Tag Archive for: Requirements & Requirements Management
Jama Connect® Features in Five: Jira Integration
Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of the powerful features in Jama Connect®… in about five minutes.
In this Features in Five Integration Series video, Mario Maldari– Director, Solutions Architecture at Jama Software® – will demonstrate the Jama Connect® to Jira® integration.
VIDEO TRANSCRIPT
Mario Maldari: Hello and welcome to the Features in Five Integration Series. My name is Mario Maldari and I’m the Director of Solution Architecture here at Jama Software. Today, we’ll be walking through the Jama Connect to Jira integration. We make it possible for you to integrate Jama Connect with preferred best-of-breed software to achieve Live Traceability™ across the end-to-end development cycle. Live requirements traceability is the ability for any engineer at any time to see the most up-to-date and complete upstream and downstream information for any requirement, no matter the stage of systems development or how many siloed tools and teams it spans. This enables significant productivity and quality improvements, dramatically reduces the risk of product delays, cost overruns, defects, rework, and recalls, and ultimately results in faster time to market. Let’s get started.
The Jama Connect to Jira integration allows for bidirectional synchronization of data between requirements and tasks. This allows for teams such as software developers to stay in their tool of choice and enjoy the benefit of real-time updates between the two applications. Today, we’ll be covering two core use cases for the integration. We’ll be creating a defect in Jama Connect that will synchronize to Jira, and then we’ll be creating an epic in Jira that’ll synchronize over to Jama Connect. Let’s start by executing a test case at Jama Connect’s Test Center. Let’s start our test run here and we can go through and pass or fail steps accordingly. We get to an issue, we can log a defect right from the test, and we can set things like priority. Go ahead and save that defect. And we can go ahead and save and close this test.
Maldari: Then we can open up the test record here and we can take a look at the relationships. And as expected, we will see a link to a downstream defect that we just created. Let’s take a look and open up that defect. And we can see there’s an integration URL to the corresponding defect over in Jira that was just created. And as a developer, I can see a new defect came in and I can start to work on this defect. I can also change things like priority. I can also add a comment. Any field that’s set up to participate in the integration, such as name, description, comments, priority, all of these things can be modified from Jira and that will be synchronized over into Jama Connect. And now you’ll see that there’s a Jama Connect URL here, and this will take us back to the defect that we just created in Jama Connect.
And we can see that the priority has been set below. We can see that there’s a comment that’s been added to add an attachment, and we can actually go ahead and add an attachment here, a picture of our cracked camera. And we’ll attach that to the item. So conversely, anything in Jama Connect that’s participating in the integration, any field, name, description, priority, all of these changes from the Jama Connect side will also be reflected over on the Jira side. And so if we navigate back over into the Jira defect, we’ll do that by following this URL here, we can see that our attachment came over onto the Jira defect.
Similarly, if we’re in Jira now, we’re working and we want to create an epic, we can go ahead and create an epic. Usability improvement, we can go ahead and create that. And then let’s take a look at that epic that we just created here. Similar to the defect scenario, any field that’s set up and configured in the integration will synchronize between the two applications, and that includes the name, description again, comments, and priority. Any field that’s configured will sync over. Then if I refresh this epic that I just created, you can see now that there’s a Jama Connect URL to the correspondent epic that’s just been created in Jama Connect. So I can go here into Jama Connect and I can add things like tables and further elaborate the description, and ask the development team to fill out the table for me.
Maldari: But more importantly, what I can do is start to establish traceability within Jama Connect now. Assuming maybe this usability improvement request came from a particular customer, I can link it to an upstream requirement, or initiative, in this case, usability improvement from the customer. And so I can start to establish traceability now, now that it’s in Jama Connect. All the work is being done in Jira on this epic, but the traceability is being established within Jama Connect. So I’m always getting the latest changes over from the Jira side participating in my traceability within Jama Connect. Let’s take a look back over to the epic in Jira, and we can see the table that I just added from Jama Connect showing up here. You can even see that there’s now an upstream link reference that gives me a reference to the traceability that I just created on the Jama Connect side.
So as you can see, the integration allows teams such as software developers to work in Jira while allowing for real-time status updates to flow over to Jama Connect and be reflected in various traceability views. This way, teams are guaranteed to have the latest status on their projects. Thank you for watching this Future in Five session on the Jira integration for Jama Connect. If you’re an existing customer and want to learn more, please reach out to your customer success manager or consultant. If you’re not yet a client, please go to our website at jamasoftware.com to learn more about the platform and how we can help optimize your development process.
https://www-dev.jamasoftware.com/media/2024/02/FIF-Jira-Integration.jpg10801920Mario Maldari/media/jama-logo-primary.svgMario Maldari2024-03-01 03:00:552024-03-04 13:54:53Jama Connect® Features in Five: Jira Integration
The ‘Square Root’-Process Model for System Engineering
In the rapidly evolving field of systems engineering, the traditional V-model has served as the cornerstone for development, defining system requirements and verification processes. However, the demands of modern engineering necessitate an extension of the V-Model to reduce time-to-market and elevate customer satisfaction. This article introduces the ‘square root’ model that extends the V-model that embeds continuous feedback and integration throughout the product lifecycle. By considering production, operation, support, and end-of-life sustainability from inception, the ‘square root’ model, visually represented in the accompanying diagram, ensures that engineering efforts align with practical constraints and market needs.
Leveraging Jama Connect®‘s advanced features, we will explore how this model fosters collaboration, efficiency, and strategic foresight, setting a new standard for systems engineering excellence.
Throughout this article, when ‘product’ is mentioned, understand that it can also refer to a service, software, or system.
There are aspects in engineering and feedback loops that the V-model implies to improve the engineering assets (mainly Verification and Validation focused) at the same information abstraction level; This article will describe the need to extend the traditional V-model to ensure the estimated time-to-market can be met with ease, customer satisfaction improves each product iteration and create a better tomorrow, using Jama Connect unique features to support your engineering teams to achieve these results.
Where the traditional V-model, starting at ‘Stakeholder Requirements’ and ending at ‘Acceptance Tests’ (or ‘Validation’), describes the engineering’s team involvement in the product being engineered, it is important to understand that this is only a small part in the entire lifecycle of a product. It’s the repeatable part for that product’s new releases and it’s the part that can be used to analyze the impact of changes before that change gets implemented in production.
The word “constraint” has a negative connotation; Design constraints are limitations on what designers can do with a design. These limitations are usually byproducts of having deadlines, budgets, brand guidelines (and similar guidelines, see below), laws and regulations, finite resources, and limited decision power in terms of tools and processes.
Some product engineers view design constraints in a bad light because they feel like they’re being boxed in by a brick wall, while others embrace design constraints as directional guidelines that open the doors to creativity and strategic problem-solving.
On the surface, having design constraints can indeed feel like a bad thing; however, they can be extremely useful. Being limited to certain choices doesn’t necessarily mean being limited to certain outcomes. Often enough there are alternative options that are, at least, almost as good as what you originally envisioned.
Design constraints can come from various sources, in this article we’ll talk about the constraints that focus on time-to-market, customer satisfaction, and zero waste. In other words, design guidelines come from:
Production;
Operation and Support;
(Ecological) Sustainability; the recycling of your product’s used materials.
