Understanding the Quick Pace of Anesthesiology

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Dr. David Nelson is an anesthesiologist practicing in Austin, TX.  With over 30 years of experience in the field, he shares how his practice has changed with outpatient surgery and the emergence of ambulatory surgery centers, what medical devices he uses and why, what documentation really is and why it’s vital for reimbursement, and his message for people in the medical device industry. He has also founded a medical device company and is working on a very interesting technology to change the way unused drugs are discarded in the hospital setting.

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Episode Transcript

This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.

Patrick Kothe 00:31

Welcome. The world of anesthesiology, like a lot of medical specialties has been changing. Today we're going to hear from Dr. David Nelson, who has over 30 years of experience in the field. And he's going to share how his practice has changed with outpatient surgery and the emergence of ambulatory surgery centers, what medical devices he uses and why what documentation really is, and why it's vital for reimbursement. And his message for people in the medical device industry. He's also founded a medical device company, and is working on a very interesting technology. So I know you'll be interested in learning more about what the problem is that he and his team are solving. Dr. Nelson earned his medical degree from the University of Texas Medical School in San Antonio, and completed his residency in anesthesiology at the University of Texas Health Science Center. Also in San Antonio. He currently practices in Austin, where he's a partner in US Anesthesia Partners, Central Texas division. He is, or has been medical director or the chief of anesthesiology at several ambulatory surgery centers. He holds seven us patents, successfully licensing one to a major medical device company and is the founder of Vigilant Devices, which we'll discuss later. Here's our conversation. Dr. Nelson, welcome.

David Nelson, MD 02:07

Hey, thank you. It's great to be here.

Patrick Kothe 02:10

So we've got some pretty interesting things to discuss today. And I'd like to start off discussing the clinical practice of anesthesiology. Can you explain to me what anesthesiology is all about?

David Nelson, MD 02:23

Basically, what an anesthesiologist does on on any given day, I mean there's several different sub specialties of anesthesia. One of my specialties is orthopedic anesthesia. I started yesterday doing pediatric cases ended up doing octogenarians that had hip fractures. So it's there's a lot of variety in what we do. But basically what we do is ensure a patient's comfort and safety during the course of a surgery or a procedure. Classically we were in the operating room and just you know doing surgeries, doing anesthesia for surgeries, but now it's evolved into anesthesia for all sorts of procedures outside the operating room like endoscopy ease and, and also, you know, we're heavily involved and the obstetric suites, delivering you know, helping to deliver babies helping make sure that laboring patients are comfortable with epidurals or managing them during c sections, but basically during during an operation where they're not only to render the patient, insensitive to pain or to the surgical stimulus, but we're also there to ensure their safety, monitor the vital signs, pick up subtle signs of any deterioration and gressil signs and do what needs to be done to make sure the patient makes it safely through surgery and then postoperatively. We ensure that patients comfortable that they're not having side effects of anesthesia, if they are there, we manage those and then ensure their transition either home in the case of outpatient surgery, or up to the floor or to ICU in the case of a very ill patient.

Patrick Kothe 04:03

So you mentioned that that you've got a specialty in orthopedics. How did you decide that that's the direction that you want to go in.

David Nelson, MD 04:11

Initially, some of the orthopedic literature started coming out that peripheral nerve blocks could help with pain management and with overall with outcomes in orthopedic anesthesia. What we've been able to do, utilizing peripheral nerve blocks regional anesthesia is convert what classically would have been inpatient procedure like a rotator cuff repair, for example, into an outpatient procedure and the reason why patients would have been inpatients in the first place was purely because of pain control. It's a very painful surgery, you wouldn't expect it but it is and and patients would go up to the floor and they would get a bunch of narcotics and they'd have all the side effects and narcotics and opioids and and end up staying 36 hours when if you do a peripheral nerve block and you numb up the shoulder than the patient's insensitive pain and they can manage their pain better with non opioid types of medications like ibuprofen or Tylenol and those sorts of things. So the reason why I got him interested in it was see the bad effects of opioids. And this is long before the opioid crisis, I can see the the bad effects that they were having on patients, particularly elderly patients pick our patients who have sensitivity, so opioids, we can get them safely through surgery with minimal side effects and, and back to their normal lives.

Patrick Kothe 05:36

Well, I can certainly empathize with with that I've had rotator cuff surgery, I've had the opioids and didn't, it didn't treat me very well. And I'm sitting here after re injuring my rotator cuff thinking, I've got to go get to get it done again. But I'm waiting for this pandemic to kind of settle down a little bit.

David Nelson, MD 05:58

You and several million other people are waiting for the pandemic to settle down before they have their routine orthopedic procedures or their colonoscopies or anything else. I hate to put it this way, but it's really hurt our business.

Patrick Kothe 06:12

Well, let's kind of get good back into into the specialty. You said that you care for patients in a lot of different settings. You originally started off strictly in the hospital, and now it's kind of gone throughout the hospital and two surgery centers. What How did that come about? And why did it come about?

