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Innovating Medical Devices: Need to Know

Oct 20 | 12:45 PM

Technology is constantly evolving in order to bring new and advanced developments in how patients and physicians can track medical conditions. Many diagnostics that were previously only performed in a clinic can now be measured remotely while the individual is going about their daily activities. When it comes to the future of high-tech, innovative medical devices, the future certainly does look bright. Join us as Dr Rupesh Ghyar from IIT- Bombay BETIC walks us through some of the current medical device trends and how they affect the healthcare industry.

[Music] all right uh good evening so my name is dr devanshi and i'm a clinical ops and run working for metrics and on behalf of netflix i would uh well i would like to welcome you all to today's session uh for this session we have with us dr rupesh gyar uh if i'm pronouncing your name correctly i'm sorry um he was the senior executive officer at b tech lab iit bombay uh dr rupage did mechanical engineering from c o e p pune then went on to do a master's in bioengineering from the university of strathclyde and followed by a doctorate from iit bombay where his phd thesis focused on the systematic approach for functional and surgical suitability evaluation of mega endo prosthesis which involves standardization of fea coupled with experimental evaluation today on netflix he is going to be talking about innovative medical devices thank you very much for the kind the introduction and welcome all good evening to all of you i may be the odd man out here most of you are doctors most of you are clinicians physicians but i do have a good message from the engineering community so i'm wearing a different hat today it's not just the engineering but more on the part of being creative being innovative and how can we all work together so that's primary my message here please do not look at it as a presentation which is going to be theoretical although i am coming from verticality bombay there are no equations in my presentation there is no theory in my presentation and that is not what it is so today here more or less i am going to give you a story the experience that we have had in past few years and what we've been able to achieve together so please listen carefully it's just going to be a good evening for you and enjoy the story of a few good people who try to do some good things so let me introduce myself i am dr rupesh kahr i'm the senior executive officer at betik and vettix stands for biomedical engineering and technology incubation center this center primarily focuses on developing innovative medical devices this is a brainchild and visionary professor b ravi who's behind all this he's a professor of mechanical engineering at iit bombay this is the team part of the team which is there and let me now move on to the story so what really we did in last few years what kind of people we got together what kind of devices we develop how doctors and engineers came together so that is something which i'll try to share this all by the way started with the left person in the left side most image will say dr manish agarwal so he is an ortho oncologist as some of you may recognize and the right side is the professor b ravi who is the academic head of betty he is the principal investigator of betik and right in middle at the back you will see small me that's me so i'm trying to connect literally here the dots in between with people from the medical side to the academic or engineering side that's what the role is and that's what bettik is trying to do so what we primarily tried to do this through connecting these two main streams of engineering medical and others with the thread of medical devices now you all must have seen medical devices from stethoscope to thermometers to ventilators now which you all must have been aware to pulse oximeter these are all medical devices and just to give you a background eighty percent of these medical devices in india or in most of the countries asian countries are imported now why that matters is you are getting your devices and they are working fine but if you look at it as a country 80 80 of medical devices which goes to about 40 000 crore rupees worth of medical devices is what is getting imported in this country so we do have a very strong engineering background we have a very strong medical background as a country we have good two streams so why are we not developing our own devices then that's a very basic question which came to us that why is there a reason for us importing these devices then as in we have the strong suits we have the people then we realize that there is a gap in the product development part now product development is what you'll see the four different valleys of death and this is a slide which were made by professor ravi to simplify the gaps as well as this is something which is referred throughout whether in india whether it is daily different government places this is a borrowed slide by a lot of people and this was our understanding when we started so a lot of people if you see the image the concept part a lot of people a lot of doctors lot of engineers have concept and in different laboratories academic places they convert that concept into proof of concept so that value of death is crossed by ideation and lot of people have these ideation part they'll have a sketch about it or a small basic proof of concept also proof of concept gets converted into a functional prototype which starts looking like a product but is not a product and that is called as invention lot of prototyping labs are able to do that and lot of people are able to convert these prototypes proof of conception to protect however you don't see a lot of products coming out of india so if that is the background if a lot of ideas were there lot of inventions were there lot of prototypes existed why do not we have products and there is a bigger deeper value of that which is where the innovation happens and this is something which is not there product to scaled up part in market a lot of people are able to do because india has a good industrial network okay so industry has been able to convert so if you give industry a good product they are good at production commercialization distribution sales