What is a Mission Statement and a Vision Statement? Why do you think they are important?

Find some mission and vision statements online for some of the medical device companies out there and compare/contrast them. Do you think these statements reflect at all on their culture and values in real life? Perhaps if you already work for a medical…[Read more]

What is EI? How do you know you have it? How do you get it? Do you need it? Why? Think about this concept and discuss a few things.

Firstly, how and why do you think EI affects success in selling?

Next, what impact do you think it would also have on Marketing?

What sorts of cases could you think of where EI is particularly important in…[Read more]

What is EI? How do you know you have it? How do you get it? Do you need it? Why? Think about this concept and discuss a few things.

Firstly, how and why do you think EI affects success in selling?

Next, what impact do you think it would also have on Marketing?

What sorts of cases could you think of where EI is particularly important in…[Read more]

What is EI? How do you know you have it? How do you get it? Do you need it? Why? Think about this concept and discuss a few things.

Firstly, how and why do you think EI affects success in selling?

Next, what impact do you think it would also have on Marketing?

What sorts of cases could you think of where EI is particularly important in…[Read more]

Being able to look at the financial statements of a company and determine some guesses on its health is a good skill to have.

All public companies in the US must publish their financial statements quarterly and yearly. Take a look at the statements for your favorite company. Post here about your impressions on its health, describing some key…[Read more]

Many who work on medical device projects never really get training in basic business. Those who have business degrees will find this module to be quite elementary, but it is often the case that engineers and scientists never even get this basic material and training on the subject. This is why we cover it here.

To deal with companies it is nice…[Read more]

This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept.

Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product might really be great, and not fail. Then, inevitably, it happens…. something goes wrong. You get a bad lot that gets sold and winds up hurting people. You then…[Read more]

This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework.

Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA currently regulate e-cigarettes?

Here we have a situation where there is an electronic device that vaporizes…[Read more]

This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework.

Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA currently regulate e-cigarettes?

Here we have a situation where there is an electronic device that vaporizes…[Read more]

In this module I have given you basic information on the FDA and regulation of medical devices. That is good to know, just so you can function in this industry. However, if you are going to develop devices, the real thing to do is to be up on the latest news with the FDA and the regulatory atmosphere, because it will always impact your…[Read more]

Go out on the internet and check out the de Novo 510K process. In September 2014 there was a new ruling on how to go about a de Novo, and it supposedly streamlines the process greatly. How does this work? What is a de Novo 510K? What do you think about the process and how it fits into the regulatory structure that you already know?

One good exercise for this module is to try to discuss and figure out the regulatory pathway for a medical device. So let’s give it a whirl!

I am not a regulatory person. All I have is experience, and I can be wrong on my guesses just as you can. So what, though? The point is to discuss how we think the FDA would handle something. Regulatory…[Read more]

Let’s say there’s an Android app which connects via bluetooth to a blood glucose meter and then relays live or stored information on the meter over the internet to your doctor, who then may use the information to make decisions on your treatment.

Refer to all the questions I asked in the discussion topic: Antibiotic-releasing hip stem, and…[Read more]

Think about a case where your laboratory is working on a brand new biomaterial that has never been used in a medical device to date. In order to get that material to the point where it can undergo clinical trials in any device, you will need to know a lot about it.

What kinds of tests will you need to run to find out the initial biocompatibility…[Read more]

Think about a case where your laboratory is working on a brand new biomaterial that has never been used in a medical device to date. In order to get that material to the point where it can undergo clinical trials in any device, you will need to know a lot about it.

What kinds of tests will you need to run to find out the initial biocompatibility…[Read more]

Take the scenario where an animal study has been designed and as near as you can tell, the design is not flawed. That is to say, you think the design will give you no problems.

Your company outsources this animal study to a university located about 1000 mi (1600 km) away where one of the members of your research team has a lot of connections…[Read more]

What do you think the challenges are in doing project management for medical devices, as opposed to, let’s say, being a project manager for building a school or skyscraper?

What do you think the challenges are in doing project management for medical devices, as opposed to, let’s say, being a project manager for building a school or skyscraper?

I didn’t touch on Portfolios in this course’s project management lectures. How does a portfolio relate to a Project, Program and to Strategy? (We talk about these things more in depth in the Project Management course. For this course, we only spend a single module on Project Management. In reality, you could take any week of this course and…[Read more]

I didn’t touch on Portfolios in this course’s project management lectures. How does a portfolio relate to a Project, Program and to Strategy? (We talk about these things more in depth in the Project Management course. For this course, we only spend a single module on Project Management. In reality, you could take any week of this course and…[Read more]