Hopefully the difference in these concepts has been solidified through this course and the Medical Device Development course. What are those differences? Now considering this, think about how a Design needs “V&V” but a Process also needs its own “V&V”….   Read more»

After this week you should have a basic understanding of how medical devices are regulated and approved in the EU. A lot of people say that it is easier to get devices approved in the EU than in the US….   Read more»

As an engineer or any professional device person, you need to keep track of the trends in your field. Personally, for me, I tend to have a 30,000 ft view of the entire medical field, so I can give you…   Read more»

Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if they are lucky…   Read more»

In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work in and why?

It is important to understand the process of Risk Management which includes Risk Analysis and how this is a living process that flows throughout the entire medical device development process. For more training on this, I recommend this course on…   Read more»

We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far! This module deals with the DHF contents and how to make one. There…   Read more»

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 technical workers who interact directly with patients….   Read more»

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? Promotion: How will you promote the product? Viral marketing? Internet…   Read more»

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…   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…   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…   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…   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…   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?…   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…   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?…   Read more»

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…   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…   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…   Read more»