These design constraints facilitate engineering with the end in mind. Your team’s early decisions during product definition must include upgradability, serviceability, and for sure: disposal, and sustainability.
Please Note: As these are complex topics by themself and not part of the core business of Jama Software, this article will only emphasize the need for feedback from these product lifecycle phases into the product definition as design constraints. Design constraints might also be known and used as Non-functional Requirements (i.e., the different ‘-bilities’, like producibility, serviceability, etc.)
Production and Manufacturing
When production and manufacturing aren’t involved from the start, your engineering team might waste valuable engineering time and effort on a product that cannot be manufactured with the means your production facilities have at their disposal. This means that the product’s entire time-to-market will need to be extended to re-engineer the product to your current production capabilities; wasting precious time and putting your competitive edge at an unnecessary risk.
As an example, a Printed Circuit Board (PCB) might require that a set of components must be aligned in the same direction and at a specified distance when wave soldered to avoid short-circuits in operation. These wave soldering characteristics can be recorded and maintained in Jama Connect as Design Constraints. Source: https://www.mclpcb.com/blog/wave-soldering-issues/
The other side of this same coin; By knowing what your production facilities can and cannot do at the start of the product definition, your teams are capable of estimating when the new bleeding-/leading-edge product they are developing needs new production means.
These insights, when considered at the beginning of the product definition, will allow your teams to research, develop, and implement the required new production techniques and have them ready when the product hits the factory shop floor. This includes having purchasing ready with new suppliers, their delivery times, required stock levels, and other input required for your factory shop floor to hit the ground running producing your new product when it completes its V-cycle.
Operation and Support
The full value of a system or product is realized in its use and operation during the expected product lifespan. Your customers want to receive a product that meets their expectations, but those expectations extend beyond a product that works on day one. Customer Satisfaction, and thus Customer Lifetime Value, is heavily influenced by the ease and availability of maintenance, servicing, and upgrades that will extend the product’s lifespan. When a customer calculates Return on Investment (ROI), they are not only considering receiving a working product, but they are also factoring in;
Mean Time Between Failures (MTBF, a metric for failures in repairable systems);
Mean Time to Failure (MTTF, a failures that require system replacement);
Mean Time to Repair/Recovery/Respond/Resolve (MTTR, is the average time it takes to repair/recover/respond/resolve a failure in a product, service or system, usually technical or mechanical. It includes both the repair time and any testing time. The clock doesn’t stop on this metric until the system is fully functional again); and
Mean Time to Acknowledge (MTTA, a metric useful for tracking your team’s responsiveness and your alert system’s effectiveness).
Reliability represent a series of metrics designed to help customers understand how often incidents occur and how quickly they, in collaboration with your Operation and Support, bounces back from those incidents. Valuable indicators to determine if their investment, and any additional investment to keep it operational, is effective.
Analysis of these reliability, MBTF, MTTF, MTTR and MTTA metrics focused on means to reduce these indicators, lead to product enhancements that improve customer satisfaction for both users (better uptime, improved performance, etc.) and decision makers (value on their investment).
E.g., the accessibility of a repairable component, to improve the MBTF, can be recorded and maintained in Jama Connect as a design constraint.
Sustainability
For sustainability, it all starts with the design. The design decisions for the product contribute 80% to the carbon footprint of the solution! How to make your products and systems ‘green’ from the start, a topic most companies struggle with.
Once your teams start to include sustainability in your product’s mission, you’ll need a structured approach, as several factors will push for different considerations. The most obvious considerations are the choice of materials and the optimizing the production process (reducing carbon emissions).
However, the repairability/serviceability of the product should be considered with a more extended lifetime vision, just like upgradeability and reusing components.
Techniques like Lifecycle Analysis (LCA, shows how much influence a product has on the environment during its entire life cycle: from raw material extraction to waste processing) exist to determine the Design Constraints necessary for the sustainability of the product being developed.
The (material) considerations that come out of an LCA (e.g. switch from fossil fuels to hydrogen) can be recorded and maintained in Jama Connect as a design constraints.
Jama Connect supports the ‘square root’-model
Collaborate with stakeholders from Production, Operation & Support and Environment, Health & Safety
Recording design constraints is not unique to a (Requirements Management, or Product Definition) application like Jama Connect; The ability to collaborate with colleagues in reviews, from the respective product lifecycle phases that normally don’t have to deal with the product definition phase (and thus don’t work in Jama Connect) is unique.
This unique feature allows your teams to engineer your products with the end result in mind, by involving the stakeholders from beyond their own engineering reach, to collaborate and achieve the optimum time-to-market, best customer satisfaction and create a better tomorrow for ourselves and future generations.
These stakeholders don’t require to be Jama Connect users to be invited and collaborate in a review within Jama Connect. Involving those stakeholders into the review process allows these stakeholders to verify their design constraints are adequately and sufficiently addressed by the requirements of your product definition.
First step in sustainability; reuse as much as possible
Not only does reusing and synchronizing requirements reduce your time-to-market and improve quality, but it is also a key strategy for getting your products sustainable. Jama Connect can help reducing the struggle to build on existing work when requirements, and their corresponding test cases, are spread across documents and systems, missing Live Traceability™. Your teams must manually identify and copy related content increasing the risk of rework and gaps. Additionally, teams tend to lack visibility across efforts, causing necessary changes to not propagate across reused content, potentially impacting quality and disconnected product design efforts.
Jama Connect simplifies and enhances the process of reusing requirements and verifications by allowing you to copy selected content with its container and its traced items. Synchronization ensures visibility and enables key use cases such as parallel product definitions, common content libraries (i.e. reusable component libraries) and product variants.
Further reading
INCOSE (International Council on Systems Engineering): INCOSE is a professional organization dedicated to promoting and advancing the field of systems engineering. Their website (www.incose.org) offers a wealth of resources, including publications, articles, and conferences, that cover various topics in systems engineering, including the V-Model.
https://www-dev.jamasoftware.com/media/2024/02/2024-2-29-square-root-process-model-for-system-engineering.png512986Danny Beerens/media/jama-logo-primary.svgDanny Beerens2024-02-29 03:00:372024-02-26 17:26:07The ‘Square Root’-Process Model for System Engineering
The Seven Steps to Performing FMEA
Welcome to this deep dive into the world of FMEA
Failure Mode and Effects Analysis (FMEA) is a powerful tool used in various industries to identify and mitigate potential failures in a process, product, or system. In this blog, we will take a detailed look at the seven steps involved in performing an FMEA.
Clearly define the boundaries of the process, product, or system you are analyzing, assemble a multidisciplinary team consisting of experts from different areas to ensure a comprehensive analysis.
2: Break down the process.
Divide the process into manageable steps or components. This helps to identify potential failure modes at each stage.
3: Identify potential failure modes.
Brainstorm all potential failure modes for each process step. These are the ways in which the process or component could fail to perform its intended function.
4: Assess the severity.
Assign a severity rating to each failure mode based on its potential impact on the customer, product, or process. This helps prioritize which failure modes require immediate attention.
5: Determine the causes.