that is something which is very easily doable by industry so the values of depth if you see we saw there was a deeper value of that of converting these prototypes into products and that is where we thought there is value which we should be able to create as an ecosystem there was a critical gap of translation of these research ideas prototypes into marketable products that's something which we thought was missing and there were a lot of good people brilliant people who had ideas but not good products and that's where betty came in picture and biomedical engineering technology innovation or incubation center came in picture bottom two lines if you see are a representative image so 50 000 is what usually you take to convert an concept into proof of concept about one order magnitude 5 lakh rupees is required to convert proof of concept to prototype and probably that is one of the reasons so first reason is that there was a technology gap or ecosystem gap to convert but the second is also the order of magnitude of investment which goes at a personal level you can do fifty thousand five lakh and that's why you had good individual innovators but fi lag beyond that is 50 lakhs it requires a systematic systemic approach you need a systemic investment in that somebody willing to put investment because there is going to be revenue generation out of it that is no more exploratory that requires a system kind of approach of getting that kind of support and that's why there was a gap also and then industry can put once you have a product which is functionally proven tested right industry can scale it up and please do not underestimate the effort which industry puts in putting production lines invention lines uh this is also something which we try to put out that it is not that industry is only productionizing commercializing please understand the value worth which is put in innovator you know invention we always think that it's a million dollar idea but in reality it is probably ten percent of the value and ideally it is just one to two percent with our experience what we have understood there's a lot of effort which goes into making it product there are certifications there are standards and often this is a mismatch so academia thinks uh that oh we have the great prototype and that's it it's ready industry thinks that i have to invest into it i have to put time energy and dismiss succeed in market or not there's a huge risk so i should have more value and there is always this gap between who has higher value so that is something which was the learning we realized that that value has to be analyzed and then de-risk also the bottom part is called prn technology readiness level which is a borrowed term from space industry so at a concept stage it is just about prl1 technology readiness level is only one once you have about proof of concept it's three and once you have about a prototype it's five once you have emi emc safety tested as per certification it is six once you have the clinical testing done it is about seven and eight and market launch product is about nine so please understand there is a whole value which goes into adding these things so each ecosystem stakeholder has to be appreciated for the contribution which they bring so let me now that i have said the background let me bring you to uh the people who were involved in this journey so we started with iit bombay british iit bombay and then we started again two more institute who joined us college of engineering pune vnit nakpoor and this journey grew on where we now have over 15 partners who have similar better cells in maharashtra seven of these are about engineering institute partners which include creditors college of engineering uh mit adp and seven of them are medical colleges or hospitals who have joined this journey and mission of developing innovative medical devices and this number is growing again we didn't think that it will grow but this has grown to about 15 centers or sub cells of better cells being in present in these institute and these also have people who are focused who want to develop these devices let me move on to the part what we really as and why should we listen to uh what i'm saying and uh why should you hear us why are variance typical let me give you a basic numbers so what we have been able to do in last five six years is about have about 15 cents we have about 100 plus doctors there are 200 plus doctors who we are interacting working with we have about 40 plus functional prototypes which we have made filed more than 55 plus patents we have about 1000 plus people who have been trained in medical device development in last six years not just that what are the tangible outputs we have 16 startups which are created out of betic network so these are 16 devices which are commercialized now in market some of them are in early stage some are in late stage we have 14 devices which we are working with indian industry we are empowering indian industry medical device industry with innovative product so if you can just count about 30 devices in last six years it's a good number that we have been able to do so we have walked this path of idea to product multiple times we have been able to do that that's something we have streamlined the process it's a systematic approach we also have training material which we have created up based on our learning so this is something uh which i would have loved to invite all of you you could have visited betty iit bombay to see the facilities so not just the people the processes but the facilities also we have been able to create the left hand side images are iit bombay but excel at iit bombay the center it has basic ideation facility 3d cad modeling 3d printing metal prototyping so this is something helpful to convert your prototype into product much early stage or at least idea to a prototype stage but early stage these are some of the facilities which can help the second part of it similar facilities are there at college of engineering puny and vienna and at the bottom you will see mgm school of physiotherapy has a state of the gate state of the art gate lab human movement science center which is established so that is also something which exists we have been able to create these facilities what are the products we develop in case that's a question