David Nelson, MD 06:30

I think it was back in the late 60s, people began to realize that there were procedures that really did not belong in a hospital, and that those procedures can be done safely in you know, smaller, more intimate settings. And that can be done in those settings with minimal interruption of the patient's life. When you go to a hospital, and you're scheduled to have surgery, there's nothing wrong with you know, having an outpatient surgery at the hospital, obviously, but you may get your surgery delayed because an emergency comes in and they have to use that or space. And so one of the first outpatient surgery centers that was ever thought of and conceived and executed was here in Austin as Bailey square surgery center. Gradually that caught on and gradually the insurers figured out that these these procedures that they were paying a lot of money to have done because obviously a hospital has pretty high overhead for all the things that it does could be done cheaper, safer, you know, more efficiently at an outpatient surgery center.

Patrick Kothe 07:34

Your work right now are you know, what percentage is done in surgery centers, what percentage is done in the or what percentage is done in other locations? The percentage I'd

David Nelson, MD 07:45

say probably right now I'm doing depending on the week in the month is probably 70%. outpatient and in surgery centers. I'm starting a new outpatient surgical Hospital, where we'll do 23 hour stays. And once once I gets up and running, then I'll probably spend closer to 80% of my time in those in an outpatient setting.

Patrick Kothe 08:11

Are those surgery centers owned by companies by physician groups by hospitals? what's what's it like in the Austin market?

David Nelson, MD 08:21

There's a mixture of all those surgery centers that are in the HCA system. They're owned by HCA outpatient division, the ascension healthcare network here contracts with a group called USP tenant and usppi tenant actually administers and runs the surgery centers, essential health care network takes a percentage so they're collectively usppi tenant and essentially down 51%. A lot of times, there's physician investors, the surgeons are actually investors in the surgery center as well. And so they own the other 49%.

Patrick Kothe 09:00

So let's talk a little bit on the business side. You're You said you're a member of a group of roughly 100 anesthesiologists. How did that group come about? There's been a lot a lot of changes over the years with groups coming together and being bought pulled apart. Tell me about the evolution of your group.

David Nelson, MD 09:21

Well, our group was founded in 1973 by an enterprising and then enterprising young man named Dennis Bowyer who he went to the old brackenridge Hospital kind of hung out in the surgeon's lounge lounge and offered to do cases it was an open staff back then started doing his his share cases and started getting more business hired some nurse anesthetist that he worked with and would be supervising then he, you know, just started growing from there. And so then we spread from the old Breckinridge hospital to when Seaton was built started staffing seating again, it was open to staff, but up Detrick suite started getting a lot busier and women started hearing about epidurals. And so, these guys took it upon themselves to teach themselves how to do epidurals because it wasn't mid late 70s epidurals weren't all that commonplace. Offering that service, the other group didn't offer service and they were able to get a kind of an exclusive contract at that facility. There are facilities that we've in the past have shared with other anaesthesia groups where it's kind of a mixed, you know, we staff one week they staff the next or we staff, a certain group of surgeons, they staff others, presently, we don't have any facilities like that. But it's it's so it's kind of evolved now to where facilities expect to have a cell provider, you provide a medical director for the facility. Look, I'm medical director at this new surgery center that I was telling telling you about. You're also kind of the chief of anesthesiology there, you staff the place you provide the anesthesia caregivers according to the schedule and help enforce the policies and procedures of the other facility.

Patrick Kothe 11:03

So at this point, most of it is one group. There's only one group at a hospital.

David Nelson, MD 11:11

Right now it's there's not a whole lot of MC staffs anymore, kind of understood that you're going to, you're going to provide all the coverage for all the cases that are given facility hasn't always been that way and may evolve back to the old way. But there's competition between groups to try to get new facilities. And it's one of those things where sometimes we saw it, he's not happy or threatened to go out and get another group or, you know, we're not immune from competition. We're not immune from those kind of, you know, threats and things like that.

Patrick Kothe 11:41

He sees geologists are a group. In some instances, do these are the surgeons part of groups? Are they part of individual practices? Are they working for the facilities? Or do you have a combination of all of those as well?

David Nelson, MD 11:58

Yeah, a combination of all those. So it varies by specialty, obviously. So like the general surgeons here tend to be in smaller groups of 10 or less. And then there's, there's surgeons who are employed by healthcare organizations. And then, like, there's big mega groups like Texas, orthopedics here that have 20 to 30 surgeons, in our practice, we have become part of a national anaesthesia group, the Affordable Care Act that was ongoing, it really accelerated those sorts of things. Because there's so much compliance. There's the electronic medical records, there's the criteria and guidelines that kind of forced a lot of smaller medical groups hands, what we've done is we're able to consolidate all the compliance staff that we have with all the other groups that we have across the country, that is king, right? So we're able to generate this as our safety record. This is how many patients You know, this is what our satisfaction surveys show these sorts of things. And so the way that things are evolving, especially for us and for a lot of the hospital based specialties, like radiology, and pathology, er medicine is that we're being acquired by these national groups, essentially for for efficiency, essentially, to help meet all these criteria that the government now mandates.

