Dr. Ruddle describes the invention process from the idea to developing a market-version product.
Microcracks & the Inventor's Journey Ruddle Insights into Two Key Topics
There is a lot of buzz about the incidence of microcracks related to endodontic treatment. Separately, many clinicians have inquired about how they may bring their innovative ideas to market. This show reveals Ruddle’s opinions on each topic and offers some sage advice. Also, enjoy some family footage from Hawaii!
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INTRO: Recent APICES Meeting
Welcome to The Ruddle Show. I’m Lisette, and in case you don’t already know it, this is my dad, Cliff Ruddle. For our show today, we’re gonna start off talking about microcracks and the controversies surrounding them. And then, we’re gonna go on and talk about the Inventor’s Journey, what the steps are to bring an idea to a market-version product. But first, before we start, why don’t you tell us a little bit about what you were doing recently, in Chicago.
Well, it was really exciting. Phyllis and I flew to Chicago, in conjunction with the American Association of Endodontics’ APICES Meeting. APICES is annual, and the dues that the members pay actually pays to fly each resident from their respective places, cities, to Chicago, pays for their room and board, and they get breakfast, lunch, and dinner. And I can tell you, they were fed very, very well. So, it’s always fun to be part of tomorrow, because the residents are the future of endodontics.
So, the APICES Meeting is a meeting for endodontics residents.
Yep. So, they had 300- and, I don’t know, -10, or something signed up. They had a very big attendance they were thrilled about. There was a presence of vendors there. And so, we had quite a show, with ongoing, multiple speakers, and then, the people were running around, looking at their favorite products.
I think we actually have a picture to show, of you at the meeting. Why don’t we show that.
Now, why don’t you tell us what you’re doing, in this photo?
Well, I’m trying to see.
Okay. So, in Santa Barbara, there’s a well-renowned prosthodontist. His name is Dr. Assad Mora, and many of you might know him in another context. He invented the MoraVision.
I’ve heard of it.
And what the MoraVision does is, we don’t get locked into oculars. So, when we’re looking at work, we can look at a wall. And the way he has the cameras in his set-up, which is about as big as two fists, it projects the image the camera sees on a wall. Could be 16 by 20 or some huge format, and then, you put on these glasses, 3D glasses, and all of a sudden you can see depth of field. So, you get a really great, 3D look. So, Assad Mora saw me, motioned me to come over, and wouldn’t you know, I put on the glasses, and I saw the truth.
Kind of seems like it’s like the IMAX of dentistry.
You can call it the [laughs] IMAX of dentistry.
So, anyway, that was a fun meeting.
Did you lecture, there?
I did give a lecture. There was several speakers, and it was – I was proud to be one of them. And, normally, you give a topic or a theme that the committee wants you to speak about. In this instance, they wanted me to speak about whatever I wanted to talk about. So, what I decided is, rather than send the colleague down Ruddle’s pathway, to where it goes nowhere, I decided it’d be Q and A.
So, we did a whole 90 minutes on questions and answers. So, the start of my lecture really – I just spent like about three minutes each on a recent trip I took to Asia. I spent another three minutes on Shape-Clean-Pack, non-surgical retreatment, three minutes, and microsurgery. This was just eye candy to get them loosened up, because there’s always hesitation, sometimes, by young kids to ask a question. So, this was to get ‘em really loosened up and ready for the challenge, and then, we went right into Q and A. And we went into Q and A for probably well over an hour.
What were their questions?
Oh, that was interesting. They had a company from Chicago that can take real-time questions. It can weight those questions by key words. So, if the key word is ‘glasses’, then, all the questions that have glasses in ‘em will be weighted and come to the top, so you can get to the most important questions.
And so, what were the most popular questions?
Oh [laughs], what the most popular questions were on what’s goin’ on, right now, in a marketplace. And that is, they wanted to know what Ruddle’s opinion was on GentleWave. And you and I’ve already filmed a segment on that, and it will appear on this show, in, I don’t know, a few weeks.
Oh, right. Okay.
And so, we have a – we do have an opinion. We have a lot to say. So, they wanted to know what I thought, and those sometimes ended up being 10-, 15-minute exchanges. The second question that was most frequently asked was, what do I think of minimally invasive endodontics? We’ve never heard about that in our office, have we?
Sounds like their questions are the questions everyone has, right now [laughs].
The last thing they wanted to know the most about was, what do I think of single-cone and bioceramic cement? So, GentleWave, minimally invasive, and single-cone. There you go.
Okay. Well, I think we’ll probably be dealing with all of those issues on future shows. But now, let’s just get started with the show we have for today. [Music playing]
SEGMENT 1: Controversy - Microcracks
So, today, we’re gonna start off the show talking about microcracks. In the last few years, there’s been much written in the endodontic literature, regarding microcracks. Can you tell us a little bit about what the literature’s reporting, give us your opinion, and explain to us this drawing that you created, behind us.
