When paths converge in the realm of medicine, the result can be nothing short of extraordinary. Discover the serendipitous journey of Dr. Gary Kitay, esteemed orthopedic and hand surgeon, whose early exposure to the nuts and bolts of his father's hardware store set the stage for a career in the tactile world of orthopedics. In a revealing conversation, Dr. Michael Koren and Dr. Gary Kitay stitch together the tapestry of clinical research and personal calling, unraveling how a love for statistics and mathematics shepherded Dr. Koren's cardiology practice while Dr. Kitay's affinity for anatomy and hands-on healing carved out his surgical niche. Their discussion peels back the layers on the immediate satisfaction of surgical successes as opposed to the patient wait-and-see of internal medicine, offering a rare glimpse into the passions that pulse through the veins of healthcare professionals.
Step inside the meticulous framework of medical device regulation and witness the birth of innovation through the lens of the FDA's classification system. We dissect the distinctions between class one, two, and three devices, illuminating the pivotal role of clinical trials in the journey from concept to patient care. With the introduction of the hand immobilizer, a deceptively simple class one device poised to redefine surgical support, we navigate the ethical maze of informed consent and the gratifying challenges that accompany the design and implementation of medical advancements. Join us as we unravel the complexities of device innovation and patient care, all the while championing the collaborative spirit that drives medicine forward.
Take Home Talking Points: ✋Orthopedic Surgeon's Innovations in Medicine
✋Regulation and Innovation in Medical Devices
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
When paths converge in the realm of medicine, the result can be nothing short of extraordinary. Discover the serendipitous journey of Dr. Gary Kitay, esteemed orthopedic and hand surgeon, whose early exposure to the nuts and bolts of his father's hardware store set the stage for a career in the tactile world of orthopedics. In a revealing conversation, Dr. Michael Koren and Dr. Gary Kitay stitch together the tapestry of clinical research and personal calling, unraveling how a love for statistics and mathematics shepherded Dr. Koren's cardiology practice while Dr. Kitay's affinity for anatomy and hands-on healing carved out his surgical niche. Their discussion peels back the layers on the immediate satisfaction of surgical successes as opposed to the patient wait-and-see of internal medicine, offering a rare glimpse into the passions that pulse through the veins of healthcare professionals.
Step inside the meticulous framework of medical device regulation and witness the birth of innovation through the lens of the FDA's classification system. We dissect the distinctions between class one, two, and three devices, illuminating the pivotal role of clinical trials in the journey from concept to patient care. With the introduction of the hand immobilizer, a deceptively simple class one device poised to redefine surgical support, we navigate the ethical maze of informed consent and the gratifying challenges that accompany the design and implementation of medical advancements. Join us as we unravel the complexities of device innovation and patient care, all the while championing the collaborative spirit that drives medicine forward.
Take Home Talking Points: ✋Orthopedic Surgeon's Innovations in Medicine
✋Regulation and Innovation in Medical Devices
Check out the full series: ✅Part 1: Innovation and Ingenuity in Medicine - Released January 31, 2024 ✅Part 2: Pioneering Orthopedics and the Complex Ethics of Treating Athletes - Release February 7, 2024 ✅Part 3: Laughter and Libations in the Lab Orthopedic Advances and Scotch Studies -Release February 14, 2024
Welcome to MedEvidence, where we help you navigate the truth behind medical research with unbiased, evidence-proven facts, powered by ENCORE Research Group and hosted by cardiologist and top medical researcher, Dr. Michael Koren.
Dr. Michael Koren:
Hello, my name is Dr. Michael Koren and I'm delighted to host another episode of MedEvidence Two Docs Talk, and this is a particular privilege today to have Dr. Garry Kitay join me. Garry and I have known each other for many, many years. Garry is a local orthopedist hand surgeon and today we're going to talk about how an orthopedist views the world of clinical research.
Dr. Garry Kitay:
Well, Michael, thank you so much for the opportunity and I'm very happy to be here.
Dr. Michael Koren:
That's great and that's great. So Garry and I have worked on a few projects before, and before we get into that, let's just talk about something that's real. That's what we do in this program. We talk about real things and we're both physicians, but you're a surgeon and I'm an internist and we've had different training and our views of research are different based on that training.
Dr. Michael Koren:
But fundamentally there are certain personality types that seem to be attracted to one specialty versus another. And I remember when I was in medical school first year medical school there was a professor that liked to go around the room and determine what your specialty would be, based on his perception of your personality, and he would go by and kind of pick out people, some people he had more trouble with, like me than others. But there's certain types that will be going into psychiatry or maybe people that don't necessarily want to interact with other people so much might be pathologists or people who love kids, maybe pediatricians, or you're interested in women's health, you may become an obstetrician, but surgeons are generally perceived to be people that are very direct, sort of results driven and a little bit macho. You know that's the stereotype whereas intern is some more sort of analytical and thinking through things, maybe long-winded in the decision-making. So let's start with that. Did you have that experience or did that impact your decision to go into orthopedics?
