Once the physician has an idea, they must determine which class their device falls into. The next concern would be the presentation of the idea to the FDA. They would need to submit an Investigational...

Quality assurance is all of the processes established to ensure that a company is producing the best product to their customers. This process protects the safety of consumers that use the product. Qua...

I believe it is important to protect your investments. It takes time and money to build a company. When dealing with medical devices, it can be an even longer process, due to the scientific process be...

I am referring to the material having the desired interface with the tissue. Breast tissue is soft and fluid. A biomaterial acting as an implant must be fluid in nature as well, to match the interfac...

In order to test this new bio-material, I would perform testing based on the ISO 10993 international standard. This standard has 18 parts that evaluate how a device will be used and which tests to per...

It is important to be precise when selecting biomaterials for a device. They behave differently and have different interactions in the body. Some are necessary for a rigid role while others are meant ...

The issues that can present in this situation can arise from the vast distance between the contracting company and the outsourcing company. The main issue can be lack of communication, which can lead ...

I believe the main challenge for project management for medical devices is that there are more strict regulations with the FDA. If a project is not approved, it can set the schedule for compilation of...

For an argument in favor of academia, I would highlight that this job would be ideal if your career goal is to conduct research. Academia requires significant research and discovery, and those in acad...

COVID-19 has affected every area of life. The medical device development industry is no exception. Some changes have been delays to clinical trials and disrupted regulatory processes. Due to the need ...