My senior year’s capstone or design project was the development of a computational pipeline to help sort and categorize different cell types into its biological classifications. Our market research involved defining a target market, which in this case would be…   Read more»

I think that the team should first have a strong basis of understanding for what is being examined and needed to be defined. Preferentially, the decision should come down to a cross-functional project team that can have multiple perspective/inputs to…   Read more»

Having worked at a medical device company as a QA intern, I worked on ensuring compliancy with CAPA records, some of which that were opened because of design controls issues. I think largely, CAPA reports require a heavy dosage of…   Read more»

Design controls are important for any manufacturing or R&D role because it allows it would ideally provide limitations of what is safe enough to be used or allowed in specifications, which is typically discovered during experimentation/research, or mistakes found/recalls made…   Read more»

I think to revise design controls for a medical device, it starts with understanding why the controls are there in the first place, including the history or events that may have lead to the controls being implemented in the first…   Read more»

There is a whole sea of CROs and medical/pharmaceutical groups that are looking for all types of participants to participate in one of their clinical trial. Each study having its own inclusion/exclusion criteria makes it easy to find a wide…   Read more»

Given my background in research, medical devices, and clinical trials, I feel that I would be able to take on any role comfortably after the typical training and learning curve procedures. However, in terms of personal preference and overall skills,…   Read more»

From my internship at a CRO, I was able to observe the workings of phase 1 and 2 clinical trials that were happening. For the study in its second phase, I was able to witness a developed drug undergo its…   Read more»

I think this is an interesting question to pose for those with or without entrepreneurship ambitions. I think most biopharama or medical device companies share a similar mission objective in the sense that it generally follow the guidelines of collaboration,…   Read more»

Like many of the posters above, I would also like to reiterate the importance of the sales and marketing team behind any product’s development and marketability. It is important for any product to be: a.) known by its consumer base…   Read more»

In a business perspective, I believe that a company should consider run their advertisements based on the general demographic of a specific channel. For example, advertisements for toys or games could be run on channels that typically have more younger…   Read more»

I like alot of the points mentioned above arguing for both sides. On one hand, I strongly agree that it is not ethical to establish large margins for medical products that consumers would find to be a necessity for their…   Read more»

From the state/government perspective, I worked for a non-profit organization that focused on providing kids with physical activity and lunches during the summer. The way they handled their finances was that the city would spend every allocated amount possible towards…   Read more»

I completely understand the point of view you are conveying. I too always thought it was a bit strange that whenever there is any type of legal issue or controversy in regards to a corporation’s actions or outcome, it is…   Read more»

I absolutely believe that when a client is requesting a contract company to build out a medical device, it is absolutely necessary and recommended that the client come in as needed to observe, measure, analyze, and determine whether or not…   Read more»

I completely agree with the synopsis and iteration of significance of quality assurance and control, but I would also like to add that regulatory affairs is equally important in maintaining that the company is following all applicable local, state, federal,…   Read more»

I personally have familiarity working on quality, specifically in the medical device industry. In quality assurance, the management and verification of Corrective Action Preventive Action (CAPA) is essential to ensuring that issues in the quality or efficiency of a product…   Read more»

MDSAP has its benefits and disadvantages that the other users described above. I won’t be going into that since most of it will be a repeat of what they said. What I would like to address is a typical company’s…   Read more»

I absolutely believe that the slow moving process of the FDA approval process of a medical device is a sign that the system works. It is the FDA’s duty to ensure that every product out on the has been throughly…   Read more»

To my knowledge, general regulations and restrictions on what is the acceptable threshold or guidelines for a medical product should already be listed on the federal website. Of course, not all medical products are treated the same because of variations…   Read more»