Boy, you’re asking an awful lot of me. Okay. Let’s get started by first looking at the drawings here, on the left. And we have in green, we have in blue and red, the different kinds of fractures that we all see in everyday practice. The red one, the vertical one, is usually the hopeless one, because it runs through-and-through the root, coronal, apical. Some of these, oblique, the blue fractures, depending on where they occur, the tooth could be salvageable through orthodontic tooth eruption and things like that. And sometimes, horizontal fractures, as they move more apical – as they move more apical, sometimes, you can go and surgically take out the root tip and save the upper two-thirds.
I’m not talking about horizontal, vertical, or oblique fractures. I’d like to bring your attention to these cross-sections. So, fi we do an imaginary cross-section at more or less any level, through the mandibular incisor, you’ll see the ovoid shaped root. And a lot of times, they’ll have two canals or a ribbon-shaped canal, and you’re seeing that clearly. What we’re looking at, on that drawing on the right, then, is, we’re looking at fractures that are purportedly occurring secondary to shaping canals.
And, personally, I don’t think this even exists, but I’m talking about it today. We’re talking about it, because there’s so many articles in the literature, it’s so up and down in the literature, that one would have the – you might even assume that if you put a file in a root, I mean, geez, are you gonna crack the root? So, there are cracks, then, that are alleged in the literature to happen from the inside, out, on the left, here. And then, you can see that sometimes, just looking at specimens, through SEM, you can see cracks from the outside, in. So, those obviously never occurred, on the far right, from anybody ever shaping a canal.
So, let’s talk a little bit about some of those factors that do influence treatment. [inaudible] look over here, now. Okay. So, when we look over at our correct camera, what I’d like to say, first, is, there’s several things that do influence this purported problem. One could be the apical size of the canal. In other words, in the old days, oftentimes we were all trained to take large, D-0 diameter files to length, like a 40, or a 45, or even a 50. The reason we did that, purportedly, was so that we had a big enough space apically to accommodate fluids and irrigants. And, of course, that would help or enhance our cleaning.
The other thing that we often emphasize is taper. So, the apical one-third taper, the taper in this region of the canal, we all know the deep shape or the vertical three, four, five millimeters, that taper, that’s what holds our reagents and limits their flow, periapically. That would be inadvertent and cause a sodium hypochlorite accident. We also want deep shape so we can move thermal-softened gutta-percha into the cross-sectional anatomy. So, all these things together, apical one-third taper, diameter, that could have some influence, if we’re not thinking about the anatomy of the tooth we’re actually working in.
If we think about the teeth we’re working in, then, the shapes need to be appropriate for the canals that are in those roots. The other thing to talk about is pre-enlargement versus crown-down. Okay. What is the difference? Most dentists don’t know the difference, but there’s a [laughs] critical difference. Crown-down was a word coined many, many decades ago, to mean, start coronally – start coronally, with your biggest file diameters, like a 50 or a 60, and let that work in a little bit, then, going to a 50 and a 40 and a 30. And by going from big tips to small tips, we’d work our way progressively down the root.
Obviously, when you put a big file in the coronal one-third of a canal, there’s a lot of load, a lot of torque on that file, because you’re doing a lot of work. That’s crown-down. Never liked it, never really appreciated it. I did like the end result of it. And so, another idea that we introduced, back in the late ‘70s, early ‘80s, was pre-enlargement. Pre-enlargement’s just the antithesis. It’s going from a small tip, not a big tip, a small tip to a bigger size.
So, if this is a file, and it has a small tip, the small tip is flexible, and it can follow the glide path. And it’s the bicycle steering wheel. It steers that file through curvature, but the workload, then, on a progressively increasing percentage tapered file, not a fixed tapered, means that the workload is pushed up to the bigger cross-sectional diameters, the stronger blades, the more efficient blades. So, we’re getting the same effect as crown-down, although we’re doing it in a much kinder way, because a little file can go in at the tip, follow nicely, and then, cut up, on its bigger, stronger, more efficient blades.
It seems that crown-down might be a little dangerous, because when do you know to switch to the smaller file, before you create too much pressure, before you would switch to the smaller file? Like, maybe that would be dangerous and crack the tooth, if you’re putting too much pressure.
Oh, well, you would always switch just before you heard [breaking sound].
Before you heard.
Before the crack, you’d stop. That’s when you would go to a smaller size.
No, you really don’t know, and that’s the whole thing. And so, it’s led to a lot of abuse of that method. And so, many years ago, with the launch of Protaper, we cleaned that up, in 2001. And we did pre-enlargement, before. We used G-G’s small to big, 1 before the 2, to get to the 3, to bridge to the 4. So, we were doing that, if you will, pre-enlargement, in the old days, but 2001, we put those same geometries on the SX or the shaper files, 1 and 2. And they cut up on their body, they cut away from length, and this is very flexible and could follow easily.
And also, I know that you write that – to use a brushing technique when you do pre-enlargement. So, that probably opens up the canal better, without creating a lot of pressure on the canal wall.
Oh, that’s a great – an excellent observation by Lisette. When you brush, what you’re doing is, you’re able to place the file into eccentricities, off the rounder parts of canals. There’s spins in the isthmus areas, and there’s figure eights, and there’s irregular cross-sections. So, by brushing out into those irregularities, you really can get more metal-dentin contact, and we have a better preparation. So, yes, brushing’s really important. And the thing that, really, I’ll just play off of you, the brushing means there’s no torque. Because when you lift the file up, even a half a millimeter, because you’re gonna start painting, well, the file’s loose. So, there’s no torque. It’s not binding.
