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Podcast microcurrent in Europe according MDR

This post is also available in: English (Englisch)

Podcast microcurrent in Europe according MDR

In this episode we speak about microcurrent therapy, frequency specific microcurrent and the regulatory pathway of the development of microcurrent devices in Europe according the medical-device-regulation (MDR). We have in interview Dr. Thorsten Stüker a technical engineer and physican who studied also at the Massachusetts Institute of Technology which is also well known as the MIT in Boston. Listen to this episode carefully because this will change you way of thinking about microcurrent generally.

Here are the fully show notes and the transkription

 

I: Hello. Welcome to our new podcast from Mikrostrom.com, the German microcurrent platform for microcurrent therapy and microcurrent devices. Here we are again with a new version of our English podcast. I know that the last one was approximately 12 months ago, so more than a year ago, but here we are again with an English version of our podcast. #00:00:33-1#

Today, I have a very interesting interview partner for everyone who’s interested in microcurrent generally and, of course, in microcurrent devices and microcurrent technology. With me here on Skype online is Dr Stüker. He’s a physician from Germany and a developer in electronics software and hardware. Hello, Dr Stüker. #00:01:00-9#

TS: Hello, Mr Walitschek. Let me introduce myself. I studied [unclear #00:01:10-0#] physics and later changed to Boston and studied at MiT for [unclear #00:01:18-6#] studies. I had to decide to work for nuclear, history or the military and I decided I didn’t want to. I was regretting it as it’s impossible for me to work in an industry which is not pacifistic, so I changed. I worked for the automotive industry, for consumer industries and later I started to develop for the medical industry. #00:01:54-8#

Microcurrent systems came to me between 2005/2006 when I had my first contact with the microcurrent idea, and years later when I read the first literature about it, a friend had the next contact to microcurrent. This is when I slowly decided to begin developing my microcurrent devices. Most of the devices’ development in the market really had no level, I have no idea why because there are really good engineers. For example, there is a device on the market developed in Munich which is technically good, of high quality with a high quality development. But also the rest of devices on the market, their development is not the best idea for whoever was doing it. #00:03:24-5#

My idea for a high level device developed because we are speaking about [unclear #00:03:29-5#] of customers and we have to speak all the time about the security of customers. I decided to start, and a few years later I began to develop my first owned device and was getting it into the market. Now, I’m in co-operation with one of the big manufacturers of microcurrent devices in Germany. Taking a look at Germany and other European markets, there are only a handful of companies selling microcurrent devices and from this handful there is now one company which is selling medical microcurrent devices fitting the conditions, the rules and laws for medical devices. #00:04:40-0#

I: You’re a physician and very well known in any kind of electronic developments, but one of your specialities is that you also studied in the US. We also have listeners from the US and the UK and I know you studied at the MiT. #00:05:05-5#

TS: Yes, I studied nucleus. When you study nucleus it’s another world. It’s like you’re dreaming about summer but in reality it’s winter. #00:05:20-5#

I: Sheldon Cooper would say this, right? #00:05:27-9#

TS: Yes. When you’re studying nucleus you discuss mathematics at a high level, but mostly you discuss physics of the nucleus. Maybe you’re speaking about [splice?] and other effects, but electronics is a bit further away. In my biography I came to electronics because in Germany you have more than one form of school, and when you’re stuck in one school form there’s no chance to study directly after school so I had to learn another job. It’s totally different in Germany than America and England. In Germany you learn for three and half years and afterwards you do an [unclear #00:06:27-3#] exam which shows after your studies you’re able to work in this job. After this, you do other studies if you want to become a meister. You can compare it with a bachelors but when you’re a master you’re allowed to enter university to study. From the beginning, I learned electronics. This was an add-on in my biography and I never lost contact in this field. Normally, people who study nucleus have less contact with electronics because there’s no need for it. You don’t need electronics to discuss about no trans-feed in a bond solid reactor. #00:07:50-8#

