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Medical technology companies, especially those developing medical devices with increasing complexity and product variations, are faced with a wide range of methods for managing risk. The toughest part is often deciding which specific methods and data points need to be captured to prove that all angles of risk analysis for product development took place. Against this backdrop of constant innovation, medical device manufacturers face unique challenges to comply with significant regulatory changes in Europe and the United States — some that could support new product development, while others could hinder it.

Changes in compliance standards, such as the new Medical Device Regulation (MDR) in Europe, include sweeping changes regarding how companies and distributors demonstrate the safety and efficiency of products. Companies are required to show clinical evidence for all products as well as provide systems and documents to remain compliant during the device lifecycle. One-way companies are reacting is by adopting modern requirement management solutions for improved agility and flexibility. With the ability to trace all aspects managed in one place, unified cloud requirement management applications can help maintain compliance and facilitate engaged collaboration across geographies. Evolving a regulatory environment means it is no longer feasible to have unrelated content without convenient access.

Whether regulatory authorities are tightening rules around medical devices or responding to market innovation, manufacturers must be prepared to demonstrate their products are safe and effective across the total lifecycle using a more comprehensive array of data sources. Critical factors for medical device makers must transform the way they innovate, design for manufacturability, and differentiate their products in the market. A centralized Agile alternative to disconnected, document-based processes enables pathways to faster product development, improved quality, and compliance to safety regulations.

How can you modernize and where should you start to meet these compliance challenges while streamlining your development processes and creating efficiency? Three improvement strategies can be used to insert risk control as a crucial part of the medical device development framework to comply with ISO standards and EU Medical Device Regulation (MDR).

RELATED: Getting the Most Out of Your Lab Partnership Ahead of the EU’s MDR

Three Strategies to Streamline Workflow and Strengthen Collaboration when Developing Medical Devices

With the magnitude and complexity of data expanding, medical device firms are working to assemble and analyze data faster. Much of this data is often spread out across information silos. As a result, medical device companies are increasingly looking to modern clinical requirements and safety management systems, including central data capture, that collect and clean this clinical data, all in one manageable platform.

According to a study by the Emergo Group, nearly 60 percent of medical device builders say clinical data management rules are the most challenging component of Europe’s new MDR. An equivalent percentage of companies say they don’t have a strategy for compliance. Having an approach that incorporates a complete view of data can help with the preparation and ongoing compliance. To have a plan of action, three strategies that can help you to focus on a trustful quality and efficient control of developing advanced medical products.

Establish a Single Source of Truth Framework for Reliable Insights

Through medical device development, many disparate documents are gathered into a collected set of information and submitted to regulators. This auditing process can be a time consuming and very manual exercise often done too late in the development cycle. Optimizing workflows to centralize information sets in an item-based approach where processes and documentation move from the document-centric model to a relational database approach can protect your quality of building new products and services. A workflow-driven, traceable methodology, and managing all information sets in real-time brings better handling to safety-controlled development cycles, and maintains a continuous state of acceptance readiness.

Streamline Risk Control with Requirement Definitions

Using a centralized information gathering approach, you can author the risk process directly connected to your development work. Your risk acceptability criteria can be defined and documented as part of the risk assessment related to the required development specifications. Moving to connected risk-requirements workflows, provides a collaborative place where the risk management plans can be viewed holistically by the entire development team in the context of the medical device development environment where requirements, specifications, validations, and risks are analyzed.

Enable Your Expert Community

Building complex products is never a one-person show. Medical device manufacturers when implementing tools, resources, and techniques to develop safe and successful products faster. A substantial factor for success is the team’s understanding and engagement at every aspect and stage of the development lifecycle, creating a robust traceable collaboration community and the ability to initiate a flexible evaluation process. These factors can have a significant impact on achieving a timely and cost-effective control that assures product quality due to a risk embedded impact analysis.

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Why Risk Management, Why Now?

Medical device developers can optimize the development cycle by bringing risk control and development data together in an information-centric and automated fashion and instead focus on quality, innovation, and efficiency, as well as time to release, allowing medical device builders to recognize new product revenue within shorter release cycles.

Early transitions to renewed regulations, such as the new European MDR/FDA standards, are critical in giving products a competitive advantage. Companies can turn this around into an opportunity by adhering to the following recommended steps:

Implement a strategic, information centric approach early on to ensure market compliance and build a trustful reliable data source
Handle your risk control elements directly connected to your traced development activities
Make use of Jama’s consulting expertise and the available medical assets such as ISO 14971, FMEA, FTA, and 21 CFR Part 820 to rollout your renewed strategy based on industry best practices.

