A new year has begun and ‘everyone’ is hoping that 2021 will be better than 2020, ‘some’ see opportunities for improvement and ‘a few’ are exploring new digital solutions.

***Please note – this episode features an excerpt from the next instalment, an interview with a post-Covid-19 patient and his experience with frequency-specific microcurrent***

We’ve already discussed online training courses and the like in a previous episode (episode from Wednesday, 27 May 2020 – Training, seminars, courses, coaching & more) and can see once again that there’s still plenty in the ‘pipeline’ here.

However, even beyond specific online training courses – such as those we offer on our internal training platform for users of frequency-specific microcurrent therapy – there are opportunities to exchange ideas and incorporate practical tips into one’s day-to-day practice.

This episode focuses on the outlook for frequency-specific microcurrent therapy in 2021. What lessons can we take away from 2020, and what specific plans are in place for 2021?

00:00:00
Patrick Walitschek: Welcome to a new episode from LuXXaMed GmbH. My name is Patrick Walitschek and I’d like to welcome you to the first episode of 2021. It’s now mid-January, and our last episode was released on 24 December 2020 – certainly, let’s call it an ‘interesting’ year. And now we’re back in 2021. This episode is a little – well, how shall I put it – a brief preview of some of what’s to come this year: the ideas we have, what we’d like to do, which seminars and so on are planned, and, of course, a bit of a preview of the upcoming podcast episodes and a sort of round-up of the microcurrent podcast, covering the theory and what else is planned for this year. Let’s perhaps start by saying that the year has actually begun almost exactly as last year ended. This year, medical device manufacturers across Europe are also facing something quite specific that was actually due to come into force last year. It was postponed by the European Commission due to the coronavirus pandemic – namely the MDR, the Medical Device Regulation. The Medical Device Regulation poses an enormous challenge for all manufacturers across Europe, as it imposes requirements not only on the products themselves, but on everything associated with them – the company itself, quality management and, colloquially speaking, the authorisation process; to be precise, this is referred to as the CE Declaration of Conformity or CE marking. And yes, the MDR is setting a completely new course here, and naturally this applies to all manufacturers of microcurrent devices as well. We began preparing for this several years ago. We’ve made a lot of changes in production, in quality assurance and, of course, in the regulatory side of things. In fact, you could say that the regulatory side has, in principle, become almost less of a hurdle than the entire development process. Because in order not only to launch a new product onto the market, but also to maintain an existing product on the market, a great many things simply have to be completely redesigned from scratch. And this year’s deadline is 26 May. That’s when the Regulation comes into force – and this time, it’s definitely final. It will certainly be the final deadline. A postponement is definitely no longer on the cards. In other words, the MDR is coming. What does that actually mean for you as a user, or more generally for anyone outside a medical device manufacturer? Well, first of all, for users it means that there may well be problems and supply difficulties in various areas – probably less so in the field of physiotherapy, but particularly when it comes to high-risk products, where there could certainly be issues. This is because very, very strict guidelines and requirements are being imposed here – not only on manufacturers, but also in the field of, for example, physiotherapy equipment; after all, from therapy tables and fitness equipment right through to electrotherapy and ultrasound devices and so on, these manufacturers must comply with the Medical Devices Regulation, both as a company and as individuals, as very specific requirements are also placed on certain individuals and, of course, on the CE declaration or the CE conformity assessment for the products. The subject of clinical evaluation has set entirely new – well, how shall I put it? – standards. This means that products must, of course, be clinically effective in order to be allowed on the market at all. However, this clinical evaluation is carried out by the notified body, which could be TÜV Medizinprodukt, DEKRA or various other institutions – and, more recently, exclusively by a medical professional, meaning a doctor who examines the whole process and checks whether the evidence of efficacy is in place for all indications, all claims and so on. So it’s an extremely labour-intensive process, but it goes even further, because doing it once is not enough. You have to maintain it constantly, update it regularly, and carry out studies across a wide range of areas. So that’s just a small part of it. Another aspect, for example, is biocompatibility: All materials that come into contact with the patient must be biocompatible and must be assessed for biocompatibility – and this applies not only to the raw materials themselves, but also to the components, and must be maintained throughout the product’s entire lifespan. So, as we can see, this is absolutely fascinating. As I said, the therapist, alternative practitioner or doctor won’t notice much of this at first, because the products they have are the ones they have and use, but for