I feel that the rules are necessary. While it is nice to thank a collaborator and talk business over a dinner or conclude a deal with a gift, it is influencing the other party in a way that has nothing…   Read more»

Initially, I imagined this course would be about the considerations put into each medical device and the creation of devices and was not expecting a course on the industry itself. However, the course has been extremely helpful and I came…   Read more»

An NDA seems to be a precursor to a patent where a developing idea can be reserved and kept secret while it is developed into an idea that is capable of being patented. NDAs cannot substitute a patent and are…   Read more»

I agree with the previous post: matrix organizations are definitely better suited for collaboration projects. They are more efficient and would save resources and allow for a more seamless flow between departments in the project.

I definitely think that there should be a balance between team relationship and expertise. It is possible to develop a good team dynamic from random individuals so long as there is proper leadership, so a strong leader with expertise in…   Read more»

I also see myself to be better suited for a middle management role. I have limited experience and would not be suited for an upper management position which would require expertise on a more global level. Middle management is in…   Read more»

As others have mentioned, a thorough understanding and full participation from all members is crucial for a risk management meeting. In order to ensure unique thought and involvement, I feel that it would be best to have members analyze risks…   Read more»

I believe that thorough documentation of failures and tests with attention to a variety of components would be the best way to analyze risk. Often times, failures due to one cause can indicate weaknesses in different parts of the design….   Read more»

“As Far As Possible” (AFAP) sounds like a very general term that is open to interpretation and so it becomes the work of the company to meet industry standards for risk assessment and minimalization. This would include the use of…   Read more»

During a design review, at least within the bounds of our senior project, we would evaluate our project step by step with our customer and group members. Usually, during this time, problems were pointed out and points were clarified by…   Read more»

Early verification and a thorough verification are both necessary to ensure that no problems arise in the future. I agree that the cost to compensate for a mistake far exceeds that of taking preventative measures. By implementing multiple checkpoints throughout…   Read more»

While I agree that outsourcing can be a cost-effective and overall wise move for a company, there are also a few drawbacks to consider. Primarily, outsourcing adds another step to bringing the product to market. Transfer between the company and…   Read more»

Validation is not necessary when there is an update to the design which has no bearing on the usability or function of the product. For example, changing the color of a device from blue to green, where color has no…   Read more»

Design verification deals with confirming the inputs of the project with its outputs. It is a way to see that the requirements have been met and that the device was created in its entirety. Validation confirms the function of the…   Read more»

In our student organizations, minutes were always a chore delegated to the lowest ranking member. However, last year it became an issue when our minutes were not posted on the website. We were finalizing a project and erroneously left out…   Read more»

I feel that it is acceptable to take the risk of a clinical trial when the results of the trial are expected to either benefit or not affect those involved. This would be in the case of testing an intervention…   Read more»

Placebo-controlled studies are a necessity when it comes to establishing the efficacy of a drug, however, their ethical foundation comes into question when a placebo is given instead of an established treatment. This would be like giving a diabetic a…   Read more»

I feel that, while not necessary, it is very advantageous to have a clinical background in the role of a CRA and especially in the role of a principal investigator. The reason for this is that a clinician has been…   Read more»

While the comparison between Apple and a medical device company is a bit of a stretch, they do use some similar techniques in terms of advertising. My father, who is a physician, always comes back from conferences with company-sponsored pamphlet…   Read more»

Participation is an important aspect of marketing because of how easy it is to block out all the noise. Companies need to make it so that their consumers seek out and engage with the company and the product rather than…   Read more»