Welcome to qiological. Mini-series dedicated to sports and orthopedic acupuncture for the next few days, I'll be bringing you several podcasts a day from the sports acupuncture alliances conference in San Jose. In addition to interviews and discussions with speakers of the conference, you'll also be hearing from participants and you'll have a special front row seat at a round table conversation around the issues, running a sports medicine practice. The sports acupuncture Alliance was created to promote the study and practice of sports and orthopedic acupuncture. I'm delighted that they were willing to partner with qiological to bring you this mini series so that those of you who are not able to attend the conference could learn from the speakers as well as the participants, and to get a taste of what it's like to be here at this special event. Please enjoy these discussions and take what you learn here and use it in your clinic. You know, needles are an essential aspect of our practices that I suspect most of us don't know much about. Other than that, we have some brands or types that we'd like to use, but what goes into a needle and how needle technology over the years has changed? Well, I know for myself, I'm pretty ignorant about it. So I'm delighted to have Matt pike here with me. Matt is a principal at LASA OMS, and he's also the president of Seren USA. He's been involved with the sourcing and manufacturer of acupuncture needles for a long, long. We are going to get into the backstory on this essential tool that we all use every day in the work that we do. And we're going to talk a little about a new needle that's being introduced here at the conference. That's been specifically designed and manufactured for sports and orthopedic acupuncture map. Welcome to qiological.

Thanks for having me, Michael.

I'm looking forward to talking with you today. You know, I know that you are a principal at LASA, one of our sponsors, and, uh, you're also the president of Sarah in America. So you've got a lot of experience with needles and with acupuncturists, this is, this is not an infomercial for you guys. I've got you today because you have. A lot of experience with acupuncture needles. Can you give us a little background on how you've gotten involved with needles and, and how long you've

been doing this? Yeah, so it all started. My mother married a person who was an acupuncturist that had a hard time when he graduated from. Uh, acupuncture school finding product. So we took it upon himself to travel to Asia and start collecting products. And, you know, as you can imagine, back in the time when acupuncture is fairly new in the United States, he ended up graduating from the new England school of acupuncture, which is the oldest school still in existence in the United States. And, um, he's. Bringing in all these exciting products and handing them out to his friends. And before you knew it, this company called wellness, medical supplies began and he never really was able to do have a big practice because, uh, sourcing products and selling them in the U S market to people that needed them, kind of became this, uh, overtaking, uh, piece of his life. So that's kind of what got me into it from a young age, going on vacations with the family. And, uh, and speaking as person. So his name was Thomas Reiki, Mackie, and he was the founder of OMS medical supplies. And then, uh, essentially a co-founder of Seren America, which is a joint venture between Sarah incorporation and OMS medical supplies. And then a little bit later in life, my mother created a company called LASA medical supplies, and then the two companies merged. So you could imagine as a child kind of, uh, following, uh, around with them, Uh, that's kind of what I spoke to my C was a stepfather of mine and that's how we kind of converse with each other is his acupuncture supplies. So then later I became, I was on the board of directors of Seren, uh, America, which I started learning more and more about acupuncture needles from a relatively young age and then maybe 12 years ago, or so my wife and I, um, took over the operations of possible.

W I did not know that backstory that's fascinating. He basically had his own itch that he needed to scratch. And. Turns out that he helped all his friends get their hands on good needles and

supplies.

That's right. And at the time, uh, all mouse was the only importer of acupuncture needles. So a kind of an exciting time to be. And you could imagine the excitement he had when he was finding different types of high-end maxes and different types of cupping sets, et cetera. And so it was, it was a, essentially something that was really a passionate. Well,

it's a whole different world in Asia where it's common. That's exactly right. Yeah. What are some changes that you've seen? With needles over the years. I mean, you've been, you, you know, you grew up with this basically.

Yeah. So I think in order to, to talk about the changes, you probably need to take a little step back and understand, uh, what kind of, where we were at 40 years ago in acupuncture or longer. So back from the beginning, acupuncture needles were all. Reusable. They had to be autoclaved or somehow sterilized between uses and all acupuncture needles were handmade. And it was really in 1978, a small company in Japan revolutionized the industry. And they created the first single use disposable acupuncture needle. And so today you wouldn't even think of acupuncture as having reusable needles, but it was really not that long ago, 1978, when that company revolutionized the industry and the name of that company is Saron corporation. So they created that first single use disposable needle. And really what did that do it. Allowed acupuncture to be accepted in the Western countries and which ultimately paved the way for the FDA to be able to classify needles as class two. Cause they would never allow a reusable needle to be used, you know, in a large scale in the United States. Wow. What does it mean to be a class? Uh, different levels of classification, class, one being kind of very simple medical devices, class to being something a little bit more invasive, like an acupuncture needle that pierces the skin. And then class three would be more like implantable stuff. So at each of these different levels, Medical devices requires a different levels of scrutiny by the FDA to being a class one medical device into the United States. It could be as simple as just registering the device, but the bigger class, two medical device that requires something called a five 10 K, which is showing that that needle is, is equivalent of some other needle that's been accepted in the United States. So in

1978, there was a revolution in needles that. Without that we wouldn't be where we are today.

