There is most certainly an ethical component(or lack there of) when it comes to releasing medical devices or anything consumers could sustain harm from without proper testing. There is a reason why there are established statutes in place that allow for checks and balances to ensure products are safe and functional before they are released for public consumption. Not taking the proper care most assuredly makes that company/individual liable and ethically devoid.

In the medical device industry, there is a large push to be first-to-market and minimize project timelines in order to capture/increase market share, increase revenue, and reduce costs. Sometimes, businesses will push the ethical envelope in order to do this. In working for a large medical device company, I've seen projects being rushed on seemingly impossible timelines in order to satisfy management's objectives. From my perspective, this means overworked employees and corners being cut when possible. Ultimately, this may have detrimental consequences if mistakes were made along the way and is a responsibility of the company to bear if it does.

One thing I have heard - in defense of businesses and minimizing timelines - is that in medical devices, the longer it takes to get a product to market, the longer a patient won't be able to use that product which could potentially be life-saving. 

Personally, I don't agree with rushing timelines since disastrous mistakes could be made but I can understand the urgency of getting a product to market that can be used to save lives.

Does anyone have any thoughts on this?

Thanks,
Matt

While I understand companies wanting to rush timelines and get their products out to market and - as @mmd55 said above - especially in medical devices where a new device might be life or death for a patient, there needs to be some care taken when trying to reduce timelines. I would rather put out a well designed and high quality product that may be a few days late rather than putting out a device at risk but a few days ahead of schedule. It can be disastrous to put out a product too early and there are some huge issues with the product. I don't agree, but I do understand that companies are on a budget and losing days on a project means money lost.

There are definitely ethical aspects that come into play by rushing the release of a medical product to the public. By doing this, the company is neglecting the safety and well-being of the public and putting individuals' lives at risk. It is crucial that marketing managers make sure that their product is safe by conducting multiple tests before releasing it. There are thousands of products that were recalled due to insufficient testing, and many of these products posed life threatening risks to the consumers. Again, the public's safety and well-being should always be held paramount, therefore, project managers should avoid rushing the development of medical products (regardless if they are tight on time) to ensure the product's safety and optimal utility.   

I don't believe this week's simulation was an example of un-ethically rushing a product to market. The license agreement was a business agreement between the vendor and the client. The agreement gives a royalty to the vendor every time the client sells a product coated with HydroSurf. In this case, the license agreement was signed before internal and external verification was complete. They signed this agreement with the risk that the product launch might fail. If there is no way to pass the verification tests, the product would not have been brought to market. So it is not unethical to sign the agreement, it is just a huge business risk to both the vendor and client.

The most common ethical concern in the medical device and pharmaceutical industries is cutting corners in order to rush a product to the market. While many engineers and scientists want to properly conduct verification/validation testing and risk analysis, more profit-oriented managers and supervisors may pressure them to have the product market ready sooner than possible. This can result in certain safety measure being overlooked. This is why the FDA monitors class II and class III devices closely before they can be sold on the market. This also goes for drugs, whose clinical trials are also scrutinized by the FDA.

@jal58 I disagree partially with your comment that this week's simulation was not an example of un-ethically rushing a product to market. You mentioned "If there is no way to pass the verification tests, the product would not have been brought to market". What if ExtReam also sent the product to testing to Toxson and what if the result was "false negative"? Management's decision in this case to show sample to client without finishing the project, and signing license without completing verification shows they cared for getting the project move faster and not keeping in mind the unethical aspect that this could actually be toxic. But again, this is not completely management's fault since they were probably told about the passing result at Toxson. But they should have been careful with communicating information with client before communicating with internal members (chemists/Engineers). This makes their decision somewhat unethical. 

It causes a big ethical dilemma when trying to decide between getting a product out on the market to help patients as soon as possible and delaying the release for extra testing. It is best ethically to take the time and money to complete all testing and validation until there are no risks involved, but budgets and timelines do not always allow for this. 

There's a difference between a company that rushes a product to market while deliberately concealing known safety concerns versus one that makes a calculated, transparent decision to accelerate timelines while openly acknowledging the remaining uncertainties to all stakeholders involved. As pointed out, signing a license agreement before verification is complete isn't unethical if both parties understand and accept the risk. What concerns me more, though, is the internal culture that was described, where employees feel overworked and pressured to cut corners quietly rather than raise red flags through proper channels. In those environments, the problem isn't just one manager's decision; it's a systemic failure where people who see the problems feel they can't speak up without professional consequences. I think biomedical engineering programs and companies alike need to invest more heavily in building ethical reporting cultures, not just regulatory compliance frameworks, because rules alone don't catch everything that happens behind closed doors. 

