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 out learning a lot more about the industry than I had ever imagined I would while still in academia. This…[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 most often used when an idea cannot be patented. An NDA has little bearing over cases that are outside of the direct agreement between the…[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 motivating a group is of utmost importance. Then, individuals who are sufficiently knowledgeable in their…[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 charge of smaller groups of individuals and is an important link in the chain of command whereas upper management…[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 independently, drawing from their own backgrounds and then compiling the list of risks together for…[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. By monitoring the reason for failure along with other aspects of the design, it is possible o improve the…[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 up-to-date methods of analyzing risk and constantly updating documentation and procedures to ensure that risk is…[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 the group members. This is a constructive meeting that allows the group to track progress and ensure that…[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 the process, and doing testing on batches based on a statistically representative…[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 the location that the work is being outsourced to will cost additional time and money, which could…[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 bearing on function, would not be re-validated. However, it is good practice to validate all designs because it is important to…[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 product in the intended application. For example, a car would be verified by checking if it had an engine, wheels,…[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 an important aspect of it that was discussed during the previous week’s meeting. While tedious, minutes are…[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 that can be supported by pre-clinical trials to have the ability to positively impact the patient. It is not ethical to deny an established…[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 placebo to control for the testing of a novel drug while there are already other, effective drugs…[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 trained to understand the day to day operations in a clinical setting, and have been directly involved in the administration of care.…[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 and models that show the designs of new and improved products. This targeted advertisement is important…[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 just stumble upon a commercial or billboard. Some interesting methods I have seen include sweepstakes/ surveys and the…[Read more]

I feel that there is a strong negative connotation to the word “manipulation” and that its use in this field is not always appropriate. When the features of a product or the availability of a product convince a consumer that they should purchase it, that is simply persuasion. However, if an individual is coerced into buying a product, either with…[Read more]