Risk analysis and moving forward with a project
In this week's lecture, we learned about risk analysis/evaluation and how a risk assessment is created for a project. A project team uses this risk assessment in order to tackle the risks of a project through avoidance, mitigation or acceptance, however we also learned that a risk assessment may even result in a project being cancelled if the risk is too high. What are some examples of high risks that may cause a team to rethink a project?
For me, safety is always the #1 priority of any project. If anything about the product is deemed too unsafe for a project and there are no ways to completely design out the safety risk or implement any safeguards, it would be too risky to continue on with the project.
Risk analysis may not even just pertain to the physical interactions with the desired patient. Will the product more marketable than others? Will the product cause some type of extreme aversion due to it's color scheme? These are exaggerations, but there a multitudes of factors that can nip a project in the bud. One that stands out most to me is profitability risk; will this product make enough money to warrant creating it? I would say that most projects end up dying this way. If you can't sell it to your own company, how can you expect to sell it to customers. In addition, non-profitability can shed light on the device/idea. Why isn't it going to make money? Once answered; this question may help solve the issues of the project that is DOA.
I would have to agree, I think safety is one of the biggest risks that could potentially cause a product to be cancelled in the medical device industry. The second leading reason for a project to be cancelled or re-evaluated due to high risk has to be cost. A mismanagement of project funds can lead to a project team realizing that their project cost is higher than the customer's budgeted funds. It can also be determined that a reduction of funds, to help mitigate the risk of exceeding the customer's budget, may result in creating further scope risks. Additionally, prior to a project starting, the risk management team can determine that the risk of the project not being completed with-in the customer's budget is too high. The team can then deem to cancel the project before even starting it. So far the risk of safety and cost are two of the most obvious risks that can cancel a project, I am curious to hear other high risks that can cause a project team to cancel the project.
I really admire the commitment to safety; it is an asset in an industry where misunderstandings of risk can have life altering consequences. One scenario I can think of is where a new risk for an existing similar product on the market. This will shift the probability, consequence, or both for the new or existing risk. If the recalculated risk exceeds the potential benefit, then I could see this scrapping the project.
This topic reminds me of the very depressing calculations some car manufacturers seem to have done in the past. Some companies are aware of problems in their device (in this case vehicles) so a hazard has been identified. The math they do determines that the probability of a hazardous situation and then the probability of harm from that hazardous situation is low enough that the product can be released anyway, even though the hazard could and will result in death. They determine that the payouts they will make to the families of those harmed or killed is less than they would lose if they scrapped the model of vehicle. I have not heard of this happening in medical devices, and I hope it is because there is a higher standard of ethics in the field.
I agree that safety should be the #1 think risk management and project teams should look into before pushing a product to market. If the medical device is not safe to use then there is no reason it should be going out to market and endangering people's lives. @ag2357 mentioned the effects of not properly looking into the risk of safety for cars. One example of risk management not looking in depth of a medical device would be when Allergen's textured breast implants often used in breast augmentation surgeries being recalled in 2019. After FDA analysis, it was found that the implants lead to an increased risk of cancer of the immune system --- six times more likely to be the cause than other textured implants in the market --- and the FDA ruled that they would likely cause serious, adverse health consequences, and potentially death. 246,381 of these devices were recalled. Risk analysis is necessary to not just determine the proper functioning of a product but also that is safe for use when put on the market. Especially with medical devices, it is important that risk management teams are thorough with their analysis of products because they directly impact the health and safety of the customers using them.
I agree with what @sandra-raju and other commenters had to say about how safety should be highly prioritized when judging a risk assessment in regards to cancelling a project or not. At the end of the day the mission for every company should be to create a product that would help their patients whether it be to cure their ailment or provide relief. If the product that is being created is dangerous towards the patient it is counterintuitive to be functioning in that manner as a company. Furthermore, it is morally irresponsible to be knowingly releasing a product that has the potential for harming its customers. Asides from safety I think that the environmental affects from creating a product should also be considered. Whenever a company creates a drug, there are several chemical processes that are conducted which results in waste that needs to be managed. If this is an aspect that is overlooked, the manufacturing of the product could result in harming nearby ecosystems that could result in severe environmental damage in the long run. For example, Merck was found dumping a hazardous waste into a river in Pennsylvania and this resulted in 1,000 fish in the river dying due to cyanide poisoning. This caused the ecosystem to diminish and suffer which affected the nearby businesses and homes. Although this event occurred due to human error, this risk should be accounted for in a risk assessment. If the production plant makes an error and the environmental is affected negatively to a degree that people die I believe a product should be cancelled, otherwise the location of manufacturing should be moved.