Medical Device Compliance Archives

Tag Archive for: Medical Device Compliance

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.

The landscape of medical device development is shifting rapidly. And it’s not just balancing innovative gains with safety that medical device companies must worry about anymore.

In our opinion, there are three main challenges medical device companies will be facing in the coming years (if they aren’t already):

The rise of connected, software-driven medical devices
Increasingly strict medical device regulation
New market entrants making a disruptive splash

Given that the medical device industry is slated to skyrocket to $800 billion by 2030, there’s obviously a lot at stake. Luckily though, there are some antidotes that we explain in our eBook, “Overcoming the Three Biggest Challenges in Medical Device Development,” which is available to download here.

Here’s a closer look at some of those big problems that need to be accounted for in modern medical device development.

Challenge One: The Rise of Connected, Software-Driven Medical Devices

Until fairly recently, software embedded within medical devices had limited functionality. Gradually, like so many products, software came to dominate the core features and functionalities of medical devices.

That combination of quality hardware and sophisticated software has made medical devices a lot more complex, which equates with increased development work for those building the products.

Add to that the element of connectivity which, while extremely powerful and convenient, can introduce a variety of risks — including malware and hackers — and the landscape of medical device development has expanded significantly.

Teams building modern medical devices must not only keep pace with the rapid rate of innovation and demands of the market, but also manage risk that only grows with the complexity of the product design. Managing the development of medical devices through documents and spreadsheets isn’t a path to long-term success, and companies must find new ways to develop their products or get left behind.

Read our eBook, How to Overecome Three of the Biggest Challenges in Medical Device Development

Challenge Two: Increasingly Strict Medical Device Regulation

The increasing complexity of medical devices is forcing regulators to take another look at existing rules and guidance, and for good reason. In the first quarter of 2019, the average size of a medical device recall was 823,126, which was the highest quarter since 2006, according to Stericycle’s Recall Index. And, among all recalls, quality issues were the main cause.

Whether it’s ISO 14971 or ISO 13485, compliance with government and industry regulations remains a constant weight for medical device developers, as regulatory bodies struggle to stay current speed of the market.

This is making medical device compliance increasingly costly and making regulatory standards harder to interpret. For instance, one of the most difficult and time-consuming aspects of proving medical device compliance is sorting through the documentation produced by the design and development teams, including outputs from multiple software tools. Even in a best-case documentation scenario, determining the right documentation to show FDA compliance and systematic management of risks is tricky.

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

Challenge Three: New Market Entrants Making a Disruptive Splash

When names like Apple and Amazon decide to start competing within your industry, there is ample reason to worry. These sorts of household names benefit from instant brand recognition, quick distribution, and seemingly unlimited resources.

For instance, Apple’s Watch Series 4 received a Class II de novo clearance from the FDA for both its electrocardiogram (EKG) and notification of irregular heart rhythm clearances.

Despite the intimidating nature of goliath companies getting into the medical device space, it’s important to remember most of them are still somewhat new to FDA regulation. This introduces new risks for those tech companies with nontraditional FDA-regulation backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution, which has prompted an overhaul of that system.

For medical device companies, this situation sharpens the focus on an ongoing business problem: Evaluating how your processes are being executed and making sure you’re getting your product right the first time.

To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!

SEE MORE RESOURCES

Based in Minnesota, Elucent Medical is a medical device developer focused on creating precise, wireless surgical navigation tools for tumor identification and excision. Founded in 2014, Elucent is helmed by three veterans of venture-backed biotech companies, CEO Laura King, CTO Dan van der Weide, and Dr. Fred Lee; as well as Dr. Lee Gravatt Wilke, Director of the University of Wisconsin Health Breast Center and chair of the research committee of the American Society of Breast Surgeons.

The team at Elucent has been using Jama Connect™ for about a year to manage requirements, tests, and reviews throughout the product development cycle.

