I would like to think that most companies do wight the benefits vs the risks in product development. I think they have to because, in the long run, they have to think about the probability or possibility of things going wrong. And if many things go wrong then they would lose out on a lot of money. So yes, while the reward is motivating, I do think they think in some way think of the livelihood or how it can have an impact on the consumer. However, I am sure there may be companies that want to make a quick, fast income, so they may not all be trustworthy and not take into account the risks that may be involved. In order to decipher, I would look into the background of the company and into any relevant reviews from different sources. You can learn a lot about a company based on reviews, its background, and its purpose. Also, it depends on if I want to be a consumer or an investor.

@vkeithley

Medical devices for human application are used for diagnostic and/or treatment. These devices are used for patient care and scientific purposes. Researchers making medical devices are faced with the task of making devices safe for human use so risk management - identifying, understanding, controlling, and prevent failures that can result is highly important. Risk Analysis plays a essential role in the development of medical devices design. Risk analysis is a tool for the evaluation of potential problems which could be encountered in connection with developing or taking a drug, or using a medical device.

A minority of biotechnology companies would look at the rewards compared to the risks because the potential to reap the benefits of the reward is better than the associated risk. The majority of companies bear more risks than rewards because biotechnology has to do with patents and the general population, which have a greater effect compared to something that is more niche, such as only users of social media. There is more potential for harm in the biotechnology industry, and this carries bigger rewards if certain events or scenarios go well, as in the case of Elizabeth Holmes, who was in the biotechnology sector, and the claim was that with a drop of blood we would be able to get lots of genetic information. Holmes then lied to the public about the device she was using, but she was reaping the rewards and didn't consider the risks associated with her actions. She eventually had to shut down due to the fradulent claims that she made. The method I use to determine what is more important is the taking of responsibility if a company takes an action and it is incorrect compared to years after an action when the company does not confess to their misdeeds. Most companies twist the truth about the products they make, but most companies want to do right by the patient and the public and offer apologies as well as recalls in order to show good faith and to keep this good public image of the company.

When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these factors I think are highly valued by companies releasing these kinds of products. However, I think companies definitely outweigh risks over reward purely due to what is at stake concerning biomedical devices. Some of these devices are going to directly interact with a patient, and although their purpose might be to improve quality of life, companies have to consider the large risk that if there is an error on their end, the risk can possibly lead to the loss of a life or serious damage to the patient's well-being. This not only leads to personal detriment (sense of failure from a non-working product and self-blame related to the patient's health), but also the detriment of the company. This can lead to other customers giving up on your product, losing brand loyalty/switching to a different company, or flat out sue for damages that may not even be caused by your device due to the negative reaction it had with someone else. Especially when it comes to Class II and Class III medical devices where the impact to someone's quality of life is so direct (as seen in the slides) risk grows exponentially, and the reward will have to be much greater (or at some equivalent level according to the designer) in order to confidently release a biomedical device.

When releasing a biomedical device, there is of course a lot of reward from both a monetary standpoint, as well as a personal wellness perspective as the feeling of helping others may be a reward in itself. Both of these factors I think are highly valued by companies releasing these kinds of products. However, I think companies definitely outweigh risks over reward purely due to what is at stake concerning biomedical devices. Some of these devices are going to directly interact with a patient, and although their purpose might be to improve quality of life, companies have to consider the large risk that if there is an error on their end, the risk can possibly lead to the loss of a life or serious damage to the patient's well-being. This not only leads to personal detriment (sense of failure from a non-working product and self-blame related to the patient's health), but also the detriment of the company. This can lead to other customers giving up on your product, losing brand loyalty/switching to a different company, or flat out sue for damages that may not even be caused by your device due to the negative reaction it had with someone else. Especially when it comes to Class II and Class III medical devices where the impact to someone's quality of life is so direct (as seen in the slides) risk grows exponentially, and the reward will have to be much greater (or at some equivalent level according to the designer) in order to confidently release a biomedical device.

Risk management happens throughout the lifecycle of the device, so it is absolutely looked at to determine the rewards and profits that the device could bring. However, it is often not the primary reason the project will continue or cease. Risks are inherent in every medical device, even something as simple as a tongue depressor has a choking hazard. The thing that drives the development of a project is the market for it. If surgeons or other clinicians would buy the medical device and it would make a profit, the project would be greenlit. The thing about medical devices is that surgeons are likely intimately aware of most of the potential risks associated with the device. This is why when managing risks, a consulting surgeon is often invited to review the risk management documents to ensure that it all makes sense. Therefore, if surgeons have stated that they would desire a medical device, they are likely aware of the risks that might be inherent of it. Overall, risk is simply a result of the medical device and how it needs to be classified and mitigated during the design process. It is not the end-all be-all of the project and is not the ultimate determinant unless the market for this device is not ensured. If surgeons have not stated that they would use this device, then risk plays a little more into whether a device should go into development. If there is a ridiculously high risk associated with a device for something with an alternate option, then the project would likely not move forward with the project.

Overall, the weight that risk management has in whether or not the device is worth the reward in the end depends on the situation. If there is a guaranteed market for the device, risk likely has little to no weight. If the device has safer alternatives, the project will likely not move forward.

It is important to understand both. In order for a device to be successful, the rewards have to be evident to appeal to the market. Although it can be tempting for companies to be solely focused on the rewards, it is important to understand that these devices have a direct impact on patient's health since they are medical devices. Therefore, it is more difficult for a medical device company to more focused on the rewards, in comparison to a company in another industry, as the risks can be very severe. A medical device company has to consider how every possible part of a device can go wrong and the effect that it may have on the patient. If a company neglects to strongly consider risks, that company will likely face lawsuits in the future and have a damaged reputation if patients are negatively affected by the product. There should be a balance between risk and reward within a medical device company in which the company is able to research and develop innovative ideas and products while monitoring different issues that can arise as well as ensuring that they are complying with regulatory standards. 

In biotechnology risk vs reward is a dangerous territory to consider. As other posts have suggested, its because our effects in the field directly impact someone's life, and in most cases it isn't just one. In other industries, the balance between these factors can vary among companies, influenced by corporate culture, leadership philosophy, industry norms, financial considerations, and the regulatory environment. Some companies, driven by a pursuit of groundbreaking innovation and financial success, may prioritize potential rewards, while others, adopting a more risk-averse approach, may emphasize rigorous risk management strategies. With our regulations I think it is foolish to speed run and pursue rewards, but that's not to say you can't. The key lies in finding a balanced approach that allows for informed decision-making and a nuanced understanding of the potential outcomes associated with project development.

From what I've learned so far, many biotech companies do prioritize potential rewards over risks, aiming for innovation and growth. However, some also conduct thorough risk assessments to balance these factors. They might use a mix of quantitative analysis and expert judgment to determine which outweighs the other in a project's context.

While it may seem that companies tend to outweigh reward more than risk (due to media headlines and such), I believe that most companies outweigh the risk more. First of all, liability is of utmost important in the biotechnology industry. If a company were to take a risk and get sued, they’d lose all funding and support. Second of all, most of these companies work with human subjects. Because of this, taking risks is much more complicated. No company wants to willingly put human lives at risks, even if there is a chance of a large reward. However, we sometimes hear of stories of this happening, so it seems like more companies outweigh risks.