Digital transformation helps companies secure a competitive advantage through improved productivity, greater customer loyalty, happier employees and a larger bottom line. It’s the foundation on which companies build more value for their customers. In the past, digital transformation may have been considered an IT project, but the reality is that it ripples throughout every part of the business.
Digital transformation has become more critical during the pandemic as companies are challenged with working remotely and delivering on customer expectations without missing a beat. One study found that over half of IT decision makers (59%) reported plans for accelerating digital transformation efforts when previously, only 15% of companies were prioritizing digital transformation.
As companies move forward, they need tools that support the delivery of what their customers expect, whether it’s faster, more connected experiences or getting the products they need delivered at record speed.
Why is digital transformation important?
Digital transformation helps your company secure a competitive edge that delights your customers and streamlines back-end operations. For example, you may need greater traceability across a product’s life cycle, the ability for employees to collaborate in real time or greater visibility into risk management. It’s the strategy that underpins your decision about what tools are essential. A few benefits include:
Improves the customer experience.
Even if you’re using the tools to develop better products, a digital-first culture has a direct effect on the customer experience. And improving the customer experience is key, since 86% of buyers are willing to pay more for a great customer experience. During 2020, the customer experience overtook product and price as the key brand differentiator.
Builds a stronger employee experience.
Most companies know that employees are their greatest asset, and by providing your people with the tools they need to do a better job, you create a more engaged and efficient workplace, which translates to happier customers.
Optimizes processes.
Digital transformation helps you optimize existing processes and make them more efficient. You can streamline workflows, improve digital processes, automate time-consuming tasks and overall make your workplace more efficient.
Creates greater profitability.
Research shows that 80% of organizations that completed digital transformation reported improving profits, and 85% reported improvements in market share. On average, leaders forecast 23% higher revenue than that of their competitors.
Improves agility and productivity.
During 2020 companies learned that agility wasn’t important; it was essential. Tools that support digital transformation help your company innovate faster, streamline workflows and improve productivity.
How can companies embrace digital transformation and achieve better results?
Developing a digital transformation strategy, or revisiting an existing strategy, is a good place to start in creating more agility and success in your plans. What tools will help you meet digitizing requirements or, if you’re developing products, meet complex product requirements? Consider doing the following.
Define what it means to your company.
What is your desired outcome once your digital transformation strategy is deployed? It’s all about the end game, so define your goals well upfront. Consider examining the people, processes, data and technology that you use now, and then align those elements with your goals. Where are the gaps? Are you struggling with efficient collaboration? Is product development inefficient? Identify the areas that matter most.
Foster a digital culture.
Digital adoption comes from the top down. Share your strategy with employees, and get buy-in. How will their jobs improve due to the changes, and how will they be able to serve customers better? Share these details to get everyone on board.
Define value.
A key goal for any digital transformation strategy should be to provide value. How does the strategy serve your overall business vision? Do you need to streamline processes, drive greater revenue or develop larger customer value? You need a baseline and the ability to successfully measure those changes while staying agile.
Support agility.
It’s critical to stay fluid enough to adjust to fast-changing market conditions and respond quickly. Rigid KPIs need to give way to more flexible and agile requirements that have room for iteration. Adaptive design allows you to pursue more frequent changes to transformation strategies and thereby generate the best results.
As you define your strategy, it also helps to be aware of a few potential pitfalls so that you can avoid them. For example, more technology isn’t always the answer. Success lies in adopting the right technology. Consider these common pitfalls:
Failure to define a digital transformation strategy.
Digital transformation must start with a vision, and adoption of technologies and tools must directly stem from that vision. How can the technology support the goals and objectives?
Not asking the right questions.
Asking the right questions can help you shape your digital transformation strategy. For example, what do you truly need to better meet customer demands? Do you need to streamline complex product development through improved collaboration? Do you need real-time collaboration to improve workflows? Look at overarching goals and narrow down the tools that make accomplishing those goals easier.
Lack of leadership support.
Digital transformation isn’t a “one and done” project but instead a living, breathing process of iteration. It requires leadership support in continuously revisiting the strategy and making changes as needed to improve the strategy.
Creating strategy in a silo.
The IT department may have largely been responsible for digital transformation in the past, but that is no longer the case. It’s a cross-functional project that affects leaders, as well as employees, from all parts of the business.
Moving Into the Future with Greater Success
Digital transformation is a critical element on the path to the future. Few businesses will stand the test of time without a strong plan to adopt beneficial technologies, such as those needed to digitize requirements management and complex product development. For example, as product development processes become more complex, traditional document-based requirements management has shown its age and limitations. This alone is a powerful opportunity in digital transformation strategy.
However, many organizations haven’t upgraded their requirements and risk management processes to keep pace with innovation, putting them at risk for slow development cycles, costly changes and regulatory recalls. Identifying opportunities such as this will help your company adopt digital transformation with great strength and success into the future.
https://www.jamasoftware.com/media/2021/03/2021-03-30_digital-transformation_1024x512.jpeg5121024Jama Software/media/jama-logo-primary.svgJama Software2021-03-30 03:00:452021-04-16 17:46:26What Is Digital Transformation?
Do you know the most common product development challenges engineers face? In this post, we have identified them and provided solutions that enable a more modern and efficient product development process.
