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

Overview of FDA ISO 13485 and 21 CFR Part 820 Harmonization

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

US Quality System Regulation (QSR)

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

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

ISO 13485

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

Why harmonize?

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

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

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

RELATED: The Complete Guide to ISO 13485 for Medical Devices

What will change?

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

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

Impact on medical device manufacturers

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

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

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

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

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

When will implementation be completed?

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

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

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

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

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

AI, XR and Data: Manufacturing Technology Predictions for 2024

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

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

AI’s 2024 Prospects

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

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

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

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

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

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

RELATED: 2024 Predictions for Product and Engineering Teams

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

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

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

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

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

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

AR/VR

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

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

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

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

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

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

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

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

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

Data and Digitization

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

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

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

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

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

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

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

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

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

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

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

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

Where The Insurance Industry Needs Requirements Management: Two Scenarios

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

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

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

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

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

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

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

Gathering, Documenting, and Reusing Requirements

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

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

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

The Four Main Challenges for Insurance Requirements Management

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

1. Introduction of Agile Methodology

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

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

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

2. Unwillingness to Change Outdated Requirements Processes

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

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

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

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

3. Reliance on Document-Based Requirements Management Tools

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

4. Complex Collaboration Across Teams, Departments, and Stakeholders

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

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

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

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

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

Read the complete story here »

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

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

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

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from IndustryWeek, titled “How Can Technology Advance Our Lean Effort?” – written by Doug Berger and Conrad Leiva originally published on November 20, 2023.

How Can Technology Advance Our Lean Effort?

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

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

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

Extending Value

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

1. Reducing Waste

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

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

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

RELATED: Best Practices Guide to Requirements & Requirements Management

2. Reducing Inventory

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

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

3. Improving People Utilization

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

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

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

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

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

Where Do I Start?

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

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

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

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

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

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

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

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

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 “Why penetration testing is critical to every robust cyber security strategy” – originally published on November 2, 2023.

Foreward by Josh Turpen – Chief Product Officer, Jama Software®

A big “Thank You!” to Chris Dickens for a great article. As part of our security program here at Jama Software, we have a layered approach to security tests and scans. Scans are done on every build, automated tests are run on every build, and active PEN tests are done multiple times per year. As the only SOC 2 Type 2 product in the space, we have set a high bar for ourselves because we know the importance of security to our customers.

Why Penetration Testing is Critical to Every Robust Cyber Security Strategy

Chris Dickens, Senior Solutions Engineer at HackerOne, outlines an effective penetration testing strategy.

Digital transformation has become an essential requirement for any business that wants to remain competitive in an increasingly digital global landscape.

However, it’s not always straightforward. In many cases, digitizing key processes can expose businesses to a wide array of new cyber security risks they aren’t used to, potentially leading to damaging breaches, attacks and/or loss of sensitive data if they aren’t careful.

In order to protect against such threats, a well-rounded cyber security strategy needs to be put in place alongside any digital transformation initiative.

However, cyber security isn’t a ‘one and done’ activity, strategies must be continuously evaluated and tested to ensure they remain effective.

Cyber criminals constantly evolve their attacks, so cyber security must also evolve. Whatever works now will likely be outdated in just a few weeks or months.

One of the best ways to stay ahead is through regular penetration testing (pentesting), which can give companies a fast, accurate snapshot of the current state of their cyber defences. This point in time activity features ethical hackers putting themselves into the shoes of malicious actors in an attempt to breach a system’s security for the purpose of vulnerability identification.

Typically, both humans and automated programs are used to research, probe, and attack a network using various methods and channels known to be used by cybercriminals.

But too many still don’t fully understand how pentesting works, or how they can effectively implement it into their wider security strategy.

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

How has pentesting changed?

The era of secretive, closed-door penetration testing is a thing of the past. In those days, you had to depend on the skills and schedules of usually big companies, enduring long waits, and limited insight into the results and tester’s actions.

Nowadays, penetration testing has evolved significantly. It often commences within a few days and is typically conducted on a smaller scale more frequently. This transformation is credited to innovative platforms that offer real-time transparency into the testing process and a more inclusive approach when bringing testers on board.

The emphasis is now on results and experience from the ethical hacking community rather than formal education and certification. The creation of new AI-based hacking methods and willingness to test source code has also greatly improved the output.