Identify the root causes or factors contributing to each failure mode. This requires conducting thorough analysis and gathering relevant data.
6: Evaluate the current detection controls.
Assess the effectiveness of the current controls in place to detect or prevent failure modes from occurring. Identify any gaps or weaknesses that need to be addressed.
7: Calculate the risk priority number RPM.
The RPM is a numerical score obtained by multiplying severity, occurrence, and detection ratings. This allows you to prioritize which failure modes require immediate action
By following these seven steps, you can perform a comprehensive FMEA and proactively identify and mitigate potential failures or risks in your process, product, or system. Remember, FMEA is an iterative process that requires continuous improvement. Regularly review and update your analysis as new information becomes available and track the effectiveness of your implemented actions. Thank you for diving deep into the seven steps of performing FMEA. Now you have a better understanding of how to apply this critical process in your industry.
Note: This article was drafted with the aid of AI. Additional content, edits for accuracy, and industry expertise by Karrie Sundbom, McKenzie Jonsson, and Decoteau Wilkerson.
https://www-dev.jamasoftware.com/media/2024/02/2024-2-22-seven-steps-fmea.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2024-02-22 03:00:272024-02-21 12:49:39The Seven Steps to Performing FMEA
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Scilife, titled “Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization” – written by Angel Buendia and originally published on March 31, 2023 and updated January 3, 2024.
Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization
The US Quality System Regulation describes the requirements for quality management systems of medical device manufacturers based in the United States. It was launched in 1997, making it more than 25 years old. While the regulation originally shared many concepts with ISO13485:1996, it still needs to be updated sufficiently to encompass the changes in the industry.
Set to start work in 2018, the complexity of the update, paired with a global pandemic, has delayed the harmonization. However, we should be seeing the final rule soon.
ISO 13485
ISO 13485:2016 describes the requirements for a quality management system for medical device companies. The first version of ISO 13485, based on ISO 9001 Quality Management Systems, was issued in 1996. The standard is updated every five years.
Why harmonize?
Having harmonized regulatory systems in the major global markets significantly helps medical device manufacturers comply with international regulations. Furthermore, global harmonization work, such as the MDSAP, can more easily take steps to reach international regulatory alignment.
The FDA acknowledges the strength of the ISO 13485 approach to quality management and points to several ISO 13485 principles that are stronger than the FDA 21 CFR 820.
Medical device regulations aim to improve the safety and efficiency of medical devices on the market. The harmonization of standards helps medical device manufacturers streamline their processes and ensure the quality of their medical devices globally.
While the two regulations have evolved to be substantially similar, there are some key differences that the FDA will need to address. In their communication from February 2023, FDA outlines the scope and proposed updates to the regulation. While most of the changes are about revising the regulation to mimic ISO 13485 closer, there are more extensive updates afoot:
Definitions: The FDA is planning to revise some of the definitions in the US regulation, such as “management with executive responsibility,” “Device Master Record (DMR),” “customer,” and others, to match ISO 13485. Likewise, the FDA is choosing to retain some of its definitions that do not match the international standard, such as “manufacturer,” “product,” and “device.”
Incorporate ISO 13485 by reference: The FDA will remove all Quality System Regulation (QSR) provisions substantially similar to ISO 13485 and directly reference the standard.
Quality system requirements: Currently, quality management systems in the US must comply with CFR 21 part 820. A proposed regulation modification will ensure that quality system requirements are standardized across regulations, highlighting compliance with FDA requirements where there are discrepancies.
Clarification of concepts: the FDA is clarifying the concepts of organization, safety and performance, and validation of processes to explain how ISO 13485 relates to the statutory and regulatory framework in the US.
Supplementary provisions: the FDA is looking to add additional requirements to ensure consistency and alignment with other regulations and laws in the US. These additional requirements fall within record control and controls for labeling and packaging.
Conforming amendments: The FDA will amend other parts of the CFR, such as part 4, to reflect the modifications made to part 820.
Language updates: The new Quality System Management Regulation (QSMR) also plans to update the language surrounding some concepts to adapt sections of ISO 13485 to existing FDA requirements. For example, to comply with the ISO 13485 section on the identification of medical devices, US manufacturers must label their devices with a Unique Device Identifier (UDI). Additionally, manufacturers must submit medical device reports (MDRs) to the FDA as described in 21 CFR 803 for compliance with the ISO 13485 section on reporting.
Impact on medical device manufacturers
So, how will this harmonization of regulations impact medical device manufacturers? The two regulations have evolved to resemble each other, and the day-to-day operations of medical device manufacturers will likely stay the same. However, quality departments will need to change their quality systems substantially.
Risk management activities must be increased. Several risk analyses are required in ISO 13485 to identify potential hazards in device design and hazards due to user errors. Essentially, US manufacturers must shift to a proactive risk management system instead of the reactive system of the past. A proactive risk management system actively monitors market behavior and trends to identify and mitigate risk, and it builds risk management plans that define how to handle any data that might impact the device’s benefit-risk profile.
Harmonization to ISO 13485 will not change the authority of the FDA. Medical device manufacturers with an ISO 13485 certification will not be exempt from FDA inspections, nor will they be granted certificates of conformance based on their ISO 13485. However, obtaining ISO 13485 certification will significantly help companies comply with the FDA regulations, as having formalized and effective processes are required for both certifications. Likewise, having FDA certification will help manufacturers obtain ISO 13485 due to the similarity in process requirements.
Regulatory compliance is expensive. By harmonizing regulations and standards, the FDA ensures that manufacturers can obtain compliance with both the FDA requirements and ISO 13485 relatively quickly, as the quality system processes will be similar. Once the initial implementation is complete, medical device manufacturers can save significant resources on quality system compliance due to the reduced need for quality management systems that comply with different regulations. The FDA estimates annualized net cost savings of approximately $439 million due to the reduction in compliance efforts of medical device manufacturers who currently comply with both standards. This includes reductions in personnel training, information technology needs, and documentation requirements.
The big question is – when will this final rule be issued, and when will medical device manufacturers have to comply with it?
In February 2022, the FDA gave the public 90 days to comment on the proposed rule. They then suggested a one-year implementation time. A one-year implementation date is short for medical device manufacturers and the FDA; the industry has called for a more extended implementation period.
However, there has yet to be any news on the implementation date of the rule. The first anniversary of the proposed rule has come and gone and the QSR and QSMR were both missing from the FDAs semiannual regulatory agenda issued in February 2023. Based on that, it is unlikely we will see the harmonization rule published in 2023.
https://www-dev.jamasoftware.com/media/2024/02/spotlight-ad-4-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2024-02-20 03:00:202024-02-16 12:28:12Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization
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.
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.
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].
https://www-dev.jamasoftware.com/media/2024/02/2024-2-08-secure-by-design.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2024-02-15 03:00:272024-02-13 10:06:47Secure by Design: A Crucial Imperative for Medical Device Teams
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.”
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.
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.”
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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 Innovation News Network, titled “Expanding EV infrastructure in the US: Both on- and off-road” – originally published on November 20, 2023.