An ideal product development process requires close collaboration between teams, up-to-date knowledge of applicable regulations, and efficient requirements management platforms for defining, verifying, and validating requirements. However, not every manager is convinced that his or her team needs to do a better job on requirements development and management, or that such an investment will pay off—despite numerous industry studies which indicate that requirements issues are a pervasive cause of project distress.
With the growing complexity of products and software, the more complicated the process required to build it becomes—and the accompanying increased risk of flaws which can lead to expensive, and potentially reputation-harming recalls.
These new complexities have raised the stakes—and made the case—for the need to optimize the product development process from end to end. Engineering and design teams need solutions to the most common product development challenges that provide purposeful, structured collaboration; connect globally distributed team members; and accurately capture and facilitate feedback, decision making, and context for requirements under review.
Doing so requires first overcoming some significant obstacles. To help navigate the journey toward better product development, let’s examine ten of the most prominent product development challenges engineers face and their corresponding solutions.
1. Move on from outdated legacy or document-based solutions
The Product Development Challenge: The traditional approach to managing risks and requirements is highly manual. Teams that operate with a documents-based approach, exchange numerous spreadsheets, and versioned documents via email. This method has real drawbacks:
No single source of truth: A spreadsheet with a project’s traceability matrices could have many cells, but no guarantee its data was authoritative or even up to date. Different versions might be floating around, requiring any changes to be painstakingly manually coordinated to achieve team-wide alignment.
Limited collaboration: Sending complex requirements documents over email leads to important updates getting lost in people’s inboxes and projects being delayed. As remote teams become more common, such issues are even trickier to manage.
Excessive rework: Without effective change management—which is very hard for teams who rely on static, emailed requirements documents—teams often end up developing (or testing) off of older versions of requirements which inevitably leads to misalignment and costly rework.
The Solution: Jama Connect™ provides the single source of truth absent from document-based solutions. Teams from anywhere can collaborate in real-time on a unified platform and capture accurate feedback, review progress, and conduct approvals. That leads to earlier identification and control of risks, which helps reduce rework and keep projects on schedule and under budget.
2. Simplify compliance and meet regulations or standards
The Product Development Challenge: Product development has become much more complicated over time. As a result, so has product risk—and the accompanying regulatory compliance required.
A Jama Software-sponsored survey on Engineering.com found that 62% of respondents reported being reprimanded by regulatory agencies for product development issues. More broadly, recalls have been increasing in certain industries, with medical device recalls more than doubling year-over-year in Q1 2018, due primarily to software-related defects.
The Solution: To address these product development challenges, Jama Connect is engineered to ensure quality with frameworks aligned to key industry standards that streamline design, development, and risk management while maintaining compliance.
Jama Connect helps customers in industries like medical device, aerospace, and automotive solve this product development challenge by streamlining their quality and risk management processes with defined processes for development and production and detailed traceability—from the high-level user needs and systems requirements through to validation and verification. Teams can streamline their product development with templates aligned with industry standards, compliant reviews and approvals, and end-to-end traceability making audit preparation and record-keeping a straightforward process.
3. Establish and implement effective review cycles
The Product Development Challenge: Without the right platform and processes in place, review cycles can be time-consuming and fragmented. For example, under the manual approach to requirements management described earlier, a review cycle can be repeatedly delayed due to versioning issues with documents and lack of visibility throughout the review process. Teams can also spend hours per week in review meetings, just to ensure everyone is on the same page.
Streamlined review cycles require:
One source of truth for requirements and tests
A straightforward way to send items like requirements, user stories, or test cases for review
Best practices for each of the major roles involved (i.e., reviewer, approver, moderator)
Real-time collaboration within a shared, dynamic requirements management platform
A formal approval process to capture and record sign-off
The Solution: Jama Connect Review Center can solve this product development challenge by serving as the single place for reviewers, approvers, and moderators to collect and manage all requirements and feedback for a project in real-time.
Inviting internal and external collaborators into a review cycle is easy, plus roles can be assigned and all agreed-upon requirements approved much more quickly than with manual processes. Pharmaceutical manufacturer Grifols reduced its planning time by 80% by using Jama Connect to accelerate review cycles.
4. Enable secure, cross-functional collaboration across teams, customers, and complex supply chains
The Product Development Challenge: People working together is at the very core of all product development work. The ability to effectively collaborate is critical for innovation. In this era of rapidly accelerating change, structured and strategic team collaboration is the key to improving the product development process for all team members. And in this era, the “team” includes everyone across the supply chain.
Today’s market demands require companies to build partnerships and seek solutions with more specialized materials. These partnerships mean greater sharing of data across distributed teams, partner organizations, and business units, sending a ripple effect through the supply chain as subsystem suppliers must anticipate features on the finished products and get ahead of release schedules and component costs.
But for engineers who are used to working on internal, siloed teams, these new partnerships present previously unforeseen challenges. What worked before doesn’t work today.
Aligned requirements management is necessary for developing products that meet all customer and market requirements while adhering to industry regulations and standards. More specifically, optimized gathering and authoring of requirements are needed to ensure product quality and meet specific requirements, minimize risks, accurately scope projects, enable collaboration, and align teams.
