From research I did, there are 6 steps to package development for medical devices. The first step is consulting the regulations. This step is to determine if the medical device falls under the FDA requirements regulations for packaging. The second step is gathering packaging design requirements.The third step is establishing packaging system…[Read more]

From my experience working for Zimmer Biomet, I would say this company is a functional organization. I am currently working as a Quality engineer, but we work with other groups such as manufacturing and R&D. I have only been working here for a few months but I think I would be better suited for a more project-based company. I like to constantly be…[Read more]

To add on to what everyone said above, the intent of the Risk Management Plan is to “Differentiate most critical product features related to safety/harm, Quantify and determine acceptability of risk, Provide focus and priority for product development and lifecycle activities (such as V&V, CAPA, etc.)”. The Risk Management Plan includes: ass…[Read more]

As the majority stated above, I do not think there are a lot of risk and default in the Validation & Verification procedures. The V&V procedures are “…driven by the regulatory environment and international standards.” As long as the procedures are done properly, I do not see any major issues. I agree with hc255, where an issue can be that the…[Read more]

This is based on the article project manager. To prepare a successful project for designing a Medical Device these steps should be taken. The first step is the background which includes history, requirements, and solution. The second step is the proposal. This step includes the company’s vision/goals, a blueprint of the plan, time frame,…[Read more]

The Quality plan is an important and essential part that should be implemented. As stated by puneet, there is a certain quality standards that must be maintained throughout the project. Also, “…deploying and executing a quality plan incorrectly can lead to compliance gaps and actually create more problems than it solves”. A correctly pro…[Read more]

I believe that the Regulatory Compliance will remain the same and it will be a long and tedious process for the FDA to approve these medical devices. I also believe that it will be difficult to secure funding and that the cost will always remain high. The reason for this is as bnb6 mentioned, high cost is an issue in the medical field as a whole.…[Read more]

I completely understand where you are coming from and believe that companies should provide more resources for a team to keep up with deadlines or at least give them more time instead of canceling the project. I do think it is difficult though to hire more employees to keep projects running. Every company has a certain budget that can go into…[Read more]

I can understand where you are coming from and do see conducting clinical trials as an expensive, long, and risky investment. The problem is that I do not see an alternative to testing these devices. One thing that can be possibly done is to make the regulatory path more efficient as srg36 mentioned above. But aside from that, clinical trials are…[Read more]

As an NJIT student in the BME department, I personally believe this is a proper investment. Ceteris paribus, what separates two engineers are their interpersonal skills. However, a key assumption is that both individuals have a solid foundation in their respective fields. Without that technical foundation, interpersonal skills are not as…[Read more]

A real industry project is actually very similar to how simulations are done. The similarity is that each member of the group usually does their own research before meeting. When you meet in person you will discuss possible solutions as done in the simulations. Your team will discuss the pros and cons to each solution. One difference is that…[Read more]

As someone who works in industry, interpersonal skills are very important in order to be successful. Interpersonal skills include verbal communication, listening skills, problem-solving, decision-making, and ect. These are extremely important because a successful engineer is able to listen and get every detail of an issue. They are then able to…[Read more]