An NDA is a useful tool when pitching your idea to prospective investors and even when searching for patent attorney’s for your idea. By state and federal law patent attorney’s would have an obligation to not reveal your idea and…   Read more»

An example of kickbacks that happened within NJ about a decade ago involved many of the top orthopedic device companies in the area. Zimmer, Biomet, Depuy, Smith & Nephew, and Stryker (although Stryker was not directly fined for kickbacks they…   Read more»

I do not believe this is an over-restriction in fact the companies do have many loopholes. During undergraduate I worked part time as a clinical research coordinator for a pain management practice and every week at least 3-4 times a…   Read more»

Currently I work as a Process Engineer and the organization type I work in is a matrix organization. We have associate directors in our group and a director that oversees several departments and has the strategic outlook for our Manufacturing…   Read more»

Organizational type depends on the goals of the company. Larger companies with multiple product lines and established brands would benefit from a matrix organization. In this situation the main advantage is the information flow between departments and knowledge transfer between…   Read more»

I agree with Ginger that it would be ideal to work with people are knowledgeable and easy to collaborate with. In my current role as a Process Engineer I work in a matrix organization and have to deal with many…   Read more»

My current role is that of process engineer at my company, within the manufacturing and science technology division. During this phase of the products life cycle we have to assess risks that arise from global investigations usually related to user…   Read more»

The best strategy in running risk management meetings is to ensure understanding of the device. A basic understanding of the device components, it’s functionality, and how the end user will be utilizing the device are all key in recognizing risks…   Read more»

I agree with aaq2 in respect to mitigation being the best strategy for countering high severity risk. I do not agree with the fact that risk acceptance is wise option based off cost of acceptance being less than the cost…   Read more»

I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verification shipping study. As a precautionary action in…   Read more»

I agree with dbonanno1 that you can rationalize failures during the verification process. For example, at work we have a new combination product releasing and I was part of the team conducting verification shipping study. As a precautionary action in…   Read more»

A successful validation process will ensure that each requirement for a use is fulfilled, essentially end user needs are met. An important aspect of a validation plan is knowing your target customer/end user so that you can confirm that the…   Read more»

As mentioned in previous posts design verification is an important step in design control process to ensure that the inputs are equal to the design outputs. Verification is an important step as the testing done during verification can satisfy both…   Read more»

Ensuring that your DHF is constantly updated is the best practice in ensuring that it will have all the necessary documents during an audit. As discussed in the past 2 weeks of class the DHF is a living document and…   Read more»

Insufficient design controls will result in a loss for the company. The loss will occur first off by the product not making it to market and this will result in a trickle down effect. As the time, money, and energy…   Read more»

Since the DHF is important for both informative purposes and audit it is essential that the file maintain accurate information as a “living document”. The best step towards this is having a dedicated team in the product development phase assigned…   Read more»

Design controls are mandated by the FDA according to 21 CFR (Code of Federal Regulations) towards medical device manufacturers. They are guidelines that help to ensure a proper quality device is created and provide checks and balances for the manufacturer….   Read more»

Placebos have been viewed as a necessary process in bolstering scientific proof on the effectiveness of products and evidence that one product is superior to another, within many industries. Personally I believe that placebos are necessary in order to gain…   Read more»

In my opinion double blind studies are more accurate as it sets a reliable baseline for the trial. As an example from the lecture would be the double blind multi-center study. In this example Dr. Simon shows that a doctor’s…   Read more»

Having clinical trial experience is definitely advantageous in the medical device field as you encounter problems that may not have been thought about during the design of the product, and gives good insight into human factors of the product. After…   Read more»