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People looking off into the distance toward 2025 medical device predictions

2025 Expert Predictions for Medical Device & Life Sciences: Innovations in Patient-Centered Care and the Future of Medical Device Design

As patient-centered care takes center stage, the medical industry is witnessing an unprecedented transformation in how devices are designed, developed, and regulated. From the rise of direct-to-patient products and AI-enabled diagnostics to the challenges posed by cybersecurity and evolving regulatory landscapes, 2025 promises to be a pivotal year for medical innovation.

In part five of our annual predictions series, Richard Matt – Medical Product Consultant at Aspen Medical Risk Consulting, and Vincent Balgos – Director, Solutions & Consulting at Jama Software, share their insights on the future of medical devices. Together, they explore how digital solutions are reshaping patient care, the hurdles the industry must overcome, and the exciting possibilities for advancing remote monitoring, telehealth, and AI-powered solutions.

We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE) HERE, Automotive HERE, Semiconductor HERE, and Aerospace & Defense HERE – Plus, stay tuned for our future topic, AECO.

With patient-centered care becoming increasingly important, how do you see software and digital solutions transforming the design and development of medical devices in the next few years?

Richard Matt: Software development needs to mature to a place of contributing equally with other specialties instead of excelling independently. Far too many companies are being held back by technical siloing, usually led by software. The tragedy is that software personnel are among the most creative and productive employees. Their collaboration needs to mature to a place of creating opportunities for other specialties to be as efficient and achieve this together.

Vincent Balgos: There is a growing trend of direct-to-patient products (hearing aids, CGM’s, smartwatch apps) that includes complex software and digital solutions. In addition, most traditional med devices are now connected to the internet or other devices. I’d expect this trend to continue in this digital age, but with that growth, there will be some unintended side effects. Specifically, cybersecurity threats will continue to become a significant factor during the design, development, and on-market phases of the product.

RELATED: Integrate Cybersecurity and Safety Risk Management in Jama Connect® to Simplify and Accelerate Medical Device Development

Regulatory compliance and data security are paramount in life sciences. What advancements in software do you think will be most effective in managing compliance and protecting sensitive patient data?

Matt: Big data will become more available and utilized systematically to provide answers to questions that have been answered inadequately for decades. Protecting patient data is a simple matter of awareness and giving cybersecurity the sliver of attention it needs to close off the dominant attack vectors.

Balgos: In recent conferences I’ve attended (and read about), AI/ML continue to dominate the discussion around software advancements. Whether providing internal value to organizations, or external facing with AI/ML enabled devices, the impact that AI/ML has (generative, predictive) will play a major factor in the security of data (whether positive or negative). The regulatory guidance of AI/ML is still evolving so it’ll be interesting to see how it unfolds in the future.

As AI and machine learning continue to evolve, what role do you see these technologies playing in medical diagnostics, treatment personalization, and device functionality by 2025?

Matt: AI and ML will continue to evolve, as they have for generations. We have made recent, significant steps forward in natural language recognition, but the integration of that forward movement with diagnostics and treatment personalization will continue to be slow and incremental.

Balgos: The expansion of AI/ML in various traditional areas of med devices is continuing to grow at an exponential rate. Looking at FDA’s dataset, the # of authorized AI/ML enabled devices continue to grow YoY as much as 40% with applications in new areas. Currently, predictive AI is supporting medical professions with their clinical assessment/decisions in a supportive role and seems to be the common use case. But there are current talks now on how generative AI could add potential value in these device areas as well.

What are the biggest hurdles the industry faces in adopting cutting-edge software solutions in device manufacturing and patient care? How can companies proactively address these challenges?

Matt: The biggest hurdle is technical siloing, which software leads very capably. Companies can proactively address this challenge by implementing a systems-approach to problem solving / product development that respects all the technical contributions needed to succeed and ensures software personnel use their exceptional abstraction abilities to work in collaboration with the rest of the company.

Balgos: Some of the biggest hurdles my customers talk to me about are the evolving regulatory landscape, continuing pressures to accelerate development, scalability and ongoing resource and budget constrictions. For changing regulatory, I do recommend folks to work with a qualified regulatory affairs profession for guidance (and is now required in EU). For acceleration, scalability and resource constraints, companies are proactively looking for ways to maximize efficiency and looking to innovative ways to help organizations (e.g., AI applications).

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

How do you foresee the growing demand for remote patient monitoring and telehealth impacting product development for medical devices? What innovations do you think are necessary to support these shifts?

Matt: COVID was an unplanned stress test on our remote work capabilities. We need to analyze the results of that stress test to identify strengths and weaknesses to build into our next generation products and services.

Balgos: Based on the new FDA CDRH Director’s speech at MedTech Conf 2024, these demands coincide with their Home as a Health Care Hub initiative where these homestead digital solutions are becoming more at the forefront of healthcare for many patients. With these increasing interests and demands, I think connectivity of these devices will continue to rise, AI/ML will play a major factor in delivering value, and also improvements in the human factors/usability aspects of these devices will be something to watch. Transitioning from a professionally trained clinical staff to the general population, there will need to be a shift in developing these at home devices to be extremely ‘easy to use’, especially with those that struggle with technology, complex processes, and tedious tactile tasks.

With these innovations, there will be some side effects such as cybersecurity, post market updates, and the interoperability of all these devices. While they seem daunting, I’m confident that industry will rise to the challenge as they have with other previous challenges

Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Balgos: In early 2026, the FDA’s final rule on the Quality Management System Regulation (QMSR) will be effective, thereby incorporating ISO 13485 elements into the current Quality System Regulation (QSR). QMSR will supersede QSR.

This image shows people looking off into the distance to portray viewers reading about 2025 predictions for aerospace & defense.

2025 Expert Predictions for Aerospace and Defense: AI, Sustainability, and the Next Frontier

Aerospace and defense are at the cusp of revolutionary changes, driven by advancements in artificial intelligence, autonomous systems, sustainable technologies, and digital transformation.

In part four of our annual predictions series, Vance Hilderman, CEO at AFuzion and Jama Software’s industry experts Cary Bryczek , Director of Solutions & Consulting; Karl Mulcahy, Global Sales Manager of Aerospace & Defense and Matt Macias, General Manager of Aerospace & Defense share their insights on the trends, challenges, and innovations shaping the future of aerospace and defense.

From the integration of AI in autonomous systems to the adoption of digital twins for operational efficiency and the pursuit of sustainable practices, these insights offer a glimpse into the opportunities and disruptions that lie ahead. Whether it’s navigating cybersecurity challenges or adapting to shifting geopolitical conditions, this year’s predictions provide a roadmap for industry leaders to thrive in 2025 and beyond.

We like to stay on top of trends in other industries as well. Read our predictions for Industrial & Consumer Electronics (ICE) HERE, Automotive HERE, and Semiconductor HERE – Plus, stay tuned for future topics, including Medical Device & Life Sciences, and AECO.

Editor’s Note: Responses reflect a mix of British and American English, depending on the respondent.

Question 1 – With the rising integration of AI, machine learning (ML), and autonomous systems, how do you foresee these technologies reshaping aerospace and defense operations? What are the most promising applications and potential challenges?