And also, we brush away from furcal danger in furcated teeth, so, those are passive preparations, versus very active preparations. Okay. So, we go on to factors that are influencing treatment. Let’s get back to – I just mentioned three things, apical diameter, apical one-third taper, deep shape. And then, we talked about crown-down versus pre-enlargement. Now, let’s talk about the files, themselves. Obviously, file design makes a big difference, and that’s why everybody is presumably coming to market with something that’s easier, better, and faster, safer, all those words. That’s what everybody’s hopes are.
But the fact is, files are quite different, from manufacturer to manufacturer. So, without going to all the variables, we could just say that files, basically, have a tip diameter and different tip configurations. There’s different tapers. There’s progressively increasing tapers, like the Eiffel Tower. There are progressively decreasing tapers, to be respectful of anatomy in the body of the canal. Of course, there’s rake angle, cutting angle, helical angle. There’s all these different things that balance the file out and help it to move through the canal, in a smooth, passive way.
So, there’s been a lot of interest with the launch of WaveOne Gold, many years ago now, to have a different movement. So, historically, things have ran in a clockwise, rotary motion, but WaveOne Gold uses unequal bidirectional angles. So, the cutting, engaging angle is 150 degrees, the disengaging angle is 30 degrees. So, if you take 30 from 150, the net’s 120. So, after three cutting cycles, you’ve made one circle. And by the time the file’s made one circle, it’s auguring debris more effectively out of the apical part of the canal and pulling it up into the pulp chamber, where it can be cycled out, too.
Did the literature that you were reading say – like, was there any study that actually compared rotary versus reciprocation, and did they come to any conclusion, that one is safer than the other?
Well, absolutely, there was a [laughs] study. And it was a little bit irritating, because it was an outlier, meaning, it’s probably the only one around. But it was a study – and I have it, right here, and it was a – well, I guess we can say it was a – the Turkish researchers, from various universities, what they did is, they reported in March of 2019, so, just very recent, that they were comparing an eight-percent [laughs] taper file with a one-percent taper file. Head to head.
And they did show crack propagation. And their conclusion was that Protaper Universal was demonstrated as significantly increased percentage rate of microcracks’, when they compared it to a one-percent tapered file. Okay. We can’t even report this kinda literature. This is like – you know, they need to have a journal of retractions, where they take some of these flawed papers that don’t have good methodology, and they need to be put in a completely different journal for clowns, okay? That would be my comment on that paper.
I’ll show the camera. There are six papers here. All six of these papers were published in the last two years, two and a-half years, at most. Only two papers said that there were microcracks, related to instrumentation, okay? That means four of these other papers in the last two and a-half years, plus the latest paper in the “International Endodontic Journal” said there are zero crack propagations related to instrumentation. They happen for another reason that I’ll talk about, in just a moment.
And by the way, we will put up this reference list on our website, if you’re interested in going back and reading these articles.
Well, very good. Okay. The last comment, remember, we were talkin’ about factors that influence treatment. We were talkin’ about files. And so, I said, ‘design of the file’. Remember, I mentioned the movement, spinning has been more passive. It’s been thought to be more passive than this back-and-forth, stop-on-a-dime, boomp, boomp, boomp, boomp. Even hear a little click-click-click-click-click-click-click, when you’re working, everything’s fine. Everything’s fine. The key on all this stuff is, is, do you have a glide path? If you have a glide path, these files will readily follow a pilot hole, and they’ll work passively, probably anybody’s files on Planet Earth.
The last one was heat treatment, and that’s what really changed the game, is when manufacturers started putting files in cassettes and running them up to proprietary temperatures, and then, letting them cool back down. So, heat treatment made files way more resistant to cycling fatigue, and they made the files really, like, spaghetti in hot water, like, flexible. So, flexible files aren’t putting a lot of load, internally, on these small, irregular cross-sections. So --
Are most of the popular files that you can purchase nowadays, heat treated? Are most files heat treated?
Almost everything, now, has some kind of heat treatment. To play off of you, some files are heat treated, pre-machining. That means, the raw stock is heat treated. And then, they machine the file. And then, some files are heated post-machining, which means, the whole file’s constructed. Then, it’s put in the cassette and heated up and allowed to cool down. But heat treatment, whether it’s pre- or post-machining, has been a wonderful, wonderful thing for patients and dentists, alike. Okay.
So, that’s kinda like the factors that come with the shaping. I’ve identified the factors that come from our files. And the only thing we have left to do is to maybe look at some of the reasons, then, that researchers are seeing cracks.
Yeah. Because you said, what did the other four say was causing the cracks?
Basically, paper after paper after paper says that if you have a glide path, if you’re using good clinical skills, and you’re not pushing and horsing files, if you have the glide path, there are zero cracks. One paper, though, to really point out, in closing, two papers, is, the paper here from The Academic Center for Dentistry in Amsterdam, it’s called ACTA, A-C-T-A, and what they found out, that there were zero microcracks related to instrumentation. However, they said, specimen preparation was, for them, the number-one issue, because these things have to be put in alcohol, dehydrated.
