Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

Posted by: @orleron 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? I would…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron Perhaps in your career you will meet (or be) a physician who works in a hospital or private practice and wishes to create his or her own medical device.  Though this is a noble goal, what challenges…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

Posted by: @orleron 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? Project management for medical devices would require a…   Read more»

Posted by: @orleron The DMR is largely used for US products. It is required by the FDA. The equivalent to the DMR for European products is called the Technical File (for European class I, IIa, and IIb devices) or the…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

Posted by: @orleron We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron 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? The laboratory…   Read more»

Posted by: @orleron 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…   Read more»

Posted by: @orleron 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…   Read more»