Why Cybersecurity is crucial in the Medical Device & SaMD Industry
Cybersecurity is new and uncharted territory for many industries, particularly for those working in the Healthcare and Life Science spaces. As more and more Software as a Medical Device (SaMD) has been adopted in the market, the threat to secure data and PHI has become a primary focal point for governing bodies like the FDA. Due to this changing landscape, new guidances have recently emerged to help companies developing SaMD solutions who seek to market their products.
Below you will learn how this new guidance draft can affect your product’s development and production processes as a SaMD manufacturer.
Exponential Growth in Cybersecurity
The digital revolution that resulted in the IoT, IoMT, and Software as Medical Device ( SaMD) has given us a world full of connected devices. Unfortunately, this also comes with potential security threats like cyberattacks on equipment used by hospitals or for healthcare in general. Because of the dangers that compromised medical devices pose to sensitive data like Personal Health Information (PHI), the FDA has drafted guidance discussing the potential measures companies can take to protect their SaMD cybersecurity threats.
Cyberattacks against healthcare organizations are rising, with medical devices becoming increasingly popular targets. These attacks not only result in data breaches but also increased delivery costs for your organization from potential lawsuits.
A quality team that understands the cybersecurity landscape can help you better assess how these new measures will affect your organization. Sierra Labs has worked with multiple SaMD organizations developing software solutions for this industry. Regulatory roadmaps don’t have to be complicated if you start with a quality team that can guide you every step of the way.
New procedures for SaMD Development
Medical device manufacturers are required to be aware of potential cybersecurity threats. With new procedures, SaMD developers and manufacturers are expected to comply with more proactive measures.
The new guidance provides information about hardware and the potential security vulnerabilities that can be exploited through these systems and how you should respond if certain things go wrong with them - deploying countermeasures!
The Medical Device industry regulatory bodies would have to take responsibility for cybersecurity in a manner similar to how they ensure the safety of any regulated products. The manufacturer must produce evidence from their Quality Management System (QMS) and risk assessment frameworks, which show compliance with federal regulations on this topic. These controls ensure protection to devices that may be prone to hackers like any other software or hardware without adequate protection mechanisms against them!
For further clarification between Medical Device Software vs. Software as a Medical Device, check out Medical Device Software & SaMDs: A Crash Course!
The FDA recommends your organization have open lines of communication between each user regarding any potential risks. Better to stay proactive than reactive!
The guidance overall requires constant monitoring and appropriate corrective and preventive action from medical device manufacturers, alongside timely communication to medical device users to establish their awareness of cybersecurity threats.
New Guidance Difference from ISO 14971:2019
The FDA’s expectation for performing security risk management is a distinct process from performing safety risk management as described in ISO 14971:2019. In comparison to the ISO standard which establishes a framework for risk analysis, evaluation and control, the FDA guidance for cybersecurity focuses on exploitability, or the ability to exploit vulnerabilities embedded within a device and/or system.
Defining medical device risk while taking a sneak peek into ISO 14971:2019.
This new guidance places great emphasis on the process and issuance of a Software Bill of Materials (SBOM). To effectively manage their assets, users need a Software Bill of Materials - or SBOM. These set documents are formatted for them to understand the potential impact on devices (and connected systems). It also allows the deployment of countermeasures so that safety and effectiveness are maintained at all times.
Both ISO 14971 and the Cybersecurity Guidance for Medical Devices by the FDA recommend that manufacturers establish a security risk management process encompassing design controls, production validation, and corrective and preventive actions (CAPA) to ensure both safety and security risks are adequately addressed.
How does this affect your development?
It is imperative to capture cyber risks as they arise, and this can be done by documenting every stage of a company's cybersecurity efforts. Proper documentation in an eQMS will help you embed cybersecurity measures in each stage of the development process, including:
- Hardware Supply Chain
- Manufacturing
- Deployment
- Third-party software integrations
- Software updates
As medical device manufacturers, giving healthcare organizations who are adopting your systems full transparency on the vulnerabilities in your systems will be critical in preventing data breaches. Understanding the measures your team must take to be fully committed will only benefit your organization when it comes time to submit an application for FDA approval.
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Industry Experts in SaMD
Your organization can avoid costly and exhaustive issues with the implementation of well-written CAPAs at early stages, but it isn't the simplest task to do. We provide more than just an eQMS software solution but added assistance and guidance for SaMD compliance.
Sierra Labs has experience working with early-stage medical device companies who do not have a clear criteria outlined for their own quality processes. We can simplify this process for your team by helping you implement the necessary well-documented procedures for FDA audits and ISO standards.
Here at Sierra Labs, we help companies solidify their regulatory foundation by creating a unique and tailored quality program to meet organizational objectives with complete transparency and visibility across their entire operation.
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