That's true. I mean, some other company would have done it, but it happened to be Sarah in that, that, that did that.

And it really paved the way for things. You know, I remember when I was in acupuncture school, oh my God. 20 years ago at this point. And we had an autoclave and we learned to do that because it was just something that you were supposed to learn to do. And. I remember getting out of school and going and pricing and autoclave and thinking about all the Michigan that goes with autoclaving and I thought, why would I ever do that when I've got disposable meals?

Yeah. From, from a safety standpoint, that just, it wouldn't work. Yep.

So there were handmade then. And now how are they made? I mean, obviously by machines, what's the process look like?

So surprisingly what's interesting is, uh, 40 years later, there's still the majority of the needles manufactured in the world market are still handmade. The only difference between what was pre 40 years ago and now is that those needles are single use disposal. So the majority of the needles are still handmade and it's a person sitting in front of a grinding wheel with essentially wire stainless steel wire, and very carefully grinding those needles. And these people are amazing at what they do. But obviously when it's handmade, you're introducing all sorts of humans. So Sarah needles, on the other hand, you know, they've gone through many different phases of, of manufacturing from the beginning of being more rudimentary, kind of simple kind of train systems where a trolley goes through an assembly line and little mini robots would pick it up and, and, uh, and do some operation on them. And now it's these huge, you know, robotic machines, almost like what you would see in a car. Plants, uh, that are moving the needles from station station and, and acting upon it in different ways. So automated manufacturing, the grinding machines, those are all, um, the grinding wheels are, are running through a computerized system. Then the needles go through. An entire bathing system where they do a more of a basic solution or acidic solution, a more water-based solution. And they spend a tremendous amount of time cleaning the needles to get all the solvent, get all the grease and all the manufacturing stuff out of it. And then it goes to the assembly place location, which is in a clean. And those robotic machines will put it through its process. Yeah. Ultimately coming out with, with boxes of needles, all untouched by human hand. So it's pretty amazing, amazing system. If you like technology, you would just be blown away, kicking a tour of the Sarah and manufacturing fussy.

It sounds fascinating. Well, you said most of the needles are still handmade. So does that include, I mean, I know there's some other big manufacturers, like the Korean DBCs there's, I don't know all the brands from China. These, are they still hand grinding those or do they have some sort of a

lot? Surprisingly, a lot of them are, and I don't want to mention names at this point, but like the Korean manufacturing company that you talked about, I visited their facility. Amazing. State-of-the-art. If you saw the two systems, they are completely like separate. There there's nothing similar to their manufacturing process, but even the DBC needles, it's a very simplistic manufacturing system. That's extremely fast and extremely efficient. And dung bong, as you may know, is probably the largest manufacturer of acupuncture needles in the world. They produce well over a billion needles a year, and this company. It has to have fast processing to be able to support the large throughput. So theirs is an amazing system, but it's, there's still some kind of manual components to it. Whereas Sarah, on the other hand is a much slower process. The machines cost a lot more money and they, they wouldn't be able to handle the same throughput given the same square footage and they don't have to, since. Their whole goal is producing the highest quality needle in the world. It's, um, you know, the process of a little bit slower to be able to support that other big changes between them as, as you mentioned, DVC, and I'm talking about Seren a little bit, is that the quality control at, in each of those steps, but that being said, so that's an example of two different companies out there that have these automated systems, but in China, the majority of the needle's developed are all done by. There is one company that has so many automated manufacturing that's though lots of accompany as well, which just recently was purchased maybe 10 years ago, seven years ago, by a large Chinese public company. That's invested a lot of money into their manufacturing. Yeah. I

suspect as time goes on, we'll probably see more and more of these manufacturers move toward this automation is that. That sound

right? Yeah. I think as, as time goes on, you know, people demand quality and in order to produce a high quality needle, you have to have automated manufacturing. When you have a manual process there it's, it's all about error. Humans make mistakes and it's a non repeatable process. So the only way to have a manufacturing process that is repeat, you know, that you can. Produce high quality needles. You need to have an automated manufacturing process that has reproducible processes. So if something were to you find out that could be improved upon, you can modify the machine, you can insert another step you can modify or tweak the machines, um, to be able to fix that problem. But if you don't have that automated manufacturing process, You can't reproduce the needle the same way every time. And therefore you can't increase the quality of the. Well, at least it's very difficult to, so I think long-term things will go towards that. And I think users want high quality products. So they're going to start weeding out the needles that are not as superior.

