Ethically speaking, one cannot skip over any regulations, regardless of what the situation might be, monetarily. The main aspect of the situation must be that the device follows all regulations and protocols as written.
In actuality, it might, at first, seem reasonable to cut a few corners and then cover them as time moves forward. However, with the amount of regulation done, companies might very well be caught, and as PM, the entire blame would fall on you.
Therefore, it is better to be realistic with overhead management and follow protocol rather than try to cut corners and be terrified of being caught at all moments.

Any unethical practices should be avoided from a design standpoint. However, if a project does find itself in a situation like you have outlined the reality is they may take some of the actions you have mentioned. In contemplating taking these actions, the decision makers would most likely weigh what they stand to lose by remaining ethical against the likelihood and the consequences if their unethical behavior leads to a serious issue. Companies should probably have contingency planning and funding for when projects get delayed.

In addition to what ak977 said, the main mission of medical device companies is to improve healthcare. Cutting corners just to increase profit or prevent the company from losing money is unethical and could result in people having issues with the company's products. Not only is this against the company's mission but it could also cost the company even more money in lawsuits in the future if something does go wrong. While budget and timing are extremely important, it is important that all regulations are always followed because the whole reason they were made are for quality control and to ensure safety of patients.

I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidance made the packaging requirements more stringent for blood glucose meters. The label of the products need to prominently display the their accuracy of their blood glucose results. The updated FDA Guidance affects all products that will be launched into the market post it's release. Fortunately it didn't require companies to update the labeling and packaging of product that is already in the market. To develop and update the artwork of the packaging for a medical device takes an incredible long time and a lot of money, especially for global products because things such as translations, graphical representations, registration numbers and addresses, country distribution list, which all need to be approved by each country individually. For products that will be launched in the market post the FDA Guidance will need to comply to the requirements, providing their patients awareness of the accuracy differences in the products that are commercially available.

To go back to amin-sadig's point, I am not sure about products that are in the middle of development, specifically in the middle of a clinical trial where the protocol has already been approved and initiated. I believe it should be the same, where if it hasn't launched yet the product needs to meet the regulation standards. Unfortunately at that point, the company will have to weight the project's product portfolio influence, priority, and return on investment to determine if the project will continue and meet the requirements or be terminated. Larger decisions such as these are approached to the product design committee by the project management office, where the description the project's status and a request for an increase in budget and an extension in schedule are presented. Then the committee will review the project's overall importance and decide to conduct the additional tests needed or cancel the project. And if the project is further along in the development process, I don't think a company would suggest ending the project since so much time and money had already been invested into it.

I don't believe any medical device should ever cut the corners just to make it into the market. The biggest advantage in becoming a competitor in the medical product industry is to aim to have the highest quality and performance. Referencing back to my experience, knowing that you need to represent accuracy in your labeling for a blood glucose meter, you wouldn't want to cut corners in the reliability tests when those results will have to be displayed on your product. Clinical trial data becomes public once completed. These results would be used by competitive marketing departments to compare and promote their own products compared to yours. You wouldn't want your product to be the least accurate one in the market, then you wouldn't be making any profit and it could potentially harm the company reputation. I think if there is the potential to make a statement of equivalency to save time and money when situations occur like this, that should be the line. Otherwise, the new tests should be done, and completed to the highest standards.

Ethically speaking, I do not believe any project manager should feel the need to work those under his wing to exhaustion. The overall goal and objectives for the project are set forth in the beginning and if you are working your employees to the brink of exhaustion then you as a project manager did not plan accordingly or ask for sufficient resources. As a project manager, he or she should have the best interest of those working on the project as well. If the team is able to achieve the original goals set forth, there should not be a pressing need to push the team to exhaustion to achieve other milestones that would be a nice to have. There are other ways in optimizing a process in order to achieve extra milestones within a project aside from the original goals such as delegating resources effectively.

So first of all, regulations are rarely released by surprise. When a government entity releases a new version of a regulation they generally give a company plenty of advance notice and time to comply. What this means for the project manager is that the upcoming release of new regulations should be discussed early in the project planning process. This should also be included in the project risk management process. Additionally all this information should be communicated to stakeholders. Having open and honest dicussions with the regulatory agencies is also helpful. There should absolutely be no unethical conduct to get around regulations. This is a great way for company executives to end up in jail.

This is a very interesting case to me. I honestly wouldn't know what to do. In my life though I have always found that honesty is a better policy. Releasing a product and banking on a placebo test is probably what is most often done but I would hope not to be done otherwise. I would ask for an extension, or make an appeal to the FDA hoping to come around at a later date. Cutting corners will usually get you caught and puts to many lives at risk. If you're looking for a job after either scenario, I think it would be better to say " I couldn't comply with new regulations in time" rather than "I cut corners and may have killed people".

I think that it is important that the project manager remains ethical while facing the pressure of a timeline with rapidly approaching deadlines. Any unethical behavior from a project manager could add a ton of risk to a device that may already be a high risk device. The added risk could result in potentially serious injury, or even death, if the product makes it out onto the market after corners were cut at some point during the project lifecycle.

I don’t think that a company can authorize any of the unethical examples you just suggested. If a new regulation was established, designing a placebo study to circumvent this regulation would not only be unethical but most likely illegal. The first option in this scenario would be to attempt to reevaluate the schedule and see if it is still possible to meet the original deadlines set. New tasks would need to be created and added to account for changes. Overtime may need to be offered to some employees in order to still complete all tasks by their deadlines. The next option would be to create the new tasks for this new regulation and then evaluate if the deadlines can be extended. The point here is that cuts made to the project or the process really should come as a last resort. Other measures should be taken first so that the quality of the product remains a priority.

As many have mentioned above, most company SOPs will not allow for any unethical activity to get around the FDA. And if a company decides to go against the policy, they will have to pay for the consequences. This is why it's always a good idea to overestimate rather than underestimate when it comes to project timelines. As PM, you should build in buffer zones in case something comes up and the project needs to be shifted accordingly. The policies that may apply when you first set out the project scope may not be exactly the same 1 month later so the scope needs to be mapped out in such a way that it can account for any changes that may occur.

When dealing with regulations you really can’t fake or placebo the project. If you get away with it, and the product gets released does not mean that you are now good for life. FDA audits can go back as far as they want and can reveal a fake test and then the company will face a huge blow back from it. Anyone involved in the falsified documents, even if not employed any more by the company, could face financial and legal repercussions. It could result in jail time or loss of licenses in the field. This “placebo” could ruin the lives and careers of anyone that is involved in the project. I believe that if financial issues is a concern than their might need to be cut backs on employment or other financial burdens as other luxurious expenditures. The day to day finances will have to reallocated to focus on just the project to guarantee the safety of the company and product line.

Anything that is unethical will end up causing problems in the end. I believe any medical device companies will try their best to avoid anything unethical, or they will eventually have to deal with the FDA. PM’s need to set boundaries and should oversee all work. Have meeting with the team and see how you can be more complaint. Come up with a contingency plan if the team will fall behind. Majority of employees will have SOPs to follow, so not following procedure will lead to dire consequences, so there are no cutting corners. A lot of money goes into these projects. Let’s say there was a major issue with the project that was overlooked. The company will lose more than just money. What I learned from working in the medical device industry, there is no cutting corners. We have to follow procedure, and be compliant.