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KartikeyaKulkarni replied to the topic "FDA rules too strict?" – 1 month, 3 weeks ago
The FDA operates under established rules which serve as protective measures and also create restrictive barriers. On one side, they are essential for protecting patients by ensuring that unsafe or ineffective products don’t make it to the market. The history… Read more»
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KartikeyaKulkarni replied to the topic "Role of clinical trials for medical devices & pharmaceuticals" – 1 month, 3 weeks ago
The safety and effectiveness of drugs and medical devices depend on clinical trials as their fundamental research method. The organization of these trials follows distinct methods. The evaluation process for medications involves multiple clinical trial stages which examine drug delivery… Read more»
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KartikeyaKulkarni replied to the topic "Research for the Fututre or Now?" – 2 months ago
When I think about research, I don’t see it as an either or between the future and the present. Both are important. Some research is focused on solving problems we face right now, like making diagnostics quicker or improving existing… Read more»
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KartikeyaKulkarni replied to the topic "Cutting Corners in Research" – 2 months ago
I think cutting corners in research might save time in the short run, but it usually creates bigger problems later. If data is collected without proper controls, if documentation is skipped, or if safety steps are ignored, the entire project… Read more»
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KartikeyaKulkarni replied to the topic "Regulations in Industry vs. Academia" – 2 months ago
I believe in industry, regulations are much stricter because the end goal is to bring a product to market for patients. Companies have to follow standards like GLP, GMP, ISO, and go through clinical trials with agencies such as the… Read more»
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KartikeyaKulkarni replied to the topic "Why is project planning important?" – 2 months ago
I believe project planing is important because it makes sure timelines, budgets, and milestones are clear from the start and regularly monitored. Tools like Gantt charts or milestone planning help teams see if prototype testing is moving on schedule or… Read more»
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KartikeyaKulkarni replied to the topic "Milestones Missed: Failure or Success?" – 2 months ago
The failure to reach a milestone does not necessarily indicate defeat. The results will emerge based on how the situation gets handled. The team might have faced some issue and the team’s identification and rectification of the problem that needed… Read more»
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KartikeyaKulkarni replied to the topic "PM requirement (education wise)" – 2 months ago
As I was going through the project management, I was thinking about how important the early phases are in medical device projects.The process becomes confusing when objectives remain undefined or team members fail to receive proper inputs. The project runs… Read more»
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KartikeyaKulkarni replied to the topic "Biomedical Engineers vs. Mechanical Engineers: Who has the advantage in Biomechanics?" – 2 months, 1 week ago
I’ve encountered this argument multiple times and I believe it fails to recognize the essential contributions biomedical engineers make to their field. Yes, mechanical engineers have strong foundations in design and mechanics, and that can make it easier for them… Read more»
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KartikeyaKulkarni replied to the topic "Medical Device News" – 2 months, 1 week ago
Medical technology has experienced a major breakthrough through AI systems which now enable better disease detection at early stages. A startup company created an AI-based blood screening method which identifies ovarian cancer during its initial development stages. The test analyzes… Read more»
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KartikeyaKulkarni posted a new topic "Bridging Design Innovation with Regulatory Compliance in Early Stages of Device Development" – 2 months, 1 week ago
Something I’ve been thinking about in the device development is how tricky it is to balance the creativity of the engineer with regulatory compliance, I.e. finding the right balance between innovation and regulation. One one side, we as engineers rapidly… Read more»
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KartikeyaKulkarni replied to the topic "Thoughts on BME degree, "a little of everything"" – 2 months, 1 week ago
For me, Biomedical engineering is a little of everything. Through my bachelor’s, I had the chance to touch and learn from so many different areas like mechanical design, electronics, bash scripting, PLC coding, drug delivery and much more. And each… Read more»
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KartikeyaKulkarni replied to the topic "Academia vs. Industry: Why I Prefer Industry" – 2 months, 1 week ago
I would completely agree with you that the divide between academia and industry comes down to research versus results. According to me, academia provides many valuable benefits yet I have decided to pursue a career path in the industry. The… Read more»
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KartikeyaKulkarni liked forum post "Why I Prefer Industry" – 2 months, 1 week ago