The FDA’s QSR part 820 outlines the requirements for maintaining the quality, safety, and effectiveness of medical devices. It also ensures that the medical device manufacturing process is compliant with FDA regulations. ISO 9001:2000 is an international standard for quality…   Read more»

Although testing is a significant component of the slowdown behind the FDA process of medical devices, other components also impact the deceleration of the process. One of the components is meeting the quality standard of the manufacturing process for the…   Read more»

Some biocompatibility testing techniques include cytotoxicity testing, hemocompatibility testing, and implantation testing. All of these testing methods can be conducted either in vitro or in vivo. Cytotoxicity testing tests the toxic effects of a material on cultured cells for in vitro…   Read more»

The research path for making medical devices depends on the career goals an individual is trying to achieve. In terms of academia, the research for medical devices would be more focused on the academic side, where the goal would be…   Read more»

Both academia and industry research are vastly different but similar in some aspects. For academia, expertise in grant writing and deep research skills are needed. For academia, a project is funded through grants which is why the researcher needs to…   Read more»

Although academia and industry are quite different, they both use project management strategies to reach their end goal. It is true that in industry the strategies are more structured with feasible deliverables, unlike academia or research. However, I do think…   Read more»

In my opinion, the most affected stakeholder group would be the investors. Factors such as revenue and press recognition would affect the investor’s financial impact. For example, abundant revenue and profit can cause an increase in stock prices and financial…   Read more»

There are multiple ways one can ensure that the quality of a project is being held to a certain standard and that the risks are being adequately mitigated to not throw off the entire project. One of the ways is…   Read more»

I believe that as a major, BME is facing the issue of not being broad enough. At NJIT students are encouraged to choose their track (biomaterials, biomechanics, or medical device and imaging) as soon as they enter NJIT and are…   Read more»

Like many others, I agree that students in BME should be familiar with various coding languages. However, it also depends on the type of specialization that the student is pursuing that defines how advanced coding should that student know.  Typically,…   Read more»

Although Telehealth has provided more access to healthcare, I believe it also has caused more harm. After having the opportunity to shadow different clinicians, I was able to observe first-hand the effects of Telehealth.  Depending on the scenario, if the…   Read more»