I think the best answer definitely depends on the overall size of the project. In this case, I feel like a liaison assigned to FactoSet could work since the project is not as complex. This is just one person and…   Read more»

Medical device projects definitely should utilize cost estimation effectively and efficiently. A way to do that is investigating a project that was highly similar to the current project you are working on. Medical device projects deal with FDA regulation procedures…   Read more»

A Work Breakdown Structure (WBS) is definitely a useful tool in a project, especially when it comes to medical devices. Most of what I am about to say definitely depends on the size of the project since the complexities of…   Read more»

These certifications are definitely useful in building your resume and marketability. Employers will be more keen in hiring someone with more project management knowledge and experience. The Google PMP is a newer certificate available on a more broad scale to…   Read more»

Early start (ES) and early finish (EF) can be helpful in scheduling flexibility and resource planning. In terms of scheduling flexibility, ES helps the team know the earliest date the task can start and helps prepare for the task that…   Read more»

Gantt charts can be a useful tool in all stages of designing a medical device. Pros of using Gantt charts is that they identify which tasks have slack and which tasks are on the critical path. Tasks that have slack…   Read more»

Keeping all these details in mind, I think a balance of both perspectives can be valid depending on the product and the function of that product. Mimicking worst case scenarios helps combat Murphy’s law as much as possible. It is…   Read more»

Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is finding primary and back up options for the parts/materials they will be using for the…   Read more»

I think the previous post has made some excellent posts and definitely highlights the potential problems with this exemption program from the FDA. However, even with all of these points stated, I feel this is still a program that can…   Read more»

I agree that companies can utilize techniques to create a DDP that is both structured but flexible such as a Gantt chart. Gantt charts are great at keeping your team informed about the development progress. It also helps identify which…   Read more»

@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation…   Read more»