Tag Archive for: compliance Page 2

Tag Archive for: compliance

Jama Connect Review Center

Reviews play a key role in successful product and systems development, helping to ensure a new project meets stakeholder, market, and compliance requirements.

By taking an iterative and collaborative approach to reviewing requirements and tests in real-time, Jama Connect™ Review Center improves stakeholder alignment, reduces lengthy review cycles, and eases the path to compliance.

To that end, we are excited to announce today that we have made significant improvements to Review Center, an already beloved feature of the Jama Connect platform, which are available now to our customers.

Within Jama Connect Review Center, users can now streamline reviews and ease the path to regulatory compliance thanks to:

  • A new Review Center Wizard that streamlines review set up for particular objectives
  • Simplified application, management, and accessibility of electronic signatures for reviews
  • Easier configuration of review settings, such as ones used to apply electronic signatures per FDA 21 CFR Part 11 to ensure they can be properly referenced and signed off on across different teams.

Additionally, customers can now add electronic signature roles, prevent reviews with e-signatures from being deleted, view review activity history for audits, and better set expectations for participants based on their role.

 

Streamline the review process with clearly identified participant roles and electronic signature settings.

These enhancements make the review process more straightforward and help customers meet compliance requirements for standards like FDA 21 CFR Part 11.

In the coming months, we’ll continue to invest in review and approval enhancements to improve collaboration and further address 21 CFR Part 11 compliance in Jama Connect Review Center.

Review Center Departs from Traditional, Document-Based Reviews

Traditional review processes often stifle collaboration and focus on a document-based approach, resulting in misalignment, long review cycles, versioning issues, and an abundance of unnecessary meetings.

By creating a centralized place to manage and collaborate on reviews, Jama Connect Review Center eliminates the need for lengthy, in-person meetings or back-and-forth emailing, making reviews more efficient and scalable.

 

Gain visibility into all major review activities.

Michelle Seitz, Senior Business Analyst at MediSync, believes one of the most significant benefits of Jama Connect is the reduced time and effort it takes to complete review cycles using Review Center.

“My favorite part of Jama right now is when I get a collection of requirements to send out for a review,” Seitz says. “It is so much better with Jama. It’s the first time I’ve had a product that works as seamlessly as Jama does to produce a review and get feedback without having to do all the track changes and stuff that we used to have to do in Microsoft Word.”

And the results of the improved review process speak for themselves.

MediSync says that Jama Connect has saved the organization 80% of planning time that previously would have been wasted on meetings, sorting through versioned documents and emails, and consolidating feedback in review cycles.

Global healthcare leader Grifols says that Review Center has helped it shorten review cycles from three months to fewer than 30 days, while reducing budget overruns. They estimate savings of over 80 hours per project in medical device development thanks to Jama Connect Review Center.

As an organization, Jama Software is committed to improving stakeholder alignment, reducing lengthy review cycles, and easing the path to compliance by providing our customers with a modern approach to reviews and collaboration. And with Review Center’s new improvements and feature enhancements, we can confidently say that we are doing just that.

To learn more about best practices for moving through reviews quickly and seamlessly, download the “Jama Software Guide to Review Center Best Practices.” 

Ossur uses Jama for Medical Device Development

In medical device development, control of quality and risk is heavily driven by regulatory requirements. Compliance with international medical device standards like ISO 13485 and ISO 14971 can drain resources and reduce operational agility if the means of demonstrating compliance are not agile themselves.

The more complex the project, the higher the risk. And the higher the risk, the more stringent the medical device compliance procedures. Managing hundreds of requirements in a document-based system without traceability becomes a major chore.

Össur, a global leader in non-invasive orthopedics, had for several years been relying on an internally developed document-based process to manage its product requirements. While their system had been working as intended, they felt there was an opportunity to streamline procedures and compliance tasks.

The Costs of a Rigid Requirements System in Medical Device Development

Continually evolving its processes has always been a key to success for Össur, whose cutting-edge prosthetics technologies have been showcased in publications like Popular Science and have been worn in competition in the Olympic Games. They examined their development cycle for inefficiencies and noted their requirements process unfolded in a sequential manner that was costing them an enormous amount of time and effort.