lingering in your mind uh this is the beautiful image of the products which we were able to develop left top corner that you can see from glaucoma screening device and since your doctors or professionals from different streams you can always see that various devices which may be related to you also so glaucoma screening device for eye we have something as an endotracheal tube blockage detector a smart stethoscope so you can convert any stethoscope i'll cover that story soon smart surgery planners planes then your calipers to implants which are patient-specific surgical instrument for laparoscope and then burn units or isolation units not just that all the red names are the 16 startups which are companies which are formed by these innovators and doctors working together to develop these devices in india it's very important for me to mention that it is possible and on the right hand side blue are the devices which we are working with industry now industry has come forward in saying that but you have you people seem to be doing good you have a good framework you have the idea of converting these devices so can you now help us develop this device so we are working with industry which is current msme industries develop their products also so these are some of those devices from ot lights to cameras and noti lights to prosthetic legs so i'll cover only few of these stories i have more of these stories but i'll try to give you a glimpse because it's a varied audience let me try to cover so ah this is the process in case you want to develop devices we have an indian way of developing devices this is a very systematic approach define develop deliver deployment it's a 4d process if you want to develop any medical device this is the need to know how if you want to know how to develop these are the 16 steps each four processes the defined develop deliver deploy process is further subdivided into 16 sub steps so define covers the team building doctors and engineers working together the clinical immersion where the engineers have to be introduced to the clinical environment defining your problem very well and then generating concern develop is more of the engineering side where detailed design of the concept has to be brought out the prototypes have to be made then they have to be functionally made as physically rapid prototypes deliver is the testing part the pilot manufacturing the pre-clinical testing the safety testing then the human clinical studies and then the certification and deploy is the part where you generate the ip protect the ip generate a business model go to mass production and distribution so these are 16 steps which we also take the innovators through as well as we have worked them for any medical device this is very critical and each of them has their own specifics which have to be looked upon so example wise digital stethoscope which you may have heard about so we developed a concept that the doctor left hand side you'll see there are three images right three people who are there one of them is a doctor the middle one is an electronics engineer and the stripe one is a computer engineer we put them in a camp together and the doctor said heart and lung sounds need to be transmitted from one place to another lower resource setting people lower resource setting places in india do not have experts for heart and lung sounds so can that that heart and lungs be recorded and transmitted and the engineers and doctors started working for five days and four nights continuously they worked in the cam and they came out with a proof of concept if you see there is a laptop attached there is a device it converts any stethoscope you attach it to any stethoscope and it can capture the heart and lung sounds recorded and then store it as well as transmit it that journey from the proof of concept you can see in images a prototype was made which was 3d printed so product which is injection molded and tested on safety testing pass and then the last part where it is already deployed so there is an app there is ml ai all the buzzwords it's a device which can be attached to any scope now what is the practical application let me tell you that during covid this got a very good response because all the doctors were in ppe kids and they started responding that this is a very good tool where you don't have to be close to the patient so because the data comes wirelessly uh you can directly see that in your pp kit you have your headphones and the device is completely bluetooth wise transmitting the heart and lungs on so auscultation can be done without physically contacting the patient so you can just pass on the device or you can have your ppa touch the patient and the data keeps coming to you not just that it can be recorded on your mobile application transmitted we do some analytical software on it which can identify abnormalities also that is what is the stage which we are doing right now so this is something which already is in market it's a device which is sold uh from an idea from a doctor who's saying can that transmission can be done of heart and lung sound so actually a physical product more than 2500 devices sold in market already people are using and transmitting this so that's the journey it is possible and if you see the timeline 2018 to 2020 and in last year it is even more so it is possible in that two to three years time period from an idea to come to a product level in india it is possible that's just to give you the confidence that it can be done another such story is about diabetic food screening device there is an electrical engineer that will see nissan there is dr rajni who's a physiotherapist and she has a phd into food biomechanics and they identified that because of diabetes every 30 seconds there is an amputation because of diabetes and that's where they said that can there be a device which can help identify and then we started understanding that the current devices of monofilament vibration perception temperature these are various devices and lot of diabetic people and diabetologists or the people who treat this they are not able to do because it's a 25 minute test and that is where it becomes difficult so what we did was we started developing a device which can now screen patients and the diabetic pulses can be detected or the probability of that can be done