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; for example if you…   Read more»

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 establishin the project scope to reflect revenue goals, strategic…   Read more»

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. Tampering with the results of a study is…   Read more»

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 device’s product life cycle. These tools help anticipate any potential hazards, regulatory challenges, component obsolescence, or…   Read more»

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 than be planned and effective. This separation can lead to gaps in traceability, late…   Read more»

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 any who are…   Read more»

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) devices and requires…   Read more»

An intersting extension to the proposed question gk376, the best way to mediate such an opposing conversation is to do just as you had said, stay neutral. Ultimately any dispute between an expert in the field and a project manager…   Read more»

An interesting thought, when working in device development or research there are often questions that come up regularly throughout the process. Having the project manager on site to administer instructions and help to resolve any issues that may arrise during…   Read more»

An interesting thought Jacob; in my experience a project manager needs to be the most all around member of the team. That is to say, medical device projects often involve doctors, or biology specialists explaining or focusing on the importance…   Read more»