Podcasts about class ii

Matt is solo this week for an in-depth discussion on spray foam insulation, focusing on the differences between closed-cell and open-cell foam and the benefits of creating a conditioned attic space. Traditionally, HVAC systems and ductwork are placed in unconditioned attics in the South, leading to energy loss, duct leakage, and humidity issues. By using spray foam insulation at the roofline, homeowners can effectively seal and condition their attic, improving efficiency and reducing moisture problems.Matt highlights Owens Corning Ultra-Pure Natural Polymers closed-cell spray foam as his preferred insulation choice, citing its high R-value (~R7 per inch), low VOC emissions, excellent air sealing, and moisture resistance. Unlike open-cell foam, which can allow vapor to pass through, closed-cell acts as a Class II vapor retarder, preventing moisture accumulation at the roof deck. This is crucial in humid climates where improper insulation can lead to condensation issues, a phenomenon known as "ping pong water" that can cause long-term damage to the roof structure.For humidity control, Matt advises builders to install dehumidifiers or controlled air supply in conditioned attics to maintain proper moisture levels. He also stresses the importance of hiring experienced spray foam contractors, ensuring the correct thickness and installation quality.Another key topic is roof durability and leak prevention. Matt recommends using full peel-and-stick underlayment beneath metal or tile roofs for long-term water protection. He debunks the myth that spray foam prevents leaks, explaining that small, intermittent leaks can go undetected, leading to hidden rot over time.Tune in for everything you need to know (and more!) about spray foam insulation.Thank you to our episode sponsor Aquor Water Systems. Learn more at aquorwatersystems.com.Find Matt and The Build Show on the web:Build Show Videos: https://buildshownetwork.com/go/mattrisingerInstagram: @risingerbuild and @thebuildshowYouTube channel: https://www.youtube.com/@buildshowWebsite: https://risingerbuild.com/ and https://buildshownetwork.com/ Save the Date for Build Show LIVE 2025 in Dallax, TX: October 16-18, 2025! Don't miss a single episode of Build Show content. Sign up for our newsletter.

David James Clark, DDS, joins with Dr. George Schmidt during the latest podcast episode. Dr. Clark explains the art and science of monolithic injection-molded composite dentistry and talks about utilizing injection-molding of composites with modern preparations, super-anatomic clear matrices and heated multi-viscosity composite to solve so many problems without resorting to crowns. (Dr Clark is a speaker at AGD's upcoming scientific session in Montreal, July 9-12.) Dr. Clark is director of Bioclear Learning Centers International. He founded the Academy of Microscope Enhanced Dentistry, creates curriculum for dental schools and has lectured in 25 countries. He developed the Bioclear Matrix System for placement of biologically appropriate and esthetically pleasing direct composite restorations for facilitating injection-molding of the Clark Class I and Class II preparations, diastema closure, and black triangle elimination combined with papilla regeneration. The Clark Class I and Class II preparations and restorations are now being evaluated in in vivo and in vitro studies. He owns several patents. He published the first guide to dentinal and enamel cracks based on clinical microscope dentistry (16× magnification). Clark is a 1986 graduate of the University of Washington School of Dentistry.

Stephen Watkins, application engineering manager at Nilfisk, discusses the features and benefits of appliances for combustible dust and compares them to Class II Division 2 vacuum systems.

Send us a textLast month, the FAA announced changes in screening for color vision deficiency.  On this episode we discuss what pilots will be directly affected and address some of the common questions being asked right now by our patients and aviation medical examiners across the country. What tests will be allowed? What happens if my AME doesn't have one of the new approved computer-based color vision screening tests? What happens if I have a color vision waiver now with a Class III medical and want to move up to a Class I or Class II certificate?

On this episode of The Founder's Sandbox, Brenda speaks with Jane Zhang, CEO and Founder of Remmie Health about Scalable AI in Pediatrics. Jane progressed through her professional career as Biomedical Engineer, PhD Adjunct Professor, Big Pharma and it was upon living a very personal situation that she wanted be become a “builder": entrepreneurship was calling her.  Listen to Jane's podcast, as she shares where this whole idea of building something for the people at home to be able to examine, share, and, in the future - get assistance in identifying ENT diseases- became very important to her. Jane shares how she has built a product and services for at home examinations of the ear, nose, and throat and her real experience of developing a FDA approved Class 1 device, now in clinical trials.  Remmie 3 is a FDA-registered and CE Marked next generation intelligent otoscope designed for patients of all ages. You can find out more about Jane and Remmie Health at: https://www.linkedin.com/in/janeyzhang https://medium.com/@janeyqz/my-experience-with-my-sons-recurring-ear-infections-a-3-part-story-fdbc4ea0016e https://remmiehealth.com/   https://www.linkedin.com/company/remmiehealth/ Remmie was present at MEDICA 2024, the most important international fair dedicated to medicine and hospital technology. The event will took place in Düsseldorf, Germany, from 11 to 14 November 2024. https://www.ca-mi.eu/en/germany/01/2024/medica-dusseldorf-11-14-november-2024/ and at the American Speech-Language-Hearing Association 2024 ASHA Convention from December 5-7 in Seattle, Washington. https://convention.asha.org/       Transcript:  00:04 Hi, I'm pleased to announce something very special to me, a new subscription-based service through Next Act Advisors that allows members exclusive access to personal industry insights and bespoke 00:32 corporate governance knowledge. This comes in the form of blogs, personal book recommendations, and early access to the founder's sandbox podcast episodes before they released to the public. If you want more white glove information on building your startup with information like what was in today's episode, sign up with the link in the show notes to enjoy being a special member of Next Act Advisors. 01:01 As a thank you to Founders Sandbox listeners, you can use code SANDBOX25 at checkout to enjoy 25% off your membership costs. Thank you. 01:18 Welcome back to the Founders Sandbox. I am Brenda McCabe, your host. This is a monthly podcast in which I reach entrepreneurs, business owners, and I have as my guest, entrepreneurs and business owners, professional service providers, and corporate board directors who bring their own stories about building resilient, purpose-driven, and sustainable businesses with great corporate governance. 01:47 I want to assist entrepreneurs and entrepreneurs in building those scalable, well-governed and resilient businesses. And by bringing my guests to the podcast, they too want to use the power of the enterprise, small, medium and large to create change for a better world. We're going to tell stories in this podcast today. And my guest is Jane Zhang. She's CEO of Remmie and she's joining us here from the state of Washington. 02:17 Jane and I go back almost, I don't know, four or five years now. Jane was at the UCLA MedTech competition. She had just founded Remmie in 2018 and then actually put some bones around it and financing into 2020 was actually seeking external investment dilutive type. And I couldn't help. 02:46 but remember Jane's origin story of why she started Remmie. And we're gonna start with that. So Jane, I would love for you to walk down memory lane with me and go back to when we met in the campus at the UCLA MedTech. And what was your origin story? Yeah, Brenda, I really appreciate this opportunity and thank you for the great intro. It was. 03:14 It was unforgettable why I, every day I'm reminded of why I'm on this mission because my own son, who was a preschooler back then, had recurring ear, nose and throat issues, especially ear infections. It was basically nonstop. A lot of the weekends, my colleagues would ask me, what are you doing on the weekend? I'd be like, 03:43 My son is having a fever I'm taking next week off. So it happened four times. In the first year he went to childcare. And one of the times he had a high fever, we went to the ER and it took us four hours sitting there nonstop with his crying and screaming. And the other times we were referred to an ENT specialist who was about to put in ear tubes in his ears. And other times we were 04:12 misdiagnosed because he had air nose and hands with mouse disease where we were given antibiotics. I give him 10 days and he's still spiking a fever. It keeps on coming back. And the doctor said there was a it was a moment of revelation where this physician, my pediatrician told me, come, come take a look by yourself. I was like, what? Why? And he said the throat or the back of his throat was all white blisters. So this was not an air infection. 04:43 um who gave you antibiotics that was the question he asked me he said you should be able to look by yourself and why weren't you doing that i was like what really i'm a bio medical engineer by training by the way um especially in low resource setting diagnostics or like basically home home diagnostic kits um he asked me why aren't you looking by yourself i was like what am i supposed to look uh and with what 05:11 So that's where this whole idea of building something for the people at home to be able to examine, share, and in the future getting assistance in identifying ENT diseases became very important to me. Wow. So you had at that time been working 05:36 for a large pharmaceutical company. As you said, you are a biomedical engineer by training, and you just completed your executive MBA, I think at UCLA. So what made you make the jump? One thing is going to the emergency room with your child time and time again. You talked about your aha moment and how can I in a low resource, right? At home. 06:03 be able to actually diagnose and actually treat my child. What happened that made you want to actually become an entrepreneur, Jane? One thing is working on the research side, but becoming an entrepreneur, what made you do that? It was very, so it was like everything kind of lined up in a way, and it just, my background, I was an engineer by training. 06:32 I worked as a scientist, you know, like in all the way up to postdoctoral level research. And then I took a turn into getting more into product development, business development, and commercial operations, because I thought that was really going to help me broaden my vision of the my view of how things work, you know, that I'm basically a curiosity driven person. 06:57 And at that point, while I was working in a big corporate, in a pharmaceutical company, I was sort of getting more experienced in a commercial side of things. I figured I had two choices, probably one, two, actually three choices I was considering, right? Like one is to go back to research and become a faculty member. In fact, I did, you know, that was kind of my way of rethinking my whole, reorienting my whole career path. 07:25 Um, the other one was going to become an investor. Um, the third was to fund my own company and just go on this path of building things. Um, I, I thought, uh, this issue of my child's problem just really was hitting at home that this is, because it's after I talked to many people, I was not alone. I'm not the only person who's going through this. Everyone I talked to said, Oh my gosh, that was me. Um, 07:54 I was like, this is a big deal. It not only impacts your child's health, it impacts your productivity at the prime time of your life when you just had the child. And it was just like really hitting a home. I had to do this after a couple of years of hiatus in academics, in academia, as a faculty member of engineering in University of Washington. After completing my MBA, in the meantime, I decided being a builder. 08:24 an entrepreneur is the calling for me. Is the path, is the path to shift. Amazing. Talk to me about the number of ENT cases that you are addressing with Remy today. Talk to me about that. I guess a striking number was 70 million in the US, both adults and children. A year, right? And it's really fast. A year. Yeah. 08:53 suffering from some ENT diseases. And this is not just specialty disease that I'm talking about, it's every day. Like anything that you have when you have a sore throat, a painful nose or ear infection or cold and flu, it impacts these organs. The first line organs being impacted are your ENT, but it doesn't stop there, right? For children, it is very highly occurring. Like if you look at the number of children who go see ENT issues, ear infections alone is... 09:22 about 24 million a year, that's 80% of any children before the age of eight or three, they've already had one ear infection, not to mention 30% have more than three a year. And adults, like when you're thinking about, sinusitis, sore throat, strapped throat, how all these impact the overall population quite a bit. So what is the solution at that? 09:50 Remy provides. You're going to walk us through kind of the, it's AI powered ENT, so ear, nose and throat health platform. It has many components. What's the patient experience today that you're attacking and how is it going to look in the future? Walk us through the product, please. Yeah. I love that way of thinking and thinking as a patient or a user of any anything that we are providing. 10:20 So you already kind of heard my journey of nonstop sort of rotation in like a spinning wheel among pediatrics office, urgent care, ENT's office, and ER, right? And then over again for another episode, if it's recurring or chronic. The experience that we're trying to provide is along the line of how the disease progresses and how physicians examine. 10:50 a quadrant or like a progression lifetime along that line. What I mean is when you first have a pain or some sort of discomfort, you would want to, you know, a doctor when they examine you, they would check, they would look, they would look with a, right now they look with an otoscope, which is a glorified flashlight plus magnifier, obviously very, very high fidelity. 11:20 That's the first step. They look, they examine. And then the second thing they do is, well, obviously you have to be in person first with the physician, right? So there's no sharing per se, which we're trying to build towards is you can look, you know, if a doctor is using an otoscope, why can't the patient be taught how to use it? It's very similar to a thermometer in a way, except it's a camera. So, you know, if a physician is looking with their eye. 11:48 we can make it digitized as a camera for patients to use at home. And if you have to be in person today, you should be able to transmit this, whatever you're looking at or collecting over the internet in terms of sharing. And then the third step of the whole diagnosis journey is basically analyze. The physician kind of asks you how you feel, they aggregate a lot of information about you, who you are, what you're going through and your physical presentation of the symptoms. 12:19 that should also be partly supported by AI. So that's kind of what I'm working towards is, it's like a million doctors supporting every single physician, every, you know, one doctor being supported by a million in terms of the insights that's used to go into their diagnosis. And did I mention that the misdiagnosis rate is about 40% on any day? Misdiagnosis meaning either, you know, 12:49 you're prescribed antibiotics where you're not, you should not have been, or you're referred to a specialist where you should not have been, or you went to the ER, because you did not receive the care in time. I guess that's a broader sense of misdiagnosis, which means you missed the opportunity for diagnosis in the proper setting. So, but that's very prevalent in terms of misdiagnosis. So we like to support anyone who's 13:17 first examining the condition with AI tools, being a patient or a primary care physician. Before we get into the AI question that I have for you, talk to me about some of the communities that can benefit from the use of an AI-powered ENT device. Yeah. I. 13:46 The first thing that comes to my mind is home users, any general lay person at home who may not have the resources to see a physician in person. It could be someone who's lack of access in a way that they are in a remote area, lack of resources to pay for healthcare, or even lack of time. Someone who is working, who has a job but just doesn't have the time to. 14:15 to see a doctor. So I would think under underserved communities, population who are at lack of resources such as time, money, or you know, driving. You know, driving is a hassle for a lot of families and just anywhere at home. Anyone who is, you know, even I was talking to a bunch of undergrad, you know, college students are like, we're so used to just sitting on our couch and see a doctor. 14:45 That's possible. And that was really the key moment when I was sitting as a judge. The first time I actually was exposed to you, Jane, met you and heard about Remy, it was the possibility that digital health, right? I'm not having to go into a doctor's office. And the digital health to use preventatively, right? To prevent disease. 15:13 diseases to progress. I think, and then, you know, AI is just an added layer on top, so that truly was a moment when I thought everybody, well, at least there's 70 million cases a year of ear, nose, and throat, what this platform may offer for other disease areas where we don't have necessarily to go into the doctor's office. So it was fascinating. That's what brought us into this relationship. 15:41 So talk to me about, we've talked about the platform, where you're going, how it's offered. What has been your founder experience? All right, you decided you took a head issue and went back to the academic world. You really wanted to become an entrepreneur, started the company. You won a competition out of UCLA, I think business case. That's about the time I met you, right? Talk to me about how the journey has been in terms of 16:10 resources, the resources that you have received, non-dilutive funding, where are you on that path, and how many healthcare systems are currently either testing or looking into the use of Remy? That's a loaded question. So talk to me about the journey of financing and where the product is being used today. Absolutely. The journey is long and very, 16:40 full of support, you know, like that's, that's a very upfront, you know, support from my very early days where my MBA classmates kind of joined force on this project, you know, as in its infancy, the UCLA, which, you know, venture accelerator, which was my, you know, first founder, basically, we, we came out of the incubator, equipped to talk to the world about our business case. And we got 17:09 $33,000 overnight from the business plan competition, NAP business plan competition, and the early UCLA founders who just showing overwhelming support. And we, in fact, we sold our product, first 25 units of our, you know, the digital otoscope in the early days before we graduated and gotten our first 100K of investor check before we graduated. So, 17:39 That was when we had to fund the company because we need to find a place to park the money as students part-time. So this was all full-time working, you know, professionals part-time on a weekend going to MBA. And then I, the past just went really interesting because of the pandemic. There was an overwhelming uptake of virtual care. 18:07 telehealth services, institutions who are looking at this new modality of care. And all of a sudden it was like, there were like 800 telehealth companies in the US at some point and they were all of our potential customers. We started co-calling them and we're getting quite a bit of feedback. In fact, many of them were working today. We are working with Rocket Doctor, for example. They've gotten, they've taken over half a million costs in the past couple of years. 18:35 in terms of virtual care services. They have sites at pharmacies and enabled stations of remote care for people who are not accessing an office in person. We are working with five school districts in five different states and these are school districts which leverage Remy for all of their nursing rooms and introducing it to their students and parents. And we are working 19:05 So we got very strong non-dilutive funding. Actually early days we had seed funding from Platinum Play, we have seed funding from United Healthcare Accelerator powered by Techstars. We had in-kind support from CTIP, which is consortium for technology and innovation in pediatrics, which is a large innovation, hospital innovation consortia of, I would say that's growing, you know, 19:34 at least children's hospitals in the West and Midwest. They are providing enormous support, including clinical collaborations, partnerships, granting services, regulatory guardrail, they're FDA-funded. So now we're working with them in terms of a clinical study site in Lowery Children's in Chicago, which is one of our primary sites 20:04 testing out not only REMI, Otoscopes, but REMI-AI, funded by the NIH, which is National Institute of Health under the Small Business Innovation and Research Grant at 3.5 million so far. So overall, there was overwhelming support also from my state, I'm from Washington. So the Life Science Institute of Washington also kind of invested. And last but not least, 20:32 I have to mention TIE, T-I-E, which is an angel funding investor group that has given us enormous support in terms of networking, in terms of fine tuning the business plans, mentorship sessions. It just goes on. There are a few other investors that we've been working with and overall we've raised about... 20:56 4.75 million in non-delutive funding, non-delutive, and then about another a million in the deletive. So this has gone into a clinical study phase where we're looking at success outcomes in terms of technology readiness, validation of performance of AI clearance through FDA as a class two device in a couple of years. And then commercially. 21:22 being able to facilitate telehealth services already. In addition to allowing the patients to see and examine, we're enabling physicians remotely examine and prescribe. And in the future, assisting both the physician and the patients in terms of prescription and receiving the accurate diagnosis. I'm looking at the, heading the all, I guess, 21:52 health care or the goals of health care today, the five aims, I believe, at least, you know, cutting costs, improving quality, increasing access. Yeah, all of that. Amazing. And as of today, so you've raised about 4.75 non dilutive, you're no longer raising dilutive funding until you get through the clinical trials. When will that be happening? 22:22 The study with Children's Hospital, Lurie Children's is happening now actually, so it's underway. And we are looking at in a year that we will have some tangible, really good results in terms of both the patient satisfaction, physicians demand and performance of the technology. 22:50 And what is the desired outcome? Because I got really excited too, because this will be maybe not the first, but one of the earliest FDA approved Class II devices jointly with AI, correct? 23:08 Yes, that's a very hot topic right now in terms of the use of AI, the governance of AI, who benefits from it and who pays for it. Ultimately, the AI that we are developing would be augmenting the physician's decision making. 23:33 in the meantime, directly benefiting the patients because they can potentially receive pre-screening alerts and results faster and earlier before they go or even while they're waiting for the physician's appointments. So I would say that the outcome, first and foremost, is the satisfaction of the patient and the physicians. We would like to work alongside with, you know, really 24:00 key influencer in the medical field, medically validating the performance and understanding the bias of the data. What would it be if we manipulate bias at one way or the other in terms of the algorithm development, right? Whether or not we're collecting comprehensive population-based data, have we looked at cases of 24:28 one way or the other, you know, like in general, understanding the algorithm development and the AI readout. I think there's a lot of misunderstanding about AI these days, right? People generalize it to be generative. But AI has been a concept that is, you know, it was a different name back then. It was data analysis, it was imaging analysis, it was big data. For a while, the algorithm is evolving, the capability is evolving. 24:57 Um, the, I guess before one investor was asking me, what, how do you handle data hallucination or AI hallucination, which basically means the AI is starting to give out fake results, um, based on ungrounded, um, facts or cheating or lying to you. Um, and there's also another different kind of AI, which was data driven or validated. Uh, it won't tell you anything that you don't tell it. 25:27 to, you know, it's kind of limited or confined to a set of outcomes. For us, it is the former at this point, it's less generative. We understand the ins and outs of the data that's going in and we know why it's, you know, spinning out the results while we are the other on the outcome, on the output side. I would say generative has got a lot of potential, but within health, healthcare, we just need to catch up a lot. 25:56 a lot faster for it to be widely applicable. Currently, is it fair to say that Remy does have the largest database of imaging within ENT? 26:11 We are one of the top in the world. The data size as the use case grows, as the user base grows would be growing. The data are aggregating and being applicable to algorithm training in an aggregation basis or the identified anonymized. 26:39 It's an interesting part about the platform we're building is the users can benefit and they know what their, they benefit early, you know, rather than just being, benefiting from AI telling them what to do or assisting them. They're benefiting from non-AI capabilities of the technology, facilitating their visits, shortening their distance from their pain to a prescription, for example, or diagnosis. 27:09 already, early on. So we sort of de-risk the path to AI. And AI becomes more of a later phase. But it is definitely going to augment and assist the human journey all in all. Excellent. And so while sticking with the actual platform, and one of the third elements that I was particularly interested in when 27:37 we did invest from the Thai fund was the lack of the shortage of primary care physicians, and specifically even pediatricians in the United States at this time. Talk to me a bit about how as the tech, that platform of Remy builds out, will this enable doctors will it substitute doctors? What's the what's the how will this address this? 28:06 actually, it's tsunami that is now on us of this shortage of doctors in such a common disease area. Yeah, yeah. I definitely think that it is a tsunami coming at us just from my experience of having to book out. My wild child checkup is like four months out. I was like, by the time I get my son's appointment for his 11 years old checkup, he's 12. Yeah, so just to give you. 28:36 idea and then I got a letter from my in the mail saying that I'm quitting, you know, my physician is quitting real life, right. So I basically think that the AI will be enabling the physicians to free up their time, you know, from some non acute or issues that they so in the meantime, providing the quality of care that patients need not to sacrifice the quality. 29:06 to free up their time and become more efficient in a way. Especially I can think about ER avoidance, right? As a big use case for Remy and referral pre-screening, right? Specialty referral pre-screening, both of those, you know, are gonna free up quite a bit of our, you know, healthcare resources in terms of leaving them for those acute cases and really needing, you know, attention of the physicians. Yeah. 29:35 ER avoidance, basically you go, before you go to the ER, while you're waiting in the ER, you can perform a test or some sort of a visit with Remy using the Remy technology and specialties per screening. Per screening could be like, while you're waiting for the specialist appointments, which might be three, four months out, you can get the insights that you need already. So both use cases, I think, will free up quite a bit of our time. 30:04 both from pediatricians, nurses, mid-level providers, and specialists, EV doctors and specialists. Oh, Remy. Can you, for my listeners, talk about where they can find Remy today? 30:22 Yeah, we are, we're in, on Amazon, if you search Remy, we are website, remyhouse.com. We have a very convenient e-commerce, shipping and handling protocols. So you should be able to order on Friday, receive on Monday, for example, or even faster than that. And then we are, we are at your clinic. We're maybe at your clinic, maybe at your school district, we are working with a few of these. 30:52 physicians, clinics, there are logos on our website. If you're one of the patients of the clinics, you will get these at a discount, easily accessible rate. And if you visit us at the exhibits, in terms of commercial and marketing exposures, we are gonna be at Medica in Germany. That is next week, November 11th to 14th. 31:20 in Dusseldorf in Germany, we are part of the Washington State Pavilion to exhibit there. And then we are publishing, you know, academically we are collaborating with United, sorry, University of Southern California, USC in the speech and speech hearing and language pathologist community, especially in collaboration with USC. 31:50 We are publishing a poster there that's going to be December 5 to 7 in Seattle, Washington. Excellent. Let's switch to the founder sandbox. I'm passionate about working with company owners on their purpose, their scalability and their resilience. And I have a founder here in the sandbox with me today. 32:18 You're into what your sixth year of being a CEO. Tell me, what does resilience mean to you? Jane. 32:31 Oh my gosh, there are so many places you just have to hold on to. Hold on to the idea. I think first and foremost, it's something that you believe. There is some belief that this is there. You know, like it's worth your time. It's worth the effort. It's worth. Keep going. Right. So if you give up, it's it's probably you don't believe in it enough. Right. At some point, because of, you know, all the failures and problems that comes up. 33:02 Yeah, don't get me started. And then the belief is there. I think this is the future, the calling. It's historically inevitable, right? If it's Remy or someone else, it should be done, right? So that's my belief. And it's driven me every day when I wake up. And then when I think about resilience, I also think about when I'm fundraising, talking to investors, I get... 33:31 99% knows, right? And then 1%, yes. But does that mean that I'm not a good company, a good founder? No, it just means we're not good fit, right? Like investors have their own thesis, their goals to fill, their speed, stage of company, check sizes, everything has to meet perfectly. And even personality wise, those investors are gonna be with you for a while. You trust each other. 34:00 So that's fundraising. And then just keep going at it. And product wise, people say no to my product. Oftentimes for various reasons, customers are always right. Again, does that mean that I'm not a good product or services? No, the more I talk to them, the more nos I get, the more yes I will get as well. So again, that's sort of on the market research or understanding the general 34:30 target, you know, like as you're looking for the product market fit, you know, again, the keyword here is fit. And then the third piece is, is just just interpersonal, you know, like, people, oftentimes, I mean, like or dislike each other for a reason. And there's nothing wrong with, you know, knowing 34:56 knowing more getting more so I have a very big mentor mentor community I reach out to them every time I need an answer and they're just all willing to help that really helps with the mentality the the resilience as well you know I know I'm being supported I know I know people love me like my products are being loved my services are needed and my mentors really support me so that's that's what really helps with the positivity yeah excellent thank you for those four nuggets 35:26 your own words about what resilience means to you. Thank you for talking about your product and believing in the future of telehealth with Remy or not. It's very, very humble. And I loved, so the key word is fit, right? Fit with your investor, fit with your customers, what they're wanting, fit with the belief. Take that to the next. 35:55 question, fit or purpose driven? Are you fit for purpose? What is purpose driven enterprise? All right, so this this goes beyond the resilience to enterprise. Purpose driven, what's that mean to you? 36:09 I think I started the journey caring about sort of mental house of women, you know, that's like, you know, besides children's health, health, right. So, and I spent my whole journey, whole research doing underserved community health diagnostics, right. So I've been working on, you know, the 36:36 the worst diseases you can think about HIV, tuberculosis, these pathology pathogens, right? I was kind of in a class three bio lab, working while I was pregnant, tuberculosis. So you name it, right? Like any sort of crazy things that happen to people, I have really strong sort of desire to 37:05 help them or address it. Also something that's probably rooted in my family. You know, like I don't talk about that a whole lot, but my dad came out of sort of this pure poverty, right? Like he, my grandpa was a shepherd and he sort of, I guess long story short, my dad was also kind of a, would be a beneficiary of Remy. He had a perforated eardrum because he listened to 37:34 English radios too much before he came to UK for study, you know, as a first generation college student from his family. So nowadays he still has a deaf ear, right, like perforated eardrums. So I'm still thinking, you know, is there something I can do for him? But overall, I felt as a, like, just to echo where I started in the beginning, you know, as a woman in the prime years of, you know, career. 38:04 you know, where I wanted to be, you know, I was earning good money, I was having a good corporate job, I was caring for my child, you know, which really kind of pampered my productivity at work. I think that's kind of an issue that nobody really talks about because everybody wants top performers, you know, like you need to be working when your child is sick or something like that. But, you know, overall, it's kind of 38:30 issue that's there and near to my heart as women and children's health, especially for underserved communities. Thank you. Thank you, Jane. 38:41 Wow. Scalable growth. Take that resilience plus your purposefulness and scale it. Is it truly what the platform will become scalable? What does scalable mean to you? 39:11 how, you know, help the physicians in a way. You will, I will scale really well if I can, you know, bring benefits to ease their work, ease their stress at work. There are patients coming in, they're getting text messages from the patient, hey, what's going on with me if I can see this image? I was like, that's crazy. Like, how do you respond to that, right? Like in a way that polite and shows that you're a human, you care, but if you get 300 of those a day, how do you... 39:40 How do you do that? And then they say, oh, they send them to my charts. Again, that's losing or like the patient just waiting. How do you address this mismatch of having physicians providing care at top quality and efficiency while being a human to the patients and then the patients are satisfied and getting the needs met. I'm trying to make my story. 40:10 or resonating with physicians that they can be, just to give you an example, right? A physician mentioned that 50% of my, this was a specialist who said 50% of the patients who came to me should not have been in my office because I wanted to help those who can, they need me for a procedure most of the time. If they come to me for diagnostics confirmation, I could have done that. 40:40 with their information gathered in front of me already, before they come. So that's kind of the point. And it's almost like whenever they're open or free, aggregating physicians time across all these physicians who have time, whenever they have time to care for patients aggregated across all these issues, whenever they have an issue, we're trying to build sort of a bridge 41:11 the aggregation would really help address the problem of mismatch of asynchronous visits or waiting and not getting the answers. I don't know if that's too abstract. No, I get it. And you know what? Kind of along the lines of purpose, your purpose, caring about mental health for mothers, you also by the adoption of Remy Health in settings with the patients using it from home. 41:41 or being screened early on, you're clearly affecting the mental health of our caregivers, our physicians. And we do know that tsunamis here, there's a high level of attrition. Doctors actually just quitting. And if through tech enabled or AI powered, intelligent aggregation of data informs the decisions to reduce number of visits. 42:10 or have them more productive while in the setting, the clinical setting can move the needle, so be it. So thank you, Jane. This has been absolutely an amazing interview. I have one last question. Did you have fun in the sandbox today? Yes. 42:33 Absolutely, Randa. I really, really appreciate the opportunity. It's wonderful to every time I talk to you, it's wonderful, but especially interesting when we're like in this setting and you know, podcasting to more to a greater audience and really appreciate what you do for the community. Thank you. Thank you. So to my listeners, if you'd like this episode with Jane Tseng, CEO of Remy, 43:03 resilience and scalable and purpose-driven life story, as well as the origin story, as well as the product. Remy, sign up for the monthly release where founders and business owners, corporate directors and professional service providers provide their own stories on how to build with strong governance, a resilient, scalable and purpose-driven company to make profits for good. 43:32 Sign off for this month. Thank you for joining us.    

