How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a software company and have you make a program like Microsoft Office? Or can I throw you onto a construction site and make you build a skyscraper?

What…[Read more]

Some of you taking this class might work in industry already, and not necessarily in the medical device field either. Whatever industry you work with, share some of your experiences about the following:

* What sorts of project management software or systems does your company have?

* How advanced would you say your company’s project management…[Read more]

Describe your thoughts on what regulations or codes each of the following clinical trials would need to comply with:

Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe

Embolic coil device manufactured in the EU and sold only in the EU

Angioplasty catheter manufactured in India and sold only in…[Read more]

If you have made it this far in the course, you know that GMP’s must be implemented, but they are not a set list of requirements. Rather, they are a framework with general requirements. Do you think that this ambiguity makes the process more difficult for companies and even to an extent sets them up for initial failure? Specifically, do you think…[Read more]

What happens with projects that are currently being carried out when the Quality System for the company changes drastically? Is there a certain time where a project has just reached a point where it can be considered “grandfathered” into the previous system or handled slightly differently than a brand new project? What if the project is already…[Read more]

At each stage of the product life cycle, certain aspects are key. For example, in the early stage, Development, it is important to be compliant with FDA and EU regulations but even before that to have a coherent research method to focus on a product and its vision. This can be helped by using Project Management and Project Evaluation systems…[Read more]

Taking the ISO names for these processes: IQ, OQ, PQ, let’s look at some devices and summarize what kinds of tests or data you would want to collect to complete each of them. In other words, for each process below, what would the IQ testing look like? What would the OQ and PQ testing look like?

Syringe Filling Process – filling syringes with an…[Read more]

What are the FDA and ISO saying in reference to process validation where :

“inspection” ≈ “monitoring”

and

“test” ≈ “measurement”

Would IS ultimately still require “full” verification for a process that supposedly did not need validation?

What are your views on this? Do you believe their approval processes that allow a com…[Read more]

This module discusses many of the contents of the device master record (DMR), and among those contents were the procedures on post-market surveillance. Post market surveillance is becoming an increasingly scrutinized and important component of device development as the FDA begins to require it for more and more products.

What are some ways in…[Read more]

There is some reference to this subject in the modules for this course and the Medical Device Development course.

One school of thought says that the DHF is sealed at the end of Design Transfer and never altered again. Any alterations to the devices SOP’s, labeling, packaging, etc. can be added to the DMR so long as they are not changing the…[Read more]

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”. How do these two sets of V&V overlap and go together? What sets them apart?

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. Here’s another piece of interesting information: In 2012, I personally visited over 60 different medical device companies and met with at least…[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 some basics of what everyone is thinking as a whole, but not too much in-depth for one particular area, like orthopedics for example.

In this…[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 enough to work in medical device development. I hope you have learned that and now have some idea of what is possible.

On the flip…[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 medical device Risk Management.

The hint is in that link. What is the major ISO regulation governing…[Read more]

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 medical device Risk Management.

The hint is in that link. What is the major ISO regulation governing…[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 is also something called a Device Master Record (DMR), which we do not go over much in this course, formally, but you will…[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.

On the other hand, there are a lot of people without the clinical background who can and do work in…[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 Advertising?
Placement:
Who sells it? Where is it sold?

In rec…[Read more]