The Solution: Requirements gathering should follow a systematic process, focused on what eventual end users will do and the requirements that must be met to support those behaviors. This approach ensures that both high- and low-level requirements and their dependencies are covered and that corresponding tests can be set up and run.
As teams seek input and feedback on product and systems requirements, tools like Jama Connect are critical in capturing these insights in real-time. With everyone having access to the most up-to-date information, stakeholders can stay informed and aligned, reviews can be streamlined, and teams have better visibility into the progress of their work. This helps reduce the complexities of communication and saves time by having a single source of information regardless of geographic or institutional location, which enables collaboration across a variety of relationships. Having a single platform where these teams can come together to review and connect will keep programs on track, keep teams collaborating, not let insights slip through cracks, and allow for innovation.
Engineers typically collaborate with outside companies by exchanging requirements. Data Exchange for Jama Connect enables the transfer of requirements and associated metadata between customers and suppliers. The solution allows for the import, export, and update of requirements data to create an ongoing exchange throughout the product development lifecycle, allowing for collaboration to extend to remote engineering teams and companies.
RBC Medical saved an average of $150,000 per project by upgrading to Jama Connect eliminating the back-and-forth email tag that characterized its previously manual processes.
5. Ensure product quality and improve change management with complete traceability
The Product Development Challenge: Maintaining cross-team visibility and staying on top of disparate documentation and processes along the way is a central challenge of working with manual, document-based workflows. It becomes difficult to accurately assess the impact of a proposed change (i.e., perform impact analysis) and to ultimately ensure requirements are properly tracked across the entire product development lifecycle.
The Solution: To make impact analysis more scalable, teams need end-to-end traceability. In Jama Connect, links that are downstream from modified items get automatically flagged as “suspect,” and relevant contributors can be notified right away to take corrective action. Modern traceability software maps out the relationships and interdependencies in product development, allowing for assiduous tracking of risks and requirements in their full historical context.
Important data, such as the percent of downstream test cases that have passed and where coverage may be missing, is also easy to view, while the system’s requirements can be updated in a centralized place as the project progresses.
The right requirements management technology can provide clear traceability that allows teams to maintain a rigorous formal change management process; reveals interdependencies with the process; and enables alignment, making it easier to bring in the right decision-makers at the right time. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as products and systems become more complex and software-driven.
The result is improved confidence that teams are working with the right requirements, have the information they need to conduct useful impact analysis and are generally able to trace forward from, and back to, requirements as needed.
6. Manage development complexities across hardware and software teams
The Product Development Challenge: Software is an ingrained part of modern product development and one that can greatly increase risk if not properly managed. Moreover, complex software requirements have to be managed in tandem with those for hardware. The growing connectivity embedded into today’s ever more complex and often safety-critical products, puts pressure on both software and hardware teams to manage their development processes with more efficiency and effectivity. In fact, in a recent study from Engineering.com, over the last five years, 76% of respondents reported dealing with three or more increased measures of complexity and 25% saw their products become more complex in five or more ways.
The Solution: In a platform like Jama Connect, risks and requirements related to software and hardware can be managed proactively, not reactively. Teams can quickly see the full historical context around a requirement when they receive invitations to contribute to a project. Out-of-the-box frameworks that include industry-specific, software development methodology and risk management also minimize setup time, so that important risks in software and hardware can be identified, assessed, and acted upon as early as possible.
Configurable workflows accommodate various process styles, development methods, and tools to ensure adoption, with flexibility to support your Agile, Scaled Agile or Hybrid development process. Requirements data can be integrated with other tools across the development process to ensure everyone stays aligned.
One of the most common scenarios is integration of requirements to Atlassian Jira. With the Jama Connect for Jira integration, product teams can maintain critical information about their product requirements and test cases and directly connect them to development activities in Atlassian Jira, including sprint planning, task management, estimations, and defect and issue tracking.
7. Increase quality and efficiency by testing earlier in the lifecycle
The Product Development Challenge: It’s well understood that identifying potential defects earlier in the lifecycle prevents costly rework. But how can organizations proactively involve QA at the front end of the process?
The Solution: Early testing prevents defects from surviving until the late stages of the lifecycle, when they become especially costly to fix. In addition, early and frequent testing allows for innovation.
The National Institute of Standards and Technology has estimated that the relative cost of fixing a software bug is 30 times higher in production than in the requirements and architecture stage of development.
Conducting some form of testing, at every stage of the product development lifecycle, is highly recommended. Getting the right feedback at the right time ensures that you can deliver a high-quality product on time.
In the early stages of development, performing customer exploratory testing is the most cost-effective way to make sure your product strategy is on the mark. And, at the end of the development lifecycle, conduct system integration tests to ensure components are working harmoniously.
Jama Connects helps engineering and quality assurance teams define, organize, and execute requirements-based test plans and test cases to ensure quality and compliance. Teams can streamline reviews and approvals, perform manual testing, and integrate with trusted test execution and automation solutions.
8. Implement effective requirements versioning, baselining, and change management
The Product Development Challenge: Legacy requirements management systems frequently complicate version control, due to the prevalence of conflicting requirements documents that are manually managed, often owned by varied teams and then distributed cross-functionally. Likewise, they don’t provide the right infrastructure for effective change management, because of the difficulty involved in identifying the latest versions and applying any needed changes amid all of the different documentation in question. Changes might ultimately be made only at a late stage, and at great cost.
