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At TechCrunch Disrupt we talk with Starkey Hearing Technologies and Pinpoint Pharma about their newest medical devices and technologies.

The distinction between hearing aids as a medical device and wireless earbuds as mass consumer product is vanishing. Starkey Hearing Technologies is bridging that divide with a new hearing aid that doubles as a fitness tracker, high quality headphones, and a language translator. That’s right: we’ve got Babble fish now!

Then, Paul talks with the founder of Pinpoint Pharma about their efforts to print prescription drugs for animals. Because of their precision equipment, they can make drug dosages more accurate than pharmacists can by hand, reducing the number of adverse side effects and doing so at a superior price point. What’s bizarre, though, is that the regulatory maze of health insurance means that this superior method will benefit pets before people.

Why are hearing aids avoided? Does hearing loss lead to cognitive decline? Can hearing aids have multiple functions? What are the latest medical devices and technologies hitting the market right now from start-​ups? What can specialized pet medicine teach us about human medicine?

Further Reading:

Hedging Against Skynet, Building Tomorrow Episode

Health Care without Health Insurance, Building Tomorrow Episode

A Better Choice: Healthcare Solutions for America, Free Thoughts Episode

Transcript

[music]

00:02 Paul Matzko: Welcome back to part two of our TechCrunch Disrupt series of episodes for Building Tomorrow. I’m your host, Paul Matzko, and today we’re talking about all things related to health innovation at this year’s conference. Now, after drones and autonomous vehicles, I would say that medical devices were the single largest category of exhibitors on start-​up alley. And we’ll play you an interview with a start-​up that’s producing a new kind of hearing aid that can do well, as you’ll hear, it sounds like it can do pretty much anything.

00:37 Paul Matzko: I am sitting with Dr. Dave Fabry, who’s the CIO of Starkey Hearing Technologies. We’re gonna talk about their new product, the Livio AI, which is a hearing aid, but much more. Welcome, thank you for taking the time to talk to me, Doctor.

00:51 Dr. Dave Fabry: Thank you very much, it’s my pleasure.

00:52 Paul Matzko: So this is a hearing aid that I think doesn’t do justice to what this device does. So it’s going to improve people with hearing loss, it’s designed to help them hear what’s going on around them, but maybe describe some of the more innovative elements of this device.

01:07 Dr. Dave Fabry: Sure. Yeah, I’m an audiologist, my background. This is my 35th year in the profession. I’ve worked on industry and on the clinical side, and what we’re particularly… What I’ve spent 35 years doing is trying to persuade people to address the fact that they have hearing loss and consider wearing hearing aids. In many cases that path to hearing health is one that is delayed by seven to 10 years. This product, Livio AI, is directed to try to raise… You can either try to do a number of things to address stigma associated with hearing loss, you can try to make them smaller and cosmetically appealing, and we think we’ve done that with the package of this. It’s a good looking small device. You didn’t even know I was wearing it.

01:45 Paul Matzko: No, I did not.

01:46 Dr. Dave Fabry: But you can also do it by amping up the technology. Hearing aids, as we traditionally think of them, are stand-​alone devices that are designed to amplify sound to compensate for a person’s hearing loss. About four years ago, we were among the first to introduce a device that was connected directly between a smart phone and the hearing aid without an intermediary device. So we were able to stream crystal clear audio, whether it was phone calls, whether it was Siri, navigation, any app with any audio at all could be streamed directly from the phone to the hearing aids, making it a connected device.

02:20 Dr. Dave Fabry: Livio AI is the next generation on our journey as a company to move it into a multi-​purpose, multi-​function device. As you said, some of the things… First, we have to begin with the state-​of-​the-​art hearing aid to compensate for hearing loss, and that’s always going to be our expectation. We’re 50 years in the business. The next thing that we’re interested in doing is adding features that will be of interest to people like myself, I’m a baby boomer. My parents were concerned about things, health conditions such as cancer and cardiovascular disease. Hearing loss was sort of an afterthought, it’s really a disability in that many people, the older you get, the more likely you are to have a hearing loss. By the age 70, you got about a 50-50 chance of having some measurable hearing loss. And yet, many times when people go to see their primary care doctor they’ll say, “Oh, your hearing’s normal for your age.” I hate those words, because…

03:11 Paul Matzko: It just assumes that you’re gonna have that.

