In my experience in the industry, I have found that it is relatively easy to bend to the pressure of being unethical about certain standards. Not meeting these standards means a lot of extra work for everyone involved. It can be tempting to stretch the truth or avoid admitting failures but there can be catastrophic repercussions of this type of thought. I do not think that many companies have much of a system in place to encourage proper ethics. The culture of the company would dictate this and far too often employees feel the pressure to produce results at all costs.

Design verification methods are extremely important since they allow for experimental and clinical procedures to be conducted safely and effectively surrounding product design mechanisms. The ethics surrounding these verification methods is just as important, as it is with any form of experimental processes in the STEM, or any, field. I do think that in this day-and-age, we see more techniques and procedures in place to help reduce or eliminate cutting corners during design verification, but I do believe it still occurs with more frequency than it should. This process is intended to make sure these devices are safe and effective for use by medical personnel or the public, and cutting corners could prove severe in consequence.

I don't know or hear of any company that does such things. It's illegal and unethical behavior for a company. The skipping and instead the data would be dangerous for the patient in the biomedical device development. I believe that is one of the reasons why the FDA regulations are slow and careful. It's not a good decision for a company considering the following cost of the lawsuit. The time and money saved by skipping are far from the cost of the following problem. It's a much better choice to cancel the project if the price of re-examing exceeds the profit.

I don't know of any companies that have specifically hid their failures but I know that the FDA is very strict when it comes to this. Negligence is typically not encouraged within the field but there are some people who definitely try to hide things that don't suit their device or medical process moving forward, which could put the consumers at risk. In my job, when there is a situation with a process that falls outside of the norm, an emergency CAPA (Corrective and Preventive Action) is created with the help of the client's engineers and management to create a way to continue processing while accommodating the issue. When the CAPA process is initiated, a NOE (Notification of Event) is also written and is sent to the client's company once the investigation is over and the root cause was discovered. All of the NOEs and CAPAS related to issues with the processes and instructions are expected to be included in the paperwork that will be filled with the FDA as long as it is related to a process failure or process issue that arose that caused a change to occur. I definitely feel like design verification and validation are extremely important so that the companies know that their process or medical device is safe for the patients that really need them.

At all costs, the medical gadget should ensure verification. Before being made available, every product must pass verification. Verifying the design helps to confirm that the product is used for the intended purpose. It's unethical and immoral to skip steps, especially when it comes to devices of class 2 and 3 where the actually interact with the patient body. By carrying out this procedure correctly, any other mistakes that can cause a setback might be exposed.

I assume that a company that encourages neglect of any issues that create more time, money, or effort would not be a very successful company, therefore, would not be much of a company for long. As a verification/ validation engineer there must be a code of ethics that one must operate by as they are extremely vital in ensuring the device was built properly and up to the standards of the initial design and more importantly the customer's standards. Ethical standards must be upheld even more so in the medical device industry as certain products can be life or death for their users. If verification standards are not met and neglected who is to say that when this device hits the market, recalls will cost even more time, money, and effort than fixing the mistake originally. It is understood that employees face a lot of pressure to meet deadlines and company standards, however efficient communication and proper team work throughout the project life cycle should overall help negate these stresses and tackle any verification/ validation issues at the root.

I don't know if there is a company that does this, but I don't think they will either. Because, no matter how little it is desired to give revisions within the company, after each document is produced, a number is given and recorded. If you want to fix a document without revision, this will be even more of a problem. If you realize your mistake and correct a previous document, you will need to correct another document that is related to it, and this will affect all documents. Therefore, no matter how few revisions are requested, it is imperative to give revisions to ensure the continuity of the work and to ensure that it is easy to follow. Therefore, I do not think that companies will do this.

Hi cem34,
It goes without saying that neglecting to record unsuccessful instances during design verification in the name of saving time is a serious ethical violation. This increases risk and reduces the reliability and safety of the final product. Recording all outcomes, including unsuccessful tests and revisions, is essential for regulatory compliance, quality assurance, and product safety. I don't know of any companies but choosing to ignore these steps may lead to hidden design flaws, increasing the risk of device failure or harm to users, and can damage the company’s reputation.