To make the QA process more efficient for newly developing technologies, my approach would not be different, even though some of the tools I would use might be upgraded. One of my first steps would b...

Oh, how I wish an investment in QA/QC infrastructure was a part of this nation's strategy in addressing and abating the spread of COVID-19. Having quality systems and professionals in place to mitiga...

Quality Assurance (QA) is more about preventive measures, having the right systems and processes in place, and complying with industry regulations and standards. Quality Control (QC), however, focuse...

I think the FDA heard your complaint, because beginning in 2019, FDA began making significant revisions to its 510(K) process to simplify the procedural steps and acknowledge that with the rapid advan...

Having already lived this experience, while being outside of the academic health setting, there are several things that I know now, but didn't know then. One of my first moves would be to gather an a...

My concern here is not drugs banned in the US but used in other countries. Instead, it's drugs banned in other countries but in wide-use here, like Ritalin and several opioids. In terms of restricti...

I was glad to have a lecture that distinguished between product development and product management. In small operations there is a tendency to blend the two together. Having spent most of my career ...

As others have noted, it seems that social media marketing strategies have become the predominant tactic for marketing to consumers, even those in the medical device and biotechnology industries. The...

In my opinion, emotional intelligence (EI) does not just encompass the ability to discern behaviors, emotional responses, and impluses of prospective client; it is the absolute key to fostering and su...

There are a couple of advantages that I see pertaining to having a DBA or trade name. The first one was already mentioned, where a company is acquired by a new owner. The new owners will likely have...

Ratios are very important in establishing industry financial standards and norms. Generally, it is important to note what industry your company is residing in. Some industries just are not high marg...

I find that nearly 3/4ths of the people I run into who are start-up companies are gravitating towards the LLC corporate structure, pointing out that they want to avoid double taxes. This is logic is ...

The financial incentives that drive industry, without question, account for the different pace than academia. What I have noticed is that partnerships with the private sector "quicken" the normal pac...

Initially, I leaned towards calling the Initiation or the Planning phases as the most crucial phases, but after a taste of real-life projects, I'm more convinced that the Monitoring phase is the most ...

I haven't had to directly participate in pre-clinical research involving animals. However, as the research administrator for my area, I have had more than one experience of test mice and rats dying u...