Posted by: @fo3 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or contracts, and how they can help protect…   Read more»

Posted by: @mmd55 I recently received a job offer and while reviewing my offer I noticed I would have to sign a non-compete agreement, which is an industry standard. I asked the recruiter if I would be able to read…   Read more»

Posted by: @cef3 Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how…   Read more»

Posted by: @hg93 As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is…   Read more»

Personally I seem to like the idea of a Project Based Organization structure. To answer your question on which type of medical device company would benefit the most from this, I would imagine one which mainly focuses on R&D would…   Read more»

Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

This brings up a fair point. There is only so much a company can do to reduce the risk to their consumers. At the end of the day, there is not going to be a representative of every company in…   Read more»

Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

Posted by: @rajamharrison Do you believe risk management is an important part of the planning phase?  Is it necessary or it is just a waste of money and time? Why? Risk management is an important preventative action that one can…   Read more»

As Ridmehta, mentioned most major projects will come with some surprises. It may be impossible to map out perfectly when each segment a project will be completed down to the minute. However, the Gantt charts serves as a guide and…   Read more»

Hi Hodafattel, I do not work in the industry, however, I can elaborate on each of the two terms which you have mentioned. Validation is quite important in a product, but it may not need to always be performed. Validation…   Read more»

Posted by: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify,…   Read more»

An instance were I had to create a Gantt chart for the project which I was working on was actually my first time doing so. I think the key when creating one is to have in mind that the Gantt…   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»

I believe that their are great positives that come with this Act, but also some negatives. Two factors which should largely be considered at play in this case is the risk severity associated with the treatment, and how severe the…   Read more»

Like Anthony said, need may also be a driving factor for individuals to enroll in clinical trials. One other form of compensation may be trials which are low risk but the method at which they are performed is providing the…   Read more»

For me personally, I would elect to be a Clinical Quality Auditor (CQA). This is the individual which is responsible for verifying that all records are in compliance with the set standards and guidelines. Since their main function is to…   Read more»

Generating interest for a product before it is released is difficult to do if you are a medical device company, with respect to the consumer side. Attracting the attention of investors, and perhaps B2B sales is some that may generate…   Read more»

Personally, for me I am just starting out and would prefer to gain more time as an engineer before switching positions later in my career path. I believe that someone who has had a few years as an engineer developing…   Read more»