Tag Archive for: Requirements & Requirements Management

The Software Factory: A Modern Approach to Software Development

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.


RELATED: Loram Rides the Fast Track to Software Safety with Jama Connect®


Key Components of a Software Factory

  • 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.

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


How Can Jama Connect® Help?

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.

2024 Predictions for Product and Engineering Teams

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.

In the final part of this six-part series, we asked our own industry experts Josh Turpen – Chief Product Officer, and Preston Mitchell – Vice President, Global Solutions, to weigh in on the product development and engineering trends they’re anticipating in the coming year 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, 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.


RELATED: How to Plan for Large Language Model (LLM) Adoption Within Your Engineering Organization


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.


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


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.

[Webinar Recap] Critical Alignment for Security, Safety & Product Development 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.


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


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.


RELATED: Unlocking the Potential: The Importance of Software Defined Vehicles Explained


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.


CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
Critical Alignment for Security, Safety & Product Development Teams


2024 Predictions for SoftTech Product, Systems, and Software Development

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.


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


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.


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


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!

2024 Predictions for Medical Device & Life Sciences 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.


RELATED: Understanding Integrated Risk Management for Medical Devices


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.


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


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.

2024 Predictions for Industrial and Consumer Electronics (ICE) Product 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.


RELATED: Jama Connect® for Robotics Datasheet


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.


RELATED: IEC 61508 Overview: The Complete Guide for Functional Safety in Industrial Manufacturing


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.


2024 Predictions for Aerospace & Defense Product, Systems, and Software 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.

Aside from this, trends from past years are still going strong: Model-Based Systems Engineering (MBSE) and the use of a Digital Thread throughout programs allows teams to tame the ever-growing complexity.

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.


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


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.

**CIMdata: Digital Thread in Aerospace and Defense

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.

** IATA: Net-Zero Carbon Emissions by 2050

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.


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


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.


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


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.


2024 Predictions for Automotive Product, Systems, and Software Development

2024 Predictions for Automotive Product, Systems, and Software Development

As the automotive landscape accelerates into 2024, we want to better understand and discuss what is driving change in the development of products, systems, and software, and how teams are evolving to address these 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 one of this six-part series, we asked the following industry experts to weigh in on the automotive 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 predictions for Aerospace & Defense HERE, Industrial & Consumer Electronics (ICE) HERE, Medical Device & Life Sciences HERE, SoftTech HERE, and Product & Engineering Teams HERE.

2024 Predictions for Automotive Product, Systems, and Software Development

STEVE NEEMEH: Electrified power continues to be at the forefront of today’s automotive industry. Governments are driving this prioritization through regulation. For example:

    • Norway: The first in the world, aims to have 100% zero-emission cars by 2025.
    • Netherlands: 100% electric vehicle sales by 2030.
    • India: 30% electric mobility by 2030.
  • China: 20-25% of new car sales to be electric by 2025.
  • France: Ban on fossil fuel-powered vehicles by 2040.
  • UK: Ban on the sale of new petrol and diesel vehicles by 2030 and hybrids by 2035.
  • USA: California leads the way with executive order N-79-20 which sets a 2035 date for ZEV sales.
  • Germany: Ban on combustion engines by 2030

The mainstream acceptance of electric vehicles took a huge step over the last decade but will hit roadblocks along the way going forward, as the infrastructure, engineering tools and capability, supply chain, and consumer acceptance, slowly catch up with the dream of pure clean mobility.

The trends are moving towards software and software-enabled and defined vehicles. Although clean technology powers vehicles, software can make it a reality by overcoming some of these challenges. Connected vehicles, optimized power management, services on-demand, improvements in reliability and maintainability, and, of course, autonomy, are all powered by software.

CHRISTIAN SCHRADER: SDV – Software Defined Vehicle. The value perceived by the driver and the passengers today is largely driven by software: GPS, autonomy functions, virtual displays in the car including head up display (HUD), infotainment system, connectivity with mobile devices, cloud services, over-the-air updates. Also new value recognition (paid software services in the car/cloud).

Classic Autosar control applications will remain an ongoing topic for classical subsystems: steering, braking, headlamp control, battery etc.

JUDY CURRAN: As far as how the vehicle looks:

  1. Lighting design continues to differentiate sports utility vehicles( SUVs) and trucks between original equipment manufacturers (OEMs.)
  2. Potential move back to new car-like body styles after years of SUVs, cross-over utility vehicles (CUVs.) Aerodynamics are improved in cars, and cars are less expensive to help offset the cost of electric vehicles (EVs.)
  3. Growth of smaller vehicles, and/or less contented vehicles as cars are becoming unaffordable; for example, less leather, more man-made leather likes. Less buttons; everything on the screen. However, there will still be a growing number of premium vehicles which will be highly contented. We will see many high price vehicles, and a drive toward a larger group of low-priced vehicles. The middle class is getting pushed out of the middle-priced vehicles. Most OEMS will want to win the business of the high price vehicles for obvious reasons.
  4. Less vehicle refreshes; it is too expensive to do a minor facelift. Customers don’t expect these any longer. Components will be used for a longer number of years, and potentially across vehicles to save money.