03:13 Dr. Dave Fabry: It’s assumed that you’re just gonna have to deal with it. And we say, now that the data show a couple of important things that lead into why we developed this product. First of all, that we know that many cardiologists will say that the ear in the aging individual is a good overall indication of cardiovascular health. The blood supply that goes to the ears and the eyes is very small, and when you start to have blockage or a risk of stroke and things like that, any cardiovascular condition, the blood supply to the ears and the eyes are often the first to go, and that’s why they show up in collaboration, in correlation rather, with cardiovascular disease.

03:52 Dr. Dave Fabry: So one of the things that we’ve looked at is the increase in obesity in the US. Physical activity is declining. So with that also comes conditions like diabetes, it’s elevated risk when you’re overweight. Cardiovascular disease, as I said, and hearing loss are correlated. So the first thing we did in this product, we put in a motion sensor that many people might be familiar with if they wear a Fitbit or an Apple Watch or some activity tracker, and we’ve incorporated that in the app directly on our product as a score that can be monitored every day. There are three components that may look familiar to you. Step count, we’re setting 10,000 steps a day, which in general serves as the default for most fitness trackers. We also want to encourage people to be physically active by doing exercise. A brisk walk or more. This motion sensor in the hearing aid can track the steps that you take every day, and whether you’re exercising.

04:47 Dr. Dave Fabry: And then the final thing is just simply getting or moving around every hour for even just a few minutes. It’s good for joints, it’s good for muscle. And so that part of the physical side of the equation is something that can be monitored directly in the instrument instead of having to have a secondary device.

05:03 Paul Matzko: Like a separate device.

05:04 Dr. Dave Fabry: A separate device. They’re already wearing their hearing aids and we know that they’re physically active, we can track it, we can record a score from zero to 100 every day. That’s the first time it’s been introduced in a hearing aid directly. We’re coupled also to Apple Health. But the nice thing is, is I have a dog. My dog likes to go for walks, I can just take my hearing aid, I can go for a walk, I can leave the phone behind, when I come back in range of the phone it’ll couple and it’ll update the steps, so I have no step regret, every step gets counted.

05:32 Paul Matzko: That’s good. It’s important when you are trying to get it to 10,000.

05:34 Dr. Dave Fabry: It’s important, yes.

05:34 Paul Matzko: That’s right, every one counts.

05:35 Dr. Dave Fabry: And then the other part, the fitness… First time in a hearing aid that we’re incorporating this motion sensor that can track steps, exercise, and movement, but then the brain function is really in response to research that has shown that untreated hearing loss in the aging population is correlated with cognitive decline. We know that people who previously if they didn’t have hearing loss earlier in life, they were active, vibrant, socially active, that as they start to have some difficulty, like the noise here at TechCrunch, they start pulling back. It can lead to… And data have shown that it leads to social isolation, even depression, and ultimately cognitive decline. Now I’m not here to say that hearing aids will prevent dementia, but we know that the longer people wait after being diagnosed with a hearing loss to doing something about it, the greater the risk for actually expediting that cognitive decline. And so what we’ve done is we’ve built in the other side of this THRIVE score, the wellness score, in the app that can be viewed and monitored by the end user, by the patient, is first use.

06:40 Dr. Dave Fabry: We know that the more people use their hearing aids that compensate for hearing loss, the better they’re going to do. And when you think about it, your ears are really just a very sophisticated sensor, much in the way that your eyes are a sensor, your finger tips are a sensor, your tongue for taste is a sensor. Where you really hear is in your brain. They’re all feeding input into that, and so the brain is where the hearing occurs. And so we know the more you stimulate the brain by using amplification appropriate for your loss, the better your brain is going to be stimulated. The second element that we’re talking about is social engagement. We employ AI and machine learning in this hearing aid to constantly monitor every environment where the person is, and what it can determine is, is it a quiet or noisy environment? Is there speech present? Are they streaming a phone call or watching a television program? The most important stimulus that most of us hear on a daily basis is what? Speech.

07:36 Paul Matzko: Right.

