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
https://www.jamasoftware.com/media/2023/10/2023-10-19-ionq-customer-story-1.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2023-10-19 03:00:002024-01-17 23:06:01Leading Quantum Computing Company, IonQ, Selects Jama Connect® to Decrease Review Cycles, Reduce Rework, and Improve Communication and Collaboration
In this blog, we recap our webinar, “Application of Systems Engineering in Healthcare”. Click HERE to watch the entire webinar.
When it comes to healthcare, the first to market usually gains 80% of the market share, making development speed one of the most crucial aspects of success – or failure. That’s why many organizations are looking at systems engineering as a way of connecting needs to solutions.
In this webinar, Chris Unger of PracticalSE LLC and Vincent Balgos Director, Medical Device Solutions at Jama Software® have partnered up for an engaging webinar on the application of systems engineering in healthcare.
We invite you to join in as we delve into transformative role systems engineering is playing in the healthcare industry.
What to Expect:
1. The Power of Simplicity:
Discover how focusing on the basics, while maintaining world-class performance levels, can yield astonishing returns. We’ll show you how simplicity can be a game-changer in the complex world of healthcare systems engineering.
2. Market-Driven vs. Contract-Driven:
Intrigued by the difference between market-driven and contract-driven industries? We’ll explore how systems engineering varies in these two landscapes. Learn why “Market Driven” industries emphasize competitive value creation and use cases more than traditional requirements, and how this shift can redefine your approach in healthcare.
3. Striking the Perfect Balance:
Explore the ideal state of systems engineering in healthcare, often a harmonious blend of Agile, Lean Startup, and more traditional systems approaches. Uncover strategies to adapt, innovate, and succeed in this dynamic field.
Don’t miss this opportunity to gain a comprehensive understanding of how systems engineering can revolutionize healthcare. Whether you’re a seasoned professional or just beginning your journey in healthcare systems, this webinar promises valuable takeaways for all.
Below is an abbreviated transcript of our webinar.
Application of Systems Engineering in Healthcare
Chris Unger: We’re going to talk today about systems engineering in the medical industry, particularly medical device development. So the medical device industry faces several challenges. There’s clearly constant time pressure in developing and launching safe and effective products. We’ve got to be faster than the competition with better products. And as you can see from the statistics, this is a challenge. Part of the challenges in delivering things on time is the shifting regulatory landscape. I’m sure everyone’s aware of MDR. There’s software for medical devices. The FDA is going to think about redoing design controls next year. When we were at GE Healthcare, there were like 8,000 regulations we had to monitor. So it’s a very challenging and shifting regulatory landscape. Not only do you have to be compliant with regulations, but you have to ensure your device is safe. And so quality issues, safety and just keeping performance are key elements of delivering on time and that’s getting more and more expensive as you can see here, billions of dollars of financial risk of getting this wrong.
So to make all that harder, there’s a constant increase in complexity. When I first started, there were typical software development teams were 20 to 40 people. It’s now hundreds of people and lots of interactions. So additional things like AI, machine learning, or new technologies, really have to manage a lot of complexity inside of your devices. The organizational structure is getting more and more complex. There’s a heavy focus on acquisition, so you’re integrating new teams, new cultures, and geographically distributed development teams. So that makes it all challenging. So we’re going to talk about how systems engineering can help address some of these particular challenges.
Unger: As I mentioned, a key differentiator is getting to market faster. So the success of a program in a market-driven environment is basically profits. The first mover tends to collect the lion’s share of the profits. We typically have many customers. You don’t have a single customer marketing and product management tells you roughly what they think the competition will be and what differentiates versus in a contract-driven environment, success is satisfying the contract. So within GE Healthcare, the avionics and oil and gas businesses typically had a single customer. We would produce a floating city block to British Petroleum or Shell, go to the North Sea or the Caribbean and you had a contract and you delivered to that contract versus an engine, an aircraft engine, or a medical device, we deliver to the marketplace. We decide the timing, we decide the features.
So the stakeholders and market-driven are internal to the business and you can negotiate budget and time. If you get a really, really cool feature, you can take an extra month or quarter to develop it, versus in a contract-driven, it’s really fixed. So the challenges of market-driven and contract-driven are different. Contract-driven requirements are a key commitment. You’ve got to negotiate a formal design control versus within a market-driven environment they’re critical. You have to deliver validated requirements, but they’re definitely an internal business tool that helps communication across all the business functions.
So what’s the value of systems engineering in a market-driven industry? We basically turn the ambiguous needs that we get from product marketing or product management and turn them into clear and feasible solutions to be implemented by the hardware and software teams. The key value we produce is that those implementations seamlessly integrate into the customer’s workflow and work systems. So they work really well from day one, they reliably meet their needs. They work really well after five years and not just meet their needs, they delight the customer. We really want to deliver something that the customer enjoys using. So we have to make it work day one, we need to make it work day 50. We need to make it work for every single customer. So you have to deal with all the known variability of hardware and process. Every installation and every service event has to produce a uniform, high-quality, high-performing product.