Dr. Garry Kitay:
Well, for me personally, orthopedics. I relate that somewhat to my father. He owned a hardware store and the bolts and screws and screwdrivers I think that's my personal connection to orthopedics where I use a lot of the same tools that he sold in his store.
Dr. Michael Koren:
Beautiful. I love it. Yeah, so it maybe helped with some expenses during medical school.
Dr. Garry Kitay:
That's right. That's right. It was in the same city where Kitay's hardware was.
Dr. Michael Koren:
Oh, very nice, and where was that?
Dr. Garry Kitay:
In Manhattan.
Dr. Michael Koren:
New York City.
Dr. Garry Kitay:
Ninetieth Street and I was on 168th Street.
Dr. Michael Koren:
Okay, so not too far, that's exciting.
Dr. Garry Kitay:
I think that traditionally that's kind of the way people look at surgical versus non-surgical. I think that's changed to some degree. I think that we're all very interested in evidence-based medicine in the surgical fields as well.
Dr. Garry Kitay:
We want to do things that are proven and to do fact-based treatments for our patients. But I do think that we all, all us physicians, delay our gratification because we all study hard, we all go to medical school, but I think there is maybe a desire, like you said, to see the results a little sometimes quicker, and I think you can do that in a lot of surgical fields, as opposed to it might be a little bit difficult in a lot of the, you know, medical, non-surgical fields.
Dr. Michael Koren:
Right? And how about the tinkering elements of surgery? Do you think that's important?
Dr. Garry Kitay:
I think that you have to want to be able to use your hands and be comfortable with that. So I do agree with that, and maybe that's for me. It's a little bit of that hardware connection as well. Sure, Sure.
Dr. Michael Koren:
Do you think reflect itself on inclinations to get involved in clinical research? So for me, for example, I actually struggled during medical school to decide if I was going to go into surgery or into cardiology. I knew that if I was going to do an internal medicine specialty it would be cardiology, because it's kind of a little bit more surgical, fast-paced act in that sort of way. So I was kind of a hybrid person. But to me I made the decision to do internal medicine because of how rich the statistics were. I was always fascinated with the mathematics and statistics. So I'm curious to see what your thoughts are with regard to that in the orthopedic space, and you personally.
Dr. Garry Kitay:
Well, first, personally, you know you're what you're exposed to in medical school. So I mean, for me it was things that I love was neuroscience, and I had these instructors called Kandel and Schwartz, sure, yeah.
Dr. Michael Koren:
Very famous.
Dr. Garry Kitay:
And they taught the course. You know that was.
Dr. Michael Koren:
Columbia University yeah.
Dr. Garry Kitay:
Yeah, and I really loved anatomy, you know, and in the end anatomy won over for me and I just love to, you know, see the structures, expose the nerves, the blood vessels, and that's also why I went more into hand surgery because of actually not trying to avoid those structures but to actually treat those structures. So that was more for me personally, the anatomy thing, the anatomy part of medicine which I love kind of exploring and being part of, and that went over the neuroscience part.
Dr. Michael Koren:
Got it, got it, yeah. So we're going to look at something that you're working on now, which is a bit of a tinkering type of experiment, and we're going to sort of educate the audience about how you became inspired to look at this particular thing and then get a little bit into the process of how you evaluate that, how you market it, what needs to be marketed specifically under FDA rules, what can be sort of marketed more informally, et cetera. So, to start the conversation, tell us a little bit about some of the stuff you've done in the OR and ideas you've gotten that have been beyond standards of medicine. What are the concepts of how to improve your surgical technique or improve the way we do things?
Dr. Garry Kitay:
I mean just, to take a step back. There's procedures that all orthopedic surgeons or all hand surgeons do that are a carpal tunnel release, creating a new joint at the base of the thumb. But in the end everybody has their own variations on it because you think what you feel works best for your patients in your hands and there is always different variations and individual inputs and sometimes when you're doing certain procedures you can say, well, I think I can improve on that, and sometimes you'll try and write about that and publish it and sometimes you can even try and prove it's better, but sometimes it's more just what's better for you in your hands. So one thing that I'm always interested in is infection rates and trying to minimize that. So something I'm working on is called a glove gown interface to make sure the gloves stay stable and there's no introduction of potential contaminants onto the field.