so what it does it gives you three different stimuluses and takes the patient record system so that's a beautiful device the startup has formed patent has been filed the device already is in market and uh there is sales which have happened and the device already is in clinical studies as well as market both at the same time all the regulatory clearances are done for this the third device is about fluff food sensors so club foot uh condition where the feet are turned inward for babies and the braces which exist uh there are different braces which exist and which can be used correctively but india is a very typical problem very different problem because these patients come from low resource setting to a big hospital and the braces have to be one for two to three years sorry two to three months and they have to be worn 23 hours time however this information is mentioned to the patients uh unfortunately indian parents being indian parents sometimes these braces are not worn for six hours sometimes they are not wound for a day and the problem is once the child becomes weight bearing that is when reoccurrence happens and that's what has to be avoided so what we did was we made these braces smart by putting sensors in it now the doctor started getting the information every week whether the brace has been worn correctly and the brace has been worn for how long now that is very interesting because you can do course correction that we call up the patient's parent or on that visit itself mentioned to the parents saying that look if you continue this recurrence will happen we did a clinical study 90 kids 90 patients they received this and none of them had reoccurrence so that is how technology can help identify a screen monitor and there is a clinical application of technology into monitoring these patients again the left top image will see electronics engineer mechanical engineer and a pediatric surgeon working together to develop this device so that idea got converted into a device similar example left top you'll see there is again a laparoscopic surgeon senior laparoscopic surgeon and there is an engineer he's a material scientist and we're working together where the doctor said when i do laparoscopic surgeries my laparoscopic instruments are just straight instruments and it's very difficult because my reach has been now optimized as in it is reduced i cannot have wrist like motions in the patient's anatomy or if i want to suture it becomes difficult because my instruments are straight so can you provide additional degrees of freedom that is what was the question now these instruments are already 5 mm 10 mm small instruments long instruments lot of engineering is there but we started developing and then came out with concept so you'll see the pink image actually it is a proof of concept of seven degrees of freedom of the end effector of a laparoscopic instrument in the patient's body and that is just made from paper and pins the proof of concept to the prototype that is plastic printed took some time more cad and engineering design and at the right hand side you will see metal prototype and metal functional device so after iterations of getting the engineering right and everything it is possible to convert that idea into product and then it is getting tested pre-clinical testing and the part where the doctor is actually trying to use it so that gives you more better degrees of them better accessibility and it is possible to convert that idea into reality so that's how again we work with the doctor and the engineers together and develop this device another example dr manish agarwal left hand side top you'll see working with one of the mechanical engineers to develop a reusable biopsy gun where you can control the tissue sample again same brainstorming generating different concept cad model prototype functional device it does take effort although i am putting it in one image there is at least a year or two years of work which goes into that and then a company there is an indian company for the previous device this device we empowered the indian manufacturer by giving this technology and now they are coming into production for these devices uh one one great example which we have had if you ask me innovation wise um so the law left top image is something where he understood uh mr anis he understood that there is a problem with the current polio calipers the government given oleo calipers are simple but the problem is if you want to sit on a chair then you have to manually unlock it now for us that would not be a big problem because we would say yeah that's okay you can just unlock with your hand and then sit but imagine every time you sit on a chair get right up you need your hands so what is the part of the prosthesis that was given the authentic device it is not very user friendly and they were heavy their look and feel was not great so he said that why do i have to use my hands so that i can bend the leg and then that i might as well put my hand on my knee and bend it so the device is not doing the job and he understood that problem very well then he went through the whole process or define develop deliver deploy we trained him we actually got the proof of concept prototype we put engineers together and developed this device now the device is so beautiful that if you just put your weight onto it it will not unlock so it can sustain and put your weight on to it but the moment you lift your leg it is like your knee and it just bends back if you want to bend it back that's a beautiful innovation if you see and he came out with that idea that can i not use my weight instead of my hand so now your hands are free not just that he is able to cycle with it he can just go on a bike ride he can pedal it so he does not need the locking unlocking that is again the part of the innovation the mechanism which is there to give you an idea that okay earlier examples where doctors and engineer electronics or mechanical were working together here the doctor and anis who is not a engineer was working together he is not even 12th pass so we really appreciate the kind of zeal enthusiasm he had there's a lot of inspiration and learning if you have a problem he himself is a polio patient he himself solved the problem the device is made now he has a startup now which is formed he received