These three documents were the backbone of the entire Capstone project. These documents follow the project’s journey from it’s conception to its completion. The requirements document describe the project’s overall characteristic from its physical characteristics to its technical features. These requirements were all based off of the customer needs…[Read more]

In Capstone I and II, I participate in my team’s weekly design review meeting along with our advisor. During design review meetings, my team and I would start it off by discussing the milestones we’ve accomplished and missed; These milestones were set at the beginning of the project. During these meetings we give and get inputs from everyone about…[Read more]

Meeting minutes is good to keep track of because this also helps you keep in track of what phase you are in in a project. For Capstone, I have weekly meetings with my group members and advisor, and everything that was discussed in the meeting is logged; we also discuss where we currently stand regarding the project which tells us what we need to…[Read more]

For Capstone II, I had to make up a test method to validate the product. I don’t remember having to use a specific set of criteria for validation. When I had to do it along with my team, we thought of what could be done by ourselves to validate our design. For example, I was responsible for the mechanical properties of the product. So what I did…[Read more]

Having completed Capstone I and II, the requirements and test plan documents are the most important documentation you have for your product. These documents describe the product’s mechanical properties, electrical properties, biocompatibility and the likes. These documents are also considered living documents because if there are any additions to…[Read more]

I agree with your stand regarding clinical trials. It is necessary for discovery but comes with greater risk in the form of a negative impact on the well-being of the subject when the experiment goes awry. I think that human subjects are necessary in clinical trials however its still ways a way before we can completely eliminate this method…[Read more]

I agree with the consensus here. Double blind study will produce a more reliable/unbiased result because the data that will be collected is based solely on observations by the investigators. I think that if the investigator has prior knowledge as to who got placebo or the actual drug can affect their judgment when recording results; because in a…[Read more]

I think that informed consent is an important aspect in a clinical trial or hospitals because this protects clinics/hospitals/laboratories/organizations from liabilities when things go awry. In the case of Henrietta Lacks, her cells were cultured and used for research without her consent. I think that Johns Hopkins should’ve done their due…[Read more]

You’re definitely right about the financial burden being less in partnerships as oppose to sole proprietorship. Also, you are right about the great risk in choosing the right partner. I think that entering a partnership is something that will only work with someone who you fully trust. Someone who is really close to you where you both share the…[Read more]

I agree with what gaberuiz13 says. In this time and age, it is really challenging to land a first job offer as a recent graduate especially not having any industry experience from internships or co-ops; especially true in engineering. Even having average to good credentials/grades right out of college is challenging in landing that first job that…[Read more]

If I were to be an owner of a business, I would want to own a piece of an LLC. A LLC can have multiple owners including corporations. Therefore, the possibilities are endless in addition to being able to sell shares to raise funds; and being able to take out a loan more easily compared to a say sole proprietorship. Also, the tax is passed on to…[Read more]

Sounding off to the previous posts. I think that R&D and Quality Assurance/Compliance conflicts in most cases due to the differences in the role they play and the overall objective they need to meet. Quality assurance/compliance dictates whether each or several procedures/processes are within company or regulatory agency guidelines to ensure that…[Read more]

Echoing on what dh239 posted; This is what happened in the Ford Pinto case. The company knew that there was a flaw in the design and they did the risk analysis and calculated the amount that would be needed to change the part that was defective. It would cost them a little over $10 to make the change for each car and they thought that because they…[Read more]

Although quality can be burdensome due to several factors mentioned in majority of the posts here; I think that its worthwhile for companies to implement it, especially for companies in the medical/healthcare space. Quality Assurance/Control makes sure that the processes and procedures that a product undergoes are within the company’s guidelines…[Read more]

As of now, animal testing is the closest we can get when it comes to testing new medicines, vaccines or medical devices on a living subject before moving on to actual human subjects. This is due to the limitations in our current technology and mathematical methodologies which we use to simulate changes in a system. For example, in one of the BME…[Read more]

In the industry research is done by scientists or engineers as oppose to grad-students or post-docs in academia. I think that researchers in the industry setting is a better approach since you have a wider selection of candidates that will do the research. I’m not bashing or discrediting grad-students and post-docs, but I believe that being in the…[Read more]

I think research that will yield results to be used for now can lead to research ideas that can be improved upon; which will then pave the way to a research study that will be used for future generation or vice-versa. This is the beauty in research, where discoveries have applications in the current generation and the future. So, personally either…[Read more]

In Capstone I and II, there are several milestones set to ensure completion of the project at the end of the 2 semester course. Here, if milestones were met its marked completed but if it is missed; a team must have a contingency plan to ensure that the project isn’t stalled. So a missed milestone is a failure if and only if there is no…[Read more]

Managers and engineers play completely different roles in projects, which can cause ethical dilemmas that has no clear answer(s). Managers are mostly concerned with the end results where they must meet certain deadlines, budget and etc. to make a profit for the company. Engineers, on the other hand, are the mind behind these projects where their…[Read more]

I think that the main challenge project management for medical devices face is the lengthy time of certain projects. This is mainly due to the rigorous protocols and strict regulations enforced by the FDA or other regulatory agencies alike. Since medical devices are in direct contact with humans, testing can be quite a challenge where specific…[Read more]