Some examples of device changes that need to be controlled are updates to the materials used, switching suppliers, or adjusting a device’s size or shape. Even small changes like replacing adhesives, updating sterilization methods, or modifying software code can affect…   Read more»

I think it really depends on the company and how much they value quality in their process. Some teams tend to see design controls as just another set of documents to complete for FDA or ISO compliance, especially when project…   Read more»

A contract manufacturer has a lot of responsibility when it comes to process validation. Besides qualifying multiple machines and setting up preventive maintenance, they should also provide clear IQ, OQ, and PQ documentation that shows each step of the process…   Read more»

That’s a really good point about catching design issues early and I actually can relate. From my experience during my internship, I’ve seen how important proper documentation is, even though it can feel time consuming. I haven’t personally seen a…   Read more»

Design control is definitely one of the most important parts of developing a medical device because it helps ensure safety, effectiveness, and regulatory compliance. But when it’s not applied properly, a lot of issues can come up. From what I’ve…   Read more»

From my experience as a QC/QA intern at Case Medical, I’ve seen how validation and verification are similar but serve different purposes. Verification is more about checking that a product was made correctly according to the design. For example, I…   Read more»

If I were involved in clinical research, I would want to take on the role of a Clinical Investigator because it connects closely with the kind of work I already do as a Quality Engineering intern In my current role,…   Read more»

That is actually a really good question, and I agree with most of the responses because it seems reasonable to think that only the patient needs to be unaware of what treatment they are receiving. The reason double blind studies…   Read more»

Clinical studies are a vital part of medical progress because they test whether years of lab research can actually improve real lives. For example, the covid 19 vaccine trials showed how research can quickly turn into life-saving solutions. Many patients…   Read more»

Medical device companies can build trust with both doctors and patients by creating marketing that focuses on education, honesty, and transparency. For doctors, trust grows when companies share clear, evidence-based research that demonstrates a device’s safety, reliability, and clinical value….   Read more»

When I think about branding and color, it’s clear that companies put a lot of thought into how people emotionally respond to what they see. In the medical field, I often notice brands using shades of blue, white, and green….   Read more»

Cook MedicalMission: Cook Medical’s mission is to provide innovative and minimally invasive medical devices that improve patient care and advance healthcare around the world.Vision: While Cook Medical does not list a formal vision statement, the company emphasizes collaboration with physicians…   Read more»

I think an engineer or scientist can absolutely start a successful business without an MBA. While business school offers useful connections and credibility, most of what you need to run a company can be learned through experience, mentorship, and self-study….   Read more»

If a father owns a sole proprietorship and wants his two sons to continue the business, he would need to restructure it since a sole proprietorship cannot be transferred to others. One option would be to close the sole proprietorship…   Read more»

I think most engineering students could benefit from learning a bit more about the business side of things. The engineering management class does a nice job introducing project management and basic economics, but it only scratches the surface. Once you…   Read more»

I think companies should put more resources into quality assurance because it creates a stronger foundation for product safety and long-term reliability. As technology and standards keep changing, the best approach is for companies to make QA a continuous process…   Read more»

Ensuring the safety and effectiveness of medical devices is becoming more complex as technology evolves. One of the biggest challenges is keeping up with rapid innovation while maintaining strict quality standards. Devices that use artificial intelligence, software, or the internet…   Read more»

I think bringing emerging technologies into quality assurance could really help companies work smarter and more efficiently. Tools like artificial intelligence, the internet of things, and machine learning can make it easier to create quality procedures and prevent issues before…   Read more»

I think regulations mostly help innovation rather than slow it down because without them there would be no structure, no trust, and no way to ensure that devices are actually safe for patients. I think this way because when I…   Read more»

I think the FDA does a good job overall, but approval does not mean a drug is perfectly safe. It really means that the benefits outweigh the risks for most patients. When I think about Accutane, for example, I understand…   Read more»