So with those constraints, we want to optimize the business value. So when we have multiple options, marketing will tell us the customer value of these options. The implementation teams will tell us the delivery and product cost of those functions. The role of systems engineering is to make trade-offs between those and really optimize the business impact based on the cost of implementation. So we want to make sure the work done by those implementation teams is tied to the maximum market impact. And associated with that is managing technical risks. If you go down a path and it turns out to be infeasible, while it might’ve been nice if it worked, you just wasted a lot of that work. So that cost has to be scaled by risk.
In doing all those first four bullets, our key value is making sure design decisions are identified and closed predictably, and that the team acts with one voice. So decisions are framed, the options are agreed to, the decision criteria are agreed to and the final decision is closed and stays closed as stakeholders change. So once you have a frozen design, do you want to make sure that actually integrates easily and when you have integration or quality problems, they’re found early and resolved early. When you have time to react, it’s a lot easier to adjust your design in the first half of your program. It’s really hard when you find severe quality issues with a month left before shipping.
Unger: And so really winning products happen when systems thinkers are effective. So clearly there’s going to be a need for some systems engineering process thinkers, but they’re system thinkers across the entire program. And so we want to make sure that everybody’s involved in systems and that the creativity of the entire program is maximized. So getting specific to GE Healthcare, what is systems engineering at GE Healthcare? Well, we have the essential customer-perceived performance. So a lot of our programs are imaging, so we have the image quality. Still, we also have things like maternal-infant care where we deliver the right humidity and temperature around the neonate. In delivering that essential performance, you’ve got to make sure it’s safe and you’ve got to make sure you have regulatory compliance. And I mentioned we really want products that are easy to use and delight the customer. So usability is a critical part of systems engineering. In doing that, we make sure we define the right implementation requirements and the right reliability strategy, and that it can be installed and serviced properly.
So with that being the overall goal, how do we organize? Well, there are a lot of things that are common across all of our product teams. We do have common program milestones. We do have a common systems’ lifecycle. It’s basically the V-cycle with iteration and agile built in. What differs is that different product teams at GE Healthcare have different levels of safety hazards, so FDA risk. We go from anesthesia where you can easily kill somebody down to ultrasound, where it’s non-ionizing equipment, that’s the light handheld probes. You can’t pinch or crush anybody to even service software that has zero patient impact. There are also almost no risks for anybody and we respond to that by adjusting the process rigor so that the higher-risk safety risk modalities have higher process rigor.
Additionally, things vary across the world or we have different locations with different cultures and different sizes of organizations. We have many systems engineers across the company, but the SE team sizes vary from less than 10. In fact, we had some sites with maybe 10 engineers and the systems engineer was half a person to teams that had over a hundred systems engineers. The scale of the programs we work on is less than 10 engineers and months-long programs to many hundred as engineers applied to a program that might last three years and were based on technology developed over the prior decade. And you want some systems engineering thinking even during that basic research decade.
Unger: The organization goes from product centralized, it’s like the SE GM for that hundred engineering group where they all reported to a dotted or solid line, to decentralized in where that team of 10 with one or half a systems engineer, there the manager was a general engineering manager and did not have a lot of systems engineering experience. So I joke that if there is a way of organizing systems engineering, we have one of those within our group somewhere.
But how did we think about tailoring? And so this is a page I put together that was generalized that you might be able to use. Obviously, as I mentioned, higher technical risks including safety risks. One way of measuring that is how many risks there are in your hazard analysis. For things that are a higher risk we looked for a higher level of functional excellence, more process documentation, more process compliance, and higher rigor of the technical design reviews, and maybe more independent reviewers. Team experience. This is subjective to measure, but Joel Goldstein did a very nice study, from Carnegie Mellon, that the value of systems engineering increases with program complexity, but it decreases with a more experienced team if you have a small team that is experiencing the technology and the application, they can get by with less process rigor and while systems engineering excellence delivers some value, it delivers less value.
https://www.jamasoftware.com/media/2023/10/Application-of-Systems-Engineering-in-Healthcare-1.png5121024Chris Unger/media/jama-logo-primary.svgChris Unger2023-10-17 03:00:072024-01-17 23:07:52[Webinar Recap] Application of Systems Engineering in Healthcare
In this video, we’ll discuss the Software as a Medical Device (also known as SaMD) framework in Jama Connect.
Jama Connect® Features in Five: SaMD Framework
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 video, Romer De Los Santos – Senior Consultant at Jama Software® – will go over some highlights of the Software as a Medical Device (also known as SaMD) framework in Jama Connect.
VIDEO TRANSCRIPT
Romer De Los Santos: Hello. My name is Romer De Los Santos and I’m a senior consultant here at Jama Software. In this video, we’ll go over some highlights around Jama Connect’s new Software as a Medical Device (also known as SaMD) framework.
Anyone who has worked developing medical device software has struggled with balancing the creation and maintenance of the required documentation with the day-to-day struggle of developing and testing software. And because software cycles are highly iterative, they are incompatible with traditional waterfall development.
Jama Connect’s new SaMD framework is designed to help alleviate the burden of documentation so that your team can focus on development. This purpose-built framework allows users working on both simple and complex software projects to use Jama Connect right out of the box. Its design was born from over 20 years of hands-on experience developing medical device software.
Some highlights of this framework include:
Templates like Software Development Plans that are designed to be compliant with IEC62304. These documents come with a customizable report that you can modify with your own branding.
