This is Module 3.1.1. We're now focused on medical devices. Medical devices are actually really vital part of the landscape of [INAUDIBLE] marketplace. The prior two modules focused almost exclusively on pharmaceuticals. Now we're turning our attention to a space that's actually, at least globally, for some of the greatest innovations can come and, quite honestly, could actually really enhance the functional status folks beyond a certain point. That's what very much excites me, and personally, I remember both my parents actually could have gotten some of these devices particularly some of the cardiac stuff too late. And but just knowing that there would be options for other people's parents in the futures is quite wonderful. Let's begin. So on our right here we have the famous Pacemaker, portable pacemaker, that goes in, actually those were much smaller, that's a pretty big one right now. And, when we look about medical devices, the key to understand is the regulation space with it. So the role of government here is essentially to focus on what is going to be determining a safe technology, and what can be put into the market. So government agencies are going to be determine both the approval of these technologies, and we'll talk about this a little bit later, their payment reimbursement. The second important difference that people are concerned about is that the users of these technologies generally do not pay for them. Their health insurance company does very rarely would you go to say your friendly neighborhood target and say let me go buy an inflatable cardiac defibrillator, and I'll install that later with some help of my friends coming over. First it's very expensive to do that. There aren't many items at target that are In excess of $2000-3000, let alone $30,000 for that little device you're seeing there. But on top of that, there's also the issue of how it would actually be deployed. So health insurance providers are key for this technology in these places whereas pharmaceuticals you just pop them in your hand. So you need to understand for devices process, and also the bureaucratic details in order to plan the assessment. When you actually do a technology assessment in preparation of the regulatory aspect you are gathering, analyzing information to figure out what the performance of a technology is. Once that technology regulatory stage is passed, you need to make sure that your information is actually, collect and so that if you ever have to go back you can actually make sure that it's not initially lost. And an understanding of this whole process for development and the reimbursements necessary to prevent any mistakes really from occurring, so we just go into market as quickly as you can. So, how do we actually go and make it into a market? So, this applies to drugs as well, and we talked about this actually in the first course. But just to review, I'm going to take it we're going to go much more specific in devices in just a slide or two. The ideas that there's going to be four key steps, these are going to very by country to country and innovation to innovation. First step that is kind of key is to obtain a patent. Recall a patent grants exclusive rights to sell the product for about 20 years, and that the next step is to go for regulatory approval from the FDA, or whatever government agency in different countries you might be looking at [INAUDIBLE] and you are. And this process of getting approval for something that's safe, and also effective could be a very long multi stage process. Then, number three, you need to get payers, public prior agree to cover that drug, or in this case, device. You'll need to make sure that you are leaving the standards of different payers, and that medicare's particular standard is reasonable and necessary, and providers must then be persuaded to use that technology to make sure it can get to the marketplace. So to create a patent, anywhere from 8 months to 2 years for the patent office to grant it. As Brian said earlier, what's the determination anyone who invents or discovers any new or useful process machine, manufacture composition of matter, or any new and useful improvement there of may obtain a patent. The standard is novel and non-obvious, 20 years and you can get some extensions. The medical devices are different in the FDA approval process. We're going to talk a lot about how things go through there differently with investigational new drugs. In this case, what you have to go is for either the Pre-market approval, otherwise known as PMAs, or Pre-market notifications known as 510(k)s by the statute that their associated with. So the FDA receives about 50 to 70 of these really brand new, break through technologies, these PMAs per year and about 4,000 510(k)s. Agency for the FDA responsible for approval of devices is center for devices and radiological health, which is just tucked away many different parts of the FDA. So, one thing to keep in mind is that's the definition of what is a medical device. Basically, it is an instrument, apparatus, implement, machine, contrivance, in vitro reagent, is component part or accessory which is recognized by the United States, if it has Pharma associated with it, it is intended for use of a specific disease or condition, or mitigation or prevention of disease, and the key thing is that it is not dependent upon being metabolized for the achievement of its primary intended purposes. So what we see over here is a stint, and a stint is put into an artery that once it's cleaned out by balloon angioplasty to keep it open you can coat that stent with a drug, unless its one of those drug-alluding stents, and that would actually be a combination. But most medical devices are not dependent upon metabolization. So, different medical device classes, we have class one, the most basic one that's out there because it's really just for band aids, tongue depressors, any things we need momentarily in the body but generally pretty safe, it's low risk. In the subject pre market approval, then we get to class two, these are usually things that are cleared the 5 10 k process. These pose either a low or moderate risk, and then we finally get to class 3, PMA, pre market approval, these have higher risk. They're breakthrough products, and they have a much more expensive application process. Marginal criteria when people ask me and they have new ideas, and technologies is that are you leaving it in the person. So here's our person, there, there, and they're smiling. So if you're actually putting something inside and they're going to stay, I don't know, 10 to 15 to 20 years, that usually is the criteria because the first time a technology is ever been developed that way for that purpose, there's pre-market approval. Now if it's something that has been around like a pacemaker for awhile, then it could fall into class 2 because it has already been cleared for that type of technology. So the agency that examines the data that's there, they look at very simple products like tongue depressors and adhesive strips for allowing them on the market. 30% of all devices are Class I, 60% fall in Class II, the dominant one, and 10% for the extraordinary and new technologies in Class III. And then all these devices are subject to general controls marketing, proper labeling and monitoring performance and then there's radiation emitting laser pointers facing additional controls to minimize radiation risk. This concludes module 3.1.1 looking at medical devices in the market space.