@mmd55 agreed, I also don't agree with rushing timelines. You make a good point on things taking longer preventing a patient from receiving that potentially lifesaving medical device, however, I would argue that taking a longer time to ensure things work outweighs that. I've worked at a company where one of the blades of a medical device broke off in a patient during the procedure. It was a major finding. This boiled down to that product line having been rushed both by management and the customer.

In some instances, rushing can work though. For example, the covid vaccine. Was RUSHED to completion. As people were actively dying in the hundreds from the illness. I would say that this was maybe a unique case however because the vaccine was able to be rushed due to the pooled shared knowledge of so many professionals working on it at once. In short, that Marketing Manager SHOULD NOT have given that Hydrosurf sample out. But it is the unfortunate reality that happens in the real world. The best you can do is test as thoroughly as you can in the new time constraint you have to ensure safety and efficacy. And report if otherwise.  

In my opinion, giving a product its license before verifying it is unethical because it will directly impact the safety of patients in biomedical manufacturing. Regardless of any marketing or stakeholder pressure, speeding or skipping over the verification testing puts the entire reason for going through the development and regulatory process at risk. The purpose of verification testing is to prove a product meets the required safety and performance standards; if a product receives an approved license without verification testing data, then the risk of something bad happening increases. Some might say that there is a potential benefit to getting products to patients sooner by speeding up timelines, but the long-term consequences (such as recalls, regulatory fines, or harm to patients) outweigh the short-term benefits. For that reason, I believe it is the responsibility of the project manager and team to stand firm against any premature approvals, even when faced with pressure to do otherwise.

Though I have not experienced a case of pre-approval before testing was finished, I have seen examples of many instances where there is a deadline imposed on work and there Is an increase of pressure with this type of deadline being put onto employees, which increases the chances of them making a mistake or not performing at their highest level. Strong communication and ethical decision-making should always be at the forefront when making decisions regarding an instance where you would be willing to sacrifice safety for timely completion of a project. Are there any reasons why you would think that an instance exists where pre-approval may be acceptable when the risks associated with an early approval were made known?

As many have said, rushing a medical device product means cutting corners, which can have severe ethical and health concerns down the line. There will be an understandable push to rush to be first to market, but from an engineering standpoint, if your company is first to market then ends up having widespread product recalls, it would severely negatively impact your company's reputation and potentially damage its survivability if the company was a startup. The FDA has strict regulations for good reason, and if you seek to market the device internationally, there are other regulatory agencies you must work with that may have their own requirements. It is the responsibility of a medical device company to do their best to ensure their product is not harming users. Ethically, I don't believe increased profit supercedes that responsibility. Even if you were to look at it through a strictly financial lens, that increased risk that comes from cutting corners may lead to damage to your company's reputation, increased costs in terms of lawsuit settlements or having to redesign/test the product, and the cost of recalling a product. 

I honestly found this situation uncomfortable because I can see how easy it is to feel pressured into signing off on something before it is fully ready, especially when deadlines and management expectations are involved. I haven’t personally approved a product license before testing was complete, but I have been in situations where I felt rushed to move forward despite having doubts, and that hesitation always sticks with me. In biomedical manufacturing, I do think there are serious ethical concerns with rushing a product to market or pre-approving a license because these products directly affect people’s health and safety, and skipping proper verification could lead to harm or recalls. Even if the goal is to stay competitive, patient safety should always come first, and moving forward without full validation feels like an unnecessary risk. Overall, I think situations like this come down to integrity and responsibility, and even if there is pressure, it is important to speak up or at least document concerns to protect both the company and the people who rely on the product.

I luckily have never had the experience of someone involved on my project signing off on a product that has yet have verification tests completed, however as others have said this is a very concerning situation. This is not only an ethical issue, but also a massive regulatory red flag. The simulation does not cover this aspect, but an FDA audit would kill this project and those involved if they discovered they did not complete verification or validation before licensing. I understand the thought process behind the move to meet deadlines and prepare for later stages of the project, but this is a major issue. Its hard to believe that these situations occur in real life, but I suppose the simulation would not cover it if it did not occur. I think in a real life scenario, it would be important to report this issue up to higher ups within the company and "nip it in the bud" before it snowballed into a larger and more difficult scenario to recover from as it did in the simulation. Another thing to note is the repercussions of this premature signing far outweigh the potential benefits. This could lead to FDA audits, litigation, recalls, and career damage that may not be recoverable. While their may be some potential for short term success, the long term risks far outweigh any benefits. In short, these situations are never worth it and rushing products to market is not a sustainable nor ethical practice in the medical device industry.