 So, let's go into those 16 steps one by one. Step number one was to form a team and I mentioned that team has to be multidisciplinary. What disciplines do we need medical device innovation? I would say four critical disciplines. There should be one person in the team who knows bio. It could be a doctor, it could be a biomedical engineer or someone else who knows human anatomy. Number two you need is a creative person, a designer, industrial designer, product designer, creative designer. If nothing else works, architect is fine. Anyone who is a creative mindset who can look at, we can visualize ideas and sketch them. The third we need is electronics, E, which is electronics, I mean electronics I mean a group of people, electronics, electrical, computer science, software, IT all this I would group as E. Because if you don't have E, you cannot use that what I told you those earlier, those great new technologies, all of which have need electronics and software capability. And the fourth one is mechanical, but M also stands for mechanical manufacturing materials and so on. And you need these people in the room because they are the ones who give physical shape to the thing and actually get it manufactured. So these four are absolutely critical for elements of a team of a medical device innovation. Step number two is clinical immersion, you can't sit here and create a medical device and then go to hospital and tell the doctor here is a nice new great device, start using it. If there is a good chance they will laugh at you because you never did your homework. What is the problem that they really want to be solved? Is there only existing solution? What is the real pain point? So you need to go to hospitals, talk to doctors and watch those procedures. And please this can be done, this should be done with great care. You have to take prior permission. You can't just walk in and say I want to meet you or I want to see you treating patients. Patient data is important, patient privacy is important, you have to take care of those things. But what are you, when you go to the hospitals and watch the doctors doing either diagnosis or treatment, look at what devices they are using. If you go to multiple hospitals, see are they using the same device, different devices. Is there a difference in the time taken for treatment or diagnosis, the skill level of the doctor, what are the variations of patients and other complications and so on? This you must watch very carefully. You look at all procedures, diagnosis and treatment including follow-up, see what is happening, what is happening to the patient, are they comfortable, not comfortable, are they having pain. Is a doctor having trouble, all those you have to observe carefully. And then ask questions. But if you notice something funny here, what is funny here? Why is there three times? Why is why three times? Because doctors may say that I am having, I need a device for like this, doing like this. If you just go headlong and start developing that device, you may miss out some great opportunity. If you do not ask a question why, ask a doctor why and you may say I need this device to treat this complication. Then you can ask a doctor why is this complication happening and they say maybe because of this reason. And you may finally find that maybe solving this root cause is better than solving the or creating a duplicate device at a lower cost, which is what most doctors want is can you make a cheaper version of an existing device? You make a cheaper version, you can reduce cost maybe half, maybe one-third. You can never bring it down to one percent, but if you ask why multiple times and go to the root cause, you may be able to do the treatment or diagnosis at one hundredth cost. It is possible. And I'll show you examples of that anyway. So what we say is that whatever you want to do, define your problem as clearly as possible in as few words as possible. We typically say ten words is a good target or less than ten words. But it must satisfy three criteria as far as we are concerned medical domain. One is it should not be vague. So it must always, if you make it vague, it is very difficult to evaluate or find out if the idea is good or bad. So idea must be very clear. Number two, it must not point to a solution. You cannot say treat this thing using ultrasound. You can't tell us how to solve the problem. Tell us what the problem is. Don't tell how to solve the problem in the problem definition. And number three, by asking why multiple times go to the root cause. So let me give an example of what it, how it should be. In my opinion, a good problem definition must have three things. It must have the desired outcome, which is what you want. It must have somehow clinical need, which means you also mention why you need that. And also in some way you define who is a target domain. What this means is who, who is that. An example, if you say I want a portable cabinet to safely store medicines in rural hospitals, it has taken care of the three things. Whatever one is a portable cabinet, that is my desired outcome. Why I need it to store medicines? And for whom it is meant, rural hospitals. Is a reasonably good example of a well-defined problem statement. Now step number four, concept and feasibility. The issue many times with engineers is that they fall in love with an idea. You generate a concept and somehow you latch on to that. And then your mind blanks out to anything else that may be out there, which may be better than that. Okay, so what we say is don't fall in love. Be very clinical about it and pass it through four filters. I have four filters. Filter number one, is there a significant local market requirement for that? If there is no market for that, why are you doing this project? Number two, have a value proposition. The feasibility of doing something much greater, not 10%, 20% improvement that is not worth it. Can I make it 10 times, 20 times, better, faster, easier or less expensive? The third thing is capability of doing so. If you do not have the right kind of materials and skills and equipment and so on, you can't do that. And expertise. There's no point starting something which will take next 20 years to develop. So by 20 years, everything will change anyway. So no point doing something which takes so much time. So do with your capabilities, what you can put out in the market in next two, three, four years maximum. But the fourth one is the full-time commitment of the innovator as well as the stakeholders. In medical domain, we have doctors many times coming to us and they say that this is a great problem, why don't you solve