How can cutting-edge air decontamination technology reshape healthcare and reduce infections? In today's episode of Tech Talks Daily, we explore this question with Dr. Deborah Birx, Chief Medical & Science Advisor at ActivePure Medical and former White House Coronavirus Response Coordinator, and Amy Carenza, Chief Commercial Officer at ActivePure. Together, they discuss how ActivePure's innovative technology is transforming air and surface purification in healthcare and beyond. ActivePure's advanced photohydrolysis technology, built on principles originally developed by NASA, replicates natural outdoor air purification indoors. Unlike traditional cleaning or filtration methods, this FDA-cleared Class II medical device offers continuous protection in occupied spaces, achieving remarkable results: a 96-99% reduction in MRSA and a 70% decrease in total healthcare-associated infections (HAIs). Dr. Birx and Amy explain how this breakthrough technology deactivates pathogens in real time, effectively filling the gaps left by manual cleaning processes. The conversation delves into the broader implications of ActivePure's solutions, from reducing hospital stays and improving healthcare outcomes to applications in food production, energy-efficient air management, and even residential use. Dr. Birx shares insights from recent studies, including findings published in PLOS ONE and the Journal of Infection Control, which highlight the technology's safety and efficacy. Meanwhile, Amy Carenza discusses how ActivePure is driving innovation to meet operational, quality, and sustainability goals across various industries. As we look to the future, the discussion touches on upcoming advancements in infection prevention, particularly for multi-drug resistant organisms, and the potential for ActivePure's technology to align with efforts to reduce chemical exposures and improve overall public health. How do you see air decontamination technology shaping healthcare and other industries? Join us for this fascinating discussion and share your thoughts!

Voicemail: 951-292-4377;  Split Hand Poker;  Class II gaming;  Lower payouts on craps prop bets;  Low-roller advice for a high-limit craps table

Quick Summary: In this episode of the Vet Dental Show, Dr. Brett Beckman shares practical advice for veterinary dental teams. Topics covered include using mouth gags during surgery, managing incisor extractions, handling complex tooth extractions, and using tools like the Vetome. Dr. Beckman also discusses the importance of choosing appropriate methods for specific malocclusions and the pros and cons of referrals versus in-house procedures.     Guest, Cast, and Crew Information: Host: Dr. Brett Beckman, Board Certified Veterinary Dentist Guest: None Sponsored by: IVDI      Main Talking Points: Using syringe barrels as mouth gags in different-sized animals. Tips for incisor extractions and dealing with difficult suture closures. Managing extraction of complex teeth, especially lateral incisors. The value of the Vetome tool for easy extractions. Treating class II malocclusion with mandibular canine extractions. Why the mandibular second molar extraction can be particularly challenging.     Interesting Quotes: "When it comes to extractions, slow, deliberate movements ensure better control and prevent fractures." "The Vetome has been a game-changer in how we approach extractions—efficient, precise, and effective."     Timestamps: [00:00] – Introduction and overview. [01:10] – Discussion on using mouth gags and practical techniques. [04:05] – Tips and tricks for incisor extractions and managing dehiscence. [07:30] – Importance of the Vetome tool for easy and efficient extractions. [10:20] – Treating class II malocclusions and mandibular canine extractions. [12:50] – Managing the mandibular second molar extraction challenges.     (Veterinary dentistry, mouth gags, tooth extraction, incisor extraction, Vetome, dental surgery tools, class II malocclusion, canine tooth extraction, veterinary dental procedures, periodontal disease)     Key Points Summary: Use syringe barrels as mouth gags for different animal sizes, ensuring comfort. Avoid flaps in simple incisor extractions; they often lead to dehiscence. The Vetome is an invaluable tool for efficient extractions in challenging cases. Class II malocclusions can be treated with mandibular canine extractions if other treatments are not viable. The mandibular second molar presents specific extraction challenges due to its deep placement and thick bone structure.     Affiliate & Sponsor Links: Link: IVDI.org/inv  

Ever wondered how to pivot from general dentistry to a specialized practice that truly excites you? Join us on this episode of Dental Practice Heroes as Dr. Paul Etchison chats with Dr. Dan Briskie and Dr. Taher Dhoon from the Colorado Surgical Institute. We share our personal journeys and insights on transitioning from routine procedures like Class II fillings to focusing on more complex and fulfilling work, such as orthodontics and veneers. Dr. Dune reveals his fascinating path from corporate dentistry to owning his practice, highlighting the significance of continuous education and the integration of specialized services like single implants and full arch surgeries. We also discuss strategies for maintaining patient trust and ensuring smooth team dynamics during this transformative journey.Text us your feedback!Please leave a review on whatever app you are listening on! It only take a moment and would make such a difference to our growth!Join the DPH Hero Collective and take your practice and your life to the next level! Access to over 37 hours of training videos for you and your team. Access to every document, checklist, protocol, and system that Dr. Etchison uses in his practice. Weekly live content, live webinars, office hours, hotseats, group coaching sessions Access to a community of like minded Dental Practice Owners helping each other succeed! At DPH, we don't coach you on anything we haven't personally accomplished ourselves. We provide: One on One Coaching for Doctors, or Doctors and Teams Group Coaching Programs for Teams Minicourses on every practice management topic you need to know Team Coaching for your Front Desk Exactly what you need to level up, whatever level of practice you are at. Visit www.dentalpracticeheroes.com to Learn more, and check out our new 7 Phase OmniPractice Total Team Success Program to learn how to systematize your office, all while creating a leadership team to help you manage it all.