Patrick Kothe 13:27

So is your 100 person. Group here in Austin? Is it affiliated with the national group? Or is it now part of the national group or the national group? You're no longer 100 person group, you're a larger group.

David Nelson, MD 13:39

We're out we were Central Texas division of United States and see your partner's got it.

Patrick Kothe 13:44

So let's go back to the coordination of of the schedule. So you've got a lot of different surgeons that are coming in a lot of different facilities that are happening. I'm assuming that there are some surgeons that work better with certain anesthesiologists than others to people team up. Is it? Is it just your staffing a room and whoever walks in or how does that work?

David Nelson, MD 14:09

Yeah, there's a lot of thought that goes into, you know, our daily schedule in certain places like certain towns, like when I was in San Antonio, I had a group of surgeons that I worked with, and on Tuesday, I'll be working with surgeon a and I would follow that surgeon around, you know, they might have hospital Mayo, five different hospitals if they were doing surgeries and and i would follow them around to all those places. It's a little nerve wracking to be honest with you. So the way we do it is, you know, you're not always going to be in the same place throughout the day, but we start somebody out, based on their skill set load funds, there's, especially these outpatient surgery centers or smaller staff, you know, you only have 20 people credential there and you have three people on that given day that you can send out with their store, looking Those things and then you backfill to the hospitals. Today we had an open heart. So we had to get one of our cardiovascular anesthesiologist to the hospital to do that case, and then stabbed all the outpatient surgery centers and can be pretty complicated. But we have a pecking order of people who, you know, worked like yesterday, so get off earlier today. And so we had to see, okay, well, that case over there, we're going to put them in that case, because it's going to finish, you know, earlier or early ish, and that should get them out. And they should be out and wait, oh, we just had three add on. So now that person has to go, you know, across town to to a different hospital. And so

Patrick Kothe 15:40

who, who has the pleasure of doing this changing schedule,

David Nelson, MD 15:44

we have two different zones. We have the North Zone and South Zone. So we have a nurse nurses and anesthesiologists that just sit there and watch the schedule like a hawk. They're continually getting feedback and calls from hospital a surgery center B. And they're telling them well, you know, I so and so's running light, we're going to we're not going to finish when we said there are so we we anticipate we're not going to be able to start so and so on time, the other surgeon on time, so you got to send send us another body, a bit of a chess match continually throughout the day, main thing you never want to have is coverage failures. Yeah. Because that'll that'll be talking about competition and making a name for yourself. Well, one way to destroy that name is to have coverage by Absolutely.

Patrick Kothe 16:31

So you mentioned nurse anesthetist, does your group employ nurse anesthetist? And are they in every case? Or how often are they there?

David Nelson, MD 16:39

We do employ nurse nurses, we use what's called the anesthesia care team model where we're in charge of the preoperative assessments and the interoperative management of the patients as well as post operative management. We work with the nurse anesthetist, they're in the operating room, we anesthetize the patient. So we're there for induction. And throughout the case, monitoring the progress of the case and the stability of the patient. They're in there doing the same thing. But in you know, in deference to what what our management plan is. So we took gather, we develop a management plan that we execute throughout throughout the surgery. And then we come back in to finish the case, we're there for the emergence of the patient from the anaesthetic, and then we manage the patient in the recovery room.

Patrick Kothe 17:31

Healthcare is not as transparent as many of us would like it to be in terms of your what pricing is and things. How does this all work? And how does your group work with with billing

David Nelson, MD 17:41

as a patient, you're going to get several different bills, you get one bill from the hospital, you get a bill from the anesthesiologist, you might get a bill from the radiologist, you might get a bill from the pathologist and the surgeon. So we typically are not employed by the hospital. If you are, if you were a surgeon that was employed by the hospital, you'd still be sending out a bill independent of the hospital, we send out a bill and it's based on contracted rates. Typically, obviously, if the patient's Medicare or Medicaid, there's only one rate and the government determines that right and lump it or like it. And so what the patient ends up seeing those is something that's really, really confusing. And like you said, it's not very transparent. So, you know, when you get the explanation of benefits, it may say that we build X amount to your insurance company, you can ever take that to be what we get paid. And so there's a charge. And then the insurance company reimburses US based on what our contracted rate is, we provide a lot of documentation, sometimes these things get dragged out, because the insurance company wants more documentation. The billing is such a arduous task, in many cases that, you know, if a patient is willing to pay cash, we will offer significant discount for that, you know, if you're involved in a car accident, you see the kind of back and forth dealings that you have to endure to get your car repaired or your shingles replaced on your house. Well, you know, insurance companies and the healthcare industry is different, and definitely not a better, you know, that's kind of battle that we have to fight all the time.

Patrick Kothe 19:20

So you've got to, I'm sure several people that are involved in in the billing side of things as well and chasing it down from your standpoint. What does documentation look like in order to be able to get those bills done correctly?

