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 you are too indecisive to act upon it.

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 there is new or needs improvement at their job? Having interpersonal skills is fantastic, however eventually you will have to perform. If…[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 very skillful technically, however they insult everybody that they meet. That person will be less successful because…[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 for a company and an NDA. The NDA will have specific things that they either have not patented yet, can’t stop other people from using (like a…[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 current career path based on this information. I enjoyed getting practical information about the Medical Device Field. I am also planning on…[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 on someone’s word and were burned by it. There used to be a time when you shook hands with someone, looked them…[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 back to my original account. We are departmentalized in the hospital we are stationed at as the “Biomedical…[Read more]

It would be most challenging to work under a matrix organization. This is simply because the resources on your team are split. Situations like that can lead to staff getting burnt out due to the amount of work given by 2 or more bosses. Because of this, you have to be overly conscious about how much work you are giving to each staff member and…[Read more]

In my opinion, with a new group of people, it is better to have the project group with people who are competent in their expertise vs people who you have a good relationship with. It would be great if everyone got along somewhat, but I would rather have a great product with a team I may not get along with. If you are a team where everyone likes…[Read more]

“As far as possible” to me would be to the point of common sense. Meaning, depending on the target product audience, there should be a level of intelligence that you expect the user to have. Take a tongue depressor for example. AFAP would be you assuming the user won’t try to swallow it. So the labeling on the package will say, “Do Not Swallow” or…[Read more]

Labels are an essential part of risk management, but I agree that they are the least useful. This is because (from my experience) people do not normally read the warning labels. Think about things that you use on a daily basis, how many of the labels do you actually read before you use the product? The bulk of the risk management has to go into…[Read more]

Personally, for any business/professional meeting I think it would be most effective to follow Robert’s Rules of Order. (At the end of the post I will link a basic overview of what that is)

The first thing you will need to do is make an agenda to send out prior to the meeting. In the agenda, everything that needs to be addressed should be…[Read more]

As jz365 has mentioned, the EU has a different regulatory body than the US. For the EU, no design controls are not “needed”. Yet, that will limit your market size because it is needed in the US. I would recommend adhering to whichever regulatory body is more strict because it can help ensure you have a safer product for the masses, and it will…[Read more]

Each of the documents explains the other’s disadvantage. Not being specific enough can have it’s drawbacks, as well as being too specific. The advantage of the DID is that you can show a customer a broad view of what the product will look like, and at the same time they can have a say in coloring etc. The DSD allows more technically inclined…[Read more]

Verification is making sure what you say is going to happen actually happens .. If you say a product is supposed to do something and it does not do it, you’ll end up getting sued and, even worse, could hurt someone. For a good verification process, you should make sure the results are repeatable over a large number of trials.

For biological statistics, t & z tests are useful for data analysis. You would want your power to be at lest 80% to be considered a good test, however the higher the power the better. you would use a t test when you know the population deviation (sigma) and the z test when you are estimating that same value.

I personally would not skip the validation process. 1) you would want to confidently state what parameters your device will conform to without any doubt. 2) If anything happens, it leaves you open to a law suit. Whether it’s required or not, it is best practice in my opinion to still utilize it.

Honestly, minutes are one of the most important aspects of a meeting. If something is not in the minutes, it did not happen. That’s why it is important that the person taking the minutes is paying attention and takes great meeting minutes. You also don’t want to mishear something and write it down because as with my second sentence if it’s in the…[Read more]

Clinical trials are necessary because regardless of the amount of pre-clinical trials you conduct, nothing done pre-clinically will directly transfer over to a clinical observation. In other words, using something similar to humans is not the same as using humans. For example, if you are testing the fibers of the sheep spinal discs because they…[Read more]

I do not think having a clinical background is overly necessary to perform clinical research. Like any job, you end up getting trained to do things the specific way your employer wants you to do them anyway. The biggest plus to having a clinical background (i.e. RN), however, would be if the patient in the study has an adverse effect to what is…[Read more]