Well, I think as an acupuncturist, I know for myself, I just want to know that I can open up a packet of needles and do my job without having to think too much about. How's this needle going to work. I mean, on occasion I go to insert in the needle and it's like, something's not quite right with the way it's going in it, but it is so phenomenally rare these days. Right. Um, I mean, I'd love handmade stuff, but I like the idea of non handmaiden.

Right. Exactly. Well, I think, um, it's, it's just a Testament that you're not the only person out there with those requests. And that's why companies like last Soma exists that are trying to weed out all of the bad needles out there and making sure that any product that we sell, our products that, um, That are quality and going to be able to do their job well. So, um, I think you, along with, uh, all acupuncture itself, there feel the same way. Oh, this

is, you know, clearly part of the evolution of our particular trade here in the states, like you were saying your stepfather, um, he was just looking to find some needles, period. Just get some needles. And now we're looking at, you know, very high tech stuff that, I mean, needles are simple and yet they're,

high-tech. They are. And I think, you know, if it was just somebody putting a needle in the body, that's one thing, but the acupuncturist there's a little bit more there. You guys are trained to be able to understand, you know, I'm going through this layer of the skin. Now I'm going in through the muscle tissue and now I'm touching bone and, and to be a. Feel all those different areas of the body and be able to do your job well, uh, requires a refined needle that is going to be able to support that. I think even though, like you said, at a high level, these needles are very simplistic. There's a lot of technology that goes into producing a high quality needle, not to mention this. Then, you know, that's the worst possible thing that could happen to an acupuncturist is God forbid, a, a needle breaking in a human body. And so dealing with these such small needles and making sure that the needles are quality enough, that they won't have anything collapsed during a treatment as is really. So we spend a tremendous amount of time every year, analyzing all the needles that we sell, as well as analyzing new needles and then for the U S market and making sure we understand which needles are good, which needles aren't good. And making decisions about what products to carry based on that.

People like you out there on the front line, uh, checking this stuff out for us. I I'd like to get your thoughts on another aspect of needles here. There's there's often some discussion that I've heard among my colleagues about coded versus non coded needles. Can you tell us a bit about

this? Yeah. And that's an area where there's, there's a lot of confusion about this subject, ultimately. So coated needle helps the needle be inserted a little bit more easily. The downfall is the FDA doesn't require any verbiage on the packaging to suggest whether it is coded or not. And then on top of that, I think there's also a tremendous amount of confusion where we lost CMS, did a survey recently asking people about the needles that they use and what's important. And what was really surprising is a lot of the people were adamant. I don't like Silicon coding or any type of coding on my needle for that matter yet the needle that they said that they used did have Silicon coding, or I don't, you know, or vice versa. And we thought that was really surprising that there's so much confusion about it. And on top of that, there's many different types of coding. There's, periling coding, there's Teflon, coding, there's different types of Silicon oils. And then there's. The more Silicon like Seren, for example, uses a particular type of Silicon. That only goes on the first few millimeters of the. And they can get away with this because the needle body is so polished that they don't need extra Silicon to kind of mask any problems with the needles, any roughness and such, but the silicone that Sarah uses for instance is cured at temperature. And when the Silicon is cute, it's actually a hard substance. It's not an oil that doesn't come. Of the needle and it needs an industrial solvent to be able to remove it. So there is a lot of confusion and there is a lot of technology behind this. Um, and I I'll be the first to admit, I don't know a tremendous amount about it, except that that silicone, that Seren uses is a very special Silicon. That's used in a lot of hypodermic needles, but I do know that people in there's a preference, some people love, so it comes some people. Don't want Silicon in there is, and this confusion out there. So that's something we'll have to work on in the coming years to try to rectify.

And it sounds like the FDA does not require this information to be on the package. And so it can be very difficult for the end user acupuncturist in this case to actually know what.