07:37 Dr. Dave Fabry: The human voice. We can monitor that and log that when a person is around and engaged in conversation with other humans. We’ll total those up and give a point total each day for the engagement that they have. And then the final piece is what we call active listening. In this case, we want them to wear their hearing aids, talk to other people and get out in the world. Wear their hearing aids everywhere they go, wear them when they’re at TechCrunch, when they’re in challenging environments, wear them when they go to a restaurant and gym because, two things, one is they’ll begin to see how much better they’re going to do in those situations. And then it also allows the hearing aids to be optimized by their professional or even to a degree within the app by themselves. They have some capability of customizing the function…

08:23 Paul Matzko: Nice, yeah.

08:24 Dr. Dave Fabry: To their liking. But most people still…

08:27 Paul Matzko: Rather than having to go manually and [08:29] ____.

08:29 Dr. Dave Fabry: Yeah, they can adjust it so that it can operate pretty automatically the majority of the time. But that in turn, we also have incorporated a telehealth feature in here that we’re calling Hearing Care Anywhere. If I’m at a difficult listening situation like this, I can actually initiate a request that goes to the cloud and that my professional will notice… They receive a request that says, “I’m at TechCrunch and I’m having trouble hearing male voices.” They can in turn send an adjusted setting without me needing to go always back into the clinic for adjustment.

09:03 Paul Matzko: That’s more convenient, yeah.

09:03 Dr. Dave Fabry: We’re not… We’re trying to make it convenient for the professional and the clinician by enabling this telehealth, which we think is a large part of the future, because even though people can adjust themselves, most feel most confident in the hands of the professional.

09:17 Paul Matzko: Right, right. Sure.

09:18 Dr. Dave Fabry: The other thing that we’re really quite excited about in this case, and first again for the hearing aid market, is realtime translation. So, my wife and I were just in Paris last week, and my high school French can only take me so far.

09:32 Paul Matzko: [chuckle] That’s right. [09:32] ____. Bonjour.

09:32 Dr. Dave Fabry: Yeah. Yeah, exactly. And so what we do is we incorporate a realtime translation feature in here that can go both ways. I found it very useful. Two ways, one is if I’m in a situation where you’re a native French speaker, you want to speak to me and I wanna be able to understand it. There are lots of translation type products on the market, but what this does is if you speak French into this, it will translate into English, the language that I understand, acoustically to my ears, amplified for my hearing loss. So, it’s discreet and only I hear the translated sound. The other way that I found it quite useful to polish up on my high school French, similar to some of the other language training programs, is that if I just switched the direction, so I go French to English then if I say, “Where is the bathroom?” and it will go, “Où est la salle de bain”, and it’ll give me a pronunciation guide acoustically discreetly, and then I can use it to coach myself to improve. But we’re really excited about that and we’ve had terrific response from the translation.

10:37 Paul Matzko: Does it used like a Google Translate? What’s the service it’s using?

10:40 Dr. Dave Fabry: It’s using a number of different AI services that we’re putting in and embedding with that. We can translate 27 languages right now. We really don’t wanna hitch our wagon to one or the other, but we wanna be able to take advantage of that machine learning, of that AI, as those improvements continue to work we’ll develop our own and collaborate with others.

10:55 Paul Matzko: That’s really exciting. So, you’ve got a translator in your ear, you’ve got a fitness tracker in your ear, a health, mental, and cardiovascular health medical device in your ear. Something else I saw on the product list was geo-​tagged adjustments.

11:15 Dr. Dave Fabry: Yeah, yeah.

11:16 Paul Matzko: I thought that was actually a cool feature.

11:17 Dr. Dave Fabry: Yeah, and that was what I kind of showed you in the sense, like here I could go in here, I can use the GPS that’s embedded in the phone so that I could tag this location, and so that when I return to this situation, it will remember the settings that I made. Another feature that is quite useful that also uses that geo-​tagging is one we call “Find My Hearing Aids”. This will show that my hearing aids are connected to the phone and exactly where we are right now in the Moscone Center, and even kind of a divining rod that shows how close the devices are to the phone if I happen to leave them behind.

11:49 Paul Matzko: So inevitably, those times when you think you forgot them at home, they’re actually in your pocket, now you’ll know.

11:54 Dr. Dave Fabry: Exactly. My mind… Yeah, I’m working on that cognitive at times. We also have gesture control that motion sensors, so I can tap the side of the hearing instrument and enable streaming from a remote microphone, or from a TV device, very natural user interface without having to fumble for the controls.