David Nelson, MD 19:34

We have switched. A lot of a lot of anaesthesia groups are still on paper, handwritten records. So one of the things we did to make things for our fellow physicians for the insurance companies very well we've we've gone through our own electronic medical record legibility and the conciseness of electronic medical record is there's no comparison to that, you know, versus 100 record chords. Apple today I was doing an orthopedic case I put in peripheral nerve Cath or femoral nerve catheter, and I did it under ultrasound. Okay, so I document everything from the type of needle used the type of local anesthetic used. And because I'm using ultrasound, I take a picture of the actual block itself, the actual catheter in place. And then I submit that to the insurance company, because I'm billing for ultrasound as well. When we go back to the operating room, we document the times, you know, when we hit the operating room, when we put the patient asleep, when, when we were ready for the surgeon to make his initial incision, when the surgeon made his initial incision, when they finished the case, when we got to recover the room, then we have to document the patient's recovery document, a post post anaesthetic note and those sorts of things with the supervision of the nurse nurses going back to that. So we have to document that we were there for the induction of anesthesia. And we were there periodically during the case, and that we were there for the emergence from anesthesia in order to bill for supervision, the nurse nurses, and we have to document the preoperative pre anesthetic evaluation of the patient. There's different ways of billing for different things. So when we do a procedure, that's one flat fee. And the documentation is all that all these different components of it, like I was just talking about thermal thermal nerve block. But when we go into the operating room, that's a time based billing. And so it's based on 15 minute intervals, when we call them 15 minutes equals one unit. And so we get a number of units, depending on the complexity of the case, you know, for the pre anesthetic evaluation for the preparation of the patient, we start billing our time during the case as well. That's a reason why the times are so critical. As soon as you hit recovery, we can be waiting to turn your bill in for an hour, you know, you get your there's a normal amount of time that's usual and incredible, that you you know, when you get to recover easily, within five minutes, you've checked the patient out to the pacu. Nurse and, and you're ready to go on to the next case.

Patrick Kothe 22:19

So you're documenting what you're doing in your system, the surgeon is has got his his own system is doing the hospital has their own system, because supplies, you know you're using supplies, but you're not paying for those supplies the hospital's paying for those supplies. So they have some documentation to do to the systems talk to each other.

David Nelson, MD 22:36

Typically, what's done from the hospital side is they have a blanket rate that they charge for given surgery and the cost of the tracheal tubes and the medications and all those things are kind of standardized. It's not like you're swiping You know, you're scanning a barcode on every single thing you use. Now for the big ticket items. Yeah, we do scan barcodes.

Patrick Kothe 23:01

There's different compensation models for different physician groups, as your compensation model based on the number of surgeries, is it based on profitability, you know, how is what's the comp model look like?

David Nelson, MD 23:15

So basically, I'm in a partnership we have, we start off every day with X number of cases to do X number of people to do those cases. And everybody stays until the works done. And of course, hospitals we staffed 20 473 65 so as a partner in mind group, you may have a week where you work 70 hours a week where you work 45 hours, it's just whatever it takes to get the work done. Now, all that being said, there's a lot of other groups where basically eat what you kill, you do X number of cases, you put X number of units on the book, and if you're part of a large group, they decide that a unit is based on the payer mix, you know, you might have 80% Medicaid that month, God forbid and 20% insured. So you're gonna have a lower unit rate in that given month, and you might put a lot of units on the books, but it said that given right so they base that on you know, taking out overhead they take out the practice cost and then that comes up with a you know per unit cost and so people will volunteer to do more work or take less we on some guys that are slowing down we'll have somebody come in and work for him during the afternoon and they'll put less units on book but they're comfortable where they are and that's where we also have part time people that work for us that are there from six to three every day and and then we've got guys who are full partners like myself who take all the night call that so the the compensation for a full partner is based on doing a full partners work.

Patrick Kothe 24:52

To help us understand what you do every day. Let's walk through a typical surgery. Let's use an orthopedic surgery you pick which one It is. And let's talk about, you know, the the pre surgery activities that you have and then what's going on in surgery and then after surgery. So what what procedure do you think would be a good one to?

David Nelson, MD 25:12

Well, since you're going to have another rotator cuff, let's go on that. Thanks. So we, you know, we come in a typical day starts around, you know, on average around 6am. They're checking off patients, and we talked to the patient, you know, the pre op nurses usually started their IV and gotten them prepped for surgery. And then we talked to them about the anesthetic. And so we give them what their options are, if there are any, you know, I mean, obviously, there's some surgeries where you're going to go to sleep, and you're gonna have an endotracheal tube. And then there's other surgeries where you could do a general anaesthetic or spinal, or you could maybe have local with IV sedation, that sort of thing. So we give patients all their options

Patrick Kothe 25:57

when they do and at that point to calm the patient. Because I imagine there's some some that aren't too calm.

David Nelson, MD 26:03

Basically, you take things slowly, and you make sure that all their questions are answered you after doing a while you get a sense of you know, this patient is extremely nervous, they're not hearing a word I'm saying, you may have to talk to one of their family members and get them to help calm the patient at the other times, they resort to you know, pharmaceutical means but that's the last resort. I mean, because what what you want to do is you want to convey we have a well thought out plan that you're going to conduct that plan safely, and that you're going to take good care of them. It's being a well thought out plan.