Vance Hilderman: AI & ML are already used for ground planning, flight plan optimization, flight deck monitoring, and assists. Militaries are using AI onboard UAVs (Unmanned Aerial Vehicle) and fighter aircraft but real-time AI on commercial aircraft is not yet allowed for safety-related operations.

Cary Bryczek: We will see an explosion in systems engineering utilizing AI. AI will not only be used to write requirements but decompose the requirements into lower-level requirements, create architecture models and establish traceability throughout. It’s beginning to happen right now! AI assistants for systems engineers will create enormous time savings so the actual engineering can be performed.

Karl Mulcahy: AI/ML I’m sure is of interest to these companies to make internal development practices more efficient, but also to enhance their offerings e.g., AI monitoring for better insights/decision making on a battlefield.

However, with ongoing security aspects a constant concern for sensitive projects within the defence world particularly, it may require more maturity and capabilities within customer environments for internal efficiency gains.

Matt Macias: The aviation industry is already demonstrating prototypes leveraging AI and autonomous operation with a large number of new and existing companies developing transformational vehicles to provide new ways for people and goods to utilize airborne mobility’s advantages. There is a strong desire to bring the consumer faster, safer and more cost-effective ways to travel. We see many new startups and innovative ideas in the work, which is very exciting. We also see a great rise in the pursuit of novel, innovative cyber-system approaches and new vehicle designs, propulsion and operations.

In the defense world we see AI/Autonomous systems enabling disruptive changes in the systems and total architectures utilized for security. These new technologies are enabling breakthroughs in new missions and exposing unexpected vulnerabilities. We saw this clearly in Ukraine with the successful use of inexpensive, modified consumer drones defeating far more expensive systems. We also see this in the changes and cancelations of some larger DOD systems programs, where there appears to be a shift in focus to very different, lower-cost systems. For example, drones that operate in a “constellation” of unique, adaptable, or “swarms” of “expendable” or essentially single-use systems that can potentially overwhelm more traditional manned or legacy systems. This is not only changing the approaches to military strategy, but it is revolutionizing the development of tomorrow’s military systems, leading (as in commercial aviation) to an explosion of new ideas and new programs. We also see a rapid growth of disruptive companies taking market share from traditional defense contractors.

All in all, this is a very exciting time for anyone who is interested in aviation, space and defense innovation.

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

Question 2 – As a follow-up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML?

Hilderman: When used on the flight deck for real-time flight controls, it needs to be certified which is not yet possible for commercial aviation. We’re working on this.

Bryczek: I would say none to be honest. The technology is there to protect intellectual property. Perhaps the only concern I have is do we have the energy infrastructure ready to drive some of the computing power behind it all.

Macias: Currently, the most immediate negative impacts of AI & ML is the disruption of well-established commercial markets and in the case of defense, the unexpected vulnerability of military systems that we have invested heavily into ensure our security.

We don’t know yet how advanced air mobility systems might change the flow of people and goods around our cities, but it is likely that not likely in 2025. In the mid-term future, we will see disruptions as we seek new norms, such as increased noise, safety challenges, privacy challenges, etc. We can also see that the major militaries of the world are very concerned about countering the asymmetric threats autonomous systems pose to our larger defense platforms, likely to accelerate as AI is applied in the future.

Question 3 – As global demand for sustainable practices intensifies, what innovations in product design, materials, or manufacturing processes do you think will most significantly impact sustainability efforts in aerospace and defense?

Hilderman: eVTOL. [Editor’s note: Electric Vertical Take-Off and Landing (eVTOL) aircraft are a type of VTOL (Vertical Take-Off and Landing) vehicle that use electric power for vertical takeoff, landing, and hovering. Unlike traditional VTOLs, eVTOLs rely solely on electric propulsion.]

Bryczek: We are going to continue to see more research and development efforts into alternative geological materials to mitigate the need to use rare earth elements. Systems will need to be redesigned, or new systems built altogether that utilize different materials. It’s not just global political unrest that is driving this but also socio-environmental resistance to the mining/extraction process that ruin the environment.

Mulcahy: Better collaboration across teams using tools to capture outcomes, integrate data sets, and ensure better decision-making/more efficient ways of incorporating science and research into the manufacture of products.

Macias: Aerospace and Defense is an industry that has struggled greatly with achieving solutions for sustainability. A significant innovation focus is being applied to this ongoing challenge. We can see major positive impacts already in more efficient structures (increased use of carbon fiber composites and advanced designs) and advancement in the efficiency of traditional propulsion systems. In work and over the horizon there is a strong desire to harness advanced, model-based design approaches (including AI, generative design, MDO, MBSE), and advanced manufacturing automations (3D printing, advanced robotics, etc.) to enable dramatic innovations that will increase the efficiency of flight and other operations.

However, what the industry most dearly seeks is a sustainable power source for A&D systems. This will have great value as these systems consume a great deal of energy and in the case of defense systems, the cost of getting fuel to the point of need is extremely high. The challenges of electrification, sustainable aviation fuels (SAF), hydrogen propulsion, etc. continue to be a major focus of the A&D industry but also continue to present very significant challenges of affordability, reliability, power density/weight, and the logistics of fuel delivery.

Question 4 – Cybersecurity remains a top priority in aerospace and defense. What proactive steps do you believe the industry should take to strengthen security measures, particularly in software development and data management for connected and autonomous systems?

Hilderman: Mandate formal usage of DO-326A and ED-202A for cybersecurity within Avionics.

Bryczek: We already have terrific security policies and guidelines as Vance has pointed out that both the US and Europe have crafted. Developers need to be held accountable to follow security by design and to leverage zero-trust architecture. Still too often do I see security performed as an afterthought.

Macias: Security assurance is critical as we advance our use of autonomous systems and integrated data networks. This is and will remain a subject of constant focus, priority and challenge. The application of careful and advanced cybersecurity approaches must be a primary focus of all parts of the A&D system lifecycle including IP protection and security in operational data. As our systems become more intelligent and as the leverage is greater and greater computing power, this will only increase.

Question 5 – Given the shift toward digital transformation, what role do you see digital twins and simulation technologies playing in enhancing operational efficiency, project accuracy, and training in aerospace and defense?

Hilderman: Aircrafts are increasingly automated meaning less pilot involvement which means less onboard “practice;” this means simulation-based training is even more important.

Mulcahy: With more complex products being designed and worked across companies to deliver a larger product/initiative, going digital will be important to ensure alignment.

It will be important to ensure ways to share data seamlessly across tools to understand wider impacts, relationships and identify risks at an earlier stage.

Macias: The A&D industry is seeking the total usage of comprehensive digital twins that harness simulations in near real-time to instruct all aspects of a system’s lifecycle. Simulation driven, model-based development when harmonized into a comprehensive digital twin will enable dramatic breakthroughs in program efficiency, quality, and innovative capabilities. Because of the dramatic increase in ability of the engineering teams to cycle through massive numbers of virtual design and operational scenarios leading companies are enabling dramatic improvements in optimization and deep insights into the function of the designed systems early and throughout ongoing design changes.