Mallory Hacker is an Assistant Professor for Neurology in the team of David Charles, who is Professor of Neurology, Vice-Chair for Business Development and Strategy, as well as the Medical Director for Telehealth at Vanderbilt University Medical Center in Nashville, Tennessee. In 2006, after a stay at Alim Louis Benabids team in Grenoble, France, David started to investigate the question of whether subthalamic DBS could lead to slowing of motor progression in patients with early stages of Parkinson's Disease. In a one-of-a kind trial, he collected data on the first patients which were published in 2014.In subsequent follow up trials, many of which were first-authored by Mallory Hacker, Class II evidence that supports this hypothesis could be established. It was a great joy to host Mallory in my lab in Berlin in 2022 and we have looked at the effects of lead locations on patients enrolled in the pilot trial. This is what convinced me that there might be something: The few patients that did not progress at all in their motor symptoms after two years were all precisely stimulated at the optimal location within the STN, while the ones that did progress, were more off target. Indeed, these same optimally placed patients had lower stimulation amplitudes and received less medication – but still had a clearly better outcome. Since the original trial, David and Mallory have been hard at work in trying to secure funding for a phase III pivotal trial, and we discuss how difficult this process has been, but also, that there is hope on the horizon, regarding the next steps!

About the show In the first half, Dr. Joel Wallach addressed the human body's ability to achieve healing through natural remedies that aid in the recovery from chronic conditions that plague Americans today. Referencing biblical figures like Adam, Noah, and Methuselah, who were said to have lived for hundreds of years, he connected their longevity to the notion that they inhabited the "land and milk honey." Wallach suggested that this milk was "glacial milk"-- ground-up rocks at the top of glaciers that released white silt, heavy in minerals that flowed into streams, which the biblical-era figures drank, and this greatly increased their lifespans. Wallach announced the publication of his new book on metabolic syndrome (related conditions said to increase the risk of heart disease, stroke, and diabetes). About 1/3 of American adults have the syndrome, he reported, but rather than a genetic problem, he attributes it to nutritional deficiencies and not avoiding the "bad stuff," which he listed as fried foods, processed meat, oils, gluten soy, wheat, barley, rye, oats, buckwheat, sugar, and carbonated drinks. In response to a caller's inquiry about Bell's palsy, Wallach said he believes the condition is due to the cramping of a cranial nerve from osteoporosis and can be reversed with the proper nutrients that rebuild the myelin in the brain and spinal cord. ------------------ Chemist Steve Colbern, who specializes in materials science, says that he and his wife displayed evidence of being visited and implanted by the alien Greys. In the latter half, he shared his research about Mars-- he believes that plant life and past civilizations on the Red Planet have been covered up and also updated his work with the late Dr. Roger Leir, whom he initially contacted for the removal of an alien implant in his toe. Regarding Mars, Colbern asserted that evidence for plant life has been seen clearly in the Orbiter mission photos, as well as huge trees near the planet's south pole. In the rover photographs, there's what looks like foundations of buildings, as well as metallic junk and crash debris, he added. One Roper poll reported that about 3% of the public has been affected by alien abduction at least once, and according to Colburn's research, about .1% of the population "are Class II experiencers that are actually part of the alien program." Hybrids are the primary purpose of the program, he continued, though abductions seem to be decreasing in number. The hybrids, raised aboard their ships, look mostly indistinguishable from regular humans, he noted, and the Greys' agenda is to use them to repopulate our planet after a devastating war or pandemic. "But they're not going to do anything to us; they're going to wait for us to do it to ourselves," Colburn clarified. He shared that the Greys have said they hail from planets within 100 light years, and are part of an alliance of seven similar species. In addition to the alien implant he had removed, he believes he still has several others embedded in him, including one "that started giving out radio signals when I was doing a Japanese TV show." During the last half-hour, George featured his 6/28/21 interview with hypnotherapist Barbara Lamb on children's ET encounters. --- Send in a voice message: https://podcasters.spotify.com/pod/show/georgenoory/message

Class II's are only easy when they are small (but not too small), supragingival, easily accessible with straight-forward anatomy. In other words, about 1% of the Class IIs we encounter - because the vast majority I see are subgingival, wide, with awkward root concavities and tricky access. I went from using sectional matrices 97% of the time to now just using them 30% of the time - this is thanks to a circumferential matrix I started to use last year which is a game changer. I now do not need to use a wedge in most scenarios (something I used to think was a crime!) and have been using the ‘contact opening technique'. Meet Dr Sunny Sadana, who has brought the Greater Curve system to the UK and taught me a lot about efficiency with direct restorations. We also discuss fee-setting and patient communication - this part of the video is only available for those on our Protrusive Guidance network. https://youtu.be/QF3b8V_29Vw Watch PDP188 on Youtube Protrusive Dental Pearl  Pre-wedging; use this technique before beginning any restorative work on the tooth you are working on, this will allow a greater field of view to work in. It also helps suppress the papilla to get better access to the caries. This can all be achieved by numbing the area first and wedging with adequate enough pressure for there to be separation. It also reduced iatrogenic damage and is also worthwhile considering using a wedge-guard/fender wedge. Check out the DRE Composite Course Access the CPD quiz through our app on https://www.protrusive.app, either on your browser or by downloading our mobile app. For the full educational experience, our Ultimate Education Plan gives you access to all our courses, webinars, and exclusive monthly content. Join us on Protrusive Guidance, our own platform for dental professionals. No need for Facebook anymore!

722: How Airway, Jaw Joints, & Autonomic Nervous System Issues Are Creating Today's Orthodontic Patients – Dr. Drew McDonaldToday, orthodontics goes beyond just straight teeth. With better technology and better imaging, we can now include joints and airway for more comprehensive care. To highlight the importance of imaging in the future of orthodontics, Kirk Behrendt brings back Dr. Drew McDonald, instructor from the Chicago Study Club, who explains how it leads to better outcomes, especially for Class II patients. Stop going in blind into orthodontic cases! To learn how imaging drives treatment and what you could be missing without it, listen to Episode 722 of The Best Practices Show!Learn More About Dr. McDonald:Join Dr. McDonald on Facebook: https://www.facebook.com/drew.mcdonald.984Follow Dr. McDonald on Instagram: https://www.instagram.com/drdrewmcdonaldContact Dr. McDonald for speaking engagements: https://www.orthobymcdonald.comLearn more about Chicago Study Club: https://chicagostudyclub.comEmail Kirk for Dr. McDonald's previous Master Classes:

Episode Summary: In this illuminating episode of Functional Health Radio, host Dr. Kristin Hieshetter delves into the concerning trends of declining life expectancy and rising chronic disease rates in the United States. With a powerful narrative that highlights statistics from the CDC and the World Economic Forum, the episode serves as a wake-up call to the healthcare system's dire need for preventive strategies and well-being-oriented models. Dr. Hieshetter addresses the significant impact on the health of low-level laser therapy (LLLT), distinguishing it from traditional medical laser applications. She explains the different classes of lasers and their medical applications, focusing on the potential of Class II low-level lasers in enhancing the body's healing capabilities. Dr. Hieshetter also discusses the concept of hormesis and its importance in understanding the therapeutic use of lasers. Key Takeaways: The life expectancy in the United States has been declining, which, coupled with increasing rates of chronic diseases in children, calls for an urgent revamp of the healthcare system. Low-Level Laser Therapy (LLLT) is a promising, non-invasive treatment that can accelerate the body's healing process and manage various conditions without the risks associated with higher-class lasers. Dr. Kristin Hieshetter distinguishes between the different classes of lasers, emphasizing the safe application of Class II low-level lasers. The principle of hormesis is crucial in LLLT, as it represents the fine balance needed for optimal dosing—where too much or too little can be ineffective or harmful. Inspiring case studies demonstrate the profound impact of LLLT in improving conditions as diverse as broken bones, post-operative pain, chronic pain management, and even stroke recovery. Notable Quotes: "Life expectancy of the United States of America fell for both men and women." "Forbes magazine said that the future of healthcare is to collectively transform the existing system from treatment-based recovery to prevention and well-being." "With low-level lasers, it's not about power, and it's not depth of penetration. These are not surgical procedures." "Photons are those little energized packets of light that, when applied to living systems, trigger photochemical changes within cells responsive to photons." "If we can change brains, we can change pain and pain perception. This is where it gets fun." Resources: The podcast does not explicitly mention any URLs or social media handles, but interested listeners can refer to the website of Erchonia (www.erchonia.com) as it was discussed in relation to preferred laser devices by Dr. Kristin Hieshetter. Readers may also look into "The Brain's Way of Healing" by Norman Doidge for an in-depth exploration of healing through low-level laser therapy. Tune in to the full episode of Functional Health Radio with Dr. Kristin Hieshetter to discover transformative health insights and learn about the future of healthcare through preventative measures and innovative treatments like low-level laser therapy. Stay connected for more episodes that pave the way towards a healthier society.  

On this episode we dust off things in the hangar, get ready for the prime of flying season, and discuss hot air ballooning ups and downs -- from what's required in an annual inspection to the angst of "aeronauts" having to obtain a Class II medical certificate.

The episode explores Aaron Call's journey from engineer to entrepreneur, and his insights on innovation, market intelligence and the future of Medtech.About the guest: Aaron Call is the innovative founding principal of Jaunt, a company specializing in market intelligence and strategic decision-making for the medical device industry. With a rich background in biomedical engineering and product management, Aaron has been instrumental in guiding both startups and established enterprises through the complex landscape of medical technology. His expertise extends to Class I and Class II medical devices, digital health technologies, and he holds patents in the medical device field. Aaron's leadership at Jaunt is marked by a commitment to empowering companies with the insights and strategies needed to succeed in the dynamic world of medical technology. Join us as we explore Aaron's journey from engineer to entrepreneur and delve into his insights on innovation, market intelligence, and the future of MedTech.Main Topics:Medical device development and market fitMarket research methods for disruptive innovationMarket analysis and decision-making in the medical industryEngineering background and its impact on business decisionsMedical device industry trends, AI, and fundraising.Links:Aaron Call - LinkedInJaunt WebsiteAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf   MDCG 2024-1 Vigilance System for CE - Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf   Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable: MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf eQMS your eQMS SmartEye - The best eQMS ever:  https://eqms-smarteye.com UK Future Regulation roadmap - We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf Course Training EU MDR Green Belt - February and March 2024 : https://school.easymedicaldevice.com/gb/ Notified Bodies and Approved Bodies UK Approved bodies - They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf   GDP video Good Documentation Practices - Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI ROW USA US FDA Quality Management System Regulation - Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked US FDA IVD Reclassification - Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program Non-IVD: https://www.fda.gov/media/174458/download?attachment IVD: https://www.fda.gov/media/174459/download?attachment eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc   Saudi Arabia Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262   Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf   Events Medtech Conf - RAPS Workshop - Feb 27th until March 1st: https://medtechconf.com/event/raps-events/ Podcast Nostalgia - Relisten again and again Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/ Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/ Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/ Whatsapp Community: Whatsapp community - Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

August de Oliveira joins Totally Oral to discuss his latest teaching endeavor: MOD Institute and the importance of 3D printed dentistry.  August also hints at future trends in digital dentistry and if Skynet is inevitable given all the advances in AI.  

On August 16, 2022, President Biden signed the Inflation Reduction Act (IRA) into law. The IRA provides tax incentives and grants for solar, wind, hydrogen, nuclear, oil and gas, and carbon capture, utilization and storage projects (CCUS). Specifically the IRA amends section 45Q of the tax code to provide credits for the capture and storage of carbon dioxide (CO2) in underground geologic formations. In the second environmental and energy law spin off episode of Briefly Legal, join attorneys Tim Sowecke and Alyssa Sloan as they discuss the growth of CCUS projects and the monetization of CO2 under the IRA, with a specific focus on the management of CO2 as a waste product in industrial and oil and gas operations under the Safe Drinking Water Act's (SDWA) Underground Injection Control (UIC) program. They'll highlight important jurisdictional distinctions between UIC Class VI wells used to collect CO2 emissions from large point sources like power generation or industrial facilities, and Class II wells used to dispose of CO2 as a waste product in oil and gas operations. They'll also touch on environmental justice considerations in the siting of CCUS projects. Whether you're an oil and gas operator trying to manage CO2 emissions, an entrepreneur looking at opportunities in the nascent carbon market, or just someone wanting to know more about carbon capture and storage, this episode will shed light on some of the latest efforts to capture and commoditize CO2 in the United States. About Tim Sowecke and Alyssa SloanConnect with Crowe & Dunlevy:Website | Facebook | Twitter | LinkedIn

Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Amy Sehnert, MD With the FDA's approval of CAMZYOS® (mavacamten), the first and only cardiac myosin inhibitor for symptomatic New York Heart Association (NYHA) class II-III adult patients, healthcare professionals and patients now have another treatment option that targets HCM at the source. Learn more about the clinical trial data that supported the FDA approval, and how healthcare professionals can prescribe CAMZYOS from Dr. Amy Sehnert, Vice President and Head of Cardiomyopathy and Heart Failure Clinical Development at Bristol Myers Squibb.

Host: Charles Turck, PharmD, BCPS, BCCCP Guest: Amy Sehnert, MD With the FDA's approval of CAMZYOS® (mavacamten), the first and only cardiac myosin inhibitor for symptomatic New York Heart Association (NYHA) class II-III adult patients, healthcare professionals and patients now have another treatment option that targets HCM at the source. Learn more about the clinical trial data that supported the FDA approval, and how healthcare professionals can prescribe CAMZYOS from Dr. Amy Sehnert, Vice President and Head of Cardiomyopathy and Heart Failure Clinical Development at Bristol Myers Squibb.

Today on the Life Science Success Podcast, we have a very special guest with us—David Hibbard, the Vice President of Engineering at Sunrise Labs. With over 25 years of experience in medical device development, David has been at the forefront of innovation in areas ranging from Stress Echocardiography to Robotics.   The interview features David Hibbard, VP of Engineering at Sunrise Labs, who has over 25 years of experience in medical device development. He holds a biomedical engineering degree from Boston University. Sunrise Labs specializes in Class II and Class III medical devices and focuses on end-to-end service, from software to hardware. The team size is just under 100 people, with approximately 70 to 80 engineers. David discusses the importance of strong project management, emphasizing the need to understand regulatory strategy and timelines, and advises that good client relationships are formed through transparency and integration, even in daily scrums. On the topic of leadership, David mentions the importance of good integrity and communication for long-term partnerships. He emphasizes that understanding the end user's needs is crucial for successful medical device development. Hibbard also talks about the use of AI to improve code robustness and mentions some of the challenges they are facing with remote work and maintaining a work-life balance in the current environment.

In orthodontics, the name Dr. Luis Carriere is synonymous with innovation, clinical expertise, and a commitment to advancing the field.While many may associate his name with the Carriere Motion Class II and Class III corrector, Dr. Carriere is much more than an inventor. He is a master clinician, a gentleman of the highest order, and a second-generation orthodontist following in the footsteps of his renowned father.In this Greatest Hits Series, we revisit a popular episode where he graciously shared his insights into different clinical aspects of orthodontics.Among these clinical aspects we talk about is the crucial role of the tongue in malocclusions and overall oral health.The improper positioning of the tongue during functions like swallowing, chewing, and speaking can contribute to malocclusions and open bites.Dr. Carriere stresses the importance of training patients to reposition their tongues correctly. Understanding and addressing the tongue's role in orthodontics is essential for achieving long-term stability and preventing relapse.Tune in to learn from one of the leading experts in our profession.Key Takeaways- Meet the world-renowned Dr. Luis Carriere (01:19)- Difference between practicing in Spain and the USA (06:58)- What we must do as a profession to educate our patients (10:08)- The Motion Appliance (17:39)- The 5 components of Class II correction (19:39)- TMJ disorders and mandible position (25:58)- Orthodontic treatment and tongue positioning (34:26)Additional Resources

In this week's episode, we'll discuss the findings from the final analysis of the CLL2-GIVe trial, learn how NOTCH2 mutants promote resistance to chemotherapy in diffuse large B-cell lymphoma, and discuss the role of DBY/HLA class II complexes in chronic graft-versus-host disease.

