During risk management, a method to analyze risk is to calculate the probability of failure. Of course, it is kind of straightforward (still complicated) to do so when designing a product that has some sort of predecessors in the market. You could collect data based on those and assess the probability of malfunction, error etc.
What happens when you design a product that is original? How can someone assess the probability of failure in that case? Are those assessments accurate? How much accuracy is required at this stage?
When evaluating the risks for a novel product, it is best to look at as many similar products currently on the market and document their risks and see how they can apply to your product. Looking at the probability of failures for similar products can give a good idea of how your product might fail. While they might not be extremely accurate, it will give a solid foundation on what to expect.
For example, if a company wanted to release a type of hydrogel injection that senses high glucose levels and delivers the appropriate amount of insulin in response, it would be worth looking into other injections and their risks.
When creating an "original" product, a very important step is to analyze the market that it will become a part of. Having an idea of the potential consumer can help further assess the probability of failure and see what aspects would be more beneficial for marketing purposes and what to improve on. It is impossible to truly remove all probabilities of failure from any product as there can be many unforeseen circumstances and issues that will come up but having a good risk management plan will help minimize any damages that this causes. An assessment of the probability of failures is not going to be completely accurate but it will help create an idea of where the weak points in this product lie and what should be expected when the product hits the market. The highest amount of accuracy possible is desired for this stage as this will be the most crucial time for the product. Extensive efforts were most likely done in the marketing, planning, and production sides so being prepared for any possible failures and having a strategy that assesses these failures with a plan to combat it will only help the longevity of this product's lifetime.
I agree with srp98's opinion. In modern society, a lot of products have been released and are still being released. The case of creating a completely different new product are unlikely. Therefore, there would definitely be products on the market that have similar functions or purposes to the product people are trying to make. If they analyze the specification of the similar products, they would be able to accurately evaluate the failure potential of the proposed product.
@srp98 I agree with you about looking at other similar products to build foundation for your own product, however you cannot allow yourself to fully buy in to their methods, because it takes away from the uniqueness of your product. It is not the most ideal situation when all your values (for experimental data/failure rate and other numerical data) match up with other products. Use them as guidelines, but more so as a schematic of how yours should look or improve from those. Try to avoid the trap of getting the exact same results as another product!
As many others have suggested, it is a good start to look at similar products. Even if a true predicate device does not exist, risk strategies can be adopted from other products. The risk analysis process should also be standardized within the company. They should be able to apply risk management to any product, even original ones.
An example of risk analysis is an FMEA Feature Mode & Effects Analysis. In this analysis, each feature or process is assigned a value for Severity, Detection, and Occurence. This is use to determine how extensive a failure might be, how likely it is to be detected, and how often it may happen. By standardizing the values given, a new risk management strategy can be created for the new product
I agree with the above posts that suggest looking into the probability of failure for similar products on the market when designing a new product. As mentioned above it is also important to understand the target user. Understanding the user and how they would use the device would provide insight to how a device could potentially fail. Additionally, it would be beneficial for a company to conduct a human usability study to determine if the customer can effectively and safely use the new device. A survey with initial background questions could help provide insight as well to how the user might interact with the device. It would be helpful to take these responses into consideration when assessing the failure modes of the device. What are some ways the FDA or other regulatory agencies might assess probability of failure? How can a company determine whether or not they have created a strong Failure Mode and Effects Analysis document and evaluated all possible scenarios?
As Dr. Simon mentioned before one of the steps of marketing a new device is analyzing similar devices and being aware of what's out there in the market. As new as an item may seem there's always some other product or method that was referenced and understanding the miscalculations of those related ideas can minimize the margin of error for the device being proposed. Also being considerate of the needs of the audience the device is tailored to will avoid any failures that occur.
Designing a product that is original can be both exciting and challenging. It may involve new technology, new materials, or a new approach to solving a problem. In this case, assessing the probability of failure can be difficult, as there may be little or no data to draw upon. Before designing the product, conducting market research should assess the need for the product, identify potential competitors, and understand customer preferences. Also, once the product design is complete, create prototypes and test them with a group of potential customers. This can help to identify potential usability issues, customer preferences, and areas for improvement. It is important to note that these assessments may not be completely accurate, as the success of an original product is inherently uncertain. However, by conducting thorough research and analysis, and seeking expert advice, it is possible to gain a better understanding of the potential risks and challenges associated with the product. In terms of accuracy, it is important to aim for as much accuracy as possible at this stage, as it can help to inform decision-making and minimize potential risks. However, it is also important to remain open to the possibility of failure and to be prepared to adapt and make changes as necessary. By taking a measured approach and being willing to learn and adapt, the probability of success for an original product can be increased
I believe that any novel product needs to be analyzed for the probability of failure. Since the product is new, we have to consider testing similar products that contain similar specifications and functions. Also, we need to take a look at the product flaws such as the design, manufacturing, materials, and function of the product itself. The fact that the product is brand new, makes the risk management team strategize new insights on how the device could likely malfunction. So, we might also need to consider the audience the product is intended to as well.
