I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs and medical devices has been a reactive process. The two examples being the Biologics Act of 1902 after a tetanus outbreak from diphtheria…[Read more]

Over a medical device’s lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a reclassification process that can be used to update the class of the device type based on current information. The type of the device being changed…[Read more]

With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker the new combination product required new clinical trials using the prior 6 trial data sets in addition to one more trial that showed the ability of the patient to use the system successfully. If you…[Read more]

In my experience working in clinical diagnostic laboratories I have had to adhere to many quality control standards and guidelines. When a new device is being validated for clinical use it must have a clear quality control procedure and tracking system developed. If the quality control documentation can not be traced back to when the device was…[Read more]

As someone who has never worked in industry, I’m curious to know what happens when a project does get scrapped. I’m sure the repercussions would be determined by the size of the company, but if a project loses funding or gets derailed for some reason what happens to the employees who were working on that project? I’m sure for larger companies the…[Read more]

I am not currently working in the medical device industry, but throughout my career as a Medical Technologist I have experienced what it is like to work in a strictly functional organization. Previously I worked for a company called BioReference where I would run cancer diagnostic FISH (Fluorescence in situ hybridization) assays. Currently I work…[Read more]

In response to vcf3, ih37, and jl959, I feel there has been a misunderstanding of what the 70:30 ratio actually represents. When it is said that an individual’s success relies 70% on interpersonal skill and 30% technical knowledge, I do not think it necessarily means that the person has high interpersonal skills and consequentially has low t…[Read more]