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

In February, the US Food and Drug Administration (FDA) issued guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions. The Abbreviated 510(k) Program allows manufacturers to seek FDA approval for new devices by demonstrating substantial equivalence to devices currently on the market. This new guidance creates an optional pathway — the Safety and Performance Based Pathway — for gaining that approval.

So, what is this Safety and Performance Based Pathway? Why did the FDA create it? How might it affect medical device development? Let’s examine those questions.

What is the Safety and Performance Based Pathway?

The existing Abbreviated 510(k) Program, established in 1998, was designed to lower the regulatory burden on both manufactures and the FDA and speed new medical devices to market. It permits manufactures to gain FDA approval by demonstrating their new device provides equal or better performance than an approved device that’s currently on the market (a so-called, “predicate device”).

The new Safety and Performance Based Pathway will allow manufacturers to gain approval by demonstrating that their new device meets a set of FDA-identified safety and performance criteria for its device category, rather than making a direct comparison with a predicate device.

The scope of this new pathway is limited. Issued on February 1, 2019, the guidance document states that this pathway applies only to specific device types the FDA understands very well and for which it has issued safety and performance criteria.

To that end, the FDA has begun releasing and soliciting industry feedback on guidance for specific device categories, starting with four documents issued on September 19, 2019. In each document, the FDA identifies the intended use and design characteristics of the device class along with the testing performance criteria for the class. The four device types for which the FDA has issued guidance are:

Conventional Foley catheters
Cutaneous electrodes for reporting purposes
Orthopedic, non-spinal, metallic bone screws
Spinal plating systems

The FDA plans to expand the program by rolling out many more such documents in the coming months.

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Why has the FDA created the Safety and Performance Pathway?

The new pathway is part of the FDA’s effort to reduce the regulatory burden on both medical device manufacturers and the agency while speeding safer, more effective products to market with FDA approval. With the Safety and Performance Pathway, the FDA hopes to reduce manufacturer’s dependence on direct comparison with predicate devices, especially older predicates that rely on dated technologies. According to the agency, of the 3,173 devices cleared through the Abbreviated 510(k) pathway in 2017, roughly 20% were predicated on devices that were more than 10 years old.

When the new pathway was first announced in November 2018, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) said in a press release that, “Rather than looking to the past as a baseline for safety and effectiveness — and rely on predicate devices that are sometimes decades old as our point of comparison — our premarket review would be based on a contemporary baseline that looks to the future and a baseline that can be updated as technologies advance.

“Through this new path, a company would demonstrate that a novel device meets modern performance-based criteria that have been established or recognized by the FDA and reflect current technological principles,” they wrote. “These criteria would reflect the safety and performance of modern predicate devices. We’d like this efficient new pathway to eventually supplant the practice of manufacturers comparing their new device technologically to a specific, and sometimes old, predicate device.”

The press release also stated that the agency is investigating whether it can retire older devices as eligible predicates. Such a move could require Congressional approval, however.

“To be clear, we don’t believe devices that rely on old predicates are unsafe, or that older devices need to be removed from the market,” Gottlieb and Shuren wrote in their statement. “However, we believe that encouraging product developers to use more modern predicates would give patients and their doctors a choice among older and newer versions of a type of device, promote greater competition to adopt modern features that improve safety and performance, and help make sure that newer devices reflect more modern technology and standards that can improve patient care and outcomes. It would help the overall product environment continue to evolve in the direction toward more modern performance standards.”

Learn how Jama Software can help medical device developers better manage risk with ISO 14971 by downloading our white paper.

Pushback from Medical Device Industry Lawyers

Some think that with their stated goal of encouraging innovation, the FDA is overstepping its authority.

In an email to MobiHealthNews, Bradley Merrill Thompson, a lawyer who counsels on FDA regulatory issues, said phasing out old devices would be “essentially forcing companies to innovate regardless of whether the marketplace perceives a need,” thus driving unnecessary R&D and higher healthcare costs. He believes that if the FDA feels it needs to drive innovation through new regulatory changes, it would need to convince Congress to update the Medical Device Regulation Act of 1976.

“The 1976 statute is very clear, and FDA can’t simply ignore it,” Thompson wrote. “If FDA wants to change the statute, then to Congress they should go. Congress in turn could bring together all of the various stakeholders including patients, healthcare professionals and medical device manufacturers to talk about what they need and the best way to do this. FDA has no mandate to do this on its own.”

Possible Effects on Medical Device Development

Thompson’s legal concerns seem to apply only to the FDA’s investigation into retiring older predicate devices from the original Abbreviated 510(k) Program, however. From an engineering standpoint, the new Safety and Performance Based Pathway appears to offer manufacturers some important benefits.