Jason Hiltner, Elucent’s VP of Research and Development, had worked with requirements management solutions like CaliberRM before, and he had seen other product teams depend on IBM Rational DOORS and Microsoft Word and Excel. With those experiences in mind, he knew he needed a more intuitive, centralized platform to support innovation at Elucent.

Jama Connect makes Elucent’s product development process more efficient and more collaborative, while facilitating traceability from requirements through testing in compliance with FDA regulations.

And Elucent is creating some amazing things with the help of Jama Connect. Since it’s difficult to locate precise spots in the body, especially in soft tissue, Elucent has developed the SmartClip™ — a tiny implantable product that marks the location of cancerous tissue so surgeons can identify and excise the cancerous tissue more easily. Patients don’t have to endure repeated excisions because surgeons haven’t located or removed all of the cancerous tissue, and the SmartClip™ eliminates the need for painful and costly radiology localization.

The EnVisio™ Navigation System, which is designed to enable real-time 360° navigation in the surgical sightline and provides distance, depth and direction to the SmartClip(s): guiding a surgeon’s tools to make tissue excision and removal even more exact. The team’s hard work was rewarded when the EnVisio™ Navigation System was granted FDA clearance in 2019.

Elucent’s first market will be surgical excision in breast-conserving surgery, and their technology has wide applicability for localization of cancerous lesions throughout the body. Hiltner says the initial response to the clinical product has been “phenomenal for sure.”

Learn how to move beyond the frustrations of document-based requirement systems, streamline your development and set yourself apart from the competition by watching our webinar, “Balancing Compliance & Innovation in the Medical Device Industry.”

We asked Hiltner and Judson Guericke, Senior Director of Quality at Elucent, to tell us more about how they’re leveraging Jama.

Jama Software: What corporate or industry challenge led to your decision to seek out a solution and ultimately purchase Jama Connect? Was there one particular problem that became a huge pain point?

Jason Hiltner: Obviously, in our industry, we have to have well-documented requirements that start with the customer requirements, go to the product requirements, link to the design descriptions and the software requirements, and lead to verification. If you’re going to do that, you need to start with something that allows you to have traceability. We also needed something with a central database, so we weren’t managing a bunch of different revisions of documents and emailing documents again. The big thing I wanted was a platform I could very easily maintain and not have questions about: I would know where things were and be able to easily do reviews. I also knew we needed something stable, robust and cloud-accessible.

How long have you been using Jama Connect, and what was the adoption process like?

Hiltner: We’ve been using Jama Connect for about a year. We’re a startup, so I talked over the idea [of a requirements management solution] with a small group of people. We’re a very lean and focused organization; we’re at only 11 people. We compared a couple of tools and got recommendations from people who had done a more exhaustive search. We went with Jama Connect in spite of the fact that it was more costly than some other tools. The deployment and implementation process was as smooth as I could have hoped for. We had a bunch of sessions with Zeb Geary, a Jama Professional Services consultant, and we were up and running, creating requirements in less than a week. It’s as flexible as I hoped it would be.

“We were up and running, creating requirements in less than a week.” – Jason Hiltner, VP of Research and Development at Elucent Medical

What was the feature/capability/business aspect of Jama Software that won you over?

Guericke: The collaboration and customer support for implementation. The biggest benefit for us is the efficiency in completing and gaining agreement on requirements and testing procedures.

Hiltner: We wanted something that would be very usable, something that would be maintained and around for a while. Our product has customer requirements that flow down to product requirements, which flow down to software requirements and design descriptions. We also maintain our verification suite within Jama.

Guericke: We needed a solution that would facilitate traceability from requirements through testing to comply with FDA expectations for design control. Jama Connect provided a traceability functionality that worked well for our needs. In addition, the collaboration capability of Jama aided us greatly in the definition of our requirements.

How do you measure success for this project? How are you using Jama Software to get there?

Hiltner: Now that we have that [FDA] clearance on the EnVisio Navigation System, success will mean surgeons utilizing our product to improve patient care.

