This is a really good question and post to make. When working in the medical device industry, whether that be in the R&D sector, manufacturing, etc. each one of us will run into this question. There are a few fundamentals…   Read more»

As many others have mentioned, this would be considered a major change. If a product failed to meet the regulations needed by the country in which the product would be sold in, this is something that would most likely be…   Read more»

@dev-doshi completely agree. I work in a medical device manufacturer. And for us, the name of the game isn’t pure avoidance, but risk mitigation. By the time we start planning out the manufacture of a device, we’re looking more at…   Read more»

Similarly to what others have mentioned, in my job, the go-to is Microsoft Team’s messages and Outlook for sending emails and setting up emails. Teams allows for quick communication–messaging and even calls when its urgent. Outlook allows for setting up…   Read more»

Absolutely agree with many of the viewpoints here, meet about it, meet about it, meet about it! The team should have a final Lessons Learned meeting at the conclusion of a project, and the biggest issues highlighted. Everyone should bring…   Read more»

@dev-doshi Very valid input. However, to comment on one of your suggestions, in order to make the ‘nooks and crannies’ check easier, the team should be aligned and clear on what their roles and expectations are. The PM needs to…   Read more»

@vanshamin This is an interesting/insightful perspective. By mentioning that the metric itself shouldn’t become a target, might you mean essentially that the PM should ensure they shouldn’t put on ‘blinders’ over the situation so to say? Because agreed, however, the…   Read more»

Several of the comments on here touched on good points including communication and research. However, the best path may be to source the document directly from an ERP system that has revisions of a doc. If there is a controlled…   Read more»

This is a fun one! I work as a process dev engineer in manufacturing and my company heavily manufactures medical devices. Often there’s no way to really anticipate scrap turnout and issues. What helps is if we’ve manufactured similar devices…   Read more»

I noticed several others have pointed out that changes typically shouldn’t be done all at once; agreed, this is true. Typically changes are made to a machine/tool or process in a controlled way. However, I feel I should point out…   Read more»

@at644, while usually true, having documented procedures does not always guarantee compliance. Procedures can and will help avoid the pitfalls of treating design control and project management as two different entities but ensuring that staff follow the procedures would be…   Read more»

When you mention the product life cycle, that can apply to a variety of things as there are several different components that make up the product life cycle. There is the development phase, introduction phase, growth phase, maturity phase, and…   Read more»

To ensure that the DHF is done properly and completely a PM would need to be cognizant and responsible for all nine steps involved throughout the entirety of the project. While they wouldn’t be responsible for actually generating every individual…   Read more»

Various people agree with the concept that roles should not only be clearly defined, but defined early in a project, or even before the project commences. This is essential to promote a sense of ownership and responsibility amongst team members….   Read more»

Reading through the responses, I agree with many of what was proposed; there are several good options for how to control expectations including consistent communication with shareholders, clearly defining project scope early on, and using a tiered control system. However,…   Read more»

Reading through the responses, I noticed that many suggested having team meetings as a whole as well as additional individual meetings with those involved to try and resolve the conflicts. While this is a solid approach that can work, I…   Read more»

The neat (and maybe painful part) of being a project manager is, that dependent on the industry, you can be expected to be a jack of all trades. In my job for example (working in a medical device manufacturer), the…   Read more»

@njq3 , this is exactly the point I want to touch upon. You mentioned how you sort of came into the leadership role in your current company and grew into it. The original posts asks about what makes a leader,…   Read more»

Reading through the posts, I’ve noticed many have highlighted the importance of listening, defining roles, and respect. All very valid points in ensuring proper communication in a team. To take it one step further though, I’d like to specify a…   Read more»

@an83 Exactly. To add onto this, from the outside, it seems it may be difficult to even grasp a consulting position in the first place as a new graduate with-assuming-little to no experience. Consulting should be chosen if it is…   Read more»