Avoidance is most easily incorporated during the product design phase. During the design phase the device is still conceptual, and hazards can be eliminated before they are built into the product. In addition, design changes at this stage are less…   Read more»

I agree that it is important to remain impartial when dealing with conflicts between team members. However, this becomes much more challenging when the project manager and a team member are the ones experiencing issues. I have experienced this while…   Read more»

Detailed planning should definitely take place before the planning phase of the project management process concludes. However, I think it’s important that the project management plan should not be viewed as a document that is finalized and instead be treated…   Read more»

Hi everyone!
My name is Sarah Gildea, and I am pursuing a graduate certificate in Biomedical Device Development at NJIT. I look forward to connecting with all of you!
Here is my LinkedIn: https://www.linkedin.com/in/sarah-gildea1/

While I do not have direct experience in the medical device industry, I have experience working at a local retail store whose structure closely resembled a matrix organization. As a supervisor and department head of the toy department, I reported…   Read more»

After completing the simulation, I do not believe changing the Design Specification Document (DSD) is necessary to resolve the failed verification test. When I asked if there is a minimum or maximum temperature the product must remain at, Dr. Simon…   Read more»

While I don’t have any formal industry experience, I do have experience following the design control process for my undergraduate capstone process. Over the course of one year, my team was developing a prototype of the arm that could train…   Read more»

I also have wondered why the design inputs and specifications are split into two documents. The Design Input Document falls under the planning phase of the PDCA cycle and focuses on user needs and intended use while the Design Specification…   Read more»

I agree that it is crucial to treat a DHF as a living document that is built throughout the project rather than assembled at the end. Waiting until the design is completed significantly increases the risk of missing documentation or…   Read more»

It is extremely important to have justified specifications for each design input when following design controls for medical devices. To determine specification, you would look at each design input individually and define a measurable value or range that meets that…   Read more»

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 monitor progress and ensure that everyone stays…   Read more»

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 the budget and timeline. One…   Read more»

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 understand the risk of the device or its intended…   Read more»

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 into every phase of the project, rather than treated as a final step. This…   Read more»

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 responsibilities at the start of the project. Everyone on a team…   Read more»

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 meeting and focus on…   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»