I think making changes in the design early would be the most efficient when completing a cost/benefit analysis. Changing the design early on is usually cheap because nothing has been manufactured yet, and it removes the risk instead of just…   Read more»

I think that risk acceptance does not really create a higher probability of risk, but it does mean the risk stays the same because nothing is being done to lower it. Usually companies only accept risks that are low in…   Read more»

Some benefits of implementing a risk management assessment for a device include finding problems early before the device reaches patients, making the device safer. It also saves the company time and money, since it is cheaper to fix a problem…   Read more»

I agree, a surgeon, nurse, and patient can all want different things from the same device. I think one way to make sure everyone is considered is to actually go into the hospital and see how the device would be…   Read more»

I agree, this was something we struggled with too. One way I think about it is that the user need can stay the same, like “easy to operate by surgeons,” but you break it down into something you can actually…   Read more»

The good thing about the DID is that it gives an overall description of the device and what the user needs. However, it is not descriptive in detail, so it would be hard to build or test the device from…   Read more»

To define success criteria, the team must have a plan and a step by step process. First they need to know what the device is supposed to do and the user needs. Then they set criteria that can actually be…   Read more»

I think that verification and validation are both equally important. It can be somewhat simultaneous depending on what the design or device is. However, if they are worked on simultaneously, it could potentially overlook the purpose of each one and…   Read more»

When it comes to design, user needs are the first step. If you do not know user needs, you cannot continue on to the next part. Knowing what the user needs is key to developing a successful design or product….   Read more»

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»