Expanding EV Infrastructure in the US: Both On- and Off-Road
The expansion of electric vehicle infrastructure in the US has been challenged by various issues, from governance to location. Here, we explore the issues and how they can be combated.
The evolution and expansion of electric vehicle (EV) infrastructure, encompassing both on-road charging stations and off-highway electrification, is a burgeoning topic in the United States. This issue has been characterized by significant regional disparities, with varying levels of availability across different parts of the country.
Furthermore, it is marked by distinct challenges that arise in urban versus rural settings as well as on- and off-road contexts. The role of government support and policy direction also comes into play in shaping this landscape.
As interest in electric vehicles continues to surge, understanding the intricacies behind their supporting infrastructure becomes increasingly crucial. Off-highway electric vehicles have their own unique set of requirements when it comes to charging infrastructure, presenting numerous design and manufacturing challenges.
Looking ahead, predicting future trends within this area is challenging due to its rapidly evolving nature but nonetheless vital for planning and strategizing growth trajectories within this realm.
Availability of EV infrastructure in the US
The uneven distribution of electric vehicle charging stations across the United States underscores a significant disparity, with coastal areas generally boasting greater availability than their counterparts in the Midwest and rural regions.
This can be attributed to several factors, including regional disparities in both population density and average income level, which directly influence infrastructure cost and consumer adoption rates of EV technology.
For instance, densely populated urban centers, particularly those along the coasts such as New York City or San Francisco, tend to have higher per capita incomes. These areas are more likely to invest in expensive EV technology and support the infrastructure costs associated with establishing charging stations.
The increased presence of these facilities subsequently encourages more consumers within these regions to adopt electric vehicles due to decreased concerns over charging time.
In contrast, regions characterized by lower population densities or average income levels –such as many Midwestern states and rural areas – are typically less equipped with EV charging infrastructure. This results from a combination of factors: reduced consumer demand for EV technology due to financial constraints; longer distances between destinations that increase concern over charging times; and higher per-unit infrastructure costs arising from the need for more extensive grid enhancements in less developed areas.
As such, despite growing national interest in reducing carbon emissions through transitioning towards electric vehicles, these challenges contribute significantly towards regional disparities in the availability of EV charging stations across America.
Thus, it is imperative that future efforts aimed at expanding this crucial segment of green transportation infrastructure consider these distinctive geographical characteristics and obstacles.
The challenges of expanding EV charging infrastructure
Significant stumbling blocks surface when scrutinizing the surge in electric vehicle utilization, particularly pertaining to potential power supply problems, prohibitive price points of charging stations, and a paucity of policies promoting progress. These issues include:
Infrastructure costs
The establishment of an extensive network of charging stations necessitates substantial capital outlay from both public and private sectors. The latter’s involvement is critical since government funding alone may not suffice.
Technological limitations
Current technology restricts rapid mass-charging capabilities, potentially leading to power grid stress during peak demand periods. This limitation necessitates additional investments in technology development and grid reinforcements.
Public awareness
Despite growing interest in electric vehicles, many potential users remain uninformed about their benefits or how to utilize existing EV infrastructure effectively.
Sustainability concerns
While electric vehicles significantly reduce greenhouse gas emissions compared to conventional fuel cars, the production process itself can have a substantial environmental footprint, largely due to battery manufacturing processes.
The availability of EV infrastructure in rural and urban areas
Differences in the accessibility and utilization of EV charging stations between rural and urban areas present a nuanced challenge in promoting wider adoption of this sustainable mode of transportation. Rural EV adoption faces obstacles such as a lack of public charging infrastructure due to less population density and greater travel distances.
Moreover, financial considerations play into these disparities as well; the high cost associated with the installation and maintenance of charging stations may not be justified by the potential low usage in rural settings. This situation leads to EV accessibility being heavily skewed towards urban regions where there is higher demand.
On the other hand, urban planning challenges also arise in expanding EV infrastructure within cities. The densely populated nature of urban environments results in space constraints for installing new charging stations. Available funding also becomes a critical factor – adequate EV infrastructure funding is necessary for both the construction and operation of sufficient charging facilities to meet growing demands.
Additionally, differences between these two types of geographies are reflected not only on human mobility but also have an impact on the environment.
While increased use of electric vehicles can significantly reduce greenhouse gas emissions in densely populated cities, achieving similar outcomes in rural areas can prove much more difficult due to their unique characteristics.
Government support
In light of these challenges, it is noteworthy to mention the initiatives taken by American governmental bodies to bolster the proliferation and accessibility of charging amenities for electric vehicles. The US Government has employed a mixture of methods to support this development:
Federal incentives
At the federal level, several incentives have been introduced over recent years to encourage EV adoption. For instance, the Electric Drive Vehicle Battery and Component Manufacturing Initiative provided $2bn in grants for manufacturing of advanced batteries and electric drive components.
Private partnerships
On top of direct funding, the US government also fosters private partnerships aiming at enhancing electric vehicle infrastructure. An example would be the ‘EV Everywhere Grand Challenge’, launched by the Department of Energy (DOE), which works with national laboratories, universities, private industries, and other governmental agencies to increase availability of high-speed charging stations across country.
Infrastructure financing
Additionally, there are efforts directed at infusing capital into public charging infrastructure through financing programs like the Clean Cities Alternative Fuel Vehicle Deployment Initiatives which allocated millions towards building EV charging stations nationwide.
Technological advancements and environmental impact
Given that environmental impact is a key driver behind the shift towards electric vehicles, governmental policies are expanding physical infrastructure but also investing in research & development for technological advancements that could reduce emissions further while improving EV range and battery life.
Developing off-highway EV charging infrastructure
The development of charging facilities for electric vehicles designed for non-highway use represents a unique and complex challenge, necessitating innovative solutions and strategies. Off-highway adaptations require not only the installation of charging stations in remote or less accessible areas but also the incorporation of infrastructure financing to support their construction and maintenance.
Technological advancements have been pivotal in addressing these challenges, making it feasible to develop energy-efficient charging systems that can withstand harsh environmental conditions while providing reliable service. These advancements range from solar-powered charging stations to smart grid technologies that optimize electricity usage during off-peak hours.
Investing in this type of infrastructure is critical for promoting sustainable solutions within the transportation sector, particularly in industries such as mining, agriculture, and construction where off-road vehicles are prevalent. The integration of renewable energy sources with charging infrastructure offers dual benefits: reducing greenhouse gas emissions associated with traditional fossil fuel-based power generation and extending the reach of EV technology into areas beyond urban centers.
Furthermore, public-private partnerships offer potential avenues for securing necessary funding without placing undue financial burden on local communities or individual businesses.
As such, developing an efficient and resilient off-road EV charging network requires a holistic approach incorporating technological innovation, targeted investment strategies, and sustainability considerations.
The challenges of designing and manufacturing off-highway EVs
Designing and manufacturing electric off-highway vehicles presents unique challenges, with research indicating that a significant one is ensuring these machines can withstand the rigors of heavy-duty applications, an issue reported by 60% of manufacturers. Battery longevity is a critical concern in this regard since off-road vehicles often operate in extreme conditions that could quickly diminish battery life.
Similarly, terrain adaptability is another challenge. Electric vehicles must be designed to handle diverse terrains, from rocky landscapes to sandy dunes, without compromising on performance or energy efficiency.