When I couldn’t work for the military or for the unsecure nuclear industry, I changed my view what to do with my life and changed planning my life. I decided to develop electronic, mechanical and mechatronic devices so I can live, I can pay my bills and I’m free with everything I do. So I was getting out of this position. When you get out of this position to develop a microcurrent device, a few things are in your brain because you’re looking at most devices on the market and nobody is ready for the MDR, a new regulation of medical devices. #00:09:01-7#

I: We will come back to this topic later. #00:09:05-4#

TS: I learned security-thinking while studying to be an electronics specialist. This knowledge helped me to develop devices which are firstly, secure and secondly, really able and powerful. In my view, something has to be done in the market. There has to be a new device that works well and fits Dr Carolyn McMakin’s ideas for her frequency-specific microcurrent and fit the therapy forms which Luxxamed in Germany is doing. Luxxamed is a company also developing medical microcurrent devices. #00:10:09-9#

I: In Germany and Europe, would you say there has to be a change in philosophy, even in strategy, developing and marketing microcurrent devices? #00:10:33-0#

TS: There are parts of the problem. The first part is the patient security. There are many devices on the market and you look to the rules, for example, the risk of an electric shock. There’s a big risk for many people who are connected to devices which are definitely unsecure so there has to be a change in the market to get these patients surely secured. #00:11:08-5#

I: The risk management of companies and even security of the devices, of course, but would you say patient security will change with the new guideline, the MDR Medical Device Regulation? Or is security and efficiency of microcurrent devices more connected to the understanding of development, the engineering, also the quality management system? How would you bring these three things together in a microcurrent device point of view? #00:11:59-0#

TS: When you look at devices in the market and you look behind the scenes, you see manufacturers are getting somebody to build up a device completely. They’re carrying it for a technical laboratory, selling it for a few years – the fact is they’re not allowed to normally, but they still do it. Without better and deeper control, there is no chance to get security and the efficiency in this market. One of the most important facts is, if you want to build up microcurrent devices, the current and voltage of the device, the pulse form and exactness of the frequencies fit together to a really good device and vice versa. If you have not got the correct voltage or the correct current regulation, for example, the correct frequent currents, the correct frequencies, you have a device which is not working correctly. In this moment, something happened in the European Union, some say because somebody was selling bigger breasts to girls for much money with bad materials. #00:13:44-9#

I: You mean the PIP scandal? #00:13:47-0#

TS: I didn’t want to say it aloud but, yes. #00:13:50-8#

I: But we can say it aloud because everyone knows it, hopefully. #00:13:55-6#

TS: This scandal was the beginning of a process in the EU. It was the last nail which was needed that [unclear #00:14:07-7#] of the regulations for security in medical devices in the EU were starting to change the behaviour of the government and the behaviour of the regulatory affairs for microcurrent devices. #00:14:30-5#

I: That’s a good explanation “the last nail,” because most people think MDR started with the PIP scandal, and that’s wrong. It started much before. #00:14:48-0#

TS: It started much before. First, when this was coming out, they were looking to America at the new, first versions of FDA regulations for microcurrent and other medical devices. They started to set up really high levels of control of device manufacturers and the control of efficiency of devices. #00:15:10-8#

I: Do you think it’s a good sign of the European Union, or the European Commission, for medical manufacturers in general? Or do you think it’s over-regulated? #00:15:25-9#

TS: In Europe, when we’re producing microcurrent devices which are high level secure, a real high level efficient and have a high level of quality, then we have a medical device which fits in a fast way the FDA regulations or our regulations in [unclear #00:15:52-5# ]. If we look at this, especially with the change of deepness of controls looking to MDR, you’ll find it’s not the rules that are changing, if you look at (60) (61), for example, there are not so many changes. #00:16:20-7#

