When a technical or regulatory problem arises in medical device development, how should project managers weigh the importance of deadlines for a project’s completion against patient safety? While some industries may put pressure on project managers to continue working to meet deadlines, ignoring an issue with safety or compliance could lead to even greater risk for patients and the organization involved.
How can a project manager determine whether the issue at hand requires a temporary delay, a change in the work plan, or reevaluation of the entire project? Which types of professionals, such as engineers, quality assurance experts, regulatory affairs people, or clinical specialists, should be involved in this decision? Is meeting a deadline sufficient justification for tolerating such risks in a medical device project?
The timetable is only one aspect of the project‚ and a project which is delivered on time may not be ideal․ And an open issue in the compliance or safety world can be a much more serious problem later on in the patient's life․The harder question is whether the problem is serious enough to stop the project entirely‚ or whether the team could find a workaround․ This is a decision that should not rest solely with the project manager․ It also allows engineers to consider the technical complexity and representatives from quality‚ regulatory and clinical to consider the risks․Simultaneously‚ but it would be impractical if not impossible to delay the project every time a hitch is encountered‚ and so the severity of problems must be recognized; in this fashion‚ the delay is more easily justified than acting on an unresolved risk‚ which could threaten patient safety․
When a technical or regulatory problem arises in medical device development, how should project managers weigh the importance of deadlines for a project’s completion against patient safety? While some industries may put pressure on project managers to continue working to meet deadlines, ignoring an issue with safety or compliance could lead to even greater risk for patients and the organization involved.
From a moral perspective most would argue there are few, if any, situations where a project manager should prioritize deadlines over a patient safety. Failing to meet internal metrics and scheduling milestones may certainly have negative consequences, but usually those fail to compare in magnitude and/or breadth a potentially unsafe medical device could cause to patients. An exception may be the development of a new device whose benefit is so large that a delay of release would incur more harm to patients than the potential defect.
However, you could also make a financial argument that prioritizing deadlines over patient safety is an irresponsible business decision. The consequences of a defective medical device that risks patient safety could potentially be immense. These could include lawsuits over knowingly failing to meet regulations, expensive recalls, and potential backlash from customers and stakeholders. Though this tradeoff may look different project to project depending on class of device, company, etc., I would argue more times than not the correct business decision would be to risk missing the deadline and accepting the consequences that come with that decision.
How can a project manager determine whether the issue at hand requires a temporary delay, a change in the work plan, or reevaluation of the entire project? Which types of professionals, such as engineers, quality assurance experts, regulatory affairs people, or clinical specialists, should be involved in this decision? Is meeting a deadline sufficient justification for tolerating such risks in a medical device project?
As mentioned in a previous reply, this is not a decision the project manager should make in a vacuum. Customers and executives should be included, as they are the ones who in the end are most exposed to risk by the decision being made. Additionally, engineers in conjunction with quality/regulatory personnel should be included since they are the ones most intimate with the product, how to rectify defects, and how to be compliant with applicable regulations
Working in pharmaceutical manufacturing has made me look at this question a little differently. I agree that patient safety should come before meeting a deadline, but I also don't think the decision should simply be between “keep going” or “stop the entire project.” When an issue comes up, I think the first step should be understanding the severity of the risk and then involving the right people to determine what actually needs to change. Sometimes the issue may only affect one part of the project, while other work can safely continue.
This also made me think about the change control process discussed in the lecture. A change shouldn't just be made quickly because there is pressure to meet a deadline. It needs to be evaluated, approved, implemented, and then verified. In a regulated environment, I think following that process is actually part of protecting the patient, even if it causes a delay. At the same time, unnecessary delays can have consequences too, especially when patients are waiting for a treatment or device. How do you think a project team should determine when a safety concern is serious enough to stop the entire project versus only pausing the affected part of it?
Now that I am months away from joining the industry, I think of these situations since there is a possibility it can occur. Meeting a deadline is never sufficient justification for tolerating safety or regulatory risks. Harming customers or patients and violating FDA regulations cost vastly more time and money than any temporary delay.
In a different course I learned that when such delays do arise due to technical or regulatory issues, a project manager should consult with the risk management file, which in medical device projects is a way to prove that product safety hazards have been systematically identified, evaluated, and controlled. If the issue cannot be controlled or the probability of harming a patient increases, then the project manager must force a delay.
Another important action the project manager must take when an issue arrises, is to assemble members from each department to tackle the issue at hand and determine any changes that must be made. The project manager should also have thresholds that helps them decide whether the issue can be fixed or the entire project needs t be reevaluated.
A project manager is to balance the project timeline based on the projects needs and issues. The patients safety is always the first concern as there are many blocks if the problem is not solved. The main one is the FDA as they review the medical device and can tell the company any issues they see and they will tell the company to fix the issue. Even within the medical device company, there is always a CAPA team that helps "solve" any complaints that the company may receive when the medical device goes on the market. There are many steps that a medical device has to go through before hitting the market and must pass each step. The best way is to make sure it is safe and effective because it makes it more profitable for the company to fix issues earlier on.
@ahmed-elmonier I agree with your point that a safety concern does not always mean the entire project needs to stop because a safety concern does not necessarily affect every part of the project. I believe that the project manager should not deal with that issue alone but involve everyone in the project to evaluate the severity and potential impact of the issue because each person in a project has a different role so they may have a different perspective on the issue. The issue may range from product quality to affecting a patient's safety. To answer your question, I believe if the issue only affects a single part of the project then pausing the affected part of it while allowing the other safe parts to continue would be suitable to reduce unnecessary delays. However, if the issue could affect the overall safety or effectiveness of the product, then stopping the project would be the more responsible and reasonable decision. I also agree that following the change control process is important because it ensures that changes are properly reviewed and verified rather than being made under pressure.