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 increasingly rely on consulting agreements, research grants, or educational events. They…   Read more»

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 information confidential. A patent grants the inventor…   Read more»

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, such as early-stage discussions before formal documentation is…   Read more»

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, but in a matrix organization, that authority becomes shared….   Read more»

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 weak matrix, authority between project managers and functional…   Read more»

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 matrix structures reduce departmental and…   Read more»

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»