In order to minimize errors with dates so that the task is minimally affected by lateness, it would be efficient to see previous projects that are along the same vein and have a similar scope and compare them. It would…   Read more»

The planning phase is crucial to make sure that the user’s requirements and design inputs are compatible and can be executed. People should take into account of different protocols/ tests are going to take place during the project. Unless a…   Read more»

With uncontrollable factors like time, it is hard to estimate properly how long a project will take. The best way to go about finding a viable estimate is to look back on previous executions of similar protocols or tasks and…   Read more»

When it comes to asking for input for DID, it is important to at least have R&D and production engineers available during these meetings. Whereas marketing and the customer have a specific image in mind, the engineers are the ones…   Read more»

All these factors are important for each aspect of the project because they all rely on consistent communication within the team and the company to ensure that the project goes to completion and upholds all the company’s values. The team…   Read more»

Logging work is important because it keeps you and the other people on your team aware of what goes on in a daily basis. I usually keep track of my own projects in a personal planner and on a work…   Read more»

A product risk related to medical devices would be something like improper execution of protocol. The purpose of protocol is to make sure there is proof of product production and that employees are aware of the process of manufacturing, cleaning,…   Read more»

The most effective method of resolution when it comes to experiment failures is to troubleshoot what went wrong in the situation and come up with a plan of action to remedy the problem. With the bottle label simulation, we recognized…   Read more»

Verification and validation are alike, yet different in what their purpose proves. Like mb698 said, validation is to make sure the user needs are consistently met according to medical benefits. Verification is to make sure there is evidence that all…   Read more»

The simulations are a great way to learn how to deal with problems during protocol and work with a team to solve these problems. I do agree that in person meetings would be best to figure out how to fix…   Read more»

I would agree that success is mainly based on interpersonal skills and the rest based on technical skills. Many companies do train new employees on company policy, procedure, software, etc. and usually colleagues help out newcomers with any tasks or…   Read more»

In reference to health and wellness apps, I think period tracking apps for women would classify under the second category, because these apps can track whether or not a woman is pregnant, late on her period for a reason, or…   Read more»

While everyone has said that initiating the project idea is the hardest part (and rightfully so because it determines if the project will exist at all or not), Verification is also something to consider because execution is different than making…   Read more»

I personally haven’t worked under a project manager but from my experience working under another engineer, I can suggest that organization and patience is key with working with team members. The engineer I report to is extremely organized and keeps…   Read more»

I do think that the world is moving towards a global medical device regulation system, especially with EU MDR. It is a hassle on companies though, changing their products so that they are compliant to the new regulation. With any…   Read more»

In order to prevent from “low priority” projects from being stopped before finishing, the company should look at their budget, their current structure, and other parameters that would allow them to sustain projects before they even start these low priority…   Read more»

I currently work as an intern at Getinge in the Production Engineering department. From the description of different types of organization structures, Getinge is more of a functional one, because there are different departments like R&D, Quality, HR, etc. and…   Read more»

With most models, they all have the consequence of not looking at the broad picture, since it only involves at the model at hand. The purpose of the project life cycle model is to view the process of the project…   Read more»

@sam-dokshI agree with your plan that medical devices planning should start with FDA Design Controls, and within those controls, budget, and other necessary constraints, companies can start planning for their next product. It would be beneficial too to pull ideas…   Read more»

@jea42Despite that EU MDR puts medical device companies in a difficult situation to quickly comply, I agree there are positives to the new regulations. With concepts like UDI that will allow better traceability and effectiveness of the products in the…   Read more»