In this week's project simulation, a marketing manager gave a product to another company to try before the product finished all the verification testing. The simulation states that you signed off on the license even though it was not finished, although you had apprehensions about doing so. Has anyone ever been put in a situation like the one presented, where a member of the team approved a product license before the actual product was finished? In reading some of the other blog posts, I saw that someone had to work and fix a product that had to be recalled. Although this is not the same thing, there is still a time-sensitive and stressful component to fixing the product. In biomedical manufacturing, because many of these products have the potential to cause grave problems to individuals if not properly tested, do you also find ethical problems with rushing a product to market or pre-approving a license before the testing of the product is complete?
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.