I have been working as an intern in industry research for the last couple months and what I can gather is that it is generally heavily regulated by agencies like the Food and Drug Administration (FDA), which adheres to strict…   Read more»

Making sure a medical device is biocompatible for the duration of its lifecycle is crucial. This prevents adverse reactions such as inflammation or implant loosening. Manufacturers can achieve this through careful material selection, like titanium alloys, which have the ability…   Read more»

Project Management (PM) plays a vital role in both pre-clinical and clinical studies by providing structure, organization, and oversight to ensure that these complex and highly regulated processes are completed efficiently and effectively. PM helps structure and organize the entire…   Read more»

This is a very interesting question that I think would certainly be worth analyzing for all colleges that contain professors that conduct research in academia. In my experience at NJIT there has certainly been instances of both cases. When looking…   Read more»

When weighing out the pros and cons of conducting academia research versus industry research, I would be lying if I said that academia research does not seem like it would be more enjoyable than industry research. Having the ability to…   Read more»

There are many hurdles that companies face when attempting to align themselves with ISO 10993’s biocompatibility principles. First, medical devices are often made with complex materials to enhance their performance in the human body. In this respect, it may be…   Read more»

Absolutely, I agree that regulatory consultants play an invaluable role in guiding companies through the complex landscape of medical device development. Beyond the critical support in the preclinical phase that you’ve outlined, another area where consultants prove crucial is in…   Read more»

The regulatory environments for pre-clinical research in industry versus academia exhibit notable differences driven by their end goals and the nature of their outcomes. In the industry, the process is heavily regulated to ensure that medical products meet stringent safety…   Read more»

I agree that the complex and rigorous regulatory process of medical device development is difficult for companies to navigate. This is where regulatory consultants can play a crucial role in navigating the intricate requirements for FDA approval and other compliance…   Read more»

As many mentioned, it’s clear that there are significant differences between academia and industry research, particularly in terms of how they use their skills in each field. However, I also think the skills themselves are similar. For further/higher education, in…   Read more»

Hello cem34,I recently discovered what Gantt chart was in the last year. I had a course where we were developing a medical device and a part of this process was creating a Gantt chart for all of our project milestones….   Read more»

Hruship101,I liked the question you brought up. I think it is super situational. We learned about that in the planning phase there are different types of Gantt chart situations. For example, a finish to start situation requires for the last task…   Read more»

I wanted to start off by saying that there is definitely a point where a project needs to be shutdown. I have owned some businesses in the past 3 years and would like to share a personal experience that I…   Read more»

I think one of the best ways to stay on budget and on schedule is prudence and constant vigilance. As long as you are regularly meeting with people involved at all levels of the project, then you will recognize any…   Read more»

I believe, that when working in a team knowing individual strengths and weaknesses facilitates better collaboration knowing what each team member is good at and where they need improvement can really help reduce stress by making task distribution smoother and…   Read more»

I don’t have industry experience, but I do have 5+ years working in research/academia and have worked under many different project managers of differing skill levels. I have found that no matter what the organization level of the PM is,…   Read more»