An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate, plus Compl...

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matters. The study has to show specific results that sh...

While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the specific pathways that medical products can take,...

You can make medical device marketing more ethical and accurate by doing a human-factors testing, something similar to testing that's done during device design. Before releasing ads about the product ...

I think one way to keep medical device marketing effective while still being ethical is implementing something similar to a traceability matrix into the marketing process. This would require every sta...

For marketing products in general, knowing who your audience is can determine how to optimize your marketing strategy towards that audience. For medical devices specifically, that audience would typic...

Physicians branching out into entrepreneurship can have positive effects on healthcare. However, access can also be an issue with newly developed technologies. Not every community will equally benefit...

I think that the corporate veil is an important protection that allows people to take on the risk of starting a company or investing in one in the first place. Without that protection, the uncertainty...

Recently, Electronic Arts (EA), a once publicly traded company, agreed to a deal that will make it go private Once this transition happens, EA will no longer have to publish quarterly earnings that al...

Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system. AI can indeed help handle routine pats, like che...

It's true that having things be more measurable makes it easier to provide clear results. One way I see of preventing that can be to create a checklist between QA and QC that explains what standards Q...

While creating one unified quality system sound more efficient, it can actually create more problems when companies work in different regions. Depending on the countries, their rules can be different,...

The FDA's Breakthrough Devices and Safer Technologies (STeP) programs are designed to speed up innovation for unmet medical needs. It gives manufacturers earlier and more frequent interactions with re...

The FDA's classification framework works well for physical devices because risk is tied to how much contact the patient makes with the device. Software wouldn't exactly work with that classification, ...

I think the classification that the project will be in can also affect how early or late creative freedom should be considered. Since different classes will have pathways with varying qualifications t...