First, the alternative pathway will allow manufactures to focus on surpassing safety and performance criteria rather than on making a comparison with a predicate device. Designers will have greater liberty to move away from predicate designs and technologies, since there is no need to make a direct comparison with a predicate device.

Second, for new devices in the FDA’s “well-understood” categories, the new pathway should speed time to market. The impact will be limited initially, but it should increase as guidance for more device types is released.

Finally, by establishing modern performance benchmarks for FDA approval that can be updated over time, the new pathway should help increase the safety and performance of new medical devices, at least those in designated device categories.

As we look to the future of medical device development, we can expect to see additional and extended guidelines from the FDA and other governing bodies on how to safely bring new products to market in a way that enables innovation. Stay tuned.

Download our eBook, Conquering Connectivity, Competition and Compliance, to learn about the top three challenges that modern medical device makers face and how to overcome them.

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

This is a guest post from Jason Swoboda, general manager of the medical device engineering firm, Velentium. It originally appeared on their blog.

Medical device developers face a common challenge: Harnessing the best ideas from the Agile methodology on projects that, because of their regulatory environment, appear to demand a classic waterfall model.

It’s not that the classic waterfall model is bad. Among other advantages, it’s a very clean way to visualize and map a complicated process. But anyone familiar with the debates surrounding development models is aware that, as with all models, the waterfall model has limitations. One of the first and most frustrating limitations that developers frequently encounter with the classic waterfall model is its demand that requirements be nearly complete before design can start.

“I can’t move forward until you deliver complete requirements,” the developer says to the end user.

“I can’t clarify requirements any further until we see a first-pass iteration of the product,” the end user responds.

“But I can’t develop an early version of the product without knowing what I’m supposed to make!”

At this point we no longer have a waterfall model; we have an eddy. We’re caught in an infinite loop and we haven’t even made it out of phase one.

The waterfall model is laid out the way it is because, when it works, it helps developers minimize waste and forestall misunderstandings. Clean labels and discrete phases should also, in theory, ease workloads for documentation, oversight, compliance transparency, and process improvement reviews. But actual conditions rarely conform to these convenient patterns. When they don’t, we’re confronted with a choice: attempt to force conditions to fit the expected pattern, however frustrating and inefficient that may be… or adapt on the fly as best we can.

Learn how to avoid common pitfalls of the Agile methodology in embedded systems by watching our webinar.

That’s why the Agile methodology is so appealing: it offers options that anticipate and prevent the bottlenecking and potential crisis points to which static development models are normally vulnerable. But which approach is right for medical device development?

Velentium believes that if you become too attached to any one model — even one that has “agile” in its name — you’re no longer “agile” by definition. Rigidly adhering to a single approach for every effort by definition cannot be flexible, speedy, and nimble.

At the same time, Velentium is also a company whose principles dictate their practices. So, here’s their guiding star: take a continuous deployment approach to projects. Focus on delivering value as early as possible, and then adding value iteration by iteration until the project is completed. They shed light on their development practices in the text and models below.

Velentium’s Iterative Development Process

As we develop sequentially around these quadrants, the first question to ask is: What’s the smallest slice of the final product we can build that contains a basic version of the most important functions of the whole? (Randy Armstrong’s “Know Your Why” is really helpful here). The answer will guide us through our first rotation. Then, as we prepare for the next turn around the spiral, we determine which of those functions would be the most valuable to expand first. What’s our next benchmark? Which additions will enable testing we can’t meaningfully conduct yet? What does the end user need to see first? What will help clarify requirements or refine project scope? If the project were unexpectedly cut short immediately after the next iteration, what would be the most valuable functionality we could implement by then? These are the questions that will guide our decision-making for what to do at the outset of each development round or sprint.

This process involves key stakeholders, to whom iterations are shown for feedback at regular intervals. Development proceeds in partnership, with open lines of communication and process transparency.

If you overlay this process atop the classic waterfall model, it looks like this:

It still starts with the requirements. We want them as complete and as clear as possible. But we don’t let compiling them exhaustively impede forward momentum, and we don’t expect them to remain static for the duration of the project. Instead, we anticipate changing needs due to evolving market conditions, new research or regulations, and clarification achieved through the development process itself.

We’ve found it’s important to chart the course as well as you can, start moving, and be ready to incorporate new data and updated information into a dynamic master plan as you go. So, in the midst of lingering unknowns on requirements, we move ahead to early design. We let design (and design feedback) inform and complete our requirements.