In specifying a highly complex Össur medical device, several engineers would collaborate on drafting requirements and compiling the requirements document. The document would then be circulated for review. Once approved, the requirements would be verified. If any requirement needed to be added or changed, however, the entire review and approval cycle had to be repeated.

“Our old system was very rigid,” said David Langlois, Director of R&D for Bionic Solutions at Össur. “The minimum effort was always quite high, which means the overhead was also high.”

Össur knew it was time for a change. They wanted something that was as close to a turn-key solution as possible — one that would provide traceability and dynamic content management, and would be scalable across their organization. Plus, it needed to be capable of handling the complete development chain — from requirements through verification and validation, along with easing the path to compliance to ISO standards like ISO 13485 and ISO 14971 — for a diverse product line.

After evaluating several alternatives, including some designed specifically for medical device development, Össur chose Jama Connect™.

 Learn more about how Jama Connect helps teams improve medical device development.

Replacing Process Rigidity with Speed and Agility

Össur began using Jama Connect in 2018, starting with a small group of developers working on bionic lower-limb prosthetics. They immediately began seeing dramatic improvements in their process, especially in the areas of traceability, impact analysis, and test management.

As soon as they began importing their data into Jama Connect, Össur’s engineers saw they had traceability gaps. “Catching these gaps would probably have taken hours or days in our old system,” says Langlois. “With Jama, it became obvious in a matter of minutes.”

With Jama Connect’s impact analysis, teams can quickly gain an accurate understanding of the implications of a proposed change. So, in turn, they can make better informed business decisions. “That brings a lot of value when you’re trying to run a review, and you want to know whether you have gaps in your test coverage,” says Langlois. “With Jama, it’s a five-minute question instead of one that takes hours.”

In addition, Össur feels Jama Connect’s test coverage and built-in metrics are making its testing process far more predictable and efficient. “One thing that’s very powerful about Jama Connect is that, after a few test runs, you can actually quantify pretty accurately what sort of effort is required,” Langlois says. “Jama provides all these metrics that allow you to identify where your bottlenecks are, giving you a better understanding of where the time is going and where you’re losing money.”

Leveraging Jama Connect’s Flexibility for a Faster, More Flexible Future

As Össur branches Jama out into other areas of its organization, it plans to allow individual teams to configure Jama Connect in a way that best suits how they work. And Össur is already thinking about ways to integrate with some of the other solutions it’s currently using.

“As a software developer, I think Jama Connect’s integration with Jira is going to be very useful for me,” says Matthías Kristjánsson, Product Lead Designer at Össur. “Today, we actually make duplicates of our requirements into the Jira system. Being able to connect them straight to Jama and remove that step — so they’re directly connected to a requirement or specification — will be valuable.”

Read the full case study to learn more about how Össur is using Jama Connect to grow more agile and efficient and assure compliance with relevant regulatory standards.

Compliance Audit with modern requirements management

This post on the pains of compliance is part of a series. You can find Part II on legacy software pains here, Part III on enabling innovation here, Part V on moving from DOORS to Jama Connect here, and Part VI on migration solutions here. 

As the devices around us become increasingly powerful, their ability to harm us may be increasing as well. And while the majority of connected devices and products are safe, there are recent headlines that reinforce the importance of compliance audits and properly managing risk.

Recently, a hacker remotely killed the engine of a car while a motorist unknowingly drove down the highway. Another recent example happened to Toyota, when mistakes during development caused failing brakes and random accelerations, resulting in the automobile maker recalling almost two million cars.

But in spite of dramatic incidents like these, today’s products are remarkably reliable. We generally feel safe stepping into a plane or taking a ride in our car. We feel safe, because those in the automotive and aerospace industries must prove compliance with industry standards and regulations that ensure their products adhere to high safety standards.

Regulatory Compliance is Good for Business

Even though corners are sometimes cut, most companies recognize that compliance is essential in the long run. While the ethical argument is a no-brainer, compliance with regulatory standards also enables customer confidence, boosts quality, and motivates employees.