Material sourcing poses yet another problem due to the need for lightweight but highly durable materials for construction. This brings us to durability concerns which are paramount because, unlike regular city electric cars, off-highway EVs have to endure harsher operational conditions requiring them to be more robust and longer-lasting.
Finally, cost efficiency continues to be an obstacle as developing high-performance, yet affordable electric off-highway vehicles remains a struggle for many manufacturers, due to the high costs associated with batteries and other essential components.
The future of EV infrastructure both on- and off-road
Transitioning from the challenges of designing and manufacturing electric off-highway vehicles, it is pivotal to envision what the future holds for EV infrastructure. This includes both on- and off-road contexts, as each comes with its unique set of considerations pertaining to infrastructure financing, renewable energy integration, vehicle-to-grid technology, and battery disposal methods.
The future landscape of EV infrastructure will likely be shaped by a variety of factors. The pace at which this change occurs may largely hinge upon infrastructure financing – securing sufficient funds to create an expansive network of charging stations that facilitate higher EV adoption rates. As more consumers opt for electric vehicles, there will be an increased demand for reliable and accessible charging facilities.
Therefore, investment in this sector is crucial not only for supporting current users but also promoting further uptake.
Simultaneously, the integration of renewable energy sources into these infrastructures represents a crucial aspect. By harnessing power from sustainable resources such as solar or wind energy, the environmental impact can be further mitigated while optimizing energy usage overall.
Moreover, vehicle-to-grid technology presents another promising avenue where electric cars do not just draw power but can feed surplus back into the grid during peak demand hours – thereby acting as mobile energy storage units. This could revolutionize how electricity grids operate while offering additional revenue streams for EV owners.
Lastly are considerations regarding battery disposal methods. With growing numbers of electric vehicles on- and off-road comes increased volumes of spent batteries which necessitate effective recycling or disposal strategies to minimize environmental harm and potential resource losses.
Thus, these aspects collectively indicate a multifaceted future wherein technological advancements must go together with strategic planning and responsible practices.
The US Government’s solutions offer hope
In conclusion, the path to an electrified future, both on- and off-road, resembles a vast and uncharted road. Despite challenges such as regional disparities in charging station availability, hurdles in infrastructure expansion, and manufacturing complexities for off-highway vehicles, progress is being made.
The US Government’s support, alongside innovative solutions, offers hope that these obstacles can be overcome. As the dawn breaks on this new era of transportation, one cannot help but feel a sense of anticipation for what lies ahead – a highway illuminated by the promise of sustainable mobility.
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In this blog, we recap our whitepaper, “Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management” – Download the entire thing HERE
Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management
In an industry as longstanding, complex, and regulated as insurance, it’s easy for inefficiencies to creep in. Companies use the same old systems and processes that others have used for decades, and in the crunch to manage the day-to-day business, the drive to update and streamline can get lost in the shuffle.
But in the modern business world, where everything moves at the speed of the Internet and consumers expect new and improved products constantly, insurance companies can’t afford to fall behind on product upgrades and new product development. Old systems and processes keep products from getting to market in a timely manner. How can insurance product developers keep up with demand while meeting business needs and regulatory requirements?
The right requirements management solution can help bridge the gap between product development and the marketplace.
Where The Insurance Industry Needs Requirements Management: Two Scenarios
There are two main scenarios where requirements are needed in the insurance industry. The first is in the policy administration systems that automate the day-to-day operations of an insurance company. While every insurance company is unique, most share processes for day-to-day operations and have some kind of policy administration system. It may be a unique proprietary system, designed specifically for that company, or it may be provided by an outside software vendor. This policy administration system manages the day-to-day operations of the insurance company in three areas:
Policy Administration: To administer an insurance policy, the company must quote, bind, and issue the policy and process endorsements, cancellations, reinstatements, and renewals.
Billing/Accounting Administration: The policy administration system must also manage the financial side of each policy. This administration involves processing initial down payments and providing payment plan options; processing cancellations or reinstatements around non-payment of premiums; processing refunds and collections; and producing an annual statement and statistical reporting.
Claims Administration: Finally, the policy administration system must process insurance claims, including first notice of loss, claims payments, and reinsurance.
Even listing the basic types of information that must be processed doesn’t capture the complexity of the details that have to be managed by the policy administration system. For example, while there is one set of requirements related to insured risk and coverages, there is an entirely different set of requirements for the output to describe both static and variable data that must be printed. In addition, every policy needs to have changes at some point, which are processed as endorsements. There are different rules for different types of endorsements, which will be captured as separate requirements. At each stage and level of the policy there are different requirements that must be applied.
The list of requirements across different functions and processes in the insurance industry is almost endless; managing these requirements according to the massive number of variables across products, risks, jurisdictions, and so on can quickly become overwhelming and cumbersome. In addition, when the requirements aren’t managed or applied properly, gaps and errors can easily arise, leading to administrative challenges at best, legal challenges at worst.
The second area where the insurance industry needs requirements management is in the new and enhanced insurance products and services that insurance companies want to develop and roll out to customers. Designing and introducing new products and services involves new states or geographies with different rules and regulations. Enhancing existing products can involve rate changes or additional coverages. In addition, with new or enhanced products, the policy administration system will need new or upgraded interfaces and other upgrades to the system. Introducing even one new or enhanced product can cause system-wide ripples that can impact everyone from the corporate office to the local agent.
In a world this complex, with this many details, insurance companies need a purpose-built requirements management system to allow them to effectively and efficiently respond to change.
The common thread to implementing a robust and comprehensive policy administration system is understanding the requirements of the core business processes.
Business requirements are the needs of the company, regardless of whether there’s a system to process the work.
Stakeholder requirements are the requirements needed for a specific user to be able to process that information in a specific type of system, but they do not need to be specific to the system. These requirements are the ones that a user (such as an agent or claims adjustor) would need to accomplish the business requirements.
Solution requirements (functional and non-functional) are the technical requirements that each software solution must have to accomplish stakeholder requirements.
The big key to gathering requirements in all three areas is that the requirements must be reusable. While each software company may have a preference on the format used for the implementation, the business and stakeholder requirements should be reusable within any system so that software requirements can be tailored to the specific implementation strategy.
The Four Main Challenges for Insurance Requirements Management
There are currently four main challenges facing the insurance industry when it comes to requirements management.
1. Introduction of Agile Methodology
The move to agile methodology created a mindset in the insurance industry that requirements weren’t necessary for software development and upgrades. Shortly after the agile revolution began, the IIBA, International Institute of Business Analysis, which is the governing body for business analysts, suggested that business analysts had to adjust to this methodology by evolving to support these new ways of working—not just in software development, but in any area of business analysis where changes happen rapidly. Since then, business analysts often say, “requirements are in the code,” suggesting that requirements are just an extra step that takes too much time.
The reality is that not everyone is a developer who can read and interpret code. Business analysts know the requirements of the business and stakeholders, but they don’t necessarily know how to gauge whether the software meets those requirements. Likewise, software developers may not know the needs of the insurance business without someone who can communicate requirements.