While this may sound quite daunting for the business involved, pentesting is an incredibly effective way to discover major vulnerabilities in their security before they can be exploited, which is critically important for keeping sensitive data safe.

Arguably, penetration testing’s best advantage, however, is its thorough coverage and documentation. Due to its in-depth and refined testing, in most cases, vulnerabilities are discovered and documented, including details on how the bug can be exploited, its impact on an organisation’s compliance, and advice on how to remediate the issues.

Unlike other offensive security engagements, pentesting also allows organisations to test internal systems alongside unfinished applications – this is especially useful when leading up to a new product announcement or organisation acquisition.

Using pentests to inform both present and future security strategies

As mentioned, pentesting is a great way for businesses to gauge the effectiveness of their existing security defences at that moment in time.

However, too many organisations tend to treat it as though it’s the beginning and the end of the process, which it isn’t.

Pentesting is a tool, not a strategy, and as valuable as they are, pentests are only useful if the results are translated into an effective overall security strategy for the future.

An effective modern pentesting strategy should contain the following elements:

  1. Establish key security priorities- First and foremost, businesses must determine what they need to protect. While it’s impossible to protect everything all the time, key assets should be prioritized based upon the damage the asset would cause if it was to be compromised. Typically, highly sensitive information such as proprietary IP, competitive and legal information, and personally identifiable information (PII) will be top of the list.
  2. Get security buy-in from all employees- A sustainable security culture requires buy-in at all levels of an organization, from the executive board to the reception desk. If every employee takes responsibility for company security, it’s much easier to build a model where risks are shared, and teams across the company can scale securely.
  3. Use pentesting as a regular security touchpoint- Regular penetration testing is a great way to promote a more proactive approach to security. All too often, organizations aim to meet only the minimum requirements for compliance – and believe themselves to be secure, which is a highly risky strategy. By contrast, combining regular pentests with bug bounty programs provides a continuous feedback loop that allows companies to quickly identify new vulnerabilities and deal with them before they come to the attention of malicious actors.
  4. Make robust cyber security a strategic differentiator- A recent study by PwC found that 87% of global CEOs are investing in cyber security as a way of building trust with customers. If the lifeblood of the digital economy is data, its heart is digital trust. Organizations with a sound security strategy can quickly turn it into a strategic differentiator for their brand, which is invaluable in highly competitive business sectors and industries.

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

The best cyber security strategies can quickly adapt to change

Modern enterprise security is not easy. As more businesses embrace digital transformation and cloud computing becomes the new normal, reliance on IT is at an all-time high.

Consequently, even a small data breach can potentially have a devastating impact. On top of this, attack surfaces are exponentially larger than they were just a few years ago and continue to grow at an alarming rate.

The best practice approach for security teams is to color outside of the lines by infusing new and independent thinking. With this in mind, penetration testing offers much more than just a scan and definitely more than a tick-box compliance requirement.

By developing a cyber security program that employs an agile approach, organizations can prioritize flexibility and make rapid changes when needed.

Engaging ethical hackers enables organizations to deploy an army of specialized experts that will work around the clock to identify vulnerabilities and conduct pentests for both regulatory compliance and customer assessments. In today’s highly competitive and volatile business environment, few organizations can afford to forego such a crucial security advantage.

Contributor Details
Chris Dickens – Senior Solutions Engineer, HackerOne

Image showing someone reading code off of a computer screen.

In this blog, we present a preview of our customer story, “Leading Quantum Computing Company Selects Jama Connect® to Decrease Review Cycles, Reduce Rework, and Improve Communication and Collaboration” – To download the entire story, CLICK HERE

Leading Quantum Computing Company, IonQ, Selects Jama Connect® to Decrease Review Cycles, Reduce Rework, and Improve Communication and Collaboration

With a return on their investment in less than six months, the IonQ team is confident they made the right selection.

About IonQ:

  • Founded in 2015 by Chris Monroe and Jungsang Kim to “build the world’s best quantum computers to solve the world’s most complex problems.”
  • Leveraging 25 years of academic research to build the world’s leading quantum computers.
  • Expanding quantum computing availability to the cloud through partnerships with Microsoft and Amazon Web Services, and Google Cloud Platform.
  • Headquartered in Maryland.

