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.
1. Use multiple risk tools
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.
2. Leverage rapid prototyping
Throughout development, rapid prototyping can be a valuable tool for risk management. It can help you evaluate preliminary hazards in typical use environments, test the device-user interface for error, and identify potential design risks. You can also evaluate one or more subsystems at a time for functionality and study how the physical representation of your product requirements can impact safety and effectiveness.
3. Practice iterative risk management
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.
4. Identify modern risk factors
There are many modern risk factors for life science products, and understanding them is key to a more robust approach to mitigation and control. Whether related to cybersecurity, device mobility, automation, big data analytics, interconnectivity, or otherwise, these risk factors need serious attention throughout the product development process.
5. Look at the whole product life cycle
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.
6. Discard common risk management myths
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.
7. Preserve and reuse risk data when possible
Perhaps the most valuable thing you can do to bolster your risk management activities is setting up procedures for preservation of risk data when possible. Apart from ensuring the data is available for premarket submission or any postmarket regulatory interaction, it’s accessible for reuse in future projects. Whether that means an updated version of a current product or advancement of a new one with a similar risk profile, being able to recycle appropriate risk analysis data can save time and resources while maintaining a higher level of fidelity in your risk activities.