12:13 Paul Matzko: That’s great, Yeah. Now, one last piece here. So I know a lot of our listeners are gonna be millennials, Gen Z, Gen X. So they’re not thinking about the hearing aid functionally of this. So they should be, because again, like you said, 50-50 by the time you’re 70. So it’s gonna come for us too, inevitably. Do you see a future? Maybe this is not specifically for the Livio or for Starkey, but do you see a future in which some kind of hearing aid style device, or really just headphones that does a lot of the same functionality is something that we all just wear all day long, whether or not we have hearing loss?

12:50 Dr. Dave Fabry: Well, and I think it’s a very important question you raised, because right now there’s a stigma associated with hearing loss and hearing aids, and only about 30% of the people with measurable hearing loss actually wear hearing aids. What I’m finding with the baby boom generation like myself is, I’m less stigmatized by hearing loss and hearing aids, but I have higher expectations that they’ll meet my needs or exceed my expectations. And we think this device is a first step towards that. And to your point, I’ve been wearing these devices, even with very minimal hearing loss for about the last three months. No one even knows that I’m wearing them, and if they do and I explain what they do, they say, “How do I get them? I don’t even have a hearing loss, and I wanna get them.”

13:28 Dr. Dave Fabry: The issue that I see, think about the way… And I’m old enough, I’m a lot older than you. Computers, we used to have the entry point into the computer was through the keyboard, then we had the mouse, now we have touch display, now we have voice. Think about Siri, Alexa, think about all of the aging population and the fact that they may have some hearing loss, but want to use that front-​end, natural user interface of a voice. That’s where we think the big opportunity is, is that it’s the entry point into the World Wide Web, into the CPU of the computer, into your phone. And that we think has a lot of appeal, not only for people with hearing loss, but for everybody.

14:07 Paul Matzko: Yeah, well, wonderful. Dr. Fabry, thank you for taking the time to talk to me.

14:10 Dr. Dave Fabry: My pleasure.

14:10 Paul Matzko: I appreciate it.

14:10 Dr. Dave Fabry: Thanks very much.

14:11 Paul Matzko: And good luck with the rest of your TechCrunch Disrupt.

14:13 Dr. Dave Fabry: Thank you.

14:13 Paul Matzko: As it so happens, news recently broke that Starkey will have two major competitors soon. Apple and Google have announced that they are forming partnerships with other hearing aid companies. Now, if you think about those air pods that Apple likes to promote, it’s a pretty good foundation for something that sits in your ear and amplifies sound, which at the end of the day is what a hearing aid is. The question is whether companies that make headphones can develop the medical device aspect more quickly than the medical device makers can develop the multifunction stuff. So it’ll be an exciting race, but the fact that there are so many entrance into this space goes to show you that the hearing aid sitting in your ear that is kind of the future of wearable tech. Our next start-​up interview isn’t about making a medical device, but they are innovating how we, or more accurately, our pets, will get their medicine in the future. Listen in.

15:12 Paul Matzko: I’m sitting here with Arun Giridhar, who is the CEO and co-​founder of Pinpoint Pharma. Now, Arun, you have a medical device designed to allow the, maybe I should say manufacture, but the mixing of pharmaceutical compounds for animals, for pets. Is that right?

15:31 Arun Giridhar: Sort of. We don’t think of it ourselves as a medical device, we are primarily a compounding pharmacy for veterinarians, except that we are a 21st century compounding pharmacy. We make custom medicine for pets on demand. What’s different about us is that we have a proprietary printing technology that is much more efficient, much more precise, and much more rapid than traditional compounding pharmacies which largely do things by hand.

16:01 Paul Matzko: And that’s actually been an issue for pharmaceutical companies, or pharmacies, I should say, that are focused on compounding for humans, prescription drugs for humans. A scarcity of compounding pharmacies, especially in under-​served and rural areas. Is the same thing been true on the pet’s side, that a pharmacy that’s willing to do onsite compounding for pet prescriptions?

16:30 Arun Giridhar: I cannot speak about the human side because we are specifically focused on pet medicine.

16:35 Paul Matzko: Absolutely, Yeah.