Guericke: Confidence in assuring complete coverage from customer requirements to product requirements to software requirements to verification and validation. I really like how intuitive Jama Connect is. It was very easy for me to figure out how to navigate and use. There was some learning curve on the system configuration, but the support provided by the Jama Software team made that much easier.

Interested in learning more about using Jama Connect to build medical devices? Download our brochure, “Jama Software for Medical Device Development.”

Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units so the system can be evaluated holistically and by each constituent part. This approach is critical to how we align Jama Connect™ to tackle the daunting complexity of medical device development.

In our experience working with some of the market’s foremost medical innovators, we’ve seen that teams who embrace systems thinking are better-positioned to modernize and improve their product development processes. Jama Connect is informed by systems thinking and regulatory requirements, while its framework remains flexible enough to accommodate the unique needs of diverse development teams.

In this post, we’ll lay out how and why complex medical device development teams should be using systems thinking to streamline and strengthen processes, according to a recent webinar.

Why Systems Thinking?

Complex medical device development teams use 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 assuming they know the answers.

A systems thinking approach opens up your team and organization to procedure-level improvements and the ability to take full advantage of solutions that support them.

Even manufacturers developing complex systems that involve multiple disciplines and require the management of numerous subsystems may not be realizing the full value of systems thinking for managing design, collaboration and traceability across teams.

Visibility and Collaboration

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

Complex medical device development requires that the right people have visibility into the relevant parts of the system, and a systems-thinking approach helps ensure that the right questions are being asked and addressed.

Systems thinking also drives teams to coordinate and communicate through a common system need. Collaboration becomes easier and more effective when teams are free to find approaches within their disciplines that are most effective for them, while still meeting the needs of the system.

Design History File, Verification and Traceability

Systems thinking also gives teams better tools for managing complexity and change during the design process. With an applied systems approach, organizations can realize and resolve inefficiencies in their product development processes while producing the necessary outputs for the design history file (DHF). Jama Connect, designed to support systems thinking, aligns how your team works with the artifacts required for compliance and the DHF.

If you’re following ISO 13485 and the FDA regulations for design control, for instance, you’re already driving toward a general systems approach. The regulations require the definition of user and patient needs and the tracing of engineering responses to those needs as design inputs. However, the regulations rightly leave room for manufacturers to define their own procedures, so long as the outcome demonstrates the relationship between the needs, the subsequent design inputs and the resulting design outputs and verifications.

Applying a systems approach to how you work means that the value of understanding the interrelatedness of the design requirements doesn’t just live in the trace matrix document. This value is realized when you can visualize and interact with the trace during your design definition activities and beyond. The trace must be maintained throughout the design process to be helpful. Thus, the matrix you need for your DHF becomes a byproduct of how you work, not something you stitched together at the end of the design stage when you needed that documentation.

The same can be said for your design input files and other artifacts: They’re most valuable when they are considered as byproducts of how you work.

Additionally, verification and quality teams can leverage systems thinking to assess and define verification activities for the system even as other teams explore their responses to the system needs.

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 Medical Device Developers

Our professional services team has also established a recommended framework for Jama Connect via our Medical Device Services. This framework, informed by systems thinking, guides regulatory compliance while remaining flexible enough to accommodate the diverse needs of teams and organizations.

In this framework, the need for documentation informs rather than constrains, and it isn’t at odds with your drive to improve your process or the solutions you deploy to realize those improvements.

Stay tuned for more posts about improving medical device development and the integral role Jama Software is playing for its customers.

With the rising amount of connected devices in circulation, the number of potential targets for hackers and other cyber criminals to exploit continues to rise. Among the most common targets for attack: medical devices.

A survey released in October of 148 healthcare IT and security executives, conducted by Klas Research and the College of Healthcare Information Management Executives (CHIME), showed that an astonishing 18% of provider organizations had medical devices impacted by malware or ransomware in the last 18 months.

