The graduate program at the New Jersey Institute of Technology should contain a better ratio of academic to practical courses, I believe the ratio should be 50/50 to better prepare the students to the skills, knowledge and responsibilities needed for…   Read more»

The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.  The United States and the European Union approach these challenges…   Read more»

Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billion this year.  But the F.D.A. is not at the table with members of…   Read more»

The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications.  The quality system regulations (QSR) for FDA regulated products are known as current good…   Read more»

When managing research in Industry, there is a “how to” guide for basic Research Scientists in Industry: Step 1: Your boss tells you to do a study. You may not know much about the subject, Do a literature search, Get…   Read more»

The way research is being funded is also different between Academia and Industry.  In Academia, you apply for a grant – you write a very large document, you hope that you get the grant, the grant money comes in -…   Read more»

When it comes to the valuing of research in making medical devices in academia, they do it for the love of it, “Neat-o!”, they believe they are helping people and they are also curious, they really do boldly go where…   Read more»

Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their medical device according to the applicable regulatory requirements, most often the FDA’s Quality System Regulations or ISO 13485.  But…   Read more»

Medical device product and project risk management can rarely exist without the other. This becomes apparent when you are responsible for the project meeting its objectives.  Along with this responsibility is the responsibility of compliance with all applicable regulatory and…   Read more»

Teamwork is essential in the Medical Device Development, Life Sciences and Biotech Industries, and it is the glue that ties everything together and generates answers.  Researchers in many fields, currently recognize that no single person can contribute all the necessary…   Read more»

Due to the occurrence of a global virus pandemic during the past few years, changes in where and how we work have dramatically occurred.  Hybrid-style work arrangements I where employees work from home for a few days and in the…   Read more»

@jh597 The graduate program at the New Jersey Institute of Technology should contain a better ratio of academic to practical courses, I believe the ratio should be 50/50 to better prepare the students to the skills, knowledge and responsibilities needed…   Read more»

What is the best career choice after finishing your postgraduate degree – ‘industry’ or ‘academia?’”  It is really important to understand the differences between both career choices because the context of work changes when you pick one or the other…   Read more»