@ronakmandaliya made some points that I agree with. Quality specialists and engineers are some of the most important contributors to a business. Research and development/discovery can bring about most of the issues that would require quality engineering oversight, though other…   Read more»

Academia research mainly focused is on research and discovery the love of science and learning. However, we see that it is different in industry work that allows their researchers to feel a sense of immediate impact on patient lives by…   Read more»

Diversity is the bedrock of all successful enterprises. The more diverse your workforce the more honorable people a company will amass for their leadership and employee pool. An honorable person is selfless, forthcoming, and honest. Honor requires you to have faith,…   Read more»

Posted by: @hzy2 Has anyone seen the documentary called The Bleeding Edge on Netflix? The documentary talks about a medical device (Essure) that was cleared by FDA and implanted into women for sterilization purposes. Following implantation, these women started to…   Read more»

I haven’t been fortunate enough to be a part of a QC team but I would imagine that organizational skills play a tremendously important role in the success of this team. There should be a couple areas that a QC…   Read more»

Posted by: @tulikadasp In this age, different emerging technologies are beginning to rapidly change the nature of work. Internet of things(IoT), Artificial intelligence (AI), Machine learning are just a few examples of the new, disruptive technologies that are impacting the…   Read more»

I totally understand how jaded you feel about the state of medicine and the treatment vs cure conversation. I get it. Just thinking about diseases like  pancreatic cancer and how much of a death sentence it has become in our society,…   Read more»

I can think of a few drugs that are banned in the US including angiotensin receptor blocker / heartburn medication Ranitidine (Zantac) was recalled in 2020 due to the presence of low levels of a contaminant NDMA and are no…   Read more»

I have several examples of Quality department issues with work experience over the years. To be specific, I will talk about our quality department where I currently work. Unfortunately, depending on the organization, people are able to get away with…   Read more»

If I am QA auditor, there are two things that I am going to focus on: identifying the deficiencies of the regulatory framework of the project and to identify employees who are non-compliant. It should be understood that FDA standards…   Read more»

Working in a military hospital that services civilians in the city in which we are located I have seen poor quality of service due to incorrectly written consults for additional services and treatments for patients.  We have a quality assurance…   Read more»

I believe keeping a relevant knowledge of new technologies is the same as any field: continue reading research and engaging in new educational classes or forums. I think continuing ones education in a particular field, whether it be through talks…   Read more»

I believe keeping an open line of communication and having an understanding among the various departments is key. I do not think that this level of checks and balances should cause any confusion or bring about any bad relations between…   Read more»

Just as important as the planning phase of any project or product, the quality of said product or project is vital. Without a quality assurance or control team, a medical device could be faulty without the attention or knowledge of…   Read more»

  If I were involved with a medical device development project, biomaterial selection would be important.  Choosing the right biomaterial is important for project success.  Biomaterial selection involves a number of tests to ensure safety for the end users.  Depending…   Read more»

I am on the fence with this topic.  On one hand, animal studies have contributed greatly to the medical innovation.  That innovation has been accomplished in medical device development and novel treatments.  It seems as though the life of humans…   Read more»

If you select polymers then you will certainly need implantation, genotoxicity, system toxicity, irritation, sensitization, and cytotoxicity test.  Test like these are provided by many companies, and the delivery time can vary.  Therefore, as the project manager you have to…   Read more»

Posted by: @mrlee5 There are scientists who are developing and using animal-free methods that are actually shown to be relevant to human health for studying diseases and testing products. There is a variety of cell-based tests and tissue models that…   Read more»

Posted by: @carrissap10 Being that I am a dog owner of two amazing Pitbull’s, I believe that there could be another way to experiment with animals. The animal testing should not have to require an animal losing their life. There…   Read more»

Posted by: @sahitya-sadineni Although science has been around for a while, technology is something that has been evolving in the past 20 years. Pre-clinical is very important to every and any kind of medical research. But what is also important…   Read more»