Well, I'll tell you even more surprising. There was a company, again, I'm not going to name names, but there was a company that has needles in the United States that we approached and were testing. As I mentioned, we do these tests annually, our needles, and then periodically with other brands of needles. We were able to find that there was a coding on the needle and we asked the company, what kind of coding do you have? And they said, our needles aren't coded. So we sent it off to a lab where they did a test and they were able to show that there was, um, I don't remember all the chemicals, but silicone of some sort on the needle. And it was shocking to us to hear that. So maybe the importer of the needle didn't realize, and the manufacturer wasn't telling them, but again, it just compounds that problem even. It is something that we need to, to work work on more. That being said, Silicon oils. And the Silicon I talked about with that Seren uses have been prevalent in hypodermic needles since the beginning of time. And the average amount of Silicon in a hypodermic needle is somewhere along the lines of 10,000 times more Silicon than I'm an acupuncture needle, just by virtue of the diameter being lard or the length being large of these needles and people who have insulin issues. Uh, taking insulin diabetics. I mean, they're, they're pop putting those needles in their body over and over and over again. And there's no, you don't hear about problems with them. And if so, in my personal opinion, which may not matter much, I think it's fairly safe and it's an accepted thing in the medical industry, but that being said. It's something that, uh, companies probably should be more transparent about.

Yeah. I did not realize that hypodermic needles for a long time, as you say, have used Silicon coating. That was not even in my awareness and that this is a very standard medical practice to coat

needles. Right. And a lot of the needle manufacturers actually produce their own silicone as well. So it's, I think that's been that way for many, many, many years. You

mentioned that you you're constantly looking at products, you're reviewing products, you're constantly testing for quality. What kind of quality tests do you do? I mean, you sound a little bit like an urban Porter in that. Oh, we, we have this product come in. Let's let's see what we actually

have. Well, there's a lot that goes in the manufacturing needle and there's a lot behind the scenes that one may not even realize. So when we do tests on needles, Obvious things like tensile strength, we test things like the angle of the needle. Not only do we test the needle tip, but we may the angle that the needle tip makes, but we also measure the consistency. So if you see a needle tip that one needle is very pointed and the next needle is not so pointed. Red flags come up right away. Hey, these are hands. Similarly you measure the length of the needle. Is the needle length, always 30 millimeters, let's say for the particular lot you're looking at, or is it sometimes 35 and sometimes 22 or 25. And that'll tell you a lot about their quality control and whether it's say it's using an automated manufacturing process or is it done by hand, but then there's also items that are quite a bit more, less obvious, like needle cleanliness. Well, there's a lot of needles out in the world market that are just not clean. I think I mentioned earlier with the Seren manufacturing process, they go through all of these different baths to be able to clean the needles from alkaline to acid and trying to get rid of all the residual byproduct of the manufacturing grinding process. So cleanliness is a big deal and it doesn't matter how if you sterilize the product of it's still. Dirt on it, the residual manufacturing stuff. That's not good. So you've probably seen when you've inserted say an inexpensive needle into someone's body and you may remove it and see a little dark spot. And that's, that's residual elements from manufacturing. So needle cleanliness is one, does the needle detached from the handle. So you put a needle into a very thick muscle and you pull it out. Well, the needle detached from the, from the needle handle on that. So that's a big thing that we'll test. Also, if it's, again, if it's an automated manufacturing process, you can reproduce the process you did to assemble the needle. If it's made by hand, you can't and then there's going to be discrepancies in those. And then another one that's that is not obvious at all is even the blister packaging. It has nothing to do with the needle itself at all, but the. Blister package, believe it or not. And people can test this at home when they open their favorite needle and you peel back the blister pack. Can you find holes in the glue? That's holding that blister pack together. And if you can find a hole where you say, oh, there's a little. Area that's missing with the glue that's, uh, opportunity for air or other things to get into the blister pack that could compromise the sterility of the needle in the long run. So at any rate, there's many different things like that we look at, but then we'd do penetration testing tests, uh, that allows us to understand like how rough the needle is, whether it has Silicon coding or other types of cordings, et cetera. So it's a fairly extensive test. We do. Some of the things are more important than others, but it gives us. Kind of a high level. We also test for bacteria and we test for mold. So it's a quite a lengthy process. Uh, more recently, you know, we've been more interested in softer needles and stiffer needles. So we're testing for those things as well, just to kind of get a, a breakdown of, of where our needles fit and, uh, whether anything has changed as well as, you know, what, what needles out in the U S market or world market. I like as well. You

mentioned softer, harder needles. That's not something that I think about when I think about using an acupuncture needle. What are the issues or benefits of a harder or softer needle?

