In my opinion, risk management is especially important during the planning phases of your device. As you plan on the design, the materials and the application, I feel as if it is extremely important to analyze and weight the risks that the device could cause. If it going to be implanted inside of the body, you have to think of a way to either make sure that the material you are using is biocompatible or that you are able to prove protection against a foreign body immune response such as giving medication to the patient. Also, it is easy to think of some generic risks that could occur while building your device and what it could be the possible issues that could arise. I also think that after a prototype of the device is created, an analysis of the device to see if there are any unplanned risks that weren't thought of in the beginning process is a good way to try and mitigate them before the pre-clinical and clinical trials. I definitely think it is better to try and reduce the risks in the beginning but risk management is very important throughout the entire process. 

I think risk management is the most critical when designing the product, because as discussed in lecture, the most effective way to manage risk is to design it out. Designing the risk out of the device is much more preferable than implementing safeguards or warnings because it eliminates the possibility of the hazard occurring in the first place; safeguards or warnings can only decrease its severity or probability. But if the product's risks were not comprehensively analyzed during the design phase, you might already be at a much later phase of the project, and it is no longer feasible to overhaul the design. Of course, risk management is necessary throughout the entirety of the product's life cycle, but in my opinion risk management during the design phase is the most important for this reason.

I think that an argument can be made that the manufacturing process requires the most attention out of the three listed stages. Risk management during the product, the product designing, and the manufacturing process all entail identifying potential risks and planning risk management. However, during the manufacturing process, consideration needs to be given to the potential risks associated with ongoing day to day activities. Risks can arise at any moment during this stage of the product cycle, therefore, it is extremely important to have a plan in place to identify these risks and understand the probability of the risks arising and their potential impacts. The ability to mitigate risks during the manufacturing process and handle risk that have arisen are extremely crucial to continue a product. At this stage of the product life cycle it is easy to face a risk and drop a project, hence its importance of risk management. Overall, risk management has its importance at each stage of the product's life cycle and should be handled attentively.

Risk management is definitely most important during the premarket stage. By avoiding risks at this point, the company saves a huge amount of time and money. All forms of optimization are important to cover as soon as possible but risk management is no exception. In this stage, the design is probably the most important, as others in this thread have argued. Ultimately, it is important to minimize risk as early as possible to have time and money and most importantly to save lives.

As others have mentioned, I also believe that risk management is the most important during the planning phase. It is because in this phase, the developer should think of all possible interactions that their product may have with the patient, whether that be in a material sense or in a mechanically interactive way. Understandably so, you also can't plan for everything so there may be risks that come up later which would then be the next most important risk to address. Still, I generally think that in the planning is when risk management is most important. I think of it this way; it is better to plan for a risk and try to prevent it/minimize it from happening and maybe deal with one risk that needs to fixed post market than developing a product, sending it out to the market, and then doing insane damage control when multiple risks you didn't account for are dangerous.

I agree with what @sm2744 stated that the planning phase should be under the most scrutiny when it comes to risk management. When working on a medical device it is extremely crucial that the user is not harmed in any aspect when using the device so meticulous planning would help reduce the chances of risks that could occur further down the project life cycle. The planning phase is responsible for outlining how the entire project will be run in terms of manufacturing, testing, and marketing. In particular SOPs should be stringently revised and checked to make sure that no errors occur when any experiments or testing is conducted. In my experience, there was a time where my research lab had a typo in the SOP and all of our results from the conducted experiment were inconclusive due to that measurement typo. Thankfully it was an IHC stain and not a an animal study, however, when conducting clinical trials an error of this degree could result in unethical practices and several operating violations. Although the planning phase cannot predict what will occur in the future of the product with proper risk assessment and evaluation it can help mitigate any risks that may occur in the future.

I think the most important risk management stage of the project would be during the manufacturing stage because of the different risks that were not accounted for in the product design of the project. In the planning stage of the project, most of it is planned and predicted based on how certain obstacles can be mitigated and solved, but during manufacturing, different variables can knock the planning down. If the product during the planning stage had a lower viscosity and when it was time to manufacture, it had a higher viscosity, this would pose an issue, such as being higher than predicted, which could jam the equipment and larger equipment that can handle these types of viscosities. Even if we solved the viscosity issue, would this derail the other plans down the road where the product would need lower viscosity in order to coat this other component, and due to the manufacturing process, this would affect other pieces of the project? The post-market and pre-market have their own risk issues, but during the product relationship, the more abundant issues are caused by the planning not taking every variable into account or other hindrances. In the post-market, issues are brought to light, which can be resolved sometimes easily, but the planning and product realization have already mitigated most of the risk. The product realization or manufacturing is where risk management is important because this sets the device for success.

Risk management should be a team effort and should thus be equally as important across all functional areas. Although Quality may be the department that actually develops the documentation pertaining to risk management, such as an FMEA, every department should consider different potential risks to the device. Within research and development, a scientist or engineer may find a potential flaw with the project when it undergoes a particular test. In that case, that is a potential risk that should be identified and raised to the rest of the project team. The same can be the case in manufacturing in which an engineer finds a flaw in the manufacturing process of a specific part in the device. That is also another risk identified through daily work activities. If the manufacturing and R&D engineers do not report those issues, those risks may not be considered in the documentation and issues could arise after the device reaches the market. Therefore, it is essential for the success of the project that each member tries to look for potential risks and discuss them with the rest of the team. 

Though risk management is a continuous process and must be done throughout the entirety of a product's lifecycle, I think it is undoubtedly most important in the early stages. Evaluating risk during the planning phase allows a project team to adjust the design of the device to create the best risk effect analysis. Dr. Simon gave a good example of this during the lecture, saying that early risk management for the design of a fan can include a cage around it to keep people from cutting their fingers on the blade. If the risk analysis is done too late, the cage may not be able to be added to the design and the fan would have a higher chance of cutting people's fingers. In this case, risk management is still important because the fan could have posted signs alerting the user of the risk of cutting their finger, but this is not as effective as the cage. Thus, risk management is needed for every stage of the product lifecycle, but it can create the most effective results in the planning and design phases. 

Just as many have said above, it is clear that risk management is a crucial process conducted throughout each stage and area of the project, but I would argue that the product design stage requires the most attention and awareness. To start, decisions made during this phase of the project have a downstream impact, meaning that they can directly influence the manufacturing process, regulatory compliance, and user safety. By assessing potential risks early, the product designers have an opportunity to identify and mitigate issues that might lead to product malfunctions or user dissatisfaction early on. On the other hand, if errors occur during any of the subsequent phases, more severe issues can be created that are costly and difficult to mitigate later on. Furthermore, identifying and mitigating risk during the design phase can save cost and time that would be wasted during adjustments later on in the project. For example, if a design flaw that hinders user safety is caught early on, it will be far less disruptive and costly than discovering the flaw during the manufacturing stage or, worse, post-market release. Lastly, for medical device industries that are required to follow strict regulatory standards, the product design phase is a pivotal phase for establishing quality and regulatory requirements form the start. Heightened awareness to potential risks during this phase helps ensure that the product will meet these standards, reducing the likelihood of regulatory setbacks and costly non-compliance issues. That being said, risk management in the manufacturing stage is also critical, when it comes to controlling quality and consistency, but focusing on the product design stage often has the greatest ripple effect across all other areas.