a 50 lakh rupees government grant for that and for all those devices all the startups which we have come we have that grant now which is taken forward and he has he is now going to launch the production market to help other polio patients that's how problem solving works creativity works right uh so it is not that necessary the technical education it helps it makes it efficient but sometimes your willingness passion can over compensate the gaps which are there to understand so he now employs engineers he has a startup where engineers are working with him so that's another way of how beautiful it can be done so these are some of the examples i thought i will mention one such example is a very simple device there's an orthopedic surgeon top left or crushing stranded and mayura in the middle that you'll see mechanical engineer so instead of creating your splints which are which require hot water or something if a kid falls in school and requires an early immobilization he created a small device it's a roll you dip it in normal water squeeze it and apply in three to five minutes it hardens so early immobilization can be taken care so if there is something incident has happened from that place to another place instead of the sticks or having unhealthy clothes which is wrapped around this is a small roll you dip it in water applied and then at least for few hours it is immobilized and then that can be immediately removed by the doctor who wants to further inspect so velcro wise this is the device iso 13485 facilities created in pune and the device already is now getting into market so that's another one more success story so how do we do this uh although we have the facility people process in place we have also created a streamlined mechanism so we have a lot of doctors who came to us that is the clinical unmet need who identified that they had gaps so they came to us there are lot of aspiring innovators who came to us the left side again so we put them together into a streamlined mechanism called medha medha is a medical device hackathon so we put them together for two days early proof of concept is developed each team has four people doctor mechanical engineer electronics engineer and designer and if their idea and the problem is worthwhile and it is doing good and they come out with a good concept they themselves feel that they are able to quickly come out with a proof of concept only two days so literally 36 hours two days and one night they are able to come out with a proof of cancer it is possible we have done more than 11 such hackathons where each hackathon had about 10 different teams concept which were developed now that brings me to the second part which is the second pipeline part which is medic now if you know your team is good your idea is coming out well we take these people and train them for a week in a medical device innovation camp as we speak there is a camp which is going on and this camp is four days and five nights people work continuously together to develop devices we train them how to develop the device and walk them through the 4-d process as we speak because of pandemic we could not do this even physically like earlier we became creative we did it online and virtual event and this virtual event as we speak we receive 200 plus applications we have about 90 teams 90 people who were shortlisted and 19 1 9 19 teams were formed each team has one doctor one mechanical engineer one electronics engineer one biomedical engineer and one designer or entrepreneur and they are working for last one month so second october it started and the 24th october is the last date where they will submit their prototypes and they'll pitch they work for one month continuously and they have 19 live problems which were given by doctors they are now converting those ideas they brainstorm generated concepts and those prototypes are getting billed as we speak and on saturday that will be their second last day and sunday they will pitch in front of a jury panel and everybody else what was the prototype and how they solve the problem not just that it doesn't stop there we also take it forward that okay if your idea is good team is good problem is good and prototype is good we actually take them through a better fellowship where we support them at one of the betting centers and take that idea forward and we do a medical device expo where these ideas are put out for doctors to give feedback industry to give feedback investors to give feedback incidentally 24th of october sunday we have this exhibition open and if it is allowed maybe i'll pass on the link you all can visit and see the expo all the startups which develop the devices if you all say okay then i'll pass on that link to you on 24th october sunday you can visit you can see all those devices which are developed as well as you can see uh interact with these innovators as well as the other teams which have in the e-medic develop these devices you can interact with them will certainly share them and then if the story doesn't end if your device is good problem is good you got attraction then you go and incubate into one of the business incubator where you actually start your company or you license it to somebody who already has a company there are two different ways not every product means a startup you have to identify that early and how long do you want to cross that values of that you also also identify that part so sometimes you start your own company as innovator if you have the passion energy and the product requires that or sometimes you just bypass only license to indian industry again i stress the word indian industry there's no point and fun of the whole journey starting and then you license to some mnc which will again 10 times jack the price and then the indian patient and doctors are again importing those devices so we prefer that we try to give it to indian industry empower them with innovative devices so that's the journey so the bottom line was bedside which is the clinical bedside to engineering bench to business to again bedside so the patients can benefit out of these and the doctors can benefit so we also have try to share our best practices whatever we have learned so professor ravi on the left side you will see has written down penned down a book called essence of medical device innovation this