Built-in risk analysis designed to be compliant with ISO14971 that takes advantage of Jama Connect’s built-in look-up table feature.
A new SOUP/OTS item type is designed to capture information about third-party developed software components in compliance with the FDA’s guidance on Off the Shelf, (or OTS)Software Use In Medical Devices.
A new External Resource item type to capture and trace items tracked outside of Jama Connect.
De Los Santos: The SaMD framework gives new medical device manufacturers a great starting point. It has been designed to with regulations like IEC 62304 and ISO 14971 in mind. However, manufacturers are still required to define their own quality management system.
Although regulations specify what needs to be documented, there’s no universally accepted document name or format. Jama Connect can be configured to use your company’s own jargon and the document templates required by your own quality management system.
The framework is organized into four major components in a document-centric structure. This means that items are organized into documents rather than by function.
This structure is easier for new users to recognize and work on. It also facilitates the generation of documents that will be submitted to the system of record of your choice.
For your convenience, the framework includes customizable export templates for multiple documents. You can change the logo, headers, footers, fonts, and style of your document to match your company’s branding requirements.
Project-level documentation includes planning documentation such as the Software Development Plan and Software Verification Validation Plan.
IEC 62304 has specific requirements for software development plans that have been incorporated into the template for your convenience.
De Los Santos: While IEC 62304 does not require a separate Software Verification or Validation Plan, it does require specific information about how verification and validation will be performed. This document template includes sections for the required information.
System-Level Documentation includes documents that define the requirements, testing, and design of the whole system. It can include items like User or Stakeholder Needs, Design input documents, Product Requirements Specifications, and Software Architecture documents.
Sub-System Level Documentation can be organized into individual components, software or otherwise. Each component includes the requirements, test cases, and design documentation.
The Risk Management Plan, FMEAs, and risk analysis are centralized in the Risk component. By default, the FMEA and risk analysis are organized as you would see them in Excel. It also takes advantage of Jama Connect’s built-in look-up matrix feature to do your risk calculations.
Of course, not all medical device software projects are multi-component projects. A software project that consists of a single software component doesn’t need to have system and subsystem-level requirements. In this case, remove the System Requirement and System Architecture item types from the relationship diagram to create a single-level structure.
OTS/SOUP components are documented through a new item type that is specifically designed to capture the information specified in the FDA’s guidance on OTS Software Use in Medical Devices.
De Los Santos: Jama Connect allows you to trace the specific sections of your design documentation that utilize third-party components to this item type. This makes tracking where these software components are used easy.
Finally, we’ve added a catch-all item called External Resource. External Resource items allow you to trace items that may be tracked outside of Jama Connect. This can be items like instructions for use, labeling, package inserts, specifications, schematics, and pretty much anything else you need to trace.
I hope you got a lot out of this quick look at the new SaMD framework in Jama Connect. If you want to learn more about Jama Connect and how it can optimize your product development process, please visit our website at jamasoftware.com – If you’re already a Jama Connect customer and would like more information about Medical Device Software, please contact your customer success manager or a Jama Software consultant.
https://www.jamasoftware.com/media/2023/10/FIF-SaMD-1.jpg10801920Romer De Los Santos/media/jama-logo-primary.svgRomer De Los Santos2023-10-13 03:00:322024-01-17 23:09:29Jama Connect® Features in Five: SaMD Framework
Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software
Jama Connect® 9.5 proven to scale to at least 10 million requirements in a single project to handle the largest product, systems, and software development efforts.
Jama Software®, the industry-leading requirements management and traceability solution provider, has announced that Jama Connect® has set yet another scalability record with over 10 million requirements managed in a single project (within a standard cloud instance) with P75 user interface load times under three (3) seconds. 10 million requirements per project represents a new benchmark in the industry, clearly showing that Jama Connect is able to meet both the current and future scalability needs of our customers. It is also important to note that no project data storage limits were hit during this boundary condition test, so the actual limit has not yet been reached.
Engineering organizations are looking for software partners that can handle large-scale, collaborative projects that span engineering disciplines, customers, and suppliers. This performance benchmark demonstrates Jama Connect’s unique ability to handle the scale required within a single project. Today, our customers work with tens of millions of requirements across projects in a single instance of Jama Connect. This latest single project scalability milestone adds to Jama Connect’s market-leading standing for security, scalability, and performance in the cloud including:
Over 100,000 trailing 90-day active users
Daily users spanning 82 countries
16ms First Input Delay (FID) response times
P75 response times of 2.7 seconds
The only requirements management application that is SOC 2 Type 2 certified at the environment AND application layers
The richest REST API with over 200 separate API functions
Over 600 million API cloud service requests per month
“Jama Software continues to lead the market in performance, security, and usability at scale,” said Josh Turpen, Chief Product Officer at Jama Software. “We are pushing beyond the 10 million threshold and will continue to deliver unmatched cloud capabilities to our customers.”
About Jama Software
Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries.
For more information about Jama Connect services, please visit www.jamasoftware.com
https://www.jamasoftware.com/media/2023/10/2023-10-05-v3-largest-scale-by-rm-software-release.jpg5121024Karrie Sundbom/media/jama-logo-primary.svgKarrie Sundbom2023-10-05 06:30:222023-10-05 11:49:06Jama Software® Announces Largest Scale Achieved by Any Requirements Management Software
In this blog, we recap our webinar, “Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development”. Click HERE to watch the entire webinar.
