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jbh8 replied to the topic "Product Labeling" – 1 year, 9 months ago
Although the damage may have been due to either party, ultimately it is the product company’s responsibility to fix the actual labeling as they are the manufacturers of the product, while the stores are the distributors. There is still some… Read more»
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jbh8 posted a new topic "Multiple Regulatory Filings Process" – 1 year, 9 months ago
I worked as an intern for a commercial technical operations team at a biopharmaceutical company, where some of the documentation I worked with was regulatory filings from different markets including the U.S., Europe, and Japan. There was some disconnect between… Read more»
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jbh8 replied to the topic "Professors in Academia" – 1 year, 9 months ago
I think it is dependent on a case by case basis. In my experience, I have met professors that are inclined to research, or a combination of both. There may be a professor who is content with simply presenting lecture… Read more»
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jbh8 replied to the topic "Why Are Dental Implants So Expensive?" – 1 year, 9 months ago
Although a dental implant procedure may present as a simple procedure with a simple medical device, there are a few components to be considered. The implant itself has multiple comments that comprise materials with varying costs. The procedure itself requires… Read more»
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jbh8 replied to the topic "Skills to get into research" – 1 year, 9 months ago
Both academic research and industry research require a few similar skills and knowledge. However, a major difference is the specificity of knowledge in a field. I believe master’s and PhD roles are a better fit in academia research, rather than… Read more»
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jbh8 replied to the topic "FDA Consultants in medical devices projects" – 1 year, 9 months ago
I agree that a FDA consultant should be included in the first project meeting. However, I believe this should also extend to other international regulatory bodies, specifically any international market the company is seeking to enter. It does not have… Read more»
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jbh8 replied to the topic "How to Avoid Scope Creep" – 1 year, 9 months ago
One user had previously mentioned that defining what is not within the scope would help avoiding scope creep. I agree with their point as it can ensure the team does not deviate towards any objectives clearly stated as not in… Read more»
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jbh8 replied to the topic "Due Diligence" – 1 year, 9 months ago
During the initiation stage, one question I would ask myself is if there are potential ethical and social issues in regards to the product. And if so, how does the team plan to address them if possible? For example, a… Read more»
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jbh8 replied to the topic "Benefits of an academia relationship" – 1 year, 9 months ago
An amicable and collaborative academia relationship can have a positive cascading effect on future students. For example, an undergraduate student joins an academic lab following their completion of that lab director’s course. From there, the student learns new skills and… Read more»
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jbh8 replied to the topic "Software engineering addition to Biomedical Engineering" – 1 year, 9 months ago
Based on my undergraduate experience, I believe that it is dependent on the BME student’s specialization on whether they should take advanced coding techniques in different languages. It should not be required for all BME students, but rather be offered… Read more»
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jbh8 replied to the topic "Changing Careers" – 1 year, 9 months ago
As a high school student and college undergraduate student, I had always believed your major would define your future career path. However now as a master’s student who recently graduated with a B.S. in BME, I see that no one… Read more»
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jbh8 became a registered member 1 year, 9 months ago