Kids Getting Hurt: Consequences on Facial GrowthEpisode #626 with Dr. Drew McDonaldKids get hurt — a lot. But even when they “seem fine”, those facial traumas can have severe consequences on their growth and development. To help you detect those issues early, Kirk Behrendt brings back Dr. Drew McDonald, instructor from the Chicago Study Club, with advice for seeing the signs and asking parents the right questions about their child's injuries. You can save children from a lifetime of pain and suffering! To learn how, listen to Episode 626 of The Best Practices Show!Episode Resources:Send Kirk an email for Dr. McDonald's Master Classes!Join Dr. McDonald on FacebookFollow Dr. McDonald on InstagramLearn more on Dr. McDonald's websiteSubscribe to The Best Practices Show PodcastJoin ACT's To The Top Study ClubSee ACT's Live Events ScheduleGet The Best Practices Magazine for free!Write a review on iTunesLinks Mentioned in This Episode:Register for Chicago Study ClubFollow Kids Getting HurtMain Takeaways:Problems with growth and occlusion start early in life.You need 3D and CBCTs to see and diagnose joint issues.Even seemingly benign injuries can lead to severe growth issues.Know where to look so you can get children the help that they need.Ask parents good and thorough questions about their child's injuries.Quotes:“One of the biggest issues that we run into as orthodontists is relapse. Why did everything we tried to accomplish — why are we watching it unravel? The topic we're going to talk about today is one of the most important issues that I see, which is that a lot of things under the surface, especially joints, airway issues, issues with kids' necks or adults' necks, can really be the undoing of their bite, of their occlusion, of their growth — and they start early in life.” (3:16—3:45)“I saw a little four-year-old guy yesterday. He's not growing well. His lower jaw is extremely retrognathic. He's very Class II. He also has a bilateral crossbite. He has extremely narrow development. This little kid's jaws also click and pop. And as I'm doing my exam, I'm asking his parents, ‘Does he ever mention this to you?' They go, ‘We thought that was normal. We thought everyone's jaws click and pop. We didn't know he was hurting, but he said it right here.' My next question immediately is, ‘Do you recall any head or neck trauma? Any falls? Falls down the stairs? Normal, typical, kid stuff?' And to a tee, a lot of parents go, ‘Well, we never had a car accident. He never had to go to the hospital or anything. But we do remember normal kid stuff.' Well, “normal kid...

Have you ever been frustrated with a product and said "Hey, I can do this better?"  I think we all have and have often wondered how we can make that change.  Well Dr. Matt Burton decided to take action on those thoughts.Dr. Matthew Burton, DDS has worked as an established dental practitioner in Illinois since 2008. Like most dentists, his schedule was filled with one of the most common procedures: the Class II composite restoration. After several years in his practice working on hundreds of fillings, Dr. Burton became frustrated with the available Class II matrix systems. He tried nearly every system, but none of them provided the efficiency and consistent results he was seeking. He found that the major difficulty lies in properly placing and wedging the matrix bands. If not performed correctly, it cost him valuable time, required unnecessary & timely post polymerization adjustments, and ultimately led to a lack of confidence in the procedure.   Furthermore, Dr. Burton has discovered that different components from different matrix systems, when combined, produce consistently outstanding results.  Dr. Burton began contemplating new ideas to make his chair-side time more efficient. He discovered that he could simplify & streamline the Class II restoration process by simply re-designing the wedge to "split" down the middle. The flexible Split Wedge allows for proper gingival seal, perfect matrix contour, while greatly minimizing flash.  He ultimately realized that the design of this wedge played a critical role in achieving excellent outcomes in an incredibly efficient way.  With no other products like it on the market, Dr. Burton knew there would be demand for his matrix systems. In 2017, he formed Burton Dental Innovations to begin marketing and selling his products to other dentists who face the same challenges in their own practices. Dr. Burton enjoys testing new and forward thinking technology, and embraces these advancements as crucial to office efficiency and case outcome.   He has realized the importance of digital scanning and how software integration platforms are  a key element to utilizing scan data.Dr. Burton began teaching CE courses to dentists around the world in July 2020 and is enthusiastic to continue to share what he has learned and how it has helped shape a high level of care in his office.  

In this week's episode we will review optimizing the value of post-transplant lenalidomide maintenance in multiple myeloma. Next, T-cell immunotherapies targeting AML antigens upregulate MHC Class II expression on AML cells. Finally, young bugs rejuvenate old blood: transplanting fecal microbiota from younger mice into older mice improved hematopoietic stem cell function and restored lymphoid differentiation potential.

Episode Description On March 1, 2023, Rep. Jan Schakowsky (D-IL) introduced the Medical Device Nonvisual Accessibility Act  in the House of Representatives. The goal of this act is to make home use medical equipment and devices accessible to blind and visually impaired individuals in the United States. If passed, this legislation would amend the federal Food, Drug, and Cosmetic Act to establish non-visual accessibility standards for Class II and III devices with digital interfaces. Class II and III devices include devices that are more invasive and involve a higher risk of injury or death, so it is much more important that these devices are used safely and as directed. The FDA would, in consultation with the U.S. Access Board, set regulations and a final rule according to those standards. The passage of this legislation would make it easier for people who are blind and low vision to manage their health safely and independently by ensuring that product manufacturers incorporate accessible design in the beginning stages of development for home use medical devices. This bill has 32 original co-sponsors and is bipartisan with 3 Republicans and 29 Democrats. Learn more about this 2023 ACB Legislative Imperative. Find out more at https://acb-advocacy-update.pinecast.co

Physical therapy is difficult. It's made even more complex in that by the time we live. The demands on our time are greater than ever. We're also human, meaning we lose the paper they give us with the exercises on it. We also have to attempt to decipher the ancient hieroglyphic structure of the photocopied page, unsure if we're even doing the movements properly. Plus, we forget to take our medication. Allimb offers an AI-enhanced solution to these problems. Plus, it runs on your phone, not someone else's hardware, and will absolutely change the way you recover.I watched my father battle all 3 of these issues over the past year. He had both knees totally replaced within the span of 7 months. Most pro athletes wouldn't even undertake such a challenge. But my dad did, at 77 years old. The physical pain wasn't what bothered him, he just wanted, as all of us do after any traumatic injury or medical procedure, to get better. He faced massive trials with the proprietary exercise bike they assigned him, which was running a build of Android from the mid-2010s. You couldn't even re-launch the application when it would freeze, you'd have to call and wait on hold for about 20 minutes to get someone to remotely reset your bike. A truly miserable experience, especially when there are enough barriers between you and your recovery.What is Allimb?Allimb has 3 separate products on offer. Each one is tailored to a different market, in both the business and end-user spaces. Allimb's technology, which they call MotionCare, combines sensor data and AI to help users recover properly by creating both trackable accountability and using AI vision to track your form and help correct any irregularities.Allimb also has a medication tracking element, Allimb Health, which allows physicians to know if a patient is taking their medication by analyzing the data from the physical therapy alongside other tracking methods. Allimb Care is developed for insurance companies. Allimb offers their software and some exercise programs bundled together to those companies for assignment to their customers.Allimb MedPro is made for healthcare professionals and offers a full suite of the aforementioned physical therapy tracking as well as data analytics and AI integrations for a variety of useful tools. Currently, Allimb's product is considered a Class II Medical Device. Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Some examples of Class II devices include powered wheelchairs and some pregnancy test kits and interestingly enough contact lenses. They are currently seeking full FDA approval.Want to learn more?Currently only available overseas, I hope they can find a market here in the United States. I feel their product would really help a lot of people with their recovery, my father included. If you'd like to learn more about Allimb, its founders, or medical product offerings you are welcome to visit their website.Interview by Todd Cochrane of Geek News Central.Sponsored by: Get $5 to protect your credit card information online with Privacy. Amazon Prime gives you more than just free shipping. Get free music, TV shows, movies, videogames and more. The most flexible tools for podcasting. Get a 30 day free trial of storage and statistics.

Physical therapy is difficult. It's made even more complex in that by the time we live. The demands on our time are greater than ever. We're also human, meaning we lose the paper they give us with the exercises on it. We also have to attempt to decipher the ancient hieroglyphic structure of the photocopied page, unsure if we're even doing the movements properly. Plus, we forget to take our medication. Allimb offers an AI-enhanced solution to these problems. Plus, it runs on your phone, not someone else's hardware, and will absolutely change the way you recover.I watched my father battle all 3 of these issues over the past year. He had both knees totally replaced within the span of 7 months. Most pro athletes wouldn't even undertake such a challenge. But my dad did, at 77 years old. The physical pain wasn't what bothered him, he just wanted, as all of us do after any traumatic injury or medical procedure, to get better. He faced massive trials with the proprietary exercise bike they assigned him, which was running a build of Android from the mid-2010s. You couldn't even re-launch the application when it would freeze, you'd have to call and wait on hold for about 20 minutes to get someone to remotely reset your bike. A truly miserable experience, especially when there are enough barriers between you and your recovery.What is Allimb?Allimb has 3 separate products on offer. Each one is tailored to a different market, in both the business and end-user spaces. Allimb's technology, which they call MotionCare, combines sensor data and AI to help users recover properly by creating both trackable accountability and using AI vision to track your form and help correct any irregularities.Allimb also has a medication tracking element, Allimb Health, which allows physicians to know if a patient is taking their medication by analyzing the data from the physical therapy alongside other tracking methods. Allimb Care is developed for insurance companies. Allimb offers their software and some exercise programs bundled together to those companies for assignment to their customers.Allimb MedPro is made for healthcare professionals and offers a full suite of the aforementioned physical therapy tracking as well as data analytics and AI integrations for a variety of useful tools. Currently, Allimb's product is considered a Class II Medical Device. Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Some examples of Class II devices include powered wheelchairs and some pregnancy test kits and interestingly enough contact lenses. They are currently seeking full FDA approval.Want to learn more?Currently only available overseas, I hope they can find a market here in the United States. I feel their product would really help a lot of people with their recovery, my father included. If you'd like to learn more about Allimb, its founders, or medical product offerings you are welcome to visit their website.Interview by Todd Cochrane of Geek News Central.Sponsored by: Get $5 to protect your credit card information online with Privacy. Amazon Prime gives you more than just free shipping. Get free music, TV shows, movies, videogames and more. The most flexible tools for podcasting. Get a 30 day free trial of storage and statistics.

Copper IUDs have soared in popularity as a safe alternative to hormone-based birth control for women but is this really true?From what I've seen over the last 14 years, the opposite is true, yet when a woman notices chronic symptoms such as yeast infections, anxiety and panic attacks, and even psychosis after insertion of this device, she is often gaslit and told to see a psychiatrist.Please know it's not all in your head. If you or a loved one are experiencing adverse reactions to the copper IUD, please share this episode. You may save a life.The copper IUD is a Class II medical intrauterine device that's inserted into the uterus for long-term birth control (up to 10 years). It's a T-shaped plastic frame with copper wire coiled around the stem and two copper sleeves along the arms that continuously release copper into the lining of the uterus. This process produces an inflammatory reaction in the uterus that is toxic to sperm, which helps prevent fertilization.In this episode, we discuss:The detrimental side-effects of the copper IUDWhy the copper IUD is not a safer or better form of birth controlThe multi-district lawsuit against the manufacturer of the copper IUDWhy the copper IUD was recalled in 2014What copper toxicity is and how it impacts a woman's bodyClick here to read the full transcript and resource links.

The Committee, the report, and a heavy dose of J6 reality. Tore and Gavin go deep. Benny the robot does his thing. The Trump fantasy report to fuel their blood lust. Zero indictable evidence with no crimes. Let's look at the players. Proud boys and the Stone uncovered. Helmets on protestors? Ego trips and gay prostitutes. The masses were pissed but peaceful. So many operations taking place that day. Legal framing using proximity. So many factions that our infighting creates weak spots. The preliminary setup involved lots of data. Even the Amish bailed. Not many actual reporters, but lots of thirsty ho's. Informants and clowns did abound. Confusion defined the police coms. Bottom line, DJT did the unexpected. DOJ troops were ready paddy wagons. It was all spontaneous, right? The insiders are now hiding as the truth crawls out. Investigating J6 isn't over. It will circle back very soon. Learn more about your ad choices. Visit podcastchoices.com/adchoices

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don't qualify for exemption and how that intersects with how a device is classed?This is the focus of today's episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.Listen to the episode to learn how Mike is thinking about the meaning of 510(k) exemptions, how classifications do and don't intersect with exemptions, and why some items are exempt.Some of the highlights of this episode include:The meaning of 510(k) exemptWhy “exempt” may not be the best wordWhat unregulated medical devices are calledClassifications don't necessarily mean that a device is exemptComparing and contrasting Class I and Class IIThe difference between general controls and special controlsExamples of exemptions and why they're exemptThe shades of gray in regulationThe regulatory logicMemorable quotes from Mike Drues:“An exempt device, whether it's a Class I exempt or a Class II exempt device, it doesn't matter, is still a regulated medical device.”“Instead of calling these special controls, we should call them specific controls.”“One of my frustrations with a lot of folks in this business is they just follow the regulations like a recipe, like a computer executing lines of code one by one without asking does this make sense?”“What is much much more important than the answer is the logic you use to get the answer.”Links:Mike Drues LinkedInCDRH Website: Class I and Class II Device ExemptionsList of Exempt Devices by regulation number (CDRH Website): Medical Device Exemptions 510(k) and GMP RequirementsWebinar: When do we need FDA's permission to market our device and when do we not? (Nov 2020)Webinar: Special Controls: What are they, and how can we use them to our advantage? (May 2022)Webinar: Understanding the Medical Device Classification System (July 2020)Webinar: General Wellness Devices and Wearables (May, 2018)Jon Speer LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the FDA's use of the word “exempt” and what it means for medical device manufacturers. During this discussion, we look at the relationship between 510k exempt and Class of device. Specifically, the following questions are addressed:Could you please explain what 510k exempt actually means?Are all Class I medical devices exempt and all Class II devices not exempt?What's the difference between Class I exempt and Class II exempt?What is the difference between general controls and special controls? How are these relevant to exempt status?Could you give some examples of products that are Class I exempt and explain why they are afforded that status?Now could you do the same for Class II products that are exempt and give reasons why?What are the most important takeaways with all of this for medical device manufacturers?Listen to this episode and see how 510k exempt may affect your company's products and future regulatory submissions. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

Bill is a degreed engineer who has developed many Class II and Class III medical devices from concept through commercialization and is currently the CEO of Singlepass.co Before serving as the CEO of Spinal Singularity for over 2 years, Bill previously served as the VP of R&D for Direct Flow Medical until its sudden closure in November of 2017 and the Director of R&D for Endologix from 2010 until 2017.  He was CEO and co-founder of Endomed from 1993 until its sale in 2005 to LeMaitre Vascular.  Bill has over 3 decades of medical device development and launch experience and holds 13 US and several international patents. He has also developed and licensed many physician inspired medical devices in vascular surgery, endovascular therapies, and orthopedic surgery.Get interviewed on the Matt Brown Show: www.mattbrownshow.com

You maybe ask yourself how to get to distribute your Medical Device in the US? Then listen to the story of MysteryVibe with their devices. He will answer questions such as: - Why the US market and not the EU? - What was the interaction with consultants for the Quality and Regulatory aspects? - How is it to work with a Quality Management System? - How is the logistic of the product working? - Why perform Clinical Investigations? So I hope this will help you understand the market by listening to the MysteryVibe Journey. Who is Dr.Soumyadip Rakshit? Dr. Soum Rakshit is the Co-Founder & CEO of award-winning sexual health company, MysteryVibe. Their mission is to make sexual health accessible to all – across all ages, genders & orientations. In his role as CEO of MysteryVibe, he focuses on pushing the boundaries on R&D, customer experience and supporting their long-term goal of making sexual health an integral part of our overall health. Soumyadip passionately believes that by empowering people with actionable knowledge & purposeful innovation is the way to make this happen. Soumyadip built and sold his first startup in defence electronics by age 26, and has won 20+ International design awards for his product designs. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Dr. Soumyadip Rakshit Linkedin: https://www.linkedin.com/in/soum Mysteryvibe website: https://mysteryvibe.com/ Literature on disease targeted: https://eventclass.org/contxt_essm2022/scientific/online-program/session?s=P-07#e524 MysteryVibe LinkedIn Page: https://www.linkedin.com/company/mysteryvibe/ Easy Medical Device Authorized Representative: https://easymedicaldevice.com/authorised-representative-and-importer/  