Evaluate Your Compliance Against ASPICE, ISO 26262, or ISO 21434 with Diagnostic Services Offerings from Jama Software®
During the webinar, experts Steve Rush, Principal Consultant, and Sampath Yerramalla, Senior Consultant, explored various service offerings within Jama Connect that provide insights into compliance status against these critical automotive standards.
Key takeaways from this webinar:
Learn about available diagnostic offerings in Jama Connect, such as: ASPICE, ISOS26262, and ISO21434
Learn about the benefits of diagnostic offerings, how they will expose risks to compliance, and which one is best for your organization
See firsthand how Jama Connect helps teams reduce unacceptable risks
Discover how Jama Connect can empower Automotive and Semiconductor development teams to evaluate and ensure compliance.
Below is an abbreviated transcript of our webinar.
Compliance Made Easy with Jama Connect for Automotive and Semiconductor Development
Steve Rush: Hi everyone. I’m happy to be here today to take you through the presentation. I wanted to start with a high level agenda and an introduction. We’ll be discussing Automotive compliance in general. To start, we’ll be looking at specific service offerings that you can use to help leverage, to evaluate your compliance against certain Automotive standards.
There are two forces often related that I like to think about when it comes to compliance that really impact the organization as a whole, from engineers to executives and everybody really in between. And those are process and quality. And I like to think about compliance as the intersection of those two often related ideas. Meeting the objectives of these standards may achieve both process and quality, but developing a compliant process and system, this will speed up development by instituting good process and reducing rework. It will help catch and identify defects early in the development process. However, there’s many evolving regulations and standards in this Automotive sector that make the idea of compliance all the more challenging to understand, let alone demonstrate. Perhaps you don’t even know where to start when it comes to achieving compliance in an Automotive system. It might feel like you are building a car while it’s driving.
At the same time tasked with implementing the process and tools to support the process and unsure which should come first. And we want to talk a little bit about this through the lens of compliance and make the case that Jama Connect is a tool well suited to get you up and running quickly, optimized against popular Automotive standards. To assist with this, we’ll discuss the diagnostic that Jama Software offers as a service that’ll help you navigate these important compliance questions. But I fully believe that by meeting the objectives of some of these critical Automotive standards we will discuss today that you’ll balance both process and quality and achieve compliance.
Sam Yerramalla: Today we are highlighting some offerings that will help guide Automotive customers or prospects like you with your compliance process. We feel these diagnostics can be very helpful whether you are a customer of Jama Software or a prospect. If you’re a Jama Software prospect who’s not yet purchased Jama Connect, these diagnostics makes the case that Jama Connect can help you meet the objectives of the Automotive standards. And namely, there are three standards offerings that we provide. One is the ASPICE Diagnostics, the Automotive Functional Safety Diagnostics, and the Cybersecurity Diagnostics. Now these diagnostics can help you navigate the classic process versus tool conundrum. That is if you’re trying to understand whether you should build the process first or buy the tool first, you’ll first see firsthand how Jama Connect will help shape the process. If you’re a Jama Software customer, you can use these diagnostics as a baseline. Oftentimes, we get busy with our day-to-day work and we may drift away from the larger big picture.
And these diagnostics are meant to guide you to bring light into areas that you need improvement or any optimization of your current Jama Connect process. You can also be paired with a Jama Software consultant or a solutions architect who will take you through the diagnostics start to finish. The time commitment for each of these diagnostics is about two to three hours. We feel that’s reasonable considering the benefits you may get out of this. We focus on the outcomes and the objectives and how this will truly help meet your compliance needs by optimizing your Jama Connect usage. If you’re a customer or getting up and running in Jama Connect, if you’re a prospect who’s looking for purchasing Jama, you can see these diagnostics offerings along with other offerings that we provide on the Jama Software Success Program page at Jamasoftware.com/success. Here you’ll see details on the compliance offerings that we just mentioned and a lot more other offerings including offerings on onboarding Jama Connect, improving your process and requirements, quality, traceability, et cetera.
Yerramalla: You can also request an offering if you have a service program with no assigned consultant and our operations team will pair you up with someone. So as far as the Automotive standards and alignments are concerned, the diagnostics offerings that we provide are aligned to the three standards, the Automotive Spice, ISO 26262 and ISO 21434. Only certain areas of those standards are in scope. For example, things like part seven of the ISO 26262 for production and operation and decommissioning are not covered here. But you will see some of these sections here are covered by the diagnostics. So depending on which diagnostics is right for you, the risks that are identified will align to the different areas that you see on the screen. Now, it may be that you want to align to more than one standard. We certainly put you through multiple diagnostics to identify your risks pertaining to each of these standard.
The model which we use is the same, but the recommendation we provide and tailored solution that the diagnostics provides will be custom based on each scenario. And if you don’t know where to get started or you don’t know which of these diagnostics that you need to start first. Some things are obvious, again, that if you’re looking for cybersecurity compliance and that is of the greatest concern for you, then Cybersecurity Diagnostics, the 21434 is right.
