I agree with @srg36 that even if you use project management tools like Pert charts, Gantt charts, there will still inevitably encounter pitfalls, but you will be able to more effectively manage these scenarios with these management tools. As Dr. Simon mentions in lecture, it is important not only to schedule the tasks but to account for costs and…[Read more]

I agree with @srg36 that the way to master the skill is a lot of practice and experience. I would like to add reading to that list. I took Technical Writing as an undergraduate course, I was good but not essential. Nobody was really in my field then and the teacher tried to generalized all students so they could only provide the structure but not…[Read more]

I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and sometimes tedious to chase these related docs. An automated updating system can be a huge help. I found this Medical Device Document…[Read more]

I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders with the adoption of new technologies such as bioelectronics because they could both…[Read more]

Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: to be placed in the teeth, in which case they are in Class IIa, – to be used…[Read more]

I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can be executed. I agree that it can be frustrating for upper management to make these decisions without having input from the Project/Portfolio managers who will end up doing the work, but the reality…[Read more]

@srg36 there is a difference between inventorship and ownership. Even if an employee comes up with an invention at most hospitals and research institutions you assign you rights to the employer. This is actually usually included when you sign your employee agreement on your first day with HR. At sloan, if you create an invention while you’re an…[Read more]

I agree with @srg36 that placebos are very important. The expectation is a very powerful thing. Similar to the example Dr. Simon mentioned in the lecture, sometimes, when people call to make an appointment with a doctor/therapist, they already feel better even before they see the doctor/therapist. Another point I want to point out is that in most…[Read more]

I agree with @srg36 about the nuances when it comes to quality control. Quality assurance process and quality control processes are crucial for any company/organization. In fact, it’s so important that it should be paid attention carefully and fully invested so that it function as efficiently as possible. For example: hiring the best people…[Read more]

Adding to @srg36, De Novo means an application sent by the medical device sponsor to FDA. So it establishes a new “device type” along with classification, regulation, necessary controls and product code, and it is eligible to serve as a predicate for new medical devices, where appropriate 510k process. So instead of going through 510k process…[Read more]

@Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III determination and to submit to have down classed to Class I or II is inefficient. Having the deNovo process is both time and money saving for both the…[Read more]