The Solution: A requirements management platform like Jama Connect can solve this product development challenge by allowing teams to align their releases to ensure they deliver a cohesive solution/product to their customers. With versioning, baselining, and change management of the requirements in place, teams are able to manage and reuse requirements throughout the development lifecycle. This allows development teams to improve reuse, reduce design inconsistencies, and reduce the discrepancies found during testing, verification, and validation.
Jama Connect offers full control over the requirements you are choosing to reuse. You can not only choose the set of requirements you want to reuse but also the version of those requirements as well. This allows you to take the best and most applicable version of your requirements forward to your next project.
Studies reveal that 60 to 80 percent of requirements, code, and tests are shared between projects. With Jama Connect, you can reuse your data for effective sequential or parallel product development which saves your development teams time and improves time-to-market.
9. Make it easier to coordinate remote engineering teams
The Product Development Challenge: Remote work is on the rise. Although it has many benefits in team flexibility and cost savings for the organization as a whole, it can complicate collaboration and result in additional operational silos as each remote engineer settles into their own workflow and preferred set of tools.
The Solution: Modern platforms that enable real-time, structured collaboration simulate the efficiency of engineering teams working together in a shared physical workspace. For example, engineers can be easily invited into Jama Connect conversations and reviews, notify each other with custom messages and supporting context, and be assured that they’re always working with the latest information.
Such a setup solves this product development challenge by reducing silos and keeping everyone aligned. Buffer’s State of Remote Work survey for 2020 found that communication and collaboration were among the most cited challenges with telecommuting. Teams that still operate in silos with legacy systems will not be equipped to meet the demands of the market going forward. In this era of rapidly accelerating change, structured and strategic team collaboration is one of the best ways to address the product development challenges and obstacles of the modern product development landscape.
10. Build a more effective and efficient product development process
The Product Development Challenge: Product development is complex and, in most cases, will span multiple teams, solutions, and methodologies. Outdated legacy tools and a documents-based approach aren’t enough for this reality, as they aren’t purpose-built for complicated requirements management.
The often-quoted CHAOS Reports from The Standish Group indicate that three of the biggest contributors to projects that fail or are “challenged” are:
Lack of user input
Incomplete requirements and specifications
Changing requirements and specifications
The Solution: An evolutionary leap forward comes from modernizing requirements definitions as well as engineering and management processes—including minimizing the time your team members spend eliciting, analyzing, documenting, validating, and managing the requirements for their products.
Do you have product development challenges you need to solve?
Jama Connect is a solution for managing complex product requirements from idea through development, launch, and iteration. It brings people and data together in one place, providing visibility and actionable insights into the product development lifecycle. Our platform equips teams to track decisions and ensure the quality of the product they set out to build.
We’d love to speak with you and share how Jama Connect can help your teams find solutions to your unique product development challenges and overcome these 10 common ones. Connect with us today and get started with a better approach to managing requirements in product development.
To learn more about optimizing engineer team collaboration to streamline product development, download our eBook now!
https://www.jamasoftware.com/media/2020/07/2020-08-23_Top10ChallengesBlogPost_1024x512.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2020-07-23 03:00:432020-07-23 03:00:4310 Biggest Product Development Challenges Engineers Face… And How to Solve Them
Medical device developers innovate to move people forward. Theybuild to help experts help others. But getting there is never an easy road. It can take up to 7 years to get a new medical device to market. And cost up to $1 billion dollars.
Empower your teams with a platform that helps you overcome key challenges and accelerate your product development process.On a single platform, you can lower costs, minimize regulatory disruption, overcome compliance obstacles, and connect teams. Jama Connect activatesa digital transformation and brings your product to the people who need it, faster.
With Jama Connect for Medical Device Development, here’s what’s possible: Ensure product quality and safety across development teamswith increased collaboration. Manage development costs and leave behind document-based and legacy solutions that limit innovation. Stay in control in an evolving regulatory environment. Stay competitive as connected devices rise in the market and your teams work to support a wider range of complexity. Word docs and spreadsheets won’t make it possible. Realize value quickly, through an out of the box solution that’s already configured for medical device development. Accelerate development, with built-in support aligned to key regulations and procedure guides created to support design control activities.
With Jama Connect, you can produce Export Templates including trace reports and a Design History File and receive training to ensure team success. Get the features you need to navigate the complexity of successful product development. Free your teams to focus on innovation and rise to meet those who need your product the most, in the workplace and every day.
“Jama Connect frees us up to focus on the design of the product, not the logistics of the work that needs to be done. We are able to spend our time more effectively — helping our customers.”Scott Britt, Systems Engineering Manager, RBC Medical Innovations
“We all want to spend more time being creative and innovating our products, and Jama Connect gives us more opportunities to do that.”Lars Jensen, Product Quality Assurance Manager, 3Shape
To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!
https://www.jamasoftware.com/media/2020/07/2020-07-16_JamaConnectMedDeviceVideo_Blog_1024x512.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2020-07-16 03:00:192020-07-16 03:00:19Why Global Medical Device Companies Choose Jama Connect
Infographic: Jama Connect™ for Medical Device Development
We’re excited to share our latest infographic for the Jama Connect for Medical Device Development solution which explains how Jama Connect can help accelerate innovation, maintain product quality, and manage the ever-changing complex regulations in medical device development. This is a single powerful platform for medical device teams to manage design controls for device requirements and related risks, simplifying regulatory submissions, and audit preparations while accelerating time to market.