Medical devices were defined in the report as “biomedical devices used by healthcare-delivery organizations in the pursuit of patient care.”

The report also stated that only 39% of the respondents were “very confident or confident that their current strategy protects patient safety and prevents disruptions in care.”

Although organizations are making gains in developing and maturing their overall security programs, the report says, progress has been slow. This is particularly true when it comes to securing medical devices, the study shows. Unsurprisingly, respondents cited patient safety as their top concern with unsecured medical devices.

“Unsecured and poorly secured medical devices put patients at risk of harm if those devices are hacked,” said Russell Branzell, president and CEO of CHIME, in a press release about the report. “In recent years, that risk has increased exponentially as devices in hospitals and health organizations have become more and more interconnected.”

Adam Gale, president of Klas, also weighed in on the findings: “Safeguarding medical devices requires a joint effort by provider organizations and device manufacturers. Many providers have the basic building blocks for a general security program in place and are making progress.”

A large majority of the survey respondents (96%) identified manufacturer-related factors as a root cause of medical device security issues. The majority of respondents also reported struggles related to out-of-date operating systems or the inability to patch devices, which have been found to be major security risks. The study also discovered that, on average, one third of medical device manufacturers have said their devices cannot be patched.

“Medical device security is a three-way relationship between provider organizations, the manufacturers, and the regulators,” said Dan Czech, director of market analysis-cybersecurity at Klas, in the announcement about the findings.

Provider organizations can follow industry-accepted best practices such as network segmentation, Czech said. “Manufacturers can include security in the design of all products going forward and can consistently patch currently offered medical devices,” he said. “Regulators can provide incentives and disincentives for manufacturers and organizations to secure their devices and can offer the needed guidance to direct the healthcare industry.”

The threats against medical devices have become such a concern that two U.S. federal agencies recently announced a new initiative to address vulnerabilities. In October 2018, the U.S. Food and Drug Administration and the U.S. Department of Homeland Security (DHS) announced a memorandum of agreement to implement a new framework for greater coordination and cooperation between the two agencies for addressing cybersecurity in medical devices.

“As innovation in medical devices advances and more of them are connected to hospital networks or to other devices, making sure the devices are adequately protected against intrusions is paramount to protecting patients,” said Scott Gottlieb, FDA commissioner, in the memorandum announcement.

The partnership between the two agencies will enable them to share information about the constantly evolving threats against medical devices and help organizations in the healthcare industry proactively respond when vulnerabilities are identified.

This isn’t the first time the two agencies have collaborated on medical device security. In recent years they have been focused on the coordination of vulnerability disclosures. The partnership allows device manufacturers to receive technical information from cybersecurity researchers regarding identified vulnerabilities in their products so they can respond to potential threats in a timely way.

Author Bob Violino is a freelance writer who covers a variety of technology and business topics.

The rapid pace of medical innovation has increased the need for medical device companies to incorporate software and new technologies into their products to keep up with market demand.

As medical device manufacturers have adapted their products to incorporate software, tech companies have also seen the market opportunity and entered the medical device landscape.

These developments have led to changes in the FDA’s regulatory processes. For example, the proposed creation of a “Center of Excellence for Digital Health (CoE)” would modernize the FDA’s regulatory approach to meeting the needs of the growing digital health market.

Whether you’re an established medical device company or a new player, every stakeholder faces numerous challenges to keep up with the pace of the market while delivering compliant products that ensure patient safety.

Complexity and Connectivity are on the Rise

In the past, medical device software was generally used to display readings and manually turn equipment on and off. Complexity in requirements and customer needs, however, has made medical device software far more complex.

As with consumer electronics, patients and healthcare professionals expect today’s medical devices to be better, faster, safer and cheaper than their predecessors.

While these market drivers create new, exciting opportunities to innovate, they also carry inherent complexity and risk.