IonQ, Inc. is a leader in quantum computing, with a proven track record of innovation and deployment. IonQ’s latest generation quantum computer, IonQ Forte, is the latest in a line of cutting-edge systems, boasting an industryleading 29 algorithmic qubits. And IonQ Aria is the most powerful commercially available quantum system, with 25 algorithmic qubits. Along with record performance, IonQ has defined what it believes is the best path forward to scale. IonQ is the only company with its quantum systems available through the cloud on Amazon Braket, Microsoft Azure, and Google Cloud, as well as through direct API access. IonQ was founded in 2015 by Dr. Christopher Monroe and Dr. Jungsang Kim based on 25 years of pioneering research. IonQ began trading on the New York Stock Exchange in 2021, making it the world’s first public pure-play quantum computing company.

CUSTOMER STORY OVERVIEW

Growing fast in an emerging market, IonQ has implemented an ever-growing number of engineering best practices. The company’s team became frustrated managing requirements with Google Sheets and needed to solve core problems, such as linking between levels of requirements without extensive lookup tables. After rigorous evaluation, they selected Jama Connect® and are very pleased with the outcome.

CHALLENGES

  • Linking between levels of requirements without extensive lookup tables
  • Lack of clear traceability
  • Managing complexities across hardware and software
  • Lengthy review cycles

EVALUATION

  • Easy-to-use platform with an intuitive interface
  • Ability to view relationships between requirements
  • Change control and a review and locking function for requirements
  • Within budget

OUTCOMES

  • 25% decrease in review cycle time
  • 20% savings of systems engineers’ time (previously spent on manual processes)
  • 25% improvement in communication and collaboration
  • ROI in less than six months

TO READ THE FULL CUSTOMER STORY, DOWNLOAD IT HERE:
Leading Quantum Computing Company, IonQ, Selects Jama Connect® to Decrease Review Cycles, Reduce Rework, and Improve Communication and Collaboration


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 excerpts from an article, sourced from MedTech Dive, titled “Q&A: How Monogram’s CEO Plans to Disrupt Robotic Joint Replacement Surgery” – originally written by Susan Kelly and published on August 4, 2023.

Q&A: How Monogram’s CEO plans to disrupt robotic joint replacement surgery

The robot developer’s CEO, Benjamin Sexson, tells MedTech Dive why he believes the orthopedics market needs a fresh approach to joint reconstruction.

Seven-year-old surgical robotics company Monogram Orthopedics, which went public in May, is aiming to take on medtech heavyweights such as Stryker and Zimmer Biomet as well as smaller challengers in the growing market for robot-assisted joint replacement. CEO Benjamin Sexson, an engineer by training, sees a pressing need for personalized implants made to fit each patient’s specific anatomy.

This interview has been edited for length and clarity.

MEDTECH DIVE: What are some of the challenges in knee replacement that you are trying to solve with your surgical robot?

BENJAMIN SEXSON: The idea is to move away from what’s called mechanical alignment, which is how we’ve always done it with manual instruments. A lot of the robots on the market today are just basically helping surgeons put the knee into mechanical alignment – everybody gets the same knee, the joint line is basically restored to be parallel to the floor.

With functional, or more personalized, alignment approaches, surgeons are tweaking the plan based on, I have my patient’s specific data, I have the CT scan, and I can assess intraoperatively what do I think looks best? And they can make very, very precise and accurate tweaks to the surgical plan that, over time, we’re seeing are enhancing patient satisfaction.

Stryker and Zimmer both have the ability to use a CT scan or advanced imaging to preoperatively plan. Stryker has been driving this trend. Stryker is showing that patients are happier when you can do some degree of personalization of the surgery.

Other players in the space have been struggling [because] they are imageless. They made the bet that insurance companies would not be as accommodative in the future to reimbursing the cost of the CT scan, and so their surgeries correlate to generalized models. We think that over time, this is going to be increasingly problematic for those other players.

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

What gives you confidence that there is room for another robot in the orthopedic marketplace?

Investors generally [say], “Well, everybody already has an orthopedic robot.” OK, but really only two companies are CT-based, and only one of those companies is actually [using surgeon-initiated] cutting. So there’s really only one navigated, efficient, cutting, CT-based robot, and that’s Stryker, and they have 90% of the market. And only 10% of knees today are robotic. So there’s a huge opportunity.

It’s inefficient for a small-footprint private clinic to be forced to buy five-plus different robots, one that’s good for the spine, one for the hips, one for the knees, one for the shoulders, one for the ankles, etc. The fundamental difference between our philosophy and our competitors is that Monogram seeks to develop one robot optimized for many applications.

