All device changes, no matter how minor or major, should be documented and controlled. If you were to do device modifications or improvements, it is a good way to keep track of design changes that did not work. Furthermore, a…   Read more»

As many have mentioned before me, it might be the most helpful to work backwards from the project’s estimated completion date. This ensures that all tasks and deadlines are done before the project is expected to be concluded and gives…   Read more»

I definitely agree on the importance of taking minutes in a meeting. It proves beneficial when your team or department has several ongoing projects or multiple deadlines coming up and meetings have to cover all these tasks and responsibilities. You…   Read more»

I agree that although there isn’t a document that explicitly states a design output, it doesn’t mean that the design doesn’t have an output. The design input provides a general overview of what your product will look like and how…   Read more»

A validation process we are currently executing is to determine if a new testing equipment will provide the same result as the previous equipment. The equipment is used to test our raw material and final product. Essentially, the process requires…   Read more»

Drugs do not have to claim to cure a disease or illness but drugs have been created to help alleviate symptoms of an illness or prevent flare-ups of a disease.  Regardless of the drug’s indication, clinical trials are there to…   Read more»

Although I have not had the experience in working in either a small CRO or big pharma, as someone who is new to the industry, I think I would opt for working in a small CRO. I work for a…   Read more»

While there are risks to participating in a clinical study for new drugs, treatments, or medical devices, they are necessary to ensure that products being released to market are safe and effective for human use. It is important to note…   Read more»

The internet has definitely had an impact in the way companies can advertise and sell their products. With the growth of social media and online platforms and an increasing number of people with a digital presence, it is easier for…   Read more»

I can understand why someone from engineering might decide to go into marketing or sales. After spending time developing a product, an engineer might find the idea of promoting the product they helped develop to the people who would actually…   Read more»

As many have mentioned before me, the best way companies can market their products nowadays is through social media. With more and more social media platforms being created and gaining popularity, establishing a social media presence is a great way…   Read more»

As the posts before me have stated, I don’t think that engineers have to actively worry about the shareholder’s opinions. From personal experience, that is definitely not something I have really concerned myself with in my projects. By the time…   Read more»

Since graduating undergrad, I have only worked for a small start-up biotech company so I cannot speak on what it is like to work for a big, established company. From personal experience however, a start up certainly allows me to…   Read more»

I currently work in R&D and have not worked in QA or QC role. In R&D, because we are focused on improving or creating new formulations and not making the product that gets released, we do not always have to…   Read more»

I have not worked in a quality role; however, I agree that organizational skills and communication are very important to the job. QC is part of every step of getting the product to market, from raw materials to release testing,…   Read more»

The roles in the quality team vary between companies. Because I work in a very small company, the quality assurance and quality control team consist of the QA engineer/associate, a documents specialist, the QC associates and then the managers of…   Read more»

I can see some of the value of the 510(k). It could make the process more efficient. If a company can prove some similarity to a pre-existing, successful device, then they can use the existing research or data to back…   Read more»

As my work is currently in the process of getting a medical device FDA approved, I understand where the frustration comes from with how strict and lengthy the FDA process is. However, I do not think that the FDA rules…   Read more»

While I certainly agree with those who say that the FDA process could be made more efficient with an increase in workforce, I don’t believe that the FDA process can really be accelerated. The phases in the FDA process that…   Read more»

As many have stated before, I do agree that missing a milestone is going to be typically looked at as a failure. Regardless of the reason for missing the milestone, it reflects poor planning or poor execution and can often…   Read more»