that? Now we ask the doctor usually, sir, will you give us one hour time every week? Either you come to our lab and give us feedback or we'll come to your hospital and tell us how we are doing. The doctor cannot spend one hour per week. There's no way we can commit to developing the device because if a clinical, medical devices, clinical inputs are absolutely, absolutely critical. Okay, now go to step number five. We have done the first four steps which is to do with the defined stage of the project. Now we go to the developed stage of the project. So very quickly, digital design means that you are looking at the overall structure, what are the components into the structure? For each component, what should be the material, what should be the geometry? Geometry means the functionality and the features and material means what properties I want for that particular component. If you want a transparent component, obviously materials have to be chosen accordingly. And then you worry about manufacturing and assembling. Now, when do you make it different components? Why can't the whole product be a single piece? Why do you need multiple pieces? It could be for three or four reasons. You make different pieces when there is a, by function, you need that. Or there's a movement with respect to each other. They're made into different pieces. Or you may need different properties, like I mentioned just now, transparency property. Or for a manufacturing point of view, we have to make it separate and assemble it. Then also you may need to have separate components. So let me take an example here. These are processes for children with bone cancer. You can see that there are several components there. You have a condyle in the middle on which the kneecap or patella will glide. Then you have a collar kind of a thing which gives extension because someone's tumor may be big or small. So you put the extension pieces to cover the gap. Then you have a stem, both upper stem and lower stem, which goes into the bone. You drill a hole and the stem goes into the bone. And then you have separator. A white piece is a separator because you don't want metal to metal rubbing that creates metal particles and metallosis, blood poisoning. So you want to prevent them putting a plastic in between. Now, once you know the functionality of each of the pieces, now you know they have to be separate for because there's a movement or because by function you want to separate or you want a biocompatibility which stem goes into the bone, you know you will need different materials. And thereby you choose materials accordingly. So when you have you need high biocompatibility, the stem going into the bone, I want bone to grip the stem, then you go for titanium alloy where you have movement and you want extremely mirror surface spinach because you want very low coefficient of friction go for cobalt chromium molybdenum. And you want the polymer to separate the two metal particles. So you go for not ordinary polymer, it has to be ultra high molecular weight polymer, polyethylene. So this showed you how you decide about the various components and decide about the material and geometry component based upon functionality and properties. Then you go into the detail design. You actually go into dimensioning, the actual shape, the actual features. And thanks to CAD today, it's very easy to visualize model and visualize that but CAD also allows you to do few other things. Using CAD you can actually do the movement. You can see how it's going to move or any parts going to hit each other or hinder each other. So you can do motion analysis or kinematic analysis. You can also do assembly sequencing. You can see what sequence to assemble or disassemble. Disassemble for maintenance, let us say. And with all these things, in additional software called FEA or find element method, you can actually simulate the loads on the components and how the component will be stressed, stresses and strains. The color coding will tell you that red means you have high stress, blue means you have low stress. So with high stress, you add material where you have low stress, you remove material and so on. And then you come into the physical plane which is you create a physical prototype. Thanks to 3D printers and multi-material 3D printers like the one you see there, it's not possible to build very accurate physical replicas from the CAD models directly. Of course, your support structures which you have to remove that but you plan very well, you have minimum support structures and you can create a assembly model from 3D printed parts. It can take some loads but don't expect it to take real-life loads. But it's great to check the form and fit to some extent function also. Not true loadings but at least some basic loading function also you can try. So form check, fit check and partial functionality check can be done by 3D printed models. Then you go into the functional prototype which means the actual materials which you want to use the steel or cobalt chromium or titanium or any other specific materials, industrial plastics. So what ends up having is you have some function in mind. You create some geometry and material and tolerance is based upon these three you decide the manufacturing process. So process determines manufacturability. Manufacturability in very simple essence is how easy it is to get the desired quality at the least possible cost. So if you can't get that, you change your process or change your geometry or change your material and that's a cyclic process. So functional prototyping although it's just two words here is actually a challenge in job to do. The step number nine is about quality. You cannot do innovation game unless you think about quality and quality management. And if you have quality management system in process, what it means in real life is that you have a standard operating procedures, you have some forms, you fill up the forms, someone checks the forms, science and it becomes a record. Supposing tomorrow something goes wrong and you want to trace back saying what is the reason for that? If you are not maintaining documentation, how will you figure out that? You need to know what material was used for that batch who made the, who manufactured the part, who inspected the part. You want to look at all the history of the part. That is not possible unless you maintain records. So what typically in medical device development you do is you look at various headings of departments you can say and for each department you create certain set of standard operating procedures or SOPs and those become forms and records and so on. Then