This will extend to every aspect of the lifecycle, first into manufacturing and sustainment/service, mission development and operations health monitoring. We can envision a future where every operation of a system/vehicle is both simulated before it happens and after to assess the most efficient operation and the overall health of the system, safety of its occupants/environment. This can also have a significant impact on sustainability if the digital twin is harnessed to optimize operations for minimum energy consumption and maximize life of the system.

RELATED: Cybersecurity in the Air: Addressing Modern Threats with DO-326A

Question 6 – How do you anticipate changing geopolitical conditions and regulatory demands influencing the development of next-generation aerospace and defense products? What strategies should industry leaders consider to remain agile and compliant?

Hilderman: Defense demands will only grow; Europe will need to greatly increase spending, and USA will need to counter increased China spending.

Bryczek: In the defense industry, meeting the mission requirements and providing capabilities quickly to the warfighter trumps regulatory safety compliance requirements. Since there is no “certification” activity as in civilian aerospace systems, there is less burden on development practices. I see very little regulatory changes that will greatly impact defense. On the civilian side, regulations continue to evolve still very slowly. Leaders need to remain agile with their business strategy and align with what the political conditions offer. If there is a way to morph your product to a different market; then be bold and make it happen.

Mulcahy: With the rise of more worldwide conflicts, especially in Europe and the Middle East, more countries are spending more of their GDP on defence spending.

In today’s world, defense now goes more than just weapons, but also into space, cyber security and of course ensuring systems are secure and reliable.

New threats require new solutions to help mitigate these threats. That’s where more companies will develop more solutions and start-ups will emerge.

We often hear of a grey area in the UAV world in terms of regulations, but with more focus on the SORA (Specific Operations Risk Assessment) / SAIL (Safety Assessment Integrity Level,) it will be interesting to see what standards emerge with more civilian/military uses for UAVs for both attack and defence purposes.

Macias: As the broader world adjusts to an accelerated rate of change, we will need to introduce innovative solutions faster and leverage solutions from global partners. This will demand secure, virtual collaboration methods, new ways of joint development while protecting IP and data security, and new standards for safety, communication, and joint operations. Industry leaders should continue to seek secure, virtual collaboration methods that can bring global/multi-disciplinary teams together and ensure harmonized efforts.

Question 7 – Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Hilderman: Demand for engineers is greater than supply and this will only worsen.

Mulcahy: More innovation in the UAV / Advanced Air Mobility (AAM) markets, but also more focus on the security of these solutions and the supporting infrastructure and regulations. It will be interesting to see how this combines with AI to develop fully autonomous and intelligent UAVs for civilian/military use cases. The need for larger companies to become more digital, deliver faster, and streamline operations will continue to be a focus.

Macias: The recent past has shown that innovative concepts are accelearating at such a high pace that we are continuously being surprised and amazed at new possibliities and impacts. The industry as a whole must seek faster awareness, greater agility and increase creativity to respond, leverage, and compete in the face of such dynamic times for Aerospace and Defense systems.

In this image, we portray a new 2025 predictions series, the first blog of which focuses on industrial project / product development.

2025 Predictions for Industrial Project/Product Development: AI, Sustainability, and the Future of Connected Devices

As the Industrial, Consumer Electronics, and Energy (ICE) industry races toward 2025, a landscape of rapid innovation, complex challenges, and transformative potential emerges.

In part one of our annual predictions series, we asked Richard Matt, Lead Consultant at Aspen Medical Risk, and our own industry expert Steven Meadows, Principal Solutions Lead at Jama Software, to weigh in on the industrial product, systems, and software trends they are anticipating in the coming year and beyond.

From the groundbreaking impact of AI and augmented reality to the evolving role of software development in enabling smarter, more secure devices, these predictions highlight both opportunities and hurdles. The conversation also touched on critical concerns, including bias in AI, job displacement, and the urgent need for sustainable product design.

Read on as experts explore what’s next for the industrial industry, addressing pivotal questions about technological evolution, environmental responsibility, and the innovations that will drive the next wave of progress.

We like to stay on top of trends in other industries as well. Read our predictions Automotive, Aerospace & Defense, Semiconductor, Medical Device & Life Sciences, and Architecture, Engineering, and Construction (AEC).

Question 1 – With the rapid pace of technological evolution, which emerging technologies (such as AI, IoT, or 5G) do you believe will most significantly impact the consumer and industrial electronics landscape by 2025, and why?

Richard Matt: Leveraging the connectivity between products in ways that increase value.

Steven Meadows: Artificial intelligence (AI) is set to be a game-changer for both the industrial and consumer electronics sectors. It will enhance user experiences through smarter product interactions, enable personalized recommendations, and deliver more accurate, predictive outcomes in how products are used and optimized.

Augmented reality (AR) is another transformative technology that is significantly enhancing both personal experiences and business operations. In the consumer electronics space, AR has elevated gaming and entertainment to new heights. Meanwhile, in the industrial sector, AR has become a key tool for remote assistance, real-time data visualization, and fostering better collaboration across teams.

Quantum computing is still in its early stages, but its potential to revolutionize computing power and unlock new applications is already becoming clear. Areas such as cryptography and optimization stand to benefit greatly, and as AI continues to demand ever-greater computational resources, quantum computing will play a crucial role in supporting the complex calculations and neural networks that drive advanced AI systems.

Question 2 – As a follow-up question: Do you have any concerns or anticipate any negative impacts as it pertains to AI & ML?

Matt: My only concern is lazy implementation that doesn’t look left and right for novel synergies and intuitive interfaces.

Meadows: While I believe that the benefits of AI will ultimately outweigh its negative impacts, there are a few key areas that warrant concern:

Bias is a well-recognized issue that requires continued attention and regulation. If AI systems are trained on biased data—whether related to gender, race, or other factors—there is a risk that these biases will be perpetuated in decision-making processes. Addressing discrimination and ensuring fairness in AI outcomes should be a top priority.

Job displacement is another major concern, particularly for workers in industries like manufacturing, customer service, and transportation. These sectors may be among the most affected by automation, and it’s crucial to consider how to support workers through retraining and job transition initiatives.

RELATED: Jama Connect® for Robotics Datasheet

Question 3 – As sustainability becomes a focal point, how do you see product design and manufacturing processes in electronics evolving to meet environmental goals? What specific innovations or practices could make the biggest difference?

Matt: When product retirement becomes an integral part of product development, sustainability will be addressed naturally and effectively.

Question 4 – The push towards smart and interconnected devices is stronger than ever. How do you anticipate software development will need to adapt to support increasingly sophisticated, integrated, and secure consumer and industrial electronics?

Matt: Software development needs to mature as an integral part of product development instead of a technical specialty that keeps to itself.

Meadows: As the demand for smart, connected devices keeps growing, software development will have to keep up by making sure everything works smoothly together, processes data in real-time, and stays secure. Developers need to focus on building systems that can easily connect with different devices and platforms, using AI and machine learning (if applicable) to make devices smarter and more predictive. Edge computing will become more common, so devices can handle data quickly on-site, cutting down on delays. Security will be key, with stronger protections like encryption and regular updates to fend off cyber threats. As devices get more complex and data-heavy, software will also need to be scalable and energy-efficient, reducing its environmental impact. Ultimately, software will have to help devices work together, provide secure and personalized experiences, and keep everything running sustainably.