Why did you decide to focus first on the knee market?

I’ll start by saying that our robot is not a knee robot. It’s an orthopedic robot. It just so happens that knees are our first application for a number of reasons. One is that we didn’t want to go on a missionary effort trying to convince people in, say, the shoulder space, to use an orthopedic robot and develop a whole new surgery. We wanted to come into a market that already had billing codes and an established market presence and some level of acceptance.

There are about a million knee replacements a year in the United States, and about 10% of those fail every year. And a lot of people are not satisfied with their knee replacement. We think we can make it a lot less scary and a lot less risky.

Where are you in the process toward gaining FDA approval?

We’ve had what’s called a pre-submission meeting with the FDA. This is a 510(k) submission, so we’re going to be claiming substantial equivalence to a system that’s already on the market. Where we are is, the FDA is accepting of our clinical pathway. They’re accepting of our predicate [Stryker’s robot] and intended use. The question that’s still outstanding is whether or not the technical differences with our predicate need to be tested with clinical data. Our plan is to take a defensive approach and submit to the FDA with clinical data. Our plan is to lean heavily on capturing that data outside the U.S.

RELATED: Revolutionary Surgical Robotics Company, Monogram Orthopedics, Selects Jama Connect® For Its Unique Cloud Based Services and Ease of Use


MDR/IVDR

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 Regulatory Focus™, titled “MDR/IVDR Survey Shows NBs Have Increased Capacity” – originally written by Ferdous Al-Faruque and published on July 31, 2023.

MDR/IVDR Survey Shows Notified Bodies (NBs) Have Increased Capacity

A recent survey published by the European Commission shows a promising trend for devices and diagnostics transitioning to Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) but it’s still too early to say how successful the transition is going, two experts told Focus.

The European Commission published a survey of data from notified bodies (NB) conducted by the Austrian National Public Health Institute (Gesundheit Österreich GmbH), and research groups Areté and Civic Consulting on 25 July. The survey provides an overview of the MDR/IVDR transition process as of the end of March 2023. The results show that compared to October 2022, the number of MDR/IVDR applications and certificates has increased significantly.

Between 22 October 2022 and 31 Marodiech 2023, the number of MDR applications rose more than 40% from 8,120 to 11,418. The number of MDR certificates also rose almost 50% during that time from 1,990 to 2951.

The survey found that in October 2022 there were 22,793 products on the market with valid certificates under the Medical Device Directive and Active Implantable Device Directive (MDD/AIMDD) which means that applications for about half of those products have been submitted for transition by March 2023, and about 35% of MDD/AIMDD products submitted for transition to MDR were submitted since October 2022.

Similarly, the data shows the number of IVDR applications received by NBs has gone up more than 15% from 822 in October 2022 to 950 in March 2023, and the number of certificates they have issued for the products has gone up 24% from 268 to 331 during the same period.

“This progress is good news, [but] the survey results should be interpreted with some caution,” Sabina Hoekstra-van den Bosch, global director for regulatory strategy at TÜV SÜD GmbH and vice-president of Team-NB, told Focus.

RELATED: An Overview of the EU Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR)

While the survey takes into consideration data through 31 March 2023, Hoekstra-van den Bosch says it doesn’t take into account any potential effect of the MDR extension that went into effect on 23 March 2023. She says it is likely the effects of the delay are only now showing up in the data and notes NBs have shared new data through the end of June with the European Commission which may offer a clearer picture. (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023)

“Everyone hopes and expects, that the number of applications will increase rapidly,” said Hoekstra-van den Bosch. “[But] another expectation is that the number of certificates will rise much more slowly than the number of applications, as Regulation 2023/607 gives time until 2027/2028 to finalize certification, while in the meantime manufacturers are allowed to keep the legacy device on the EU market.”

Hoekstra-van den Bosch says calculating the transition rate for products getting MDR certified is complicated and can be interpreted differently.

She notes that the current number of AIMDD/MDD products that need to be recertified is probably being underestimated since under MDR certificates will need to be given out for products such as class IIb implantable devices that require separate certificates. On the other hand, grouping basic UDI-DI products under MDR may also mean an increase in the number of certificates.

