regulation and guidance around many areas including, 510(k) Third Party Review Program, In Vitro Diagnostics (IVDs), AI/ML, and the use of real-world and simulated data in pre-market submissions.
It would be wise for companies to start understanding and applying new draft guidances that are relevant to their products in advance of the final draft. Once a final version is issued it could drastically interrupt your product development and launch plans.
Balgos: There are a few regulations that will start or continue to have an impact on the industry:
FDA’s Final Guidance on Cybersecurity for Medical Devices – Continuing the focus on Software (SW) in previous years, this new final guidance will require ongoing discussions on the new security requirements (ex: Software Bill of Materials (SBOM)), activities, and expected documentation.
FDA’s proposed ruling on Laboratory Developed Tests (LDT) – In the latest turn of events in this long running topic, this new proposed rule to transition away from Enforcement Discretionary (ED) to more explicit LDT oversight by FDA will have significant impact to the laboratory industry. Industry feedback has been active and complex, so will be interested to see if there will be a resurgence of the previous VALID Act or will the new proposed ruling stand as is.
Based on FDA’s proposed 2024 list of prioritized guidances, there will be additional information around AI/ MLin context of lifecycle management, pre-submissions, and change management considerations.
In the EU, both the Medical Device Regulation (MDR) and In-Vitro Dianostics Regulation (IVDR) will continue to impact companies as they transition to these new rulesets. Even with the time extension on MDR, companies are continuing to struggle in converting their processes to comply with the new regulations as 2024 rolls out.
Romer De Los Santos: The FDA just released the final guidance on cybersecurity in medical devices that includes additional tasks and deliverables that medical device manufacturers must start to implement. Design and development procedures for software that is part of or is a medical device itself will need to be updated with this new guidance in mind. Software Bill of Materials (SOBM), security risk assessments, threat modeling, and consideration of the entire lifecycle for security risks and mitigations are just some of the things that are required in today’s interconnected world.
Tool Innovation – From a medical device & life sciences engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?
Monterrey: Product development costs, regulatory complexity, and time-to-market are all increasingly trending topics in the medical device industry. Companies that are thinking ahead of these trends are focusing on their competitive advantage, which includes their innovation or core Intellectual Property (IP) and leveraging the support of industry experts and built–for–purpose tools.
This includes:
Investing in existing regulatory and quality management frameworks, including software, built-in processes, and training
Hiring regulatory and quality experts who understand the regulatory landscape and have domain expertise related to their products
Integrating medical/clinical grade or complaint platform software, components, and development tools
De Los Santos: Firms will need to leverage tools like Jama Connect to start to track security risks, SBOM, and the documentation for a multitude of software variants, upgrades, and patches. While the tools enable compliance with regulatory requirements, medical device manufacturers need to create a robust and lightweight design and development process that leverages the capabilities of their tools. For many firms, this means looking at the total development lifecycle holistically instead of tacking on quick fixes to their procedures to meet current regulatory requirements.
What role will cybersecurity play in medical device & life sciences development in the coming year and beyond?
Monterrey: Per the current FDA guidance, obtaining per-market approval/clearance for a medical device with firmware or software, connected, or not connected all require some level of cybersecurity compliance, especially around risk management. This has put an extra strain on medical device manufacturers because the guidance is very technical and rigorous and currently does not provide guidance around the level of application based on the risk of the device. I hope to see a future revision that accommodates lower risk devices, but for now it’s worth investing in cybersecurity experts who can help you certify your device and associated processes.
Balgos: As noted in a recent FDA webinar around cybersecurity, there is continual discussion in how to regulate this topic, and the expected deliverables to the agency. One area is SBOM and how to properly document all the elements of software for a medical device.
De Los Santos: Cybersecurity will play a starring role as manufacturers start to revise their design and development processes to include it.
In your opinion, what are the biggest differences between medical device & life sciences companies that will survive to see 2030, and ones that don’t?
Monterrey: Those who survive to see 2030 will respect the regulatory landscape and put in place proper attention and investment, instead of those trying to delay, resist, or evade the inevitable. Although it might not feel like it, the changes being put in place are to our benefit, with the intent of providing the industry with a clearer pathway for new innovations. It will just take a while for the regulations to harmonize and for the industry to adopt to the new ways of thinking by leveraging data, tools, and expertise to rapidly innovate.