Then, when we move from requirements and design to implementation, what we or our clients learn during implementation may cause us to revisit requirements and design, and so forth. As we move through iterative development — always seeking to deliver value early and add value often — we loop through project phases in progressively longer loops, all the way into validation. We never want to get bogged down any individual step. At the same time, we don’t want to miss an opportunity to add value because we’ve arbitrarily “moved on” from a previous phase: we believe those decisions should be governed by project scope and cost/benefit analysis, not workflow theory.

To learn more about implementing the Agile methodology into your process, download our white paper, “Agile for the Enterprise: 5 Steps to Helping Teams Move More Effectively.”

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.”

Medical device product development should always start with the user in mind.

This may seem intuitive, but you’d be surprised how often the user’s needs get lost in the process of developing medical devices.

Approximately 400,000 hospitalized patients each year experience some type of preventable harm related to medical devices. The cause could be medical equipment flaws, design mishandling or user error malfunctions – all of which can be prevented with a robust usability engineering plan.

In our recent webinar, head of medical device-related research at the Bresslergroup, Christopher Kim, took attendees through the smartest way to build a usability engineering plan based on best practices he’s learned first-hand working in the medical device industry.

Knowing Your Users and Use Cases in Medical Device Development

According to Kim, you should start learning about your users by asking the following questions:

Who are the intended users of the product?
Where is the product being used?
What is the intended medical indication this product is going to treat?

Then dive even deeper into how and where they will use the product:

Are there groups of users who might interact with only specific aspects of the user interface?
Do the users in these subsets overlap or is there little interaction between use cases?
Will patients self-treat or will medical professionals use the product in a hospital or outpatient setting?
Will the product be used by EMTs in ambulances or trauma helicopters?

The answers to all of these questions should paint a vivid picture of your users and the ways and places they will use your product. From a regulatory standpoint, the FDA will check to make sure you’ve considered how product use differs depending on the environment of use. This is because the environment — for example, an adult in an ICU versus a baby in a NICU — can result in significant differences in the way your product may be used.

Kim encourages teams to think about training at this point as well. Often training becomes an afterthought, but that’s a risk you shouldn’t take. Keeping training at the forefront of your mind during the development process enables you to design and evaluate the user interface from a meaningful perspective.

Creating the uFMEA

Once you have a clear understanding of use, it’s time to create the uFMEA, or the Use Failure Mode and Effects Analysis. This will document hazards that may apply if a task is not completed correctly or at all. It should incorporate elements of, and work side-by-side with, the instructions for use and what the intended use is.

To do this, you need to think through and identify all critical tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm includes compromised medical care. All potential use errors and outcomes should be predicted before validation usability testing. A separate task analysis should be created listing the tasks to be evaluated in usability testing and a clear definition of the associated criteria for success.

Perception, Cognition and Action (PCA) analysis is also a good way to analyze what could go wrong with any given task. This includes what the user is thinking, what they see and how they act upon those inputs. Then the risk management team assigns severities, assesses the likelihood of each potential situation and analyzes the acceptable residual risk.

Once the uFMEA is created, it’s time for testing, which may lead to product design change mitigations. It’s worth mentioning that the uFMEA is a living document that will evolve as you go through the product lifecycle. Remember, it’s always better to mitigate by design upfront than to require a label after the fact.

Learn more about how Jama Connect™ helps medical device developers streamline and speed up the development process while reducing risk.

Capturing Information and Working Together on Medical Device Development

Keeping the user at the center of the development process requires collaborative thinking across multiple teams and ideas. Whether it’s a task, requirement, verification test or even verification results, Jama Connect provides a more efficient way to conduct virtual reviews of data. Review Center lets you review and approve information iteratively and informally, before you need a final design signature.

Furthermore, the new Jama Connect Risk Management Center for medical device development allows you to foster a culture in which users can conduct their work individually and administrators can capture data in a standardized way. The result is the ability to export information to Word and Excel, if necessary, as well as create a real-time dashboard of the status and progress of risk mitigation.

Regulatory Compliance Tips and Misconceptions for Medical Device Development

In the webinar, Kim also highlights requirements of various regulations including HE75:2009, IEC 62366 and 2016 FDA HF Guidance: Applying Human Factors and Usability Engineering to Medical Devices.

It’s important to note that within the last few years, the FDA introduced the term “validation,” where the term “summative study” might also be used. Thus, usability validation is a very specific element that you need to test for, which is different than other validations that are incorporated into your design.

For more on regulatory consistency and how you can reduce risk associated to human factors, watch our webinar, Accelerate Medical Device Development While Reducing Risk.