@ajm73 A PA physician pleaded guilty to accepting kickbacks from Insys in exchange for prescribing Subsys, a form of fentanyl. Insys labeled the payments as educational seminars that turned out to be ...

This course left me with the idea that medical devices are not just devices; they are essentially entire departments made up of people of different backgrounds working on a project to make this device...

While I have never been involved in meetings with outside consultants, I have had supervisors hire senior level physical therapists (PT) affiliated with our organization. I say affiliated as a researc...

I think it is natural to believe that it takes a gradual rise from entry level to middle management to upper management. An entry level employee is given a very specific set of tasks based on his spec...

It is important to to have a blend of positive personality and relevant experience among all project members. Managers generally have the option to choose their subordinates through an interview proce...

At this point we are at the stage where our roles are set. We're researching our roles more closely and outlining the best way to present the most quality information. We submit in each of our corresp...

I agree with your assertion that there needs to be a line that sets the amount of risk associated with the device that can be managed. However, "as far as possible" may not be thought of as where the ...

I believe at this point labels are a formality for companies to avoid litigation. The example of a coffee cup with a WARNING HOT label is always one that comes to mind. Everyone knows coffee is hot, b...

All drugs contain a level of risk to the user. Many of these chemicals are labeled safe by the FDA only in instances where a licensed physician may see fit for their patient. However, in devices that ...

@traceymraw I believe this article explains the expanding role academia now has on the medical device development process, as shown in this picture below. This "paradigm shift" explains that the role...

Verification is a constant process for devices such as computer-assisted surgical systems (CASS). Initially CASSs were approved for use in minimally-invasive surgery such as hysterectomy and prostatec...

@as934 This is a good idea to consider for future studies, especially ones that incorporates physical activity. With the growing smart wearable market upon us this is becoming increasingly affordable ...

The main difference between verification and validation is the end user. Verification is more or less a premarket step that distinguishes between the design inputs and outputs. This looks to answer th...

I was the secretary in my undergraduate BMES and among my roles was writing minutes for all our meetings. This was an important task as it gave us in charge the ability to check back and corroborate a...

Without naming any names, has anyone ever experienced an AE during a clinical trial, either as an investigator or patient? I have never had one happen during an experiment, but I have had several pati...