And if you’re looking for developing any functional safety products that are used in the Automotive, then the ISO 26262 diagnostics is the correct one to start with. And if you’re looking for any software process improvements or quality management, then ASPICE is the place to start. But sometimes you need both APSICE and functional safety, for example, in which case we suggest the ASPICE Diagnostics first. And the reason is that we rank in the process ASPICE about the functional safety is that if you have a high level of ASPICE maturity or on the other side, if there are several risks that are flagged from the ASPICE Diagnostics, then those will impact your Functional Safety Diagnostics already.
So you would’ve covered those parts of it that as a prerequisite for the functional safety. And then the spirit of ASPICE is really the quality management. And this is important in every engineering organization. So if you’re unsure where to start, then ASPIE Diagnostics is one place. And if you don’t need to prove compliance to the latter, it’s really good because honoring it, the lead benefits in your process.
https://www.jamasoftware.com/media/2023/09/wb-2023-09-27_Compliance-Made-Easy.png5121024Steve Rush/media/jama-logo-primary.svgSteve Rush2023-10-04 03:00:262024-01-17 23:12:38[Webinar Recap] Compliance Made Easy with Jama Connect® for Automotive and Semiconductor Development
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 “UK regulators name 3 approved bodies to ease device certification bottleneck” – originally written by Nick Paul Taylor and published on August 31, 2023.
UK regulators name 3 approved bodies to ease device certification bottleneck
A MHRA leader hailed the action as “almost doubling capacity for medical device assessment in the U.K.”
Dive Brief:
The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three more bodies to certify medical devices in the U.K.
As a result of Brexit, the U.K. is requiring manufacturers of all except the lowest-risk devices to apply for UK Conformity Assessment (UKCA) certification from an approved body. The approved bodies perform the same role as the notified bodies that issue CE marks to devices sold in the European Union.
MHRA’s designation of three approved bodies helps address a capacity shortage that led the government to stagger the transition from CE marks to UKCA certification.
MHRA automatically moved the U.K.’s three existing notified bodies, BSI, SGS and UL, to the approved body scheme when the country split from the European Union. Since then, efforts to add capacity have proceeded slowly. The U.K. affiliate of DEKRA, a notified body in the EU, became the first new approved body for medical devices 11 months ago.
Now, MHRA has designated TÜV SÜD, Intertek, and TÜV Rheinland UK. The designation clears the three bodies to certify general medical devices and empowers TÜV Rheinland UK to assess in vitro diagnostic (IVD) products. IVD capacity is lagging behind, with MHRA having designated four bodies in total.
In a statement, Laura Squire, chief healthcare quality and access officer at MHRA, hailed the addition of the three approved bodies as “almost doubling capacity for medical device assessment in the U.K.” It is unclear how many applications each approved body is capable of handling.
Even so, the designations go at least some way toward addressing a long-standing concern. The Regulatory Horizons Council identified the “lack of capacity in approved bodies within the U.K.” as a risk to patient safety and access to devices in a report two years ago.
Responding to the report early this year, the government accepted recommendations about addressing bottlenecks in device approval, notably the shortage of approved bodies, and taking mitigating steps to ensure the supply of products after the transition to UKCA. The concerns informed the decision to keep accepting devices with CE marks through 2028 or 2030, depending on the regulation.
https://www.jamasoftware.com/media/2023/09/UK-regulators-name-3-approved-bodies-to-ease-device-certification-bottleneck-1.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2023-09-28 03:00:392023-10-25 11:16:09UK Regulators Name 3 Approved Bodies to Ease Device Certification Bottleneck
To read the complete press release, go to https://www.jamasoftware.com/press/a-new-partnership-for-digital-design-product-development-excellence/
Engineering Industries eXcellence Partners with Jama Software® to Drive Innovation in Digital Design and Product Development Across Industries
PORTLAND, Ore. and CHICAGO, September 21, 2023 – Jama Software®, the industry-leading requirements management and traceability solution provider, and Engineering Group’s Industries eXcellence division, a global leader in the field of engineering services, design automation solutions, and Industry 4.0 technologies, jointly announce a strategic consulting partnership to transform the way industrial organizations design, develop, and deliver innovative products to the market.
Jama Software’s requirements management platform, Jama Connect®, provides a collaborative environment for teams to define, design and develop their product visions. By maintaining Live Traceability™ across a best-of-breed ecosystem, Jama Connect enables organizations to navigate the intricacies of modern product development, leading to faster time-to-market and improved product quality. Engineering Industries eXcellence, with its rich experience in engineering services and global network of digital transformation experts, brings a wealth of knowledge in product design, systems engineering, and technology consulting.
“We are excited to partner with the Engineering Group to deliver a holistic approach to intelligent engineering management that leverages Jama Software’s best-in-class technology with Industries eXcellence’s industrial sector expertise,” said Tom Tseki, CRO of Jama Software. “This collaboration represents our commitment to helping organizations bring innovative products to market faster, with higher quality and greater efficiency.”
Through this partnership, clients will benefit from the synergy between Jama Software’s innovative requirements management and traceability platform and Engineering Industries eXcellence’s deep industry insights, resulting in comprehensive solutions tailored to meet the unique challenges of their respective markets.