As far as how the vehicle operates:

  1. More EVs, but not 100% anytime soon. Not affordable… see biggest challenges.
  2. More software driven features; again, cheaper to change only the software, not the hardware to offer a new feature like automated braking, or stop-go
  3. Moreover, the air-software drops; OEMs able to solve quality issues with improved software releases, and charging customers for new features after the original sale of the vehicle.
  4. Most valuable features for customers are assisted driving, or improved experiences. Less customer chatter about 0-60, hp, drive and handling, etc. — more about keeping customers safe and making their lives easier.
  5. Autonomy continues to be quite a way out in the future; more ADAS features.

MATT MICKLE: One of the biggest shifts that we see is moving from internal combustion engines (ICE) to EV, we see this across the board largely due to regulations that back the production of electric vehicles. As the focus moves towards electrification, the significance of software becomes critical, and this changes the dynamic of how OEMs and large suppliers think about aspects of their business including the processes and tools that support them. The expertise required is extremely different and we see dramatic shifts in personnel to account for this.

The other obvious shift is with vehicle intelligence, which also relies heavily on software. More and more we move towards higher levels of autonomy faster than expected and automakers are needing to adapt quickly to keep up, leading to many dramatic changes. There are also many advancements related to this in regard to how mobility is achieved. With the rise of car sharing and mobility as a service, the need for the ability to update the vehicle on the fly and have modularity throughout the vehicle are essential to sustain the rapid increase in adoption and demand of these services. I’ve heard multiple people talk about how their children never plan to get licenses, it’s not even interesting to them.

STEVE RUSH: The software defined vehicle will continue to be a major trend in the next year. Feature development and new technologies will emerge as this trend becomes a reality.

Localization of mobility is another major trend. I’ll touch on this in the regulatory section.

Biggest Challenges – What are some of the biggest challenges you think Automotive companies will be working to overcome in 2024?

NEEMEH: From a business standpoint, electrified power continues to dominate the headlines, but the headlines have changed.

  • Leading automotive company has delayed $12B in EV spending and the message is that the consumer is unwilling to pay a premium for EVs.
  • GM-Honda scrapped a $5B plan to co-develop infrastructure around EVs.
  • Tesla has cut prices multiple times over the last year.

Compounding the problem is the availability of money. Interest rates have been rising and are currently at the highest they have been in a generation. This makes capitalization difficult for startups, and the list of bankrupt startup EV companies is getting longer. Proterra, Lordstown, IndieEV, and WM Motors, are just a few examples. Availability of investment is going to impact technology development and limit the applicability of EVs. However, the business case is evolving and with international government support, it is by no means going away.

SCHRADER: Managing software complexity

CURRAN:

  1. Profitability of electrified vehicles. Most are not profitable. Expensive new technology combined with the general affordability of new cars. Customers, especially younger customers, struggle to afford housing, and vehicles with higher interest rates.
  2. Transitioning suppliers from ICE to EV components but keeping ICE strong. Making sure those suppliers that primarily profit from ICE remain profitable, and don’t go bankrupt on lower volumes. ICE can still make up 50% of the volume in the next decade, and we need the ICE suppliers to survive.
  3. Hiring right skills; software skills, simulation skills
  4. Labor cost; especially for the non-union plants now that they see the packages agreed by the United Auto Workers (UAW.) Potentially more unionization.
  5. Too many companies in the business; too many OEMs now with all the new Chinese, and EV companies. The population is not growing at the same rate as the ability to produce cars. There will be consolidation. Too many suppliers of some commodities; for example, 80+ lidar suppliers. There will be consolidation.

MICKLE: Clearly automakers have faced many challenges with their supply chain in recent times whether it be from semiconductor shortages, lack of battery production facilities, geopolitical events, or world health crises. Some of these things still linger and will continue to cause a challenge in the industry, but additionally, I would say many of the same things that are driving advancement within the industry are requiring such a shift that they also present many challenges to overcome.

With a change to more of a software focus, there is an extreme shift in the expertise that is needed for the production of vehicles. Suppliers with a large focus in ICE are already starting to try and shift their business models with the eventuality of this disappearing almost completely. As so much focus is put on software, companies are scrambling to deal with prevention of cyber threats. Also, battery technology, infrastructure and production have to keep up with the exponential demand.

RUSH: Data. The software defined vehicle will present a number of challenges from a data perspective – connectivity and communication with the vehicle, storing and retrieving it efficiently and at scale. This is a major challenge. Traditional web technologies like REST APIs simply won’t meet the communication and connectivity need. New technologies will emerge to support connected vehicles.