I: There are actually no changes. #00:16:22-7#

TS: It has nothing to do with the MDR, it has to do with the further development of the rule of (60) (61). The deepness of the control which is increasing now, is five times. In this moment, all devices which do not fit these rules will fall out from the market so there should not be a chance to sell a device in the European market which does not fit the rules. This, for device manufacturers which were always doing best practices, it’s really hard because they also have to fit the new documentation rules and fulfil the new development rules. But for all the other manufacturers which were not doing best practices, it will be the end because they have no chance to set up a quality management system according to the rules of the MDR and all the other rules you have because there is one main difference between the medical device regulation in Germany until now and 2020. Starting from 2020, everything you do in the case of a medical device is controlled. Today, you can set up a device, they are making a single control of a single device and nobody really looks into it, but starting from 2020, there is no chance to produce a device without a quality management system which is certified from a notified body. [unclear DEKA or Medset?] #00:18:35-6#

I: In my opinion, the MDR is the right signal from the European Union, or the European Commission, because if you produce and develop medical devices generally – it doesn’t matter if it’s a microcurrent device or an ultrasound device, shortwave device or any other devices, and we don’t speak about high risk devices like Level 3 or Risk Class 3 devices – but it’s the right signal because today, what I see in the market, is most manufacturers have the MDD, the Medical Device Directive, have the Harmonised Standards, but there is no real control over the government and the notified bodies. #00:19:33-6#

I think the MDR is a good signal. It is hard to achieve the MDR compliance, for sure, but in the end, companies which are really working, actually worked, on the MDR – because in one-and-a-half or approximately two years it’s on – we have to do risk management now, you have to have production which is controlled over a quality management system. You have to have a clinical evaluation which is now since last year according to the MEDDEV Guideline Revision 4. Clinical evaluation will be the hardest target to achieve for any company in the market, it doesn’t matter if you are small or big. The risk management is the same as before, there is no change in electricity security and there you’ll have a change in the post-market surveillance and post-market clinical follow-up. In my opinion, the companies which will achieve and in the end survive, especially the microcurrent production development companies which are coming out like mushrooms, it’s quite a good signal that people have to make a clinical evaluation all the time, not only once and not only on some studies and scientific papers published in the US or somewhere. It is helpful but in the end you have to make your own clinical evaluation. For sure, risk management is the last border to have an unsecured device in the market. There are some other topics in the MDR, the equivalent devices; maybe this is a challenge for companies to take an equivalent device and to rate the equivalence from the other device to your device. You have to have a qualified person in your company and if you’re using nano materials you will be in trouble, for sure. #00:22:30-6#

Let’s focus on the microcurrent production and developments. We have no nano materials normally. The qualified person you have to have in Germany. If I’m right, you need to have security officers for medical devices which have to be noticed to the government but I think it’s only in Germany, but the qualified person will be doing almost the same job. The qualified person has to do any other activities like risk management, has to update their technical documentation, the stat files and all this on the stock. #00:23:13-3#

In the end, all companies which will survive the MDR in 2020 are qualified companies and especially the microcurrent companies are the right ones in the market. Not only the patients but users can be sure that these companies achieve a certain level of quality, production and development which is state-of-the-art, or state-of-the-technical view; they can be sure these devices are correct, these devices are able to stay in the market for many years and are clinically evaluated so they’re efficient and effective so patients, in the end, take the price which is a pain free life. Do you agree? #00:24:25-0#

TS: That’s a nice sentence, “they spring up like mushrooms,” this is also because there were no regulations for PLM manufacturing so people were buying an OEM device, doing some changes on it and were selling it with their own label. No-one saw where it came from, no-one could even trace where it came from. And from now on, all these parts are changing. In my opinion, I believe after this you may have one or two companies from Germany which will stay alive. #00:25:06-8#

I: I would say one. Maybe two. But in the end, you’re right, the small ones will die. #00:25:17-9#

TS: The small ones will die. The non-serious ones will be killed. #00:25:30-4#

I: They will be charged in the first section, then they will be caught in the second section and then the last section they will be killed. Sure. #00:25:42-9#

