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 ...

If I worked in clinical research, I would like to have the role of a monitor. Monitors have the role of ensuring clinical trials are run safely and ethically, that data is accurate and reliable, and t...

The placebo effect can make it difficult to tell whether improvements in patients are due to the actual drug or simply their belief that they are receiving treatment. To differentiate, results are com...

While many GCP guidelines involve extensive documentation, I believe they are absolutely necessary to protect patients participating in clinical trials. These standards are the foundation for building...

A clever example of participation that I have personally witnessed is how brands interact with people’s videos on TikTok. Many companies now reply to user generated social media content in the comment...

Novo Nordisk has experienced remarkable growth in recent years, due to the success of its drugs Ozempic and Wegovy. The company’s market value and revenue increased significantly in both 2023 and 2024...

I believe my skillset would be best suited for product management. I am highly organized and skilled at managing multiple tasks and priorities at once, which are both important traits for overseeing a...