And they looked at just teeth that had never even had endodontics. And half of ‘em had fractures, some starting from the outside, in, some from the inside, out. So, these teeth weren’t even touched with instruments. So, that’s something that every reader should understand, is, preparation specimens and how they’re done and conducted and how they’re dehydrated, et cetera.
And then, this last paper, by the “International Endodontic Journal”, a wonderful paper, by – lead author was Gustavo De-Deus. De-Deus is a neat guy, in Rio de Janeiro, and, in his paper, he said, you know what? Nobody’s ever looked at the extraction, itself. [laughs] I mean, you know, you gotta get in there with the forceps, er, er, er, luxate the tooth, elevators, boom! Pop it out. Just the extraction process, he said, was pretty much responsible for all fractures in roots.
So, I hope this little session, together, has helped our audience better appreciate that we need to be careful. We need to be aware of the apical diameter, the apical one-third taper, and we should be aware of pre-enlargement or crown-down, how the file’s made --
Glide path, a reproducible glide path.
-- glide path. What else did I say? Glide path. Did I say glide path?
Oh, glide path, right! We forgot to say glide path with enough vigor, that they’re going to not have a glide path. You’re going to own the glide path. And he, whoever owns the glide path, wins the shaping game of endodontics.
Well, just to close out, then, what do you think is motivating all of these articles? Could there be a commercial bias, maybe? Are they trying to promote a certain file, or say it’s safer than others?
No – we do, sadly, have some human element in the business. The business is the business of endodontics. And of course, even in academics, there are prejudices, there are bias. So, I think some is commercially driven. Sometimes, they wanna compare two files, and there may be a commercial interest with one. So, there’s a desire to have it maybe look better. I think most researchers are honest people. I think they care a lot, and they have good methodology.
But I would say, researchers should get outside the schools, sometimes, and get out into the clinical world, and talk to people, so, when they set up their papers, they’re comparing seven percent to seven percent, six to six, one to one, things like that. So, there’s probably some prejudice and bias. But I think most of the papers are – sometimes, the researchers just aren’t taking into account some of these factors that do influence microcrack propagation. And what we’ve found out was, it wasn’t due to clinical endodontics. It was more related to the specimen preparation.
And – or the extraction, yeah.
So, those are some interesting things to think about, when we read our next microcrack article [laughs]. Thank you. [Music playing]
SEGMENT 2: The Inventor’s Journey
So, now, we’re gonna move on and talk a little bit about the Inventor’s Journey. Over the past two decades, my dad, Cliff Ruddle, has taken several ideas through an invention process that ultimately led to a market-version product. Clearly, inventing a product is a serious endeavor. And I have seen him have to learn a lot about things like engineering, nanotechnology, machining, electronics, just to name a few. And being his daughter and working for him, and observing the process, I have also noticed the qualities that are necessary to bring a product to market. For example, imagination, creativity, perseverance, hard work.
Every month or so, I would say, our office is contacted by a dentist who has an idea and wants my dad’s coaching on how to turn their idea into a market-version product. Behind me, here, you’ve identified the steps to take. And can you tell us a little bit more about this journey to becoming an inventor.
Sure. Well, this is all fun stuff, and it’s not for everybody. But lots of people do, as Lisette said, approach us, quite frequently, and they wanna know how to do something. So, we wrote an article about it, I guess a few years ago, and that’s been helpful for some. And we decided to take some of that article, editorial, and put it into a show. So, here we are, today. So, let’s go invent.
And incidentally, you can find that article on our website as well.
Well, thank you. And that would be an opening to, let’s go invent. Isn’t that what Steve Jobs says, ‘Let’s go invent tomorrow’? All right. So, here we are. We’re gonna invent tomorrow, today. Well, it starts with an idea. When you have an idea, you need to understand that you shouldn’t quite uncork the bottle. Maybe just hesitate a little bit, before you have the whole champagne bottle, because you need to ask yourself a few questions. ‘Is my idea relevant?’ In other words, if we’re talking endodontics, then, you need to have an idea that can be widely used by international dentists. It can’t be something that is very specific, has almost no market appeal, and three guys do it, when no one’s looking.
So, number one, does it have wide application? Is it affordable? You might have a great idea, ‘Let’s go take endodontics to the moon’, but maybe that’s not appropriate, or maybe it’s too costly. So, let’s kinda cost this out, roughly, and understand, is there really a way forward that can be mass produced, and the dentists can afford to buy it? Number one, a lot of people ask me questions, they wanna know how to do something, or they want – they have a great idea, but is it feasible? Can you actually do it? And so, you might even think about running this idea by some respected people. You might want to even make a proof of concept.
It’s – it doesn’t matter if it’s ugly, doesn’t matter if it’s bulky and way out of scale. The main thing is, is just to see if the idea works. So, as an example, when I was doing the EndoActivator, many years ago, Bob Sharp and I were talking about different ways to agitate an intercanal fluid, and you can begin to make some various tips. They can be conical, they can be paddle shaped, they can be figure eight, they can have flanges that flop around, like forward thrust to displace fluid. So, anyway, check it out. Make a proof of concept.