Regulations – What changing regulatory guidelines do you anticipate having an impact on companies in 2024?

NEEMEH: The regulations promoting EVs that I mentioned before will not change in the short term. They will continue to drive innovation to overcome the challenges of modernizing our transportation networks.

A good example is the research being done at Purdue University to electrify the highways themselves so that charging can be done while the car is in motion. These kinds of breakthroughs would change the landscape and the paradigm by which we view vehicles. Today we see charging stations replacing gas stations with the limitation being the time it takes to charge. What if we didn’t need charging stations? The latest press release on the topic can be found here:

Building the first highway segment that can charge electric vehicles as they drive – Purdue University News

SCHRADER: Continued and increasing ISO 26262 demands in the wake of ADAS/AD functions. SOTIF for ADAS/AV. Also increased cybersecurity constraints (an insecure software in the car is a detriment to the SDV value recognition).

CURRAN:

  1. Regulations will continue for customer safety; active/ADAS safety and passive/crash safety.
  2. Regulations will continue for environment; fuel economy, percent EVs, zero carbon footprint.

MICKLE: I think the biggest challenges when it comes to regulation are mostly around policies that have been put in place to either accelerate the shift to EV or to take advantage of the safety benefits from AD and ADAS systems. For example, the Climate plan which has set a deadline for the sale of non-zero tailpipe emissions by 2035, or the Inflation Reduction Act to incentivize the transition to electric vehicles. This is causing major disruption as automakers have to adapt quickly.

Regulations themselves are adapting and rapidly being developed to ensure that safety and security are considered first and foremost. Also, standard bodies are working to harmonize in order to ensure that as complexity increases, the ability to maintain safety and security in development doesn’t become a tangled mess of jargon and specialized knowledge but is accessible. This is especially important as there are starting to be many more new players in the industry offering new technologies and causing the need for constant communication and integration.

RUSH: The regulatory space is quite murky when it comes to the future of mobility, and we are not likely to see broader regulatory alignment at the national or global level – it will be driven at the local level by municipalities and communities. Communities are demanding more transparency when it comes to safety concerns. I think partnerships between municipalities and mobility companies will deepen which will clarify the regulatory space.


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


Tool Innovation – From an Automotive 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?

NEEMEH: ASPICE 4.0 has just been released for review and adoption. Most notable are the changes to include hardware and machine learning in an attempt to adapt to the technologies that are impactful for automotive companies. This release and functional safety put a tremendous focus on the establishment of tools and processes as a part of an organization’s engineering development, release, and production process. Software is becoming the focus of development as a part of the movement towards software-defined vehicles, and the ALM tools are at the heart of the quality of these software systems.

SCHRADER: “Real” MBSE processes: Moving from separated “islands” to a more seamless end-to-end MBSE workflow. This is already of utmost importance and will continue to be like this beyond 2024.

CURRAN:

  1. Using AI/ML techniques on the wealth of data that they have; help develop new products faster by being able to mine data for similar designs. This is especially important for suppliers who design the same part for tens of vehicles a year; examples — sensors, latches, antennae, etc.
  2. Using simulation to validate designs instead of physical testing; this has been a goal for years and will continue to improve. There will never be zero testing, but definitely less testing and later in the program.

MICKLE: First, is that organizations need to find a way to keep track of all of the moving pieces, especially with regards to the integration of more and more software. Software and systems engineering teams traditionally work in very different ways and now will have to come together to handle the rapid change necessary for continuous development of software, while still adhering to the rigorous change management needed for compliance.

Additionally, organizations need to find ways to easily communicate with other players in their supply chain to adapt to the rapid pace of development — without dangerous gaps in impact from changes that may be made. It is essential that they need to find a way to not only communicate but understand the overall state across the supply chain.

RUSH: Configuration management will be the central shift from a process and tool capability standpoint. Configuration management, meaning the reuse of engineering assets across different variants and feature sets as well as branching from previous engineering work to kickstart new work. Many traditional automotive and semiconductor companies have been doing this for some time, but the burden of legacy tools with clunky and complicated user experiences will drive a shift toward more modern tooling.

Younger companies have matured to become multi-platform companies. This will drive configuration management needs at these younger companies.

What role will cybersecurity play in Automotive development in the coming year and beyond?

NEEMEH: Software-defined vehicles mean connected vehicles, which in turn means vulnerabilities. The UN treaty UNECE WP.29 defines a protocol to follow for compliance. Many countries have signed this treaty and full-blown implementation of the required cybersecurity management systems has begun with many OEMs. These cyber systems are essentially processes that are corollary to functional safety and require the right tools and processes to be implemented in the management of the software systems. This is another reason to focus on “how” you are developing your vehicle and not just what you are developing. The most difficult part to deal with in cybersecurity is the crossover between IT, Engineering, and Operations. There isn’t one owner. Therefore, orchestrating implementation requires cultural change within an organization.