Hoekstra-van den Bosch says the MDR extension and publication of a Medical Device Coordination Group (MDCG) guidance encouraging manufacturers to not wait until the last minute are all good signs and if left unheeded may still result in bottlenecks for products getting recertified. (RELATED: Euro Roundup: EU answers questions about the extension of MDR transition, removal of ‘sell off’ periods, Regulatory Focus 30 March 2023)

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

“The [Austrian National Public Health Institute] survey shows some hopeful signs, but the ‘proof in the pudding is the eating,’” Hoekstra-van den Bosch said. “We are eagerly anticipating the publication of the next editions of the European Commission’s survey results.”

Gert Bos, executive director of the Qserve Group, says his main concern about products transitioning to MDR/IVDR has to do with communication between NBs and manufacturers.

“On the one hand many notified bodies indicate they can handle more applications, whereas manufacturers are not all speeding up their processes to get to the application phase,” he told Focus. “Meanwhile, companies on their second and third dossier may currently be waiting for 12 to 18 months to get feedback on their responses to the previous rounds of questions.”

Bos says there is plenty of guidance on how the new MDR system should work but there is still not enough guidance on what is considered sufficient evidence regarding clinical support, toxicity, biocompatibility testing, and general performance testing.

“The good news is that the structured dialogues between manufacturers and notified bodies are starting to bring clearer expectations,” he added. “So, we are going slowly in the right direction.”

Bos is also concerned that when applications do get feedback from NBs, they may contain deficiencies that could have been addressed in the first review round.

The survey sheds some light on the topic and lists the key reasons for why an MDR application was refused and shows some interesting trends.

In October 2022, the top two reasons were insufficient NB resources or because the application was outside the scope of the NB’s designation, with 61 and 66 applications being refused for those reasons, respectively. However, the top three reasons given for an application refusal in March 2023 were the wrong qualification or classification of a product with 74 refusals, the application was not complete with 80 refusals and the application was outside the NB’s designation with 208 refusals.

RELATED: European Union Medical Device Regulation (EU MDR): What You Need to Know

The number of refusals due to insufficient NB resources dropped to 31 which shows that NBs have started to significantly increase their capacity to handle incoming applications.

Bos is also worried that while global production processes have significantly improved in the past three decades, it has come to a halt due to delays in the MDR transition process.

“The problems rise to the level that such reviews on supply chain and production change approvals are starting to take priority over the more lengthy full MDR review processes,” he said. “This might in the coming 12 months fill the spare notified body capacity, in which case we’ll be walking straight into a further bottleneck when too many MDR and IVDR applications come in the second half of next year.

“Again the message is clear: Don’t delay your MDR and IVDR applications, but talk with your notified body about having the elements of the continued improvement reviewed in parallel,” he added. “It might free up the blocked production processes and will be useful in the full application as part of the new production has already been reviewed by the notified body.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Survey

© 2023 Regulatory Affairs Professionals Society.


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 Reuters, titled “EU Seals New US Data Transfer Pact, But Challenge Likely” – originally written by Foo Yun Chee and published on July 10, 2023.

EU Seals New US Data Transfer Pact, But Challenge Likely

BRUSSELS, July 10 (Reuters) – The European Commission announced a new data transfer pact with the United States on Monday, seeking to end the legal uncertainty plaguing thousands of companies that transfer personal data across the Atlantic.

The move was immediately criticized by a non-profit group noyb, led by privacy activist Max Schrems, which said it would challenge the agreement.

The commission and the United States had been struggling to reach a new agreement after Europe’s top court annulled two previous pacts that underpinned the transfer of personal data across the Atlantic for services ranging from cloud infrastructure to payroll and banking.

The commission, the EU’s executive arm, said measures taken by the United States ensured an adequate level of protection for Europeans’ personal data transferred across the Atlantic for commercial use.

It said new binding safeguards, such as limiting U.S. Intelligence services’ access to EU data to what is “necessary and proportionate” and the establishment of a Data Protection Review Court for Europeans, address the concerns raised by Europe’s top court.

RELATED: Why It Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System

U.S. President Joe Biden welcomed the data transfer pact and said it reflected a “joint commitment to strong data privacy protections.”

EU justice chief Didier Reynders said he was confident of fending off any legal challenge.

“The principles of the data privacy framework are solid, and I am convinced that we have made significant progress which meets the requirements of the European Court of Justice case law,” he told a news conference. “I am very confident of fighting, defending the new data agreement.”