Question 5 – Supply chain resilience and component shortages remain major concerns. How do you think electronics companies can leverage technology and software solutions to manage these challenges and improve supply chain agility?

Matt: Electronics companies can create a supply chain database with predictive algorithms that direct when to engage alternative suppliers.

RELATED: The Top Challenges in Industrial Manufacturing and Consumer Electronic Development

Question 6 – Data privacy and cybersecurity risks continue to grow with the rise of connected devices. What proactive steps do you recommend electronics firms take to safeguard consumer data and ensure robust cybersecurity standards in product development?

Matt: There are not that many attack vectors, so give cybersecurity a sliver of attention with qualified personnel. That is all you need to stop 80% of cyberattacks.

Meadows: To protect consumer data and keep devices secure, electronics companies should take a proactive, “security-first” approach right from the start of product development. This means using end-to-end encryption to keep data safe, adding multi-factor authentication (MFA) for user logins, and making sure devices have secure boot processes to stop unauthorized changes. Regular security checks and penetration tests should be part of the process to spot weaknesses before products are released.

Question 7 – Are there any additional insights you have regarding predictions, events, or trends you anticipate happening in 2025 and beyond?

Matt: Only ‘motherhood and apple pie’ suggestions:

Find something that gives a customer base a significant need and build a minimum-viable product around fulfilling that need.

Be laser-focused on your customer’s abilities and needs.

Connect with the Jama Software® Team in Person: Our Fall 2024 Event Lineup

Join the Jama Software® team in person this fall at some of the industry’s most exciting events. Whether you’re attending to learn about the latest trends in cybersecurity, systems engineering, requirements management, or Model-Based Systems Engineering (MBSE), our team of subject matter experts will be on hand to meet, discuss, and demonstrate how Jama Connect® can help you tackle complex development challenges.

Below is our lineup of events for September and October—let’s connect!

SIDO Lyon Cyber Expo – Lyon, France – September 18-19, 2024

  • Event Theme: Cybersecurity
  • Jama Software Representatives: Narmin Alizada, Partner Account Manager and Atef Ghribi, Senior Solutions Architect
  • Booth Number: E334
  • About this Event: Jama Software is exhibiting alongside Sofiatech at SIDO Lyon, the premier event for innovation in IoT, AI, XR, and Robotics! Visit us at Booth E334 — we’re excited to connect with forward-thinking leaders and innovators shaping the future.
  • Learn More: https://www.sido-lyon.com/en/visit/pre-register/

AUTOMA 2024 – Dusseldorf, Germany – October 14-16, 2024

  • Industry: Oil & Gas
  • Jama Software Representatives: Mate Harsing, Solutions Architect and Vlad Tanasescu, General Manager – ICE
  • Booth Number: 23
  • About this Event: The AUTOMA Congress is a B2B networking event focused on automation and digitalization throughout the oil & gas lifecycle. Connect with us at Booth 30 to see how Jama Connect empowers oil & gas companies to improve efficiency, quality, and schedules while reducing overall costs.
  • Learn More: https://automacongress.com/about/

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

Insuretech Connect – Las Vegas, USA – October 15-17, 2024

  • Industry: Insurance
  • Jama Software Representatives: Brian Morrisroe, Sales Lead and Susan Manupelli, Senior Solutions Architect
  • Booth Number: 3155
  • About this Event: Insuretech Connect is the world’s largest gathering of insurance innovation! Discover solutions to your biggest challenges, gain access to unique and meaningful education, and meet the insurance industry’s best and brightest.
  • Learn More: https://vegas.insuretechconnect.com/

MedTech Conference – Toronto, Canada – October 15-17, 2024

  • Industry: Medical Device & Life Sciences
  • Jama Software Representatives: Vincent Balgos, Director – Solutions & Consulting and Jason Gaither, Senior Account Executive
  • Booth Number: 503
  • About this Event: The MedTech Conference in Toronto is where industry innovators come together to drive the future of healthcare. Visit Booth #503 to connect with Jason Gaither and Vincent Balgos for live Jama Connect demos, expert insights, and exclusive swag!
  • Learn More: https://themedtechconference.com/

Autodesk University 2024 – San Diego, USA – October 15-17, 2024

  • Industry: Architecture, Engineering, Construction (AEC)
  • Jama Software Representatives: Joe Gould, Senior Account Executive, Steven Meadows, Principal Solutions Lead, and Kevin Andrewjeski, General Manager – Growth Markets
  • Booth Number: 163
  • About this Event: Autodesk University unites professionals from architecture, engineering, construction, product design, manufacturing, media, and entertainment to forge connections, celebrate innovations, and bring the future of AEC to life.
  • Learn More: https://conferences.autodesk.com/flow/autodesk/au2024/web/page/overview

Congress ELIV 2024 – Bonn, Germany – October 16-17, 2024

  • Industry: Automotive & Semiconductor
  • Jama Software Representatives: Matt Mickle, Director – Solutions & Consulting, Stefan Stange, Managing Director – Sales, and Neil Stroud, General Manager – Auto & Semi
  • Booth Number: 41
  • About this Event: Join us at ELIV Congress 2024 and discover the future of digital innovation in automotive electronics, software and application industry!
  • Learn More: https://www.vdi-wissensforum.de/eliv/call-for-papers/

RELATED: The Benefits of Jama Connect®: Supercharge Your Systems Development and Engineering Process

TSIA World Envision – Las Vegas, Nevada, USA – October 21-23, 2024

  • Industry: Softech
  • Jama Software Representatives: Brian Morrisroe, Sales Lead and Steven Meadows, Principal Solutions Lead
  • Booth Number: 226
  • About this Event: We’re sponsoring the TSIA World Envision Expo in Las Vegas, where tech executives and professionals gather to network, connect, and explore solutions. Visit us at Booth #226 and join our Expo Theatre Session on Wednesday, October 23, at 12:15 PM to discover the power of Jama Connect.
  • Learn More: https://www.tsia.com/conference

Reuters Automotive USA 2024 – Detroit, Michigan, USA – October 21-23, 2024

  • Industry: Automotive & Semiconductor
  • Jama Software Representatives: Neil Stroud, General Manager – Auto & Semi and Steve Rush, Principal Solutions Consultant
  • Booth Number: 18
  • About this Event: Reuters’ Automotive USA is the automotive industry gathers to hear from trailblazing OEMs, innovative solution providers, and government agencies tackling today’s biggest challenges. Be sure to stop by the Jama Software booth #18 and say hi!
  • Learn More: https://events.reutersevents.com/automotive/automotive-usa

NDIA 27th Annual System and Mission Engineering Conference – Norfolk, Virginia, USA – October 27-31, 2024

  • Industry: Aerospace & Defense,
  • Jama Software Representatives: Cary Bryczek, Director – Solutions & Consulting and Rob Wilmot, Senior Account Executive
  • Booth Number: 4
  • About this Event: The Annual Systems & Mission Engineering Conference gathers defense professionals from industry, government, and academia to discuss improving defense acquisition and system performance. Jama Software is hosting a workshop on Monday, October 28 at 5:00pm in the Imagination Meeting Room. No prior experience with MBSE or Jama Connect is required. Space is limited. Contact us to learn more!
  • Learn More: https://www.ndia.org/events/2024/10/28/systems-mission-engineering-2024

We’re excited to meet with you and explore how Jama Connect can optimize your complex projects. Don’t miss this chance to connect with our experts, dive into the latest innovations, and gain insights tailored to your specific needs. Be sure to mark your calendar and reach out to schedule a one-on-one conversation at any of these events!