16:35 Arun Giridhar: We find that the missing need is not so much rural or geography-​based, it is across the entire nation, in that many veterinarians are deeply aware that different pets need different kinds of medicines. For example, you have different species, even within the same species you have different body masses, and veterinarians are used to dosing, they are trained to dose in milligrams per kilogram of body weight, but the fineness needed to distinguish between an 8 pound cat, and a 12 pound cat, or even a 40 pound dog and an 80 pound dog, often that gets rounded to the nearest available off-​the-​shelf product. And in that sense, a veterinarian is familiar with the need to do custom dosing, but many times they are not able to get the service they ideally should have. And that’s where we believe that we can step in.

17:28 Paul Matzko: So is that a function of… The difference between an 8 pound and 12 pound cat is half as much, again, body mass, whereas for a human being precision is important, but the difference between a 200 and a 202 pound human is relatively slight as a percentage of total body mass.

17:44 Arun Giridhar: Partly, partly. But speaking a little bit about humans, because we did speak with a lot of doctors, pharmacists, nurses, and other people. So far we’ve interviewed close to 250 people to get an idea of where the problems are. On the human side it’s not just a function of body mass, it’s also about, for example, a newborn, neonatal medicine is extremely different from normal adult medicine. So they need far tinier doses. A nurse once told me that the stomach capacity of a newborn human is about seven milliliters. So if you are off by point one mL, it can make a fairly big difference, in that that’s the entire stomach capacity. So how do you dose appropriately, how do you do that? Same thing with older people, geriatric medicine. If someone has partial organ failure or metabolism issues, they are going to process medicines differently. Now having said all that, these are all things we learned when we spoke with the 200 plus people that I mentioned, across the entire ecosystem, but we have chosen to focus on pet medicine because that’s where we believe that there’s a cleaner market. There’s also a more knowledgeable population that’s already familiar with custom medicine based on body mass and individual factors.

19:05 Paul Matzko: We’ll get to that cleaner comment here in a minute, but I’m pushing us ahead of ourselves. First, how does this system actually work? So walk me through, on the ground level there’s a pharmacy that is working with you guys. I come in asking for a particular medicine that needs to be customized to me. How’s that process gonna look?

19:30 Arun Giridhar: We are catering straight to veterinarians, so I’ll tell you how the process works…

19:33 Paul Matzko: No, sorry. For the animals, yeah.

19:34 Arun Giridhar: Right, from the veterinarian. Let’s say you take your pet to the veterinarian, they decide this is the medicine this specific pet ought to have. It can be… Let’s say that you have a 12 pound cat, it’s slightly heavier than average cat. Now, your veterinarian is going to use their knowledge to figure out how much medicine this cat needs, in what form, whether it’s oral or not, and if it is oral, what flavor. And those things can all be customized. There is as much variation across pets as taste variation across humans. What works for one pet doesn’t work for another.

20:08 Arun Giridhar: The veterinarian then goes to our website and places an order. They say, “Make this medicine in this many milligrams per dose, this many doses, in this product form.” Whether it’s oral or not, and if it’s oral it can be pretty much any form. Whether it’s liquid, solid, chewable, all that. If it’s skin absorbable, they specify that. And we pretty much print that medicine. What our technology does, it’s kind of like an inkjet printer for medicine. It’s how a regular inkjet takes liquid ink and puts it on blank paper, that’s your final product. We take liquid medicine and put it on blank substrates. So the substrates are just inner carriers, but the medicine is added to the substrate in perfect concordance with what the specific patient needs. That’s where the thing comes. And once we print it, which is a pretty rapid process, we just ship it straight to the client. That would be the pet owner in this case. So that’s how it works.

21:02 Paul Matzko: Oh okay, thanks. So it can then at that point bypass… It doesn’t have to go to the veterinarian’s office first and then to the patient, it can go straight to the patient at that point.

21:10 Arun Giridhar: Yes. We did offer the choice to veterinarians that we can ship it to you and you can give it to the patient or however they wanted to do it, but they expressed a preference for shipping it straight to the client. That way the client does not have to make two trips to the veterinarian’s office.

21:24 Paul Matzko: Yeah, more convenient.

21:24 Arun Giridhar: Convenience, yeah.

21:25 Paul Matzko: And is that something that can be done? You can order it one day and by the next business day have it express shipped to you? What’s the time frame for that?