Carolyn Harding with Shelly Corbin, Roxanne Groff & James Yskamp. Petitioners & legal counsel to Revoke Primacy of Ohio Class II oil & gas Injection Wells from the Ohio Department of Natural Resources. Shelly Corbin(Takóni Kókipešni) is Itazipco/Mnicoujou, Lakota and a member of the Cheyenne River Reservation. She has served over 15 years in the military and continues to serve in the Ohio Air National Guard. Currently, as the Campaign Representative for the Beyond Dirty Fuels Campaign at Sierra Club she focuses on oil and gas infrastructure and waste related issues of the fracking industry across Ohio. Shelly is committed to connecting with the land, relationships and herself to strengthen community, connection & unity with the living world. As a founding member of the grassroots group, Save Our Rural Environment, Roxanne Groff fought the permitting of strip mines in Athens County. Her interest in state law and the lack of implementation of rules by the regulatory agencies, led her to run for public office, first for Township Trustee, then for the County Commissioner. She participates in campaigns to raise awareness and challenge industry abuses that will affect the health and wellbeing of citizens. Roxanne works with Buckeye Environmental Network and the Ohio Brine Task Force, to stop dangerous bills in the Ohio General Assembly, regarding toxic radioactive oil and gas waste as a commodity, inadequate rules for injection wells and oil and gas waste facilities, and the current Petition to revoke primacy of Class II injection wells from ODNR. James Yskamp is a senior attorney at Earthjustice in the Fossil Fuels Program, where he works on matters involving oil and gas and petrochemical infrastructure in the Appalachian Ohio River Valley. Since 2014, James has been representing clients in Ohio and Pennsylvania in a variety of environmental civil matters, including cases involving water rights, citizen suit litigation, air quality permitting, water quality permitting, mineral rights, pipeline challenges, and land use and zoning. James also teaches a course in environmental law at the University of Akron School of Law. On Oct 11, 27 Ohio grassroots and non-profit environmental organizations, delivered a petition to the the US EPA, “to Determine by Rule that Ohio's Class II Injection Well Permitting Program No Longer Represents an Effective Program to Prevent Underground Injection that Endangers Drinking Water Sources and Fails to Comply with the Requirements of the Safe Drinking Water Act.” Sierra Club Ohio Beyond Dirty Fuels Campaign webpage: https://www.sierraclub.org/ohio/fighting-oil-and-gas Take Action on Petition: https://addup.sierraclub.org/campaigns/tell-the-us-epa-that-ohioans-had-enough-no-more-radioactive-waste-in-our-communities?_ga=2.165206204.227122745.1667409785-1269332763.1654095636&_gl=1*1c0gf9v*_ga*MTI2OTMzMjc2My4xNjU0MDk1NjM2*_ga_41DQ5KQCWV*MTY2NzQwOTc4NC41MS4xLjE2Njc0MTA0NzcuMC4wLjA. Ohio Brine Task Force webpage: https://www.ohbrinetaskforce.org Buckeye Environmental Network webpage: https://benohio.org EarthJustice law: https://earthjustice.org GrassRoot Ohio w/ Carolyn Harding - Conversations with every-day people, working on important issues here in Columbus and all around Ohio! There's a time to listen and learn, a time to organize and strategize, And a time to Stand Up/ Fight Back! Fridays 5:00pm, EST on 94.1FM & streaming @ WGRN.org We air on Sundays at 4:00pm EST, at 107.1 FM, Wheeling/Moundsville WV on WEJP-LP FM. Face Book: https://www.facebook.com/GrassRootOhio/ Instagram: https://www.instagram.com/grassroot_ohio/ All shows/podcasts archived at SoundCloud! https://soundcloud.com/user-42674753 Apple Podcast: https://podcasts.apple.com/.../grassroot-ohio/id1522559085 YouTube: https://www.youtube.com/user/cinublue/featured... Intro and Exit music for GrassRoot Ohio is "Resilient" by Rising Appalachia: https://youtu.be/tx17RvPMaQ8 Photo by Ted Auch of FracTracker Alliance

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the Special Controls that are part of the FDA's regulatory requirements for Class II devices. During the conversation, the purpose of these Special Controls is presented. Additionally, ways to use these regulatory requirements to gain a competitive advantage is also discussed. Specifically, the following questions are addressed:Would you please explain what we mean by Special Controls? What are they, and how and when are they used?What makes these “special”?Would you mind providing some real-world examples of Special Controls?How do Special Controls vary based on the regulatory pathway? In other words, how are they different from 510k vs a de novo?With regard to Special Controls, what are the most important takeaways to keep in mind?Listen to this episode and see if you can leverage Special Controls to gain a competitive advantage. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.

This throwback episode features Zach and Kevin talking to an adhesive dentistry pioneer!   Dr. Raymond Bertolotti is perhaps best known for introducing "total etch"  to North America in 1984. He has been credited with coining the phrase "adhesion dentistry" in 1985.  Dr. Bertolotti first used "Adhesion Dentistry" when he retitled his "Cosmetic Dentistry" seminar, reflecting the true nature of what he was using to achieve aesthetic results with minimal invasion. In America, Dr. Bertolotti  also introduced Caries Detector in 1984, Panavia in 1985,  cantilevered PFM adhesion bridges in 1986, intraoral tin plating in 1989, self-etching primers in 1992,  HealOzone in 2004, and all-ceramic zirconia adhesion bridges in 2017.  The sectional Contact Matrix system, "Microprime B",  Accolade PV,       "Microetcher" sandblasting,  and intraoral tin-plating are also his innovations. His materials and techniques continue to reflect a compilation of international knowledge which has been evolved into a "how to do it" seminar of international reputation. He maintains both his adhesion.com website and has seminars on Ruiz Dental Seminars Today we talk about polymerization shrinkage and the Class II restoration and how Bulk EZ is a game changing product for gap free restorations. Go get your ticket and your room for Voices of Dentistry 2023! If you want to interact with us, head over to the Very Clinical Facebook Group! Join the Very Dental Facebook group using the password "Timmerman," Hornbrook" or "McWethy." If you'd like to support the Very Dental Podcast Network then you should support our sponsors!  Cosmedent has an amazing fall line up of continuing education! Coming up on September 22nd through the 23rd is our friend Dr. Artie Volker teaching “Composite Power 101!” Dr. Corky Willhite is offering his legendary “Ultimate Esthetics” course! Both courses have lots of hands on exercises and as always they're limited to 15 people which guarantees lots of individual time with instructors! Don't miss your chance to learn in the greatest classroom in dentistry with some legendary instructors using the best of materials! Go check it out at verydentalpodcast.com/CEE! -- Our friends at CAD-Ray want you to know that there has never been a better time to get into intraoral scanning! They sell and support all kinds of digital dentistry products from scanners, to printers and even cloud based software! For instance, the Medit i600 itraoral scanner is priced at just about $13,000! And if you didn't know, CAD-Ray now distributes 3Shape scanners and the amazing Trios 4 wireless just had a $10,000 price cut! It comes in under $25,000. And all these options come with CAD-Ray's unbeatable support! Go check it out at verydentalpodcast.com/cadray! -- If there is one thing that's changed the way I look at teeth the most, it's probably the headlight I use with my loupes. Our friends at Enova make amazing loupes and distribute Zumax dental microscopes, both the best you can buy. But the amazing, weightless and cordless Qubit, Quasar or Quantum headlights (all others are just toys) are the biggest game changer. But be careful…if you try one, you're going to buy one! Why haven't you checked out Enova Illumination yet? You can get a killer deal on all things Enova by using the Very Dental link you'll find at verydentalpodcast.com/Enova! -- Have you been looking at your supply bill lately? Prices are REALLY going up on all the things you use every day in your office. Our friends at Crazy Dental understand and are here to help! Very Dental listeners can get 10% off their orders from Crazy Dental by using coupon code “VERYDENTAL10”! Go check out their amazing catalog and save yourself 10% off of their already amazing prices at verydentalpodcast.com/crazy! -- If you're looking for a one stop dental marketing solution, then look no further than the Wonderist Agency. Wonderist can help you with branding and a killer website. They'll design ad campaigns no matter how you want to get your name out there. But maybe most importantly, they'll show you how your marketing plan is working! They have industry leading analytics that help you understand what works and what doesn't in your area and they'll help you spend your marketing dollar in the wisest way possible! Go check out the Wonderist Agency at verydentalpodcast.com/Wonderist!

Dental podcast: Welcome to DentalTalk. I'm Dr. Phil Klein. Today we'll be discussing the use and benefits of heated composite on injection molded Class II restorations. Our guest is Dr. Joshua Solomon, a second-generation dentist who has been in practice in California for 20 years.

Natural Cycles° is a leading women's health company that developed the world's first birth control app, which has been used by millions of women around the world. As a Class II medical device, the NC° app is cleared by the FDA in the United States and certified to be used as a contraceptive in Europe, Australia, and Singapore. It has also received regulatory clearances to integrate with third party wearables. For a monthly or annual subscription fee, users have access to and can switch between NC° Birth Control, NC° Plan Pregnancy, and NC° Follow Pregnancy modes within the app. NC° Birth Control's clinical effectiveness and real life effectiveness is proven to be 93% effective with typical use and 98% effective with perfect use. Founded in 2013 by Physicists Dr. Elina Berglund and Dr. Raoul Scherwitzl, Natural Cycles° is committed to pioneering women's health with research and passion. The company's on-staff research team has contributed to 14 peer-reviewed research papers.Dr. Elina Berglund Scherwitzl is the CEO and co-founder of Natural Cycles - the world's first app to be certified as a contraception both in Europe and by the FDA. She was part of the team that discovered the Higgs boson at the CERN laboratory, which led to the Nobel Prize in physics in 2013. Following this success, Elina applied her skills from particle physics to create a unique algorithm that could accurately pinpoint when a woman was fertile based on her body temperature.https://www.naturalcycles.com/Instagram: https://www.instagram.com/naturalcyclesFacebook: https://www.facebook.com/NaturalCyclesNCTikTok: @naturalcycles FemTech Focus is a 501c3 non-profit organization founded to bring awareness externally and internally for the FemTech industry and to empower the key stakeholders including entrepreneurs, investors, physicians, governments, and biopharma with resources and research to elevate women's health and wellness globally. Subscribe and Donate: www.femtechfocus.orgThe FemTech Focus Podcast with Dr. Brittany Barreto is a meaningfully provocative conversational series that brings women's health experts - including doctors, scientists, inventors, and founders - on air to talk about the innovative technology, services, and products that are improving women, female, and girl's health and wellness, collectively known as FemTech. The podcast gives the host, Dr. Brittany Barreto, and guests an engaging, friendly environment to learn about the past, present, and future of women's health and wellness. Linkedin: @FemTech Focus @Brittany BarretoTwitter: @Femtech_Focus @DrBrittBInstagram: @FemTechFocus @DrBrittanyBarretoFacebook: @FemTech Focus @Dr. Brittany Barreto

Join me for a summary of Dr Bing Fang's lecture entitled: Biomechanical Research and clinical application of orthopaedic Treatment on Adolescent mandibular retrognathia. It was part of the first International Orthodontic Foundation online symposium, with Ravi Nanda: https://www.iofglobal.org Intrusion with aligners Clinical risk of anterior intrusion, can cause retroclination / proclination. Plan with assessing lower incisor inclination relative to skeletal structure from a cephalogram To figure out this problem they designed a finite element study to figure out what happens for different lower incisor inclinations If the IMPA angle exceeded 100 the intrusive force will be in front of CR resulting in a moment causing lingual root torque and buccal crown torque If the IMPA angle less than 100 the intrusive force will be behind the CR resulting in a moment causing buccal root torque and lingual crown torque Plan intrusion: Proclined teeth: intrusion and retraction at the same time with lingual crown torque Retroclined teeth: Intrusion, with labial crown torque Advanced Mandibular Spring AMS with aligner Telescopic arm with spring. Distalization of posterior and no movement in the anterior along with anterior bit turbos Class II elastics are used day time, appliance at night Inserts into connectors which are imbedded into the aligner How does it work Finite model analysis, favourable for advancing the mandible – PDL even stress, promote mandibular growth, stress on condylar anterior aspect and posterior glenoid fossa #alignerorthodontics #class2 #Bingfang #farooqahmed

Bluberi was a small Canadian slot manufacturer that specialized in Class II games when Andrew Burke was hired to take them to the next level. With expertise in game development, he immediately began working with Bluberi's design teams to make a splash in the Class III market. With a background in Class II and experience at AGS as their vice president of slot products, Burke brings a vision and strategy to Bluberi where he hopes to build the company into a powerhouse along with a vastly experienced team he's assembled. He spoke with GGB Publisher Roger Gros at the Bluberi headquarters in May.

Vivek Thakkar  has over a dozen years of experience in regulatory affairs for Class II and III medical devices, while at Roche, JUUL, Cardinal Health, and Abbott Vascular. He is also a frequent speaker on software, artificial intelligence, and machine learning. Vivek is now focused on start-ups and consults with medical device companies to identify and refine their regulatory strategies in the software as a medical device space.In this episodeVivek shares the definition of software as a medical device, the regulatory requirements during product development, how hardware and software programs are similar and different, working with teams that do not have a medical device background, how changes are made to software products, AI and machine learning and what is being done today vs. what will be coming, and the challenges specific to software products that the industry and regulatory bodies are attempting to overcome.Links from this episode:Vivek Thakkar LinkedInMastering Medical Device:WebsitePat Kothe LinkedIn

Do you have a Software as a Medical Device or maybe you plan to have one? Then listen to this episode with Vivek Thakkar which will provide you some insight on what is SaMD and how to get Certified. If you need more details, please contact us so we can help you. Who is Vivek Thakkar? Regulatory affairs professional with a Master's degree and 12 years of experience with Class II and Class III medical devices. Currently supporting regulatory activities for Artificial Intelligence and Machine Learning (AI/ML) in Software as a Medical Device (SaMD). Proven success in building and executing global regulatory strategies for interventional cardiovascular products. Skilled at hiring, training, and inspiring regulatory experts for medical device submissions. Passion for simplifying Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses… Links Vivek Thakkar Linkedin: https://www.linkedin.com/in/vivekbthakkar/ Blog post SaMD: https://easymedicaldevice.com/SaMD Clinical Evaluation Software: https://www.youtube.com/watch?v=HIycmCuBsi0 Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

On this two-part edition of The Milk Check, the Jacoby team lets listeners in on a monthly mass balance meeting. The meeting splits neatly into two episodes, one led by Global Strategy Director Don Street and the other led by Head of Risk Management and Trading Strategy Jacob Menge. In part one, we evaluate milk production data and forecast what Q2 will look like in terms of overall milk production and class allocation. Ted disagrees with Don about supply-side expectations moving forward, and Don puts forward a modification to his predictive model. In part two, we will zoom out to talk inflation, interest rates and the macroeconomic factors impacting dairy markets. Jacob presents a bird's eye view of various commodities markets and interesting trends to note in dairy and beyond. T3: Hi everybody, and welcome to the Milk Check. This month, we recorded our monthly mass balance and charting meeting. It is a monthly meeting that we hold internally where our whole trading team gets together. We look at the milk production and cold storage reports, and we look at some of the technical charts and we share our opinions about what we think this data is telling us and what we think this data is predicting about what'll happen in the future. We had some really interesting discussions this month. I think you'll really enjoy eavesdropping into these discussions. It was a long meeting but it was a really good meeting. So, what we've decided to do this month is split it into two parts. The first part is Don leading the discussion about the mass balance. What we think is happening in Class I milk, Class II milk, Class III milk, and Class IV milk. It was a great discussion. I hope you enjoy it. Thanks for listening in. Don Street: All right. You should see the PowerPoint for Mass Balance, April 2022. At this point, not completely, but all the data for Q1 that really counts we have. We'll get more early next week with dairy products. But we have it and now we're really at the point of what will Q2 hold. And I'm going to walk you through a couple of scenarios on that, and then we'll look for your guys' input. So again, Q1s in the book, down 9/10ths of a percent on milk for the quarter. But clearly a steady progression towards trying to get to zero change year over year on milk. January was the big down, February less, March even less. We still have this reality that Q2 of last year was up 4% on average. And I think that's going to be difficult to be positive over it. It's just a question of how much negative under that will be. But nonetheless, with these improving milk numbers, my projection is getting stronger. So, a month ago I thought we'd be down 1.7% for the quarter. Now I'm at 1.4% negative. You could argue, well, it's all in the same ballpark and I would concede that point. But nonetheless, two months ago I think I was talking over that we would have a reduction of over 2%. So, when you add two months together, the second quarters not looking as dire as I once thought, but I still don't think the market's anticipating this very well. And to maybe add that, had several people tell me in Chicago this week that they thought we'd be even on milk production year over year by the end of the quarter. I just don't think that's possible. And mainly it's because of cow numbers. Now, USDA really threw a curve when they restated the February numbers last week, adding about 10,000 cows that apparently shouldn't have been taken out of the herd. But I've now taken this forward projection and trying to listen to all the voices that will not see a strong change in cow numbers, but we should be past bottom. So, I've just added or increased this herd at 5,000 head a month from March. March is a known number until it's revised. So, you can just see this as you go down on the 2022 column. It's 5,000 head more a month. And that puts Q2 down on cows at about 0.9%. So, two months ago, that was 1.3% down,

