Welcome, so in this section of our course, we're going to step away from the technical aspects that you've been learning. And really think about how to get your medical software, or your lab prototype out into the hands of people in the real world. It will be just as important to get and basic overview of the business side of things so that you can launch your venture. My name is Aisha Coryshi, and I'll be doing this section with Dr like Ally. The goals of this section, in this week's lectures are as follows, first we will discuss the changing models in health care. Then we will go into the nuts and bolts of starting a new healthcare venture, a broad overview to speak. And then we will end with when and how to raise capital. As an outline of the lectures themselves, the first two lectures presented by Dr lickle. Will include value drivers and digital medicine, as well as changing business models in health care. I will then return to go through setting up a new healthcare venture, finding your first paying customer, and when and how to raise capital. For extra material and to follow along with in the textbook, please refer to chapter 6 and 7 in our introduction to medical software textbook. >> This is Greg look like in this segment, we'll talk about value drivers in digital medicine and what is moving this field forward. And as we're thinking about the different drivers, let's also use this metaphor of a car driver. Driving technology forward and going from an antiquated to a more modern place, a more modern direction. There are many drivers of digital health as the digital transformation is affecting healthcare as it has other industries. The benefits here are overcoming costs, improving on legacy technologies. But particularly around a shift in power from providers from payers towards patients. And indeed, many of us believe that patient empowerment is one of the main factors that is driving change in health care. The health care system in particular in the United States is very complicated. Previously we discussed the healthcare hassle map as well as the high costs and relatively low quality. There's been significant efforts now to create improvements. All of which should drive power and decision making capabilities back into a patient's hands. Some of this has been codified and put in place by the Affordable Care Act. So the Affordable Care Act focused on one of the things that talked about was the triple aim. Of reducing costs, improving quality as well as improving patient satisfaction. Well, all of this is dependent on a shift in power towards the patient, giving the patients the greater ability to select the best therapy. The best type of care and that empowerment is very much being driven by technology. Which creates information and better choices for patients as well as improve transparency. And begins to level the playing field from some of the asymmetry is that we have talked about in previous lectures. Now, frequently it's brought up of whether these digital therapeutics are effective or not. I'd like to mention a couple examples where that have been demonstrated that digital therapeutics indeed are quite effective. A well known example is para therapeutics which is a small company that developed technology called Reset. That was one of the first digital therapeutics approved by the FDA for using cognitive behavioral therapy. For improvement in behavioral health conditions as well as for addiction and reduction in cravings. It has been demonstrated that this is effective. As illustrated by the fact that that clinical trials did receive FDA approval as a as a landmark decision several years ago. Other types of digital therapeutics have been developed such as insomnia apps. And video games for hyperactivity and attention deficit disorder, also more recently approved by the FDA. And the list continues to grow, there are start ups focused on treating amblyopia, which is lazy. There are also other companies that are focused on developing digital pills that keep track of compliance to drugs. And it's been demonstrated that these digital pills, improve compliance. So that, patients who were previously had difficulty receiving treatment for conditions such as schizophrenia. Bipolar disorder and even chemotherapy experienced significant benefit. Once there compliance was tracked using these digital techniques. Now there is a expanding landscape of digital applications, including digital therapeutics as well as mobile health. Sometimes called M health, health information technology where all sensors. Personalized healthcare records and telemedicine. And all of these areas have been dramatically increasing, helping drive the growth of digital medicine. For example, digital biomarkers which are collecting data from patients using a peripheral devices. Wearable devices such as a smartwatch. Smart watches which can record activity motion as well as now heart rate, oxygen saturation breathing. Other devices can record blood sugar as well as as well as other types of other types of personal activities. Now, the benefit of these types of digital biomarkers. Is that, they record continuous patient experience as opposed to episodic patient experiences. Episodic experiences are what was previously used, meaning that if a physician wanted to find out how you're doing as a patient. They would be able to record your your symptoms only once in a while, on an episodic basis. When you come into the office or perhaps when you're monitored by a clinician's assistant. Using these digital devices, these wearable devices, we can record continuous patient experiences. That gives us much better information are about, say, the blood pressure increasing and decreasing. Or heart rates increasing and decreasing during the day as well as activity. And perhaps those biological parameters can increase or decrease people's activities. It really opens up a whole new world of understanding the effects of disease on patient lives and patient experiences. And in fact the percentages are rising here, that growth rates that are that are very high. And many prospective clinical studies now are using digital biomarkers to better record patient experiences. As mentioned previously in our case study. Digital medicine is really helping address the mental health crisis through a variety of different applications. Frequently focused on cognitive behavioral therapy as well as dialectical behavioral therapy. But there are many small companies and larger companies that are using these applications for improving mental health issues. As well as improving access and scalability for delivery of mental health care. Well, one of the main drivers of the growth of digital medicine is funding. And here we see that the the amount of money pouring into digital medicine. From venture capitalists has been dramatically increasing too. The rates of Located tens of billions of dollars, $14 billion 2020 alone. And that funding is increasing in the size of the deals that are being done. As well as the total magnitude of money going in into digital medicine. And this graph illustrates the variety of different applications that are being funded under Digital medicine. Health IT Social health, we mentioned behavioral health is one of the biggest areas mobile health etcetera. So really across the board, this illustrates many opportunities in many growth areas in in digital medicine. Another important driver of digital medicine is the government. So the FDA, the Food and Drug Administration which regulates devices and drugs in the United States. Several years ago developed a digital health innovation action plan. In order to help promote the use of digital technologies and digital medicine. Recently, the FDA launched a new center of excellence focused specifically on digital health, as previously mentioned in 2018. The first digital therapeutic was approved by the FDA. And this really opened the door for many other applications in many chronic diseases. Which really demonstrates the FDA's commitment to improving access and scalability through digital techniques. The FDA also launched a drag published draft guidance for artificial intelligence as well as machine learning. In the application of digital medicine and digital therapeutics. I'd like to end on some thoughts around understanding value drivers and understanding value creation in digital medicine. So, as one considers what potentially will create benefits as well as create effective entrepreneurial opportunities. One should consider these types of issues such as the product and market fit the defined use cases. What is the return on investment that venture capitalists want to receive from the where their funding? Who are the payers and who is paying for the customer benefit? What is the customer satisfaction from these applications? Are their business analytics that can be applied? What is the maximum future value and what is the scalability of these applications? And importantly, are they coded for reimbursement so they can receive payment. And finally risk management such as privacy and security issues, thank yo.