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 assembled in one orientation, using uniquely shaped connectors, or applying clear color coding…   Read more»

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 carries some level of inherent risk, and the goal is…   Read more»

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, when the overall benefits of the device outweigh the potential harms,…   Read more»

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 relevant soft tissue structures and provided real-time force feedback through a…   Read more»

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 identifying the functional requirements that directly support the user need, then…   Read more»

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 mapping and tracking the entire design control process, and…   Read more»

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 raise concerns during regulatory evaluation….   Read more»

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 device without a genuine user need or large enough…   Read more»

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 correct device has been designed to meet user needs. Verification can…   Read more»

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 that patients’ rights are…   Read more»

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 compared between the placebo group and the active…   Read more»

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 trust between patients, physicians, and researchers as new medical innovations emerge. They protect…   Read more»

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 section or even create their own “stitches” with…   Read more»

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, with annual revenue reaching $33.72 billion in 2023…   Read more»

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 product’s lifecycle. I also enjoy collaborating with…   Read more»

I’ve honestly never considered looking into what type of company I was applying to until this week’s lectures. It’s been two years since I graduated with my bachelor’s degree, and I still haven’t landed my first engineering position, so I…   Read more»

I believe that most small businesses fail because of negative cash flow rather than a lack of profitability. However, this isn’t necessarily due to poor cash flow management. A company can appear profitable while still struggling financially, since revenue is…   Read more»

If I had to choose between a sole proprietorship and a partnership, I would choose a sole proprietorship. Partnerships can be risky because if one partner makes poor financial decisions or goes into debt, both parties are held liable. I…   Read more»

I think one of the biggest challenges a physician would face when trying to create their own medical device is a lack of time. The medical device design process is highly demanding, and obtaining FDA approval is far from quick…   Read more»

I agree with you that engineers should have a basic understanding of regulations and that the bulk of compliance work should be handled by regulatory specialists. Engineers should focus on ensuring that designs are innovative and technically sound while keeping…   Read more»