And then, of course, it needs to be something that dentists can easily integrate into their already successful offices. In other words, it shouldn’t take a lot of course work or redesigning the office, to get this technology aboard. So, I think those are some of the things I think about, when I think about, ‘I have an idea.’ Well, check it out, run it by people that you trust, and then, of course, is it going to do something easier, better, and faster? Because if it’s just another me-too, like, let’s go invent a pen, well, wait a minute. What if there’s a lot of pens out there? So, what’s gonna make your pen more successful, more customers wanting to buy it, as compared to this pen?
So, you wanna improve on what already exists.
Exactly. We need to exist – we need to improve on existing technology. And it should be better, easier, or faster, or have some – more affordable. There should be definite advantages. So, if we look at our list, where are we?
No, you have patent application. But --
Well, you know --
-- also, you have non-disclosure agreement, and can’t those kinda maybe happen around the same time or in reverse order?
-- yeah. Thanks. If you’re looking for maybe the most economic way forward, you might just consider getting a non-disclosure agreement, an NDA. An NDA is boilerplate. They’re not custom-made documents. They’re pretty generic. And most businesses have them. So, if I wanna sit down with you, and you’re Company A, normally, you just pull up and say, ‘Would you sign this?’ And it actually protects you and me. It doesn’t just protect me. It protects both of us.
Because, what if Lisette says, ‘I’m already working on that project’? Well, she doesn’t want me to spill my guts, and then, she has to hear me say it. And then, she has to say to me, ‘Well, you know what? I was already doing that, three months ago. And I’m not feeling very good about it.’ So, a non-disclosure is a two-way street. Okay? The non-disclosure agreement, then, can be prepared easily. It’s signed. There is usually a date when it expires. So, just please understand that when you read the small print of the NDA, it might say that when I share my idea with you, that, in 2021, it’s obsolete. You can do it, now. Even though I brought it to you, now, you can do it, because I never acted on it.
So, look at the by-when, and make sure that it makes sense to you. So, the non-disclosure is a good way to go out and be able to explain your idea to others. Back to the concept, I should’ve probably said this. When somebody has an idea, don’t send the idea to anybody. Send it to yourself. So, email yourself, and say, ‘On this date, this is what I conceived’, and spell it all out. And that is a document that timelines when you thought of the idea, and here it is, in writing.
So, it kinda protects you?
Because you have it in writing.
Because of lots of people sort of – I’ve noticed, over the last [laughs] 40-some years, a lot of people kinda stumble across the same things, at the same time, in different parts of the world, because there’s challenges, clinically. And, of course, if you’re thinking about how to resolve those challenges, then, other people are thinking about that, too. So, you might have two things kind of arriving, at the same time. So --
Yeah. I think they built the pyramids, in South America, and also in Egypt, at the same time, with no communication with each other. [laughs]
-- you know, that’s fascinating, isn’t it? I mean, there’s a – that’s a perfect example, where two civilizations were doing extraordinary things, simultaneously, and neither one knew. I guess they forgot to text each other.
All right. So, the patent, you wanna talk about the patent?
The patent’s probably the safest way to go. It’s also more costly, because now, you’re going to involve a patent attorney. And patent attorneys are specialists, and so, you don’t go to just a generic attorney. You go to somebody that has expertise. And this patent attorney can do many things for you. They can immediately go a Google search and find out what other people are doing. In other words, if I file an application, this isn’t a patent, but people commonly say, ‘I filed my patent.’ No, you didn’t even get a patent yet. You just filed an application. And, in one year, those applications are made public.
So, anybody in the world that files a patent application, in one year from today, that will be published at the U.S. Patent & Trademark Office, as an example, in North America, in the United States. And that means, anybody in the world can go to that Patent & Trademark Office and find out, ‘What’s Cliff Ruddle doing, now? What has he just disclosed, that he’s gonna be doing later?’ So, it’s a good way, so you don’t take a false pathway. Because you could be working really hard, spending money and time, blood, sweat, and tears, and then, you could find out that somebody else is, like, one day ahead of you.
So, in one year, it will publish, and then, hopefully, you’ll actually get your patent application into a patent. And when you have a patent, of course, you have a lot of power, because you can go out to anybody in industry, and you can sit down and freely explain things. You don’t even need an NDA. It wouldn’t matter if you had an NDA. That would just be another protection.
Now, when you say, ‘publish’, do you – you don’t mean, your patent will be granted, necessarily. Do you – are you saying that it will be granted in a year, or will it say, ‘Patent Pending’?
Okay. After one year, it will say, ‘Patent Pending’?
When it’s published, good point. It’s not a patent. It just means, now, everybody has permission to know what’s goin’ on in your head and what you’re working on.
But it might take – I mean, I’ve got quite a few patents. I’m not braggin’ about it. I don’t even think I like patents, because you have to defend ‘em. But patents, a lot of times, mean people may try to infringe on your IP, which means, you have to write them a letter, which means your attorney writes the letter, and all of a sudden, there’s a legal process. I’ve had to stop several companies from coming to North America, as an example. But to stop them from coming in, it might have cost me 20 or 30 or $50,000.