Jama Software® is focused on maximizing innovation success in multidisciplinary engineering organizations. Numerous firsts for humanity in fields such as fuel cells, electrification, space, software-defined vehicles, surgical robotics, and more all rely on Jama Connect® requirements management software to minimize the risk of defects, rework, cost overruns, and recalls. Using Jama Connect, engineering organizations can now intelligently manage the development process by leveraging Live Traceability™ across best-of-breed tools to measurably improve outcomes. Our rapidly growing customer base spans the automotive, medical device, life sciences, semiconductor, aerospace & defense, industrial manufacturing, consumer electronics, financial services, and insurance industries. For more information about Jama Connect services, please visit www.jamasoftware.com.
ABOUT THE ENGINEERING GROUP
The Engineering Group is a leading engineering services and solutions provider, offering a wide range of expertise in product design, system engineering, technology consulting, and more. With a track record of excellence, the Engineering Group partners with clients to drive innovation and achieve exceptional results. Learn more at Engineering Industries eXcellence (indx.com).
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EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights
Are you grappling with the intricacies of the EU Medical Device Regulation (EU MDR) and searching for clear answers to your most pressing questions? Look no further!
In this blog post, we’ve teamed up with subject matter expert Saby Ágai, Senior Professional Services Consultant at Jama Software®, who will shed light on the complex world of medical device compliance.
Overview + General Information
Why was the MDD (Medical Devices Directive) updated?
Saby Ágai: MDD entered into force in 1993, 30 years ago. There have been many changes over these three decades. There have been technological changes since then, software for example has more attention now than it had 30 years ago.
Patient demographics characteristics have changed, now it is a more aging population than it was 30 years ago. Medical device safety should correspond to these changes.
MDD was primarily focused on medical device commercialization criteria rather than looking at patient safety from a holistic perspective.
What are the most important changes introduced by the EU Medical Device Regulation?
EU MDD was focused on commercialization guardrails and market clearance criteria first.
EU MDR accounts for the full technological landscape, establishing guardrails for the regulation, manufacturing, and commercialization of medical devices.
Given that timelines may continually change, what is the latest information regarding extensions?
Implementation/Adaptation + Need for Process Improvement
The EU MDR has changed how medical devices are covered. What opportunities and challenges might this expansion present for manufacturers?
Opportunities:
Manufacturers can deliver to the market higher levels of safety for their medical devices.
Manufacturers can be more aware and in control of their medical device lifecycle.
Potentially this could result in less recalls and less rework, and fewer customer complaints. There is also an opportunity for an easier pathway to other markets like US, Canada, Japan, and others.
Challenges:
Steep learning curve to adopt to the new regulation
Lack of professional, lack of experiences how to adopt to the new regulations
Optimizing efforts and resources spent on the adoption of MDR
What strategic steps should medical device companies and regulatory experts take to ensure a successful transition in light of the changes brought on by the MDR and its effect on CE markings?
Manufacturers should have a plan for MDR transition
Expert panel of the EU could be involved to receive professional support
Regulatory professionals should be competent to the new regulations
Best practices across the medical industry should be utilized for the transition
How can medical device manufacturers improve their Quality Management Systems (QMS) to be better at compliance? What new approaches can be used to make business growth and product innovation possible?
New quality management processes should be developed to correspond to the requirements of the MDR. Manufacturers should also revisit their core processes including quality assurance, risk management, and post-market process to see if re-implementation needed to ensure compliance with new MDR.
Related: Learn about the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry:
Data & Documentation
What impact does the EU MDR’s demand for increased device traceability and technical documentation have on promoting patient safety and regulatory visibility? What potential advantages and obstacles might exist when attempting to reach these outcomes?
Patients will benefit from the increased focus on safety and regulatory visibility on medical devices that MDR demands. On the other hand, novel technologies in medical devices may suffer from delays to be available early for patients. It is a balance though between efficiency and safety that always was there. The increased volume of technical documentation can lead to higher levels of design awareness for the manufacturers, on the other hand the increased resources needed to get there need to be financed.
How can medical device manufacturers collaborate with notified bodies and competent authorities to ensure a streamlined and efficient certification process?
There is a conflict of interest that does not allow the Notified Body and Authorities to provide consulting on MDR compliance for the same manufacturer that registered for certification. Manufacturers can help the certification process by signing up for certification on time. Manufacturers also can streamline certification processes by involving competent and experienced professionals to fulfill the Person Responsible for Regulatory Compliance (aka PRRC) role.
More attention on post-market surveillance processes.
Technical documentation:
Let’s investigate the products listed in Annex XVI of the MDR and discuss the effects this will have on both manufacturers and healthcare providers. How can stakeholders take advantage of this inclusion to create positive results?
Those products are subject to the MDR, even though those are without an intended medical purpose. These products previously were unregulated products and the MDR introduces new manufacturing and surveillance requirements. A positive result is the higher level of transparency of the design, manufacturing and post market activities of these products. Users of such products benefit from a higher level of safety when using these products.
Will the stricter regulatory requirements of the EU MDR hinder or promote innovation in the medical device industry?
There is always a balancing between introducing novel technologies to patient treatments that potentially can save or extend our life as a patient versus using only high level of safety assured medical devices. If the current MDR hinders or promotes innovation only time will tell.
How can manufacturers balance the need for compliance with the desire to bring innovative products to market in a timely manner?
