A patent gives the company legal ownership of an idea or design. This allows for the owner of the patent to have exclusive ownership of the idea or design, and gives them the right to sue for patent infringement if…   Read more»

I have had two jobs where a non-compete clause in my employment agreement. The first one had clause where I could not work for a competitor within a certain distance from where I was working for six months after leaving…   Read more»

When forming a project team, I think it would be best to be able to assemble a team of people who have worked together before and have shown to be able to work well together. However, in many cases the…   Read more»

In my opinion, I think that matrix organizations are the most effective types of organizations. Since employees are still part of a functional department, it can be easier for them to align on certain strategies within their department so that…   Read more»

The organization that I work for would be considered a matrix organization. People are organized by department, and project teams are creating by taking one person from each department. This is useful because there are clear representatives of different functions…   Read more»

Post-market surveillance is now required by the FDA. Med device companies must have tracking systems in place, report medical device malfunctions, injuries and deaths, and register where the devices are being built. By conducting post-market surveillance, medical device companies will…   Read more»

In agreement with some of the replies above, some residual risk is acceptable if it is necessary for the function of the device. In these cases, it is important to consider who will be using the device. For the example…   Read more»

In my experience, FMEA has been the most beneficial tool to use for risk management. Every product in my company has a D(esign)FMEA and a P(rocess)FMEA associated with it to document which failure modes were considered, when their risk index…   Read more»

Tests used for design verification must be able to demonstrate that a particular characteristic of the medical device is conforming to the specification. As mentioned in other responses, the FDA does not specifically tell you which tests need to be…   Read more»

Design Verification testing for any medical device will demonstrate that the product meets all of the specifications listed out in the DSD/Product Specification document. For a balloon catheter, some of this testing may include testing the force required to pull…   Read more»

In my experience there are three parts to process validation: the Installation Qualification (IQ), an Operation Qualification (OQ), and a Process Qualification (PQ). The purpose of the IQ is to ensure that all equipment that it used in a process…   Read more»

In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the meeting will send out an agenda with the meeting invitation. He or she usually…   Read more»

As an R&D Engineer, I work with a lot of the types of documents that were described in this weeks lecture. For our Design Input Document (DID) we have a document called a Market Specification, which identifies the market requirements…   Read more»

When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is often called a Root Cause Analysis. In a root cause analysis the failure is…   Read more»

In a clinical trial, I would perform the monitoring duties. I would choose this because I would be able to travel to all of the locations where the clinical trial is taking place and ensure the integrity of the data…   Read more»

While I have never participated in a clinical trial as an investigator or patient, one idea for being able to track AEs is by having the patient have a wearable device such as an Apple Watch to help monitor patients…   Read more»

As mentioned above, responsibility (or blame) may depend on the wording used in the informed consent form and in the ethical practices of the sponsors and investigators running the clinical trial. For example, if the risk of death was mentioned…   Read more»

A vision statement is a general and broad statement about what a company wants to accomplish. One example is from Boston Scientific. Their vision statement is, “Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the…   Read more»

One of the advertising campaigns that has stood out has been the Nike poster featuring ex-NFL quarterback Colin Kaepernick. The ad is a close of photo of his face with the words, “Believe in something, even if it means sacrificing…   Read more»