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. 

A company that comes to mind would be Theranos; the health technology company that claimed to have developed a revolutionary blood-testing device. The company allegedly manipulated and hid failed verification and validation results to make their technology appear more reliable and accurate than it really was. Instead of documenting and addressing design failures properly, they reported only successful outcomes to investors and regulators, skipping the crucial verification steps that would have revealed the device’s inaccuracies. This not only violated engineering and testing ethics but also put patient health at risk, as many received false medical results. Eventually, the deception was exposed, leading to the company’s collapse and legal consequences for its executives. This case highlights why honesty and transparency in verification documentation are essential, especially when lives are impacted by the technology being developed. In my opinion, maintaining honesty and integrity in the design verification process is non-negotiable, especially when human health is at stake.

I am not aware of any companies that encourage their employees not to record unsuccessful instances associated with the medical device in the verification report. If a company does do this, when they submit the Design Verification File, which is an important part of the Design History File, to the FDA for approval, they may not get approval from the FDA due to suspicion that there were no problems with the medical device recorded in the DHF. One issue of ethics is that management might coerce employees into not recording the unsuccessful aspects associated with the medical device by threatening to fire them. Another issue of ethics is that the company is lying to the FDA about there not being any unsuccessful aspects that occurred when designing, manufacturing, and testing the device.

I agree that catching issues before verification officially starts is the best case, because once the verification protocol and reports are underway, going back to revise the DID or DSD can slow everything down. But I personally don’t think companies should ignore or skip documenting failed attempts just to save time. That would go against ethical design controls and could put users at risk later. Even if it feels inconvenient, every revision and unsuccessful outcome needs to be recorded because transparency is what keeps the final medical product safe and trustworthy.

In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Although this is also not the correct way of doing things, especially when it comes to something like GMP or just traceability regulations with the FDA, it does occur. When someone intentionally leaves out or does not document revisions done to processes, procedures, etc., this is a clear ethical violation. 

I have personal experience relating to this, not necessarily about someone who intentionally left something out, but the FDA itself. In my previous internship, the FDA had came in the last week of my internship (2 days before it ended). In this, they went through and asked for documents from throughout the past 7 years, and one of the types of documents they requested among many was any CAPAs that occurred. These needed to be, by regulations, written down and documented. Although it was a pharma company and the procedure is a bit different in terms of the "design controls and process," it was important that any records we had where there was an error or something was changed was documented correctly. Ethically, it is important, especially in this case because we are working with developing generic medications for peoples' everyday use.

In the device sense, it is crucial that any revisions made to any design control documents are clear and recorded properly to ensure that there is traceability, or else changes could have been made but might not have been documented properly and this is usually what we would see in an ethical violation.

Although I haven't personally witnessed businesses doing this, as I believe a majority of people haven't, I am aware that certain employees may be tempted to cut corners in order to save time by ignoring unsuccessful verification processes. Doing something like this has the potential to being extremely dangerous and unethical. Ignoring failures could endanger patients if its a medical device or cause major issues for the company like recalls or legal problems. Verification processes are in place to ensure that the design truly works and is safe. Although it may seem like a quick fix at the time, accurate documentation is important to maintaining the process' credibility and security. 

That’s a really good point about catching design issues early and I actually can relate. From my experience during my internship, I’ve seen how important proper documentation is, even though it can feel time consuming. I haven’t personally seen a company ignore failed verification attempts, but I’ve heard of situations where teams feel pressured to move fast and might not record every small revision to save time. I think skipping documentation, even if it seems like it speeds things up, can create serious problems later. It hurts traceability and accountability, and in the medical device field, that can directly impact patient safety. It also goes against the whole purpose of quality systems like ISO 13485, which are meant to ensure transparency and continuous improvement. Do you guys think the pressure to meet tight deadlines sometimes makes it harder for engineers to stay fully ethical during the verification phase?

When it comes to looking at companies who that neglect necessary steps to for the design process and other QA and QC process, I don't know of many that do cut the corners to get their products to get them out quicker. Most of the time these processes are behind the scenes and are typically done of the timeline and budgets aren't met as they are running out of time and money to get it done. I feel that even if this happens, there are so many protocol in place to limit the amount of this that acutally happens. This is why there companies have put in place verifications so that the public is not having adverse reactions to the product, as all will lead to is many lawsuits that are never good.