book is primarily about the 16 steps of innovation for medical devices which are beautifully covered by 16 stories of 16 innovators who develop 16 devices so it's not just a theoretical book about 16 steps but it is about stories of 16 people with 16 devices and how that steps can be covered there are different talks and dissemination like what we are doing right now trying to empower people by saying that it is possible to develop medical devices we try to share our best practice and the right hand side image probably we are the only lab in the country in an academic setting which has iso 13485 iso 13485 is something which is necessary for medical device and development it is an international standard that we follow so not that we just develop devices with indian people with indian ideas with the indian problem we do it such a beautiful way that it is as per the international standard so all these devices people should not take it up or use it because they were developed in india because they are best and they are good and they are solving the right problem and they are as for international standards that is what we try to do so all the practices what we are following the standard operating procedures uh the testing everything is as for international so that that is the time when we should be able to export our devices because we are at international level so something we are trying together and the last uh slide or what i would like to conclude uh by sharing you all these happy images of each image has a engineer and a doctor who are working together or a set of doctor engineer working together and probably a patient who is also involved there who is actually getting better this this is what we call our happy pictures so doctors engineers the ideas came together the prototype was developed product is there there's a company and then this is impact which is getting created so this is more or less my last slide which i said and i would like to conclude by saying that it is possible in india to develop innovate and come out with medical devices uh as long as we walk the whole journey do it systematically and then try to come out with devices which are as per the international standards or what is the requirement very important part to summarize is identifying the unmet clinical need which happens from the clinical community if you start questioning why i use this device why cannot have a better device why can't the patient have a better outcome if you start questioning that that is where the need generates right that is how it starts that the need is identified identify one of your engineering friends it doesn't matter you don't have to come to beticarity bombay i'm sure you have engineering friends just meet up just tell them that look i am facing this problem what is what could be a potential solution they are also looking at a good problem they are good thinkers they are also innovative people they may come back back with a rubbish idea stupid idea you can say yeah that part is okay but then we can improve it uh maybe it is not biocompatible can you make sure find a material which is biocompatible so that is how tinkering starts that is how innovation starts and begins and that is how you take the journey but don't stop it at proof of concept don't start stop it a prototype convert into a product and try and see if you can walk the journey to become an entrepreneur and then that is necessary in india typically saraswati and lakshmi don't go hand in hand we say no no they have to be separate but maybe durga is the force which is necessary as professor ravi says which is necessary to convert and put them together and that is how you will be able to create impact right if there is no economic to the whole innovation it's just a good idea thesis or a report somewhere sitting on some table so convert that into product is what i'll urge together try to come together first break those ivory tower barriers and maybe that will help to come out with more indigenous innovative medical device but i'll be happy to take any questions feedback comments anything that we can improve on anything that you would like to share i can take questions uh i hope i'm okay on time is that okay so we are okay we do have one request from uh doctor dietitian meanwhile maybe i can ask was was this relevant uh i don't know for all the people who are attending was this something which you were looking for [Music] please do share your feedback so we can then improve upon okay uh dr pushkar has asked if if they have any idea and they want to pitch it to btech how do they approach right so as i said year along throughout the year we keep getting we have about 450 unmet clinical needs from various doctors physician clinician and it gets difficult because there is bandwidth problem finally there are few people 24 hours but you can write to us and based on what is the stage what is the kind of problem what kind of say if you say that let's develop a pacemaker it it is very difficult at an individual level or even it requires a proper approach it's a two three years of investment you may have to apply for grants you may have to get institutional support even investors will not be immediately coming on to that because it's a high risk thing but if it is something classy device low risk something which just engineering support can help it we can do that if it's it's just part of the development where you need to say prototyping help or 3d cad we can do that so it is you write to us and maybe based on the trl level and what kind of support you are seeking we will be happy to help or we can at least direct you to the people who can help you with that um but again let's have all the stakeholders so developing the prototype is one element so is there an investor is there somebody who's going to take it forward is there a company which is interested to commercialize it let's get all of them interested and then we can take it forward uh so dr ronakraj has raised his hand i will accept his request you can just go ahead and turn on your av and ask the question yeah hello uh i apologize i joined a little late so maybe you did answer these questions but i miss them so what is the usual timeline like so if if somebody does come up with an idea for something simple for which they can make a proof and a