De Los Santos: Companies that are adaptable and innovative with not only their products, but their design and development process will survive to see 2030.
What advice would you give to new companies entering the medical device & life sciences industry?
Monterrey: Build your product for the industry – align your product development efforts with your business model and regulatory strategy and do not try to obtain premarket approval for your device without the support of experts in the industry unless you have done so successfully before.
De Los Santos: Keep it simple.
What topic(s) do you wish companies were paying more attention to?
Monterrey: I wish more companies would focus on defining their regulatory strategy early in the development lifecycle and not wait until they have only six months or less to start thinking about getting their device approved or cleared. Depending on the complexity of your device, regulatory compliance efforts could take 12-36 months, with most of the efforts around verification and validation. Six months prior is often too late and could be detrimental to your business launch plans that do not meet your stakeholder expectations.
De Los Santos: I wish companies would focus on fixing their process problems instead of patching them. A little more front-end work will save future teams lots of time.
What is the biggest mistake you see companies in medical device & life sciences making right now?
Monterrey: Two biggest mistakes I see are:
Trying to make a medical device not a medical device, even though it is a medical device
Not narrowing down a product’s intended use for the first launch
Balgos: Cutting corners for short-term gain, but in reality, these cuts will actually cause long-term consequences exponentially. Example: Documentation. Time and time again, our technical customers (and from my own personal experience) are being pressured to get products out the door and do the documentation later. There are several issues with that: 1) technical documentation and files are required for regulatory submissions for market clearance, 2) this generally conflicts with most good Engineering and Quality practices as they will need time for review/approval, and 3) it’s much harder to document something long after it’s happened. These issues culminate in taking much longer to complete the documentation, and thus impacts the long term.
De Los Santos: Companies should not make their procedures more complex than they need to be.
What is the most innovative thing you’ve seen in medical device & life sciences this year that you anticipate other companies following suit in coming years?
Monterrey: The most innovative things I have seen is the creative use of simulated and real-world data to support pre-market approval and the novel application of AI, which uses data from multiple unrelated devices to diagnose, treat, or support various diseases and medical conditions. I am seeing more products provide a technology platform for multiple intended uses. Companies that are successful, understand the long game and focus on the easiest-to-launch intended use first, generate revenue, and then focus on further product applications, including innovations that require a more rigorous regulatory pathway.
Predictions –
What do you think will remain the same in your industry throughout 2024?
Monterrey: I think 2024 will be a very innovative year meaning there are more changes to come, and we will continue to see new and novel clinical innovations continue to disrupt the industry. 2024 is going to be an exciting and unprecedented year!
Do you think there will be any major disruptors in medical device & life sciences in the coming year? How do you think it will impact the industry?
Monterrey: Major disruptors will come from those focusing on diseases and conditions that have previously been ignored or neglected. One area I would like to see advance is the use of software as a therapeutic as opposed to prescription pharmaceuticals, devices, or surgery. Because of limitations in reimbursement and the non-traditional use of software as a therapeutic device, this area has experienced challenges which has delayed its adoption.
Balgos: The emergence of AI/ML has the potential to become an industry disruptor, dependent on its application or intended use. We can see its impact already in non-medical software, so it is only a matter of time before its influence is felt in the medical industry. Hence, there are continual discussions from FDA, industry bodies and experts, in how to regulate, develop and manage AI/ML for medical devices.
What do you predict for regulation in the medical device & life sciences industry in 2024?
Will those trends still be prevalent five years from now? 10 years?
Monterrey:As I stated last year, I still see progress around the harmonization of guidances and standards, which will eventually allow for a more standard way to approach pre-market approval — but I stated previously, this will be messy and complex before it clears itself out. I primarily see the increased use of simulated and real-world data as a new way to validate devices. Animal and in-human use will decrease, and publicly available and validated datasets will become available to quickly assess new medical devices for safety and efficacy.
https://www.jamasoftware.com/media/2023/12/2023-12-28-2024-medical-predictions.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2023-12-28 03:00:452024-01-17 17:20:552024 Predictions for Medical Device & Life Sciences Product, Systems, and Software Development
2024 Predictions for Industrial and Consumer Electronics (ICE) Product Development
As the Industrial and Consumer Electronics (ICE) sector moves into 2024, we aim to gain a deeper insight into the factors driving transformation in the development of products, systems, and software and explore how teams within this sector are adapting to meet the challenges posed by these evolving complexities.
