@ajm73A 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 falsely labeled. These seminars were held but were not…   Read more»

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 possible. A company is thought to…   Read more»

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 researcher working with volunteers on one wing of our campus…   Read more»

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 specific role within…   Read more»

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 process, but depending on the company other employees may or…   Read more»

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 corresponding forms the information…   Read more»

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 line…   Read more»

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, but one person…   Read more»

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 require drug delivery,…   Read more»

@traceymrawI 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 of academia in recent years has taken on more responsibility…   Read more»

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 prostatectomy. As the market grew for CASSs, the case to use these devices in…   Read more»

@as934This 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 over time. For a project that includes an ECG in their…   Read more»

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 the question of how closely the current design matches…   Read more»

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 any future decisions…   Read more»

It is important to find the root cause of death before making any initial assessments on what to blame. The responsibility will depend on the language in the informed consent regarding risks and adverse events. I have not been involved…   Read more»

I would like to work in a position where I’m involved with data collection and processing, so either a CRA or investigator. However, I also would consider a position such as a monitor where I’m looking over the protocol and…   Read more»

Cardinal Health, Inc. (CAH) general SWOT analysis:StrengthsLarge and growing revenue stream ($136.8 billion in 2018 and up about 190% since 2005)Large audience (over 100,000 product locations)Large share of hospital market (over 75% US hospitals with CAH equipment)Largest share of nuclear…   Read more»

Cardinal Health, Inc. (CAH)StrengthsLarge revenue stream ($136.8 billion in 2018)Large audience (over 100,000 product locations)Large share of hospital market (over 75% hospitals with CAH equipment)

Cardinal Health, Inc.StrengthsLarge revenue stream ($136.8 billion in 2018)