Patrick Kothe 26:41

At what point are you talking to the surgeon about what the surgeon plan is for for that patient,

David Nelson, MD 26:47

the surgeons typically they will schedule a procedure and they'll have a list of things. So they'll have the actual procedure, what equipment they're going to need the last for a particular type of anesthetic, and we're going to do a peripheral nerve block, they'll ask for peripheral nerve block or peripheral nerve Catherine, most surgeons are pretty good about, you know, being specific about what they they want. So you have a general idea what what they already want, when they come in, you talk some more than they may tell you they have, you know, this guy has a really complex tear, we're gonna have to put in anchors we're gonna have to do so it's gonna be a longer case that could change your aunt's anesthetic plan a bit you know, so we know pretty much ahead of time what you know what type of anesthetic brand new relationship to what type of surgery they're going to do. And then in the case of an orthopedic surgery, especially like a rotator cuff tear, I'm going to talk to them about peripheral nerve block and or catheter and what the benefits of that are, what how we're going to conduct the the anaesthetic in the operating room. So there's the preoperative part where we're putting blocks in, which translates to the post operative pain control. That's the main reason why we're putting these blocks in, and then we're talking to them about the, you know, you're gonna have a general anaesthetic, that's what you're doing your best option is after we've discussed the options, and how we're going to conduct that general anaesthetic, you're going to go off to sleep through the IV, while you're asleep, we're going to keep you asleep with more IV drugs and anesthesia gases, who get drugs to prevent side effects like nausea, headache, yada, yada. So, you know, it's a full spectrum of things that we try to hit on every time options for anesthesia side effects, how we're going to treat those side effects, what we're going to do in recovery room, if you have side effects or if you have pain.

Patrick Kothe 28:39

So how many drugs are you administering on average are for this particular surgery?

David Nelson, MD 28:47

There I would say probably nine to a dozen drugs for the sedation, you have to know for said fentanyl, for example, for sedation. prior to putting in the block when we put the block in we we give local anesthetic so there's three drugs right there already. And when you go back to the operating room, you put you off asleep with some proper fall light a cane, a couple of different drugs to prevent nausea. And then you have the anesthesia gases, which is another drug see before him, for example. You may have Oh, you're gonna have antibiotics as well. You may have one or two antibiotics depending on sir.

Patrick Kothe 29:25

What's your education? Like? I imagine there's got to be a heavy dose of pharmacological training that you have.

David Nelson, MD 29:34

And that's kind of what I always like in med school. I always like pharmacology and I like physiology. And it's it's really a combination of those two, it's applied physiology and applied pharmacology. We give drugs and we know what, what the effects are going to be. We try to anticipate those effects. Every anesthetic is a cardiovascular depressant, we know that could put you sleep, your blood pressure is going to drop it. We set you up in the beach. Chair position for shoulder surgery, we know it's gonna grab some more. So we have to anticipate those things we have to maybe premedicate with some basil presser drugs before we set you up or give you an extra amount of fluid so that when you set up that you don't have a drastic drop in your blood pressure.

Patrick Kothe 30:17

So while the operation is going, you're in there monitoring the patient, what exactly are you monitoring? What are you looking for with changes in the patient,

David Nelson, MD 30:25

the classic monitors of blood pressure, EKG, and pulse oximetry, and in tidal co2, so to back up, so the ones that have been around since 1920s, were blood pressure, and then 50s, we started using EKGs and, and then pulse oximetry came along in the 80s, and then in tidal co2 in the 90s. So basically, what we're looking for is if patients getting what we call live under anesthesia, like through an adequate dose of anesthesia and see their blood pressure going up, you'd see their heart rate going up because they're responding to the surgical stimulus. Whereas if, if you're our anesthetized patient, you may drop their blood pressure may drop their heart rate. And then pulse oximetry shows us how much oxygenation there is in the in the blood, the end tidal co2 shows us how well adequately we're ventilating the patient. And there's different perturbations of the the different lukan co2 waveform can tell you if the patient has obstructive disease, COPD, for example, maybe they're having an asthma attack, you can see a different shape on the waveform. So you look at all those things in concert, it's like when all else fails, you actually look at the patient. So you know, that's, that's one of the things that we always teach people is trust your monitors, but trust them up to a point, one of the classic comparisons of anesthesia is with flying an airplane, there are people who have trusted their instruments until they run into the ground. Right? So you have to look at the whole historical picture that's going on in the operating room with the patient what's going also in the blood pressure drops well is that because the patient's losing blood and you stand up and you look over the drape, and you know, maybe this surgeon is busy trying to stop the bleeding and hasn't alerted you that they're losing blood or, or is it because you've woken up over anesthetize a patient or, or they're having a reaction to the antibiotic you just gave. So there's all sorts of things that you have to look at. And in addition to these monitors, back in the late 70s, anesthesia was one of the highest costs malpractice insurance, the mortality rate was about one in 10,000 patients undergoing general anesthesia. Now with with the monitoring that we do, where the safest surgical subspecialty if there is and where our mortality rate is closer to one in 300,000.