In part three of this six-part series, we asked our own industry expert Steven Meadows – Principal Solutions Lead at Jama Software®, to weigh in on the ICE product, systems, and software trends he’s anticipating in the coming year and beyond.
We like to stay on top of trends in other industries as well. Read our predictions for Automotive predictions HERE, Aerospace & Defense HERE, Medical Device & Life Sciences HERE, SoftTech HERE, and Product & Engineering Teams HERE.
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact ICE product development?
Steven Meadows: The Internet of Things (IoT) continues to remain at the forefront of development across consumer electronics manufacturing. ‘Smart’ products like home security systems, laptops, kitchen appliances, and tablets are manufactured with an increasing number of sensors and inputs that transfer data to different networks and applications. With more complex and integrated systems, the need for digital product development tools to ensure product quality is becoming increasingly important.
We’re seeing a shift in oil and gas companies managing requirements from documents to digital solutions. Increasingly complex projects that incorporate the setup of facilities and adherence to multiple standards have made this shift a priority.
Cloud computing, as we wrote about last year, continues to grow across the software industry. Cloud is the golden standard, allowing for more flexible, cheaper, and sustainable solutions. More and more companies increasingly rely on cloud computing for projects and daily activities without the need for managing system administration, upgrades, and security.
Biggest Challenges – What are some of the biggest challenges you think ICE companies will be working to overcome in 2024?
Meadows: Artificial Intelligence (AI) has been at the forefront of development for years and continues to evolve, allowing for more automation, self-maintenance and diagnosis, and other areas which have improved end products.
One challenge I see for industrial and consumer electronics companies to remain competitive is incorporating AI in their products to help with less costly maintenance and production lines. AI-assisted firmware development will help with this.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Meadows: I have attended several conferences this year across different industries and it’s safe to say that more regulatory guidelines around artificial intelligence will be released and impact companies in 2024. This will certainly have an influence on product development and what companies can include in their products. It will be interesting to see what guardrails the government and other entities will enforce.
Tool Innovation – From an ICE engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?
Meadows: We’re seeing several trends across industrial and consumer electronics development. Companies at different scales, from startups to large enterprises, are placing a greater emphasis on maturing effective internal development processes and tools.
Requirements authoring has often been challenging for teams with differing experiences. Poorly defined requirements often lead to poor products and systems, more defects in the field, and costly recalls. Companies are embracing AI and machine learning in their toolset to help teams author better-quality, less ambiguous, and easily testable requirements. By applying the industry’s best-known methods for evaluating and recommending improvements across requirement statements, including the Easy Approach to Requirement Syntax (EARS) and International Council on Systems Engineering (INCOSE) guidelines, companies are noticing significant improvements with products being shipped to customers.
Our customers continue to see the value in shifting their product development process, enabled through a document-centric process, to a modern digital solution. With Live Traceability™ – and all development artifacts housed in a single source of truth inside Jama Connect® – development teams benefit from a real-time view of related artifacts and development activities. This is enabling our customers to reduce risk early on, speed time to market, as well as improve product quality.
What advice would you give to new companies entering the ICE industry?
Meadows: Make sure you place an emphasis on solid product development processes and tooling early on, even at the prototype stage. Your ideas may be great but unless you have an effective development process defined early on with the right tools to enable it, your products will ultimately suffer, and you’re introducing unnecessary risk.
https://www.jamasoftware.com/media/2023/12/2023-12-21-2024-ice-predictions-2.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2023-12-21 03:00:142024-01-17 17:26:052024 Predictions for Industrial and Consumer Electronics (ICE) Product Development
2024 Predictions for Aerospace & Defense Product, Systems, and Software Development
As the aerospace & defense industry advances into 2024, we aim to gain a deeper insight into the factors propelling transformation in the development of products, systems, and software, and explore how teams within this sector are adapting to meet the challenges posed by evolving complexities.