TS: Exactly. I guess it will make the market cleaner, It will not drive up the prices, that’s not the point, but the point is the market will be cleaned after this process because there is no chance to spring up like mushrooms, there is only the chance to work in a serious way, to develop in a serious way. Even if you’re developing a device not for medical purposes, but for sporting purposes, when you want to use it for medical purposes you need to do the entire process, except development. You have to validate and verify the functionality and the security of the device before you’re allowed to get on the market with a medical device. Even then, and this was historically different, people were developing devices, they had no – let me really say out loud – they had no idea about patient protection. There was no idea about it. They had no idea what they were doing. They were writing that it is an equivalent device but when you look on an oscilloscope, you see the behaviour of the device is totally different to all known devices which are seriously on the market. #00:27:15-4#

I: But this causes harm to any other manufacturers in the microcurrent area. #00:27:20-3#

TS: This is the point. All of them will fail because they haven’t got the ability to develop. Look at my small company. I needed to get together with another company in the German market because I have the knowledge; it’s not possible to do it alone. I’m not a lone cowboy developing microcurrent devices. [Crosstalk #00:27:52-2#] company and you need really, one guy who supports the regulatory affairs because you cannot develop, produce and uphold the regulatory affairs in a clear way with one person. This is a fact. When you look at other small manufacturers, you have a structure that’s working in the following way: for example, near Dortmund, there’s a guy selling microcurrent devices. He’s normally not allowed to sell them as medical devices but he also can’t sell them as wellness devices because of the indications of the software which is shown on the device [unclear #00:28:45-9#]. So, he had for a long time the approval from [unclear #00:28:51-4#] as one of his customers was dying, he lost this nice part so he wasn’t stopping to sell devices with a number of these [unclear #00:29:10-5#] because, for him, it was okay because [unclear #00:29:13-9#] saw this device before a couple of years, and then I can sell. In the meantime, the rules were completely changed. They were really improving the [crosstalk] #00:29:28-9#

I: Even the Harmonised Standards changed in the last years. #00:29:35-1#

TS: The Harmonised Standards, of course. Because he was not reacting to these changes, at the moment he’s also able to produce a device that’s much cheaper than any other person because he can use cheaper parts.  #00:29:53-5#

I: No traceability, no risk management, no clinical evaluation. All these points are so expensive. #00:29:59-4#

TS: He has not fulfilled all these parts because he’s doing what he’s doing. At the start of 2020, this entire business model will be lost on the market. You will only have companies selling microcurrent devices which are allowed to sell them and have the test for security, reliability and efficiency of their devices. Even devices which were set up for sports, wellness or cosmetic purposes have to be tested in the same way and have to follow the same particular standards as the same Harmonised Standards. So you have a clean market where all people who are inside this market have defined rules which they have to follow and have to be compliant to these Harmonised Standards and they have no chance to get out of these standards. This is good from me. . #00:31:09-4#

My first view on the MDR, I said it’s catastrophic. I had an interview with a guy who was writing his master’s thesis about these skills, and I told him, “It’s catastrophic, it’s a demon which is killing the medical industry. ” But after a few months thinking about it, I realised it’s not only a demon, it’s also really a big chance because, in Germany, we have one thing we can say we’re proud of: it is our quality we’re able to produce, and the second thing is the engineering we can present. Exactly this will come up now. When I take a look at the devices I develop now and then I look at the devices I was developing 10 years ago, for sure, I can say the quality today is much, much better. The software has much better user interfaces, you have really more powerful devices and you have more reliability of the devices. Everything is fulfilled because I know the devices I’m developing have to be compliant with the MDR standards, and exactly this, and you take this in the middle of the table and say, it is not a demon it is not something bad, it’s the other way around: it’s really good for the European market – not for the companies which are not staying through this process. For them it’s really sad they have to go, they have to search for another business or even close their business, but the business I’m doing is following the standards so I was getting out. I don’t even have a problem fulfilling the standards because in my construction, in my engineering ideas, everything starts with the standards myself. It is so easy to develop a device when you have such small set of standards you cannot really get out.  #00:33:44-4#

