This is the Healthcare Marketplace Specialization, Healthcare Marketplace Overview. My name is Steve Parente and this is module 4.1.1. What is a Device? What is a Drug? So what is a medical device? We can think of lots of different things. They could be things that can be implanted. They can be those moments, for example, as I get older and I go through a TSA screening machine and the guard will say something like you got some metal in you? And well that that could fit as a device as well, particularly if it stays inside. So fortunately, the Food and Drug Administration has a wonderful definition and they specified that a medical device is an instrument, an apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article that is intended in the use of diagnosis of disease, or other conditions or intended to affect the structure or any function of the body of man and woman, I added that by the way. Or other animals in which it is not dependent upon being metabolized, key word, for the achievement of its principal purposes. And that is the keyword, metabolized meaning that your body is not going to absorb it as either a large molecule structure the way it would for drugs and so it's essentially there in your body. Now, granted, there are times when some things could be drugs and devices, but the key distinction is that metabolize function. So the FDA makes that distinction. Drugs are metabolized in general and devices are not. The other thing to keep in mind is that usually the size of the market is quite different. Pharma is much larger as an industry and the devices. We’ll talk more about that later when we get to the medical device and pharma lectures and modules. Reimbursement policies are different. So in general, there's no direct prescription drug coverage for Medicare. Though, if it's going through private insurers for Medicare Part D, and/or Medicare Advantage Plans, that operates differently. And the devices are covered by Medicare generally through hospitals. Consumer is different. When for devices marketing is much more focused to hospital and physicians to convince them to use the devices because of the complexity to get that work to happen. Whereas drugs have a tremendous amount of direct-to-consumer advertisement. This concludes this module on what is a device, what is a drug.