you go to step number 10, which is your testing in the lab first. Obviously you don't want to put the medical devices in the hospitals before you test it in lab first. You don't want to take a chance. What it means is that you want to establish a reasonable evidence of safety. There's no guarantee that even after lab testing it will be perfectly fine in the real world. At least you have some reasonable level of safety. And so you subject it to various kinds of tests. You have what is called as biocompatibility test, especially if you're using a new material or a new composition of a material, you change slightly composition or the composition or structure change because of the manufacturing process, you'll have to check for what is called as biocompatibility. Essentially it means toxicity testing, skin sensory testing, it should not cause cancer. So these are all tested in the laboratories. The other than that you also test for mechanical which is it should not break, it should not bend, it should not collapse and all that. Mechanical testing also includes when you drop it it should not fracture. It could also mean that you put it through water jets and it should not leak. You also make sure that the device will not stop functioning because of some electromagnetic fields or power fluctuations. Now the device will cause disturbance to other devices in the room. So either way you have to test it for electromagnetic compatibility and electromagnetic interference. And finally if you pass all the things you can also try it on dead animals for which the regulations are not that strict but real animal testing is very highly regulated and controlled. It's only done in a specific institutions without a permissions. But it's possible to animal trials for certain class of product. You don't need to test everything on animals. Only those which go into human body that you may need to test on animals. After you do all those things then it is a time for human clinical trials. You actually try the device on human patients but not unsuspecting patients. You have to make sure you have a criteria for inclusion and exclusion. What kind of patients will try the device, number one? Number two, you look at consent forms. Patient should be informed. This is a new device. And why should you try the device unless it is better than existing devices? If anything goes wrong you should have insurance. And if you say if anything goes wrong we'll give you the current best standard treatment back to you. Which means we'll put you back on the feet anyway. So you take care of patient safety or patient safety at any cost. So safety is one part of thing. And number two why you're doing clinical trials is to look at the efficacy of the device. Is it really functioning the way you're promising the retail function? Better, faster, easier, whatever it is. Beside these two there are two more things. Especially if it's a diagnosis device you also worry about what is called a sensitivity and specificity. If you're trying to screen or diagnose a person for a disease you want to make sure that there are no false negatives. If someone has a disease the device must be able to catch the person with the disease. No false negative. It says that the disease is not there but disease is there then it is a risky part. Similarly it's also specificity. If someone doesn't have a disease the device should not say that he has a disease. That is false positive. Then he'll go and go for unnecessary treatment. You don't want that either. Got it. So this is your four criteria or four basic thumb rules for human clinical trials. Then you're getting into the 12th step which is your certification. Most academics give up by this stage. The certification is a long procedure. You have to submit a lot of documentation to say that we have done all this design properly, testing properly in the lab, biocompatibility, all those tests and maybe animal trials and human trials and all the results of that. Then the government will say that okay fine. Looks like it is safe and efficient. Now you go ahead and manufacture. License to manufacture and market is what is implied by this licensing. Now licensing depends on the class of device. If you have a low risk device the regulations are not very strict. As long as you are doing basic good practices of safety and cleanliness, a quality management system and all that government will not come in the way. Maybe you should still for safety you should go and say please give a no objection certificate, NOC. That is also for the class B which is low to medium risk. But when it comes to medium to high and high risk devices then its procedures are far more stricter. It also specify where you are doing what is the manufacturing process, your quality checks in the manufacturing processes, your site plan. Who are your neighboring manufacturers? If right next to your site there's someone else producing poisonous or toxins then you don't want to be manufacturing in this site either. So your neighboring sites are also coming into consideration when you have to get a license for manufacturing. So these are all done and for class D which is high risk like implants. The government will not trust they'll actually send an inspector to see that what you're saying on paper is actually true in the reality. So all this put together will if you pass the whole thing then you get your device certification for manufacturing and marketing. Now we go to the last stage of the life cycle. The last stage is deployed which is putting the device into the practical hospitals. Now here is where you need to give a right to yourself and exclude others from manufacturing and copying your device. That is what you get from intellectual property rights, primary of which is patent. What is a patent? It's an exclusive right given by the government of a particular country to a manufacturer in that country so that only that manufacturer can manufacture and sell legally. Others if they manufacture sell that is illegal and they can be taken to court but what do you give in return to government is a full disclosure of the innovation. You're describing in great detail how your device works. What are the components? How do they work with each other? Entire drawing explanation you give it and file it and it's publicly available. You may get scared or I'm giving away all my knowledge to the public but because it is given and then the right patent is given to you even if it is in the public no one can copy it. If someone copies exactly you can take the person to court and ask for damages. But what can be patented? Only those ideas which are novel