Quick Tip: Start with system safety requirements for your medical device
When analyzing safety risk, it helps to start with the system level requirements first.
A common practice in the medical device industry is to apply a bottom-up approach to risk analysis using a failure modes and effects analysis (FMEA) technique. Although, an FMEA is a useful technique for identifying and controlling potential failure modes, it is not effective at understanding system level hazards that may actually lead to harm.
It is important to realize that a medical device does not operate in isolation. It is a part of the bigger system that also includes the use environment. This is one reason why risk analysis requirements outlined in Clause 5 in ISO 14971:20191 start with identification of the intended use and reasonably foreseeable misuse. Risk practitioners should first consider the system level safety requirements before jumping into a device-specific failure analysis.
System safety is one of the engineering specialties embedded in the system engineering process. The primary objective of system safety is to influence the design of safety-critical systems with safety-related requirements early in the design and development process. It is time to start applying best practices in system safety from other more mature industries such as aviation and automotive.
Risk management in the medical device industry is currently an exercise in managing regulatory requirements. It is debatable if current practices are effective in fundamentally improving patient safety, accelerating innovation and reducing cost in a meaningful way. Our conservative and change-resistant culture does not facilitate a mindset of continuous improvement unless forced by a serious external event or FDA warning letters.
It is time to take a different approach. We can start by focusing on improving the requirements gathering process in the early phase of design and development. Applying best practices in system safety can help.
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ISO 14971:2019 is the International standard for application of risk management to medical devices.