Patrick Kothe 32:53

Is that technology is that training is that experience what's what's led to that decline?

David Nelson, MD 33:00

Yeah, it's all the above, but definitely technology. And sometimes you're in a dark operating room, and you can't really see when a patient's blood is turning dark or when they're deactivating, you need to be able to pick up on that, well, pulse oximetry does that or maybe they the patient is having an asthma attack, and you see Intel co2 climate, or maybe they're malignant hyperthermia, which is a very rare condition but Intel we were able to detect and treat it was universally fatal. So the fact that you can pick up things quicker and then of course yet training you'd have to know how to respond and what you're responding to. And not over interpret things. But look at everything as a trend is a concert with all the other things that are going on with the patient and

Patrick Kothe 33:51

I want to come back to the technology but let's finish up the surgery for a second. So you're you're you're in the surgery, and then patient the surgery is done. What what are your activities after after surgery is complete.

David Nelson, MD 34:05

So at the end of the case, we stopped the anaesthetic whether that's legal flooring, ventilation line of sight, we turn off to see it before I go. So we turn off the footfall or in the case of somebody having reached like a spinal, we would start removing their monitors and getting them ready to transport the recovery room. And so once we're once we're sure that they're breathing adequately, that they're starting to emerge from anesthesia, then we take them to recovery, assess that they're stable, and finish our anesthesia records and check out to the pacu Rn and and make sure they have adequate orders for whatever the patient's condition is.

Patrick Kothe 34:45

Okay, so let's let's go back and start talking a little bit about technology. What medical devices are you utilizing?

David Nelson, MD 34:55

Starting with a preoperative period. We mentioned the perfect nerve blocks so they were using peripheral nerve needles, catheters, ultrasounds to place those those needles and catheters. Obviously, venous access is very important. So we're using anything from basic IVs to central lines. And in the case of cardiac patients were having to use central lines with monitoring capabilities or Swan ganz catheters. In the pre op area, we use EKG pulse oximetry as well. And then once we get in the operating room, we're using the intitle, co2 monitoring in addition to the blood pressure and the pulse oximeter and complicated cases, in higher risk patients, we also use devices like flow tracks, which which allow us to, without a swan ganz catheter be to track blood pressure stroke volume. cardiac output provides us with intelligent feedback where we can manage fluid status in patients where instead of kind of guessing at it, and over hydrating a patient or under hydrating a patient. And so we're able to with all this technology to be, you know, much smarter about the way we manage patients interactively. Now we're looking at things like the, what's called the BIS monitor, which is a bi spectral Ray, which is a compressed eg monitoring. And we use that to assess depth of anaesthesia that the patient is, is experiencing another pain and given time, we use that a lot. Now for cases where we have to use total IB anesthesia, where they're using, for example, complex back cases, you know, neuro spine cases where they're monitoring the patient's neuro status. So we use that to assess that you're titrating the correct amount and, and the patient is not under an S test. And then also that allows us for going the other way, when we're Waking the patient up to make sure that they they are waking up the way you should. We're also looking at monitors like cerebral oximetry. All these things are extremely important for us and allows us to conduct a much more intelligent anaesthetic and much safer anesthetic I think, in particularly vulnerable patients.

Patrick Kothe 37:20

So you're using just a ton of different devices, anywhere from simple IVs and needles and things all the way up to complex monitors and things. So I imagine keeping abreast of all the changing technology sometimes can be a little bit challenging. Oh, yeah,

David Nelson, MD 37:37

every technology, you know, there's a there's a learning curve with every technology, for example, the non invasive cardiac output monitors, there's a calibration that needs to be done. And one monitor may have this specific sequence of events that has to happen. Whereas another monitor, you do things differently, we have what we call anaesthesia, technologists that help us with these monitors help us troubleshoot these monitors you and their machines are going to break they're going to have things that need to be replaced cables, things, you get to troubleshoot them all the time. So So yeah, it's it's a, it's a definite learning curve. It's definitely something that it's kind of fun to figure out some of this stuff sometimes. And it was a lot of fun to see what you can utilize kind of results you can get with embracing these technologies and understanding these technologies.

Patrick Kothe 38:26

I can also imagine that you've got all different types of technologies based on what facility you're at. Because if they're all owned by different different people, it's going to be different generations are different manufacturers are different products as well. So you've got to learn a lot of different technologies. Some places you

David Nelson, MD 38:43

have none at all, you know, I mean, yeah, basic stuff, but she does, you know, you're not going to have, obviously, cerebral oximetry, you're not going to have these cardiac output monitors, that sort of thing.

Patrick Kothe 38:52

You're kind of in a matrix situation, and you got a lot of decision makers that are in there too. So if there if there's a technology that you think can help you and your patients, and you know, it's going to be purchased by whatever facility you're at, what's the process generally like,

David Nelson, MD 39:10

you have to show clear need, obviously, and you have to show outcomes data, you have to make a very clear case that you're there to you're saying you need is actually something that is superior to what's already available, whether it's a drug, whether it's an you know, monitoring or whatever, you have to show that there's going to be some benefit to the patient to the hospital, if they purchase it.

