I think the responsibility depends on what went wrong. If the doctors and scientists followed the approved protocol, got proper informed consent, and the patient knew the risks, then it’s not really one person’s fault, since clinical trials always have…   Read more»

I would not put anything out on the market until I have more information regarding the testing and the pill. If the pill was really a placebo, it shouldn’t have done better than the placebo group, so something probably went…   Read more»

This question is actually a good point. Clinical trials should be accurate, and the placebo effect can make that harder. If the placebo group shows the same results as the group getting the real drug, that usually means the drug…   Read more»

Using color for marketing is interesting because different colors represent different meanings. For example, the color green can represent health, wealth, and nature. Nature’s Bounty, a supplement and vitamin company, uses green packaging on its bottles. TD Bank’s logo is…   Read more»

With the advancement of technology, the way companies market has tremendously changed. Instead of using media like TV or magazines, marketing now uses a lot of digital tools to attract customers. It is also way more cost efficient. Posting on…   Read more»

When it comes to sales, especially in the medical device industry, the main thing is building long lasting relationships. To be a successful sales rep, you must know your product as being in a clinical environment and building trust with…   Read more»

Yes, a company can invest its retained earnings in the stock market. It would open a brokerage account in the business’s name using its EIN, so the investments belong to the company, not the owner. Large companies like Apple do…   Read more»

If I were to open my own business, I would lean more towards a sole proprietorship rather than a partnership. Since I would be working as a freelancer on the side with my styling license, I don’t need a partner….   Read more»

A sole proprietorship is a business where one person owns everything, and it’s tied to their personal finances. Because of that, if the business becomes successful and the owner wants to pass it on to his two sons, he can’t…   Read more»

I think regulations can definitely be a barrier to improving product quality. When it comes to the FDA, there are huge amounts of paperwork and processes needed to approve an improved product. Because of this, some companies may choose not…   Read more»

This is an interesting way to think about quality control and innovation. When it comes to medical devices, patient safety has to come first, but I don’t think that means innovation has to suffer. I do think QC can feel…   Read more»

I think that even though companies know the risks that come with not following the rules, problems still happen within the companies themselves. This can come from poor management, pressure to meet deadlines, cutting costs, or steps not being double…   Read more»

I agree that the user fee system raises real concerns about bias. Even though the fees are set by Congress and paid whether or not a drug is approved, relying on industry for so much funding can still create pressure…   Read more»

During FDA inspections, the consequences depend on how serious the problem is. Serious issues can lead to warning letters, recalls, delayed approval of new products, or even fines and legal action. For smaller issues, it depends on what the problem…   Read more»

During FDA inspections, the consequences depend on how serious the problem is. Serious issues can lead to warning letters, recalls, delayed approval of new products, or even fines and legal action. For smaller issues, it depends on what the problem…   Read more»

Precision and accuracy play an important role in medical devices. The small mistakes can be life threatening when it comes to medical devices. Accuracy is how close the device gets to the right value and precision is if it gives…   Read more»

Precision and accuracy play an important role in medical devices. The small mistakes can be life threatening when it comes to medical devices. Accuracy is how close the device gets to the right value and precision is if it gives…   Read more»

When it comes to taking risks, it’s about a 50/50 chance of success. Companies can stick to the materials they know are safe, which keeps the business running, just not as fast as it could go if they took more…   Read more»

Medical devices must be biocompatible before any further steps. To test the biocompatibility, it must undergo in vivo and in vitro experiments. One technique is a cytotoxicity test, which is in vitro. The purpose of this is to test how…   Read more»

Before clinical trials, it is important for companies to test the device. I think the way they should do these tests depends on what it is they are testing and which one would be more efficient. For example, replicating an…   Read more»