Velentium test systems in place and operating at a factory.
PHOTO: VELENTIUM

Throughout the last decade, advanced technologies and innovations have been pushing the boundaries for medical device capabilities. As designers use these innovations to find better, more efficient ways of delivering care, they find an increasing need to deliver consumer-centric solutions. Medical devices must be attractive, easy to use, and provide the necessary data for the patient and physician.

On top of accelerated consumerization resulting from COVID-19, designers are faced with new challenges and must focus on important considerations when developing next-generation systems. Dan Purvis, CEO of Velentium, discusses the top three trends and impacts on medical device design that will shape the market going forward.

1. REGULATIONS WILL STEER OPPORTUNITY

Regulations and standards largely influence the manufacture of technologies and medical devices, and vice versa. In 2020, we saw the U.S. Food and Drug Administration (FDA) enact quick review and approval processes as companies rushed to get necessary devices and vaccines to market.

“We need the tech world to help us,” Purvis says. “And we’re going to be pushing through because the need warrants the risk. But after that, when it’s kind of back to normal, there will be lessons learned not just at an FDA level, but by industry and FDA together. You’re going to see enhancements to the FDA certification process, and I would be surprised if there weren’t systemic gains in the approval process as a result.”

To get your device through FDA approval, it must pass design controls. Throughout the process, it’s important to have a robust and well-documented quality management system (QMS) in place to ensure guidelines are met and that everything can be tracked.

When writing requirements for design inputs, Purvis explains, ensure that all the requirements define an ethical and safe device. Next steps include running risk analysis and risk mitigation. Continue through that process iteratively until you get to the point where the severity and the likelihood of all the different critical risks in the system are mitigated. Understanding how the different standards in quality systems apply is critical as well.

2. CYBERSECURITY, RISK MANAGEMENT

Today, most medical devices and equipment are built with software and are networked together to share data. While this embedded data and exchange of information offers safer, more convenient care, it also poses possible risks as these technologies can become vulnerable to cyber threats. Therefore, risk management must be a top priority for medical device design.

“With diagnostics, for example, the last thing you want is for somebody to intercept that wireless connection between the device and the phone and put a different value in,” Purvis says. “You don’t want to have to question what you think may be your insulin level or blood sugar level. When designing, we must take steps to ensure that the data coming to that phone is correct, because you’re going to start making therapeutic diagnoses based on that information.”

Velentium offers a training program designed to prepare medical device designers for enhanced cyber threats. Mastering Embedded Cybersecurity establishes standards and educates participants about how to avoid and mitigate cybersecurity vulnerabilities that are frequently introduced during design, development, and production phases. Curriculum is supported by the recently published book, Medical Device Cybersecurity for Engineers and Manufacturers, co-authored by security strategists and technical experts at Velentium and MedCrypt.

“We wrote this book because there’s lots of material out there for cybersecurity, but it’s all network cybersecurity,” Purvis explains. “With cybersecurity analysis, you only look at vulnerabilities’ severity and exploitability, not likelihood. Embedded cybersecurity is different, so you need different ways of doing it.”

Having a secure design at the system and product levels will guarantee a secure product lifecycle throughout the design phase, implementation, embedded software, and the supply chain.

PHOTO: VELENTIUM

3. INCREASED USE OF WEARABLES

Individuals have become notably interested in tracking and recording data regarding their personal health through wearable technologies. Wearables devices track temperature, blood pressure, oxygen levels, and electrical signals from the heart, provide immediate, real-time information to users, set automated alerts, and may even impact behaviors.

“This technology and its proactive capabilities are what you’re going to see more and more of, and then increasingly, you’re also going to see patch-based therapies,” Purivs predicts. “Where, in the past, the therapy was delivered as either an implantable or something injected, patches could be used to deliver that medication.”

Purvis also expects to see a wave of new therapies roll out as data science continues to make huge strides. Now, even fewer amounts of embedded sensors are providing an increased amount of health information, which further aids physicians to make diagnoses and predictions. And as these wearable devices become more popular and users gain more ability to tease out additional information, designers need to keep form and function top of mind.

WHAT’S NEXT

There’s been a rapid level of innovation and emergency use cases recently. Purvis predicts that moving forward, we’ll continue to see improved efficiency in the marketplace and in FDA approvals. Digital health solutions will expand and mandates for interoperability will continue, creating more opportunities for modernized care. With more advancements, ingenuity will be key as companies continue to invest in advanced technologies and partner to meet global healthcare needs.

Velentium LLC
https://www.velentium.com

About the author: Michelle Jacobson is the assistant editor of TMD. She can be reached at mjacobson@gie.net or 216.393.0323.