It always works out well when you really get along with the people in your groups. However, there does need to be some ground rules set before you begin working with someone you already know. Part of working in a group means sometimes you might not agree on everything, but keeping things professional and being flexible are a good way to alleviate…[Read more]

Once the meeting is set up and the purpose and function of the device is fully understood, it would be a good idea to have a group discussion about the potential risks associated with that product. Once the basic ones are identified, have everyone in the group fill out a risk analysis questionnaire that further uncovers any and all risks that…[Read more]

I think one reason why companies get risk analysis wrong is because they know it requires a lot of work. What I mean by this is that once risks are identified and a plan is put out to deal with those risks, part of doing the risk analysis is to follow up with those tasks. If a new risk is identified along the way that maybe wasn’t thought of…[Read more]

One technique for risk analysis that I came across is a bottom-up approach called HAZOP (Hazard and operability). This is usually used for more complex devices that has a very involved process. In this instance, multiple control factors are identified and evaluated using a risk matrix. Another approach is FTA (fault tree analysis), which is a…[Read more]

Design inputs include customer needs as well as customer requirements. These are the aspects of the product that are expected to happen. For example, if you state that your product has a sensor that should flash red when interacting with a certain indicator, it should not flash green. These are the broader inputs that are addressed in the DID. The…[Read more]

It hasn’t happened to me personally, but recording the minutes of each meeting allows everyone involved to be on the same page about what was discussed. Many times some things may be stated or decided that are later disagreed upon. If the meeting minutes are logged correctly, this can be easily resolved by referencing that. It also allows you to…[Read more]

The purpose of Design Controls is to prove to the FDA that the product has all of the necessary requirements for being released to the market. The FDA needs a way of mapping out exactly how your product was made and the steps you took to make it. It is also a way to back track if something goes wrong and to see if there are aspects of the product…[Read more]

Each document serves a different purpose. The DID gives a broader view of the product, outlining certain indicators and/or how it will function in a general sense. This document is mainly targeted towards people who are just trying to understand what your product is. However, the DSD gives the specifications of each part of the product. This…[Read more]

If there is no way of mapping out how the device was made, the effects can be very detrimental. If something were to go wrong, there needs to be way of tracing back and figuring how/what went wrong and if there’s anyway to rectify this mistake. The FDA wants to make sure that the manufacturers are held accountable for everything regarding their…[Read more]

Design controls are a way to prove that you have done everything according to the procedures outlined by the FDA. It ensures that everything is accounted for in terms of risk management and that it performs the way it is designed to. Not only does this help the manufacturer for any liability issues but it also allows for future modifications. The…[Read more]

I think the point of a double blind study is that it eliminates any biases. The researchers and doctors might expect or wish for a certain outcome and might influence the distribution of the drug/therapy, making it biased. In order to prevent situations like this, a double blind study would be used. The randomized the study is, the experiment…[Read more]

Placebos used in studies are useful because they act as a sort of control. As stated previously, the brain is very powerful and can allow you think something is happening, when it actually may not be. As long as the placebo stays in line with rules and regulations, it is ethical and is an important part of doing clinical studies. This allows the…[Read more]

Clinical trials are necessary in order to further advance the final product. As Professor Simon stated in his lecture, you can’t assume that because something works in a mouse or rabbit, it will work the same way in a human. This is why clinical trials are needed. Also, these trials are never done without the consent of the patient. Thus, they…[Read more]

EI, or emotional intelligence, is the ability to understand one’s own emotions as well as the those of other people. EI is used a lot in marketing because it allows companies to focus on things that will grab peoples’ attention and influence them to buy the product they’re trying to sell. If a company knows what the target audience’s interests…[Read more]

I don’t know if I would use the word “manipulating,” but rather influential persuasion. People who work in marketing need to be able to persuade people enough to influence them to buy the product you’re trying to sell. A huge part of the way that is done, especially today, is through social media. Now that we have the option to block these ads,…[Read more]

To me, marketing is knowing your customers and targeting your sales pitch to get them to want to buy your product. This includes things like getting advertisements sent by mail or online, commercials/infomercials, or phone calls. Marketing in the medical device community is different because it is usually targeting patients with a sickness or…[Read more]

If a company of that size existed as an Inc corporation, it would allow more people to invest in the company’s shares. This also gives the option of eventually going public, which would create a lot of revenue for the company since there will be a lot of people investing in the shares. This will also make them more well-known among other…[Read more]

I think depending on your skill set, you need to decide whether the company’s success is big factor in accepting that position. If you’re fresh out of school, I wouldn’t think that this statistic would matter too much, unless however, you really feel that you have the skills and qualifications that allow you to be a little more selective. I think…[Read more]

Private companies are not able to trade shares with the public, whereas public companies can. The benefit of staying private is that you don’t have to alter you business model to fit Wall Street’s expectations. You are also in control of who is investing in your business. However, the cons of staying private are that your company name is not going…[Read more]

There always seems to be a lack of communication between QA and other departments. In my department, whenever the QA department is testing for certain results, it may take a long time, Often times, moving forward with the process relies on obtaining these results, which delays the manufacturing process further. It also seems that they sometimes…[Read more]