21:34 Arun Giridhar: It depends on how far away they are from us. We can print it pretty much right away, in that the speed of what our process does, we can very easily make more than one dose per second, depending on the volume of medicine in each dose. It’s analogous to how if you’re printing monochrome, like just text, it comes out pretty rapidly out of the printer, but if you’re printing something graphic, it comes out a bit more slowly. So it depends a little bit on how much medicine is in each dose, all that. But we can print it right away, and we can ship it same day, so that the client can get it anywhere from overnight to two days out. That is what our business model is.

22:17 Paul Matzko: Now, with prescription printing like this, did you have a background on the printing side, or on the medical side, on the… What was the background that brought you and made you interested in this field?

22:36 Arun Giridhar: My background is in Chemical Engineering, I’m a PhD in Chemical Engineering, that’s been quite a while ago. But my entire professional career I have spent in pharmaceutical production, at both at the larger scale like half a million tablets an hour, as well as what we are doing in the custom medicine, and things in between, and about 50,000 tablets now, that kind of scale. It’s not really so much about my background as we just found where the need was, and I personally decided to apply my engineering background to where we believe the problems were. We collaborated with pharmacists, we have collaborated with medical doctors on the human side, as well as veterinarians. So it’s an interdisciplinary effort all in.

23:24 Paul Matzko: That’s really… I think it’s neat to see these different fields coming together. You’ve got the printing tech, you have the need for chemical engineering, and dosing, which obviously is the medical side, and I think it’s a neat confluence of fields. This, I think, is a good time to talk about the animal, human side. And my understanding is that it actually would be no more complicated to print pharmaceutical drugs for humans. So it’s not a degree of difficulty, of technical difficulty question. It has to do with the messiness of our health insurance system and regulatory approval. Can you walk us through that?

24:05 Arun Giridhar: Partly, yes. We had a variety of conversations with people across the ecosystem as I mentioned, and from a technological perspective, there’s nothing preventing us from printing custom medicine for humans. The issue was that… I had mentioned earlier that the animal side was a lot cleaner, and what we found was, on the animal side the people who are paying for the service are the pet owners, and they are also the people who directly visualize or witness the problem. It is very closed and localized in that sense, whereas on the human side, for example, we have great benefits in the precision of our medicine, in that we can get sub-​milligram level dosing, which is currently completely unheard-​of. So this can easily benefit neonatal care, or geriatric care, or people who are using things like warfarin, where the difference between two milligrams and three milligrams is the difference between therapeutic and overdose. One will land you in the ER. Things like narrow therapeutic index, ’cause there’s a variety of drugs, there’s a variety of patients for whom our high precision printing process will really benefit. However, the patient, we found, is the beneficiary. The doctor has to do something slightly differently, in that veterinarians are extremely used to doing things on a milligram per kilogram basis, on the human side the guidelines are not milligram per kilogram that often.

25:31 Arun Giridhar: Many times it would say something like, “Adults take take 20 milligrams, children below 12 take 10 milligrams.” It is already discretized in that sense. The third thing is, on the human side the majority of the time it’s the insurance company that pays for the medicine. And it was not clear what their incentive was. So the payer was different, the person writing the prescription has to do something different, and the beneficiary doesn’t pay, just sees the effects without having to do anything. It was a very complicated system on the human side, with the sales cycles being very long and protracted. So we decided, as a start-​up we are not going to mess around with that. We are always open to dealing with human medicine as a different vertical in the future, but we chose to focus all our attention on pet medicine, because there the problem was much more well defined, people already knew that they were not getting the exact fineness of the dosing that they needed.

26:30 Arun Giridhar: Plus, there was a huge, huge problem on the veterinary side in terms of patient compliance. This is something that humans can, for example, swallow a bitter pill, literally. You can just grin and bear it. Your cat will spit it out. First of all, if your cat is small, or if your dog is a smaller thing, you often have to buy something off the shelf and you have to subdivide it into four pieces, two pieces, four pieces. You might be doing that by hand, not all tablets are pre-​grooved, and you might not get the same amount in each quarter of a pill. You might get only three pills, the fourth might crumble into powder. You try to get this to a cat, and now it claws you, because it doesn’t want to take medicine or…

27:17 Paul Matzko: Because it’s a cat. Let’s just be… [chuckle]

27:18 Arun Giridhar: Or it might take it, but then it spits it out. So now you have… You are scratched and bleeding, the cat has spat its medicine out, there is this white foaming mess on the floor, and you don’t even know whether you gave the right dose to start with. On the animal side, therefore, it made… There was a lot of pain in getting animals to voluntarily take medicine. So we believed that customized medicine there, it’s not just about the dosing levels, it’s about if we can make something that the cat voluntarily wants to take, it will really simplify the lives of pet owners everywhere.