Bringing a medical device to market requires navigating a sea of complex and ever-changing regulations, not to mention bearing significant costs along the way. A device recall can cost $600 million, while the indirect costs of lost revenue and diminished market cap are even higher at $1-3 billion per company. Those costs are especially significant considering the price tag of product development—$75 million in FDA compliance alone, and an average timeline of three to seven years.
→Jama Connect customers have been able to reduce planning time as much as 80%, thanks to consolidated feedback replacing emails and a document-based approach to project management.
→Better quality products get out the door faster. By understanding the impact of change, capturing decisions and feedback in real-time and reusing existing IP, Jama Connect reduces medical device development time by an average of 130 days per project.
→Jama Software reduces rework, which accounts for approximately 30-50% of a given project and arises from issues such as requirements errors. Improving the ability to track requirements from design through verification and validation ensures teams build the right medical devices with the lowest possible lifecycle costs.
In this infographic,we share how, with the right requirements management solution, you can accelerate the development of cost-effective products that also comply with both safety and quality standards.
You’ll learn:
How to overcome the biggest challenges in medical device development
The ways Jama Connect for Medical Device Development can help
https://www.jamasoftware.com/media/2020/06/2020-07-07-med-device-infographic-blog-1024.jpg5121024Karrie Sundbom/media/jama-logo-primary.svgKarrie Sundbom2020-07-07 03:00:002021-04-08 21:03:58Infographic: Jama Connect™ for Medical Device Development
We wanted the solution to offer a collection of training and documentation components that aligns to industry regulations so product development teams could get ramped up quickly.
The result: an out-of-the-box configuration of Jama Connect, an accompanying Procedure Guide, and Jama Professional Services. It’s a solution designed to reduce time-to-value, account for and provide tailored guidance around customer-specific needs, and drive adoption through tailored training and on-going support. Let’s take a look at the components and see how they help achieve those goals.
Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part I, and Part III.
Procedure and Configuration guide: Jama Connect, clearly aligned with regulations.
The Jama Connect for Medical Device Development Procedure and Configuration Guide provides detailed alignment between these regulations and standards and the out of the box configuration and recommended use of Jama Connect:
ISO 13485:2016
ISO 14971:2019
21 CFR 820.30
The scope and processes described in the guide are clearly identified and justified.
An important point to note: we identified the Jama Connect capabilities that align with the most relevant design control requirements needs. Then we targeted those needs, and optimized Jama Connect to meet them exactly.
The regulations and standards establish the design control requirements and provide some guidance, but they are not prescriptive in terms of tools or techniques. The procedure and configuration guide explains in detail how to bring in best practices from systems thinking, supported by use of Jama Connect, while still complying with design control requirements. .
Teams building complex medical devices will benefit from this systems-thinking approach and the way the Procedure and Configuration Guide builds these layers into the configuration. The principles and guidance provided by the Systems Engineering Body of Knowledge (SEBoK) and the recommended use of Jama Connect will bring clarity around product definition and verification activities.
Out-of-the-box-configuration: Start with standardized guidance and build from there.
The out-of-the-box configuration provides a recommended project template that allows customers to get up and running quickly. It also serves as a starting point for customer-specific discovery and configuration. Each aspect of the configuration aligns with the applicable regulations and standard through detailed process activities and tasks described in the procedure guide
The configuration also provides Export Templates you can use to generate documentation from Jama Connect for transport into your Quality Management System (QMS), typically used to house all Design History Files for sign-off and audit.
On-site consulting and training services to align your teams quickly.
Jama Software’s Professional Services team works to help customers reach several goals:
Build adoption, decrease time-to-value, and maintain ease of use.
Focus on process alignment, people readiness, and best practices for configuration and use.
Take advantage of the recommendations and guidance described in the Procedure and Configuration Guide and built into the out of the box configuration.
Provide end-user training tailored to the customer’s use and configuration of Jama Connect .
Taken as a whole, the Jama Connect for Medical Device Development solution provides the guidance, justification and a starting framework that not only answers “what” Medical Device manufacturers should do when deploying Jama Connect, but also “how” and “why” they should do it.
In upcoming blogs in this series, we’ll explore specific aspects of the Procedure and Configuration Guide and the out of the box configuration of Jama Connect. We’ll also look at how the solution components described in this blog are applied in practice.
Download a Solution Brief for an overview that explains all the ways Jama Connect for Medical Device Development can help your teams manage shifting complexities and maintain product quality and safety.
https://www.jamasoftware.com/media/2020/06/2020-06-04_PartII_SolutionComponentsJamaConnectForMedDevices_1024x512.jpg5121024Zeb Geary/media/jama-logo-primary.svgZeb Geary2020-06-04 09:07:232020-06-04 09:07:23Part II: Solution Components of Jama Connect for Medical Device Development
Today, Jama Software announces a new solution: Jama Connect for Medical Device Development. The launch feels especially relevant right now. Over the next few weeks I’ll share details about it with you here in the blog. I’m going to talk about:
The solution background: why it came to be and what it does.