SCHRADER: End customers take secure cars as a given. On the contrary a “proven insecure” car cannot survive in the market, and it will put shade on the entire brand (e.g. Jeep in the past). Cybersecurity is a foundation to build SDV upon, if you will.

CURRAN:

  1. I think as software controls more of the safety features, it will be important that customers remain safe; no defects in the software or cyber-attacks of the software.
  2. Keeping vehicles secure; too many cases of easily being able to start and steal a vehicle.
  3. Data Ransomware can be costly, and will remain top of mind.

MICKLE: Cybersecurity is imperative. Software within vehicles will only take more and more of a central role and as a result, safety is tied to security more and more.

RUSH: The importance of cybersecurity and adherence to standards like ISO 21434 will be more important each year than it was the year prior. As new technologies emerge and the connected vehicle becomes more embedded in our lives, cybersecurity needs will be of the utmost importance to ensure adoption and build trust with consumers.

In your opinion, what are the biggest differences between Automotive companies that will survive to see 2030, and ones that don’t?

NEEMEH: As an engineer, I would love nothing more than to say technology. As a business leader, I know that the answer to this question is cash flow. The cost of money and the time value of money have both changed dramatically. Investment dollars are very hard to come by in our present environment.

SCHRADER: Those that understand software will survive. Those that understand mechanical engineering only will produce the car shells of the future, going from an OEM to a kind-of Tier 1 role. Or do you know who is actually manufacturing the case for an iPhone or a Samsung phone?

CURRAN: This hasn’t changed in years. Companies will survive if they can produce high quality, affordable, and innovative vehicles. It’s a three-legged stool. Innovative covers styling and features that the customer wants. If you don’t have these three, you will not survive. Quality is important, because as the second biggest expense in your life after a house, it better last. Affordability is obvious – if it is not affordable by enough people to make your company profitable, then you will not survive. Finally, your product needs to be desired.

MICKLE: The ability to keep up with the rapid pace of advancement of technology within the industry. There will be more changes that will be unexpected and the ability to swiftly understand the impact of those changes and adapt will be important. Also, more communication and collaboration with other players in the industry will help standards and best practices evolve with the pace of the technology.

RUSH: Automotive companies need to put their customers— drivers and passengers and the surrounding community alike — at the center of their development. There must be a higher purpose toward the future of mobility and the connected vehicle — one that puts safety and equity at the forefront of the mission. Feature development must go beyond simply monetizing the connected vehicle — it must make life easier and better for all of us. Automotive companies that miss this and focus on building flashy features or focus too much on monetization will miss out and likely won’t survive in the long term.


RELATED: A Guide to Road Vehicle Cybersecurity According to ISO 21434


What advice would you give to new companies entering the Automotive industry?

NEEMEH: Develop an infrastructure to deliver high-quality software and provide a mechanism to scale delivery in an automated fashion. AI can speed up the development and delivery of software, and the right tools (like Jama Connect®) and equipment can automate the validation. That is the future. Don’t live in the past.

SCHRADER: Focus on new, valuable stuff: Autonomy, software, electrification

CURRAN:

  1. Have a big bank account. It takes billions of dollars to get into this business; to build the plant, as well as to hire the engineers to design the car, and then the marketing/brand/warranty costs.
  2. Make sure your strategy delivers quality, affordability, and innovation/desired to be owned.
  3. If you are in the industry and on the edge to surviving, start to think about partnerships.

MICKLE: I would say to establish a holistic approach to keeping safety, security, and development in harmony rather than in isolation.

RUSH: Put the driver, passengers, and the community first when it comes to feature development.

What topic(s) do you wish companies were paying more attention to?

NEEMEH: Standards and regulations are evolving very quickly. A specification like ASPICE and ISO 26262 comes out and it implies a complete overhaul of engineering departments. It seems like an afterthought with many companies, but the implications are huge.

SCHRADER: Focus on software development: Different kinds of software, better tools and processes for these. Stuff that has been working well 15 years ago might not be state-of-the-art any more…

CURRAN:

  1. Don’t forget the basics. New and old OEMs get enamored with EV, advanced driver assistance systems (ADAS), and SDV, but then make sloppy mistakes and have recalls on old technologies. Just looked at last week’s recalls, aluminum bolts loosening on a camshaft housing, connecting rod bearings, defective weld causing a water leak into electronics, driveshaft failures, interior materials have wrong level of fire retardant. And it is across the board, BMW, VW, Subaru, Honda, etc.
  2. Simulation is great for the new technologies, but it could also really help improve the quality of the “traditional” components.

