Risk acceptance does not lead to a higher probability of risk. When you are accepting a risk, it means that the team has done all they can to mitigate the risk. There comes a point where the team can’t mitigate…   Read more»

I have used FMEA before in my role as Mission Assurance Specialist for a NASA Workforce Development Program. I find it very helpful when doing risk assessments because it has all the necessary information you need to effectively evaluate the…   Read more»

As part of my job, I am required to attend various safety training sessions to use different equipment. As part of Radiation Safety Training, I heard the importance of covering any radioactive material that you are working with, once you…   Read more»

DIDs and DSDs are living documents, which means that if an error is found, it can be corrected easily. Since DIDs and DSDs are always being changed and reviewed, an error that is found early on may be corrected. In…   Read more»

Minutes in a meeting are extremely important because they can give deadlines for projects and assignments for certain tasks. Everyone must read the meeting minutes so they are up to date on the status updates on the different project tasks,…   Read more»

This is a really good point about the updating process of living documents within the medical device process. I think organizations can balance maintaining up-to-date documentation while preventing inefficiency or information overload by having the project team note down any…   Read more»

For my capstone project, my group and I created a wound healing hydrogel for cutaneous wounds. The main issues in design and development were the design of the mold used to shape the hydrogel (this was my job) and finding…   Read more»

I don’t think that there is ever a time when a team decides to log more inputs for predictive measures. If they did that, they would have to log more outputs. If the team has more ideas of possible risks,…   Read more»

I am not aware of any companies that encourage their employees not to record unsuccessful instances associated with the medical device in the verification report. If a company does do this, when they submit the Design Verification File, which is…   Read more»

If patients are being rewarded for being tested on, the researcher may take advantage of them and perform unethical experiments. Patients have the right to leave the clinical trial whenever for whatever reason. If they receive an incentive to keep…   Read more»

In my opinion, the placebo effect does not have negative effects on a clinical trial. The placebo is the control, which is compared against the actual drug/medication that is given. If a patient in a clinical trial is given the…   Read more»

AI use in clinical trials can introduce bias into how patients are selected and who is chosen, and this is because humans make AI using their own biases. This affects the reliability of the trial results because the patients in…   Read more»

One way of clever marketing that I have noticed is Spotify Ads in the free version of Spotify. Spotify has now made it so that if you want to listen to ad-free music, you have to pay for Spotify Premium….   Read more»

If I were to create my own company, I would create a company that designs and manufactures accessible technology for people with any sort of impairment that makes it hard for them to use their hands or general hand weakness….   Read more»

Involving patients in marketing strategies can be beneficial, but there are also downsides. Having someone who might potentially use your product be able to give input on what other products they use and what made them buy those products would…   Read more»

I recently accepted a job working as a Polymer Processing Intern at New Jersey Innovation Institute. This is my first industry job, and the reason why I decided to accept this job is that I get to learn things I…   Read more»

There are plenty of engineers who have started a business without an MBA degree. I believe the best way to learn about how a business works is through working at one. Pursuing an MBA is a good way to learn…   Read more»

A sole proprietorship can be turned into an LLC, so if the dad wants to pass on the family business to his 2 sons, he would have to go through the process of converting his sole proprietorship into an LLC….   Read more»

For my capstone project last year, my group made a wound-healing hydrogel. I was in charge of designing and 3D printing a mold for the formulation to freeze and thaw in. I had to make 4 iterations of a mold…   Read more»

QA and QC are often interchanged but they are different things and companies should put equal time and effort into both. QA refers to the regulation of how a process is performed/how a product is made. It is important for…   Read more»