Establish a communication protocol at the first team meeting. Communication is the most important aspect of teamwork, in my opinion. Being fair and appropriate to everyone’s preferred method of communication while having clearly defined consequences is key to effective communication….   Read more»

This would depend on the timeline as a whole. How much time has been allocated to this segment in the project? Were there any milestones missed prior to this that have already delayed the project? The Project Manager may have…   Read more»

What I would recommend is falling back on policies and procedures. At my current job, there is a policy surrounding PTO(Paid Time Off). We have to submit a request a minimum 2 weeks prior to the date we are requesting…   Read more»

The first problem that came to mind is communication. A PM has to communicate effectively to their team, investors and clients (to name a few). They should set up a reliable communication system for each group and update them periodically….   Read more»

Missing a Milestone is bad, however, should not be deadly to a project. A well-designed project will have some wiggle room in case of tasks not going as expected. A missed milestone may also set you back budget-wise, but effective…   Read more»

It may seem straightforward to you, however, there are cases where companies are not following regulations. A recent example would be Philips Healthcare. They were forced to cease operations at both their Massachusetts and Washington facilities pending corrective actions due…   Read more»

The classes defined by the FDA are Class I, II & III. Each company may label them however they want internally. Companies tend to give the projects pseudo/ temporary names while the product is still in development.

There are different ways to get funding for a project depending on the size of the company. It also depends on if the company is privately owned or public. Overall, I would more so look at the risk for potential…   Read more»

Design Verification and Validation should, on some level, be implemented throughout the entire life cycle of a medical device. You should verify that you can make each component of the device consistently within tolerance. You should also validate that you…   Read more»

I don’t see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well which I do not think will happen. Also, the level…   Read more»

Anthony, The premise of the device is interesting and can provide needed support with suggested treatment. The reason for the disclaimer, in my opinion, is because electronics can fail. If they state that this can happen 100 % of the…   Read more»

The FDA definition for a medical device captures a broad spectrum of products that one may not initially consider a medical device. An example of this would be a bedpan. Although a band-aid is not used to treat a disease,…   Read more»

Picking the proper project team is an essential component of a project. Each project will have multiple moving parts and having a diverse project team will be beneficial. It is important to have a well-rounded team where everyone’s weaknesses and…   Read more»

A project manager needs to be able to make decisions. Communication is an important skill as well, yet without the ability to make a decision a project will fail. Having all of the information in the world won’t matter if…   Read more»

I believe education is always a proper investment. In order to succeed at anything, you need to know what is going on. How often do you go to a store or a restaurant and immediately notice when someone who works…   Read more»

I don’t feel the ratio is as literal as it seems. It’s not that a certain individual is 30% competent technically, it’s that that person’s overall success is relying on their technical knowledge 30% overall. For example, person A is…   Read more»

When I think of an NDA, I always think of the Krabby Patty formula. Mr. Krabs kept what he wanted to himself inside a bottle in his safe. Everything else that was common, he didn’t care about. The same goes…   Read more»

Dr. Simon, Wow … the semester is already almost over … I really enjoyed this course. I didn’t know about all of the roles that I could have gone into utilizing a BME degree, and I would rather change my…   Read more»

When entering into a contract, I would dissuade one from relying on a verbal agreement. A contract is similar to meeting minutes if it’s not written in the contract, it did not happen. I’ve seen countless situations where people relied…   Read more»

I work in more of a Project-based Organization. Every hospital is considered a separate account and they run as such. If another account needs help, I can go to that account to lend my expertise for a little before coming…   Read more»