Quality Assurance and Control are both crucial roles within the product development & manufacturing process. This is especially true for medical devices, where strict requirements need to be met and updated according to 21 CFR 820 or ISO13485, depending on…   Read more»

This is a harrowing example that reveals not just a risk in the product itself, but also a potential breach of trust in those who are supposed to solve a patient’s problem. Those who neglect the need for an effective…   Read more»

This is a great question that relates to a reply I gave in another thread.    As you’ve noted, engineers may have more or less responsibility depending on the size of the company they are working for. For instance, smaller…   Read more»

Balance and reality are key to success, indeed.  A combination of both would work. When developing a device, you have two things to worry about: the customer’s requirements and federal regulations. In this case, engineers must maintain a balance between…   Read more»

When it comes to newer technology that does not only involve physical devices (such as software), reform would be necessary as the FDA would need to define how it assigns these solutions. This can include categorized class designation for certain…   Read more»

Hey there, Atmeh, You bring up a point that I’ve learned at length about through courses and practical experience. I’ve learned that catching issues early in a process saves a lot of time and money. More importantly, it keeps risks…   Read more»

I unfortunately don’t have enough experience in academic research to provide a personal perspective, but I can share my experience in industry. During my time as a co-op at GAF, I saw a strong dedication to market research that helped…   Read more»

How important is the connection within a team to meet the project objectives in biotechnology?  This is one of the most fundamental aspects of a successful team, let alone a project. The connection between team members is critical in that…   Read more»

I’ve spoken at length about this in another thread, but I was tasked with creating a working prototype for a novel concept in my undergraduate capstone class. Our team settled on creating a bottle that could hold half a gallon…   Read more»

@jacobchabuel Hi, Jacob. You posed a great question. I myself am guilty of this pleasure (despite its detrimental effect). During my capstone project for my undergraduate degree, I was tasked with conceiving a novel idea to develop into a functional…   Read more»

Riddhi, you’ve provided a great introduction to this question.   I have asked myself the same questions many times recently. I have had experience in both areas to an extent, but mostly industry, I’ll admit. I am leaning towards industry…   Read more»

Is it reasonable to expect students to manage both a full academic course load and significant professional work experience? I have gotten to know people who are working full-time but taking some classes. Most (and I) agree that practical experience…   Read more»

Riddhi, you’ve provided a great introduction to this question.   I have asked myself the same questions many times recently. I have had experience in both areas to an extent, but mostly industry, I’ll admit. I am leaning towards industry…   Read more»

Between completing my undergraduate degree and master’s degree, I have gained some perspective on choosing between the “ivory tower of academia” and industry. Over the last three years of my career, I have explored both sides of the argument. In…   Read more»