Small teams building simple products can get by with spreadsheets, documents and emails to track product requirements, testing and risk. However, with larger, more distributed teams and the rise of software-driven medical devices, traceability quickly becomes too convoluted to be handled manually: There are far too many scope changes, remote team members, reviewers and requirements.

By automating traceability into a live system of record, medical device developers can establish consistent, accurate links throughout each step of the development process.

In Jama Connect, you can create relationships to link everything together and map out interdependencies among different items and decision makers.

Automating traceability not only organizes your product development process; it also saves time and gives you confidence in your compliance.

New Entrants into the Medical Device Market

On the flip side of traditional medical device organizations incorporating more sophisticated software into their releases, some of the world’s biggest tech companies are increasingly incorporating health data and functionality into their products.

Big tech healthcare is a rapidly growing segment. In fact, major tech companies have participated in 27 rounds of healthcare financing within the first eight months of 2018, equal to the total amount of rounds in 2014 alone, according to a CB Insights research brief.

Look no further than Apple’s Watch Series 4, which recently received a Class II De Novo clearance from the FDA for both its electrocardiogram (EKG) and notification of irregular heart rhythm clearances. While the letters clearly stated the watches were “not intended to replace traditional methods of diagnosis or treatment,” solutions like these are changing the way consumer electronics companies like Apple think about and develop products.

Compliance today requires a deep level of organization, document and information management, and detailed communications previously unseen in either the medical device or tech industries. This introduces new risks for tech companies with non-traditional FDA regulated backgrounds and creates fresh challenges for the FDA’s evaluation of each software solution.

The good news is being a new entrant into the healthcare market doesn’t automatically put you at a disadvantage. And you shouldn’t have to start from scratch when trying to create a process that satisfies FDA auditors.

Jama Software can help you get up and running quickly with Jama Connect and our Medical Device Services, based on a process tightly aligned to governing regulations ISO13485:2016 & 21 CFR 820.30. The approach is designed to accelerate time to value from Jama Connect and give teams confidence that the products they are developing adhere to FDA and ISO regulations.

Accelerate Medical Device Development While Reducing Risk Now

Despite these changes in the digital healthcare market, the goal remains the same: release high-quality, market-driven products that ensure patient safety.

While the changes and regulations can be overwhelming for new entrants into the market, creating a streamlined development process that balances innovation and compliance is a solid starting point that will only lead to greater product success.

Software and hardware teams need to collaborate now more than ever to produce an innovative product that complies with FDA regulations and gets you that 510k clearance letter faster.

Jama Software guides cross-functional medical device teams through the development of their Class II and Class III medical devices.

Every day, our powerful platform helps hundreds of customers manage device requirements, risks and testing. Our tailored services allow our customers to focus more on innovation and less time navigating compliance.

Learn more by registering for our expert-led webinar specifically designed for medical device product and engineering teams, “Balancing Compliance & Innovation in the Medical Device Industry.”

Few complex processes require more scrupulous attention to detail than taking a product from concept to design, through development and into manufacturing. And when it comes to medical device design and manufacturing, nothing is more critical than quality and compliance.
For more than 30 years, Fortune 500 companies have turned to Plexus engineers to design, develop and test healthcare and life sciences products. Plexus is ISO 13485 and Quality System Regulation compliant with engineering teams and manufacturing facilities around the world.
In order to ensure regulatory approval, Plexus needs to be able to guarantee traceability and documentation. After considering a variety of solutions for a collaborative, compliance – and audit-friendly requirements management tool, the team selected Jama.“Our main performance measurement is the repeat business we receive from our customers. They don’t come back if we’re not meeting the schedule and project budget. And these are things that Jama helps us do,” says Dave Strandberg, Director of Engineering Solutions.
Since introducing Jama, Plexus’ distributed teams are able to more efficiently collaborate on the requirements of their Class II and III medical devices. With Jama, Plexus has dramatically reduced the time it takes to assemble test data and shortened time to market.
Learn more about how Jama is helping Plexus deliver to their customers again and again with the confidence of proven compliance. Read the case study.