This course really helped me understand what actually occurs in the medical device world and what the work will be like day to day. I enjoyed seeing each step of the development process in a way that made sense. It…   Read more»

Conflicts in medical device consulting agreements are common because these contracts involve strict regulatory expectations, intellectual property concerns, and high financial stakes. To deal with these concerns, companies rely on structured conflict resolution methods like clear jurisdiction clauses, mandatory arbitration,…   Read more»

A written contract provides documented and clear evidence that can be utilized in court. An oral contract relies on additional proof which can be a lot harder to establish. If there is any possibility that the agreement might lead to…   Read more»

The best approach to this is to raise the concern directly with the project lead while staying calm. Stating the clear facts and not placing blame is the most important thing that can be done. Bringing up ways to fix…   Read more»

One of the best ways to avoid the two boss problem, in a matrix organization is to make expectations and priorities clear so that there are no misunderstandings. When the functional manager and the project manager set a shared hierarchy…   Read more»

Working in a matrix can be chaotic especially in medical device companies where QA, R&D, and regulatory all rely on each other but ofter pull in different directions. The structure itself isn’t the real issue, it’s how communication is dealt…   Read more»

I agree that avoidance is often the way that is preferred in manufacturing because preventing a risk before it happens is the most reliable way to protect both workers and product quality. When avoidance isn’t possible, mitigation is crucial through…   Read more»

To put a plan into action, I would focus on using tools and methods that help me stay organized about potential problems. I would start with a detailed risk register so I can track each risk, who its owned by,…   Read more»

This post brings up an important point about whether the use of FMEA has become too rigid for the reality of modern devices. FMEA is a useful starting tool but it usually fails to capture the unpredictable ways failure can…   Read more»

Rebuilding a design history file for a legacy combination product can be hard especially when the original documentation isn’t finished or does not exist. Since a lot of these products were made before modern design controls, the best method is…   Read more»

A contract manufacturer plays a important role in process validation by giving documented evidence that the manufacturing equipment, processes, and controls are capable of consistently producing products that meet specifications. A contract manufacturer is expected to give detailed process documentation,…   Read more»

Even though verification and validation may seem similar, they do serve different purposes. Verification is focused on confirming that the design meets the technical and regulatory requirements. Validation makes sure that the product meets the user’s needs and performs efficiently…   Read more»

The best way to translate a qualitative user need into a testable and quantitive design input is by breaking it down into measurable criteria. To maintain traceability, teams can utilize a design traceability matrix thank connects each user need to…   Read more»

I think that multiple design reviews should be held throughout the development process. Each stage of design can reveal different issues that might not be able to seen later. Having several reviews helps ensure that the risks are identified early…   Read more»

I think design controls can actually support innovation when they are utilized in the correct way. Although ISO 13485 and FDA 21 CFR 820 seem rigid, they help teams think through safety, user needs, and risks before going too far…   Read more»

Clinical studies are crucial in advancing medicine because they give the evidence necessary to determine whether new drugs and medical devices are effective and safe. One advantage is that they lead to discoveries that can saves lives which helps patients…   Read more»

The placebo effect can complicate clinical trials because it makes it harder to tell whether improvements in patients are because of the actual drug or the belief in the treatment. The psychological response can hide the effectiveness of a medication,…   Read more»

I think participants in pharmaceutical trials should receive compensation in some situations if it is ethical. The compensation should be based on the type of risk and time that the trial is. I think there should be a screening process…   Read more»

Participation in marketing is when brands invite customers to help shape their products. Crumbl cookies for example use changing their cookies once a week as marketing to their customers. When customers feel like their voices matter they are more likely…   Read more»

Personally, as a biomedical engineer, I would choose marketing after an engineering role. I think I would be able to use my background to understand customer needs and product design. Engineers are trained to solve problems which is why I…   Read more»