Dr. Garry Kitay:
Another thing that I've worked on that's just coming to market now is something that allows exposure of the hand and there's something we use called hand immobilizers in the OR and I thought that could be improved upon from what I use. So the company that makes the hand immobilizer that's largely used in this country. I worked with them to improve upon that and go from the current model to an improved model.
Dr. Michael Koren:
Oh nice. Congratulation on that. Very cool. So this gets into a concept that is also a regulatory concept, which is how extreme is the innovation? And so, in my role of running a clinical research company, we're very focused on the regulation and we've certainly done device work. You and I have worked on devices together. Typically, devices have what they call class one, class two and class three indications, and class one is something like very simple, like surgical gloves. So if you decide that instead of being flesh color they should be pink, for whatever reason, then that would be class one.
Dr. Michael Koren:
Something that maybe is a little bit more complicated, maybe a type of retractor or something that has a little new element of it, is more or less similar to what you're using, would be something else. And then you get into class three, where you're not getting pretty innovative and devices more and more becoming like drugs, where if it's really complicated or revolutionary, then you have to have pre-market authorization for testing and ultimately prove to the FDA that that device is safe and effective, just like the new drug process, which we call an DA, a new drug application to the FDA. So give us a little bit of flavor for that. So the stuff you're working on is class one, class three. Where do you draw the line so?
Dr. Garry Kitay:
What I'm working on now. The things I mentioned are external. They're not internal implants, so it is a class one. The other thing I was talking about is part of surgical apparel also class one and often you can expand on it, probably even more, which is, if it's a variation on something that's already been approved, you don't often have to go through the approval process once again because it's just improving on a previously accepted concept.
Dr. Michael Koren:
And I believe that's called a 510K exemption. So you tell the FDA that you plan on marketing it, but you don't feel that any formal application is required because it's similar to something that's already out there, or a trivial change to something that was already out there that doesn't put patients at any particular risk. Is that fair? Exactly so. For example, if you decided well, I always wondered why the index finger was smaller than the middle finger and I'm going to do a surgery now to change that on all my carpal tunnel repairs, that would be a little bit more revolutionary, I would imagine.
Dr. Garry Kitay:
Yeah, that would be a bizarre and revolution. But first bizarre.
Dr. Michael Koren:
Okay, well, sometimes maybe equal size could come in handy in certain occupations. I don't know. But I'm pointing out that if you wanted to do something that was a little bit more outrageous, whatever the reasons, how would you go about that? And that's not necessarily a specific device, although there would probably be something involved that would allow you to achieve those results. I'm just using an extreme example of something to help people understand that you couldn't just go ahead and start marketing something of that nature and then you would have to go through a more formal clinical trial process.
Dr. Garry Kitay:
So you're talking about, for instance, if you thought there was a benefit for lengthening a digit or something of that matter.
Dr. Michael Koren:
You said that much better than I did, yeah.
Dr. Garry Kitay:
Well, and there are times when we do that, when digits are shorter or they've been amputated and you have to so if you're restoring anatomy, we don't have to go through an approval process by that, but if you're looking to alter anatomy, for doing lengthening-.
Dr. Michael Koren:
But if you're using a device or something to allow that to occur, right.
Dr. Garry Kitay:
Then you have to show that there's a benefit to it, that you're doing something that's going to help mankind and not do something that's bizarre and potentially hurtful and detrimental. And that's where research and the approval process comes into play and that's where I'd often ask for your help in constructing the study and getting it out and proving the concept's a good one.
Dr. Michael Koren:
Right, and the purpose of that question is to assure the audience that we have ethical rules for what's considered reasonable. For example, you probably don't even need informed consent if you use a different pair of gloves for a patient, whereas something where you're going to add something, a device to lengthen a digit, would certainly require informed consent and go through a formal scientific and research process.
Dr. Garry Kitay:
Yeah, these days we use informed consent even in injections. Really we're doing injections. Yeah, we let the patient know and get it.
Dr. Michael Koren:
So this is our segue, s how everybody what you're working on right now. In our next segment, we're going to delve into it, but is this something that you would get a patient's consent for? Is this something you could do without a patient's consent?
Dr. Garry Kitay:
Right, this is something to aid in completing a procedure for the patient. I don't get consent to use this device. It's called a hand immobilizer and what it's used for is when the patient's hand is on the table, the fingers tend to curl, especially when the patient is under anesthesia. They don't control their hand and then it's hard to get access to the areas that you want to perform the procedure on.
Dr. Michael Koren:
This is a very fascinating piece of equipment, and I know that when I came to you about my hand problem, you suggested that you may redesign my hand like this, and so let's talk about that at our next session, okay.
Narrator:
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