Market regulations are prescriptive to the given market. Manufacturers probably will deliver slightly different functionalities for essentially the same medical devices depending on how the market regulation allows for more open for novel technologies.
Patient Safety
How does the EU MDR change clinical evaluation requirements? And how can the industry adapt to these changes while continuing to prioritize patient well-being and efficacy?
The MDR has more rigorous clinical evaluation requirements, necessitating robust clinical data to support the safety and performance claims of the device. For each device, the manufacturer must plan, establish, document, implement, maintain and update a post-market surveillance (PMS) system that is proportionate to the risk class and appropriate for the type of device. The PMS system actively and systematically gathers, records and analyses data on the quality, performance and safety of a device throughout its entire lifetime. Post-market clinical follow-up (PMCF) is a continuous process that updates the clinical evaluation. It is conducted in accordance with a PMCF plan that is an element of the overall PMS plan.
What opportunities does the EU MDR present for enhancing patient safety through better data collection and analysis?
Clinical evaluation and post-market related information will be more transparent for the medical devices; therefore, manufacturers will have more opportunities to analyze device safety based on adverse events of similar types of devices.
How does the increased emphasis on clinical data and post-market surveillance impact medical device manufacturers’ approach to product development and monitoring?
Clinical and post-market data collection should drive the design effort by transferring efficacy and safety related subjects back to development. Also, the analyses of similar products post market reporting enable manufacturers to enhance the safety of their medical device designs.
How can manufacturers leverage the new post-market surveillance requirements to proactively identify and address potential issues with their products?
MDR mandates and sets requirements for the post-market surveillance process. PMS process should be part of the manufacturer’s Quality Management System.
Manufacturers can use proactively the data gathered as part of the post-market activities for the following:
to update the benefit-risk determination and to improve the risk management;
to identify the need for preventive, corrective or field safety corrective action;
to identify options to improve the usability, performance and safety of the device;
to detect and report trends.
Conclusion
How will the EU MDR impact medical device companies operating outside the EU but wishing to access the European market?
For new arrivals, the new MDR is a demanding legislation to comply with in the European Union. Currently the conformity assessment bodies have limited bandwidth for new devices. Therefore, new manufacturers should assess the timing nature of their market access. For medical device companies operating outside the EU, there are further requirements set in the MDR in Article 11 on Authorized representatives.
How can Jama Software help organizations more easily comply with regulations like EU MDR?
Jama Software provides a solution for medical device manufacturers to adapt easily and to response quickly to the changes that the EU MDR demands. It’s achieved by providing best practices in medical device design in the context of the MDR.
https://www.jamasoftware.com/media/2023/09/2023-09-19-eu-mdr-saby-interview-1.jpg5121024Saby Ágai/media/jama-logo-primary.svgSaby Ágai2023-09-19 03:00:212024-01-17 23:16:15EU Medical Device Regulation (EU MDR) FAQs: Industry Expert Insights
A Wise Investment: Requirements Management and Traceability Solutions During an Economic Downturn
In the realm of business, the economy is a dynamic force that ebbs and flows, much like the tide. Economic downturns, while challenging and sometimes scary, can also present unique opportunities for businesses to reevaluate their strategies, streamline their operations, and invest wisely for future growth. One such investment — that might not be immediately obvious but holds immense potential — is in requirements management and traceability solutions. In this blog post, we’ll explore why it makes sense to invest in these solutions during an economic downturn.
1. Enhanced Efficiency and Resource Optimization:
In times of economic uncertainty, operational efficiency becomes paramount. Requirements management and traceability solutions provide a structured framework for capturing, organizing, and tracking project requirements throughout their lifecycle. By optimizing requirements management processes, businesses can ensure that resources are allocated to the most critical aspects of a project. This reduces the risk of scope creep, minimizes wasted effort, and enhances overall project efficiency. With a clear understanding of project goals and dependencies, teams can work cohesively, to not only avoid both unnecessary and costly duplication of work but also enable organizations to allocate resources where they are most needed.
Economic downturns often come with increased financial constraints, so allocating resources to any new software investments might seem counterintuitive. But investing in requirements management and traceability solutions can truly act as a risk mitigation strategy. The right requirements management and traceability solutions facilitate comprehensive end-to-end impact analysis, allowing businesses to understand how changes to requirements can affect other aspects of the project or organization. By foreseeing any potential pitfalls and addressing them proactively, companies can increase process efficiency, minimize costly errors, rework, and recalls, and streamline development to accelerate time to market — ultimately safeguarding their investments in both time and resources.
3. Regulatory Compliance and Quality Assurance:
In certain industries, compliance with regulatory standards is non-negotiable. Implementing robust requirements management and traceability solutions can streamline the process of documenting and demonstrating compliance. These solutions enable clear documentation of how each requirement maps to relevant regulations, making audits smoother and reducing the risk of non-compliance penalties. Moreover, well-managed requirements also lead to improved quality assurance practices, ensuring that products or services meet the desired standards even during challenging economic periods.
4. Agility and Adaptability:
Economic downturns often require businesses to pivot their strategies quickly to address changing market dynamics. Requirements management and traceability solutions provide a foundation for agile decision-making. When requirements are well-documented and linked, it becomes easier to assess the impact of changes, make informed decisions, and adapt to shifting priorities without causing disruptions. This agility allows businesses to seize new opportunities and respond to market demands more effectively.