Compliance audits are based on standards like ISO 26262 for automotive developers or DO178B/C for aeronautics. These have been around for decades and have helped shape the design of countless safe products. Many of these standards are based on IEC 61508, which conceptually describes best practices that lead to safe systems.

Using safety standards for compliance audits

Regardless of whether you are developing a car component or nuclear reactor, there are certain capabilities that your development process must exhibit in order to pass a compliance audit. In this day and age, it is next to impossible to do this without the support of quality solutions. Selecting the right product development solution will help you:

  • Prove complete traceability throughout every step of the development process
  • Standardize best practices, ideally with automated compliance reporting
  • Visualize and effectively manage the impact of changes
  • Support your product schedule and ensure that it is not compromised by quality and compliance requirements
  • Act as your single source of truth for risk, test, and requirements

Learn more about requirements traceability by downloading our eBook, “The Jama Software Guide to Requirements Traceability.”

Complex Product Development Demands More than Legacy Requirements Management Tools

IBM® DOORS® (IBM Engineering Requirements Management – DOORS Family) was an amazing tool – when it was originally published in 1991, almost 30 years ago. A new product was developed from scratch, called DOORS Next (IBM Engineering Requirements Management – DOORS Next) and released to the market in 20121. Yet many users of DOORS hesitate to switch. This is because instead of an easy transition to DOORS’ new product, there is a lengthy migration to DOORS Next required that’s usually very costly.

DOORS has many capabilities for working in regulated industries, but the limitations far outweigh the benefits. It does not deal well with increasing complexity or the need for collaboration and seamless integration in existing tool ecosystems. Let’s have a look at some of the limitations of DOORS:

  • Traceability: DOORS has powerful traceability capabilities, but they are hidden behind a cumbersome interface. This leads to outdated traces. Users find traceability maintenance to be difficult with DOORS, and sometimes traces are created “after the fact” for compliance audits and nothing else. This is a missed opportunity, as an up to date, easy-to-use traceability matrix creates transparency and confidence when reacting to change. Traceability is also an enabler for agility.
  • Change Management: The traceability of DOORS does support change management, e.g. via suspect links in principle. Unfortunately, this information is hidden and hard to put to use. Compare that to the actionable traceability of Jama Connect™, which proactively points out issues in the traceability matrix and suggests how to fix them.
  • Compliance Reporting: DOORS allows you to report on virtually everything – but almost everything requires scripting with its proprietary scripting language, DXL. Unless you have a responsive programmer on your team, you will have a hard time getting the information you need.
  • Best Practices: Every “module” (document) in DOORS has its own fields, and without an in-house expert, users sometimes find themselves with little guidance on how to use the tool. This results in inconsistencies, which in turn result in confusion and lack of transparency. Consider two “system specifications” with inconsistent values for “priority.” Likewise, standardized workflows guide users through their daily work. In DOORS, you need a programmer to provide this functionality.
  • Collaboration: Collaboration is the foundation for high-quality product development and a foundation for compliance, which requires transparency and managerial oversight. But when Rational DOORS was released, the Word Wide Web was just two years old. Initially, no collaboration capabilities existed at all.
  • Single Source of Truth: DOORS provides you with a single source of the truth – as long as the truth resides in DOORS. In 1991, nobody was thinking about integrating various tools into a seamless tool chain. And therefore, DOORS is an isolated silo. Due to the complexity of the user interface, often stakeholders refuse to take a peek into that silo.

See how IBM DOORS customers can migration to Jama Connect by viewing our datasheet.

What about DOORS Next?

The only thing DOORS Next shares with the DOORS solution is the name. Otherwise, it’s newly developed software. This means that the raw requirements data can be migrated, but this is possible with virtually all requirements solutions on the market. The customizations that were done to DOORS cannot be migrated. This means that users who want to switch away from DOORS are not constrained by a particularly attractive migration path.

Whether you migrate from DOORS to DOORS Next or to Jama Connect, the effort is the same. And that allows you to compare the capabilities of solutions on the market without having to worry about the migration path: It will take some effort, no matter which solution you choose.

