As you interact with the CRA profession, you will notice a heavy preference for people with a "clinical background". This means people who have been or are nurses, doctors, or other kinds of technica...

Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product: What are you selling & why? Price: How much does the product cost? When does the price change? Pro...

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 compar...

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 selli...

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 qua...

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 engin...

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 ...

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 wha...

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 de...

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...

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, an...

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 in...

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 cl...

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 outsource...

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?