Requirements and requirements management are essential for project success, in part because they reduce the risk of project failure or cost overrun. The solution is not to eliminate requirements to work faster; rather, it’s to manage requirements more efficiently to meet the demands of the market.
2. Unwillingness to Change Outdated Requirements Processes
Change is difficult for a lot of reasons, and it’s not uncommon to hear “we’ve always done it this way” or “if it’s not broken, we don’t need to fix it.”
However, outdated methods of requirements management cannot keep pace with modern needs, and relying on old processes inhibits new product development and innovation. Business analysts should be catalysts for change and demonstrate the efficiencies of new processes throughout the organization.
Another obstacle to change is summed up by the statement, “we’ve managed without requirements management all this time—why is it so important that we do this now?” This attitude represents a misunderstanding about requirements in general. They have always been necessary, and they’ve always been around, whether documented in a specific way or simply discussed in general terms.
Unfortunately, adding new processes to consistently use and reuse requirements can sometimes mean extra work that nobody has time for. Again, this is where business analysts can step
into the fray and be catalysts for change.
3. Reliance on Document-Based Requirements Management Tools
Too many insurance companies rely on document-based tools such as Microsoft Excel spreadsheets and Word documents to manage requirements. These tools are just too time-consuming to manage and can become quickly obsolete if they’re not consistently and constantly updated. It’s also very cumbersome to provide appropriate traceability for testing and test planning using these types of tools. Imagine trying to sit down with four or five different Excel documents and trace the requirements all the way through!
4. Complex Collaboration Across Teams, Departments, and Stakeholders
There is often a great deal of difficulty collaborating within teams, departments, and various stakeholders involved on a project. When it comes to developing and launching new insurance products, collaboration is vital to success, but coordinating schedules and sharing documents can often result in confusion. Fragmented collaboration also introduces the risk of siloed activities and tools; when teams and tools exist independently of one another in different formats and processes, coordination and collaboration become cumbersome at best, impossible at worst. Old tools and processes introduce risk, whereas modern requirements management systems allow people to collaborate at their own pace and provide documentation necessary to clarify and approve requirements.
To solve these challenges, any requirements management system adopted by insurance companies should address four main issues:
Maintenance and Traceability: The system must allow requirements to be easily maintained and traced across all teams, stakeholders, and functions throughout the development process. Having the ability to quickly identify requirements and their related functionality is essential for making informed decisions quickly. Lack of maintenance and traceability can lead to major product delays and make it difficult to shift resources from core business tasks to breakthrough innovation initiatives.
Easily Adapt for Future Innovation: A requirements management solution for insurance should allow current state requirements to always be ready for future state innovations, drastically reducing the time to market for new and improved products. Having the ability to integrate existing requirements with new functionality is essential to quickly move breakthrough innovative initiatives from development to market.
The traceability functionality really drew Farm Bureau Insurance to Jama Connect because it is easy to identify within the workflow.
“Traceability in Jama Connect® makes it easier to assess the impact of a proposed change,” says Blundy. “It helps identify all areas we have to modify and then gives us the ability to route the change for review and approval with ease. A single source of truth also improves consistency, for example, having templates built into Jama Connect — with all templates located in a single spot — means we’re all using the same template. And we’re following the same processes when writing, sending, and closing requirements.” – HEIDI BLUNDY, BUSINESS AND TECHNICAL ANALYST AT FARM BUREAU INSURANCE
Standardization of Reusable Requirements: Having a standard way to reuse existing requirements reduces the risk of project failure, achieves cost savings, and ultimately increases customer satisfaction and return on investment. With standardized requirements, team members who need to review and respond to the requirements can perform their roles more effectively and efficiently.
Centralization of Requirements: Effective collaboration in the development of insurance products is vital to successful product development, and having your requirements in a central place to quickly find and use is key to effective collaboration.
https://www-dev.jamasoftware.com/media/2024/01/21658cf6c5-a29c-4964-a8f2-eeb5bdddc2bb.jpeg512986Jama Software/media/jama-logo-primary.svgJama Software2024-02-01 03:00:492024-01-31 17:13:20Bridging the Gap in Insurance Product Development: How Jama Connect® Can Streamline Requirements Management
Pioneering Excellence in Healthcare: Q&A with Systems Engineering in Healthcare
The following is the transcript of a Q&A session from this event. Please note that the answers were given verbally and may not be exactly as recorded. Some changes have been made for clarity.
“What are some insights for product development teams to consider when keeping up with the speed of innovation?”
Chris Unger: Separate out research (from development), and spend certain time on long lead items. Typically, our programs are 6 to 18 months. And so, if there is basic research that takes more time, make sure you have a certain amount of your budget – 5, 10% – with risk retiring the initial basic piece of the work, and the handoff between research and [development] programs in where we think we can retire the remaining risks in the 12 months. And then the rest of it has to really focus on what is really core. Eating the elephant one bite at a time. Focus on what’s really innovative. But one of my general managers said, ‘You want your product development to be a wall. Big, small, small, big, small.’ Product development should be a phased approach where you work on various scoped tasks. Focus on the high-risk and most innovative stuff. Low-hanging fruit can wait. Spend the time really on the breakthrough, and then maybe every six months for the next year just do small iterations, maybe some covers, maybe some better user interface and workflow, while you’re buying time for the next major innovation to come through. So, portfolio management.
Bijan Elahi: With respect to risk management, innovation in new technologies is useful for reducing risk to medical devices. You may have seen the definition of “state of the art” in the latest edition of ISO 14971 Standard, which says that the manufacturers are required to consider the consolidated findings of technology research practice to incorporate into the medical devices to reduce risks as much as possible. However, it also says that the latest technology state of the art is not necessarily the latest technology [from all industries]. And medical devices, we are a little slower than other industries like semiconductors. So, for us, state of the art must be generally considered good practice, and then innovations that are proven and accessible to be used to reduce risk.
Chris Unger: The other comment I might make is one of the reasons you slow down is scope creep. For every function, every person is like, “I just need my one. It’s just small.” It’s the straw that breaks the camel’s back. And one of our most successful businesses, the ultrasound team, said that time to market and this time blocks delivery was a team effort. Instead of having one person beating away, that all the functions sort of gang up on each other. It’s like, “Well, I didn’t put my extra in.” We’re all committed to delivering this every year, something important every year. And so rather than having the program manager fighting for scope, it’s the team that says, “Look, I’m willing to commit to this limited scope to get something this year, you help me out.” So, make sure it’s the team’s focus on speed to market.
Vincent Balgos: In this post-pandemic event, collaboration can pose a challenge in working remote, hybrid, onsite, especially for systems engineering and risk management where we need to work across the aisle amongst different types of groups.
Vincent Balgos: “So my question to maybe Bijan first, is what are some lessons learned that you’d offer to maintain efficiency and progress, that works better than others? And we are a bunch of engineers here, definitely want to talk about technical, but are there any key soft skills that we may also want to consider as well?”
Bijan Elahi: In one of my classes, I teach that you need to cultivate humility and curiosity. So, what do I mean by that? As I said, risk management is a team sport, and humility does not mean self-deprecation, it means to recognize that the answer is not all within you, it’s within your team. And the curiosity part is that some people are just shy about sharing their thoughts. So, curiosity is to seek it. It doesn’t always just come to you. So, this is a soft skill that I can offer you, to cultivate humility and curiosity.