But Schrems said the latest revision was inadequate.

“Just announcing that something is ‘new,’ ‘robust’ or ‘effective’ does not cut it before the Court of Justice. We would need changes in U.S. surveillance law to make this work,” he said in a statement.

“We have various options for a challenge already in the drawer, although we are sick and tired of this legal ping-pong. We currently expect this to be back at the Court of Justice by the beginning of next year,” Schrems added.

RELATED: What is DevSecOps? A Guide to Building Secure Software

Lobbying group DigitalEurope, whose members include Airbus (AIR.PA), Amazon (AMZN.O), Apple (AAPL.O), Ericsson (ERICb.ST), Nokia (NOKIA.HE), Philips (PHG.AS) and Samsung (005930.KS), welcomed the deal.

“Data flows underpin the EU’s annual 1 trillion euros of service exports to the United States, and this decision will give companies more confidence to conduct business and help our economies to grow,” its director-general, Cecilia Bonefeld-Dahl, said.

Earlier this year, the EU’s privacy watchdog, the European Data Protection Board, said the latest data agreement still fell short and urged the commission to do more to protect Europeans’ privacy rights.

Europe’s top court scuppered the previous two deals after challenges by Schrems because of concerns about U.S. Intelligence agencies’ accessing European citizens’ private data.

Reporting by Foo Yun Chee; Additional reporting by Kanishka Singh in Washington; Editing by Philip Blenkinsop, Christina Fincher and Leslie Adler

The Thomson Reuters Trust Principles.


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 Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by Christine Fallabel and published on July 11, 2023.

Tandem’s Mobi Approved by the FDA

On Tuesday, July 11th, 2023, the Food and Drug Administration (FDA) announced the approval of Tandem’s newest insulin pump, called Mobi. This insulin pump is fully controllable from a mobile app and is now the world’s smallest durable automated insulin delivery system.

THE MOBI INSULIN PUMP

The Mobi will join a growing selection of Tandem products that support people with diabetes. Their human-centered approach to design, develop and support innovative products and services for people who use insulin is evident in this latest approval.

John Sheridan, president and chief executive officer for Tandem Diabetes Care said, “Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”

The San Diego-based company also manufactures the T:Slim X2 insulin pump with Control-IQ technology, a feature that is also part of this new release.

Control-IQ technology utilizes compatible continuous glucose monitor (CGM) sensor readings to predict blood sugar levels 30 minutes ahead of time. It then adjusts insulin delivery every five minutes to help prevent both high and low blood sugars levels. The system also delivers automatic correction boluses of insulin for up to an hour to help prevent high blood sugars.

The user can still manually bolus for snacks and meals.

The Mobi has been approved for people with diabetes aged six and older who require insulin.

RELATED: Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

MOBI FEATURES

The new Mobi has some great features that will make pumping not only easier for people, but more convenient and flexible too.

  • 200-unit insulin cartridge
  • Less than half the size of the T:Slim X2 pump
  • Detachable infusion sets that are compatible with all existing Tandem infusion sets, allowing users to mix and match infusion sites and tubing length combinations for greater flexibility
  • Control IQ technology designed for use as part of an automated insulin delivery system
  • Mobile app control with an on-pump button, providing an option for the user to utilize phone control for bolusing insulin
  • Inductive charging and capable of wireless remote software updates from a compatible smartphone

MORE CHOICES FOR PEOPLE WITH DIABETES

This new approval will greatly expand the choices people with diabetes who use insulin pumps will have, and it is the smallest and most convenient insulin pump yet.

According to the manufacturer, the Mobi is small enough to fit in a coin pocket, be clipped to clothing or fit into an adhesive sleeve—expanding where and how and insulin pump fits into your life and lifestyle.

Additionally, the Mobi insulin pump is completely controllable from a user’s mobile phone via an app, a feature many people with diabetes are looking for in newer tech releases.

People don’t want to always be juggling multiple devices, and having both blood sugar readings and insulin pumping capability from a smartphone just makes life with diabetes easier.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

MARKET AVAILABILITY COMING SOON

A limited release is expected to start in late 2023 with full commercial release planned for early 2024. To sign up for updates, please visit tandemdiabetes.com/mobi.

If you are interested in trying the Mobi insulin pump when it is available, start talking to your provider now about any necessary steps you may need to take like getting a prior authorization.