Physicians branching out into entrepreneurship can have positive effects on healthcare. However, access can also be an issue with newly developed tech...

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 fir...

Obviously, AI is already being heavily researched and expanded on, with many companies finding way on how to seamlessly implement it into their system...

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 checklis...

While creating one unified quality system sound more efficient, it can actually create more problems when companies work in different regions. Dependi...

The FDA's Breakthrough Devices and Safer Technologies (STeP) programs are designed to speed up innovation for unmet medical needs. It gives manufactur...

The FDA's classification framework works well for physical devices because risk is tied to how much contact the patient makes with the device. Softwar...

I think the classification that the project will be in can also affect how early or late creative freedom should be considered. Since different classe...

Testing biocompatibility during the designing process is important, but biocompatible for the device has to be managed across its entire lifecycle. If...

@krish I definitely agree with you that organ on a chip model are slowly reducing our dependence on animal studies. The FDA themselves have also pushe...

I have just started working in the biopharmaceutical industry, and one of the things they really hammer down is following protocol in order to stay wi...

It's fine to consider some innovation, as long you can differentiate something the project truly needs and is worth the potential extra time and resou...

I agree with having feasibility check at the initiation phase of the project. However, to add to that, maybe it would be good practice to hold a risk ...

Depending on the severity of the disagreement, it can be helpful to the team if you also bring an outside perspective, specifically someone who has fa...