During our verification testings, we at times notice deviations between the final product and the input design of our dental implant crowns. We bring in dental technicians to score every test product we produce and if any receive a score lower than acceptable, based on the potential risks, we investigate what went wrong. Often times, it has…[Read more]

Most of the design reviews I’ve witnessed were mostly informal during project meetings. From what I’ve seen, initial designs are subject to many changes throughout the course of a project. The reasons for such changes often occur to minimize testing costs, lower material consumption, and of course to pass the testing phases if the original design…[Read more]

At my company, I work in Integration. Our job is to conduct validation tests for software and scanner updates. From what I’ve experienced, I noticed that to conduct and produce a successful and sufficient validation, being as extensive and critical as appropriately possible is key. This means conducting extreme and a wide variety of trials that…[Read more]

Taking minutes and reviewing them has multiple benefits that I personally have noticed greatly during my time working in the industry. One obvious benefit of taking minutes for meetings is that it keeps everyone informed of the status of important projects. In the industry, every minute is valuable and cannot be wasted. Especially when projects…[Read more]

Although not as important as single-blind study in my opinion, double-blind study does indeed present added assurance to the accuracy of the trial results at the end. Because the investigators who interact with the subjects will not be aware of who receives the real drug and who receives the placebo, there is absolutely no possibility for an…[Read more]

I believe placebo-controlled trials are indeed beneficial and in some cases, necessary in certain developments. I believe, for instance, drugs and treatment that involve improving ones mental state would find it very beneficial to conduct PCT’s. It would be beneficial because the way our emotions, as well as physical bodies, respond to the wide…[Read more]

I believe the new Right to Try law is a good move for the most part for the obvious reasons. The best case-scenario is that the patient recovers with the help of an investigational treatment and that company attains validation for their product. Validation for drugs and medical treatments take an incredible amount of time and resources to ever…[Read more]

As funny as this video was, I believe it did still hold some truth to the dynamics of collaborating on advertising a product. Although all members of a company ultimately want the best outcome for their products, they each independently have unique perspectives, skills, outlook, and roles. This video did an excellent job in illustrating how that…[Read more]

I found one of the most memorable types of advertisements are those that attempt to discourage dangerous habits, such as driving under the influence, by illustrating the ugly outcomes that may come forth. It’s chilling and eye-opening because these types of advertisements often start off normal and comparable to how many of us live our lives. But…[Read more]

One distinct color I notice is carefully used throughout many companies is red. Aside from being used with other colors to promote things like hunger, red often gives a more aggressive and loud expression when used; and companies often use it in small amounts to dramatically draw attention to something specific. In many cases, it is used for sales…[Read more]

Piercing the corporate veil would seem to be an appropriate course of action in court when there is serious misconduct within the operations of the company. Most of the time, judges attempt to avoid piercing the corporate veil, as it stunts development within public markets and causes individuals to mistrust LLC’s. There is no set reason why a…[Read more]

The benefit of a C-corp is that you can deduct costs on your corporate taxes if you need to pay employee benefits. For any company that plans to grow, you will need a certain amount of shareholders to go public. Another benefit a C-corp provides is that they are not limited to the number of shareholders they can have whereas S-corps are. However,…[Read more]

There are a few important differences between public and private companies. The biggest would have to be that public companies open their shares to the public whereas private companies sell to certain investors and venture capitalists. This causes deviations in the standards and rules these two types of companies must abide to. A public company…[Read more]

Although I do not work in Quality, I would like to pitch in some input on how our company prepares and handles audits. Every year, our holding company carries out an unannounced mock audit. These mock audits, from what I’ve been told, are much more thorough and demanding than regular audits. Fortunately, we have passed every mock audit to date and…[Read more]

Certainly, having a department oversee another to ensure standards are met can easily create tension between the two. From what I believe, as well from what I’ve experienced in the industry, I’ve come to understand an effective way quality departments maintain good relations with other departments. Many times, teams such as R&D may get agitated if…[Read more]

I work in the Validation department in my company. Our main goal in validation is to test supporting hardware, as well as new software/software updates. To ensure that the types of tests, as well as the magnitude of testing we carry out are sufficient, our Quality department works very close with us to discuss the strategies we should follow.…[Read more]

Personally, from my experience working in the industry, I’ve actually discovered something rather interesting regarding this topic. I’ve met multiple people from very different ethnic backgrounds. Many of which are not even citizens here in the US. However, despite being from different cultures and even different countries, I’ve truly noticed that…[Read more]

Accuracy and precision are crucial factors that must be considered when developing any medical device. Medical devices today typically consist of multiple parts and dimensions. In addition, these products are produced in large quantities. It is up to the accuracy of the machines and processes that create these parts to remain both accurate to the…[Read more]

Determining how restricted a certain medical device or drug should be in order to effectively protect consumers is certainly a difficult and somewhat abstract task. Assessing the risks and possible side effects requires a tremendous amount of effort and even then, there is almost never a 100% certainty that those observations are accurate.…[Read more]

To begin, I believe before running any type of test, determining the molecular compound, as well as the intended application, of the material is the top priority. For example, titanium, certain ceramics, and synthetic polymers can all be biocompatible but won’t all necessarily be appropriate for multiple biomedical applications. (e.g. titanium is…[Read more]