Activity | smk45 | Medical Device Courses

smk45 replied to the topic "Sample Size Based on Risk Analysis" – 5 years, 11 months ago

Hi Abhishek, After doing some research, I found that conducting a hypothesis test of effects/relationships (power analysis) would be ideal in determining sample size. Studies that attempt to determine an effect such as differences between two treatments or the presence/absence… Read more»
smk45 replied to the topic "Factors to Consider While making Gantt Chart" – 5 years, 11 months ago

Hello, I have yet to gain industry experience, but I do have experience in creating Gantt charts for my Capstone class. A good practice is to start off by documenting what the purpose of the Gantt chart is and then… Read more»
smk45 replied to the topic "Minutes for meetings" – 5 years, 11 months ago

The responses on this post do a great job at illustrating why meeting minutes are important. Meeting minutes are there to represent what initiatives a company takes and serves as legal protection. The IRS, courts, and auditors will only look… Read more»
smk45 replied to the topic "When is validation is not required?" – 5 years, 11 months ago

Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability engineering process in order to reduce… Read more»
smk45 replied to the topic "Consequences Of Insufficient Design Controls" – 5 years, 11 months ago

Hi Lamiaa, thanks for bringing this topic up. From what others have mentioned, it can be seen that the problems that arise from insufficient design control are significant. I wanted to give a couple of examples of medical device failures… Read more»
smk45 replied to the topic "What are Design Controls?" – 5 years, 11 months ago

You make an interesting point Lamiaa. It definitely becomes a problem when a company strays away from adhering to their design controls. I am not quite sure what you mean when you say that “when the process becomes heavy, they… Read more»
smk45 posted a new topic "Package Development Testing & Documentation" – 5 years, 11 months ago

This week is simulation week and our project is on Bottle Label Development for a Hydrophilic Coating Product. This got me thinking about package development for products and the types of test they must pass. Any testing done on the… Read more»
smk45 posted a new topic "New Medical Device Project" – 5 years, 11 months ago

Once you get a new medical device project, the first two things you should do is find out what the user needs are and establish a design plan. When going about user needs, what kind of questions do you ask… Read more»
smk45 posted a new topic "Pros and Cons of the 3 Organizational Structures" – 5 years, 11 months ago

This week’s lecture describes that there are 3 different organizational structures: functional, projectized, and matrix organizations. Each organizational structure greatly impacts the way the company manages projects and how employees work. What do you think are some pros and cons… Read more»
smk45 posted a new topic "Fitbit Medical Device?" – 5 years, 11 months ago

I came across an article that discusses whether or not Fitbits should be classified as a medical device as per new FDA guidelines. Since it is not 100% clear as to what the FDA will regulate, it hinders big tech… Read more»
smk45 posted a new topic "FDA Regulations of Medical Device-Drug" – 5 years, 11 months ago

This week’s lecture got me thinking on how the FDA regulates a product that is both a medical device and a drug. There are clear and separate regulations for medical devices and drugs individually but what happens when you have… Read more»
smk45 posted a new topic "Risk Management Mistakes" – 5 years, 11 months ago

I came across an article online that highlights 4 reasons why a company’s risk management approach may be wrong. It was an interesting read and indicates the following as major errors: 1. Risk management and design controls are separate processes… Read more»
smk45 posted a new topic "Design Verification & Validation" – 5 years, 11 months ago

While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs. They both must… Read more»
smk45 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

Maintaining a good relationship with vendors requires effort, like everything else that is good. On-time payment to vendors is definitely a priority because you are doing business with them and this is the best way to show that you are taking things seriously and are capable of fulfilling your word. Great things come from great communication, so…[Read more]
smk45 replied to the topic Why do people work? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

The results here don’t particularly surprise me! Everyone wants to have a purpose in life and a lot of times, we draw that from our work since we dedicate most of our time in a given day to doing that. We want to be the best that we can be and having exciting, challenging work gives us a reason to conquer it. Also, having opportunity to rise in…[Read more]
smk45 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

Dr. Simon’s classes are always very practical and teaches the reality of how the medical device industry works. Taking this class has enlightened me on what kind of company I work for (matrix organization), which I didn’t think of before. Also, this class has taught me more in detail on documentation procedures that must be practiced such as risk…[Read more]
smk45 replied to the topic Overworked Americans vs. Motivation in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I believe that Americans are overworking due to a combination of factors including motivation, peer pressure, and more work to complete overall. Motivating factors in this economy is to make as much money as possible to be able to live a decent life. School tuition is very high, so in order for people to be able to pay for higher education,…[Read more]
smk45 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I would love to continue as an engineer until I become a principal engineer. Once I am a principal engineer for a few years, then I would consider looking into a management position so that I understand how to manage every level of engineering because I’ve already gone through those positions. I really do love the hands-on work that engineers do,…[Read more]
smk45 replied to the topic What’s Your Motivator? in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

One of my biggest motivation at work is to perform in such a way that my manager has minimal to no negative feedback. When I started off with CAD work, my manager came back with a lot of constructive criticism, which I greatly appreciated because it helped me understand what was expected of me. But each time I sent him my CAD work, I tried to…[Read more]
smk45 replied to the topic Single Source/Dual Source in the forum Project Management Knowledge Areas 7 years ago

Hi ks629, I think you make a valid point but I see why using a different coating from the same supplier may be beneficial. Since the contract is already signed with that specific supplier, it’s easier to change product selection within the company itself rather than seeking a new supplier. Now, it depends on why the primary source failed to be…[Read more]
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