Episode one hundred and forty-six of A History of Rock Music in Five Hundred Songs looks at “Good Vibrations” by the Beach Boys, and the history of the theremin. Click the full post to read liner notes, links to more information, and a transcript of the episode. Patreon backers also have a ten-minute bonus episode available, on "You're Gonna Miss Me" by the Thirteenth Floor Elevators. Tilt Araiza has assisted invaluably by doing a first-pass edit, and will hopefully be doing so from now on. Check out Tilt's irregular podcasts at http://www.podnose.com/jaffa-cakes-for-proust and http://sitcomclub.com/ Resources There is no Mixcloud this week, because there were too many Beach Boys songs in the episode. I used many resources for this episode, most of which will be used in future Beach Boys episodes too. It's difficult to enumerate everything here, because I have been an active member of the Beach Boys fan community for twenty-four years, and have at times just used my accumulated knowledge for this. But the resources I list here are ones I've checked for specific things. Stephen McParland has published many, many books on the California surf and hot-rod music scenes, including several on both the Beach Boys and Gary Usher.  His books can be found at https://payhip.com/CMusicBooks Andrew Doe's Bellagio 10452 site is an invaluable resource. Jon Stebbins' The Beach Boys FAQ is a good balance between accuracy and readability. And Philip Lambert's Inside the Music of Brian Wilson is an excellent, though sadly out of print, musicological analysis of Wilson's music from 1962 through 67. I have also referred to Brian Wilson's autobiography, I Am Brian Wilson, and to Mike Love's, Good Vibrations: My Life as a Beach Boy. As a good starting point for the Beach Boys' music in general, I would recommend this budget-priced three-CD set, which has a surprisingly good selection of their material on it, including the single version of "Good Vibrations". Oddly, the single version of "Good Vibrations" is not on the The Smile Sessions box set. But an entire CD of outtakes of the track is, and that was the source for the session excerpts here. Information on Lev Termen comes from Theremin: Ether Music and Espionage by Albert Glinsky Transcript In ancient Greece, the god Hermes was a god of many things, as all the Greek gods were. Among those things, he was the god of diplomacy, he was a trickster god, a god of thieves, and he was a messenger god, who conveyed messages between realms. He was also a god of secret knowledge. In short, he was the kind of god who would have made a perfect spy. But he was also an inventor. In particular he was credited in Greek myth as having invented the lyre, an instrument somewhat similar to a guitar, harp, or zither, and as having used it to create beautiful sounds. But while Hermes the trickster god invented the lyre, in Greek myth it was a mortal man, Orpheus, who raised the instrument to perfection. Orpheus was a legendary figure, the greatest poet and musician of pre-Homeric Greece, and all sorts of things were attributed to him, some of which might even have been things that a real man of that name once did. He is credited with the "Orphic tripod" -- the classification of the elements into earth, water, and fire -- and with a collection of poems called the Rhapsodiae. The word Rhapsodiae comes from the Greek words rhaptein, meaning to stitch or sew, and ōidē, meaning song -- the word from which we get our word "ode", and  originally a rhapsōdos was someone who "stitched songs together" -- a reciter of long epic poems composed of several shorter pieces that the rhapsōdos would weave into one continuous piece. It's from that that we get the English word "rhapsody", which in the sixteenth century, when it was introduced into the language, meant a literary work that was a disjointed collection of patchwork bits, stitched together without much thought as to structure, but which now means a piece of music in one movement, but which has several distinct sections. Those sections may seem unrelated, and the piece may have an improvisatory feel, but a closer look will usually reveal relationships between the sections, and the piece as a whole will have a sense of unity. When Orpheus' love, Eurydice, died, he went down into Hades, the underworld where the souls of the dead lived, and played music so beautiful, so profound and moving, that the gods agreed that Orpheus could bring the soul of his love back to the land of the living. But there was one condition -- all he had to do was keep looking forward until they were both back on Earth. If he turned around before both of them were back in the mortal realm, she would disappear forever, never to be recovered. But of course, as you all surely know, and would almost certainly have guessed even if you didn't know because you know how stories work, once Orpheus made it back to our world he turned around and looked, because he lost his nerve and didn't believe he had really achieved his goal. And Eurydice, just a few steps away from her freedom, vanished back into the underworld, this time forever. [Excerpt: Blake Jones and the Trike Shop: "Mr. Theremin's Miserlou"] Lev Sergeyevich Termen was born in St. Petersburg, in what was then the Russian Empire, on the fifteenth of August 1896, by the calendar in use in Russia at that time -- the Russian Empire was still using the Julian calendar, rather than the Gregorian calendar used in most of the rest of the world, and in the Western world the same day was the twenty-seventh of August. Young Lev was fascinated both by science and the arts. He was trained as a cellist from an early age, but while he loved music, he found the process of playing the music cumbersome -- or so he would say later. He was always irritated by the fact that the instrument is a barrier between the idea in the musician's head and the sound -- that it requires training to play. As he would say later "I realised there was a gap between music itself and its mechanical production, and I wanted to unite both of them." Music was one of his big loves, but he was also very interested in physics, and was inspired by a lecture he saw from the physicist Abram Ioffe, who for the first time showed him that physics was about real, practical, things, about the movements of atoms and fields that really existed, not just about abstractions and ideals. When Termen went to university, he studied physics -- but he specifically wanted to be an experimental physicist, not a theoretician. He wanted to do stuff involving the real world. Of course, as someone who had the misfortune to be born in the late 1890s, Termen was the right age to be drafted when World War I started, but luckily for him the Russian Army desperately needed people with experience in the new invention that was radio, which was vital for wartime communications, and he spent the war in the Army radio engineering department, erecting radio transmitters and teaching other people how to erect them, rather than on the front lines, and he managed not only to get his degree in physics but also a diploma in music. But he was also becoming more and more of a Marxist sympathiser, even though he came from a relatively affluent background, and after the Russian Revolution he stayed in what was now the Red Army, at least for a time. Once Termen's Army service was over, he started working under Ioffe, working with him on practical applications of the audion, the first amplifying vacuum tube. The first one he found was that the natural capacitance of a human body when standing near a circuit can change the capacity of the circuit. He used that to create an invisible burglar alarm -- there was an antenna sending out radio waves, and if someone came within the transmitting field of the antenna, that would cause a switch to flip and a noise to be sounded. He was then asked to create a device for measuring the density of gases, outputting a different frequency for different densities. Because gas density can have lots of minor fluctuations because of air currents and so forth, he built a circuit that would cut out all the many harmonics from the audions he was using and give just the main frequency as a single pure tone, which he could listen to with headphones. That way,  slight changes in density would show up as a slight change in the tone he heard. But he noticed that again when he moved near the circuit, that changed the capacitance of the circuit and changed the tone he was hearing. He started moving his hand around near the circuit and getting different tones. The closer his hand got to the capacitor, the higher the note sounded. And if he shook his hand a little, he could get a vibrato, just like when he shook his hand while playing the cello. He got Ioffe to come and listen to him, and Ioffe said "That's an electronic Orpheus' lament!" [Excerpt: Blake Jones and the Trike Shop, "Mr. Theremin's Miserlou"] Termen figured out how to play Massenet's "Elegy" and Saint-Saens' "The Swan" using this system. Soon the students were all fascinated, telling each other "Termen plays Gluck on a voltmeter!" He soon figured out various refinements -- by combining two circuits, using the heterodyne principle, he could allow for far finer control. He added a second antenna, for volume control, to be used by the left hand -- the right hand would choose the notes, while the left hand would change the volume, meaning the instrument could be played without touching it at all. He called the instrument the "etherphone",  but other people started calling it the termenvox -- "Termen's voice". Termen's instrument was an immediate sensation, as was his automatic burglar alarm, and he was invited to demonstrate both of them to Lenin. Lenin was very impressed by Termen -- he wrote to Trotsky later talking about Termen's inventions, and how the automatic burglar alarm might reduce the number of guards needed to guard a perimeter. But he was also impressed by Termen's musical invention. Termen held his hands to play through the first half of a melody, before leaving the Russian leader to play the second half by himself -- apparently he made quite a good job of it. Because of Lenin's advocacy for his work, Termen was sent around the Soviet Union on a propaganda tour -- what was known as an "agitprop tour", in the familiar Soviet way of creating portmanteau words. In 1923 the first piece of music written specially for the instrument was performed by Termen himself with the Leningrad Philharmonic, Andrey Paschenko's Symphonic Mystery for Termenvox and Orchestra. The score for that was later lost, but has been reconstructed, and the piece was given a "second premiere" in 2020 [Excerpt: Andrey Paschenko, "Symphonic Mystery for Termenvox and Orchestra" ] But the musical instrument wasn't the only scientific innovation that Termen was working on. He thought he could reverse death itself, and bring the dead back to life.  He was inspired in this by the way that dead organisms could be perfectly preserved in the Siberian permafrost. He thought that if he could only freeze a dead person in the permafrost, he could then revive them later -- basically the same idea as the later idea of cryogenics, although Termen seems to have thought from the accounts I've read that all it would take would be to freeze and then thaw them, and not to have considered the other things that would be necessary to bring them back to life. Termen made two attempts to actually do this, or at least made preliminary moves in that direction. The first came when his assistant, a twenty-year-old woman, died of pneumonia. Termen was heartbroken at the death of someone so young, who he'd liked a great deal, and was convinced that if he could just freeze her body for a while he could soon revive her. He talked with Ioffe about this -- Ioffe was friends with the girl's family -- and Ioffe told him that he thought that he was probably right and probably could revive her. But he also thought that it would be cruel to distress the girl's parents further by discussing it with them, and so Termen didn't get his chance to experiment. He was even keener on trying his technique shortly afterwards, when Lenin died. Termen was a fervent supporter of the Revolution, and thought Lenin was a great man whose leadership was still needed -- and he had contacts within the top echelons of the Kremlin. He got in touch with them as soon as he heard of Lenin's death, in an attempt to get the opportunity to cryopreserve his corpse and revive him. Sadly, by this time it was too late. Lenin's brain had been pickled, and so the opportunity to resurrect him as a zombie Lenin was denied forever. Termen was desperately interested in the idea of bringing people back from the dead, and he wanted to pursue it further with his lab, but he was also being pushed to give demonstrations of his music, as well as doing security work -- Ioffe, it turned out, was also working as a secret agent, making various research trips to Germany that were also intended to foment Communist revolution. For now, Termen was doing more normal security work -- his burglar alarms were being used to guard bank vaults and the like, but this was at the order of the security state. But while Termen was working on his burglar alarms and musical instruments and attempts to revive dead dictators, his main project was his doctoral work, which was on the TV. We've said before in this podcast that there's no first anything, and that goes just as much for inventions as it does for music. Most inventions build on work done by others, which builds on work done by others, and so there were a lot of people building prototype TVs at this point. In Britain we tend to say "the inventor of the TV" was John Logie Baird, but Baird was working at the same time as people like the American Charles Francis Jenkins and the Japanese inventor Kenjiro Takayanagi, all of them building on earlier work by people like Archibald Low. Termen's prototype TV, the first one in Russia, came slightly later than any of those people, but was created more or less independently, and was more advanced in several ways, with a bigger screen and better resolution. Shortly after Lenin's death, Termen was invited to demonstrate his invention to Stalin, who professed himself amazed at the "magic mirror". [Excerpt: Blake Jones and the Trike Shop, "Astronauts in Trouble"] Termen was sent off to tour Europe giving demonstrations of his inventions, particularly his musical instrument. It was on this trip that he started using the Romanisation "Leon Theremin", and this is how Western media invariably referred to him. Rather than transliterate the Cyrillic spelling of his birth name, he used the French spelling his Huguenot ancestors had used before they emigrated to Russia, and called himself Leo or Leon rather than Lev. He was known throughout his life by both names, but said to a journalist in 1928 "First of all, I am not Tair-uh-MEEN. I wrote my name with French letters for French pronunciation. I am Lev Sergeyevich Tair-MEN.". We will continue to call him Termen, partly because he expressed that mild preference (though again, he definitely went by both names through choice) but also to distinguish him from the instrument, because while his invention remained known in Russia as the termenvox, in the rest of the world it became known as the theremin. He performed at the Paris Opera, and the New York Times printed a review saying "Some musicians were extremely pessimistic about the possibilities of the device, because at times M. Theremin played lamentably out of tune. But the finest Stradivarius, in the hands of a tyro, can give forth frightful sounds. The fact that the inventor was able to perform certain pieces with absolute precision proves that there remains to be solved only questions of practice and technique." Termen also came to the UK, where he performed in front of an audience including George Bernard Shaw, Arnold Bennett, Henry Wood and others. Arnold Bennett was astonished, but Bernard Shaw, who had very strong opinions about music, as anyone who has read his criticism will be aware, compared the sound unfavourably to that of a comb and paper. After performing in Europe, Termen made his way to the US, to continue his work of performance, propagandising for the Soviet Revolution, and trying to license the patents for his inventions, to bring money both to him and to the Soviet state. He entered the US on a six-month visitor's visa, but stayed there for eleven years, renewing the visa every six months. His initial tour was a success, though at least one open-air concert had to be cancelled because, as the Communist newspaper the Daily Worker put it, "the weather on Saturday took such a counter-revolutionary turn". Nicolas Slonimsky, the musicologist we've encountered several times before, and who would become part of Termen's circle in the US, reviewed one of the performances, and described the peculiar audiences that Termen was getting -- "a considerable crop of ladies and gentlemen engaged in earnest exploration of the Great Beyond...the mental processes peculiar to believers in cosmic vibrations imparted a beatific look to some of the listeners. Boston is a seat of scientific religion; before he knows it Professor Theremin may be proclaimed Krishnamurti and sanctified as a new deity". Termen licensed his patents on the invention to RCA, who in 1929 started mass-producing the first ever theremins for general use. Termen also started working with the conductor Leopold Stokowski, including developing a new kind of theremin for Stokowski's orchestra to use, one with a fingerboard played like a cello. Stokowski said "I believe we shall have orchestras of these electric instruments. Thus will begin a new era in music history, just as modern materials and methods of construction have produced a new era of architecture." Possibly of more interest to the wider public, Lennington Sherwell, the son of an RCA salesman, took up the theremin professionally, and joined the band of Rudy Vallee, one of the most popular singers of the period. Vallee was someone who constantly experimented with new sounds, and has for example been named as the first band leader to use an electric banjo, and Vallee liked the sound of the theremin so much he ordered a custom-built left-handed one for himself. Sherwell stayed in Vallee's band for quite a while, and performed with him on the radio and in recording sessions, but it's very difficult to hear him in any of the recordings -- the recording equipment in use in 1930 was very primitive, and Vallee had a very big band with a lot of string and horn players, and his arrangements tended to have lots of instruments playing in unison rather than playing individual lines that are easy to differentiate. On top of that, the fashion at the time when playing the instrument was to try and have it sound as much like other instruments as possible -- to duplicate the sound of a cello or violin or clarinet, rather than to lean in to the instrument's own idiosyncracies. I *think* though that I can hear Sherwell's playing in the instrumental break of Vallee's big hit "You're Driving Me Crazy" -- certainly it was recorded at the time that Sherwell was in the band, and there's an instrument in there with a very pure tone, but quite a lot of vibrato, in the mid range, that seems only to be playing in the break and not the rest of the song. I'm not saying this is *definitely* a theremin solo on one of the biggest hits of 1930, but I'm not saying it's not, either: [Excerpt: Rudy Vallee, "You're Driving Me Crazy" ] Termen also invented a light show to go along with his instrument -- the illumovox, which had a light shining through a strip of gelatin of different colours, which would be rotated depending on the pitch of the theremin, so that lower notes would cause the light to shine a deep red, while the highest notes would make it shine a light blue, with different shades in between. By 1930, though, Termen's fortunes had started to turn slightly. Stokowski kept using theremins in the orchestra for a while, especially the fingerboard models to reinforce the bass, but they caused problems. As Slonimsky said "The infrasonic vibrations were so powerful...that they hit the stomach physically, causing near-nausea in the double-bass section of the orchestra". Fairly soon, the Theremin was overtaken by other instruments, like the ondes martenot, an instrument very similar to the theremin but with more precise control, and with a wider range of available timbres. And in 1931, RCA was sued by another company for patent infringement with regard to the Theremin -- the De Forest Radio Company had patents around the use of vacuum tubes in music, and they claimed damages of six thousand dollars, plus RCA had to stop making theremins. Since at the time, RCA had only made an initial batch of five