MICKLE: I would say cross training their safety, security, and development teams to ensure that there are not such differing objectives between them.

RUSH: Cybersecurity. Many companies have not yet developed or have underdeveloped procedures culture around this practice.

What is the biggest mistake you see companies in Automotive making right now?

NEEMEH: It is already clear that the EV world is going to face infrastructure issues, power delivery problems, supply chain constraints, and consumer adoption issues. Poorly predicting consumer behavior patterns, failing to anticipate the infrastructure and technology limitations, and adjusting the business model accordingly, are the mistakes I see most commonly. There is a model and a business case for EVs, but it’s not the only solution to all our energy and transportation problems.

SCHRADER: They act too slowly, backward looking

CURRAN: Hiring lots of new tech talent that are needed for software, EV, etc, but then offering buyouts to the previous team. I think it takes a mix of new tech experts with some traditional automotive engineering talent who understand the complexities of the vehicles and the manufacturing processes/variability. Recalls are up 80% this past decade over the previous decade. Vehicles are getting very complex; it takes a mix of software and hardware talent combined with more simulation tools. It is humanly not possible to validate these complex vehicles through traditional means.

MICKLE: Unwillingness to adapt to electrification or digitalization trends would be a major mistake, but also swinging too far to adjust all processes and teams to be working within a software focused method would be an overstep. Failing to recognize the need for the connection of cybersecurity and safety would also be a big disadvantage.

RUSH: Lax approach to systems engineering principles. Software and agile processes are deeply ingrained in the automotive and semiconductor industries. Younger software engineers learn these principles as they learn programming and they can conflict with systems engineering principles. Systems engineers may feel slower, but it will better address challenges of scale and safety considerations when it comes to development and verification.


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


What is the most innovative thing you’ve seen in Automotive this year that you anticipate other companies following suit in coming years?

NEEMEH: Using AI to solve labor constraints and the effective implementation of standards and regulations.

CURRAN:

  1. Hard to pick one… but definitely great improvements in battery cost, and miles per charge. Improvements in time to charge. Great to see everyone jumping on the Tesla connector to help the infrastructure situation, etc.
  2. Here are the ones that I’m most interested in. More and more safety-related features … we still have more traffic deaths every year, and even rising number of deaths. 42,000+ deaths in the US in 2021. That is a like 140 — 300 passenger planes crashing every year… just in the US. There used to be more large plane crashes, but not that many. The aerospace industry collaborated to really make air travel incredibly safe. We need to do more with ground vehicles. Automotive OEMs need to share more safety technology, and safety data and collaborate more together. Also, what new features can we create… Don’t start the car without a breathalyzer test? Number one cause of accidents in driving under the influence.

MICKLE: It may not seem sexy, but the AI to monitor parts of the driver’s body and eye positioning to send alerts to keep them focused and attentive is very innovative to me. It’s out of the box thinking like this in terms of safety which will allow for technology in Automation to progress successfully at the pace that is needed.

RUSH: Some of the new products and services coming out of Nxu (formerly Atlis Trucks) are really innovative and exciting. Specifically, Nxu One. While not strictly automotive, it’s automotive adjacent. I think it’s a great example of an innovative new product and program that can be monetized as well as puts the customer experience at the forefront. I’m interested to see where this goes.

Predictions – What do you think will remain the same in your industry throughout 2024?

NEEMEH: The adoption of EVs will continue, driven by government regulations. I don’t think that will change.

CURRAN: Same trends: EV, ADAS, SDV

MICKLE: The focus will remain on electrification and software, and it will only grow in the coming years.

RUSH: I think the software defined vehicle will continue to be the leading trend in automotive in 2024.

Do you think there will be any major disruptors in Automotive in the coming year? How do you think it will impact the industry?

NEEMEH: AI and the adoption of Software-Defined Vehicles will disrupt the supply chain and there will be winners and losers.

CURRAN: I don’t see any major disruptors other than how to use AI/ML techniques in the trends. The industry is trying to absorb the last five years of disruptions, which is more than the last 50 years’ worth. AI/ML — simulation will help.

MICKLE: I think that surprises that come will likely be from external factors due to government regulation, geopolitics, or other socio or economic disruptions.

Another possibility would be new discoveries in ecological and sustainable materials or advancements in technologies, a discovery here might have a dramatic effect on the industry.

RUSH: Nxu One. I think this is a win-win program for Nxu and customers.

Companies are trying to figure out how to monetize the future of mobility. I think you will see more startups in the charging station space – ushering in new ideas like public/private residential charging stations.

I think you may see more acquisitions of some of these disruptors. As some of the larger, traditional automotive companies look to buy over build when it comes to innovation.

What do you predict for regulation in the Automotive industry in 2024?

Will those trends still be prevalent five years from now? 10 years?