Solution Components
Design Inputs
Connect Design Inputs, Design Outputs and Verification
Traceability
We’re pleased we’ll be able to help medical device manufacturers support design control activities in the highly regulated product delivery environment and contribute to their goals of quality and safety.
Note: Now that our medical device blog series is concluded, you can go back and read the series intro, Part II, and Part III.
Streamlined and focused configuration for medical device development.
The idea for the Jama Connect for Medical Device Development solution grew from the need to align quickly to medical device regulations and standards within a requirements platform.
The highly configurable Jama Connect platform allows customers to align the system with specific requirements, risk, and test process needs. If there’s a particular type of information to capture or a specific list of values that would support the overarching process, customers can configure Jama Connect to align and support it.
However, a highly configurable system introduces challenges. During deployments, you have to ask, “Yes, we can do anything, but what should we do?” Think of a highly configurable system as a blank canvas. You can find yourself staring, directionless, and not know where to begin.
That matters when there’s an entire team staring at the blank canvas. It wastes resources and impacts the time it takes to gain value from the system. In the end, the result can be a misaligned, frustrating deployment and low user adoption.
An out-of-box configuration that brings immediate benefits.
The challenge described above is precisely why Jama Software created the Jama Connect for Medical Device Development solution. We wanted to help Medical Device manufacturers who deploy Jama Connect in a highly regulated environment:
Increase the value of Jama Connect, and decrease the time to realize that value.
Access a recommended, out-of-the-box configuration.
Maintain alignment with design control regulations and standards that Jama Connect is best suited to address.
With the Jama Connect for Medical Device Development solution, deployments no longer start with a blank canvas. Instead, the picture comes out of the box, justified and properly aligned with medical device regulations and standards. Configuration is still possible and valuable, but streamlined and focused.
Customers can hold an out-of-the-box configuration and recommended guidance against their operating procedures to:
Identify and justify unique, customer-specific needs.
Determine the best approach to address those needs.
Incorporate customer-specific nuances for tighter alignment to the company operating procedures.
In next week’s blog post, we’ll explore solution components in more detail.
Discover more details and watch a demo of the new Jama Connect for Medical Device Development solution here.
https://www.jamasoftware.com/media/2020/05/2020-05-28_V4_PartOne_JamaConnectForMedDevicesExplained_1024x512.jpg5121024Zeb Geary/media/jama-logo-primary.svgZeb Geary2020-05-28 13:00:322020-05-28 13:00:32Part One: Jama Connect™ for Medical Device Development Explained
Cities may be opening up, but many engineering teams continue to work remotely on product development as companies slowly reopen.
Has your team found its rhythm? If your organization hadn’t planned for a distributed team, staying aligned without jeopardizing quality, efficiency, or timelines could still feel challenging. Jama Software helps the distributed engineering teams of global companies like Grifols, SITA, and Einride work seamlessly and successfully, and has for years.
Here’s what they say works best to keep the product development process on track.
1. Intuitive technology
Intuitive technology is user-friendly by design. It improves efficiency and momentum on a distributed team. Technology like this helps onboard team members, keep them aligned to projects, and connected to team members and their work.
Healthcare leader Grifols adopted Jama Connect™ to help manage the product development process between teams in different countries. They cite the user-friendly, intuitive platform as a key reason they can bring everybody up the speed on changes so quickly. Right away, teams feel comfortable and encouraged to participate, comment, and engage in robust discussions.
“In the long distance between California and Spain, I feel like I’m connected to the team.”
– Carmen Pazos, Diagnostic Divisions R&D Instruments Senior Manager, Grifols Read the whole story
2. Centralized change management
Scattered engineering teams still face evolving regulations and requirements for increasingly complex products. When teams can manage change like reviews and requirements from a single, central location the risk of rework or miscommunication goes down. Relevant stakeholders that collaborate, iterate, and issue approvals in a visible area never lack context.
Multinational company SITA wanted to align remote teams and facilitate effective collaboration around requirements. They chose Jama Connect to get an efficient, easy way for cross-functional teams to review requirements and a centralized, accessible repository for all the company’s requirements.
“Jama Connect has allowed us to get more people from our other offices involved in the collaboration process … People can come into the system at a time that suits them and review things. And we know their comments will be seen by everybody else.”
The product development process requires teams that work with structured, live data, even when remote. They need to be able to define, review, and validate it at any time. Critical functionality of the product they’re working on could depend on it. Communication among teams and stakeholders needs to go beyond the basics of collaboration. It’s about more than just a conversation or a simple text edit.
Einride’s feature-based development process uses the Jama Connect platform to identify which feature should receive the highest priority for development. The collaborative elements of the Comment Stream feature helps distributed engineering teams communicate critical changes to each other as part of their daily operations. For example: Einride develops features at a fast pace, often enhancing the functionalities of their electric freight vehicles after they’re deployed. Teams need to react fast and change tracks if necessary — and collaborate with each other early in the process.