Would you say that when you’re filing a patent, would you say it’s best to be specific or vague?
That was a great question, because you need to be really vague. And the problem is, dentists are not vague people. They generally work in microns [laughs] and millimeters and fractions, and everything is very precise. So, you want your patent very precise. No, you don’t wanna say that, ‘There’s three holes. So, this is gonna be a tube, and we’re gonna shoot fluid through here. And it can emanate out of this tube, in three holes.’ Well, then, Lisa’s gonna come [laughs] along and make four holes. And somebody else is gonna do two holes. So, what you say is, ‘A singular hole or a plurality of holes’, and that covers everything. Vague. Vague, vague, vague.
Or, ‘An indeterminate amount of holes’?
Whatever it takes.
So, don’t file your patent too soon. The comment here would be very specific. A lot of times, on the manufacturing pathway, you discover economies of scale. There might be a better pricing way to do something, and it might take you – like, the goal’s out there, but you might deviate a little bit from the goal, based on manufacturing. So, if you filed your patent premature, you actually get the product, and maybe your patent doesn’t even protect the product, because another company can see another way to patent around. So, you can always file a second or a third patent.
I learned this a long time ago from John Seifert, a patent attorney, but he said, the first patent’s like a picket fence. But the pickets are like six feet apart. So, people can run through the pickets to infringe on your IP. They can go under, they can go over, and they can go around.’ Okay. So, sometimes, you file a second patent, and now, the pickets are three feet apart, and another one could put ‘em one foot apart. And all of a sudden, it’s a wall. So, patents, multiple patents on the same concept can pick up different characteristics or different things that you’re tryin’ to protect. And, altogether, they work in a very powerful way for the company or whoever owns the patents.
Okay. Well, let’s move on, now, and go to the next thing on the list, private versus corporate development. What do you mean by that?
I mean money [laughs]. Do you have any money? Anybody around here have money? Money! Okay. So, when you go to a corporation, typically, they bring expertise. That’s why you’re going to ‘em. So, maybe you’re doing a project with a micromotor, where you go to a motor company. There’s lots of people out there that make motors. So, you would go to somebody that already has expertise in motors, and they probably have tons of patents. So, you’re already under their shield or their umbrella. So, that’s a way to go, because they typically know the pathway.
They have the – you mentioned, early on in the show, you talked about engineering, injection molding, machining. There’s different things you learn, and corporations, a lot of times, have that under their roof. The problem is, private is more successful. Risk, reward, comes to mind, immediately. Because you do it yourself, you’re going to pay for R&D, you’re going to pay for prototype molds, wanna make this, make a prototype mold. We’ll spit out maybe 200 or 300. We try, we see that it works perfectly, it’s working nicely.
Well, then, we go into what’s called production molds, and they’re much more sophisticated. The tolerances are much tighter, and they’re made to run production. So, you can run 1,000 or 10 million widgets, and you’ll keep your tolerances, pretty close. So, if you go private, you’re gonna pay for all this, and you better be prepared, when the mold doesn’t work, or you have to adjust the mold. You have to write another check. Does it look like I’m writing another check? So, you have to write another check.
And then, field testing, university-based research, a lot of times, universities want 25, 30, 40, 50 grand, to test the project. And you give them the directions for use, DFUs, and you want them to follow a protocol. But whatever they find, they can publish. Now, there’s some companies that do not allow research, like GentleWave, to necessarily be published, without their blessings. And I do not like this, at all, because research, if you’re following the protocol, the company needs to give you the protocol and give it to everybody and say, ‘If you all follow the protocol, we should see similar results.’
When we forbid research to be published, that’s been following a protocol, that smells like there’s something we’re not straightforward with, and we’re not being – we’re not disclosing everything.
Okay. So, if you’re – if you do it privately, you have to pay more. But then, all the profits are – would be yours, right? So, that’s the good side?
Well, that’s a good side, because if you do it all yourself, file your IPs, at some point, I can walk into a company and say, ‘Here’s a prototype.’ This must have [inaudible]
‘And, oh, here’s my IP, you know, a list of all my patents.’ And so, you can – that has value. And so, a lot of times, you might offer to buy my IP, in exchange for what? You’d want to be the distributor. And you would then own my IP. It gets transferred under your name. I’m on the patent, still, but I don’t own it. You own it. And you can make the product, you can enhance the product, and you can decide on your distribution model. So, again, if you’re thinking about the private journey, it’s not just manufacturing a widget.
If we had your sister in here, she would tell you, ‘Oh, and then, there’s packaging and bar codes and fulfillment and regulatory and sales and marketing and shopping cart and all this ways that – to make a product, where you don’t even have to have the product in your office.’ We don’t even see some of the products. In other words, they’re made somewhere else, they go to a fulfillment center, and when you, the doctor, decide you wanna buy it, on our website, then, automatically, it tips off the fulfillment center, this order came in. And we have it set up so, within 24 hours, they’re fulfilling that order. And the doctor should get it, anywhere in the United States, the next day, within another 24 hours, so, about 48 hours.