Patrick Kothe 39:35

Our reps coming into into the O r these days.

David Nelson, MD 39:38

Sadly for us, we don't get a whole lot of love from a lot of reps because a lot of our stuff is generic. The the reps primarily are coming in to help the surgeons with a particular technology or technique. We utilize our equipment we get in service done that they move on in our specialty. One of the things that's been a lot They refer us to I forgot to mention was ultrasound in the past, like, for example, but in the peripheral nerve block would use a nerve stimulator, which was a good technique, but it was an inexact technique. Now not only can I stimulate the nerve, but I can actually go and see the nerve, see the local anesthetic spreading around the nerve. See my Catherine laid right next to the nerve, when I'm putting it in central lines, I can see the vein, see that I didn't perforate the vein, see where my my guidewire as all these sorts of things, it's enhancing efficiencies and enhancing our ability to apply techniques. And it's also enhancing safety.

Patrick Kothe 40:39

You've not only been the user of devices, but you've also invented some devices. So I'd like to quickly talk about one and then spend a little bit more time on the on the second. So let's let's talk about the needle edge that you developed. And licensed off. Tell us briefly about what that was all about and what the process was like for licensing that technology off.

David Nelson, MD 41:02

It was it was very interesting process, I'd already had two or three patents on the other device, I guess we're going to talk about put when I came up with this design for this, it's a regional anesthesia needle that allows you to thread a catheter without having to use two hands without having to go through a lot of manipulations. I didn't anticipate that I would hear things immediately about this design and or the patent, the patent issues. And within 10 days, I had one of the largest medical device manufacturers in the world, calling me wanting to license my patent. The messages, it's like, you think you've got a home run with one thing and it doesn't happen that way. And then you think, well, this is going to be a bit player. And then that is a somewhat of a home run. I was very surprised I've got a licensing deal it took off from there. So as opposed to the other patent, I've got several patents on another device. And I've been working for basically 15 years on that.

Patrick Kothe 42:03

Let's talk about that other device. And before we get into the device itself, let's talk about the need what what prompted you to look at solving a problem?

David Nelson, MD 42:14

It's always a level of frustration that you have. When I was in residency, we had a number of residents that were dismissed from residency for opioid diversion and abuse and addiction.

Patrick Kothe 42:26

When you when you say diversion, what do we what are you talking about?

David Nelson, MD 42:28

The typical drug is opioid, for example, or controlled substance is supplied in a kind of one size fits all, dosage. So for example, morphine comes in a 10 milligram bile, the average dose is five milligrams, so you end up having five milligrams at the end of administration leftover. And the law of the Controlled Substances Act actually states that you have to destroy that drug in front of the human witness. All these drugs are clear liquids. So what happens is, in the case of diversion, it's diversion by substitution. So if you want to divert a drug, you can get another clear liquid substituted for that. Drugs, keep it for yourself, keep it to sell on the street, whatever. But in in the case of all these residents, they were keeping it from themselves. And they would typically start with some of the subtle drugs like, you know, morphine, but then they would rapidly evolve and to fit now that now it's 100 times more powerful than than morphine. It's very addictive. And a lot of these people use ask him, Well, when did you know your first addicted to fentanyl, and they said the first time I ever tried it. So these people, you know, some of them were my really good friends. It ruined their lives. Several of them are dead now because I could never get over their addiction. So I always had that in the back of my mind. But then when I got into private practice, one day, I was waking up a defensive tackle from the University of Texas, on one of these small shoulder tables, and he was writhing around and I was trying to show the nurse that I had so many cc's a fit now the waist and she looked at me and nodded her head, and I started in the trash can. And I went back to taking care of that patient. At the end of the case. She said, Well, I didn't really see you do that I'm not gonna sign your administration record. And at first I got really angry. I'm like, accusing me of something, yada, yada, yada. And then I started thinking, well, this is a very imperfect system. I mean, she has no idea what I was wasting. I mean, why would anybody sign off on somebody else's waste? This is a stupid system. So that started me looking into ways that I can analyze the drugs and prove whether that clears liquid was actually what the clinician was saying it was that they're wasting. I've had probably eight different analytic technologies that I've had to look at how to obtain controlled substances to put through the analysis. You know, eventually I've found The technology that can you know, the The problem is it's like you've got mass spec GC level instruments that are 160 to $200,000. Well, you need 45 of these and up 400 bed hospital, nobody can afford that. And nobody can really say that the problem, although the problem is very serious and not going away, and if anything, it's it's increasing in prevalence. But you know that nobody's nobody's going to pay that kind of cash for

Patrick Kothe 45:27

you're looking for a small device that can analyze what drug is gone in and say this has been discarded appropriately.

David Nelson, MD 45:37

Exactly. So it analyzes the drug identifies it, what concentrations and if the drugs not there, then you know, you pick a person substituted, if they've diluted it, you know, that they've diluted it, it verifies or refutes what the waste process is saying that the drug is. So you've

Patrick Kothe 46:00

formed a company to be able to develop this technology bring this technology forward? What was it like to step from being a clinician to, to a founder of a company?

