When working on a project, and especially when leading a project, I prefer to have a smaller team. Smaller project teams make communication more effective and allow the project manager to more easily ...

For Class II and Class III medical devices long timelines and high costs are almost always inevitable. Because of this, one of the most important roles of a project manager is to maintain control over...

In addition to the challenges that would come up for filing the incorrect device classification, this may also signal to the FDA that the company submitting the classification does not completely unde...

I think the biggest challenge in managing medical device projects is balancing regulatory requirements with innovation. With medical device development, regulatory compliance needs to be implemented i...

To communicate effectively with members of a project team, the team leader or project manager should clearly set expectations regarding project goals, major deadlines, and team member roles and respon...

I have experienced working in a project team where team members have had interpersonal issues in the past. The first step to solve this is for the Project Manager to address the conflict in a private ...

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 ...