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smk45 started the topic Package Development Testing & Documentation in the forum Introduction to Project Management 7 years, 6 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 packages should measure the effects and interactions of the levels of packaging, the package contents, external…[Read more]
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smk45 replied to the topic Project management team in the forum Introduction to Project Management 7 years, 6 months ago
It is very important to pick team members wisely. Depending on the types of projects your team covers, it’s ideal to pick people who have qualities that your team may be lacking in and/or in need of. Also, having people with good interpersonal skills is a big factor to consider because these are the people you need to be in constant contact with…[Read more]
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smk45 started the topic New Medical Device Project in the forum Introduction to Project Management 7 years, 6 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 to determine what the user needs are based on your experience in industry or academic settings? Also, how has your company/research institute…[Read more]
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smk45 started the topic Pros and Cons of the 3 Organizational Structures in the forum Introduction to Project Management 7 years, 6 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 for each organizational structure and which structure do you…[Read more]
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smk45 replied to the topic Experience with Design Control in the forum Introduction to Project Management 7 years, 6 months ago
I’ve practiced the most, if not all of the 9 design controls covered in this week’s lecture in both school and work. For my undergrad senior capstone class we had to practice design controls over the span of two semesters. Our project was to construct a rat sociability chamber with programmed software capabilities. We wrote a MATLAB program to…[Read more]
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smk45 started the topic Fitbit Medical Device? in the forum Introduction to Project Management 7 years, 6 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 companies such as Google or Apple from pursuing novel projects because to avoid any complications with the FDA. In the new draft FDA…[Read more]
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smk45 replied to the topic Challenges in the Global Regulatory Environment in the forum Introduction to Project Management 7 years, 6 months ago
You bring up a great point – medical device regulation standards do not translate uniformly on a global scale. What may be deemed as a “safe” medical device in Europe for example may not pass US FDA regulations. When working for a company with global competitors, it’s hard to level up to one another because each country has their own regulation…[Read more]
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smk45 started the topic FDA Regulations of Medical Device-Drug in the forum Introduction to Project Management 7 years, 6 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 a product that falls in between both sectors? For example, drug delivery systems may be a device that slowly releases a…[Read more]
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smk45 replied to the topic Determining project priority in the forum Introduction to Project Management 7 years, 6 months ago
I think it’s important that all projects are clearly prioritized and that each team member understands the level of priority each project holds. Being able to prioritize projects well ultimately impacts the success of the project and the response from the team. Project managers need to know how to distinguish urgent vs. important tasks and ensure…[Read more]
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smk45 replied to the topic Interpersonal skills vs technical knowledge in the forum Introduction to Project Management 7 years, 6 months ago
I believe the ratio of interpersonal skills to technical skills should be 50:50 in the medical device industry. There are instances where you can talk yourself up but you can only do it for so long until your lack of technical skills catch up to you and prohibit you from advancing; this is also true vice versa. Though, it is easier said than done…[Read more]
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smk45 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management 7 years, 6 months ago
I currently work at Ethicon as a R&D Engineer co-op. There are three industries that J&J spans which are consumer products, pharmaceutical products, and medical devices. Within these industries, there are many subsidiary companies. Ethicon falls under the medical device industry Each subsidiary company is broken down further into departments such…[Read more]
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smk45 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 8 months ago
Hi Nicole,
You bring up an interesting point in that companies should be questioned if they are not willing to have legal counsel. When legal disputes arise, it forces the contractor to think twice as to why they want to do business with a particular company and if they are trustworthy enough to do so. Both parties should be fully certain that…[Read more]
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smk45 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 8 years, 8 months ago
This is all the more reason as to why being professional in business exchanges is important and should be reinforced. That is not to say table talk needs to be dry and fully factual. Various topics can be discussed but should probably stay in the realm of common business grounds to avoid getting too personal. If the conversation gets too personal,…[Read more]
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smk45 replied to the topic Consultants NDAs and CDAs in the forum Consultants and Legal Basics 8 years, 8 months ago
Hi Fady,
The consultant that was hired at your company is in violation of an NDA or CDA for sure. It is quiet irresponsible of him to just copy the document from another company and not edit out the embedded logos and macros from that other company. It would be alright to follow the organization and overall formatting from the other company he…[Read more]
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smk45 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies 8 years, 8 months ago
There definitely needs to be a balance when it comes to organizational behavior and I think a lot of people find it hard to draw the line between what is professional and what is too friendly. If employees are too friendly, work may not get done in a timely fashion and company policies may become blurred lines that are able to be manipulated to…[Read more]
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smk45 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies 8 years, 8 months ago
There definitely needs to be a balance when it comes to organizational behavior and I think a lot of people find it hard to draw the line between what is profession and what is too friendly. If employees are too friendly, work may not get done in a timely fashion and company policies may become blurred lines that are able to be manipulated to work…[Read more]
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smk45 replied to the topic Organizational structure and Culture both leading to project success? in the forum Organizational Development in Device Companies 8 years, 8 months ago
Interesting viewpoint here! Being part of an open and welcoming company culture motivates employees to perform better. Instead of fending for yourself, you are more inclined wanting to better your contribution to the overall company community. A good company culture entails good organization that is based on collaboration to ensure a win-win…[Read more]
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smk45 replied to the topic Collaboration projects in the forum Organizational Development in Device Companies 8 years, 8 months ago
I think matrix organization structure is most ideal for collaboration projects. To break down what a matrix is, it is an organizational structure that distributes responsibilities among two or more dimensions. A matrix organization structure takes multiple perspectives into account and makes one head person to run more than one group. The quality…[Read more]
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smk45 started the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 8 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 – Risk management and design controls both aim to ensure that medical devices are safe and effective.…[Read more]
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smk45 replied to the topic how far is "As Far As Possible" in the forum Risk Analysis for Medical Devices 8 years, 8 months ago
Hi Fady,
I agree that it is not clear as to what exactly “as far as possible” means and what standard it is being compared to. This statement definitely implies that all risks cannot be reduced completely, but should be significantly reduced nonetheless to ensure that the device is safe to use. As long as the manufacturers can verify that the…[Read more]
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