medical devices Archives

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As medical devices, software and technologies—and the risk management, regulations and recommendations concerning them—become more of a mainstream topic of conversation, we thought now would be a good time to round up a few newsworthy items. Check out key pieces from some recent articles and our takes on each, below.

How Samsung Is Leveraging VR to Manage Pain

Article quote: “Los Angeles-based startup AppliedVR has developed a platform with a library of interactive games and relaxing landscapes to draw users attention away from their pain, reducing dependence on pain medications with Samsung’s virtual reality hardware Gear VR. ‘Clinical findings from Cedars-Sinai and AppliedVR have shown that VR results in a 25 percent reduction in pain, in many cases obviating the need for narcotics, and a 60 percent reduction in stress and anxiety,’ says Dr. David Rhew, Samsung’s chief medical officer.”

Jama note: In a compelling example of convergence and collaboration between three different organizations—multi-national and multi-industry giant Samsung, therapeutic virtual reality startup AppliedVR, and Cedars-Sinai and other hospitals—we’re seeing the application of a disruptive technology as a solution to several types of debilitating patient problems. Programs and innovations such as these require collaboration across organizational and departmental boundaries to ensure traceability in clinical studies, and to capture requirements that exist outside traditional product development.

Trump Calls for Lower Drug Prices, Fewer Regulations with Pharmaceutical Executives

Article quote: “On Tuesday, Stephen Ubl, president of lobbying group Pharmaceutical Research and Manufacturers of America, or PhRMA, said the industry is open to working with the Trump administration on ‘market-based reforms.’ ‘Our industry takes seriously the concerns raised about the affordability and accessibility of prescription medicines, Ubl said. ‘The current system needs to evolve to enable the private sector to lead the move to a value-driven health care system.’ Drug companies provide discounts on their drugs to companies that negotiate on behalf of insurers, and there is a growing discussion about the extent to which those rebates, granted in secret, trickle down to consumers.”

Jama note: At the same time that the Trump administration calls for pharmaceutical companies to make changes, medical industries face growing uncertainty as Congress puts the Affordable Care Act under its microscope. Consequently, many companies operate in “wait and see” mode, with the knowledge that change is coming but without the knowledge of what these changes are and how business will be impacted. While repealing certain regulations could benefit these companies by accelerating the time it takes to get products to market, the need for product safety still remains. As questions multiply and uncertainty mounts, the business value of capturing, managing and maintaining product requirements remains strong and will be increasingly important as companies navigate the changes ahead.

Web-Connected Medical Devices Are Great. Unless…

Article quote: “There are many benefits to having Internet-connected medical devices. They can monitor patients and transmit important data about them doctors. They also can provide remote control of medical devices such as pacemakers. Adjusting these devices through the Internet of Things can avoid additional surgeries or other procedures that carry the risk of infection. But remote control of such a sensitive piece of equipment can be a detriment. Anything connected to the Internet potentially is at risk of hacking — and when the device being hacked is a medical device, the risk could be fatal.”

Jama note: For every new opportunity the IoT creates, it seems a new reason to worry comes along with it, and there is no greater worry than when health and safety are at stake. As medical monitoring moves into the mainstream, enabling more efficient and responsive communication for patient care, we’re also approaching an era where trust in “the doctor knows best” isn’t enough. Doctors, hospitals and the patients using these devices will all share some degree of responsibility for security awareness. But the greatest pressure will be on medical device designers and manufacturers to design and build each new product, version and variant around changing definitions of patient safety and security. And for Internet-enabled medical technologies, good health begins with good requirements management.

“The health industry will continue to consolidate through mergers and acquisitions in 2017, but the new year also likely will bring an uptick in alternative transactions, such as joint ventures, partnerships, strategic alliances and clinical affiliations.” Top health industry issues of 2017 PwC

Innovations in the medical device industry are often not created within one team. Increasingly teams are augmented with many different types of players through contract manufactures or acquisitions or even strategic alliances. The benefits of collaboration are rarely lost on industry leaders. Bringing together innovators to create a new way of doing things can revolutionize a sector, but without the correct support and infrastructure collaborations often fail.

