Medical devices are among the most regulated manufactured systems in the world. This scrutiny is justified, as these devices include biomedical devices that interact with, and may be installed in, the human body. These devices may also contain sensitive patient information and are vulnerable to security risks because they often network and communicate with classified databases. Perhaps unsurprisingly, these devices are targeted by a wide range of unauthorized sources through various methods.
Most of the efforts to secure biomedical devices focus on post-development threats, such as the Cybersecurity Framework update released by the National Institute of Standards and Technology (NIST) in April 2018. Less, and probably insufficient, attention is placed on securing the actual development of the device, such as during medical device design transfer. Let’s explore these threats that may compromise the device and discuss how they can be reduced.
Threats to Medical Device Design Transfer
Medical devices are no longer relegated to hospitals and doctor’s offices. In fact, there is a tremendous push to optimize the internet in the medical industry that has led to the growing sector of portable or wearable medical devices. These systems are typically IoT devices that utilize the internet, usually WiFi, for data transfer. As such, they are subject to cybersecurity threats and, as a result, the PCBs they are comprised of must meet rigid design and development standards. Although preventing unauthorized access to medical information is tremendously important, it is not the only security threat that medical devices face.
Nearly all device design transfers to manufacturers today are performed over the internet, either through data uploads or email, which potentially exposes the data to unauthorized interception. This threat, along with various others that may occur during medical device design transfer, are listed below.
Types of Medical Device Design Transfer Threats
- Design file access
By acquiring or gaining access to the design file(s) for your medical device, a third party could not only duplicate the design and insert lower quality devices into the market but also determine the most vulnerable points for easy data interception.
- Counterfeit components
Using inferior or untested components in your medical devices can have grave consequences, including lowered performance.
- Device documentation access
The design documentation requirements for medical devices is quite extensive and may require many data exchanges between the developer and contract manufacturer (CM) during development. The sensitivity of the information, which may include device risk assessments and potentially require a high number of transfers, makes this an area for concern.
Medical Device Design Transfer Risk Reduction
The threats to medical device design transfer do not directly expose patient information; yet, if the design is compromised by incorrect components or unauthorized access to transfer protocols, this sensitive data could be at risk. A much greater threat is the unrestricted infiltration of the medical industry supply chain by inferior devices, which can lead to unpredictable performances and product failures. To minimize the likelihood of such drastic outcomes, you should follow guidelines developed to guard against unauthorized access during medical device design transfer, such as those listed below.
- Follow design transfer regulations
Food and Drug Administration (FDA) quality management system (QMS) requirements for medical device design transfer are given in part 30 of 21 CFR 820. These should be implemented as a key part of your quality control of medical device design and development.
- Verify component supply chain
One of the most important actions you can take is to verify that your design does not include any counterfeit components. This requires reviewing supplier registration before including their components in your design and ensuring that comparable replacements are available (if needed) during manufacturing.
- Follow document control regulations
Documentation control, including transfer for your design, is regulated by the FDA in part 40 of 21 CFR 820.
In addition to the regulations set forth in 21 CFR 820, ISO 13485 presents detailed QMS guidelines that are accepted by much of the international community.
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Although secure medical device design transfer does not receive the attention that post-development data transfers do, the consequences of a breach can be equally severe, if not more so. Therefore, design security should be a consideration throughout your medical device development.
And to help you get started on the best path, we at Tempo Automation furnish information for your DFM and enable you to easily view and download DRC files. If you’re an Altium user, you can simply add these files to your PCB design software.