Leaving Legacy RM Solutions in the Past

We at Jama Software acknowledge everything that legacy RM solutions have done in the past for the discipline of requirements management and requirements engineering. But after almost 30 years, it’s time to reinvent modern requirements management.

In particular, the demands for compliance for today’s complex products can no longer be satisfied by legacy RM tools. Transparency, collaboration, best practices, and oversight – all these were non-issues in 1991 when legacy RM solutions were built.

If you are in an organization that uses a legacy RM solution, it is time to assess if it’s up to the challenges ahead and you have a choice of many modern requirements management solutions on the market.

See how Jama Connect can transform your requirements management process for legacy software customers in our whitepaper, “Jama Connect: A Modern Requirements Management Alternative to IBM DOORS.”

*IBM® and DOORS® are registered trademarks of IBM Corporation.

1 IBM United States Software Announcement 212-505, dated November 27, 2012

Today, we’re re-running this post from January to help spread the word about our upcoming webinar that dives deep into the Engineering.com report. Register here.

A new research report from Engineering.com reveals how design and engineering professionals are approaching the increasing complexity of both their products and requirements management processes.

For the report, Design Teams: Requirements Management & Product Complexity, Engineering.com surveyed nearly 250 design and engineering professionals about the growing complexity of their company’s products and how requirements are managed amidst this changing landscape.

For a full breakdown of the Engineering.com report with guidance on how to correct some of the issues raised, register for our webinar, “The Great Cost of Poor Requirements Management.”

Register now. 

While Jama Software sponsored the report, the research and its subsequent editorial readout were conducted entirely independently by Engineering.com. And the results are extremely illuminating.

Product Development Increasing in Complexity

One of the biggest takeaways, especially for requirements enthusiasts like ourselves, was that even though more than 90% of respondents reported that their products had increased in complexity over the last five years, a mere 15% relied on a dedicated requirements management platform.

Driving this increase in product complexity are many factors, including how development teams have been:

  • Integrating more electronic components, embedded software and microprocessors
  • Increasing the intricacy of mechanical designs
  • Using different materials
  • Reducing weight and shrinking size
  • Building connected products (IoT)
  • Incorporating AI or machine learning

Given the rapid increase in product complexity, product design teams need a structured information system to handle requirements throughout each stage of product development.

Without a dedicated solution, teams are stuck with ineffective requirements management, resulting in things like product outcome failures (83% of respondents) and reprimands by regulatory agencies (62% of respondents).

The Impact of Investing in Requirements Management

Despite a high percentage of teams encountering regulatory and product outcome failures, most product teams (81% of those interviewed, in fact) believe their requirements management process to be effective.

And yet how can these requirements management processes be considered effective when the majority of teams are experiencing product outcome failures and getting penalized by regulatory agencies?

The reason for this contradiction in perception, according to Engineering.com, might be that “few teams employ a formal requirements management system. Having not purchased a system, they are dismissive and forgiving of failures while offering middling praise for the unsophisticated solutions they rely on.”

In other words, most companies don’t know what they don’t know.

Requirements Management Platforms Can Help Reduce Regulatory Reprimands

It shouldn’t be a surprise that development teams in industries that were highly regulated (66%) were more likely to use a purpose-built requirements management solution.

Perhaps not coincidentally, the analysis also showed that organizations using dedicated requirements management platforms in regulated industries not only received fewer instances of warnings, recalls, fines and production stoppages than those that didn’t, but nearly half reported experiencing none of those problems at all.

Plus, across all industries, requirements management platforms were rated highest in effectiveness overall versus any other method.

As the Engineering.com report concludes: “It is clear from the data that the products most design teams are creating are becoming more complex. Yet, they have not thought of investing in the tools available that would help them manage the requirements this complexity demands.”

Here are some other takeaways from the report:

  • Product teams must manage multiple types of requirements. On average, product teams cited 4.5 different requirement types critical to their products.
  • Product feature requirements are critical to 79% of respondents (the other 21% were working on less-complex products with fewer feature requirements).
  • More than 4 out of 5 teams have experienced product outcome failures, including exceeding cost requirements (46%), lost time to market (38%), product shipped without meeting all requirements (36%), and excessive time spent tracing requirements (36%).
  • The more sophisticated the requirements management system, the more effective it was found to be.

