Quality is put in place to police R&D and other departments to ensure that effectiveness and suitability of processes are maintained across all levels. With that being said, both departments are crucial to the business. I believe that at the…   Read more»

I currently work as a Quality Engineer and still there exists some issues within the quality department. First and foremost, document control. Every procedural change or creation of procedure needs to adhere to document controls standards. Another issue is the…   Read more»

In 2015, Medline Industries, Inc. had a voluntary recall of one lot of acetaminophen tablets. The issue here was that the bottles were incorrectly labeled as showing 325mg instead of 500mg. The risk of this issue comes from possible maximum…   Read more»

Immunostimulating hydrogels are a combination product. Hydrogels depending on the peptide structure are chemically synthesized through peptide synthesis. Designer hydrogels can have small growth factors or biologics attached to the peptide strand that then forms into a hydrogel.…[Read more]

An antibiotic-releasing hip stem would fall under various categories including: device combined with a drug. This is due to the nature of the product. The device portion stems from the provider or carrier of the drug while the drug is…   Read more»

Approaching research in an academic setting typically starts when a professor has an idea and decides to use their network to figure out possible solutions. Academic research is approached through interest and exploration. IF a professor is interested in any…   Read more»

I believe that research done now will benefit both the short term and long term. It depends on the type of research that is being conducted however. Industry related research can be used short term if the results are met…   Read more»

Conducting research in academia is very different from industry but both have some striking similarities depending on the circumstances. For example, academia research is heavily supported by contracts and grants. Professors must apply for grants from various places NSF, NIH,…   Read more»

The challenges of doing project management are always present. These includes providing adequate information and communication avenues for the team members as well as the ability to track deadlines and progress. The project manager oversees all actions and activities being…   Read more»

Currently I am leading two CAPA investigations where we have to reconfigure data acquisition system which is set for revalidation in March. One of the biggest issues that we ran into was reaching adequate information/communication with the company headquarters over…   Read more»

I believe the planning phase is the most crucial to the success of the project. If a plan is well thought out then the actions, executions, and other phases after the planning phase will go to plan. That however, depends…   Read more»

Advice I would give to Biomedical Engineering students would be to 1. network your butt off. This means going to conferences as a freshman in college, regardless of location. Going to meet ups sponsored by companies and industry professionals. 2….   Read more»

A career in academia allows oneself to have control of their own schedule – sometimes. It may depend on what experiments that person runs during the day which can extend the typical 9-5 to 9-9. Likewise with industry, a position…   Read more»

I believe it ultimately depends on the student’s goals whether or not they would prefer practical vs academic courses. One could infer that courses that teach more practical applications related to industry would better suit the student for a career…   Read more»