One way to mange time effectively when developing biomedical devices is to determine the critical path. This method involves identifying the longest sequence of dependent tasks that needs to be completed in order to finish the project. Managers and team…   Read more»

The decision on the number of alternative vendors likely uses the same criteria used for solicitation planning. The evaluation criteria of price, understanding of need by seller, overall/life cycle cost, technical capability, management approach, and financial capacity was likely used….   Read more»

A WBS facilitates better project planning because it requires the project manager and other team members to have a clear understanding of what must be undertaken to reach the intended project goal. Essentially it transitions the project from being a…   Read more»

To ensure all elements of the project are properly coordinated among the 10 knowledge groups, planning meetings should be conducted to ensure every element is appropriately managed. Such meetings during the planning phase allow for the initialization of open communication…   Read more»

One strategy I think that could be implemented is tier-based data sharing. While working as an intern, I noted in Outlook there were sensitivity labels for emails: General, Public, Non-Business, Confidential, and Highly Confidential. Applying a similar labeling approach is…   Read more»

NDAs are ways to ensure a company’s confidential information about their product stays within their personnel and necessary external parties such as the FDA. As the previous user had stated, their use and what information they seek to prevent disclosure…   Read more»

Typically in the medical device industry, avoidance, mitigation, and acceptance are used as risk management approaches. Transference is uncommon. If used, as others have stated before, insurance is used as a means of transferring risk to another party. Another way…   Read more»

A majority of users defined success as the successful completion of the project; they focused more on the internal industry team’s perspective of success. From a business perspective, factors such as adoption of use, investment return, market share, and customer…   Read more»

After reading through the replies to my original post (the topic starter), I noticed a trend in medical devices suggested by previous posts that is likely to have a late finish and early finish. As the complexity and newness of…   Read more»

 I agree with a previous user that stated management of project scope is the most difficult part of a project. This previous user focused more on the scheduling and planning aspect of scope management. Another aspect of project scope management…   Read more»

The importance of strategic and business management proficiency in a project manager’s skill set should not be undervalued. Having an understanding of the business context is important when working in the medical device industry. Project managers are able to make…   Read more»

One ISO standard I think would always be followed  if ISO requirements did not exist is: ISO 10993, the standards for biocompatibility. This standard calls for evaluation of all data from materials, prior use, clinical data, and testing performed. Its…   Read more»

I’ll be providing a start-to-finish relationship example that occurred a few semesters ago on campus. The implementation of the new parking tapping card access system must be completed before the old swiping card access system is removed represents a SF…   Read more»

During my internship, I reviewed lengthy documentation as part of my summer-long project and recorded my findings in an Excel workbook. I was not aware of all of the shortcuts and tools offered in Excel. As a result, organizing my…   Read more»