hundred instruments total, and had sold 485 of them, many of them as promotional loss-leaders for future batches, they had actually made a loss of three hundred dollars even before the six thousand dollar damages, and decided not to renew their option on Termen's patents. But Termen was still working on his musical ideas. Slonimsky also introduced Termen to the avant-garde composer and theosophist Henry Cowell, who was interested in experimental sounds, and used to do things like play the strings inside the piano to get a different tone: [Excerpt: Henry Cowell, "Aeolian Harp and Sinister Resonance"] Cowell was part of a circle of composers and musicologists that included Edgard Varese, Charles Ives, and Charles Seeger and Ruth Crawford, who Cowell would introduce to each other. Crawford would later marry Seeger, and they would have several children together, including the folk singer Peggy Seeger, and Crawford would also adopt Seeger's son Pete. Cowell and Termen would together invent the rhythmicon, the first ever drum machine, though the rhythmicon could play notes as well as rhythms. Only two rhythmicons were made while Termen was in the US. The first was owned by Cowell. The second, improved, model was bought by Charles Ives, but bought as a gift for Cowell and Slonimsky to use in their compositions. Sadly, both rhythmicons eventually broke down, and no recording of either is known to exist. Termen started to get further and further into debt, especially as the Great Depression started to hit, and he also had a personal loss -- he'd been training a student and had fallen in love with her, although he was married. But when she married herself, he cut off all ties with her, though Clara Rockmore would become one of the few people to use the instrument seriously and become a real virtuoso on it. He moved into other fields, all loosely based around the same basic ideas of detecting someone's distance from an object. He built electronic gun detectors for Alcatraz and Sing-Sing prisons, and he came up with an altimeter for aeroplanes. There was also a "magic mirror" -- glass that appeared like a mirror until it was backlit, at which point it became transparent. This was put into shop windows along with a proximity detector -- every time someone stepped close to look at their reflection, the reflection would disappear and be replaced with the objects behind the mirror. He was also by this point having to spy for the USSR on a more regular basis. Every week he would meet up in a cafe with two diplomats from the Russian embassy, who would order him to drink several shots of vodka -- the idea was that they would loosen his inhibitions enough that he would not be able to hide things from them -- before he related various bits of industrial espionage he'd done for them. Having inventions of his own meant he was able to talk with engineers in the aerospace industry and get all sorts of bits of information that would otherwise not have been available, and he fed this back to Moscow. He eventually divorced his first wife, and remarried -- a Black American dancer many years his junior named Lavinia Williams, who would be the great love of his life. This caused some scandal in his social circle, more because of her race than the age gap. But by 1938 he had to leave the US. He'd been there on a six-month visa, which had been renewed every six months for more than a decade, and he'd also not been paying income tax and was massively in debt. He smuggled himself back to the USSR, but his wife was, at the last minute, not allowed on to the ship with him. He'd had to make the arrangements in secret, and hadn't even told her of the plans, so the first she knew was when he disappeared. He would later claim that the Soviets had told him she would be sent for two weeks later, but she had no knowledge of any of this. For decades, Lavinia would not even know if her husband was dead or alive. [Excerpt: Blake Jones and the Trike Shop, "Astronauts in Trouble"] When Termen got back to the USSR, he found it had changed beyond recognition. Stalin's reign of terror was now well underway, and not only could he not find a job, most of the people who he'd been in contact with at the top of the Kremlin had been purged. Termen was himself arrested and tortured into signing a false confession to counter-revolutionary activities and membership of fascist organisations. He was sentenced to eight years in a forced labour camp, which in reality was a death sentence -- it was expected that workers there would work themselves to death on starvation rations long before their sentences were up -- but relatively quickly he was transferred to a special prison where people with experience of aeronautical design were working. He was still a prisoner, but in conditions not too far removed from normal civilian life, and allowed to do scientific and technical work with some of the greatest experts in the field -- almost all of whom had also been arrested in one purge or another. One of the pieces of work Termen did was at the direct order of Laventy Beria, Stalin's right-hand man and the architect of most of the terrors of the Stalinist regime. In Spring 1945, while the USA and USSR were still supposed to be allies in World War II, Beria wanted to bug the residence of the US ambassador, and got Termen to design a bug that would get past all the normal screenings. The bug that Termen designed was entirely passive and unpowered -- it did nothing unless a microwave beam of a precise frequency was beamed at it, and only then did it start transmitting. It was placed in a wooden replica of the Great Seal of the United States, presented to the ambassador by a troupe of scouts as a gesture of friendship between the two countries. The wood in the eagle's beak was thin enough to let the sound through. It remained there for seven years, through the tenures of four ambassadors, only being unmasked when a British radio operator accidentally tuned to the frequency it was transmitting on and was horrified to hear secret diplomatic conversations. Upon its discovery, the US couldn't figure out how it worked, and eventually shared the information with MI5, who took eighteen months to reverse-engineer Termen's bug and come up with their own, which remained the standard bug in use for about a decade. The CIA's own attempts to reverse-engineer it failed altogether. It was also Termen who came up with that well-known bit of spycraft -- focussing an infra-red beam on a window pane, to use it to pick up the sound of conversations happening in the room behind it. Beria was so pleased with Termen's inventions that he got Termen to start bugging Stalin himself, so Beria would be able to keep track of Stalin's whims. Termen performed such great services for Beria that Beria actually allowed him to go free not long after his sentence was served. Not only that, but Beria nominated Termen for the Stalin Award, Class II, for his espionage work -- and Stalin, not realising that Termen had been bugging *him* as well as foreign powers, actually upgraded that to a Class I, the highest honour the Soviet state gave. While Termen was free, he found himself at a loose end, and ended up volunteering to work for the organisation he had been working for -- which went by many names but became known as the KGB from the 1950s onwards. He tried to persuade the government to let Lavinia, who he hadn't seen in eight years, come over and join him, but they wouldn't even allow him to contact her, and he eventually remarried. Meanwhile, after Stalin's death, Beria was arrested for his crimes, and charged under the same law that he had had Termen convicted under. Beria wasn't as lucky as Termen, though, and was executed. By 1964, Termen had had enough of the KGB, because they wanted him to investigate obvious pseudoscience -- they wanted him to look into aliens, UFOs, ESP... and telepathy. [Excerpt, The Beach Boys, "Good Vibrations (early version)" "She's already working on my brain"] He quit and went back to civilian life.  He started working in the acoustics lab in Moscow Conservatory, although he had to start at the bottom because everything he'd been doing for more than a quarter of a century was classified. He also wrote a short book on electronic music. In the late sixties an article on him was published in the US -- the first sign any of his old friends had that he'd not  died nearly thirty years earlier. They started corresponding with him, and he became a minor celebrity again, but this was disapproved of by the Soviet government -- electronic music was still considered bourgeois decadence and not suitable for the Soviet Union, and all his instruments were smashed and he was sacked from the conservatory. He continued working in various technical jobs until the 1980s, and still continued inventing refinements of the theremin, although he never had any official support for his work. In the eighties, a writer tried to get him some sort of official recognition -- the Stalin Prize was secret -- and the university at which he was working sent a reply saying, in part, "L.S. Termen took part in research conducted by the department as an ordinary worker and he did not show enough creative activity, nor does he have any achievements on the basis of which he could be recommended for a Government decoration." By this time he was living in shared accommodation with a bunch of other people, one room to himself and using a shared bathroom, kitchen, and so on. After Glasnost he did some interviews and was asked about this, and said "I never wanted to make demands and don't want to now. I phoned the housing department about three months ago and inquired about my turn to have a new flat. The woman told me that my turn would come in five or six years. Not a very reassuring answer if one is ninety-two years old." In 1989 he was finally allowed out of the USSR again, for the first time in fifty-one years, to attend a UNESCO sponsored symposium on electronic music. Among other things, he was given, forty-eight years late, a letter that his old colleague Edgard Varese had sent about his composition Ecuatorial, which had originally been written for theremin. Varese had wanted to revise the work, and had wanted to get modified theremins that could do what he wanted, and had asked the inventor for help, but the letter had been suppressed by the Soviet government. When he got no reply, Varese had switched to using ondes martenot instead. [Excerpt: Edgard Varese, "Ecuatorial"] In the 1970s, after the death of his third wife, Termen had started an occasional correspondence with his second wife, Lavinia, the one who had not been able to come with him to the USSR and hadn't known if he was alive for so many decades. She was now a prominent activist in Haiti, having established dance schools in many Caribbean countries, and Termen still held out hope that they could be reunited, even writing her a letter in 1988 proposing remarriage. But sadly, less than a month after Termen's first trip outside the USSR, she died -- officially of a heart attack or food poisoning, but there's a strong suspicion that she was murdered by the military dictatorship for her closeness to Jean-Bertrand Aristide, the pro-democracy activist who later became President of Haiti. Termen was finally allowed to join the Communist Party in the spring of 1991, just before the USSR finally dissolved -- he'd been forbidden up to that point because of his conviction for counter-revolutionary crimes. He was asked by a Western friend why he'd done that when everyone else was trying to *leave* the Communist Party, and he explained that he'd made a promise to Lenin. In his final years he was researching immortality, going back to the work he had done in his youth, working with biologists, trying to find a way to restore elderly bodies to youthful vigour. But sadly he died in 1993, aged ninety-seven, before he achieved his goal. On one of his last trips outside the USSR, in 1991, he visited the US, and in California he finally got to hear the song that most people associate with his invention, even though it didn't actually feature a theremin: [Excerpt: The Beach Boys, "Good Vibrations"] Back in the 1930s, when he was working with Slonimsky and Varese and Ives and the rest, Termen had set up the Theremin Studio, a sort of experimental arts lab, and in 1931 he had invited the musicologist, composer, and theoretician Joseph Schillinger to become a lecturer there. Schillinger had been one of the first composers to be really interested in the theremin, and had composed a very early piece written specifically for the instrument, the First Airphonic Suite: [Excerpt: Joseph Schillinger, "First Airphonic Suite"] But he was most influential as a theoretician. Schillinger believed that all of the arts were susceptible to rigorous mathematical analysis, and that you could use that analysis to generate new art according to mathematical principles, art that would be perfect. Schillinger planned to work with Termen to try to invent a machine that could compose, perform, and transmit music. The idea was that someone would be able to tune in a radio and listen to a piece of music in real time as it was being algorithmically composed and transmitted. The two men never achieved this, but Schillinger became very, very, respected as someone with a rigorous theory of musical structure -- though reading his magnum opus, the Schillinger System of Musical Composition, is frankly like wading through treacle. I'll read a short excerpt just to give an idea of his thinking: "On the receiving end, phasic stimuli produced by instruments encounter a metamorphic auditory integrator. This integrator represents the auditory apparatus as a whole and is a complex interdependent system. It consists of two receivers (ears), transmitters, auditory nerves, and a transformer, the auditory braincenter.  The response to a stimulus is integrated both quantitatively and selectively. The neuronic energy of response becomes the psychonic energy of auditory image. The response to stimuli and the process of integration are functional operations and, as such, can be described in mathematical terms , i.e., as  synchronization, addition, subtraction, multiplication, etc. But these integrative processes alone do not constitute the material of orchestration either.  The auditory image, whether resulting from phasic stimuli of an excitor or from selfstimulation of the auditory brain-center, can be described only in Psychological terms, of loudness, pitch, quality, etc. This leads us to the conclusion that the material of orchestration can be defined only as a group of conditions under which an integrated image results from a sonic stimulus subjected to an auditory response.  This constitutes an interdependent tripartite system, in which the existence of one component necessitates the existence of two others. The composer can imagine an integrated sonic form, yet he cannot transmit it to the auditor (unless telepathicaliy) without sonic stimulus and hearing apparatus." That's Schillinger's way of saying that if a composer wants someone to hear the music they've written, the composer needs a musical instrument and the listener needs ears and a brain. This kind of revolutionary insight made Schillinger immensely sought after in the early 1930s, and among his pupils were the swing bandleaders Benny Goodman and Tommy Dorsey, and the songwriter George Gershwin, who turned to Schillinger for advice when he was writing his opera Porgy and Bess: [Excerpt: Ella Fitzgerald and Louis Armstrong, "Here Come De Honey Man"] Another of his pupils was the trombonist and arranger Glenn Miller, who at that time was a session player working in pickup studio bands for people like Red Nichols. Miller spent some time studying with him in the early thirties, and applied those lessons when given the job of putting together arrangements for Ray Noble, his first prominent job. In 1938 Glenn Miller walked into a strip joint to see a nineteen-year-old he'd been told to take a look at. This was another trombonist, Paul Tanner, who was at the time working as a backing musician for the strippers. Miller had recently broken up his first big band, after a complete lack of success, and was looking to put together a new big band, to play arrangements in the style he had worked out while working for Noble. As Tanner later put it "he said, `Well, how soon can you come with me?' I said, `I can come right now.' I told him I was all packed, I had my toothbrush in my pocket and everything. And so I went with him that night, and I stayed with him until he broke the band up in September 1942." The new band spent a few months playing the kind of gigs that an unknown band can get, but they soon had a massive success with a song Miller had originally written as an arranging exercise set for him by Schillinger, a song that started out under the title "Miller's Tune", but soon became known worldwide as "Moonlight Serenade": [Excerpt: Glenn Miller, "Moonlight Serenade"] The Miller band had a lot of lineup changes in the four and a bit years it was together, but other than Miller himself there were only four members who were with that group throughout its career, from the early dates opening for  Freddie Fisher and His Schnickelfritzers right through to its end as the most popular band in America. They were piano player Chummy MacGregor, clarinet player Wilbur Schwartz, tenor sax player Tex Beneke, and Tanner. They played on all of Miller's big hits, like "In the Mood" and "Chattanooga Choo-Choo": [Excerpt: Glenn Miller, "Chattanooga Choo-Choo"] But in September 1942, the band broke up as the members entered the armed forces, and Tanner found himself in the Army while Miller was in the Air Force, so while both played in military bands, they weren't playing together, and Miller disappeared over the Channel, presumed dead, in 1944. Tanner became a session trombonist, based in LA, and in 1958 he found himself on a session for a film soundtrack with Dr. Samuel Hoffman. I haven't been able to discover for sure which film this was for, but the only film on which Hoffman has an IMDB credit for that year is that American International Pictures classic, Earth Vs The Spider: [Excerpt: Earth Vs The Spider trailer] Hoffman was a chiropodist, and that was how he made most of his living, but as a teenager in the 1930s he had been a professional violin player under the name Hal Hope. One of the bands he played in was led by a man named Jolly Coburn, who had seen Rudy Vallee's band with their theremin and decided to take it up himself. Hoffman had then also got a theremin, and started his own all-electronic trio, with a Hammond organ player, and with a cello-style fingerboard theremin played by William Schuman, the future Pulitzer Prize winning composer. By the 1940s, Hoffman was a full-time doctor, but he'd retained his Musicians' Union card just in case the odd gig came along, and then in 1945 he received a call from Miklos Rozsa, who was working on the soundtrack for Alfred Hitchcock's new film, Spellbound. Rozsa had tried to get Clara Rockmore, the one true virtuoso on the theremin playing at the time, to play on the soundtrack, but she'd refused -- she didn't do film soundtrack work, because in her experience they only wanted her to play on films about ghosts or aliens, and she thought it damaged the dignity of the instrument. Rozsa turned to the American Federation of Musicians, who as it turned out had precisely one theremin player who could read music and wasn't called Clara Rockmore on their books. So Dr. Samuel Hoffman, chiropodist, suddenly found himself playing on one of the most highly regarded soundtracks of one of the most successful films of the forties: [Excerpt: Miklos Rozsa, "Spellbound"] Rozsa soon asked Hoffman to play on another soundtrack, for the Billy Wilder film The Lost Weekend, another of the great classics of late forties cinema. Both films' soundtracks were nominated for the Oscar, and Spellbound's won, and Hoffman soon found himself in demand as a session player. Hoffman didn't have any of Rockmore's qualms about playing on science fiction and horror films, and anyone with any love of the genre will have heard his playing on genre classics like The Five Thousand Fingers of Dr T, The Thing From Another World, It Came From Outer Space, and of course Bernard Hermann's score for The Day The Earth Stood Still: [Excerpt: The Day The Earth Stood Still score] As well as on such less-than-classics as The Devil's Weed, Voodoo Island, The Mad Magician, and of course Billy The Kid Vs Dracula. Hoffman became something of a celebrity, and also recorded several albums of lounge music with a band led by Les Baxter, like the massive hit Music Out Of The Moon, featuring tracks like “Lunar Rhapsody”: [Excerpt: Samuel Hoffman, "Lunar Rhapsody”] [Excerpt: Neil Armstrong] That voice you