27:57 Paul Matzko: Does this mean using a different substrate that’s more appealing, tastes better to the animal? How’s that?

28:05 Arun Giridhar: It’s a variety of things, in that… I did mention pharmacists had told us that tastes vary with individual animals as much as it varies with humans. So they do not have the knowledge ahead of time to make something that will appeal to all cats. But we have the ability to tune the flavour to the individual animal. We also have the ability to tune the carrier form. For example, it can be a solid that the cat takes by mouth, but if the cat absolutely is recalcitrant on that, we can put it in another form, depending whatever the veterinarian tells us to do, we will do it, unless it’s something… We do not question the veterinarian, we completely trust the veterinarian on how any many, how much medicine this cat needs. The only reason we might push back is if something just doesn’t make any physical sense to us, we might say, “Hey, did you confuse milligrams with grams?”, or something like that.

28:57 Paul Matzko: Sure. Something on the…

28:58 Arun Giridhar: Order of magnitude, yeah. But other than that, we trust the veterinarian to know what they’re doing.

29:05 Paul Matzko: So in theory, a veterinarian could say… Is this sort of thing where they could ask the owner of the pet and say, “What’s a flavor you pet likes?” They’re like, “Tuna flavor, they like chicken flavor,” they find out, they put in the order, “Make this tuna flavored and make it in a liquid form so they can use an eye dropper to administer or something,” ’cause that’s how the owner says the…

29:28 Arun Giridhar: We can use data like that, yes. We are also planning to go one step further, in that we have these little sample packs of flavors that we can distribute to veterinarians ahead of time, and they can… Let’s say there are about five to 10 different flavors, you can feed it to a cat, or leave them all in front of the cat, see which one it takes after smelling it, and we just pick that flavor.

29:51 Paul Matzko: Oh that’s great, yeah.

29:52 Arun Giridhar: There are many ways to do this. There are many different ways, but the vision is that if a cat will voluntarily take medicine, in that our COO, for example, is a veterinarian by background. And her cat has given her trouble with going behind the couch and spitting things out, all that. But her cat is also very adept at telling the difference between a treat and a medicine.

30:16 Paul Matzko: Ah yeah. It’s smart.

30:18 Arun Giridhar: Just from the sound, just from the sound. So it can either come running to you expecting a treat, or it can run and go and hide in the closet. So the vision is that if medicine can be made in a form that pets will actually want to take, it simplifies the pet owners’ lives considerably. So about 10 to 15 minutes of struggling with the pet is now gone. That’s something we believe is worth it.

30:41 Paul Matzko: Yeah, no, anyone who’s a… Any pet owner, I think, especially someone that owns an intelligent cat, would appreciate not having to fight to get something down their gullet that they don’t want. Now on a cost comparison, how would this process compare? I know every drug is gonna have a different price point, so we have to speak in generalities here, but do you anticipate this costing more than the current prescription system, or where do you come out in the price point?

31:12 Arun Giridhar: There are two comparisons to make here. One is custom medicine versus off-​the-​shelf. In general, custom medicine is more expensive simply because you need the labor to do things by hand. However we believe… No, we are not comparing ourselves with off-​the-​shelf medicine, we are comparing ourselves with other existing custom medicine, and there we believe that since our process is a lot more rapid, we can turn things around more quickly. The economy of doing things more rapidly, we can pass on to the customer. To start with we are cost comparable with existing compounding pharmacies, but we believe that as we scale up in future the price savings can be passed on to the customer.

31:54 Paul Matzko: That’s great, yeah. Well that makes sense. You’re competing for a different segment of the market, you’re not really competing against the generic off-​the-​shelf. Well, that’s great to hear. Now maybe we can take it back to the… As I’m listening to this, and I own a pet so I appreciate the pet angle. Trying to get… I have a Greyhound, trying to get my Greyhound to swallow a pill involves pill pockets and coaxing, and again, you have to get them to believe that it’s a treat and not a medicine. So I appreciate the animal side, but part of me keeps thinking this would be really nice on the human side too, right? The ability to customize the medicine to make it a better fit, it’s better for you medically if it’s exactly calculated to your weight and to your particular situation. It’s more convenient, more pleasant of an experience, if you can adapt it so it’s not the giant pill, if you’re someone who has a swallowing issue. And there are people like that who have medical swallowing issues. So part of me keeps thinking it is striking to me that we’re doing that… In a sense, our pets will have this advanced production technology before their owners will. And that’s just very striking to me. So on the human side, what would need to change before you guys really seriously considered expanding into a human pharmaceutical space?

