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, we also learned about Investigational Device Exemption…   Read more»

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 to the public, companies could first show them to a…   Read more»

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 statement used in marketing to be required to be connected…   Read more»

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 typically be the hospital’s internal evaluation group rather than just physicians. Most…   Read more»

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 from those innovations. Telehealth, for example, requires that patients have reliable access…   Read more»

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 of a business surviving or…   Read more»

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 checking if training is up-to-date, finding documents or…   Read more»

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 QA expects, and QC…   Read more»

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, like different reporting timelines. If a company forces all other…   Read more»

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 reviewers and review timelines, helping unique promising technologies reach patients that need…   Read more»

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, due to the danger coming from inaccurate readings rather than…   Read more»

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 they need to follow, the classes that require fewer…   Read more»

Testing biocompatibility during the designing process is important, but biocompatible for the device has to be managed across its entire lifecycle. If a new method is used when making a product, like a different supplier, reassuring biocompatibility after is a…   Read more»

@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 pushed for this, as the FDA Modernization Act 2.0 allows for organ on a chip…   Read more»

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 within federal regulations. If we slip out of compliance, production can be stalled or even…   Read more»

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 resources to enact this change. In my experience working on a product, we make a list…   Read more»

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 assessment meeting and come up with a certain condition where it becomes clear…   Read more»

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 faced an issue similar to the one causing the disagreement. This way, it feels less…   Read more»

I actually see the jack of all trades aspect of BME having some positive outcomes in my own experience. For me specifically, I wanted to focus on data analysis focus jobs, but because I also had experience working in biolabs…   Read more»