Collaborating across cultures, institutional and geographical, adds unique challenges with each group having their own standards and entrenched ways of doing things. How do teams cross these divides? Unified goals, clear expectations, unique points of view are a great place to start, but also having the right tools makes overcoming the challenges of modern collaboration possible.

Unified Goal: When cross-organizational teams have a clear and unified goal for developing a product, innovation or service, they can better overcome the challenges inherent with collaborating in a complex environment. Having the shared vision makes the unity worthwhile.

Clear Roles: Clearly communicating the expectations of how and when each member of the team will be asked to participate helps alleviate the uncertainty of collaborating in a new way. Documenting the goals and setting, communicating and tracking of the collaboration help keep programs moving forward smoothly.

Unique points of view: Unlocking the creativity needed for innovation requires harnessing the insights and unique understanding across different stakeholders. Bringing unique points of view will result in more robust and better considered ideas for implementation. Having representation from across the team will help better asses the impacts of decisions and can help identify issues before they become problems.

The Right Tools: As teams seek input and feedback, tools like Jama Software are critical in capturing these insights in real-time. With everyone having the most up-to-date information, reviews can be streamlined and allow for more clear communication to what is expected by who and by when. This helps reduce complexity of communication and save time by having a single place to provide input. The teams have a single source for collaboration regardless of geographic or institutional location, which enables collaboration across a variety of relationships. Suppliers can have clients directly involved in reviews for input and progress checks or academia can collaborate with industry partners so communication can maintain an even pace despite cultural differences. Having a single platform where these teams can come together to innovate, review and connect will keep programs on track, teams collaborating and not let insights slip through cracks.

People working together is at the very core of all product development work. The ability to collaborate is critical for innovation. For companies or academia to turn the research of today into the products of tomorrow, it is critical that teams stay connected and synchronized.

When I joined Jama as CEO earlier this year, I was excited to become part of a team that was passionate about our customers and solving their problems. The companies we get to work with are a major reason I wanted to join Jama to begin with — it’s an honor and a thrill to partner with them as they build products that will change their industries and the economy. I know I’m not alone in that enthusiasm: As I met individually with every employee during my first three months on the job, over and over again “our customers” was a top reason people cited for coming to work here.

Our customers span an array of critical industries — aerospace, financial and consulting services, medical devices, government, semiconductor, consumer electronics and automotive, to name a few. I’ve now had the privilege of meeting with dozens of them, and I’ve consistently heard them describe the following market forces in play:

The new generation of smart, connected products is increasing competition.

For the first time ever, when consumers buy something new, whether a phone, a thermostat or a car, they expect its capabilities to improve over time. They expect new features over the lifetime of the product, automatic fixes where there were previously recalls, and unprecedented options for customization. With each release of Jama, we’re rolling out new features and improvements that focus on enabling innovation for our customers. We invested in building our REST API to add more even customization and extend the functionality of our solution.

Increasing complexity and new regulation add new challenges.

Development cycles are more complicated than before, requiring close coordination of hardware and software teams, often using different tools and methodologies. Connected products introduce new security risks, often into industries that were previously immune to regulatory compliance. As software becomes an increasingly critical component of new cars, the automotive industry has responded with new compliance regulations such as ISO26262, and so have we. This year we achieved ISO 26262 fit-for-purpose certification by TÜV SÜD to give our customers confidence as they navigate the path to compliance in their product development process.

Systems development teams require a purpose-built product development platform and must take a continuous engineering approach to create products for the modern world.

ALM was built for software, PLM was built for hardware, but today’s product teams require a unified set of capabilities. Teams need contextual, ongoing collaboration and a single source of truth for their data and requirements. In June, we released Jama 8, kicking off a series of releases that will build on our core traceability and collaboration features. We’re also investing in our product ecosystem with the launch of our Partner Alliance Program, working with best-of-breed solution providers to better serve our customers.

At face value, these challenges are daunting. But we get to see our customers overcome them each day through disciplined, modern management of their development processes, which lets them better capitalize on industry trends. As they work to deliver the life- and economy-critical products that are going to change the way we live, we’re glad to be their partners and are eager to foster their success every step of the way.

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.