33:23 Arun Giridhar: That is an interesting question. We right now, the situation with the human medicine was not clear, that’s why we focused on the animal side. I would say a variety of things. First is, there are some doctors specializing in certain things, for example, pediatricians, neonatologist, geriatric medicine, certain disease combinations. Like if a person has, let’s say, an endocrine disease and cancer, like diabetes and cancer, they might be seeing an endocrinologist and an oncologist, but the drug interactions may or may not be on each other’s radar. It’s often the nurse or the pharmacist who becomes the final point of contact, and they have to figure out which of these things are going to interact. There is already some knowledge that custom medicine is needed, but the tradition seems to be that on the human side they start out at the base line, and of some medicine, you then go back to the doctor in about four to six weeks, and they look at whether you’ve have had too many side effects, or not enough therapeutic effect, they adjust the dose. It’s either high or low depending on what happened. Another four to six weeks later they might adjust the dose again. So it might take you about three months to hit your steady state, and the adjusting the dose would be something like subdivide a pill, which in many cases it’s not good because pills can be coated, or it might be take two, or take them more often, all kinds of discrete ways to do it.

35:00 Arun Giridhar: That we believe can be changed up front because this is not something we do inhouse at Pinpoint, but there are… We are aware of many people in the field who, for example, take your liver function test, your blood draw, or plasma draw, or just your genetic factors, or your doctor can use your entire medical history, use their judgment to say, “This is how much you need.” The issue there is, they might be able to calculate, “You need 7.35 milligrams,” or whatever the number is, but you are torn between a five and a 10. So even if they can calculate it, there is no mechanism right now to efficiently make what you need, other than existing compounding pharmacies, most of which is currently still done by hand. So that is one thing that needs to change, is that doctors and people writing prescriptions would need to become more used to writing things on a continuum, rather than discrete levels.

36:00 Arun Giridhar: On the insurance company side, if… Let’s say that the doctor needs to do a blood draw before they prescribe this custom amount. It is not clear right now who is covering the cost of that blood test. The blood test can be very rapid, it can be done right while you wait in the doctor’s office. It usually takes no more than half an hour from what I have read in the literature by people who have come up with tests like these. Again, it’s not something Pinpoint does directly. However, there was a stymie about who would pay for that, and this is not something a pre-​prescription blood test is not currently covered, or is not familiar to many insurance companies. That sort of education we believe might need to happen. All these things are completely bypassed on the veterinary side simply because they do milligrams per kilogram basis right out of the gate. So they are extremely used to it.

36:53 Paul Matzko: Well, hopefully, as the medical community writ large sees this working on the animal side, and this I’m convinced becomes a dominant way of doing compounding prescriptions for animals, they’ll start to make changes on the health insurance, on the medical, on the human medical side that makes it possible to port this over to human medicine. So, Arun, thank you for your time. Thank you for explaining what Pinpoint Pharma does. I think our listeners will enjoy hearing about this, and I’ll put a link in the show notes to your website so they can look at you in more detail.

37:30 Arun Giridhar: Absolutely, thank you for having me.

37:33 Paul Matzko: I’ll admit that when I first heard that this technology, which promises more accurate drug dosages at a lower cost was going to improve the lives of our pets and not people first, I got a little disappointed. It shows how lifesaving and life improving technology is being delayed for humans because the health insurance system is so tangled and messed up. But I’m glad that companies like Pinpoint Pharma are finding ways of rolling out this technology anyways. Even if it means that pups will have better pills than their people do. Now, I suppose our sign off is more fitting than usual today. As always, until next week, be well.

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38:16 Paul Matzko: Building Tomorrow is produced by Test Terrible. If you enjoy our show please rate, review, and subscribe to us on iTunes, or wherever you get your podcasts. To learn about Building Tomorrow or to discover other great podcasts, visit us on the web at lib​er​tar​i​an​ism​.org.