prototype say in two months with 3d printing and all so uh from there on to finance the idea and to get the approvals how long does it typically take for an individual not a company uh so approvals are not given to individuals first of all um that's a very good question because that happens there are a lot of thinkers creators and it does happen that okay i need an approval now typically approvals in india regulatory clearances are done by cd seo cds classify the device class a b c d plus a or b is low risk device or low to medium and c and d is medium to high and high risk device based on that they'll either give you approval now that is where the time also is dependent for a class a or class b device for a class a there is no audit required but you still have to have iso one three four eight five plus class b definitely iso 13485 for the organization which is applying that has to have in place now applying to cdso you need to be an or device to organization company which has the quality management system in place iso and people or you start a company and then apply to cdsu who may give you the regulatory clearances now if it's a class cn device they may audit the facility they'll see the plant master file they'll see the device master file they'll see your testing result and class d definitely everything will be done the visit the clearances the checking everything has to be done now unfortunately fortunately if your device is something which is something which is new which is called investigational device where no similar device exists and is not approved by cdsu in india then they may ask you to do not just the testing pre-clinical emic safety they may ask you to do a clinical study and that's where your city here of course so that's where uh so pre-clinical testing does take time after prototype uh medical grade manufacturing and uh if it is an invasive device so then you may have to do animal study and that may take three months or six months that is where the timeline goes as for the risk okay so uh about these animal studies uh typically how expensive are these animal studies for uh say something like a laparoscopic instrument one thing is that i do not know clearly whether laproscopy instruments come in category b or category c from the list given online so in case of a category okay so a cauterized device is going to be a category c device whereas a non-energy source is going to be a category b yeah so uh if it is a robotic device which is using power does it fall into category c server yeah so cdsu has recently released a whole beautiful guidelines uh because when you say robotic device what you have to see is that what is the highest class risk and what is the intended use the far most important part is what is the intended use if your intended uses that it is a system which on its own will do surgery that's a different class if it is a certain assisted device right the class is different again which part of the surgery is it a critical step so typically it may go to class c what kind of software decision is going to happen because software is also classified as one of the devices so okay your hardware the electronics the software among that which is the highest class accordingly accordingly the entire system is going to be classed yeah okay okay and uh for these iso certifications uh by an individual of course i meant an individual establishing a company and venturing into it instead of joining so uh how long does this iso certification typically take so there are two parts again iso certification is for the quality management system which means do as a manufacturer of medical device not a toy manufacturer you are a medical device manufacturer so your supplier selection your environment policy your testing design change design history everything is as per quality it has nothing to do with the device per se it is the system that you have that is iso 13485 for your organization it takes about three to three months to get records in place sop is in place and then going through audit three to six months is when you can actually focus on it parallely device certification is different where you get your device c certified which is not necessary in india but you get it so that you can prove that there is a confidence that may take slightly longer time because you are applying to cbs sorry you are applying to the european union saying it is equivalent to indian cdsu you are saying this is my device this is my iso 13485 that i do everything as per the standards and now approve my device so they may take slightly longer their notified body may visit again class a b c d same thing notification is different versus certification of your place which is only saying quality management system is in place okay okay thank you so much sir i'll get in touch with you regarding my detailed queries you can always okay okay thank you so much okay so if any other questions you can raise your hand i have one hand already raised from s so i accepted your request you can uh turn on your mic and yeah hi good evening am i audible yes yes good evening so my question to the speaker is like uh sir you showed us the streamline process like from medha to medics and everything so at the end of the line uh who what is the ownership status of the product can you comment about it yeah so let's see typically innovator or independent innovator is there as i said the value is very important because the kind of risk who is taking what kind of risk one person having the idea in their mind and putting on sketch paper the risk is not there as in it is the risk was that maybe i have to buy the pen investment is there in buying the pen paper putting my one hour aside so that is the kind of risk and um time effort and the cost which has gone in then the risk and cost the cost goes increase when you say proof of concepts you have to buy some sensors you have to buy somebody the investment has increased on it then your investment goes when you say i want to make a functional device i want it as per the standard then your investment increases if you want to do testing because emic testing does cost a lot when you want to set up a company then you want to get your iso one three four eight five employ people your cost has gone increasing now here what has happened is that the person who's starting