Chris Unger: This is a good advertisement for the February webinar I am hosting with Jama Software. I was going to plan something on requirements writing techniques, which will probably be later in the year. I’d say a couple of things, make sure that you focus on communication. So, in a crisis, a lot of people just focus on getting their work done. And the first thing that you should maintain, a lesson straight off, is making sure you talk to the team, that you get consistency and use simple forms, and keep publicizing. Example like “What are my decisions? What are the important ones?” Just keep over-communicating, it’s something simple in the survival handbook, “Guys, here’s my list of decisions, here’s my list of risks.” Keep it simple, keep it single reference.
And the other thing I do is, don’t use that to communicate, use that to archive your decisions. I get really annoyed when my team says, “I wrote defects in the tool. Of course, they’re going to respond.” Talk to people, call them up, ask them questions. Do they understand? Do they understand why it’s important to do this? Do they accept that it’s their defect? I had one, my first program at my previous employer, we got to each milestone, we had like a hundred open defects. And people came to me complaining, “Well, I got rid of my defects. I fixed 50 of them and I transitioned 50 to every other defect. But it’s not fair Chris, because everybody else transitioned their defects to me last night. How am I supposed to…” But we’re a team. Don’t reassign the defect in the tool and assume they’ll accept it. Talk to them. Say, “I’m going to reassign these five defects to you. Do you agree that they’re yours?” Talk more than use the tool to communicate. I love Jama Connect. I love the risk management aspect, all the risk files. But if you are going to assign a risk mitigation to somebody, talk to them before you assign them.
Vincent Balgos: “What are some market and technology trends you see coming to the industry in 2024?”
Bijan Elahi: The big ones are Artificial Intelligence (AI) and Machine Learning (ML). A lot of medical devices are now deploying technologies that are based on AI and ML. And this has really created the challenge for risk management. In fact, we don’t know how to really completely answer this yet. This is an unanswered question. And the regulatory agencies, ISO experts, they’re all working on this. So, answering this question of how do we manage the risks of a medical device that is constantly changing? With current medical devices, if you want us to make a change to it, you’re supposed to submit something to the FDA. What about a medical device that is changing by the hour? It’s not really possible to keep making submissions. So, this is one of the challenges that’s happening in 2024.
Chris Unger: Yeah, that’s the obvious thing. I was a skeptic. People a long time ago said, “Are you doing AI machine learning?” And I kept responding with “No, it’s not ready. It’s not ready.” It’s ready. It’s coming. It’s now. It’s 2024. I wouldn’t say it’s a 2024 trend, it’s ongoing and continuing in cybersecurity. I mean, all these things are connected. That we want to network. Radiologists want to work remotely. It was a long time ago that somebody talked to us and said, “Look, this is great. I’m the head of a radiology network in northern Jersey. We’ve got five radiologists. And when people come to my clinic, I’ll do a quick read of every scan in my area, but I’m the liver guy. So, all the liver scans get sent to me. And somebody else is the head guy.
But that means a network, which means you’ve got huge network security. So, cybersecurity is just always going to get more and more critical. And we’ve never been liable. We’ve had hospitals come to us saying, somebody’s stuck a USB stick into your system and you let that virus go and it infected their network, but it went through your product. Why didn’t you protect it? And that was a huge malware. Whatever ransomware hospital costs more money than effective fiber is going to be way more effective.
Audience Question: “I was curious, looking at your workflows with the dotted lines, I recently debated whether usability engineering should be its own pillar containing risk, containing system requirements or embedded within the existing infrastructure for those. Do you have any pros or cons or suggestions on whether you should look at usability engineering independently as a whole? Or as part of the risk plan system requirements plan?”
Bijan Elahi: Usability engineering is very well integrated into risk management. It is its own discipline, and it has its own standard IEC 62366:2015. But a lot of its work products are very similar to an actual integration with an ISO 14971 workflow. So, I can’t say that it should be independent, but I say integrated with risk management.
Chris Unger: Yeah, I think it’s both and, not either or. As Bijan said, there’s a use analysis report that is mandated. So, it’s its own discipline and it’s part of everything. It’s part of workflow. Remember I said, “Gee, we want, custom things that are easy to use. No training needed, just use it.” And that’s a customer value. It’s part of marketing. Think about reliability. So, if I take this and I drop it… what are the stresses? How do I test this stuff? It’s part of uses. When we did things, it was probably two-thirds of our reliability issues were unexpected use cases. So, we had this baby warmer, and it was in Philadelphia, so they had cobblestone streets, and they were just transporting it from one wing of the hospital to the other, no baby in it. And there was an infrared warmer, it went over it and the interim warmer fell over to where the baby would be. Because it was doing a shake test going over the cobblestone. And we didn’t think about that.
Another case we had a mobile X-Ray. Takes an X-ray system, moves it into the surgery, into the ICU, the recovery room. And it’s a battery… It was probably 600, 700 pounds. Great when you have this big hulking tester and they move it over this expected ramp, something like this was easy to move it over. You get 110-pound nurse in a hospital with a two-centimeter step going into the elevator and guess what? The only way they could get over the ramp was to take a running start and use the momentum. We had wheels falling off. What was that? So, we went to the hospital and watched them. Oh! We expected like 5 Gs and the upper limit (UL) is like 50 Gs or 10 x factor plus 200 Gs. Once we designed for 200 Gs, wheels stopped falling off. So, usability is part of reliability engineering. So, it’s part of everything and it’s used in analysis report.
Audience Question: This is a more general question, but for companies that have two or more variants of a product, what are your recommendations? And this is to both of you about managing both product development and product assets. So, let’s say 90% of the assets are common across three variants and how to handle risk management when the clinical usage of those three variants could be different?
Bijan Elahi: With respect to risk management. EU MDR allows you to do risk management for a family of projects. So, if this is a family that are very similar, you can do a common risk management and then do differential risk management for the differences between them to submit.
Vincent Balgos: I’ll also add that varying management configuration is a hot topic within the medical, especially as you build family of products and then you build your… Let’s say child products off that. How do you reuse and share some of that information for efficient product development? So, this is where Jama Software is really a great, unique opportunity where we’ve actually learned from other industries, particularly in automotive and in terms of how they deal with those different types of variants. So, we’re incorporating some good practices off the bat and again, happy to talk with each of you, especially if there’s specific questions on how to solve some problems.
Audience Question: My question is about integration. I mean we see more and more devices now have the ability to work together with solutions from other vendors. How can we can be prepared for that? I mean sometimes if your product is on the market, and somebody wants to use it and integrate it with a different solution. How can we be prepared for that from both a system engineer design perspective and for risk management?
Chris Unger: System engineering is kind of simple. Keep a configuration compatibility matrix to ensure that this version of your product is compatible with what version. And then really think through the use cases. The rainy day and sunny day. We had cases where our monitoring central station… So, we built some temperature monitors, fetal monitors, cardiac monitors, but we also then built a central station that have to work with our sensors but anybody’s sensors in the world. And we did pretty good with that.
