Since I’m currently working as a manufacturing engineer in the medical device industry, I can see myself fitting best in the Sponsor role when it comes to clinical research. The sponsor is the organiz...

When learning about Good Clinical Practices (GCP) in this week’s lecture, I was reminded of a concept that I use daily as an engineer working in industry, which is Good Documentation Practices (GDP). ...

I don’t think it’s possible to eliminate the placebo effect, especially in studies that rely on patient-reported data such as pain level. But as jdfoster01 mentioned above, the placebo effect can be a...

Establishing a successful business relationship with the customer is especially valuable in the medical device industry because for many devices, the initial sale is only the first of many transaction...

Several years ago I encountered an interesting example of participation-focused marketing when I was walking around the mall. The Korean skincare brand Laneige had just arrived at Sephora, and a pop-u...

I think a lot of what makes an advertisement memorable is repetition. If people are exposed to a certain jingle or slogan over and over again, it's inevitable that it will get stuck in their mind whet...

@sm2744 I could see an S-Corp organization being difficult for biotech/med device organizations simply because S-Corps are more limited in scope than a C-Corp. S-Corps are restricted on how many owner...

A C-Corp would be better to have over an S-Corp for many of the reasons stated above; S-Corps are in general a lot more restricted in their growth and ownership as a trade-off of having pass-through t...

The typical LLP is owned by a few professionally licensed partners who benefit from the fact that each partner is not liable for any legal action taken against the other partners. For example, doctor'...

To further add on to what @mayasaunders mentioned, cleanliness in the production area is especially important when manufacturing sterile devices that make direct contact with patient tissue and/or blo...

In my job, I've seen Root Cause Analysis used most often when dealing with CAPAs. CAPA stands for Corrective and Preventive Action, and put simply is a process that is triggered when something goes wr...

I think MDSAP is a great way to standardize the auditing process and prepare companies to sell their devices to a wider, worldwide market. Currently 5 countries are part of the program: The United Sta...

A recent, infamous example of a recall is Abbott's recall of their baby formula products which occurred February 17th, 2022. The recall was initiated voluntarily by Abbott as a response to an FDA inve...

This topic brings up an interesting point - even though filing a 510(k) is easier than going the PMA route, and can greatly expedite getting new scientific breakthroughs on the market to treat patient...

I do think it's interesting to discuss using other, less conventional animal species in pre-clinical trials, especially because it could help with supply issues. In the post-pandemic world we're livin...