When you’re developing, there’s no chance of something going wrong. You have the knowledge after the development process, after the device construction is checked from the notified body, even after I have checked the laboratory that the device is secure, everything is okay. I know myself there will not be any incident coming up that the device is not secure or something like this. There is no chance of an incident your device isn’t working because you have scientific works telling you exactly if the device is working or not working before you are on the market. Now they’re coming up to equivalent standards. Something historically, you were equivalent when you said it’s microcurrent. Nobody took a look at it and everybody was simply working it out. Today, you really have to fulfil the equivalent parts so you have to show the working device is really equivalent to the device you want to sell now. You and your own company have to build up high-level standards otherwise you will not be able to be compliant. #00:35:17-6#

I: This is quite an interesting discussion about regulatory pathways. The European Union is calling for them. You’re absolutely right. I agree with you that we have to build up our own standards. Our own standards are our own quality management according to ISO 13485 in the last edition from 2016. This is my opinion about this and I absolutely agree with you that the MDR, in the end, is quite a good sign and a quite good way to produce and bring medical devices in the market. Let’s now leave the regulatory path and go back just a few minutes because we’re running late in this podcast, but I think this is quite interesting for anyone. The regulatory will cause us some other podcasts. I never found an equivalent podcast which was speaking about the MDR rules. . #00:36:36-4#

Let’s go back to microcurrent: microcurrent therapy, microcurrent devices because you give one sentence about the frequency-specific microcurrent. I know personally Dr Carolyn McMakin, and she’s absolutely great in her work, in her philosophy and in her researches she did with microcurrent in the past and she will do in the future, but give me your opinion about microcurrent generally. You know microcurrent, for me, is the first hit to treat in acute and chronic pain syndromes. From your point of view, because you’re not a medical person, you’re a physicist, you’re an engineer, but what is your point of view? Give me five sentences. #00:37:54-5#

TS: I will try to do it in a short way but normally it’s a bit too complex to do it. You could apply it to the person and you have a current floating through the cells of this person, the cells are built complex. Not only floating through the cells, it’s also floating through the nerves. Nerves are electrical connections between your brain and your organs, even the skin. You have more than one system interrogating this. When you apply microcurrent you have more than one effect: One effect is the electrical effect, for example, the cell [unclear #00:38:45-3#] is changing its structure while it is floated from the current so the osmotic behaviour of the cell changes immediately. One of the big effects of microcurrent therapy is this change of osmotic behaviour helping the cells to get acids out, for example, so everything becomes a bit faster. You have thermodynamic effects. When you switch the light on, the light bulb starts to glow -, we also have this thermo dynamic effect inside our body, a lot less than the light bulb, of course – when you apply the microcurrent, you have a warming-up effect in cells. This hits the cells with the highest resistance. The low resistance cells do not have so much power loss than the high resistance cells which is normal because if you have something zero ohm, it would be super-charged than if you have even 10,000 ampere. There will not be one degree warming-up of this super-charge cable. If you have a cable which is 1 ohm and you have 10,000 amperes, then you’d have 10,000 watt of this cable because it’s electrical laws, it’s a physical law. This law is also guilty inside the body so the terminal [unclear #00:40:34-0#] effect is really a known effect for microcurrent. But there is this third effect, now we are getting up to the bridge to a frequency-specific microcurrent following to Carolyn McMakin. The microcurrent in specific frequencies is speaking to the resonating cells which are resonating directly to this frequency. #00:41:03-5#

