Risk analysis is a vital component of life science product development. However, because FDA and other regulatory bodies aren’t specific about how to conduct risk activities that they deem appropriate, some organizations struggle in implementation. For teams dealing with this, there are a handful of ways to bolster your risk analysis.
It’s true that FDA doesn’t require specific risk analysis exercises and tools, but that doesn’t mean that applying only one is considered adequate by reviewers. Different risk activities offer different benefits; while FMEAs can help your teams identify failures in product design or manufacturing processes, use error analysis tackles the risks users can be exposed to while using your product. The right combination of risk tools can lead to more thorough risk analysis.
Many life science organizations treat risk analysis as a one-off activity. In reality, you need to take an iterative risk management approach. The controls and mitigations formulated as the result of risk analyses need to be fed back into your design activities and reevaluated for risk. This approach reduces the occurrence of hazards, hazardous situations, and harms to as low as possible.
Users and other stakeholders aren’t only exposed to hazards, hazardous situations, and harms when working directly with your life science product; there are a number of different exchanges throughout the life cycle that can expose people to risk. While these interactions cannot all be predicted and controlled, utilizing risk controls throughout the product life cycle can be effective.
There are so many myths and misconceptions around risk management, and they can have an adverse effect on your development activities when left unaddressed. Whether that means conducting risk analyses earlier in the process or tying risk activities back into your innovation work, working to apply a better-informed approach to risk management can be beneficial to your products and your organization.