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Sukrutha Bhadouria: I hope you’ve been having a good session so far. Good time so far in the conference and we are ready for the next session. Thank you all for waiting for us. Rashmi is here to give us our next talk. Rashmi is a Manufacturing Test Engineering Manager working at Robotics and Digital Solutions at Johnson and Johnson. In her career over the last 13 years, she has worked on consumer products, trained signaling, and more recently robotic applications and medical devices. She’s passionate about making an impact on our society with technology and helping fellow women in tech in their journey. Welcome Rashmi.
Rashmy Parimi: Thank you for the kind introduction. Hi everyone. I’m Rashmi. I am part of the robotics group in Johnson and Johnson currently working on the manufacturing side of one of our new robotics products soon to be released to the market and through the stock a Dr. Robot. Now see you. I’d like to transport you to this future vision where this will be a more accessible reality for a lot of people. <Laugh>.
Rashmy Parimi: I want to go back a little in the history before I transport you to where we are today and what the future looks like. A lot of you must have seen this picture on the left of an early operating room where surgery was more of a spectator show. Antiseptics and anesthetics were not something of commonplace. There was no concept of sterilization and for a lot of, I would say decades back then, laughing gas was a commonly used anesthetic.
Rashmy Parimi: Even that was not highly recommended because you know, there was mixed feelings either by the patients or the doctors to use it. A dentist came across ether being an effective anesthetic and he compelled the rest of the medical community to conduct a clinical trial to give more substantial data. And that was one of the starting milestones of making anesthesia a regular process of surgery.
Rashmy Parimi: I think the data convince people that one anesthetics are good. They’re not necessarily something that take you out of control. And also convince surgeons that they didn’t have to resort to methods like strapping down the patients to, you know, help them go through the surgery because you know, without an anesthetic the pain will make them move and that’s not something ideal. And they also felt that having a PA stable patient would give them more dexterity and stability to operate.
Rashmy Parimi: That was a very fast history of surgery back then. But from then to now, like there’s so much, you know, medicine has gone grown from deeps and bounds increasing human lifespan by at least 30 years. And even today, I think the whole fascination with watching surgery has not gone away, but it’s a little more, I’d say refined from how it was in the photo depicted on the right towards, sorry, on the left to where it is on the right where there is more advanced rendering of the surgical procedure, either during to help other specialists participate in it or to a surgeon or a medical team in a far away location to help add more perspective to a complicated situation.
Rashmy Parimi: From a very low out like low outcome pain causing and a long recovery method to introduction of laparoscopy and endo, which has improved patient outcomes and reduced the recovery time and also improved the accessibility to a lot of people for complicated procedures. So this is where I think with this is what most people are familiar with and laparoscopic was what sewed the seeds for the first ever use of robotic surgery.
Rashmy Parimi: This particular arm is maybe familiar to a lot of people as something used in, you know, large industrial assembly houses for large scale manufacturing, more like you know, car assembly facilities or other large equipment facilities. But you’ll be surprised to learn was this was one of the first experimentations of whether robotic surgery can be used or not. And you will be even more surprised to learn that the area in which this was used was brain surgery. <Laugh>. This was used to guide a percutaneous needle to do brain biopsy back about more than 25 years ago. And then this concept was further expanded to a colostomy and TransU urethral resection to further peak people’s re and research group’s interest to develop the concept of robotic surgery even more and work towards bringing it from a lab prototype to more of a reality. In 2000. one of the pioneer companies of robotic surgery, Intuitive Surgical, they broke the ground finally when their system, the first ever Da Vinci system got FDA approval for general laparoscopic surgery.
Rashmy Parimi: It was this innovative device with lo robotic arms with visual systems and also they had help from nonprofit scientific research organization, SRI, to help them advance a lot of these initial prototypes. And that’s was how most people today, if they are familiar with robotic surgery, I think this is the one name they recognize instantly.
Rashmy Parimi: Let’s talk about what are the advantages of robotic surgery that makes it so attractive to use when, you know, everyone would admit that laproscopy already takes us through a good bit of path onto, you know, smaller incisions and all of that. So we still get the same advantage as oscopy that is a smaller incision, which means quicker healing, lesser hospitalized time, which I’m sure all of you will, you know, relate to the expensive insurance bills and not having to deal with that. And also it is co like the cost saving and also the body will recover faster through a smaller incision since the amount of trauma is less. The other advantage is the precision the instruments can reach into hard to reach places of the body without having a wide incision with accurate precision and stability, which is a lot of, which makes a big difference in terms of your outcome of the surgery. And also with this precision al the comes with it, it adds an extra, I’d say boost to the surgeon’s abilities and gives them the confidence to tackle some really tricky procedures.