To dive deeper into the data about the challenges requirements management systems can solve, head over to Engineering.com and download the report, “Design Teams: Requirements Management & Product Complexity.”

Global research and consulting firm Frost & Sullivan recently released a report on the product development landscape and the challenges that those in heavily regulated industries face. And while the findings were not at all surprising, they were illuminating.

The report, titled “Safeguarding Regulated Products Amidst Growing Complexity,” found that those developing products in regulated industries — such as automotive, aerospace, medical devices, industrial technologies, and semiconductors — faced many challenges to efficiency, including stringent regulatory compliance, an influx of competitors, and significant and increasing product complexity.

The Tension Between Compliance and Innovation

The report states that many organizations continue to struggle with the tension between adhering to strict regulatory compliance standards and innovating. And while innovation and compliance aren’t mutually exclusive, without a process to help balance the two, many organizations feel forced to choose.

So, what’s holding these organizations back?

According to the Frost & Sullivan report, it’s the outdated systems and processes organizations have invested in that aren’t equipped to keep up with the speed of innovation.

“These antiquated systems are often static and spreadsheet- or even paper-based,” writes Frost & Sullivan. “And while they may offer a (possibly false) sense of reassurance against the costs and risks associated with a live digital system, they end up creating more costs and causing more harm.”

Learn how Alight Solutions transformed requirements management for its clients by downloading the case study.

The Consequences of Outdated Systems for Those in Regulated Industries

In addition to throttling innovation, the report found that these legacy systems can also lead to increasing compliance costs due to the inability to stay up to speed with changing regulations. The report also details issues with version control, errors, silos, and inhibited collaboration as outcomes of using outdated, document-based requirements management solutions.

The report was clear in its solution to this issue. Teams in highly regulated industries must use a modern, platform-based solution to manage requirements, risk, and testing in product development. And in addition to risk management and accelerating innovation, the report says, the benefits of switching to a modern requirements management solution are plentiful. More efficient and smarter systems allow for cross-organizational collaboration, the ability for key stakeholders to review and weigh in, and end-to-end traceability to easily prove compliance.

Download this recent report by Engineering.com to learn more about the gap between the increasing complexity of products and requirements management.

The report not only strongly suggests that organizations in heavily regulated industries make the switch to a modern requirements management platform, but also names Jama Connect™ as a top solution. And they provide proof.

The report outlines two case studies which highlight the power of upgrading from an outdated, legacy requirements management solution to Jama Connect.

Here’s a recap of one of the case studies.

Semiconductor Company Removes Errors While Speeding Product Development

One of the oldest semiconductor companies in the world found that to remain competitive, it was increasingly building more complex solutions that integrated software and hardware. Products and projects were getting bigger and more complex, as were the teams designing and building them. Along with more complex solutions, the company also needed to be fast to market to remain ahead in an increasingly competitive space. Hence, parallel product development was also critical, though difficult, as the company had various functions spread across global geographies.

The company used Jama Connect to create a system that enabled these teams and disciplines to work concurrently, with living documents that kept the large volumes of data needed for product development constantly up to date and manageable. As noted earlier, eliminating errors is a fundamental driver for both time to market and regulatory compliance, and Jama Connect meets that need as well.

To see the second case study and access the full Frost & Sullivan report, “Safeguarding Regulated Products Amidst Growing Complexity,” download it now.

Compliance standards, especially those that involve relatively new functional safety elements, will likely add additional requirements to the development process.

For example, the increasing complexity and abundance of automotive electronic systems led to the creation of a functional safety standard called ISO 26262 in 2011. And to ensure that new electronic functions remain functionally safe in the industry’s rapidly evolving environment, the International Organization for Standardization (ISO) recently introduced a second edition of ISO 26262 in December 2018. Similar regulations for other industries abound: DO-178B/C for aerospace standards, and IEC 60601 and ISO 14971 for medical standards.