TÜV SÜD Certification

The Top Six Things You Should Know About

In the quest for innovation, product testing, compliance, and safety certifications remain key to accessing markets and gaining customers. No one wants to buy a product, service, or process that hasn’t been thoroughly vetted by an independent body. In the context of global markets, few certifications carry the importance or significance of those from TÜV SÜD, but in the United States, the various companies that are part of the TÜV Association are not widely known. So, what is TÜV SÜD, and why is it so important to product development?

1: What does TÜV SÜD stand for?

“TÜV” stands for “Technischer Überwachungsverein,” which translates to “Technical Inspection Association” in English. There are several independent companies that are part of the TÜV Association; TÜV SÜD is headquartered in Munich and employs approximately 25,000 people around the globe.

2: What type of company is TÜV SÜD?

TÜV SÜD is focused on protecting people and the environment through rigorous testing, certification, auditing, and advisory services. The company helps ensure regulatory compliance of new and updated technologies, especially in automotive innovation and development, and it functions as a notified body in Europe for medical devices. The TÜV companies trace their origins back to the 1860s when they were first formed to oversee the safety of steam engines.

3: What is the difference between TÜV SÜD and TÜV Rheinland?

TÜV SÜD and TÜV Rheinland are different companies that both provide similar services. All TÜV companies are at least 25.1% owned by the TÜV Association. There are currently six main members of the TÜV Association, all of whom are denoted by the brand “TÜV” plus the regional suffix, such as SÜD or Rheinland. The other TÜV companies include TÜV Nord, TÜV Thüringen, TÜV Saarland, and TÜV Austria.

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

4: What is a TÜV SÜD Certification?

A TÜV SÜD Certification assures governing bodies and consumers that a product, service, or process has passed relevant safety testing and meets relevant compliance requirements. The certification process is rigorous and comprehensive and involves multiple steps, including steps to review requirements and establish processes followed during development.

5: Why is achieving TÜV SÜD Certification so important?

TÜV Certification is recognized internationally as a sign of quality and thorough review—similar to an ISO or UL certification. Although it originated in Germany, it is regarded globally as evidence that your product, service, or process has attained high standards of safety, quality, and sustainability. With a TÜV SÜD Certification, you can achieve access to additional markets and give your customers peace of mind.

6: Is Jama Connect® certified by TÜV SÜD?

Jama Connect received its first TÜV SÜD certification in 2016. Jama Connect is TÜV SÜD certified for developing safety-related products according to ISO 26262 (up to ASIL D) and IEC 61508 (up to SIL 3). Jama Software is the first vendor that is both SaaS and Agile to receive the certification. In 2019, Jama Software completed additional certification for Jama Connect as a software tool for the development of medical devices according to IEC 62304 and railway applications according to EN 50128.

RELATED READING: Simplify Compliance With Proactive Risk Management Software

Don’t neglect important certifications. Even if you are already pursuing other certifications, the TÜV SÜD Certification could be an important addition to your automotive, medical, or railway products and services. Jama Connect can help you meet the requirements tracing and process needs that will set you up to achieve the TÜV SÜD Certification and expand to new markets and customers. To learn more, contact us.

In this blog, we recap our webinar, “Bridging ALM and MBSE: Strategies for Seamless Integration” – Click HERE to watch it in its entirety.

Integrate Jama Connect® and Sparx Systems’ Enterprise Architect (EA) using LemonTree.Connect to align business and engineering objectives.

Join our experts Philipp Kalenda, Head of Consulting & Training at LieberLieber and Cary Bryczek, Director of Solution Architecture at Jama Software ® to discover how this powerful collaboration eliminates the gap between requirements engineering, system architecture, design, and product management.

You will gain a thorough understanding of these topics and more:

  • How Jama Connect®’s Live Traceability™ capabilities allow for seamless integration across best-of-breed tools.
  • How leveraging Jama Connect Traceable MBSE™ can act as a starting point for your MBSE efforts.
  • How to create a workflow for deriving systems architecture based on requirements from Jama Connect.
  • How LemonTree.Connect enables standard engineering domain practices for configuration management.
  • How to facilitate streamlined evidence that proves your architecture is satisfying requirements.

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

The following is an abbreviated transcript of our webinar.

Bridging ALM and MBSE: Strategies for Seamless Integration

Cary Bryczek: My name is Cary Bryczek. I’m the Director of Aerospace & Defense Solutions here at Jama Software. I’m really looking forward to speaking with you today on this particular topic and looking forward to Philipp’s presentation as well. So to kick things off, we are going to set … I just want to set the stage with some trends across the A&D industry that we’re seeing. I’ll talk about how those trends are creating challenges for chief engineers and describe what’s keeping them up at night. Then I’ll set the stage for Philipp’s presentation by showing you what Jama Connect’s Traceable MBSE™ looks like and how that’s designed to solve some of those challenges, and Philipp’s going to definitely take you on a deeper dive to show you how system models in Jama Connect interoperate.

In the aerospace and defense industry, developing a new system has a complexity that far exceeds commercial product development. For example, the FAA’s program to develop the unmanned aircraft traffic management system involves not just the pilot and his drone but is designed to enable autonomous and semi-autonomous operation of multiple aerial systems, including passenger and cargo delivery in a tightly integrated civil aerospace. The elements in blue that you see are all distinct systems of their own, and the new traffic management system needs to be able to integrate communications and data across all of those systems to provide this new capability.

In the highly constrained environment of outer space, NASA’s Cislunar and the Artemis program, for example, are focusing on the operation and survivability of autonomous systems. To develop a space system, NASA does not do this alone but has many contracts with companies to deliver parts of the system. For example, Blue Origin, they have two programs like the Friction Stir Additive Manufacturing Program and the Metallic Thermal Protection System are two examples of just parts of the system.

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

Bryczek: Canopy Aerospace, they’re developing a low-cost reusable thermal protection system. Roccor AKA Redwire in Erie, Colorado, they’re developing a characterization of high aspect ratio booms for these large apertures and so many more. This ecosystem of partners and contributing to a whole brings its own challenges to the pool when trying to collaborate, share data, and execute common systems engineering processes. Like the NASA’s Cislunar and Artemis initiatives for space exploration, they’re focusing on operation and survivability.

In the defense domain, we’re seeing all sorts of cases in unmanned aerial systems as well to aid tactical situations and help with strategic planning. The underlying theme of these large systems is the integration and the collaborative approaches to developing these different weapon systems and aerospace systems in very constrained environments.