those ideas which are useful and they are non obvious. You can't say that draw something and say that this is I want to file a patent for that. If someone else also come with a similar idea very easily it is an obvious idea. So obvious ideas cannot be patented. Combinations of A and B doesn't become a C and C becomes a patent that's not possible. They're all obvious things. So novel useful and non obvious and patenting is not a simple thing. It's a long process. Until recently you would take eight to ten years to get a patent in India. Now they're reducing the cycle time to four to five years. Hopefully it'll come down to two or three years in the next few years. The two major steps in the patenting as far as innovator is concerned the first thing is to file a provisional patent. The moment you have a reasonably clear idea about your innovation and you have a sketch and drawing and you can explain that you file a provisional patent. Then you have one whole year in your hands to change the drawings and file what is called as a complete specification along with claims. You claim that this is my innovation or this feature is my innovation. So you have one whole year to change the thing because don't delay the thing. The moment you think you have a good idea because someone else may also file the patent. Who knows? You think you are new? Someone else is also working on the same idea at the same time. So filing provisional patent and filing complete specifications are two critical steps for an innovator. Rest of the things are usually taken care of by the lawyer. Even patent drafting is done by a lawyer but in consolidation with you. Rest of the thing filing, putting fees, chasing the thing and hearing and publication all that the patent attorneys will take care. Again business model is a big area and you can spend a whole semester in multiple courses or you can go and do an IAM or MBA to learn about business modeling. All you need to worry about is four things. Number one, you worry about what is it that you're offering to customers? Is it a product? Is it a service? Is it a product on a one-time product or is it a product on a multiple times or is it a lease? Number two, who are the customers? In medical domain, who is the customer? Customer can be different from the user. User can be a doctor or a patient or a family member but customer is the one who paying for the device. The paying could be either by the patient or by the hospital or by insurance agency or by government. So that is customer. Or hospital also may be buying once in a while, large equipment. And then you have supply chain and distribution channel. And of course, as a startup, you have always options. You can say, you can take your technology yourself, license it to yourself and you start a company yourself, great. Or you may say, no, we will license technology to some other company. Or if you're very benevolent, you'll say, okay, I'll put my design on the open source. Let anyone copy. There's also one more option. You can give it to a for profit or for not for profit companies. You can give it to NGO, which will supply the products, manufacture supply at zero cost or very low cost to the end users. Now last but one is funding. People have tried to look at the causes of failures of innovation companies. And they found that the failures could be for many reasons but the top three reasons which come up is one is a team is not so strong. The team complimentary skills or leadership or maybe the size of the team, whatever. The team dynamics is one major cause of failure, especially in India. Reason number two is that product market fit. And we have been telling you all from beginning, if you're solving the wrong problem or you develop something and you think people should just everyone should buy this but no one is buying it, which means something is wrong. What is thought people will buy, they're not buying it, which means the product and market fit is not good. But a third reason of failures is lack of funds. Exactly time that you want to go and expand a company or buy some equipment, hire some people, you have zero cash left and then you have no other option but to wind it down. So typically you need money for four stages of the companies. One is to establish a minimum viable product which can be actually sold in the market. Typically this you can have to fund it yourself out of your own personal, family, friends, whatever. If you're working in a lab and lab has a R&D project, maybe project can fund that. Second thing is you want to, what's called establish a minimum viable market. You want to actually go and sell that to a few territories, target customers or users. Then you know that it is selling, people are talking about it and what do they like, what they don't like about it. A minimum viable market. If you have funds yourself and you can bootstrap nothing like it, otherwise you can go for what's called angel funding. Private, it could be private people or it could be government also has now several arms of the government which is giving angel funding to you. The third thing is to establish a suitable business entity. You actually want to start a company, hire a space, hire people, hire furniture, hire equipment, basic things. That needs money if you million rupees typically. Now there if you do not have funds of yourself or government or something like that. Then you look at what's called as many sources. I'm just giving you one more example here. Venture funding is one source for that. And once you start selling and then it's doing fine and all that but now you want to go international or you want to now start add one more manufacturing plant or four more manufacturing plants who distributed in all those, all the states or across the world. You need large amounts of money. Your profit margins are not sufficient to expand like that. Then you have to go to some of the sources of funding. The many other sources again you can do IPO or you can go for private equity or you can go for mergers acquisition. Several examples are like that. So this slide is just to give a hint of the need for funding and stages of funding and some examples of funding for each stage. Now last step is continuous improvement. Life never stops at version one. You have defined a unmet need, developed a normal solution, delivered a tested product and deployed in the market. Great, but life doesn't stop there. Usually when you deploy in the market you will have customer feedback coming in or complaints or suggestions and that gives you seed for going back to defining a new product or a new version and life continues like that.