We had a recall where somebody would plug in a… I forget what it was… temperature monitor? But it was a safety-critical device in the intensive care unit, and we didn’t have a fast enough response that it was plugging in. Usability. So, the nurse pulled it out, put it in again, pulled it out, and put it in again. And finally, the system had a race condition. It said you pulled it out, and when they put it in it tried to reset. So, the nurse had thought that it was plugged in it, and it wasn’t. And so, the nurse was assuming that the patient’s heart rate was monitored when it wasn’t, we had to recall the entire product. So have a standard interface. Have a compatibility matrix and test the unusual customer uses.
Bijan Elahi: With respect to risk management, if you’re making a medical device that is supposed to work with other medical devices together, then the together becomes a system. The patient is experiencing the risks that could come from the integration of all the devices that connect with your device. To manage the risk of that, what you need to know is which devices are going to plug into your device and then you test them to make sure that they’re safe together. And then you make a list of approved compatible devices that could be used with your device and your manufacturer makes another device that wants to be used with yours and you must check that too. Just keep expanding your list of approved devices.
https://www-dev.jamasoftware.com/media/2024/01/new2024-1-25-medical-q-and-a.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2024-01-31 03:00:242024-02-06 11:05:54Pioneering Excellence in Healthcare: Q&A with Systems Engineering in Healthcare
Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from IndustryWeek, titled “How Can Technology Advance Our Lean Effort?” – written by Doug Berger and Conrad Leiva originally published on November 20, 2023.
How Can Technology Advance Our Lean Effort?
Lean has played a significant role for the past few decades in driving efficiency across manufacturing organizations by providing people with the data and methods for eliminating waste, improving factory flow, and focusing on customer value. Lean techniques have promoted simple, intuitive visual and analytical approaches to decision-making, problem-solving, and continuous improvement.
The “digital lean” movement stays true to lean principles while taking advantage of the real-time and data-centric techniques from smart manufacturing and Industry 4.0.
Digital lean amplifies the core strengths of both methodologies. It works best when the operations improvement team pulls in technology to add value for specific process improvements and avoids pushing technology because there is good buzz about it. When deployed to support people and process gains, digital lean unlocks even greater levels of efficiency, quality, velocity, and adaptability in operations.
Extending Value
Digital lean achieves gains with technologies like automated data collection, analytics platforms, digital dashboards, artificial intelligence, and integrated workflow systems. It amplifies both the measurable performance and qualitative employee engagement gains.
The following illustrates the added value that well-placed digital technology can bring to a lean effort in three key areas:
1. Reducing Waste
Reducing downtime through predictive maintenance: Unplanned downtime is wasted time and disruptive. Planned maintenance on a fixed schedule, regardless of equipment condition, is also wasteful. Instead, advanced sensors for conditions such as vibration, force, and temperature can be installed on machines, monitored in real-time, and analyzed by AI-based predictive maintenance algorithms to trigger maintenance when needed based on machine usage and monitored conditions.
Reducing defects with real-time detection: Lean has always had a focus on the waste from out-of-spec quality, material scrap, and rework. Automated in-process quality monitoring through sensors, computer vision, and artificial intelligence (AI) can detect small deviations, including deviations not visible through traditional methods. It can spot in real-time when a process is trending out of its control range, triggering warnings and corrective action.
Reducing waste through enhanced value stream mapping (VSM): The typical VSM is infrequently conducted and based on estimated processing times. Digital process monitoring allows the enterprise to perform VSM with precision processing times, error rates, variations, and other statistics that are not readily available with more traditional manual tracking.
Minimizing inventory waste through automated material tracking: Auto-ID technology such as radio-frequency identification (RFID) sensors and advanced analytics make it easier to accurately track raw materials, work-in-progress and finished inventory location and levels. The consumption of raw materials is monitored in real-time and triggers replenishment automatically. This reduces unnecessary purchases and out-of-stock due to data errors or not locating inventory. Replenishment levels can be lowered with confidence.
Improving flow with automated movement and handling: Lean has long recognized that any movement of material is less than ideal. Practical considerations often limit the ability to rearrange equipment at a production site. Automated guided vehicles (AGVs) and cobots make it practical to move smaller production batch sizes to achieve continual flow of material, lessening the labor wasted in manual movement. With sensors, routing instructions, and AI, the AGV is automatically placed at the work center in anticipation of completion. From the perspective of the part, it is continuously moving from workstation to workstation with no wait time.
3. Improving People Utilization
Improving work rhythm with real-time digital dashboards: Smart dashboards are configured to automatically use collected data to generate charts, diagrams, and other displays that support everyday decision-making processes. Digital and on-displays mounted in hallways around the plant are updated in real-time. Accurate, timely data is key to improving flow and using people effectively.
Reducing errors with digital work instructions: Operators review the latest standard operating procedures (SOPs), work instructions, and checklists on monitors or mobile devices. This can improve consistency and reduce waste due to operator error.
Eliminating clerical steps with a paperless factory: “Pushing paper” is a form of wasted worker time and expertise. Every instance of a person transcribing information or data entry is non-value-added. The paperless factory eliminates this waste as well as errors introduced through manual data collection.
Improving talent use with online training: Workers are better utilized when they learn to perform a wider range of tasks. Tablets, augmented reality (AR), and virtual reality (VR) are becoming more popular to train workers on new tasks, without risking the impact of learner mistakes on the actual product, especially when the potential mistakes would be a safety concern or costly scrap.
Perform a variant of the typical value-stream mapping technique and include the steps involved with handling the paperwork. Review the wasted time and errors in your paper-based processes. Consider the improved productivity through eliminating manual steps.
Better data will give you more visibility into the value stream and areas of waste, constraints, and bottlenecks.
In a ‘What if’ mode of thinking, prioritize your areas of opportunity. Over the past several years, commercial technology solutions have reduced the need for custom solutions. This is making digital lean more available and cost-effective for all-size operations.
Do a use-case search on available technology and identify solutions that are relevant to your business.
Debrief with other companies that have deployed similar solutions.
Go into the selection process with a clear understanding of what your business needs and stick to that plan.
It can be tempting to envision a big transformation by having a long-term end state in mind. Take into consideration that technology is rapidly evolving, and your end state will inevitably change. The key is for each step in your journey to build on the prior one and lay a good foundation for expanding future capabilities. Keep your options open.
Do not underestimate the change management effort. The team will need to develop competence in smart manufacturing technology. Throughout this process, engage those employees who will be most affected. You will make better decisions and have less friction during implementation.
Digital lean harnesses advanced technologies to supercharge traditional lean manufacturing. It provides real-time insights to drive faster, more informed decision-making. It identifies and corrects inefficiencies and waste with higher velocity. Embracing digital lean equips businesses with the agility and adaptability needed to thrive in today’s rapidly evolving market landscape.
Based in the New York City area, Doug Berger is founder and president of the non-profit Industry Reimagined 2030, which is on a mission to revitalize U.S. manufacturing at a national scale.
Based in the Los Angeles area, Conrad Leiva is vice president of ecosystem and workforce development at CESMII–the Smart Manufacturing Institute.