heard there was Neil Armstrong, on Apollo 11 on its way back from the moon. He took a tape of Hoffman's album with him. But while Hoffman was something of a celebrity in the fifties, the work dried up almost overnight in 1958 when he worked at that session with Paul Tanner. The theremin is a very difficult instrument to play, and while Hoffman was a good player, he wasn't a great one -- he was getting the work because he was the best in a very small pool of players, not because he was objectively the best there could be. Tanner noticed that Hoffman was having quite some difficulty getting the pitching right in the session, and realised that the theremin must be a very difficult instrument to play because it had no markings at all. So he decided to build an instrument that had the same sound, but that was more sensibly controlled than just waving your hands near it. He built his own invention, the electrotheremin, in less than a week, despite never before having had any experience in electrical engineering. He built it using an oscillator, a length of piano wire and a contact switch that could be slid up and down the wire, changing the pitch. Two days after he finished building it, he was in the studio, cutting his own equivalent of Hoffman's forties albums, Music For Heavenly Bodies, including a new exotica version of "Moonlight Serenade", the song that Glenn Miller had written decades earlier as an exercise for Schillinger: [Excerpt: Paul Tanner, "Moonlight Serenade"] Not only could the electrotheremin let the player control the pitch more accurately, but it could also do staccato notes easily -- something that's almost impossible with an actual theremin. And, on top of that, Tanner was cheaper than Hoffman. An instrumentalist hired to play two instruments is paid extra, but not as much extra as paying for another musician to come to the session, and since Tanner was a first-call trombone player who was likely to be at the session *anyway*, you might as well hire him if you want a theremin sound, rather than paying for Hoffman. Tanner was an excellent musician -- he was a professor of music at UCLA as well as being a session player, and he authored one of the standard textbooks on jazz -- and soon he had cornered the market, leaving Hoffman with only the occasional gig. We will actually be seeing Hoffman again, playing on a session for an artist we're going to look at in a couple of months, but in LA in the early sixties, if you wanted a theremin sound, you didn't hire a theremin player, you hired Paul Tanner to play his electrotheremin -- though the instrument was so obscure that many people didn't realise he wasn't actually playing a theremin. Certainly Brian Wilson seems to have thought he was when he hired him for "I Just Wasn't Made For These Times": [Excerpt: The Beach Boys, "I Just Wasn't Made For These Times"] We talked briefly about that track back in the episode on "God Only Knows",   but three days after recording that, Tanner was called back into the studio for another session on which Brian Wilson wanted a theremin sound. This was a song titled "Good, Good, Good Vibrations", and it was inspired by a conversation he'd had with his mother as a child. He'd asked her why dogs bark at some people and not at others, and she'd said that dogs could sense vibrations that people sent out, and some people had bad vibrations and some had good ones. It's possible that this came back to mind as he was planning the Pet Sounds album, which of course ends with the sound of his own dogs barking. It's also possible that he was thinking more generally about ideas like telepathy -- he had been starting to experiment with acid by this point, and was hanging around with a crowd of people who were proto-hippies, and reading up on a lot of the mystical ideas that were shared by those people. As we saw in the last episode, there was a huge crossover between people who were being influenced by drugs, people who were interested in Eastern religion, and people who were interested in what we now might think of as pseudo-science but at the time seemed to have a reasonable amount of validity, things like telepathy and remote viewing. Wilson had also had exposure from an early age to people claiming psychic powers. Jo Ann Marks, the Wilson family's neighbour and the mother of former Beach Boy David Marks, later had something of a minor career as a psychic to the stars (at least according to obituaries posted by her son) and she would often talk about being able to sense "vibrations". The record Wilson started out making in February 1966 with the Wrecking Crew was intended as an R&B single, and was also intended to sound *strange*: [Excerpt: The Beach Boys, "Good Vibrations: Gold Star 1966-02-18"] At this stage, the song he was working on was a very straightforward verse-chorus structure, and it was going to be an altogether conventional pop song. The verses -- which actually ended up used in the final single, are dominated by organ and Ray Pohlman's bass: [Excerpt: The Beach Boys, "Good Vibrations: Gold Star 1966-02-18"] These bear a strong resemblance to the verses of "Here Today", on the Pet Sounds album which the Beach Boys were still in the middle of making: [Excerpt: The Beach Boys, "Here Today (instrumental)"] But the chorus had far more of an R&B feel than anything the Beach Boys had done before: [Excerpt: The Beach Boys, "Good Vibrations: Gold Star 1966-02-18"] It did, though, have precedent. The origins of the chorus feel come from "Can I Get a Witness?", a Holland-Dozier-Holland song that had been a hit for Marvin Gaye in 1963: [Excerpt: Marvin Gaye, "Can I Get a Witness?"] The Beach Boys had picked up on that, and also on its similarity to the feel of Lonnie Mack's instrumental cover version of Chuck Berry's "Memphis, Tennessee", which, retitled "Memphis", had also been a hit in 1963, and in 1964 they recorded an instrumental which they called "Memphis Beach" while they were recording it but later retitled "Carl's Big Chance", which was credited to Brian and Carl Wilson, but was basically just playing the "Can I Get a Witness" riff over twelve-bar blues changes, with Carl doing some surf guitar over the top: [Excerpt: The Beach Boys, "Carl's Big Chance"] The "Can I Get a Witness" feel had quickly become a standard piece of the musical toolkit – you might notice the resemblance between that riff and the “talking 'bout my generation” backing vocals on “My Generation” by the Who, for example. It was also used on "The Boy From New York City", a hit on Red Bird Records by the Ad-Libs: [Excerpt: The Ad-Libs, "The Boy From New York City"] The Beach Boys had definitely been aware of that record -- on their 1965 album Summer Days... And Summer Nights! they recorded an answer song to it, "The Girl From New York City": [Excerpt: The Beach Boys, "The Girl From New York City"] And you can see how influenced Brian was by the Ad-Libs record by laying the early instrumental takes of the "Good Vibrations" chorus from this February session under the vocal intro of "The Boy From New York City". It's not a perfect match, but you can definitely hear that there's an influence there: [Excerpt: "The Boy From New York City"/"Good Vibrations"] A few days later, Brian had Carl Wilson overdub some extra bass, got a musician in to do a jaw harp overdub, and they also did a guide vocal, which I've sometimes seen credited to Brian and sometimes Carl, and can hear as both of them depending on what I'm listening for. This guide vocal used a set of placeholder lyrics written by Brian's collaborator Tony Asher, which weren't intended to be a final lyric: [Excerpt: The Beach Boys, "Good Vibrations (first version)"] Brian then put the track away for a month, while he continued work on the Pet Sounds album. At this point, as best we can gather, he was thinking of it as something of a failed experiment. In the first of the two autobiographies credited to Brian (one whose authenticity is dubious, as it was largely put together by a ghostwriter and Brian later said he'd never even read it) he talks about how he was actually planning to give the song to Wilson Pickett rather than keep it for the Beach Boys, and one can definitely imagine a Wilson Pickett version of the song as it was at this point. But Brian's friend Danny Hutton, at that time still a minor session singer who had not yet gone on to form the group that would become Three Dog Night, asked Brian if *he* could have the song if Brian wasn't going to use it. And this seems to have spurred Brian into rethinking the whole song. And in doing so he was inspired by his very first ever musical memory. Brian has talked a lot about how the first record he remembers hearing was when he was two years old, at his maternal grandmother's house, where he heard the Glenn Miller version of "Rhapsody in Blue", a three-minute cut-down version of Gershwin's masterpiece, on which Paul Tanner had of course coincidentally played: [Excerpt: The Glenn Miller Orchestra, "Rhapsody in Blue"] Hearing that music, which Brian's mother also played for him a lot as a child, was one of the most profoundly moving experiences of Brian's young life, and "Rhapsody in Blue" has become one of those touchstone pieces that he returns to again and again. He has recorded studio versions of it twice, in the mid-nineties with Van Dyke Parks: [Excerpt: Brian Wilson and Van Dyke Parks, "Rhapsody in Blue"] and in 2010 with his solo band, as the intro and outro of an album of Gershwin covers: [Excerpt: Brian Wilson, "Rhapsody in Blue"] You'll also often see clips of him playing "Rhapsody in Blue" when sat at the piano -- it's one of his go-to songs. So he decided he was going to come up with a song that was structured like "Rhapsody in Blue" -- what publicist Derek Taylor would later describe as a "pocket symphony", but "pocket rhapsody" would possibly be a better term for it. It was going to be one continuous song, but in different sections that would have different instrumentation and different feelings to them -- he'd even record them in different studios to get different sounds for them, though he would still often have the musicians run through the whole song in each studio. He would mix and match the sections in the edit. His second attempt to record the whole track, at the start of April, gave a sign of what he was attempting, though he would not end up using any of the material from this session: [Excerpt: The Beach Boys, "Good Vibrations: Gold Star 1966-04-09" around 02:34] Nearly a month later, on the fourth of May, he was back in the studio -- this time in Western Studios rather than Gold Star where the previous sessions had been held, with yet another selection of musicians from the Wrecking Crew, plus Tanner, to record another version. This time, part of the session was used for the bridge for the eventual single: [Excerpt: The Beach Boys: "Good Vibrations: Western 1966-05-04 Second Chorus and Fade"] On the twenty-fourth of May the Wrecking Crew, with Carl Wilson on Fender bass (while Lyle Ritz continued to play string bass, and Carol Kaye, who didn't end up on the finished record at all, but who was on many of the unused sessions, played Danelectro), had another attempt at the track, this time in Sunset Studios: [Excerpt: The Beach Boys: "Good Vibrations: Sunset Sound 1966-05-24 (Parts 2&3)"] Three days later, another group of musicians, with Carl now switched to rhythm guitar, were back in Western Studios recording this: [Excerpt: The Beach Boys: "Good Vibrations: Western 1966-05-27 Part C" from 2:52] The fade from that session was used in the final track. A few days later they were in the studio again, a smaller group of people with Carl on guitar and Brian on piano, along with Don Randi on electric harpsichord, Bill Pitman on electric bass, Lyle Ritz on string bass and Hal Blaine on drums. This time there seems to have been another inspiration, though I've never heard it mentioned as an influence. In March, a band called The Association, who were friends with the Beach Boys, had released their single "Along Comes Mary", and by June it had become a big hit: [Excerpt: The Association, "Along Comes Mary"] Now the fuzz bass part they were using on the session on the second of June sounds to my ears very, very, like that intro: [Excerpt: The Beach Boys, "Good Vibrations (Inspiration) Western 1966-06-02" from 01:47] That session produced the basic track that was used for the choruses on the final single, onto which the electrotheremin was later overdubbed as Tanner wasn't at that session. Some time around this point, someone suggested to Brian that they should use a cello along with the electrotheremin in the choruses, playing triplets on the low notes. Brian has usually said that this was Carl's idea, while Brian's friend Van Dyke Parks has always said that he gave Brian the idea. Both seem quite certain of this, and neither has any reason to lie, so I suspect what might have happened is that Parks gave Brian the initial idea to have a cello on the track, while Carl in the studio suggested having it specifically play triplets. Either way, a cello part by Jesse Erlich was added to those choruses. There were more sessions in June, but everything from those sessions was scrapped. At some point around this time, Mike Love came up with a bass vocal lyric, which he sang along with the bass in the choruses in a group vocal session. On August the twenty-fourth, two months after what one would think at this point was the final instrumental session, a rough edit of the track was pulled together. By this point the chorus had altered quite a bit. It had originally just been eight bars of G-flat, four bars of B-flat, then four more bars of G-flat. But now Brian had decided to rework an idea he had used in "California Girls". In that song, each repetition of the line "I wish they all could be California" starts a tone lower than the one before. Here, after the bass hook line is repeated, everything moves up a step, repeats the line, and then moves up another step: [Excerpt: The Beach Boys, "Good Vibrations: [Alternate Edit] 1966-08-24"] But Brian was dissatisfied with this version of the track. The lyrics obviously still needed rewriting, but more than that, there was a section he thought needed totally rerecording -- this bit: [Excerpt: The Beach Boys, "Good Vibrations: [Alternate Edit] 1966-08-24"] So on the first of September, six and a half months after the first instrumental session for the song, the final one took place. This had Dennis Wilson on organ, Tommy Morgan on harmonicas, Lyle Ritz on string bass, and Hal Blaine and Carl Wilson on percussion, and replaced that with a new, gentler, version: [Excerpt: The Beach Boys: "Good Vibrations (Western 1966-09-01) [New Bridge]"] Well, that was almost the final instrumental session -- they called Paul Tanner in to a vocal overdub session to redo some of the electrotheremin parts, but that was basically it. Now all they had to do was do the final vocals. Oh, and they needed some proper lyrics. By this point Brian was no longer working with Tony Asher. He'd started working with Van Dyke Parks on some songs, but Parks wasn't interested in stepping into a track that had already been worked on so long, so Brian eventually turned to Mike Love, who'd already come up with the bass vocal hook, to write the lyrics. Love wrote them in the car, on the way to the studio, dictating them to his wife as he drove, and they're actually some of his best work. The first verse grounds everything in the sensory, in the earthy. He makes a song originally about *extra* -sensory perception into one about sensory perception -- the first verse covers sight, sound, and smell: [Excerpt: The Beach Boys, "Good Vibrations"] Carl Wilson was chosen to sing the lead vocal, but you'll notice a slight change in timbre on the line "I hear the sound of a" -- that's Brian stepping into double him on the high notes. Listen again: [Excerpt: The Beach Boys, "Good Vibrations"] For the second verse, Love's lyric moves from the sensory grounding of the first verse to the extrasensory perception that the song has always been about, with the protagonist knowing things about the woman who's the object of the song without directly perceiving them. The record is one of those where I wish I was able to play the whole thing for you, because it's a masterpiece of structure, and of editing, and of dynamics. It's also a record that even now is impossible to replicate properly on stage, though both its writers in their live performances come very close. But while someone in the audience for either the current touring Beach Boys led by Mike Love or for Brian Wilson's solo shows might come away thinking "that sounded just like the record", both have radically different interpretations of it even while sticking close to the original arrangement. The touring Beach Boys' version is all throbbing strangeness, almost garage-rock, emphasising the psychedelia of the track: [Excerpt: The Beach Boys, "Good Vibrations (live 2014)"] While Brian Wilson's live version is more meditative, emphasising the gentle aspects: [Excerpt Brian Wilson, "Good Vibrations (live at the Roxy)"] But back in 1966, there was definitely no way to reproduce it live with a five-person band. According to Tanner, they actually asked him if he would tour with them, but he refused -- his touring days were over, and also he felt he would look ridiculous, a middle-aged man on stage with a bunch of young rock and roll stars, though apparently they offered to buy him a wig so he wouldn't look so out of place. When he wouldn't tour with them, they asked him where they could get a theremin, and he pointed them in the direction of Robert Moog. Moog -- whose name is spelled M-o-o-g and often mispronounced "moog", had been a teenager in 1949, when he'd seen a schematic for a theremin in an electronic hobbyist magazine, after Samuel Hoffman had brought the instrument back into the limelight. He'd built his own, and started building others to sell to other hobbyists, and had also started branching out into other electronic instruments by the mid-sixties. His small company was the only one still manufacturing actual theremins, but when the Beach Boys came to him and asked him for one, they found it very difficult to control, and asked him if he could do anything simpler. He came up with a ribbon-controlled oscillator, on the same principle as Tanner's electro-theremin, but even simpler to operate, and the Beach Boys bought it and gave it to Mike Love to play on stage. All he had to do was run his finger up and down a metallic ribbon, with the positions of the notes marked on it, and it would come up with a good approximation of the electro-theremin sound. Love played this "woo-woo machine" as he referred to it, on stage for several years: [Excerpt: The Beach Boys, "Good Vibrations (live in Hawaii 8/26/67)"] Moog was at the time starting to build his first synthesisers, and having developed that ribbon-control mechanism he decided to include it in the early models as one of several different methods of controlling the Moog synthesiser, the instrument that became synonymous with the synthesiser in the late sixties and early seventies: [Excerpt: Gershon Kingsley and Leonid Hambro, "Rhapsody in Blue" from Switched-On Gershwin] "Good Vibrations" became the Beach Boys' biggest ever hit -- their third US number one, and their first to make number one in the UK. Brian Wilson had managed, with the help of his collaborators, to make something that combined avant-garde psychedelic music and catchy pop hooks, a truly experimental record that was also a genuine pop classic. To this day, it's often cited as the greatest single of all time. But Brian knew he could do better. He could be even more progressive. He could make an entire album using the same techniques as "Good Vibrations", one where themes could recur, where sections could be edited together and songs could be constructed in the edit. Instead of a pocket symphony, he could make a full-blown teenage symphony to God. All he had to do was to keep looking forward, believe he could achieve his goal, and whatever happened, not lose his nerve and turn back. [Excerpt: The Beach Boys, "Smile Promo" ]

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Dr. Shane Harpham is a pediatric dentist and the owner of Sea Smiles Pediatric Dentistry in Bluffton, South Carolina. Dr. Shane and I open a couple craft beers and talk about how to do the perfect class II composite restoration on a primary tooth. Some of the topics we discuss are: - Creating a team and environment to set you up for success - Treatment planning and case selection (composites vs SSCs) - Isolation techniques - Prep design, bonds, and finishing - Glass ionomers and Equia Forte - Areas that Class II restorations frequently fail - The importance of learning from your failures and always trying to improve