Jama Software® asked selected thought leaders — both internal Jama Software employees and our external partners — across various industries for the trends and events they foresee unfolding over the next year and beyond.
In part two of this six-part series, we asked the following industry experts to weigh in on the aerospace & defense product, systems, and software trends they are anticipating in the coming year:
We like to stay on top of trends in other industries as well. Read our Automotive predictions HERE, Industrial & Consumer Electronics (ICE) HERE, Medical Device & Life Sciences HERE, SoftTech HERE, and Product & Engineering Teams HERE.
Design Trends – What are the biggest trends you’re seeing in your industry right now? How will they impact aerospace & defense product, systems, and software development?
Francois Couadau: There is a lot of attention, both in academia and within the industry, around Artificial Intelligence (AI) / Machine Learning (ML.). These technologies promise many exciting applications, such as single-pilot operations for cargo and commercial flights or supercharged Intelligence, Surveillance, and Reconnaissance (ISR) capabilities for the defense sector. They have a long way to go before they’re certified for flight, but experiments are everywhere.
Guilherme Goretkin: Big trends towards more modular and loosely coupled architectures with open systems approaches like Modular Open Systems Approach (MOSA) and PYRAMID Reference Systems (PRA) utilizing open publicly available interoperability standards like Future Airborne Capabilities Environment (FACE) and ARINC 661 with the goals of reducing program risk, more software interoperability, reuse, and better sustainability.
Cary Bryczek: The biggest design trend is figuring out ways to incorporate AI into systems and products in a safe way.
Karl Mulcahy: I’m also seeing a need to work together as a consortium to deliver a product for an end customer. It’s fascinating to see how companies are approaching this, and working together across different networks, countries, and even industries.
Biggest Challenges – What are some of the biggest challenges you think aerospace & defense companies will be working to overcome in 2024?
Couadau: In the avionics projects domain, growing complexity and ever-shorter timelines go hand in hand and are the main challenge.
Bryczek: The biggest challenges are protecting against intellectual property (IP) loss and preventing security incidents from adversaries. Both the United States and European countries defense organization have set forth mission statements to protect technology advantage and counter unwanted technology transfer to ensure warfighter dominance through assured, secure, and resilient systems and a healthy, viable innovation base.
Mulcahy: On top of IP protection like Cary mentions, I believe there is a desire to modernize ways of working to help drive efficiencies in existing operations, but also to attract / retain new and emerging talent. By having best–of-breed tools, it can help attract best-of-breed talent and facilitate an easier way to realize innovation.
Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?
Couadau: In keeping with the trends, AI/ML is currently not certifiable due to lack of specialized standards. Standardization efforts are ongoing, and we should see the first documents emerge soon.
Unstable global geopolitics may also play a part. Sanctions and embargoes may change the shape of markets.
Goretkin: Cybersecurity. “DoD [Departement of Defense] policy generally requires all acquisitions containing mission-critical or mission-critical IT systems to have a cybersecurity strategy” – GAO-23-106059 Weapon Systems Annual Assessment June 2023
Bryczek: In the US the Department of Defense will continue providing more guidance on its 2023 DoD Cyber Strategy. In 2024 you will see more guidelines provided to Defense Components as well as instructions in contracts to encourage the increase of collective cyber resilience by building the cyber capability of allies and partners. Lessons learned from the war in Russia-Ukraine has sparked commentary from Assistant Secretary of Defense for Space Policy John Plumb to say. “It has driven home the need to work closely with our allies, partners, and industry to make sure we have the right cyber capabilities, cyber security, and cyber resilience to help deter conflict, and to fight and win if deterrence fails.”
Mulcahy: With sustainability a renewed global focus, especially with recent initiatives such as the 28th meeting of the Conference of the Parties (COP28), more focus will be turned to sustainability, efficiency, and developments in greener technology such as electronic / hydrogen / hybrid airborne travel. It’s exciting to see many start-ups in this domain.