Rashmy Parimi: One of the important things of having a successful surgical outcome is good visualization. When you know you cut a part of the body, there is obviously going to be blood involved and in typical surgery it could a lot of times block the view of what is going on there, but with the time your incision smaller cuts, that disadvantage can be overcome and it leads to a better outcome. And also there’s a good example that I would like to use for what, how pressure virtualization you know, improves the surgery. So having robotic vision is like if you want open surgery is like using a flashlight to look through a window into your house while robotic surgery is like opening the door, turning on the lights, and then trying to look at your house. You can see it’s evident, which is a better way to look at your house.
Rashmy Parimi: And that advantage is offered to by the advanced imaging that comes with robotics surgery and with, in addition to all of these, the other advantage is exceptional dexterity. So everyone is, you know, familiar with how surgeons have these long schedules and if things do not go as planned, there is a lot of fatigue on them with the long hours and that can lead to that showing up on the surgery itself. But with robotic surgery, one of the things that can be controlled is to remove the tremor and other fatigue related impacts so we can reduce these inadvertent, you know, punctures or nicks which can cause unwanted bleeding into the body. So let’s look at few of the areas where today robotic surgery is used in one way of the other heart surgery where these very precise repairs that are needed is done using robotics stomach, though it looks like a big area, there is a lot of fine precise procedures that can be done in a better fashion using robotics.
Rashmy Parimi: General surgery of course, is another area where with a smaller incision and the precision offered, you can do a lot more compared to non robotic surgery. And same goes with the area of GY gynecological surgery where there is, you know, access issues and you want to make sure you don’t impact the healthy tissue or healthy organ parts. Same thing goes to lungs where the access is extremely difficult and with kidneys where the, the areas so delicate important that you want to make sure you do not cause unwanted damage to the existing parts. In the area of orthopedic surgery, robotics have given an added advantage of very precise cuts and placement for implants and you know, it’s popularly used I think in hip replacement and knee replacements, which has become very common place in the society today. In the area of dental surgery, there is a product in the market today which help with dental implants and there’s, I’m sure there’s a lot more research going on.
Rashmy Parimi: And as I explained in my first example brain surgery, it started off <laugh>. The whole idea for this was sewn with brain surgery and it is still an area of widely researched today and they are trying to develop products in that area. So here I have some examples of some popular players in the market today. So roughly going over that, the first one is Johnson and Johnson’s robot monarch, which is, which has f d a approval in the lung cancer and kidney stone management space. Below that you have Medtronic’s robot Hugo, which has approvals in the general surgery space. And the picture below is Intuitives DaVinci. It’s a newer generation of it, which also has approvals in general surgery and a lot more areas on the right hand side. The first one is the Yumi robot, which is used in the dental surgery field. Their application right now is in the area of implants. The one below from Striker is the maker robot used for I think the orthopedic area. I, I don’t want to guess the wrong thing, but I think in the, a place of hip replacement probably. And the one below is from Siemens and this is a robot used in the cardiovascular area.
Rashmy Parimi: Now that I’ve peaked your interest on how, what, what are the advantages that come with this novel application? I’m sure all of you must be curious how do you break it into this field? What are your pathways? Is it something very niche? Do you have to, you know, is it very a small circle, small exclusive circle? Well, I’d like to walk you through my own career path to kind of show you it’s really not all that difficult.
Rashmy Parimi: In the next slide I will also kind of walk you through during the various stages in the life cycle of a product development, what are the different functions that interact and how, you know, different disciplines come together to successfully build a robotic surgical product.
Rashmy Parimi: I started off by education as an electrical engineer, but using that as my foundation, I have worked on firmware for different products, electricity meters, crane systems, small devices which include wearables, thermostats.
