In the current age of social media, it has proven to be a very successful way of reaching a wide audience. Social media allows for a more interactive experience with an audience through the use of polls and a comment…   Read more»

The type of corporation would ultimately depend on the goal of the company, but I would choose a Limited Liability Company (LLC). An LLC allows for multiple owners, which can be extremely valuable when forming a start-up. For example, if…   Read more»

From what I’ve heard from other more experienced individuals within industry, most individuals who have worked at a start-up company emphasize the amount of learning that they had during that opportunity. Since start-ups are smaller companies, typically an individual is…   Read more»

Engineering students should take an additional business course to be better prepared for entering industry since business classes would provide valuable information that could help in the transition from school to career. When engineers enter into the work field, sometimes…   Read more»

In my experience working in Quality last summer as an intern, Root Cause Analyses were used very frequently. They are used frequently as a starting point for Corrective Actions and Preventive Actions within medical device companies. In order to properly…   Read more»

Last summer I worked as an intern in Quality Compliance at a medical device company. Within that function, my role was centered on working on Corrective Actions and Preventive Actions (CAPAs). The work consisted of monitoring CAPAs from the Request…   Read more»

The challenges that a physician would face in trying to create a medical device is that they may not have experience with design controls, such as understanding how to develop design inputs, outputs, verification, and validation. Additionally, the physician may…   Read more»

An example of a combination product is an auto-injector. An auto-injector contains a pre-filled syringe and the device releases a plunger that contains a spring when activated to inject the drug product into the patient. Auto-injectors can be used to…   Read more»

Over the course of the last year, the FDA recalled Smiths Medical’s Computerized Ambulatory Delivery Device pump, which is a combination product which delivers a drug at a programmed time and dose. This device was recalled due to issues with…   Read more»

There is value in both types of research, as they are both important to future contributions to the field. In my experience, I would rather do research that I am able to see have an impact in my lifetime. This…   Read more»

From my experiences, I would prefer research in industry over academia, as having stricter timelines, although potentially stressful, ensures that projects are being completed. Additionally, in industry, companies are usually willing to spend more than in academia on new devices…   Read more»

In terms of the consequences of not completing a project in academia, it would depend on the project. If it is a project that has not really evolved from an idea into tangible work, or even if the project is…   Read more»

Typically a missed milestone is a failure, but it would depend on why the milestone was missed. If the milestone is the result of poor management or team members being unable to complete a milestone due to any reason that…   Read more»

It is important for project managers to be flexible in order to be able to successfully manage projects. Flexibility allows for project managers to be able to make tough decisions, particularly in regards to budget. Since medical devices are so…   Read more»

The challenges presented by doing project management for medical devices rather than for construction stem from the fact that the medical device industry is one of the most highly regulated industries in the world. As a result, it is critical…   Read more»

Academia and industry both have their own sets of benefits and present different work environments. In academia, the work is typically much more research-oriented and allows one to directly contribute to the field of biomedical engineering. Academia also opens up…   Read more»

I think it is important to have both types of classes as the informational knowledge is needed to be able to work in a practical setting. For example, if someone is working within risk management and they are working on…   Read more»

In my experience, both working remotely and onsite have their own set of benefits. Last summer I interned at a medical device company working in Quality where I primarily worked remotely. Currently, I work at a pharma company focused on…   Read more»

This question does not have a clear answer as different individuals may value different things. To some, financial compensation may be the most important factor, which may, in turn, require them to sacrifice other factors such as work-life balance. If…   Read more»

Long-term, I would hope to go into a management role, but right out of school, I would prefer to work in a more technical role. Through working in a technical role, it gives an individual the opportunity to grow in…   Read more»