NEEMEH: 10 years from now the engineering departments will be far more efficient. Collaborative development tools and automation will be commonplace. Efficiency and AI will speed up the delivery of next-generation vehicles. AI will enable engineers to focus on the solutions, rather than the paperwork or manual labor. I also see a large push towards collaborative work environments that span the globe. Exciting times!

CURRAN: I truly believe affordability will be a growing trend, because wealth in the most recent generation is predicted to be more dire than previous generations. And I hope eliminating crashes will be a bigger trend. We can do more, people.

MICKLE: As complexity increases, regulation will increase, a big thing that will be interesting to see unfold is as autonomy increases, where the responsibility falls in the case of incidents.

RUSH: I think it will be another development and building year when it comes to the regulatory space. I think you will see increased acceptance and adoption of autonomous vehicles after recent major shutdowns in service. I think new attitudes of transparency will emerge between companies and municipalities and communities, paving the way for future regulations.

The software defined vehicle is not going away and we will see more and more resources put into this vision and new technologies emerging because of it. Regarding autonomous vehicles, each year will see increased adoption of autonomous vehicles and further clarity in the regulatory space. Frankly, many of these companies are craving clear regulations and standards so they have something to work toward.

[Webinar Recap] Effective Strategies and Solutions for Successful SaMD Project Execution

In this blog, we recap our webinar, “Effective Strategies and Solutions for Successful SaMD Project Execution”. Click HERE to watch the entire webinar.


Empower your teams with insights and solutions that transcend the challenges of medical device software development.

Navigate the complex terrain of medical device software development and learn crucial insights and practical solutions to propel your projects forward.

In this webinar, Romer De Los Santos, Senior Consultant at Jama Software®, guides you through:

  • The new SaMD Framework, which features ISO-aligned document templates and customization capabilities
  • Variant Management in Jama Connect®, the key concepts required, and how it can revolutionize your workflow
  • Insights into the nuances of navigating complex medical device software projects
  • A brief exploration of the impact of US and EU regulations shaping the software landscape

Below is an abbreviated transcript of our webinar.


Effective Strategies and Solutions for Successful SaMD Project Execution

Romer De Los Santos: During this presentation, I’ll go over the challenges facing development teams working on medical device software, the key features of the Jama Connect SaMD Framework, and how you can use Jama Connect’s categories and reuse and sync features to manage releases and variants. A successful software development project in the medical device industry is a careful balancing act between documentation and development activities. Development teams have tight deadlines that are driven by market conditions. At the same time, they’re responsible for generating the required quality records according to each region where their device will be marketed. Since this isn’t a regulatory discussion, we’ll just focus on the EU and US as examples.

Medical device software development in the EU is governed by IVDR and MDR regulations. The risk classification in some software activities will differ depending on the regulation it falls under. Unlike in the US, there is no specific distinction between SiMD and SaMD software. It’s all considered medical device software. You’ll need to consider if the software you are developing is an accessory to a medical device or if is it a medical device on its own. If it is an accessory, it’ll need its own technical file. If it is sold as an integral part of the system, it should be included in the system’s technical file.


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


De Los Santos: In the US, there is a distinction between software in a medical device and software that is a medical device on its own. With the advent of AI, machine learning, cloud computing, and other innovations, the FDA has been drawing up new guidance to help modernize oversight on software development. The concept of device software functions are a key part of its modernization efforts. Each device software function has its own risk classification. The FDA has indicated that they intend to target their oversight over software that is an extension of one or more medical devices, software that transforms a mobile platform into a medical device by using attachments, displays, sensors, or including functions like a regulated medical device, software that performs patient-specific analysis and provides specific outputs or directives used in the diagnosis, treatment, mitigation, cure, or prevention of a disease or condition.

The Center for Devices and Radiological Health (CDRH) at the FDA created the Digital Health Policy Navigator to help manufacturers determine if their product’s software functions may be the focus of FDA oversight. This past September, the FDA released its new guidance on cybersecurity in medical devices. The guidance encourages the use of a secure product development framework when building software. It specifies some new deliverables such as a security risk analysis that is distinct from and in addition to the safety risk analysis specified in ISO14971.

Manufacturers will need to analyze security risks from the design and development phase through device maintenance and eventually to product end-of-life. Manufacturers are encouraged to use threat modeling to analyze security vulnerabilities in the environment where the device will be used. You’ll also need to consider all interfaces to and from the system and the Off-The-Shelf software (OTS) and Software of Unknown Provenance (SOUP) components that the system depends on. Software Bill of Materials (SBOMs) must be generated and analyzed for potential vulnerabilities. This represents more work for teams but is absolutely required in today’s interconnected world. In addition to all the required documentation for the design history file, developers also need to consider how to manage their fast development iterations, how to handle parallel development and variant and release management, how to properly triage and disposition defects, and how to manage third-party components that are part of their system.