So, there’s a whole thing with private – but, to your point, to summarize, risk versus benefit, you’re gonna usually work with a company. You’ll get a royalty. I didn’t mention that. Royalties can be anywhere from 0.5 percent up to 6 percent. Sometimes, you’ll see groups of people working together in teams, because rather than me take the whole six percent, why don’t I give three to you, I’ll take three. I’m taking less, but I’m gonna make actually more, because maybe Lisette writes articles, jumps on airplanes, goes and gives lots of lectures. Maybe she has a website, 30-, 40,000 people a day visit her.
So, I’m happy to give up three percent, because she’s gonna help grow my business. So, you can have more reward, and there’s more risk, but it’s a business. And just remember, when you do any of this stuff, it’s just like clinical practice. It’s a business. You have people, systems, structures, time management, referral management. All this stuff goes into a business. You gotta put the same love and energy and effort into this business.
Well, when you were talking about corporate development, you said that the corporate could handle regulatory. What – I see that’s on the list. So, what is regulatory?
It’s on the bottom of the list, for a reason.
I hate [laughs] regulatory. Regulatory is like, every company – or, I’m sorry, every country has figured out that they can charge to get this product into – make it up, Brazil. Anywhere in Latin America, anywhere in the world, Southeast Asia. So, to get this product in, you have to register it. That’s where regulatory – they wanna know all kinds of things. So, regulatory means, you gotta start these endeavors off with what’s called a file design history. And if you don’t have it, it can block everything. You just can’t get into a country to legally sell. So, regulatory can be onerous.
There’s people that we should tell our audience that are specialists in this. They can put their arm around you, like you go to a doctor, go to a dentist, okay. You can go to a regulatory person, and they can help you set up your project in a very specific way, with paperwork. And a design file history is the – it’s not just the drawings and the mechanical drawings. It’s the tolerances. It’s safety things, to protect patients and allied personnel that works with these products.
So, regulatory is quite onerous, and it’s quite steep, and it’s very expensive, even for something like the Endoactivator, which a lot of people say is relatively inexpensive. Phyllis isn’t here, but I think she pays like 50 grand a year on regulatory, to keep it current.
So, if you’re not naturally a very organized person, then, probably you should have [laughs] a company help you with regulatory. [laughs]
That’s one of the major reasons. And, of course, then, again -- we’ll just say six percent. But then, you get the six percent, because they’re doing all the heavy lifting. So, it makes sense, in one respect. But on the other hand, this person, Lori, your sister --
-- she has learned regulatory over the last 10 to 15 years. And, I mean, it’s a whole educational program. She gets audited. People come to the office annually or semiannually, and they need to see all the complaints and the returns and whatever there is that people are complaining about, and they have to see all this.
Okay. Well, in the interest of time, let’s close out. Why don’t you explain what the critical pathway is?
Oh, that’s a great word. I love the critical pathway. On another episode, when I forget – I forgot my handkerchief, because I was gonna – you know, I had some tears in my eyes. I was gonna tell the Mr. Kung He Le [sounds like] story.
But we’ve decided today just to make it really short. The most powerful thing you can do in your office, or in your life, or with your kids, your family, your staff, is, write it down! Number one. Two, nail it to the wall! And I didn’t say, in a closet. I said, put it in a conspicuous place, so that everybody sees it and is confronted with it! And Stanford told us, in the 1950s, when people know your goals and your dreams, and what the aspirations are, and if they’re all aboard, okay – they will be helping you figure out how to make this happen, in their sleep! [laughs] That’s pretty good.
That’s the power of the process. That’s the critical pathway. So, write it down, put it on the wall, put it in a conspicuous place, everybody sees it. And, you know what? It’ll happen.
And it doesn’t sound like – it sounds like that could be applied to any goal you have, not necessarily inventing a product.
It’s worked on everything so far, except weight loss.
Well, I think that’s all we have for today about the inventor’s journey. Hopefully, some of you now have a better idea on the path to take. [Music playing] So, that’s our show for today. We hope you enjoyed it. We’d like to leave you with a little movie we put together that shows our recent family vacation to Hawaii, because we want you to know that we’re not all about work.
And we’re looking forward to seeing you, next time, on The Ruddle Show.
CLOSE: Family Trip to Hawaii
I feel probably my favorite part of the trip was probably the breakfast, because I feel like the breakfast --
-- is when all of us come together, and we just all talk about our day, what’s gonna happen. [Music playing] I mostly paddle boarded, and I kayaked, I think, one of the days, and – yeah. It was fun, but it was scary.
Did you see any sea life?
Yeah. We saw a lot of sea life, actually. We saw multiple turtles, of course. And we saw a manta ray, which was super cool, because it jumped out of the water, as I’m paddle boarding by it.
So, it was my very first time paddle boarding, and I was really – I was kinda nervous at the beginning, because when the guy was launching us, I like, couldn’t get on my board. And it took me a little bit, I had to like, jump, and then, I flopped off. And then, I jumped, and it was like, ugh! And then, I’d like, go off again. And finally, I like, got myself together. And then, I went on the board. And it was definitely really cool, because we saw some turtles and stuff. And then – yeah. I remember – I had no idea that my grandparents were gonna be going kayaking. So, when I saw them, their unison was undeniable, their communication. They were all going at the same time, and it was [laughs] really cool to see that.
