I believe that it is the responsibility of the manufacturer to notifying the user of any side effects or risks with the drug being administered. A study can be shutdown for several reasons, one being cross contamination. A recent article…   Read more»

Out of all my entire bachelors and masters courses there are only a handful of courses which gave me insight to what it is like to work as a biomedical engineer. AMDD is one of those classes, that material we…   Read more»

The simulations are a great way to engage students into a work environment within the medical device industry. It allows students to apply the knowledge they gained within the lectures to real life scenarios that are common in the world….   Read more»

The cost of a study is dependent on the location of the study, however, the prime reason for a study conducted outside of the U.S is not cost. The research must be associated with the region the study is being…   Read more»

The first medical product that comes to mind when I heard of significant risk is a pacemaker. It is an implant which contains an electrical circuit that sends electrical impulses to the heart. My father has a pacemaker and it…   Read more»

I never saw myself in the career path of clinical research due to the constant need for travel. I was interested in a period of time in the career path of research, so I interned within the human performance lab…   Read more»

Recently, we received notification of a nonconformance within our instructions for use document which is sold in one of our major product lines. It escalated to a CAPA and HHE. A section of the document was inadvertently omitted. A complete…   Read more»

From my experience, GMP (good manufacturing practices) quality system documents are general but clear. As a new employee, the company trains you on the GMP regulations that the company upholds. If there are discrepancies, then many of the other employees…   Read more»

GMP represent good manufacturing practices, all medical companies have a list of regulations for there standards for good manufacturing practices. The company I work for has not updated the GMP quality system document for a while. The reason is because…   Read more»

During my time at my company, I have not experienced a period when sales were on a decline. However, coworkers have told me what the company did in the past when the sales weren’t good. Upper management met up and…   Read more»

The development phase is the most expensive phase within product life cycle. The development phase requires testing and creation of the products. Within an undergrad course that I took, we had to develop a product that fulfills a current market…   Read more»

I have gone through the scenario where a project was to increase sales but in the middle of the project the marketplace was no longer attractive to the project goal. As a result, many meetings were scheduled to discuss the…   Read more»

My first project as a Biomedical Engineer was to obsolete a product line that was sold to Japan. Based off marketing’s decision the cost to produce the product did not match the profit compared to other product lines that the…   Read more»

From experience, a project manager should be well informed of the current industry and market data that their product is apart of. The medical device industry is always growing and the need for medical products will always be a necessity….   Read more»

When deciding to sign a contract with a customer you need both interpersonal skills and business knowledge. From experience working with suppliers, you need to be knowledgeable of the product, risks, financial obligations required in persuading your team and vendor…   Read more»

Validation is required for a new fixture within the company I work for, its not a yes or no question. When dealing with class III medical devices, we rely on validation for new fixtures and processes. Verification are stated in…   Read more»

I never came across an expiration date for a validation. If an equipment was validated 30+ years ago and is still operational without any new changes to the fixture than the original validation is still valid. The only instances that…   Read more»

From a medical device company perspective, it is better to have preventative CAPAs than reactive CAPAs. At my current employment, we have both preventative and reactive CAPAs. In recent meetings our manager began giving out multiple preventative CAPAs to balance…   Read more»

Technical Writing courses are not given to students as a priority when in actuality the work industry requires an individual with good technical writing skills. When starting a full-time position as an engineer, I had to validate a new automatic…   Read more»

When a fixture fails on the production floor at work, the priority is to determine if it affected any products what were in contact with that fixture. If so, then it can escalate to a CAPA through the development of…   Read more»