Maybe we’ll see something around unmanned aerial systems regulations come to fruition – again with the increase of use cases in civilian / defense markets for these unmanned aerial vehicles (UAVs.)
Tool Innovation – From an aerospace & defense engineering toolset perspective, what are some of the processes you think forward-thinking firms will be working to leverage or incorporate into their process and why?
Couadau: Model-Based System Engineering tools and methods are continuing to mature and are a key pillar for complex aerospace projects. Generative AI, applied at key spots during design, is also a key design accelerator.
Bryczek: Forward-thinking organizations will be focusing their processes and supporting tools around these areas of systems engineering: Digital Engineering, Modular Open Systems Approach (MOSA), Agile DevSecOps Development, and Mission Engineering (ME). Each of these areas touch aspects of systems engineering lifecycle management and require tools to support the newer techniques. Data integration across disparate tools such as software code version control, enterprise architecture modeling tools, requirements tools, mission simulation tools, and a variety of specialized analysis tools are some of the keys to success. Open standards such as the newest version of SysML 2.0 is driving new tool innovation from both long-standing tool vendors and companies that are new to the marketplace. Processes such as mission simulation will take place much earlier in the lifecycle and will reduce the cost of some of the Verification & Validation (V&V) efforts from traditional approaches.
Mulcahy: With digitization a big focus to start / advance with in 2024, we anticipate more discussions around MBSE (in line with SysML 2.0), but also Digital Engineering** – to connect with other tools in house and work towards a Digital Twin.
Not only could this include tools that help develop software, manage parts / simulations / detailed design aspects, but also ones that ensure validation and verification are undertaken sufficiently, proving out compliance to various industry mandates — especially when it comes to safety critical systems.
With many mergers and acquisitions continuing to be a part of this industry, re-use, collaboration, and auditability will increasingly become important. Knowing who changed things, why they were changed, and a record of the associated discussion will be invaluable as new products are designed — whether they have been designed from scratch or using existing IP. Not only would this save time understanding the complexities, but also help capture that knowledge to be able to transfer it to other organizations or teams who may not have been involved in original projects.
What role will cybersecurity play in aerospace & defense development in the coming year and beyond?
Bryczek: Cybersecurity is being prioritized nearly above all else in developing every type of system, from vehicles, to satellites, to commercial and military aircraft, and the systems that perform command and control. Any system that is connected to a network or connects to other computer systems via a removable cable, whether it is operating in an air-gapped environment, embedded within an aircraft, or touching the public internet are equally scrutinized for known vulnerabilities and are being required to adhere to security policies during development. DevSecOps strategies are putting security at the forefront during all stages of the lifecycle now instead of just being a post development process. In addition, we’re seeing organizations, more often now than ever, providing human-centric training to employees around good cybersecurity practices.
In your opinion, what are the biggest differences between aerospace & defense companies that will survive to see 2030, and ones that don’t?
Couadau: Adaptability is the name of the game. In addition to the market pressures, we are used to, the aviation industry is tasked with ambitious carbon reduction goals. International Air Transport Association (IATA) predicts that 1.8 gigatons of carbon will need to be abated yearly by 2050**. Companies that embrace this change now are bound to find success in a low-carbon future.
Bryczek: The aerospace and defense companies that retain top talent, spend design dollars wisely, and make winning partnership decisions will help companies survive to 2030.
Mulcahy: Embracing modern ways of working to enhance competitive advantage by delivering projects on time / to scope.
What advice would you give to new companies entering the aerospace & defense industry?
Bryczek: New start-ups need to embrace design-thinking principles right from the outset. Early collaboration involving the target end users such as military personnel together with the engineers, designers, and data scientists will lead to faster validation of the design’s requirements and ensure that the new capability is solving the needs of the users. Companies will also need to embrace new technologies like AI, machine learning, 3D printing, and multi-scale and multi-physics simulation.
Mulcahy: With ever-changing regulations, work with experts to help your company adhere to them. Embrace help and guidance from industry experts to allow you to focus on your new innovation to the market and not re-invent the wheel.
Furthermore, working with best-of-breed tools will allow you to attract new talent and help achieve innovation quicker.
What topic(s) do you wish companies were paying more attention to?