We did a lot of boogey boarding, for sure. And when the waves weren’t too big, we started to break our boards.
So [laughs] –
Very rough waves.
-- I mean, I like big waves, but I had to stop. It was a bit too much for me.
What about jellyfish or sharks or anything? Any of that?
None of that, thankfully.
Just some sea turtles. [laughs]
They had a couple warnings for jellyfish, a couple times, but never had any encounters, thankfully. [Music playing]
Playing tennis in Maui was really fun. I know the first time that we went there, it was super humid and really, really hot. So, it took a little bit to get used to the conditions, but, overall, the courts there were really nice. And we had a really fun time playing.
Yeah. They have a really beautiful tennis club, just beautiful scenery and getting to play with your whole family is not something you get to do very often. So, I was very thankful for that.
Yeah. It was a very fun – it was very fun, playing on the tennis courts, there.
I took off my shirt, at one point. I don’t know if you were allowed to, but – yeah. Desperate times. [laughs]
[laughs] I didn’t, but my shirt, like – I would do this. And then, it would just, like, stick to me. That [laughs] was really wild. [laughs]
If you lived in Hawaii, do you think you would still be wanting to play at a high level of tennis?
No doubt about it, yeah.
I mean, it’s just definitely like – it’s definitely worth it. You would get used to the conditions. It was really hot. The ball would fly a lot more, so that was another thing that we had to get used to. We had to change the span of our strokes sometimes, make sure the ball would go in [laughs].
The humidity also made it a big heavier, though, so it was kind of a weird contrast.
Yeah, it’s kind of back and forth.
Well, yeah. Us three played a lot of tennis, and then, we also got to play with our parents, a bunch. And also, our grandpa. So, that was really special.
And then – and then, our uncle Adam got to play with us, too --
-- I think once or twice, and that was really fun. [Music playing]
As you go up farther, up the volcano, the scenery changes, and it becomes all volcanic rock, and it’s super crazy. However, I also had issues with the elevation, because it was – it made me feel very out of breath. And I always get very worried about those types of things.
Personally, I didn’t have any issues about the elevation [laughs]. I thought I was good. [crosstalk]
It was my first time going to see the volcano, so it was a really fun experience. Because it was actually really surprising, because once you get to the top, you look down, and it’s almost like a really big crater. And it was actually pretty cold, like you have to dress in layers. So, I had a really fun time. I didn’t know if it was active or not.
Yeah, our main concern was elevation. Her main concern was [crosstalk]
Was the lava.
No, the views were amazing. It was just super windy, so it’s hard to capture a lot of audio. But the clouds would come in and completely engulf us. It was pretty cool.
It was also very hard to take photos.
Yeah. A good photo.
People’s hair would be blowing, like this.
Yeah. However, those can actually make great photos, is what I found out.
Those are action shots.
What made you start dancing?
Oh, man [laughs].
It was just the volcano, and it got me in the mood, and [laughs] [crosstalk] [Music playing] I just couldn’t contain myself.
When you go to Maui, coming from California, you’re not expecting there to be a fire. And you’re just in the pool, minding our own business, and all of a sudden -- this black – black specks start falling. And the first thing I did was like put them on m y face like war paint and then, I forget who told me, I think it was mom, she was like, stop that, it’s dirty. It’s ash. I’m like, ash? And then, and then, there was a fire! [Music playing]
I thought we were going to have to evacuate.
And then, we heard that there was like 27 firefighters, fighting a fire! And in California –
We’re use to Cal fires.
-- yeah [laughs]. Like, thousands of firefighters. One of ‘em might get sick, and that’s a [inaudible] percentage. [crosstalk]
It was pretty scary. There was a lot of ash going in the pool, and that was sad.
Where would we evacuate to? Because, like, the other islands --
-- would be like – there were some kayaks on the beach, but --
Yeah. Kayaks were the last resort. [Music playing]
So, my grandparents are definitely two of the most inspirational, motivational people I have ever met. They inspired me to do so many things that I’ve never even thought to – that I can potentially do.
They’re amazing. They really motivate me to do so much. They’re -- they really inspire me. They’re really cool people. It’s fun to have them in my life.
I mean, I love them so much. It’s through their hard work that we have everything that we have, shooting at this beautiful park, going to Maui. And just -- their support is just incredible. [Music playing]
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The content presented in this show is made available in an effort to share opinions and information. Note the opinions expressed by Dr. Cliff Ruddle are his opinions only and are based on over 40 years of endodontic practice and product development, direct personal observation, fellow colleague reports, and/or information gathered from online sources. Any opinions expressed by the hosts and/or guests reflect their opinions and are not necessarily the views of The Ruddle Show. While we have taken every precaution to ensure that the content of this material is both current and accurate, errors can occur. The Ruddle Show, Advanced Endodontics, and its hosts/guests assume no responsibility or liability for any errors or omissions. Any reproduction of show content is strictly forbidden.