With week 7 we begin our second simulation and the project presented me with a question; how can you as a PM decide what factors to tweak during the test process? With the second simulation we are pre...

My time in the medical device field has been fairly limited, but as opposed to resource management the pitfall my team faced was more oriented on time restrictions. We were working on a longitudinal s...

As many others above illustrate in FS the start of one event is tied to the finish of another as with es's cutting wood example while with SF, the start of one event is tied to the progress of another...

This week we covered the concept of project planning and how to manage task start and finish times in relation to a goal. For any given project it may have subsets of designs or sections that need to ...

The idea of balancing between the PM's responisbility to provide a product to marktet and properly managing the compliance of the DHF is something I have considered as well. My initial thought is, pri...

An interesting question Jacob, I believe a degree covers you in a broader sense while a certificate is for those who are looking for a specific craft. A degree can span a wide array of disciplines; fo...

In the week 5 lecture Dr. Simon discusses the concept of the PDCA cycle again; he elaborates on this cycle saying that projects often have different phases of completion and that once a phase has been...

Project managers should align the needs of the business and customer satisfaction by ensuring that both have clear and measurable design inputs from the beginning of the project. This means firmly est...

When animal trials provide results that differ from the projects intended goal or business strategy, it is a PM's responsibility to reevaluate the project to fit the findings and not vice versa. Tampe...

In addition to marketing analysis and SWOT, tools like risk management, technology roadmapping, reimbursement strategy planning, and post-market surveillance can significantly influence a medical devi...

When design controls and project management are treated as separate systems, verification, validation, and design reviews can face the difficulties of miscommunication and ineffective progress rather ...

Throughout work on a given project, there are 9 points of design control that ultimately culminate into the Design History Form (DHF). The DHF is the end result of any project detailing the steps and ...

Design review and changes are going to be most prevalent in the check stage of the PDCA. The PDCA clearly outlines the steps and processes used to develop a system or device and gives a guideline for ...

510(k)s and PMAs differ primarily in the level of risk they assume as a project, and the amount of evidence needed to fulfill that risk. A 510(k) is typically used for Class II (and some Class I) devi...

The relationship between the FDA and Project Managers is collaborative but stringent on regulations and constraints. PMs ensure that all aspects of a projects development phases align with the constra...