“This is the biggest challenge — to know what feature has the highest priority to be improved and/or developed…as we don’t have hundreds of developers, it’s crucial for us to know this as soon as possible.”
https://www.jamasoftware.com/media/2020/05/2020-05-19_KeysToASuccessfulProductDevelopmentProcess_1024x512.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2020-05-20 16:59:492020-05-20 16:59:49Keys to a Successful Remote Product Development Process
A must-see webinar about remote collaboration is now available in our Resource Center.Matt Mickle of Jama Software and Sabina Söderstjernafrom our autonomous transport customerEinridedemonstrate how the Jama Connect platform helps remote teams communicate effectively and stay productive.
Learn how Jama Connect supports a feature-based development process for Einride.
Sabina sharesbest practices Einride teams uses as they improve and develop different features throughJama Connect. During her session you’ll learn:
How Jama Connect capabilities help identify which feature should receive the highest priority for development—an extremely helpful benefit if you don’t have a team of hundreds of developers to help you.
How the collaborative elements of Comment Stream and Review Center in Jama Connect impact Einride’s decision-making.
The remote collaboration enabled by Jama Connecthelps Einride’sCore Team fulfill its mission, despite physical distance. Together, they can ensure thatthe product built meets the specifications and requirements outlined.
See the key functions that enable remote collaboration in Jama Connect.
In Matt’s session, he works directly in the platform.You’ll see how Jama Connectworksas a modern replacement for legacy requirements management tools, and how collaboration features set it apart.
The goal is for Jama to be a very easy-to-use tool, for it to be very user-friendly so that a lot of people can jump in and get started right away. – Matt Mickle, Senior Consultant, Jama Professional Services
Matt covers three methods of communication and collaboration:
Collaboration Stream: How to create actionable communication streams to elicit feedback from stakeholders.
Reviews for Feedback and/or Approval: How to bring selected people together to get targeted feedback on a small section or component, or to get sign off on a larger body of work.
Single Source of Truth: How to keep the conversations in one place and connected to ensure nothing gets missed and you don’t have to chase down context.
Learn remote collaboration best practices and see how Jama Connect helps remote teams work more efficiently.
https://www.jamasoftware.com/media/2020/05/Einride-Webinar2_1024x512.jpg5121024Jama Software/media/jama-logo-primary.svgJama Software2020-05-07 01:00:502021-04-08 21:00:04Watch now: How to Manage Remote Collaboration for Product Development with Jama Connect™
Hear stories about how the shift to remote workimpacts product developmentpriorities and learn what best practiceswork effectively. By the end of the 50–minute webinar, you’ll see a path forward. You cansupport collaboration and innovation throughout your product development process—withoutjeopardizing quality, efficiency, or timelines.
Seehowcollaborative requirements tools in the Jama Connect™ platform help teams work remotely.
Jama Software has 10+ years’ experience helping distributed engineering teams stay aligned throughout the product development process. Clay and Aaron apply that experience as they guide you through your new remote work reality. During the webinar, Aaronlogs in toour requirements management platform Jama Connect anddemonstrate how its capabilities help you:
Conduct entirely remote reviews.
Drive collaboration across distributed teams.
Manage change remotely.
You’ll see howJama Connect can help you on a day-to-day basis. The demonstration also touches on how integrationwith your systems can facilitate change management overall—a helpful benefit even after we all return to a regular work mode.
00Jama Software/media/jama-logo-primary.svgJama Software2020-04-07 16:42:482020-04-07 16:42:48Watch It Now: Realign Engineering Teams for Remote Work with Minimal Disruption
Traceability is the tracking of requirements across the product development cycle. It documents the status of everything being worked on and shows the history of development along with the impacts of specific changes. Its benefits include easier regulatory compliance, more in-sync teams, and higher-quality releases.
A dedicated software traceability solution may be relied upon to systematically track and trace a requirement’s life. Compared to using discrete documents (e.g., spreadsheets) for the same purpose, this type of centralized platform lets teams make easier, more accurate assessments that support more informed decisions about products. It can dependably identify who made each change, what the change entailed, and why it was made – all in one system of record.
Accordingly, such a platform enables superior software requirements testing and management, in industries as varied as medical device manufacturing and automotive production. Let’s look at five tips for how to improve requirements traceability, along with how traceability software helps with each one.
1. Use Real-Time Communications To Empower Teams
Many requirements traceability processes are highly manual and disconnected:
For example, Team Member A creates a traceability matrix in Microsoft Excel. This matrix is a table containing artifacts like requirements, test cases, test runs, and identified issues. Its purpose is to show that compliance requirements for a project are being met.
However, the artifacts in it get frequently updated during the course of development and testing. So Team Member A goes back in periodically to update the traceability matrix and make sure it is fully up-to-date. This is time-consuming and error-prone work.
Team Member B then has to dig through this matrix to see if the changes are relevant to them. It’s possible that what they see at any given point isn’t accurate, though. Keeping up with changes is its own job, with many back-and-forth email barrages to navigate.
Real-time communications within a traceability solution alleviate these issues. Instead of hopping between static documents scattered across emails, team members can collaborate in one virtual space, in which they can share feedback, participate in livestream discussions, see connections between items and their authors or editors, and expedite reviews and approvals. They also have access to all comments, test cases, and activity streams from the same interface.