Well, It's really a matter of personal preference, but, uh, as time is going on, um, for facial acupuncture, for instance, a softer needle in general is more comfortable unless it gets to an extreme point where it's too soft and it's too difficult to insert and you can't control the direction of the tip, but even then there's applications like in, in Japan, Students who are learning acupuncture will use very special, soft tip needles to be able to practice their insertions and make sure that they can control that tip better. On the flip side, stiffer needles are, um, are generally for longer. Needles that are being entered into the body. So veterinarians, for instance, need long stiff needles, not veterinarians for the small, uh, animals, but I'm thinking more of a horses or sports acupuncture where they're inserting needles in the deep tissues. Uh, they may benefit from longer thicker needles. Well, if you want to make it more painless, So then you want to decrease the gauge, but as you decrease the gauge, the needle becomes flimsier. So what techniques can you use from a manufacturing perspective to make those needle stiffer? So there's all sorts of things from using different types of metal to different manufacturing process. They can use to try to make it stiffer. I

see. Well, you know, that brings us to. One of the big things I wanted to speak with you about today, which is here at the sports acupuncture, alliances, uh, conference that we're at. There's a new needle being introduced and it's, and it's been sort of designed here in the west. Can you tell us about that?

Yeah. So when you say design here in the west, let me just preface that, that we have a large network of researchers and educators that we work with, and they're constantly providing us feedback on how we can improve the existing products we have and how we can develop new products that would help them in their, in their research or their education or their practices. So the new needle that we are developing is sports acupuncture needle. It's going to be slightly stiffer, like we talked about. So it can, you can have thinner needles that are good. Less invasive, less painful yet provide the same amount of stiffness. And we also, I mean, we have two needles that we're going to be launching then, uh, one that we've already kind of pre-launched uh, maybe six months ago called the Sarah and G type and the Seren G type also had. Uh, dad had benefit that it has a slightly, like if you look at it next to another needle, it looks identical. But when you start zooming into a couple of hundred times magnification, you'll notice that the needle tip is actually rounded. So there's a lot of interesting developments going on right now in the, in the field of kind of sports, acupuncture and stiffer needles and rounded tips. That's really exciting, but yes, we're going to be launching a needle called the pro max from dong bong.

Great. You mentioned a rounder tip to the needle. What's the, what's the thought behind the

benefit of that? Yeah. Interesting. So Sarah has a research, let's just say a state-of-the-art research and development department and they have one job and that's improving their needle. Let's say two jobs, inventing new needles and improving them and going back in history. And this is why when I talk about Sarah and why I'm specifically talking about their research and development program is you can remember back in the earlier part of our conversation, that Seren revolutionized industry by creating the first single use disposable needle, but along the way, Like every couple of years, they're constantly reinventing themselves and, and improving their, uh, their products and just have kind of notable things that they've done. They produce the first single use disposable needle. They produce the thinnest needle. So the 0.10 millimeter. Sarah and J 15 is a finished needle in the world. So even that in and of itself is a Marvel and being able to create that, to make that thin needle be stiff. So that's kind of the first inkling of when we started talking about different needles, they have the shortest needle 0.3 millimeters, and then behind the scenes every year. Processes to tighten their tolerances and make their needles better. Like I mentioned, then the needle tip angle, the lengths of the needles, you know, bringing those tolerances down to, to make it better and better. But you need that state of the art manufacturing, research and development department to be able to do these things. So it's, it's really fun to work with these guys to do this, to answer your question about the needle tip and the Roundup. Yeah, this is all coming from Saron. And to talk about it, conceptually is if you have a needle that's incredibly sharp, that needle will penetrate and cut through all the tissue that you're inserting the needle into. But if that needle is more rounded, it just doesn't cut through everything. And it's. If there's a higher probability that it'll help push the skin molecules aside, help push that small little vein that it, that it touches. And so in conceptually it kind of makes sense, but in practice they were testing on for facial acupuncture and realizing that that needed. Actually produces less bruising. So this is stuff that's, you know, will be coming down the pike, uh, in, in years to come. So we ended up deciding the launch at first with the G type needle and it's, it's there to be less painful and minimize bruising. And it say it's just an amazing technology that, that allows them to do that. Yeah.

When I. Around a ticket. I mean, it makes me think about hydrodynamics. And when you think about boats, especially big ships, they don't have a sharp edge to their bow. They're often have these, these rounded bulbous bowels, because it, it goes through the water in a more smooth way. Interesting. And it's um, yeah, and it sounds like with the acupuncture needles, this is a similar thing. You can either sort of slide between things with a rounded. Or cut through things with a sharper tip. And I would say I'm thinking for myself as a practitioner, having the ability to go sort of around rather than through, or to be able to sort of sneak something into a place without being invasive about it makes a big difference. Matt, is there anything else that you'd like to share with our listeners before we, uh, get back to the conference?

I think we covered a lot. I call, I guess one thing I'd like to say is that we're all in one of the most exciting areas of medicine, and I'm really just thankful for having you, um, invite me here to tell my story a little.