Bryczek: As systems become more software-centric, security regulations, especially those related to cybersecurity become increasingly more relevant and unavoidable. The updates to security frameworks such as the National Institute of Standards and Technology (NIST) – and Network and Information Systems (NIS) in EMEA — as well as cybersecurity frameworks such as Cybersecurity Maturity Model Certification (CMCC) are no longer applicable only to government organizations but now extend to any contractor that is performing work for governments as well. As challenging and expensive as it might be to implement security practices and design security into applications throughout development and operations, not doing so from the beginning will cost more in the long run and in some cases might prevent going to market.
What is the biggest mistake you see companies in aerospace & defense making right now?
Bryczek: The biggest mistake I see companies make is assuming their legacy tools are good enough for today’s design and development environments. They simply aren’t. Legacy tools were built around document-based processes and not model-based or simulation techniques used in modern development environments. In the long run it costs more in man hours and license costs than the switch to more modern tooling.
Mulcahy: Agree here with Cary. Legacy tools prohibit companies from real collaboration and are often customized to outdated ways of working where support can no longer be given.
With more tools now available today, and in the future – the need to be open for integrations is more crucial than ever as we aspire towards the digital world
What is the most innovative thing you’ve seen in aerospace & defense this year that you anticipate other companies following suit in coming years?
Couadau: Many of the experienced players have already embraced Digital Engineering and are using it to come up with automated frameworks that alleviate certification activities. I expect that the industry will align around these practices. The entry ticket is expensive but the shortened time to market is worth it.
Bryczek: The most innovative thing I personally saw was a large aerospace company making use of internal generative AI to assist with developing specifications and planning documentation. Heavy documentation which previously took four months to author, review and approve, took only a couple of weeks. AI is spreading into many other areas of the business including training and simulation. It is most certainly being used today by warfighters in Gaza and Ukraine to create realistic training simulations to predict outcomes of various defense strategies and enhance preparedness.
Mulcahy: For an industry that is very security conscious, I’m seeing more companies embrace the cloud to get better total cost of ownership, scalability, and performance from their engineering tools. Furthermore, an increase in consortium working together to break boundaries and define new ways of working together (often across time zones and cultures) I think will become more of the norm. In addition, we see organizations utilizing companies / partners to provide strength in specific and unique areas of expertise to develop groundbreaking technology.
Do you think there will be any major disruptors in aerospace & defense in the coming year? How do you think it will impact the industry?
Couadau: We have discussed many influencing factors already: emerging technologies, environmental goals, and a changing geopolitical context are all strong forces that can challenge the status quo.
What do you predict for regulation in the aerospace & defense industry in 2024?
Will those trends still be prevalent five years from now? 10 years?
Couadau: We should see the first standards emerge around AI and Machine Learning. On our end, we happen to be contributing to SAE ARP6983. We expect these standards to lay a solid foundation for safe, observable, and certifiable AI in aeronautics for the coming decades.
Bryczek: The aerospace and defense industry will continue to be challenged with environmental decarbonization initiatives such as the Paris Agreements. More to come here.
Mulcahy: Many of our customers are working on new systems in the Aerospace Industry. Whether that’s for UAV’s, Electric Vertical Take-Off and Landing (eVTOL), AirTaxis, etc, there will need to be more regulations developed here for the development of UAVs for example, but also to govern usage of the products in the sky. Furthermore, as these start to become more of the norm, regulation will need to be established for the surrounding infrastructure, usage, and purchase of these for the consumer market.
As more companies near release dates, more will be developed regarding these regulations, with of course current regulations also enhanced to better serve today’s needs.
With more global conflict at the forefront of our lives, and with other tensions continuing to escalate, I expect defense spending to be increased in anticipation of future conflicts, with new products being developed to gain advantage.
Linking with the above, I see Space being an area of further exploration in the defense sense, but also commercialization — whether it’s advancing the space race or decluttering space (as an example). I anticipate more startups in this sub-industry.
https://www.jamasoftware.com/media/2023/12/2023-12-14-2024-ad-predictions-1.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2023-12-14 03:00:022024-01-17 17:28:072024 Predictions for Aerospace & Defense Product, Systems, and Software Development