While the initial investment in requirements management and traceability solutions might seem significant, it pales in comparison to the potential long-term cost savings. When requirements are managed efficiently, projects are less likely to overrun budgets or experience delays due to misunderstandings or miscommunications. The cost of fixing issues after they’ve occurred is far higher than preventing them in the first place. By investing in proper requirements management, businesses can avoid the financial strains that arise from project failures or inefficiencies.
Conclusion:
In the face of economic uncertainty, investing in requirements management and traceability solutions might not be the most obvious choice, but it’s certainly a strategic one. These solutions offer a structured approach to managing projects, reducing risks, enhancing efficiency, ensuring compliance, and promoting adaptability. By making this investment, businesses position themselves for not only surviving economic downturns but also thriving in the long run. As the tide of the economy inevitably turns, those who have laid a strong foundation in requirements management will be better equipped to ride the waves of change.
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Best Practices for Verification and Validation in Product Development
In the competitive landscape of modern product development, ensuring the reliability and quality of the product is essential to meet customer – and stakeholder – expectations and regulatory requirements. Verification and validation (V&V) are two crucial processes that play a pivotal role in achieving these goals. V&V are systematic methods that assess a product’s adherence to specifications and its ability to perform as intended. In this article, we will delve into the best practices for verification and validation in product development, exploring the key steps, methodologies, and benefits of each process.
Understanding Verification & Validation
Before delving into the best practices, it is essential to clarify the distinction between verification and validation. Verification focuses on assessing whether a product meets its design specifications, ensuring that each component and feature works as intended. On the other hand, validation is concerned with evaluating whether the product fulfills its intended use and customer needs. In essence, verification confirms if the product is designed correctly, while validation confirms if it is the right product for the intended application.
Incorporating V&V Early in the Development Lifecycle
To maximize the effectiveness of verification and validation, these processes must be integrated into the product development lifecycle from its early stages. By starting V&V activities early, potential issues can be identified and resolved before they escalate, reducing costs and time-to-market. Early involvement also allows for feedback to be incorporated into the design, leading to a more robust and reliable final product.
Clearly Defined Requirements
Well-defined requirements are the foundation of successful verification and validation. During the requirements gathering phase, it is vital to engage stakeholders and subject matter experts to create clear, measurable, and unambiguous specifications. These requirements serve as the baseline against which the product will be verified and validated. Proper documentation and version control are critical to ensure that changes to requirements are tracked effectively. Additionally, the later in the development process that requirements get changed, many times because they weren’t written well the first time, the more costly it is due to downstream impacts such as rework in verification and validation.
Product development teams should employ a mix of V&V techniques to comprehensively assess the product’s quality. Some commonly used methods include:
Testing: Conduct thorough testing, including unit testing, integration testing, system testing, and user acceptance testing, to verify that each component and the product as a whole performs as expected.
Simulation: Use computer simulations to evaluate the product’s behavior in various scenarios, particularly for complex systems or when physical testing is impractical or cost prohibitive.
Prototyping: Building prototypes early in the development process allows for real-world testing, uncovering potential design flaws and usability issues.
Peer Reviews: Encourage regular peer reviews of design documents, code, and other artifacts to catch errors and improve the overall quality of the product.
Model-based Design: Utilize model-based design approaches, such as Model-Driven Architecture (MDA), to create detailed models that can be verified before implementation.
Risk-Based Approach
Incorporate a risk-based approach into V&V activities to focus resources on critical areas. Identify potential risks associated with product failure and prioritize verification and validation efforts accordingly. This approach ensures that resources are allocated efficiently, concentrating on areas with the most significant impact on product performance and safety.
Independent Verification and Validation (IV&V)
Consider engaging external experts or teams for independent verification and validation. External parties can provide an unbiased assessment of the product, uncovering issues that internal teams might overlook due to familiarity or assumptions. Independent verification and validation bring additional expertise and ensure a higher level of confidence in the product’s quality.
Continuous Integration and Continuous Delivery (CI/CD)
Implementing CI/CD practices allows for continuous verification and validation throughout the development process. Automated testing and deployment pipelines can quickly detect regressions and integration issues, ensuring that the product remains stable and reliable throughout its evolution.
Documenting V&V Activities
Comprehensive documentation of all verification and validation activities is essential for compliance, knowledge retention, and continuous improvement. Properly documented V&V processes help maintain a historical record of changes, failures, and resolutions, facilitating future product iterations and troubleshooting.
V & V are integral to successful product development, ensuring that products meet the required specifications and perform as intended. By adopting best practices such as early integration, clear requirements, a mix of v&v techniques, risk-based approaches, and continuous verification, companies can create high-quality, reliable products that customers love and gain a competitive edge in the market. Moreover, investing in verification and validation from the outset of development can save time and resources, prevent costly delays, and lead to higher customer satisfaction and loyalty in the long run.
https://www.jamasoftware.com/media/2023/08/2023-09-07-verification-and-validation-1.jpg512986Jama Software/media/jama-logo-primary.svgJama Software2023-09-07 03:00:172024-01-17 23:19:12Best Practices for Verification and Validation in Product Development
