The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of their standards. They invest a lot of time and expertise into developing and maintaining them, often…   Read more»

I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying and mitigating potential hazards before a product reaches users and patients. While the process can be time-consuming and…   Read more»

A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a serious lab safety breach took place. The hazard involved the bacterium Bacillus anthracis, which causes…   Read more»

Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updates to software or firmware, and adjustments to component dimensions or…   Read more»

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

I think the four columns are a great starting point, but they might not capture the full story of the design process on their own. Inputs, specs, validation, and verification give a solid technical framework, but they don’t always reflect…   Read more»

I think our current design control systems are much stronger, but not entirely error-proof. The Therac-25 tragedy definitely pushed the industry toward stricter verification, documentation, and risk management standards, which have made a huge difference. However, with AI and increasingly…   Read more»

Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These processes make sure not only that a device is built correctly, but also that…   Read more»

The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using engineering standards, research, and benchmarking. For example, if a user states the device must be easy…   Read more»

Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in the design- essentially asking, “Did we build the device right?” This involves testing…   Read more»

When design control is used insufficiently, several serious issues can arise during the development of a medical device. One major problem is that design requirements may not be clearly defined, leading to products that fail to meet user needs or…   Read more»

A company that comes to mind would be Theranos; the health technology company that claimed to have developed a revolutionary blood-testing device. The company allegedly manipulated and hid failed verification and validation results to make their technology appear more reliable…   Read more»

Yes, I definitely feel safer knowing that validation and verification are key and required steps in the development of medical devices. These processes ensure that devices not only meet design specifications but also function correctly in real-world medical settings and…   Read more»

In my opinion, double-blind studies are definitely the most reliable way to test how well a treatment actually works. While single-blind studies help reduce some bias, there’s still a chance that researchers’ expectations can influence how results are recorded or…   Read more»

Researchers use several strategies to minimize the placebo effect and ensure their results accurately reflect a treatment’s true impact on the person’s body. One common method is the double-blind study design, where neither the participants nor the researchers know who…   Read more»

Clinical studies are essential for developing new treatments, such as testing cancer immunotherapies or innovative medical devices like heart stents, or hear valves to ensure they truly work before being approved for patients. They give researchers real-world data on how…   Read more»

I agree that emotional intelligence does play a role in marketing, and the article does clearly articulate how understanding and managing emotions can directly influence sales revenue. Marketers who are emotionally intelligent can better read their audience, craft messages that…   Read more»

I believe that biotechnology can definitely tailor their digital marketing and advertising strategies to target specific groups. Different generations and age groups consume media in different ways, so companies place ads on platforms or channels that their intended audience is…   Read more»

Some medical device companies that come to mind that utilize the psychological attributes of color are Boston Scientific, which uses dark blue. The color conveys a sense calmness, trust, and professionalism- qualities that you would expect from a medical device…   Read more»

Both QA and QC are very crucial for the development and eventual commercialization for a medical device or product but highlighting their differences is also important as they serve different purposes in ensuring patient safety. QA focuses on building strong…   Read more»