Common to all of these safety standards is a risk-based approach to determine the criticality and potential hazards associated with key system functions. The primary goal of these standards is to prevent the failure of a system or device that could cause injury, harm or death. If a failure is unavoidable, then the system should fail gracefully.

Watch our webinar: “Understanding ISO 26262 Compliance for Automotive Suppliers”

The Impact of Tools in Functional Safety

ISO 26262 complements good systems engineering practices by requiring that hardware and software safety concerns be addressed and documented in a systematic way throughout the development lifecycle. In the past, safety design was considered part of general requirements activity. But merely identifying and tracing requirements in the software and hardware teams is not enough. The common practice of hardware and software teams working in silos will not guarantee the level of safety coverage required by ISO 26262.

How can the problem be resolved?

One of the key things missing from the general approach to requirements are the traceability links between phases. Many tools do a great job of requirements management and traceability within a particular phase but provide a poor auditable trail for traceability between phases. The activities of comprehensive and complete lifecycle traceability become an auditing afterthought, to be finished after the project is completed. This is the result that ISO 26262 tries to avoid through documented attention to the development process, decision-making and selection of supporting tools.

And because functional safety is a top priority for so many of our customers, Jama went through the process of earning a certification from internationally recognized testing body TÜV SÜD. Jama Connect™ is certified as a fit-for-purpose software tool for development of safety-related products according to ISO 26262 (up to ASIL D), IEC 61508 (up to SIL 3), IEC 62304 and EN 50128, giving our customers confidence that the products they are building are safe to use.

Learn more about ISO 26262 and automotive electronics development.

Tool Implementation Strategies

Tool qualification depends upon how the tool is used, which in turn determines what impact it could have on safety. For example, depending upon its usage, can the tool introduce a hardware defect or software bug into the system? How the tool is used within a tool chain will also determine the probability that an error introduced by the tool will be detected.

A confidence level is assigned to a given tool, or a flow within a tool, based upon the probability that it will insert or cause an error, combined with the likelihood that the error will be detected during the development process. The importance of the tool confidence level is that it will determine the cost an organization must invest in tool qualification.

As with other standards, implementing the ISO 26262 process requires iteration of a number of basic steps:

  1. Determine the existing process and tools to answer the question “Where are we now?”: Review the current embedded hardware and software development processes and tool chains. Understand the application(s) to be developed and assign levels of confidence in terms of safety.
  2. Gap analysis to answer the question “Where would we like to be?”: Perform a gap or impact analysis to identify current challenges and process efficiency improvements – often done using model-based design techniques.
  3. Training and instruction: Provide design-for-safety training and instruction to address the previously identified gaps.
  4. Hands-on deployment support: Apply the knowledge gained in the previous steps to a specific pilot project. This will require assistance in a wide range of areas including requirements traceability, modeling, simulation, code generation, verification, validation, tool qualification and system integration.

Jama Software is the first SaaS and Agile vendor to be ISO 26262 fit-for-purpose certified by TÜV SÜD. Read more.

Alignment with Best Practices for Functional Safety

This holistic approach to functional safety exemplifies several key elements of good system engineering processes: collaboration, traceability, validation and verification (V&V), risk analysis and mitigation, and careful integration within the tool chain.

Watch our webinar, “Jama ISO 26262 Certification and Best Practices for Development,” to learn more about how teams creating products for any safety-critical industry can lower the costs and risks of complying with functional safety standards.

Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units. This makes it easier to evaluate the system holistically as well as in terms of its individual components.

A high-level, interconnected view of the product development process can yield new insights into how products are defined, built, released and maintained. Product managers sit at the center of the product development system, so they’re primarily responsible for understanding and directing the system.

You can think of systems thinking as a diagnostic tool: a disciplined approach to examining problems more completely and accurately before taking action. Systems thinking encourages teams to ask the right questions before charging ahead under the assumption that they already know the answers.

For product teams grappling with exceptionally complex design specs and requirements, systems thinking opens the door to procedure-level improvements and the ability to take full advantage of solutions that support them.

In this post, following up on our recent piece about systems thinking for medical device development, we talk about how product managers can leverage systems thinking to improve their processes.

