I would want to be a part of a Limited Liability Company (LLC) because it combines the flexibility of a partnership with the protection of a corporation. The main benefit of this structure protects my personal assets from business risks…   Read more»

A business needs a strategic marketing plan to serve as its essential foundation for success. The marketing strategy should prioritize understanding your target audience since this matters more than product or service promotion. The business operations depend on your target…   Read more»

The “Cost of Quality” is all about understanding that spending money on QA/QC upfront actually saves a company from far bigger losses down the road. A company that omits quality procedures for financial cost reduction purposes. The initial inspection appears…   Read more»

Quality Assurance (QA) uses preventive systems and processes to stop errors before they occur but Quality Control (QC) verifies finished products against established standards. The core distinction between QA and QC training emerges from their educational material because QA teaches…   Read more»

The QA department relies on document control to achieve audit-readiness for all project documentation which must comply with FDA regulations and other regulatory requirements. The organization needs to prove its adherence to regulatory requirements at all times. Organizations should work…   Read more»

Yes, there are several examples of drugs that have been banned in the U.S. but are still available in Europe, Asia, or other regions. The evaluation process of regulatory agencies in different countries determines the final decision through their assessment…   Read more»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»

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»