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dbonanno1 replied to the topic "FDA on Recalled Items" – 6 years ago
A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inability to assure sterility of the product, which… Read more»
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dbonanno1 replied to the topic "Discussion Topic: e-cigarettes" – 6 years ago
Based on the research I was able to find the FDA does regulate all cigarettes, smokeless (e-cigs), and roll your own tobacco and these regulations have been in effect since 2009. On August 8th, 201 the FDA finalized a rule… Read more»
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dbonanno1 replied to the topic "Academia vs. Industry Research" – 6 years ago
In my experience in working as an R&D product development engineer in the medical device industry, I would say that projects do generally get pushed to get done quicker due to project deadlines but I do not feel that it… Read more»
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dbonanno1 replied to the topic "Research for the Fututre or Now?" – 6 years ago
As many have already said in this thread, both types of research are important and I do not necessarily see one as more important than the other. There will always be a need to solve current societal problems, for this… Read more»
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dbonanno1 replied to the topic "Discussion Topic: Project Management in a medical device setting" – 6 years ago
In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentation that must been done in a certain way. All of… Read more»
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dbonanno1 replied to the topic "Project Management Softwares" – 6 years ago
I have experience working in the industry and my company uses Microsoft Project. Based on my past experiences, and in talking with others who work for my company, Microsoft Project is definitely one of the most popular softwares that is… Read more»
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dbonanno1 replied to the topic "Advice for Biomedical Engineering Students" – 6 years ago
Another piece of advice I would give to current engineering students would be to potential work in the industry for a few years before going back to get your master’s degree. This is an approach I have taken with my… Read more»
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dbonanno1 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 6 years ago
My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it… Read more»
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dbonanno1 replied to the topic "Advice for Biomedical Engineering Students" – 6 years ago
I agree with the other two posts, definitely try to get into as many co-ops / internships as you can while your still in school. I have been working in the industry for about 6 years and I did not… Read more»
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dbonanno1 replied to the topic "Discussion Topic: Academia vs. Industry" – 6 years ago
My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it… Read more»
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dbonanno1 posted a new topic "Non Compete Agreement" – 6 years ago
Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you from leaving the… Read more»
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dbonanno1 posted a new topic "Design Verification & Validation vs Clinical & Pre-Clinical Trials" – 6 years ago
For medical devices that are not used inside of humans / animals, and do need include any kind of medication dose accuracy are Clinical & Pre-Clinical Trials needed? or will Design Verification and Validation suffice? Give an example of a… Read more»
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dbonanno1 posted a new topic "The Expert" – 6 years ago
After watching the lectures from this past week, one of the slides that depicts a comic strip of what a customer wanted versus how everyone in the company perceived the customers request was shown. This comic strip immediately made me… Read more»
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dbonanno1 posted a new topic "S-Corp vs C-Corp" – 6 years ago
When i think of a companies that are corporations, I never think of that corporation being specifically an “S-Corp” or a “C-Corp”. I just think of them as a corporation, can you please provide an example of each type of… Read more»
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dbonanno1 posted a new topic "R&D vs Quality" – 6 years ago
I am currently working as an R&D Engineer for a medical device company, and have been for the past 6 years. As an R&D engineer I do have a lot of experience working with the Quality departments (QA, QC, etc.)…. Read more»
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dbonanno1 posted a new topic "Project Manager Experiences" – 6 years ago
I have been working in the industry for the past 6-7 years, and i have worked with a couple of different project managers during that time period. Each project manager i have worked for has had completely different personalities and… Read more»
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dbonanno1 started the topic Non Compete Agreement in the forum Consultants and Legal Basics 7 years, 6 months ago
Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you from leaving the company and then directly going to work for a competitor company. There are other fine details that go along…[Read more]
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dbonanno1 replied to the topic Recent Examples of Kickback Allegations in the forum Consultants and Legal Basics 7 years, 6 months ago
I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioid scheme. Galena Biopharma had to pay more than $7 million in the settlement. Two of the doctors involved actual went to jail for over 20 years. The doctors were prescribing these opioid drugs to…[Read more]
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dbonanno1 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics 7 years, 6 months ago
As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect as far as the class content / structure. I can honestly say that I did learn many different aspects about medical device development that I did not know before taking the class. The vast majority of…[Read more]
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dbonanno1 replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices 7 years, 6 months ago
As others have said in this thread I think it is very crucial to ensure that everyone attending / participating in the risk management meetings have a thorough understanding of exactly how the product works. From there as a team you should break down all the different risks associated with these 3 categories: what risks / failures are associated…[Read more]
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