The Iceberg Model: How to Put Systems Thinking Into Action

The Iceberg Model is a practical way to put systems thinking into action. We borrowed the following excellent example from the smart folks at the Northwest Earth Institute.

Picture an iceberg (doomed ship optional). The tip sticking out of the water represents the event level. Problems detected at the event level are often simple fixes: You wake up in the morning with a cold, so you take a couple of ibuprofen to feel better. However, the Iceberg Model encourages us not to assume that every issue at the event level can be quickly resolved by treating the symptom.

Just below the event level is the pattern level. As the name suggests, this is where you detect patterns: You catch more colds when you skimp on sleep. Observing patterns helps product managers forecast events and identify roadblocks before they rear their ugly heads.

Below the pattern level is the structure level. If you ask, “What’s causing this pattern?” the answer is likely to be structural. You catch more colds when you skimp on sleep, and you skimp on sleep when you’re under pressure at work or when your personal life is causing you stress.

The mental model level is where you find the attitudes, beliefs, expectations and values that allow structures to function as they do. These attitudes are often learned subconsciously: from our parents, our peers, our society. If “I’ll sleep when I’m dead” is part of your mental model, you’ll have trouble making the attitude and behavior adjustments that could help you avoid another cold.

The Iceberg Model encourages you to stop putting out fires and start addressing deeper issues. Using this model can align your team members through shared thinking and reveal opportunities to make small changes to the process that will yield big benefits.

More Visibility, Superior Collaboration

With a systems-thinking approach, complex product development teams can improve their processes by enhancing visibility and enabling more seamless collaboration and coordination between stakeholders.

Complex product development requires that the right people have visibility into the right parts of the system at the right time. Systems thinking drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more productive when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.

Compliance & Traceability

Simple changes to requirements can have far-reaching impacts, and it’s hard to isolate every system component that could be affected by a requirement modification. It’s easier to assess the impact of proposed changes – that is, to perform valuable impact analysis – when you have a roadmap that shows you precisely where each requirement or business rule was implemented in the software. Traceability gives you that roadmap.

By helping identify all the areas you may have to modify to implement a proposed change to a requirement, traceability enables impact analysis. With proper traceability, you can follow the life of a requirement both forward and backward, from origin through to implementation.

Traceability is difficult to establish after the fact, so teams can use a tool like Jama Connect from the beginning to track tasks, keep tabs on evolving requirements and contextualize test results. Traceability gives teams confidence in the safety and quality of their products, and helps them demonstrate compliance with national and international standards for highly regulated industries.

Since lower-level requirements and outputs are defined within the context of a specific system need, traceability allows teams to understand that context and the downstream impacts of any change made.

Customized Solutions for Complex Product Development

Organizations across a huge range of industries are engaged in complex product development. Systems thinking encourages teams to work through a common system need, while still employing the approaches that work best within their disciplines. To assist, Jama Connect provides visibility throughout the product development cycle and keeps stakeholders connected to minimize miscommunication and unnecessary rework.

And our Jama Professional Services consultants work with you to understand your objectives and configure the platform to support your process in the optimal way. As your process, people and data change, our experts help you realign development methodologies to best practices, elevate your requirements management skills and reinforce your process. For larger teams that want ongoing deployment and optimization assistance, our adoption services give you a team of experts at your fingertips.

Learn more about some of the ways systems thinking helps overcome complex product development with our whitepaper, “Systems Engineering and Development.”

Every company that produces medical devices has to plan for that time when they must present compliance evidence to the FDA auditor. Often the most difficult and time-consuming aspect of this process is sorting through the available documentation produced by the design and development team, including outputs from multiple software tools. Even in that best-case scenario (likely you have the added challenge of having to fill a few holes in the paper trail), assembling and delivering documentation that is comprehensive in its demonstration of risk management can be an arduous task.

When the auditor is reviewing the design and development history of your medical device they want to see the full story, from the original concept though post-production. They want to see all the angles from which you’ve examined your product, from internal actions items and decisions, to incorporation of market feedback, to safety analysis of similar products. And within that story, auditors want proof that you’ve taken action to ensure that risks that can’t be eliminated fall into an acceptable range.

