I believe that tighter financial caps on physician gifts could improve compliance, but they do not guarantee that companies won’t adapt and find loopholes. With stricter limits, companies might increa...

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 between parties that requires them to keep shared info...

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 situations where verbal commitments are practical,...

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 automatically hold authority over their project team, b...

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 that operate under a weak matrix structure. In a wea...

In the past, I have worked in a functional organizational structure, but I think I would thrive in a matrix organization, specifically one that operates as a strong matrix. I like the fact that strong...

Poka-yoke is a Lean manufacturing principle focused on preventing mistakes by making errors either impossible or immediately detectable. Common examples include designing components that can only be a...

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 device’s intended function. Every medical device c...

Risk acceptance does not necessarily increase the probability that a risk will occur. Risks are typically accepted rather than mitigated when they cannot be further reduced through design changes, whe...

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

The best way to translate a qualitative user need into a quantitative and testable design specification is through thorough research of standards and peer-reviewed literature. You must begin by identi...

I believe that the four columns (design inputs, specifications, verification, and validation) provide enough information for a design matrix. The purpose of the matrix is to serve as a tool for mappin...

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 review is not sufficient for most devices and may ra...

I believe that design controls actually support innovation rather than hinder it, because they require clearly defined user needs and plan for each stage of the design process. Creating a medical devi...

I believe it is more common for verification and validation activities to remain separate processes. Verification ensures that a device has been designed correctly, while validation confirms that the ...