So my perspective is that FDA seems to be harder on larger firms than smaller ones. Having worked with big companies such as Roche, Merck and Pfizer, the kind of questions and challenges we receive is more than what I…   Read more»

I worked on a combination product a few years ago for Pfizer. it was Xyntha a drug for Hemophilia A patients. The key to the product was to make a simplified dosage for home use with a dual chamber syringe….   Read more»

There are lot of combination product in the market today, especially combination device with drugs. One of the combination device which was recently created by Bayer’s Healthcare in September 2015 is the “Electronic Autoinjector” indicated as a treatment for relapsing-remitting…   Read more»

The 510(K) process is a process used to clear all medical device and claims, that they are safe and effective to go into the market. The institute of medicine (IOM) issued a report in 2011 on the 510(K) process regarding…   Read more»

FDA recalls of medical devices are uncommon and always cause for concern. When a product on the market starts receiving complaints or is discovered in postmarket surveillance to have issues, the company can either remove the product themselves or wait…   Read more»

In some cases it may feel too tough to follow the FDA rules ,but in the long run or looking at the long term effect these rules are fair in my opinion. For example let us take the current situation…   Read more»

The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services .  India has its own Enforcement agency called The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals…   Read more»

Having an idea to create anything is much easier than actualizing that idea and making it come to life. A physician having such idea, is mostly due to been around patients with different kinds of health issues and diseases and…   Read more»

@sanam I work at Saint Barnabas, and recently our team like many teams around the Saint Barnabas moved to remote work. So I’ve experienced first-hand how Implementing new software remote teams manage their projects, align on their tasks, and gain clarity on…   Read more»

@patricia But people  don’t always choose short-term rewards over long-run gain. All will depend of the research. It improves services and treatments not just for you but also for future generations. It helps develop new tests for diagnosis, treatments and…   Read more»

@bjv9 Today, because experiments on animals are cruel, expensive, and generally inapplicable to humans. The world’s most forward-thinking scientists have moved on to develop and use methods for studying diseases and testing products that replace animals and are actually relevant…   Read more»

I do think it is unethical however I understand the need for it. Animal testing is critical for advancing medicines and bringing them to patients. Unfortunately, until we find an ethical alternative I don’t see this changing any time soon….   Read more»

I think both are equally important. I prefer to take part in research that would help people now or in the near future (10 years down the line). I wouldn’t like to take part in research that won’t reach patients…   Read more»

Personally, I would like to conduct research that has a more current effect. This would align more so with industry. However, it would not be surprising to conduct research that is beneficial for the future through industry either. I think…   Read more»

Obviously, there can be cases made for doing research in either academia or industry. In the lab that I am currently working at, my professor is technically in a mix of both. (I will try to keep him anonymous) He…   Read more»

Like many of you have mentioned there are pros and cons for both. I think that both could be demanding and rewarding at different times. In the industry, you will always have someone overseeing what you are doing at pushing…   Read more»

Horwich. A, Weissman, J. “Deadly Conformations—Protein Misfolding in Prion Disease” Cell Press. Cell, Vol 89. 499-510. 16 May, 1997. Accessed Online 20 September 2020

There are obvious factors that will dictate which biomaterial we choose for out medical device, like biocompatibility, tissue mimicry, low toxicity, and other. However, I think the factor that would have an impact on the smoothness of the project would…   Read more»

Biomaterial selection must be given careful consideration when it comes to project management. Like others have said, the material one selects could affect the cost and/or the schedule. I believe that this part must be thoroughly thought out very early…   Read more»

What I personally find attractive in working for academia is the creative freedom and the opportunity to work in what you are passionate about. You are able to decide the topics that interest you and create a project out of…   Read more»