The process of developing medical devices is highly nuanced, involving sophisticated technologies, tight production timelines and strict regulations — and it’s only getting more complex. The FDA’s tightening of cybersecurity guidance following the Food and Drug Omnibus Reform Act of 2022 (FDORA) has added more hurdles for medical device manufacturers to overcome.
This presents additional security challenges for manufacturers of equipment like patient monitors, mobile workstations, picture archiving and communication systems (PACS), C-Arms, ultrasounds, Infusion pump and more. Fortunately, embedded readers offer a streamlined solution.
Embedded readers, which read contactless smart cards and other types of secure credentials, enable you to build authentication capabilities into medical equipment and devices, easing regulatory approvals and demonstrating your commitment to patient safety. By taking an innovative approach to medical equipment security, you can add value for your end customers and differentiate your products in a competitive market.
The 20-year Product Lifecycle: Building for the Future
When you consider the market research, product design and regulatory processes involved in launching a new medical device, the total lifecycle can span up to 20 years. That means you have to consider more than just the needs of the organization you’re looking to sell to today; you also have to consider what features and upgrades they’ll be interested in 10 years from now. From a security and compliance perspective, this means developing medical devices with a forward-thinking approach to software updates, data protection and interoperability. Continuous monitoring and proactive risk management will also be essential throughout the device's lifecycle to safeguard patient data and ensure the device remains both functional and secure as technology and compliance landscapes evolve.
Throughout this process, there’s also the question of durability. The last thing you want is repeat calls from your healthcare customers asking you to troubleshoot issues like inconsistent device connection, data reading errors and more. Each of these malfunctions has a tangible impact on the quality of patient care organizations can deliver, not to mention significant financial costs. Non-routine quality events, such as material failures, cost the medical device industry billions per year.
All in all, you can’t afford to put devices on the market that aren’t built with future functionalities in mind.
3 Ways rf IDEAS’ Embedded Readers Are Built Ready to Integrate With Your Medical Device Portfolio
rf IDEAS’ WAVE ID® Embedded OEM readers are available in a variety of models designed for seamless integration into patient monitors, ultrasounds, mobile workstations and more. They’re designed for universal compatibility, so you don’t need to invest additional time in complex configurations or custom development. Devices with our embedded readers are built ready to integrate with your customers’ systems on day one.
Here are a few immediate benefits you can expect after implementing these readers into your product portfolio:
1. Experienced, responsive partnership
rf IDEAS’ decades of experience means we’re the ideal partner to help you craft a solution tailored to your customers’ preferences. As a trusted name in healthcare, our team’s decades of insights all serve to ensure your embedded devices continuously meet customer needs.
With aftermarket assurance, we’re committed to making sure our products stay operational long-term. Lastly, our team provides technical support, customer service and up–to-date warranties — each of which result in a value solution for the end customer.
2. Long-term compatibility
Built for the long term, our embedded readers are compatible with the most secure credentials on the market, ranging from smart cards to mobile wallets to FIDO2 credentials. That means they’re compatible with a diverse range of systems, making them easily customizable for different customers, with no re-engineering needed. And thanks to rf IDEAS’ partnership with leading single-sign on software providers, such as Imprivata, our readers are ready to integrate into your customers’ existing systems immediately upon implementation.
3. Greater data security and compliance
Passwords aren’t enough to protect medical devices from hacks and data breaches. After all, an experienced attacker knows how to crack an eight-character password in only five minutes. Our embedded readers remove this vulnerability by letting employees access devices they’re authorized for using their employee badge.
Embedded readers also aid in compliance, as they're built with the latest regulatory guidance in mind, including HIPAA, EPCS, GDPR and FDORA. Through immediate and comprehensive documentation of user access, these solutions improve auditability and streamline regulatory compliance.
These advanced, interoperable security features give your end users confidence that their patients’ data will be protected, while also making your products more marketable. After all, devices that protect sensitive data not only reduce the risk of breaches but also protect brand reputation, which ultimately leads to more satisfied customers and repeat business.
Embedded Readers: The Next Step for Healthcare Cybersecurity
The quality of logical access readers you incorporate today will help you create devices that are secure, reliable and designed to stand the test of time. By embedding the right reader, you can ensure your devices meet the highest standards of security and functionality so they’re highly marketable and competitive for many years to come.
rf IDEAS’ WAVE ID® Embedded OEM readers offer a future-proof solution that addresses the security, compliance and efficiency concerns that modern healthcare organizations face.
Looking to integrate WAVE ID Embedded OEM readers into your medical product portfolio?
Learn more about our OEM solutions here.