Such features ensure that changes are communicated directly to the relevant parties and that software traceability stays on track. Team members do not have to waste time poring over a document that might not be 100% accurate or even applicable to their particular responsibilities. Basically, real-time communications remove the traditional bottlenecks of hunting for the latest updates and wondering about their relevance.
2. Chart the Impact of a Change Before it Happens
As noted above, requirements change all the time during software development. It is essential not only to keep team members in sync about these changes, but also to scope out their full impact across the product development lifecycle.
Altering one requirement will directly affect any related system requirements, along with downstream requirements and numerous verification tests. Teams need insight into what these changes will entail, so that they can see if related items are still correct, make any necessary updates, and ultimately trace the right requirements for quality and compliance purposes.
Live traceability in Jama Connect allows for better impact analysis and more streamlined navigation of upstream and downstream relationships:
For instance, links downstream from modified items are automatically flagged as “suspect” to alert team members to the need for possible action.
Relevant contributors can also be notified right away, and critical decisions prioritized; meanwhile, everyone else can save time by not being pulled into something irrelevant.
System users can see if a requirement has test cases downstream and what percentage of them have passed.
With all risks and requirements being updated in real time, teams can reliably trace them and conduct informed evaluations and analyses.
Through these capabilities, a traceability solution helps everyone be more confident that they are working with the right requirements, while avoiding getting bogged down in rework or in costly late-stage changes caused by not having an accurate picture of what is being worked on at every stage. In other words: Live traceability means that traceability is no longer an afterthought.
3. Create a Detailed Audit Trail With Well-Documented Changes
One of the main reasons for implementing traceability software is to simplify regulatory compliance. Let’s say that a hypothetical medical device manufacturer is planning to bring a new connected device to the U.S. market.
The Food and Drug Administration requires compliance with regulations such as FDA 21 CFR Part 11, regarding electronic records and e-signatures. Creating a detailed audit trail to comply with these rules is more straightforward if a unified system of record with full version histories – i.e., a software traceability solution – is in place. Jama Connect Review Center is compliant with FDA 21 CFR Part 11.
Modern traceability software maps out the relationships and interdependencies in product development, allowing for assiduous tracking of risks and requirements in their full historical context. Real-time collaboration also enables even geographically distributed teams to stay on the same page in tracking and tracing work items. This level of traceability, with visibility into who made each change and for what reasons, has become especially important as medical devices become more complex and software-driven.
In Jama Connect, risk analyses and other data such as product-specific views can also be easily exported to the correct formats to prove compliance. Industry-standard templates are available as well to minimize the setup time for creating a plan that aligns with standards such as ISO 14971:2019, ISO 13485, and FDA 21 CFR 820.30.
4. Connect Everyone and Everything with Trace Relationships
Traceability is about relationships. Because each product in development has its own particular set of customers, stakeholders, and internal team members associated with it, traceability is only possible if these individuals can be accurately connected to the items for which they are responsible.
That principle sounds simple enough on paper, but putting it into practice can be more complicated. Consider the question of who responds when a series of changes occurs and checks to see if everything is still right. With complex products, multiple team members will likely have to weigh in on and then sign off on these changes, a process that presents some big challenges:
Decision-makers might not have clear visibility into the impact of changes to requirements, like their ripple effects on downstream or upstream items.
High-quality data on requirements-related changes and why they were done might not be readily available and shareable, either.
Coordinating the decision-making process itself can be cumbersome, with everyone exchanging documents via email and struggling to get in sync.
Fortunately, these obstacles can be overcome with traceability software. By implementing a shared system of record with real-time communications capabilities, organizations can adeptly manage their trace relationships and relieve the various forms of decision pressure outlined above.
5. Make Traceability More Proactive To Ensure Test Coverage
Traceability should not be pursued after the fact. Connecting requirements and other items at a relatively late stage is a recipe for trouble, as it can become difficult to gather all the necessary information and put into proper context. Extensive manual work, and the risks that come with it, are also likely to be required in such a reactive workflow.
In contrast, proactive traceability done throughout the product development lifecycle helps reduce risk and pave the way for higher-quality products that align with all of their requirements. Automation is key to this proactivity. Traceability software like Jama Connect automatically saves user inputs, can apply risk level updates in real time in accordance with a user-defined risk matrix, and ensures a standardized approach to risk evaluation across the organization – eliminating silos and disjointed processes.
A traceability solution also provides clear visual representations of the status of requirements, test cases, and test runs along the way. These data-rich views enable better decision-making, since team members are working with live, easy-to-understand information and can communicate with each other through the same platform. For example, users can easily see test coverage levels and where gaps exist.
Take the Next Steps With Traceability Software
The right traceability software lets organizations efficiently manage all of your requirements in one place and streamline the development process of even the most complex products. It saves the entire team time and money, accelerates development lifecycles, reduces the risk of error, and results in improved product quality and regulatory compliance.
In short, traceability provides essential context and clarity. Look for a modern traceability solution that will keep projects on schedule, on budget, and within scope, thanks to better collaboration and requirements management.
https://www.jamasoftware.com/media/2017/03/Automotive_Engineering_Blog_Post.png5121024Jama Software/media/jama-logo-primary.svgJama Software2019-09-19 03:00:422019-09-19 03:00:42Five Tips for Requirements Traceability