David Nelson, MD 46:12

Scary? Yeah, you have to learn a lot of business law, you have to learn, people are going to be prepared to give you advice. But you it's worth what you pay for I have one group tell me to you got to go out and get a Delaware C Corp. And then another group said, well, p guys are saying an LLC is the way to go in there. You know, that's just one example of all the different quandaries you get yourself into, and you're you can attest to this, this is not an easy place to raise money for a medical device. If you had an app that was somehow medically related, that you develop a couple of grand and you'd be an instant hit. So raising money here, it's been been a been a challenge. And one of my big moral quandaries is we're very honest person. And I don't want to over promise and under deliver, as the lingo goes, if I get to you might get how they do it an ICU versus how do they do it in the O r, versus how do they do it in the ER, how we do in Texas versus how they do in Florida, the regulations are different. So there's been 1000s of hours of research going into what the best pitches for any given audience, our customers now are the people who have had major diversion problems. And they're the ones who, you know, sit up and listen when we go and talk about how to revise.

Patrick Kothe 47:28

Or it's really interesting to me, because technologies are really developed based on the passion of the founder and trying to solve a problem. And you've kind of looked at it from two different ways, your own personal experience with discarding these chemicals at your place, plus the emotion that you had with friends who suffered with it. So I think that that's, that's, you know, that's one part of it. The other is forming a company around that to be able to to bring that forward. And I think you've also partnered with with somebody on the business side, who can bring some of those talents to the to the team as well. So you've got you've got the clinical side, you've got the emotional side, and you've got somebody that you partner with as well. That's that's done medical device before

David Nelson, MD 48:19

going out and finding the right people, you know, not only can do a job for you, but also are a good fit for your mindset for your aspirations and goals. There's a lot a lot of people that are willing to help you The so called 10 percenters that say they'll get you this deal, or they'll do this for you, for 10%, you know, so everybody that is involved in the company has sweat equity. And they did that over several years. And that's how you know, your friends aren't who's who's going to work for you.

Patrick Kothe 48:52

Well said, our listeners are people that work within medical device, and now you work within medical devices as well. So are there some Is there a message that you that you would like to deliver directly to people that are working within industry, whether they're being a research and development person, or a sales and marketing person or CEO of a company?

David Nelson, MD 49:13

Yeah, I think I think it's, it's important for, you know, the voice of customers is always important, right? There's a lot of physicians out there that have a lot of good ideas. And there's a lot of them are scared to voice those ideas, or to actually come out and try and try things. And it's all very intimidating. I can't tell you how many times other doctors and a lot of guys in my group have an idea and they want me to help them patented. First thing I do is say, Hey, you got to, we have to sign an NDA, I'll help you but I don't really want to get involved. I think my message to medical device folks and at whatever level is to listen to the conditions because they are boots on the ground. It's very hard for the medical device to design something that is perfectly ergonomic for every application and I understand That and there's an engineer's way of doing things where you can design some of those 100% functional, but it might not be that ergonomic. So try to listen to the feedback you're getting from those folks. If they come to you with an idea, be supportive and find a way to work with them without them feeling like they're gonna get stolen from. I think a lot of a lot of innovation gets stifled because if physicians don't know where to start, they they're scared, because they don't have a lot of business acumen. And then see there have been people that have been taken advantage of try to nurture that mind that those people have and I would like to see the medical device companies, partner more with physicians, not just physicians are using their product, you've got guys with real ideas that they really just don't know how to get started. So nurture that and encourage that.

Patrick Kothe 50:49

A very interesting conversation with Dr. Nelson, a few of my takeaways. First, I was struck by the adaptability and hustle of his group, multiple locations, changes and schedule learning and using different products, different surgeons in our teams, and a variety of different surgeries. I can understand why he and his colleagues would be looking for more efficient ways of doing things. Second is comment on the fake it till you make it philosophy. I continue to hear people push this garbage. I share his belief, hey, I've taken my share risk and stepped into areas where I didn't have much knowledge. But there's a difference between fake it till you make it and learn it and be transparent until you make it. Most people have bs detectors. Don't blow your credibility based on this fad philosophy. Finally, our responsibility to listen and cultivate ideas. I tell you, it was pretty sad to hear him say that some physicians are hesitant to speak up because they fear they could be taken advantage of our jobs are to listen for good ideas, develop them and offer them to clinicians so that they can help their patients. Yeah, we're also in business to make money. But a good business person shares the profits, especially with those who have the ideas. And not every idea is great. And not every physician understands why licensing fees or royalties or ownership shares are what they are. But let me tell you, I've had plenty of blunt conversations and walked away from the table when expectations were not in line with reality. It's never a good idea to lock in higher profits by taking advantage of someone else, especially one of your own customers. play fair. It'll always pay off in the end. Thank you for listening. Please spread the word and tell a friend or two to listen to the mastering medical device podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind

 
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