Everyone–including the auditor!–wants a smooth audit process, to ensure the safety of the patient. So how can you easily produce comprehensive documentation and pass your compliance audit?

In our work with medical device companies, we’ve come up with these recommendations for using Jama in your development process. These techniques allow you to show full traceability between risks and design controls, making the task of proving compliance less daunting, less time-consuming, with the added benefit of having a positive impact on your product quality.

Use Jama to execute your risk management process

First, we recommend that you manage all design controls (requirements, risks, design specs and tests) in Jama, and synchronize data from other developer tools, such as JIRA, using the Jama Integrations Hub. This foundational set up will ensure end-to-end traceability and also ensure that all of your data is available for your audit documentation.

Also in this Jama instance, capture and manage specific medical device data pertinent to a future compliance audit, such as intended use of your product, patient and user needs, your risk management plan and any other information that defines the device, your product objectives, and information about similar products in the market.

Just like you manage requirements with Jama’s collaboration tools, you can also use Jama to execute your risk management process. This provides the team one area where they can go to understand how to document risks and what information needs to be collected, and prevents confusion around process that is vital for your FDA submissions.

To do this, we suggest you track risks as individual items. Complete a preliminary estimate of the risk by defining the probability of occurrence of the harm and the severity of that harm, and use the calculated risk priority number to assess if the risk is acceptable. As you define mitigations, use relationships to illustrate those in Jama, and then update the risk priority number post-mitigation.

Use Jama’s Review Center for both risk and design controls reviews, inviting feedback from subject matter experts and stakeholders. When anyone has questions about why a risk was estimated in a certain way, these reviews are the source of truth for why decisions were made. Using Review Center, along with documenting this information in the project space, allows teams to collaborate on risk definition (and add more as they arise), discuss mitigation plans and verification of test results, to collaborate on solutions and to finalize and document decisions.

When telling the story of your medical device’s development lifecycle to the FDA, it can be a struggle to organize the information in a cohesive manner. And if documentation is missing or decisions and action items aren’t recorded, these gaps could result in your product never reaching the market—or being pulled from the shelves. Using Jama creates much of the needed evidence and is an easy step to take that will save time and money in the long run.

More on managing risk in medical devices using Jama

Want to know more about how Jama manages risk in Jama? Check out this video to understand more. And if you’re ready to see how Jama can help you manage the development of your medical device start a free trial.

 

We’d love to hear how your teams manage documentation for compliance audits. Do you have stories about how your company passed audits for ISO 14971, ISO 13485 or 21 CFR Part 11? Our medical devices team is curious to hear about your methods for streamlining your submission process for compliance audits.

With the “intent to delay” announcement one week before HIMSS, we knew there would be a good amount of new buzz on ICD-10.

For any industry there are pragmatists, collaborators, and innovators. [Deloitte did a great job of categorizing this theory around ICD-10.] Not to over generalize by any means, the majority of insurance providers seemed to be on schedule to meet the deadline and now disgruntled, as the delay will cost them more money over time.

But on the flip side, maybe it is opportunity for these insurance providers to use ICD-10 as a strategic advantage. This could be an opportunity for insurance providers to help their care provider partners who seem to be struggling with needs assessments, IT renovation plans, testing, and more.

After all, the right hand feeds the left, and so forth—potentially by collaborating from innovators out to pragmatists, could be a strategy for saving both sides a lot of money in the remediation—especially since financial neutrality doesn’t seem to be a reality.

No one I talked to seemed to think the delay was a good idea. But naturally there will be those who will shift budgets and resources toward other projects until ICD-10 becomes the urgent project again. But who can blame them? It’s not the only pressing project for any one healthcare organization.

How do you balance 5010, ICD-10, SNOMED, ACO, HIE, Meaningful Use, EHR/EMR, and any other compliance or regulatory initiative simultaneously, each one touching thousands of people and yet straining the same budgets or overlapping budgets.

The good news from a vendor standpoint, both sides are embracing they can’t do this alone. Technology providers have the tools and knowledge to make all these regulations a reality—stabilizing the complexity while ensuring projects are completed on time and on budget.