putting so uh emimc see some tests do cost like 10 lakh rupees 20 lakh functional so if you are going to invest bootstrapping is what is called you are putting your personal money then you have 90 sorry 100 of the company shares with you right that is what is your company value value of what so company's value is 100 because you are putting the money now at the moment when you say i want to do pilot production of 50 devices which may require few lacks of rupees mole design and then you may go for a institutional body or an investor saying okay i'll give you 10 percent of my company share or 20 of them my company share give me 50 lakh rupees or 30 lakh rupees then they invest and then the sharing changes so now you are only 80 percent uh holder of the equity 20 percent is with your investor because they are bringing in money then you want to spread it to have a bigger marketing team bigger distribution channel network more uh expenditure done on visibility uh inventory stock and that is when you you will say i will raise series 8 i will dilute maybe 20 more of my company and i have one more investor who will give me now once year for that 20 which means now 40 percent of the company is with investors so that is how it starts diluting and it will happen by the time you have a product which is in market if what is the percentage of the company share is what matters now there is a different part if you say ip ip can belong to the initial inventors who license it to the company and the company pays back to the inventors or it is transferred to the company and it is a asset of the company that's that's how you put it together but percentage of what is very important what is the company sales that is when it comes in picture so your value goes on so somebody who comes at a late stage they may have just come in one month back but they brought in one cr or two cr or sales somebody just comes with the sweat activity saying that i will do the distribution i will give you sales of say 1 million rupees now there their value is going to be higher right so their efforts may be proportionate and you may have to admire that and you may have to adjust your value according to that uh yeah sir actually i had lost you there for a moment like i joined like when you started saying about 80 and 20 percent so like yeah so let me summarize saying that so typically you may start as inventor start the company and you may be 100 percent equity holder but then eventually you may have to get investors so testing requires some amount of funding manufacturing requires and there you may have in investors and these investors may take up 15 20 percent of the company shares so so that value may go down and eventually when you have a commercial successful product you may be left with 30 of the company ownership 30 to 40 and that and then eventually it even drops down when you have uh series a vc funding then less than ten percent even if you are holding ten percent of the company equity that's not bad okay so like uh i hope that's answering through this uh process like the betting process like what has been the usual trend like so we are five to six years old uh sorry i didn't get your name nor your photos so i do not know what ss stands for nor how do you look uh oh yeah actually it's a bamboo i'm a second year medical student in empire medical college so great great no no i just wanted to hear um so uh typically uh what betty company so we have this five or six year young right in that sense so the first batch of innovators their product developed in proof of concept prototype in first year product got developed in second year so io devices is one of those examples so io devices 2018 they form the company where the prototype was ready functionally tested 2019 when they got everything streamlined inventory and 2019 they launched their product 1819 and by 20 2020 and 2021 they already have like 2050 2500 devices already in sales they're already cash positive revenue positive so that is one experience where they did not require an institutional funding rate sales then they got a lot of awards lot of grants because of the work and the product development so they didn't have to reach second example i'll give you is a company called irt devices the diabetic food initially they got each of that company what came out of betty got 50 lakh rupees award from birac as a grant because they qualified from each of that 800 applications so each year we got one of the startups who went through got that 50 lakh grant but that means they didn't have to go to angel investor that is how we skip that one step but now irt devices they just are about to close around they got their turn sheet and they are about a validation about 15 to 20 cr bring 20 20 20 plus cr is what is the valuation of the company now so that is in three years of timeline you are able to and they are getting a systematic investor who is coming in picture anywhere between 50 to 30 cr is what you will get a valuation once you have your uh basic product tested tried out and early traction few customers that is where you can target cool thank you so much for entertaining my question sure more than happy uh okay we don't have any requests as of yet so thank you so much sir this was one of the most interactive sessions that i have hosted so i'm sure that if we start a club then we'll have a very uh successful following for this thank you so much for the session and uh we look forward to working with you in the future pleasure uh pleasure is mine and really interesting to hear i'm always happy to interact with creative minds interacting with innovative minds anything to do with medical devices any support any help will be happy to help please drop in a message um you can always look at us and bettick.org the emails are there my email would also be there you can write to me whatever wherever we can help we'll be happy to help but thank you very much for inviting and this is really interesting hope to connect with you all soon you

BEING ATTENDED BY

Dr. Tarini Prasad & 777 others

SPEAKERS

dr. Rupesh Ghyar

Dr. Rupesh Ghyar

Sr. Executive Officer, BETiC Lab IIT Bombay

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dr. Rupesh Ghyar

Dr. Rupesh Ghyar

Sr. Executive Officer, BETiC Lab IIT Bombay

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