So from a strategy perspective, what are these agencies trying to really do? Government agencies and aerospace and defense companies are always evolving their strategies to be able to deal with this complexity and to help streamline their engineering processes. For example, the Department of Defense (DOD) has published a new adaptive acquisition framework. This pathway is intended for large-scale traditional hardware acquisitions to facilitate rapid and iterative development and delivery of software capability to the user.

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

Bryczek: In 2018, the Digital Engineering strategy outlines a vision to modernize how the department designs, develops, delivers, and operates, as well as sustains systems securely and safely. Their vision is to connect people, processes, data, and capabilities across an end-to-end digital enterprise. The International Council on Systems Engineering (INCOSE) published its recent Vision 2035 document, and it is intended to inspire and guide the strategic direction of systems engineering, the practice of systems engineering for the global systems community.

MOSA, the Modular Open Systems Approach, it uses a system architecture that allows major subsystem components at the appropriate level to be incrementally added, removed, and replaced throughout the lifecycle of the major system. The DOD’s systems engineering and architecture group is focusing on modernizing the systems engineering practice. They’re leveraging capabilities from CERC. They’re using MOSA to build systems that can be upgraded and to incorporate new technology faster to respond to emerging threats.

When we look at this in a little bit larger view with this new modernization of the systems engineering approach, the DOD has moved away from visualizing its process using a V model in favor of what truly takes place from a process standpoint, which is that modern systems engineering is highly cyclic. You can see the outermost ring is as close to that old V model, where a concept definition is in the upper right, it moves the system definition through architecture and design and over to V & V and back-to-start around on the next cycle.

What’s important is that there’s a strong emphasis on measuring not just the system being built, but the process that’s building the system, your system’s engineering process and that data and models are at the heart of it all. To the fullest extent, models should be used in favor of documents and data should inform decision-making.

What is the industry saying? There’s a challenge to using data-driven approaches and models. The DOD has highlighted there’s a lack of an integrated approach to the implementation of these systems engineering focus areas, and it’s creating a delay in the full implementation of the digital transformation, which is necessary to ensure relevant guidance and skills.

RELATED: Leading Ground-to-Air Communications Systems Developer Indra Park Air Takes Off with Jama Connect®

Bryczek: Continuing to use legacy tools and approaches is what is making integrated approaches not possible. What is necessary is to take a federated approach to data across the tool ecosystem and to use tools with more robust APIs, and modern architectures that are standards-based. An MBSE approach requires an integrated approach to connect the system models, architecture, and requirements to the program teams the software teams, and the hardware teams. It doesn’t mean to use a siloed system modeling tool and expect those teams to be able to consume and understand that model.

What we hear quite often is, “How do I achieve the benefits of MBSE when no other engineers can access model parameters that they need for downstream decision-making?” Those with technical oversight, chief engineers who have technical oversight and responsibility for program success, executing MBSE, or even just traditional systems engineering commonly raise the following questions, “How do I know if the architecture and system requirements are satisfying all the needs? How do I know if a change in the architecture will impact testing? How do I know if a change in the architecture will impact downstream hardware or software teams? How do I detect unallocated systems architecture and requirements?”

So the question of, “How do I achieve the benefits of MBSE when no other engineers can access model parameters?” can be answered by using traceable MBSE. Now, the reality at most companies is that the end-to-end systems development process is fragmented into domain-specific tools and spreadsheets that have no built-in collaboration. Now, this leads to fragmented requirements traceability and requires significant manual effort through emails and meetings and sometimes luck to try and prevent delays rework, or cost overruns.

Most companies have come to accept the situation as an unchangeable reality given the lack of a single platform to enable this entire process, nor a method to integrate spreadsheets and desktop tools. Using Traceable MBSE, the system model in the modeling tool is joined with the Jama Connect model. Jama Connect is continually calculating traceability and coverage and provides scores that can be used to identify high-risk areas that can be drilled into to determine corrective actions. The system model can detect those changes and the modeling engineers can take the corrective actions.

CLICK HERE TO WATCH THIS WEBINAR IN ITS ENTIRETY:
Bridging ALM and MBSE: Strategies for Seamless Integration

Jama Software is always looking for news that will benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from PBC Today, titled “Integrating AI in AEC/O to Enhance Efficiency.” – originally published on June 4, 2024.

Integrating AI in AEC/O to Enhance Efficiency

AI’s use in the AEC/O industry has the potential to increase sustainability, efficiency, and decision-making, says Nemetschek Group.

From ChatGPT to the realm of robotics, AI appears to be everywhere.

In the time-honored tradition that follows the introduction of any new major technological leap – from the printing press back in the 15th century, right up to the democratization of the internet – conversations on the topic swing from the benefits AI will deliver to concerns over the risks that it poses.

As we have also seen in the past, once the dust has settled, AI will find its niche, whether it’s noticeable at the front end or hidden away at the back end of the services and technologies that we use in the future.

There’s no doubt that bad actors will use AI to their advantage, but events like the AI Safety Summit hosted in the UK last November will unite governments and the technology industry in a joint mission to create guardrails to ensure that, where possible, AI is used to benefit society, rather than compromise it.

Opportunities for AI in the AEC/O industry

Even at this early stage of AI’s evolution, there’s no doubt that the AEC/O industry should be excited about the opportunities that AI presents.

The technology has a role to play in helping the industry cut its carbon emissions and raw material waste through the implement of better ways of designing and constructing buildings.

The good news is that AI – tailored for the construction sector – already exists, although its usage remains somewhat discreet.

While it is less tangible and visible than in architecture or interior design, AI nonetheless represents a significant innovation for the construction industry; and, as the technology evolves and finds more applications where it can add value to our profession, it will become an invaluable part of our essential toolkit.

It is important that we are receptive to AI, despite any initial reservations or concerns we may have. Solutions supplemented with AI will emerge as formidable allies in addressing the crucial challenges the industry faces.

They will be essential in redefining our standards of efficiency, especially in meeting the challenges of ecological transition, precision, and profitability throughout project lifecycles.

Those are all commendable ambitions, and AI can help the industry meet them.

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

Planning and design: Navigating fluidly through complex data to facilitate decision-making while boosting productivity

Although the industry is still in the midst of a digital transition, data already plays an essential role. In fact, data processing – automated through AI-integrated tools – can revolutionize the planning and design phases of construction projects.

Aggregating information from multiple sources and stakeholders (architects, urban planners, project managers, etc) – which is always complex and prone to error or confusion – becomes smoother when supplemented with AI.

Furthermore, the digital model derived from Building Information Modelling (BIM) becomes more precise and detailed, reducing reliance on numerous – and sometimes very specific – third-party solutions.

AI also intervenes to provide more accuracy by analyzing data history heterogeneously and in real-time, thus avoiding manual inaccuracies. As a result, AI ensures the integrity of initial design models while establishing a mechanism for continuous improvement.

Such an approach significantly reduces the costly and time-consuming risks associated with human error.

Another major asset for the sector is the contextual analysis that AI can provide professionals. It leads to the overall design of a building, considering environmental factors such as local climate models. Those insights guide professionals in making proactive decisions when anticipating future challenges.

