As others have mentioned, if adverse side effects are observed after the product was used/administered by a patient during a clinical trial, it is most likely paused until effects go away and a solution is found as to what is…   Read more»

With my current experience working in the industry, taking part in clinical trials can be a very daunting task with quite a lot of paperwork. Finding a statistical significance can vary from 500 patients to even a couple thousand, so…   Read more»

These simulations definitely helped understand the topics we learned during class. I believe the last simulation we are currently working on is the most realistic where it can apply to a real life experience. While working in the industry, something…   Read more»

As the person above provided examples, an easier way to observe the difference between significant risk medical devices and non significant risk devices is looking at the classification which is defined by the FDA. If a device is labeled as…   Read more»

If a CRO is not able to deliver the expected results I am sure there is language within the contract specifying this possible outcome and steps to take to get a proper return on their money and resources. Usually, strong…   Read more»

From my experience with a CAPA usually an ER is filled out with the non-conformity which initiates the CAPA process. An example that occurred in my company was a minor one but there was a labeling issue due to a…   Read more»

As mentioned above, usually corrections and CAPAs go hand in hand. Corrections are immediately done to eliminate the non-conformity in real time. While CAPA’s, are steps taken to find the root cause of the non-conformity, document it and the necessary…   Read more»

From my experience with dealing with internal audits, the purpose of it is to prepare the company from a major audit that would occur by the FDA. It allows the company to do a thorough search to find potential holes…   Read more»

I believe in general as a company starts to focus on new processes or focuses on a new project there will always be a learning curve. However, for start up companies due to their size, for the most part you…   Read more»

As the others have mentioned, if there were no GMPs I believe most companies would not follow the guidelines set forth for good manufacturing processes mainly due to the money. Focusing on following standards makes for extra resources and time,…   Read more»

As others have mentioned, the development phase is the most expensive due to the time and effort from the design generation stage. Additionally, during the development phase, any pre-clinicial trials or clinical trials may cost up to more than millions…   Read more»

I believe the product manager has many roles which include, identifying profitable opportunities that meet market needs, launch products into the market, oversee products already in the market, and wind down products that no longer meet the market needs. A…   Read more»

I agree with the comments above where a successful team leader should have good interpersonal skills. It is essential for the leader to additionally have knowledge of the market place, costs of competitors and understand the customer you are trying…   Read more»

In the Discovery and Innovation phase of the Product Life cycle phase, it is important to understand the customer. Analyze and research the customers needs, if there is something that could fulfill a void or be done easier and a…   Read more»

As others have mentioned the main reason a product gets “killed” midway through the research phase is simply due to the money. If the research and development of the device is taking too long and upper management is not seeing…   Read more»

I don’t have experience with dealing with a launched product that failed, but the most recent example of a product having to be pulled from the market are the Samsung Note 7s. This massive recall was due to the fact…   Read more»

The purpose of the SOP is to create a step by step procedure to help workers carry out routine operations. So, I don’t believe that there is any issue with having too much detail. The purpose of this document is…   Read more»

I believe SOPs are required for the research phase, because there should be steps on the thought process of you reaching that idea, exploring the different possibilities, creating different designs, as well as other things. The DHF includes files from…   Read more»

As with each process validation, there should be an SOP for which any employee dealing with the validation should be trained to. Additionally, the validation depends on what type of medical device your company is producing, and it would depend…   Read more»

I don’t believe there is really an expiration date for a validation. Each installation qualification process gets updated every year or so. Due to this, it accounts for any changes that may occur in terms of technology, new specifications, and…   Read more»