RELATED: Jama Connect® for Digital Health Solution Overview


De Los Santos: The Jama Connect SaMD Framework is intended to alleviate some of the documentation burden while each company has its own procedures. The framework provides basic document templates that comply with requirements specified in IEC62304 and ISO14971. Furthermore, each document template includes a customizable export template for your convenience. It’s designed to keep things as simple as possible by minimizing the number of different item types and fields. The framework is versatile and includes the ability to trace to items outside of Jama Connect. This framework is designed to cover the most common use cases and is intended as a starting point for your own process. Jama Connect can easily be configured so that the tool adapts to your process rather than the other way around.

To watch the entire webinar, visit:
Effective Strategies and Solutions for Successful SaMD Project Execution

Project Lifecycle Management (PrLM): A Comprehensive Guide

In this blog, we’ll recap our eBook, “Project Lifecycle Management (PrLM): A Comprehensive Guide. Click HERE to download the entire thing.


Project Lifecycle Management (PrLM): A Comprehensive Guide

Welcome to “Project Lifecycle Management (PrLM): A Comprehensive Guide.” In our eBook, we will explore the principles, methodologies, and best practices for effective project management throughout its lifecycle. Whether you area. seasoned project manager or someone new to the field, this guide will provide you with the knowledge and tools necessary to successfully navigate the various stages of a project and deliver exceptional results.

Project Lifecycle Management (PrLM) vs. Product Lifecycle Management

We know there is often some confusion between Project Lifecycle Management (PrLM) and Product Lifecycle Management (PLM) so just to set the stage, here is the high-level difference:

  • Project Lifecycle Management (PrLM) — the focus of this paper — refers to the overall management of a project from its inception to its completion. It encompasses activities such as project planning, execution, monitoring, and delivery. PrLM focuses on managing the project-specific processes, resources, and deliverables to ensure successful project outcomes within the defined constraints of time, cost, and quality.
  • On the other hand, Product Lifecycle Management (PLM) deals with managing a product from inception to delivery throughout the course of its entire lifecycle. PLM involves the strategic planning, development, and support of a product while taking into account factors like design, engineering, manufacturing, testing, distribution, and even customer service. Throughout its lifespan, it attempts to maximize the product’s quality, functionality, financial success, and market viability.

In summary, while PrLM is concerned with managing the overall project activities, PLM is focused on managing the lifecycle of a specific product, system, or software, including its development, production, and market presence.

With that clarified, let’s begin our journey into the world of Project Lifecycle Management.

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


Understanding Project Lifecycle

What is a Project Lifecycle?

A project lifecycle refers to the series of distinct phases that a project goes through, from its initiation to its closure. It is a structured approach that helps project managers effectively plan, execute, and control their projects. Each phase of the lifecycle has specific objectives, deliverables, and activities that contribute to the overall success of the project. By understanding the project lifecycle, project managers can proactively manage risks, allocate resources efficiently, and ensure that project goals are achieved.

Importance of Project Lifecycle Management

Project lifecycle management is crucial because it provides a roadmap for project managers to follow. It enables them to break down complex projects into manageable stages, making it easier to monitor progress and track outcomes. By adhering to the project lifecycle, organizations can enhance their project success rates, improve resource allocation, and minimize risks.

Common Methodologies Used by Project Lifecycle Management

Project Lifecycle Management methodologies provide a structured framework for managing
a project from initiation to closure. It is important to note that because of the similarities in desired outcomes and development process cross-functionality, PrLM and PLM methodologies often overlap. Here are descriptions of some of the top PrLM/PLM methodologies:

  • Waterfall Model – The Waterfall model is a sequential approach to PrLM. It divides the project into distinct phases, such as requirements, design, implementation, testing, and maintenance. Each phase must be completed before moving to the next. It’s suitable for well-defined projects with stable requirements.
  • Agile PrLM – Agile PrLM is an iterative approach that emphasizes flexibility and collaboration. It allows for continuous feedback and adjustments throughout the project. Agile PrLM is ideal for projects with evolving requirements and a need for rapid iterations.
  • Stage-Gate Model – The Stage-Gate model breaks the project into stages or phases, each with a decision gate where project stakeholders review progress and decide whether to proceed to the next stage. It’s useful for ensuring alignment with strategic goals and minimizing risks.
  • Spiral Model – The Spiral model is a risk driven PrLM approach that combines elements of Waterfall and iterative development. It involves repeated cycles of planning, risk analysis, engineering, and evaluation. It’s suited for projects with evolving requirements and high uncertainty.
  • V-Model (Verification and Validation Model) – The V-Model extends the Waterfall approach by emphasizing the importance of validation and verification at each phase. It highlights the relationship between development phases and corresponding testing activities, ensuring a robust validation process.
  • Iterative and Incremental Model – This PrLM approach involves breaking the project into smaller, manageable increments that are developed and tested iteratively. It allows for early delivery of partial functionality and is commonly used in software development.
  • PRINCE2 (Projects IN Controlled Environments 2) – PRINCE2 is a structured project management methodology that includes a well-defined project lifecycle. It focuses on governance, documentation, and clear roles and responsibilities, making it popular in government and public sector projects.
  • Critical Chain Project Management (CCPM) – CCPM is a PrLM methodology that prioritizes resource management and identifies the critical chain of tasks that impact project completion. It aims to reduce project delays and improve resource utilization.
  • Design Thinking – Design Thinking is a human-centered approach to PrLM that emphasizes empathy, ideation, and prototyping. It’s often used in creative and innovative projects to solve complex problems and improve user experiences.
  • Hybrid PrLM – Hybrid methodologies combine elements of multiple PrLM approaches to tailor the methodology to the specific needs of a project. Organizations often customize their PrLM processes by selecting components from different methodologies. Selecting the appropriate PrLM methodology depends on the project’s nature, goals, constraints, and the organization’s culture. Project managers and teams may adapt or blend these methodologies to best suit the project’s unique requirements and dynamics.

RELATED: Requirements Traceability Benchmark


Common Phases of a Project Lifecycle

This image shows a circular flow chart depicting the common phases of a project lifecycle.

Although the specific phases may vary depending on the project management methodology used, there are typically five common phases in a project lifecycle: initiation, planning, execution, monitoring and control, and closure. Each phase serves a distinct purpose, from defining project objectives and creating a project plan to delivering the final outputs and conducting a post-project evaluation.

Grasping the fundamentals of project lifecycle management enables project managers to lay a strong foundation for their projects. The next chapter provides a comprehensive
overview of the project lifecycle, emphasizing its significance, the key stakeholders involved, and the challenges that may arise. With this knowledge, project managers can embark on their project journeys with confidence and a clear understanding of the path ahead.

Initiating the Project

Defining Project Objectives and Scope

The initiation phase is the starting point of a project, where the project objectives and scope are defined. This involves identifying the desired outcomes, deliverables, and benefits that the project aims to achieve. Clear and well-defined objectives help align the project team and stakeholders, providing a common understanding of what needs to be accomplished. Additionally, project scope defines the boundaries of the project, specifying what is included and excluded. It is essential to establish realistic and achievable objectives and scope to set the project on the right track from the beginning.

Conducting Feasibility Studies

Before committing resources and efforts to a project, it is crucial to assess its feasibility. Feasibility studies evaluate various aspects, such as technical, economic, operational, legal, and scheduling feasibility. This analysis helps determine whether the project is viable and aligns with organizational goals and resources. It allows
stakeholders to make informed decisions about proceeding with the project, modifying objectives, or exploring alternative approaches. Conducting thorough feasibility studies during the initiation phase minimizes the risk of undertaking projects that may prove unworkable or unprofitable in the long run.

Identifying Stakeholders and Their Requirements

Identifying and understanding project stakeholders is a critical step in the initiation phase. Stakeholders include individuals or groups who have a vested interest in or can
influence the project’s outcomes. It is essential to engage stakeholders early on to gather their requirements, expectations, and concerns. By involving stakeholders
from the beginning, project managers can gain valuable insights and build support and commitment for the project. This identification process lays the foundation for effective stakeholder management throughout the project lifecycle.

Developing a Project Charter

A project charter serves as a formal document that authorizes the existence of the project and provides a clear understanding of its objectives, scope, constraints, and stakeholders. It outlines the project’s purpose, defines the project manager’s authority, and establishes the project’s high-level requirements. Developing a project charter during the initiation phase helps align stakeholders, gain project sponsor approval, and set expectations. The project charter becomes a guiding document that shapes the project’s direction and provides a reference point throughout its lifecycle.

Establishing the Project Team and Roles

During project initiation, it is essential to assemble a capable project team and define their roles and responsibilities. This involves identifying the necessary
skills and expertise required for the project and selecting team members accordingly. Assigning roles and responsibilities clarifies expectations, promotes accountability, and ensures that all necessary tasks are covered. Building a cohesive project team in the initiation phase sets the stage for effective collaboration and lays the groundwork for successful project execution.

By effectively initiating a project, project managers establish a solid foundation for success. This chapter has explored the critical aspects of project initiation, including defining project objectives and scope, conducting feasibility studies, identifying stakeholders and their requirements, developing a project charter, and establishing the project team and roles. Through careful planning and consideration in the initiation phase, project managers can position their projects for smooth execution and set the stage for achieving the desired project outcomes.

This has been a preview of our eBook, “Project Lifecycle Management (PrLM): A Comprehensive Guide.
Click HERE to download the entire guide.