Construction and renovation: Enhancing quality and tackling logistics

AI facilitates real-time monitoring of construction progress by measuring it against the planned schedule. This approach immediately identifies programming issues or potential delays, enabling offsite managers to make informed decisions to meet deadlines.

During renovation and modernization processes, AI offers intelligent simulations, reducing the time and costs associated with these projects, even for older buildings.

While traditional buildings may lack complete historical data, AI has the capability to leverage 3D scanning and panoramic technologies to create new BIM models. This digitization process modernizes older structures to align with current design and sustainability standards.

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

Operations: Advancing data-driven management and sustainable practices through AI

AI will become an essential complement to the digital twin. It can already predict maintenance needs and automate malfunction detection through IoT sensors. This enables remote inspections and lifecycle analyses, increasing a building’s efficiency while reducing operating costs.

Perhaps more importantly, AI’s use in digital twins is pertinent in an era where sustainability is paramount, as AI algorithms can analyze real-time data from IoT sensors to identify inefficiencies in energy use.

It can also facilitate the smart search of structured and unstructured data. Therefore, AI-enhanced digital twins can also optimize other operational aspects – like space utilization and occupant comfort – by analyzing patterns and environmental variables to create an optimal work environment.

In this context, AI transforms the renovation and retrofitting process by enabling intelligent simulations that generate multiple design possibilities in seconds.

Whether the objective is sustainability or optimized lighting, AI-based models can visualize various scenarios, reducing both the time and cost associated with these projects.

The rapid advancements in AI are undeniably catalyzing a transformative shift across the AEC/O industry.

When used in conjunction with digital twins, AI is a powerful tool that enhances capabilities across planning, design, construction, and operations.

By way of practical example, a user can take a photo of a part of a building or an asset and search across the whole dataset for information relevant to the area they are interested in.

Building the future with AI

AI has quickly become a powerful tool for enhancing planning, design, construction, and operation capabilities.

It becomes the cornerstone of intelligent data-driven decision-making, which is essential for an industry aiming for innovation, sustainability, and operational excellence.

With so much focus on the environment – from governments, corporations, and consumers alike – and the AEC/O industry under immense pressure to address the damage it does to the environment, it’s imperative that it embraces technology like AI to become an even more responsible corporate citizen.

Understanding IATF 16949: A Quick Guide to Automotive Quality Management

In the ever-evolving landscape of the automotive industry, ensuring product quality and safety is paramount. One key standard that plays a crucial role in this pursuit is IATF 16949. In this article, we will delve into the intricacies of IATF 16949, exploring its significance, key elements, and benefits.

What is IATF 16949? IATF 16949, or the International Automotive Task Force 16949, is a globally recognized quality management standard specifically designed for the automotive sector. This standard is based on ISO 9001 and incorporates additional requirements tailored to the automotive industry. IATF 16949 was developed by the International Automotive Task Force (IATF) to promote quality, consistency, and continual improvement throughout the automotive supply chain.

This image portrays some of the automotive elements involved in the IATF 16949 regulation.

Key Elements of IATF 16949:

  • Customer Focus: IATF 16949 places a strong emphasis on meeting and exceeding customer requirements. This includes understanding customer needs, providing defect-free products, and consistently delivering high-quality services.
  • Process Approach: The standard adopts a process-oriented approach to quality management. Organizations are encouraged to identify, manage, and optimize key processes to enhance efficiency and effectiveness in meeting objectives.
  • Risk Management: IATF 16949 requires organizations to identify and address potential risks within their processes. This proactive approach helps in preventing issues, ensuring product safety, and maintaining a robust quality management system.
  • Supplier Quality Management: Recognizing the interconnected nature of the automotive supply chain, IATF 16949 places a significant focus on supplier quality management. Companies must work closely with their suppliers to ensure that quality standards are consistently met throughout the supply chain.
  • Continuous Improvement: The standard promotes a culture of continual improvement, urging organizations to regularly assess and enhance their processes. This commitment to ongoing refinement helps companies stay ahead in a competitive market.

Benefits of Implementing IATF 16949:

  • Global Recognition: Achieving IATF 16949 certification provides organizations with global recognition, enhancing their credibility and opening doors to new business opportunities.
  • Improved Efficiency: By adopting the standard’s process-oriented approach, organizations can streamline their operations, reduce waste, and enhance overall efficiency.
  • Enhanced Customer Satisfaction: Meeting IATF 16949 requirements ensures that products and services consistently meet or exceed customer expectations, leading to higher satisfaction levels.
  • Risk Mitigation: The focus on risk management helps organizations identify potential issues before they escalate, reducing the likelihood of defects and recalls.
  • Competitive Advantage: IATF 16949 certification provides a competitive edge in the automotive industry. Many OEMs (Original Equipment Manufacturers) prefer working with suppliers who adhere to this globally recognized standard – and many companies are required to comply.

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

Who is required to comply with IATF 16949?

Companies that are part of the automotive supply chain, including manufacturers, suppliers, and service providers, may be required to comply with IATF 16949. This includes organizations involved in the production of automotive parts, components, and assemblies.

Key stakeholders in the automotive industry, such as original equipment manufacturers (OEMs) and their suppliers, often seek IATF 16949 certification to demonstrate their commitment to quality and compliance with industry standards. Certification to this standard is often a prerequisite for becoming a supplier to major automotive companies.

It’s important for organizations in the automotive sector to assess their specific contractual requirements and the expectations of their customers to determine whether compliance with IATF 16949 is necessary for their business. Certification to IATF 16949 is typically achieved through a third-party audit process conducted by accredited certification bodies.

What is a Quality Management System?

A Quality Management System (QMS) is a comprehensive framework of policies, processes, procedures, and records that an organization establishes and maintains to ensure its products or services consistently meet or exceed customer expectations. The primary goal of a QMS is to enhance customer satisfaction by consistently delivering high-quality products or services while also meeting regulatory requirements. It encompasses various elements such as quality planning, control, assurance, and improvement. A well-implemented QMS helps organizations identify and document their processes, set quality objectives, and monitor performance against these objectives. It often involves the use of standardized methodologies, documentation, and quality tools to foster a systematic approach to quality management, ensuring that every stage of the product or service lifecycle is controlled, measured, and continually improved upon. Certification to internationally recognized QMS standards, such as IATF 16946 and ISO 9001, provides external validation of an organization’s commitment to quality and can enhance its credibility in the marketplace.

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

How can Jama Connect® help?

Jama Connect® is a powerful tool that plays a pivotal role in assisting teams in meeting the requirements of a QMS within various industries, particularly those with stringent regulatory standards.

