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 and well supported clinical trials are executed for over 5 years or more. This ensures that the proper data and research is…[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 change in a requirement in the asian market. There were already products in stock out with distribution, so there were steps taken…[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 change to prevent the non-conformity from occurring again. Essentially, correction addresses the…[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 and gives the company time to address any issues. So when the FDA rolls around the company would pass their audit. For example,…[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 see these companies using outside vendors or companies to manufacture their products. The startup, since it is still relatively new and small,…[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, which the company can save on if there weren’t GMPs. However, the reason they are there is to create a…[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 of dollars. It takes money to find animals and human subjects to test the medical device on as…[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 big part of being a product manager is understanding the market, which is done by…[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 to sell to. Along with this I believe emotional intelligence is another added skill that is needed.…[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 customer would respond to this, a potential product could be developed. Additionally, it is also important to review the…[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 the proper growth and timelines are not being met, they can begin to slowly defund the project, and focus on another…[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 that when the batteries were charging they would overheat, explode and catch fire. The initiative Samsung put out on recalling these…[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 that when the batteries were charging they would overheat, explode and catch fire. The initiative Samsung put out on recalling these…[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 for a person to read it and understand the steps, so that an individual would not have to bother another worker to figure out how…[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 the devices inception, and with good documentation practices in lies proper SOPs to document all…[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 on the the specification that was not verified, so it is now being validated. As Dr. Simon also mentioned…[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 new parameters. Also, if there is a deficiency that occurs with the product this would certainly create a…[Read more]

Due to working in the industry I was familiar with the FDA requirements and regulations, but this class certainly helped in providing background and information on how the regulations for the EU works. With the EU they have 3 major directives to follow which are the Medical Device Directive, the In Vitro Device Directive, and the Active…[Read more]

Along with having multiple vendors, as a Manager you should also account for the risks that a potential vendor may run into issues. With this you schedule and plan dates for either an early finish, which is the date for the earliest possible finish for a task, or in this case a late finish, which is the latest possible finish date.