Besides the two effects I spoke about, with the frequency-specific microcurrent therapy you are setting up a therapy which is directly working to the cells you’re targeting. Over the last 30 years, Carolyn McMakin, by herself, was starting to make scientifics about this form of microcurrent therapy and she has really great results. With these frequencies you can send this information – let me say it slow – directly to an organ, this organ is responding and the therapy is working. Frequency-specific microcurrent is one of the great chances we have in this industry because within the next 20, 30, 40 years there will be a change in this microcurrent world like in the computer world between 1970 and 2000. Looking at it this way, there is a great chance for the microcurrent device industry to have the next step of healing in their hands. We don’t know enough to speak out aloud, but we believe it will have a really big effectiveness and we have to build up standards for this. We have to do scientifics to build up real standards so we can approve the standards with clinical studies. This will be the next step of microcurrent. It’s my belief, there would be no chance outside MDR for technology like this because scientifics always really need a clear structure. #00:43:17-1#

I: Regulatory, yes. #00:43:19-0#

TS: We haven’t had this clear structure in the last 20 years but now we are getting the structure and we are able to do the scientifics to have much better devices, have a much better market field for the devices and, of course, help more people with it. #00:43:42-0#

I: That’s an absolutely great explanation about the view of frequency-specific microcurrent. I agree with you, this is an absolutely great chance for anyone: for practitioners, for physiotherapists, for medical doctors, for neuropaths and all this there’s a great chance to get another access to the problem of the people. #00:44:17-1#

We’re so delayed with our podcast but this screams after a second or maybe third session of podcasting, of course in English aswell, and we will do some other podcasts in German also because, for me, I would say a big thank you because you are a great speaking partner when we speak about microcurrents. You have a great access from the thinking part of microcurrents. You have a great access from, of course, the development side because you are a developer, and this is very [unclear #00:45:04-3# ] that you are, as a developer, also accept the regulatory parts, the regulatory compliance, because this will be changed. #00:45:19-0#

In my opinion, and this will be the last sentence on the MDR, I’m sorry for our listeners to speak so much about the regulatory affairs. The MDR and new devices are only possible when developers, engineers, technicians all that staff, work together with regulatory and the quality persons because, in the end, both have to do the same job: They have to bring new devices in the market, they have to be safe, they have to be efficient and they have to be compliant. This is my really deep opinion about this. #00:46:09-3#

TS: Let me say one word to this. They also have to be ready. It comes up only with doing scientifics to make this market bigger. I have a broad support of this technology at the doctors, at the medical staff, so you’re filling the market with a new deepness because up until now, there is a doctor and the next 70kms there’s another one, you haven’t enough devices in the market. #00:46:46-1#

I: Yes. Let’s say, for our listeners all over the world, especially Germany, Europe and Italy, for sure, we have a lot of listeners from Italy aswell, because there’s a great community of microcurrent in Italy so let’s say hello to our Italian listeners. In the next episode, we will speak about a new opportunity in the early beginning of 2019 for a new microcurrent device which is able to fulfil any requirements of the regulatory part, the quality parts, the safety parts and the efficiency parts for working in cybernetic modes, in [unclear #00:47:40-0# ] cybernetic mode of microcurrent, working in a frequency-specific mode. This will be very, very interesting. But today, I think we are almost finished and so I will say thank you Dr Stüker to speak with me about the frame of regulatory, the frame of development of microcurrent devices, and even to give a short introduction in the bio-physical reaction cells. I would say a great thank you to you. It was very nice to have you in the podcast, in our conversation. To our listeners, thank you for listening even if it was very heavy stuff for regulatory parts in this episode, but I think in the next episode we will speak more practically how specific microcurrent in 2019 can change your work, your life and the life of your patients, for sure. Thank you for listening. Thank you Dr Stüker and please, if you listeners are in the apple iTunes store, please vote for our podcast, it will be absolutely great, and if you’re listening in any other distributers of a podcast, you can vote there. If you have some questions, just go on www.mikrostrom – this is a German word, it is called mikrostrom.com . Write us an email or go on Facebook and write the German word of microcurrent as I spelled it before. If you have questions, if you have ideas for another episodes or something else, please vote us on apple iTunes, this will be absolutely nice. Thank you for listening to our podcast. Thank you Dr Stüker and so, goodbye. #00:50:01-7#

[End of interview] #00:50:01-7# 


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