During risk management, a method to analyze risk is to calculate the probability of failure. Of course, it is kind of straightforward (still complicated) to do so when designing a product that has some sort of predecessors in the market. You could collect data based on those and assess the probability of malfunction, error etc.
What happens when you design a product that is original? How can someone assess the probability of failure in that case? Are those assessments accurate? How much accuracy is required at this stage?
I find it hard to believe that most products are original. But even if they are, the methodology for making that product is most cases is not. I would assess the probability of failure by comparing products that use similar methodologies. There could be risk analysis done for those products that could apply here during those steps. For instance, 3D printing was a novel product two decades ago. But the process of building was relatively simple. You needed some motors, microcontrollers, and a method of heating and extruding the filament. The creation and controlling of the motor and microcontrollers has been around for decades. A project manager and their team could do risk management on how people used these components in the past even if they were for a different reason or part of a final product.
In regards to your 2nd question, I would generalize by saying these assessments wouldn't be accurate because they aren't the same product and until there is a long-term study, no accurate assessments can come from a novel new product. Furthermore, I believe accuracy is highly subjective, because it is dependent on the user's needs. A failure rate of 50% is ok if the customer thinks that fine.
As mentioned above, it would be ideal to try to compare the device to others on the market that may be different but have similar function or methodology. Dr. Simon mentioned in the first lecture of the semester that it is important to have clinical and market knowledge when creating a medical device. If there is a device that is created that is totally original wouldn't there have to be some clinical trials to ensure the safety of patients? Is it possible to use those clinical trials to help determine the probability of failure? Maybe it wouldn't be as simple as this but this is the ideology I have (total # of unsuccessful trials/total # of trials).
I have to do this often in my day to day at work. It is a difficult issue to handle, especially when I first started. Often, I've had my boss temper my wild ideas, but as time goes on and I see more and more examples of projects we've done; I'm beginning to understand what is feasible and what isn't. However, the coin does flip the other way; as I'm more familiar with the engineering principles behind the designs we make, I'm able to temper my bosses design proposals as well. It all relies on the knowledge you have available about the project at the moment you are quoting it. All customers expect some deviation from the initial design, and we always inform them of any changes that may occur as we test things.
Hello,
Assessing the probability of failure for an original product can be challenging because, as previously stated, there is no prior data to rely on. However, there are a few methods that can be used in lieu of comparative methods. One such approach is to use expert opinion from professionals in the field, who can provide judgment based on their knowledge and experience. This can include opinions on the likelihood of failure and the severity of those failures. This method can be subjective, and the accuracy of the assessments will depend on the expertise and experience of the individuals providing the opinions. Another approach is to use simulation and modeling techniques. This involves creating a mathematical or computer-based model of the product and then subjecting it to various tests to identify potential failure points. These simulations can help estimate the probability of failure and provide insights into the design choices that can help reduce the risk of failure. However, the accuracy of the simulations will depend on the quality of the model and the assumptions used in the analysis. Accuracy is always important in risk assessment, but it is particularly critical when designing an original product. This is because the consequences of failure can be severe, and the cost of addressing failures after the product is released can be high. It is important to balance the desire for accurate risk assessments with the need to move forward with the project. In some cases, it may be necessary to conduct further testing and analysis as the product is developed.
When designing a completely original product, assessing the probability of failure can be more challenging. In such cases, risk analysis should be done based on the expertise of the team members involved in the project. Brainstorming sessions and simulations can help to identify potential risks and their likelihood of occurrence.
Another approach is to use a structured method like Failure Modes and Effects Analysis (FMEA) that evaluates the potential failure modes and their consequences, allowing the team to take preventive actions before the product is released.
It is important to note that the accuracy of such assessments is limited by the available data and the complexity of the product. However, even though complete accuracy may not be possible, it is still important to make informed decisions based on the best available data. A reasonable level of accuracy is required to ensure that the risks are well understood and managed.
In conclusion, when designing an original product, assessing the probability of failure is a challenging but essential part of risk management. While the accuracy of such assessments may be limited, the use of structured methods like FMEA and the expertise of the project team can help to mitigate risks and ensure the product's success.
