So, this is Module 3.1.1. We're now focused on medical devices. Medical devices are actually a really vital part of the landscape of a health care marketplace. The prior two modules focused almost exclusively on pharmaceuticals. Now, we're turning attention to the space that's actually, at least globally, where some of the greatest innovation 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've gotten some of these devices, particularly some of the cardio stuff, too late. But just knowing that there'd be options for other people's parents in the future is quite wonderful. So let's begin. So on our right here we have the famous a pacemaker, a portable pacemaker, actually, those are much smaller, that's a pretty big one right now. And, when we talk about medical devices, the key to understanding is the regulation space of it. So the role of government here is essentially to focus on what is going to be determining a safe technology, and what could be put into the market. So government agencies are going to be determining both the approval of these technologies, and we'll talk about some 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. So very rarely would you go to your friendly neighborhood Target and say let me go buy an implantable cardiac defibrillator and I'll install that later with some help from my friends coming over. First, it's very expensive to do that. There aren't many items at Target that are in excess of $2 or $3000, let alone $30,000 for that little device you're seeing there. But on top of that there is also the issue of how it would actually be deployed. So health insurance providers are keen for this technology and device as well as pharmaceuticals who just pop them in your hand. So you need to understand for devices process and also they want to plan an assessment. When you actually do a technology assessment in preparation for a regulatory aspect, you're gathering and analyzing information to figure out the performance of that technology is. Once that technology regulatory stage is passed you need to make sure your information is actually collect it, so if you ever have to go back, you can actually make sure that it's not necessarily lost. And an understanding of this whole process, for development, and a reimbursement is necessary to prevent any mistakes, really, from occurring, so that you can 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, we're going to take it, we're going to go much more specific in devices in, just a slide or two. The idea is that there's going to be Four Key Steps. These are going to vary by country to country, and innovation to innovation. First step that's key is to obtain a patent, we call the patent it 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 say. And this process of getting approval for something that is safe and also effective could be a very long multi-stage process. Then, number 3, you need to get payers publicly prior agree to cover that drug or in this case device. You need to make sure that you are meeting the standards of different payers, and then Medicare's particular standard is reasonable and necessary. And providers must persuaded to then use that technology to make sure it can get to markets base. So to create a patent, anywhere from 6 months to 2 years for the patent office to grant it as Brandon said earlier, what's the determination? Anyone who invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, 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. Brandon talked 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 notification, known as 510(k)s, by the statute that they're associated with. So, the FDA receives about 50 to 70 of these really brand new, breakthrough technologies, these PMAs, per year, and about 4,000 510(k)s. The agency for the FDA responsible for approval of the devices is the Center for Devices and Radiological Health, which is just tucked away in 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 this apparatus simple machine contrivance agent there's the point which is recognized by the United States it has far more associated with it. It is intended for an initial use of a disease or condition or mitigation or presentation of a 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 stent. And a stent is put into an artery once it's cleaned out by angioplasty to keep it open. You can coat that stent with a drug, otherwise known as 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 I, the most basic one that's out there. This is really just for Band-Aids, tongue depressers, anything that's going to be momentarily in the body, but generally pretty safe, is low risk and that's subject to pre-market approval. Then we get to Class II. These are usually things that are cleared through the 510(k) process. These pose either a low or moderate risk. And then finally we get to Class III, PMA, Pre-Market Approval. These have higher risk, they're breakthrough products, and they have a much more expensive application process. My general 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 if it's the first time that technology's ever been developed that way for that purpose as Pre-Market Approval. Now, if it's something that has been around, like a pacemaker, for awhile, then it could fall to class two because it's already been cleared for that technology. So the agency that examines the data that's there. They look at very simple products, like tongue depressors, adhesive strips, before allowing them on the market. 30% of all devices are Class I. 60% fall into Class II, the dominant form, 10 percent for the extraordinarily new technologies in Class III. And then all these devices are subject to General Controls, marketing, properly labeling and monitoring performance. And anything that's radiation emitting, laser pointers as well as different technologies, face additional controls to minimize radiation risk. This concludes Module 3.1.1, looking at Medical Devices and the Market Space.
