I believe that tighter financial caps on physician gifts could improve compliance, but they do not guarantee that companies won’t adapt and find looph...

An NDA is not a substitute for a patent, although both play important roles in protecting a company’s intellectual property. An NDA is a contract betw...

I don’t believe verbal agreements should be common in the medical device industry, and in most cases, they should be avoided. While there may be some ...

I think that it would be more difficult to work as a project manager in a matrix organization. In a project-based organization, project managers autom...

After speaking with some people who have reported to multiple bosses, it’s clear that the “two-boss problem” is difficult to avoid in organizations th...

In the past, I have worked in a functional organizational structure, but I think I would thrive in a matrix organization, specifically one that operat...

Poka-yoke is a Lean manufacturing principle focused on preventing mistakes by making errors either impossible or immediately detectable. Common exampl...

I do not believe companies should strive for completely risk-free designs but rather work to reduce risk as much as possible without compromising the ...

Risk acceptance does not necessarily increase the probability that a risk will occur. Risks are typically accepted rather than mitigated when they can...

My senior project was a model of the upper extremity that trains physical therapy and medical students to perform ligament integrity tests and joint r...

The best way to translate a qualitative user need into a quantitative and testable design specification is through thorough research of standards and ...

I believe that the four columns (design inputs, specifications, verification, and validation) provide enough information for a design matrix. The purp...

I think that the number of design reviews should depend on the complexity of the device. Although the FDA requires only one formal review, a single re...

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each st...

I believe it is more common for verification and validation activities to remain separate processes. Verification ensures that a device has been desig...