Rashmy Parimi: If you see here my, I went into this was not through either medicine or robotics. I started from a very normal field, which I’m sure most of you feel <laugh> a little easy to relate to. I did have a small ex in brush with medical devices early in my career where I was working as a part of a team on a prototype of a U USB based E ECG monitored. If any of you have noticed the E ec G monitor today used in the hospitals is, it’s a big piece of equipment and it’s not portable. If it, you know, there is a, it’s used in a remote location and they want to share the data around for more opinions. It’s not easily done. There is that accessibility issue. But if it were in a USB form and the data can be collected wirelessly and shared across seamlessly without the boundary of a physical location, it it would be a B great blessing to bringing healthcare to rural areas where accessibility is a big issue.
Rashmy Parimi: The proposition of that product was very interesting. And back then I was, you know, I wanted to continue in that but then again it was just one research project. But in, as I grew in my career, one of the chances I encountered was to be part of the startup verb surgical, which was working on a soft tissue surgical platform. Today surgical has been acquired by Johnson and Johnson and that team is continuing the work on that platform. Hopefully soon that will be in the market helping people improve their quality of lives. And even if you notice through my career, the job duties I’ve done has varied from pure research projects to some integration to what I do today, which is manufacturing test. So, and all of this is more about applying your skills, existing skills across different areas. I have not taken any new courses.
Rashmy Parimi: I have always maintained this curiosity to upskill myself on the job and try to, you know, read more on things I don’t much, that was how I was able to work through different domains within the same company. So next I want to talk about what are the various disciplines and roles that participate together during the development of a product. So initially, you know, when you have, when you want to establish the user needs and make sure a certain product is feasible from a regulatory perspective, the team that typically ha does the groundwork the product managers who talk to the customers such as the physicians to make sure they understand what will help them. Then you have the systems engineers who translate those customer needs into some kind of actionable product requirements. And then the clinical engineers who also bridge the gap from a clinical perspective.
Rashmy Parimi: The regulatory affairs team helps trying to understand what, how the impact of that, you know, what is the burden of this product to make sure we are safe. And also how, how do we prove that this product is safe to use on human beings once the use case has been established And there is this clear requirements for the product. Then comes a design phase where you have design engineers and various arenas. You have electrical design engineers, mechanical design engineers, hu UI engineers, UX engineers, all coming together to build different pieces of the system and of course test engineers to test all that has been built. And for most large scale products, one of the things that has been the, you know, big made a big difference if the product moves forward in a given timeline or it does not launch off is the integration piece of it.
Rashmy Parimi: There is a lot of complex software and hardware coming together and integration plays a big role. We have the systems integration engineers trying to piece those puzzles, making sure two independent modules operate together as one big unit and also clinical engineers vein from time to time to make sure what physically was decided in the beginning is still what the goal of it is towards the end. As the product goes into its future stages, the burden is to val validate and verify it so that we have the essential documentation for FDA approval. But before that, the manufacturing team and the supplier make sure they work with various vendors and internally and to build up these units that will provide the data for FDA to review and approve the device. And once that is done during the commercialization phase, you have marketing team, the sales team, the service team to make sure the product is supported within the customers who are using it and also provide the feedback to support the next level of iteration of design and all of these resulting in a complete cycle.
Rashmy Parimi: As you can see, quality is something which is critically important through the whole process and weigh in in all of the design phases and the later validation and commercialization phases.
What is the future outlook for this field? This is illustration from before the pandemic and you can see just few years ago there’s been 77 companies and these are only the companies that are have gone public. There are a lot more stealth companies who maybe close to finishing their product. So the number of companies have increased from a few million in the beginning of last decade to a lot more billions now. So it’s a fast growing industry and there has been a lot of acceptance to make sure this field is supported. And in general you’ll see these are the two areas where there has been a lot more progress in terms of adding new procedures and support in terms of surgeon’s interest and also success rates in the field.
Sukrutha Bhadouria: Rashmy, we can wrap up. It’ll be great.
Rashmy Parimi: Yeah, so I think this is my last slide, <laugh>. So with this I hope a lot of people I know, I’m sure you have a lot of questions. I’m happy to answer that later. I please feel free to connect with me on LinkedIn. Thank you everyone for your time and thanks for having me here, <laugh>.
Sukrutha Bhadouria: Thank you so much Rashmy and thank you to everyone for attending and you know, posting all your comments and sharing your insights. Thank you.
Rashmy Parimi: Thank you.