Here are several ways in which Jama Connect facilitates compliance with QMS requirements:

  • Documenting and Managing Requirements: Jama Connect provides a centralized platform for documenting and managing requirements throughout the product development lifecycle. It allows teams to create, review, and collaborate on requirements, ensuring clarity and consistency. This centralized approach enhances communication among team members, reducing the risk of misunderstandings and improving overall requirement management efficiency.
  • Enabling Risk-Based Thinking: The platform supports risk-based thinking by providing tools to identify, assess, and mitigate risks associated with product development. Teams can systematically evaluate potential risks, assign risk levels, and implement mitigation strategies. This proactive approach aligns with the risk management requirements of QMS standards, contributing to safer and more reliable product development.
  • Assisting with Change Management Processes: Change management is a critical aspect of QMS, and Jama Connect streamlines this process. Teams can efficiently capture and evaluate proposed changes, assess their impact on requirements and other project elements, and implement changes in a controlled manner. This ensures that changes are documented, reviewed, and tracked, promoting transparency and accountability in the change management process.
  • Enabling Traceability of Processes and Products: Jama Connect offers robust traceability features, allowing teams to establish and visualize relationships between requirements, tests, and other project artifacts. This traceability is crucial for demonstrating compliance with QMS standards, as it provides a clear linkage between various stages of the development process, from initial requirements to final product validation.
  • Easy Documentation for Evidence for Audits: Jama Connect simplifies the documentation process required for audits. The platform enables teams to generate comprehensive reports, traceability matrices, and documentation trails that serve as evidence of compliance with QMS standards. This facilitates smoother and more successful audits, as auditors can easily review and verify the necessary documentation.
  • Supporting a Continuous Improvement Process: Continuous improvement is a fundamental principle of QMS, and Jama Connect supports this by providing analytics and insights into project performance. Teams can analyze data on requirements, testing, and other project metrics to identify areas for improvement. This data-driven approach fosters a culture of continuous improvement, aligning with the principles of QMS standards.
  • Supporting a Customer Focus with Traceability to Customer Needs: Jama Connect helps maintain a strong customer focus by establishing clear traceability from requirements to customer needs. This ensures that the final product aligns with customer expectations and requirements. The platform’s traceability features provide a visual representation of how each requirement contributes to meeting customer needs, strengthening the customer-centric approach advocated by QMS standards.

IATF 16949 is a critical standard for the automotive industry, emphasizing quality management, risk mitigation, and continuous improvement. Organizations that invest in achieving and maintaining IATF 16949 certification position themselves as reliable partners in a highly competitive and demanding market, ensuring the production of high-quality automotive products.

Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Matt Mickle and McKenzie Jonsson.

This image displays the title of this blog, focused on Secure by Design for medical device.

Secure by Design: A Crucial Imperative for Medical Device Teams

In today’s healthcare landscape, technology plays a crucial role in patient care. Medical devices have become essential for monitoring vital signs and administering treatments. However, as these devices become more connected and complex, ensuring their security is now more important than ever. This is where the concept of “Secure by Design” comes in, serving as a fundamental principle for medical device teams to navigate the intricate world of healthcare technology. Which begs the question, with the rise in security concerns, do regulations now need to consider whether each device is safe, effective, and secure?

Understanding the Landscape

Medical devices have advanced beyond being simple, independent systems. With the rise of the Internet of Things (IoT), devices are now interconnected, allowing for the exchange of data. While this connectivity has many advantages, it also opens vulnerabilities that could be exploited by malicious entities.

Cybersecurity threats not only put patient data at risk, but also the health of those who rely on these devices. It’s also a costly and time-consuming process for medical device companies to manage, and resolve. According to IBM Security analysis of research data compiled by Ponemon Institute, 83% of organizations have had more than one security breach, and the average cost of each breach averaged $4.3 million globally. That number more than doubles for the average cost of a security breach in the United States – $9.44 million – the highest in the world.

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

The Essence of Secure by Design

Secure by Design is a proactive approach that prioritizes security in the development process. Rather than treating security as an afterthought, it is integrated into the design and development phases. For medical device teams, this means implementing security measures from the start of a project, considering potential threats and vulnerabilities, and implementing safeguards to reduce risks.

Key Principles of Secure by Design:

  • Risk Assessment: Before beginning development, medical device teams must conduct a thorough risk assessment. This involves identifying potential threats, understanding vulnerabilities, and evaluating the potential impact of security breaches on patients and healthcare providers.
  • Data Encryption: Due to the sensitive nature of healthcare data, encryption is a crucial aspect of secure design. Implementing strong encryption protocols ensures that patient information remains confidential and secure during transmission and storage.
  • Access Control: Limiting access to medical devices is crucial. Secure by Design stresses the importance of implementing strict access controls, ensuring that only authorized personnel can interact with the device. This prevents unauthorized users from tampering with critical settings or accessing sensitive patient data.
  • Regular Software Updates: Vulnerabilities in software can leave devices vulnerable to cyber threats. It is essential for medical device teams to prioritize regular software updates and patches to address potential security risks. This ensures that devices can withstand evolving cyber threats.
  • User Education: Even the most secure devices can be compromised if users are not vigilant. Secure by Design also includes educating end-users on cybersecurity best practices. This ensures that individuals using medical devices are aware of potential risks and take necessary precautions.

Regulatory Landscape and Compliance

The healthcare industry must comply with strict regulations to protect the well-being of patients. Regulatory agencies, such as the Food and Drug Administration (FDA), acknowledge the significance of cybersecurity in medical devices. Following regulatory guidelines is not only a legal obligation, but also a dedication to ensuring the utmost safety and security for patients.

Challenges and Solutions

Implementing Secure by Design in the development of medical devices can be challenging. Balancing the need for innovation with strict security measures is complex. Additionally, the ever-changing landscape of cybersecurity threats requires constant attention.

Solutions:

  • Collaboration and Training: It is crucial to foster collaboration between cybersecurity experts and medical device developers. Ongoing training for the development team ensures they are informed about the latest security threats and mitigation strategies.
  • Third-Party Security Assessment: Engaging third-party security experts to regularly assess medical devices can provide an unbiased perspective on their security. This external validation can uncover blind spots that internal teams may miss.
  • Incident Response Planning: Despite preventative measures, security incidents can still occur. A robust incident response plan allows medical device teams to promptly and effectively address breaches, minimizing their impact on patients and healthcare providers.

RELATED: The Complete Guide to ISO 13485 for Medical Devices

The Future of Medical Device Security

As technology continues to advance, the healthcare industry is constantly evolving. Medical device teams must be proactive in anticipating and addressing potential security challenges to stay ahead of the curve. Secure by Design is not a one-time effort, but an ongoing commitment to the safety and well-being of patients.

It is not just best practice, but a moral imperative for medical device teams to integrate security into the DNA of their development process. By doing so, they contribute to a safer and more resilient healthcare ecosystem. The future of healthcare relies on innovation, connectivity, and security, and it is the responsibility of medical device teams to ensure that these pillars remain strong.

Jama Connect® for Medical Device Development

Jama Connect for Medical Device Development helps medical device teams reduce the effort required to achieve regulatory compliance throughout the development process. With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market. Learn more: Solution Overview: Jama Connect Solution for Medical Device Development

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

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

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from IndustryWeek, titled “AI, XR and Data: Manufacturing Technology Predictions for 2024” – written by Dennis Scimeca and originally published on January 3, 2024.

AI, XR and Data: Manufacturing Technology Predictions for 2024

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

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

AI’s 2024 Prospects

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

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

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

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

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

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

RELATED: 2024 Predictions for Product and Engineering Teams

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

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

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

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

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

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

AR/VR

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

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

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

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

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

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

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

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

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Data and Digitization

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

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

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

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

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

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