future products – and for innovations in particular – it will be very, very interesting. I myself carried out a study involving expert interviews, which focused on the Medical Devices Regulation; I conducted surveys specifically relating to the risk class of microcurrent devices, and it’s really, really fascinating. I even interviewed a representative from the Federal Ministry of Health who is very well versed in this particular area of the regulation and has been working on it, and here too, rather bleak scenarios for the future – particularly for small manufacturers – could well be on the horizon. And we’ll see whether that actually comes to pass. The requirements will certainly be introduced as planned. But we’ll see whether small manufacturers, too, have already started in the past – and by ‘past’ I don’t mean right now, they started last December, so they’ll definitely not manage it now – you can effectively take that for granted – but there’s definitely a lead time of, let’s say, three years, or two years, that they really should have allowed for. We’ve done that; we’ve also invested heavily in our own knowledge management to build up the expertise needed to meet these requirements. So it’s really exciting – this will be a major focus area in 2021. What will the next focus area be? Naturally, the next key area will be our new software version 3.0, for which a programme update is currently in the works, adding many, many new programmes; and rolling out the updates in the first place is currently in full swing, and we’re already seeing the first clinical feedback. That brings us back to the topic of clinical evaluation, because of course we also have to clinically evaluate this software and these updates – which, of course, we’re doing. And the feedback we received as early as last summer, when we started this process, has been very, very positive, which is why we’re able to roll out the update. It’s incredibly exciting. So this will largely take up our time right now, I’d say, until March – certainly until the end of March. Yes, and of course, running alongside this is the issue of further training and courses: what’s next? Well, the extent to which face-to-face training is actually possible now, or will become possible, is still anyone’s guess. I think – as you know, this applies to all training providers – that it’s not yet possible to say how the whole situation will develop. But we’ve, of course, made significant progress with online seminars and have invested heavily in the technology to ensure they’re designed – particularly from a technical, auditory and visual perspective – in such a way that you can take the very best from them and apply it to your day-to-day practice. After all, that’s what these seminars are meant to be for, and that’s what they should be. So that’s a major focus. As I mentioned, our internal training portal at www.luxxamed.de – many of you are familiar with it – is a specialised training tool, or let’s call it a portal, which is password-protected. So you need a username and a password to access it. We’ve now uploaded almost 17 hours of video material there, spread across a wide variety of courses. This podcast and all the previous ones are also available there. There are various e-books available for download, white papers – that is, short guides – tips on specific procedures and, of course, our user forum, where users can exchange ideas, answer each other’s questions and, naturally, showcase excellent treatment outcomes in specific areas. All of this will definitely be further refined, because we can see that the online sector in particular is extremely important, although, of course, online learning and microcurrent therapy are somewhat at odds with each other – I’ve already done two episodes on that, so I don’t want to go into too much detail now. But I suppose it’s logical that training which is heavily practice-based can only be delivered to a limited extent via webinars, audio or video. So I suppose that’s logical, but nevertheless we’ll continue to refine this and ensure we can present the material in the best possible way from a teaching perspective, so that you get the very best out of it. That’s the point. And yes, the topic of podcasts. Last year, from summer through to December, we almost managed to release an episode once a week. It’s already mid-January, and this is the first episode, but of course that’s also down to the start of the year, which is always very, very stressful. We’ve just had the TÜV in the office again, specifically for our CE conformity assessment, to ensure our products remain on the market. The TÜV visits us at least once a year. They’ve even turned up unannounced for an audit before. Just imagine: the doorbell rings at 9 o’clock in the morning, and there’s the TÜV auditor standing there saying, “Hello, here I am. Now I want to see everything.” That means, of course, you can’t really prepare for an unannounced audit, so to speak. That was quite an exciting challenge. We handled it brilliantly. We didn’t receive a single non-conformity during that audit, and it was exciting – a great experience. We’ve also had an audit by the regulatory authorities: they pop round from time to time, the relevant supervisory bodies, and take a look at everything. So, as you can see, as a manufacturer, you’re subject to relatively strict and, of course, legitimate oversight in this area. But back to the topic of the podcast: we’ll certainly be continuing with this podcast, of course. I can see that from the listening figures for this podcast, which have really skyrocketed in October, November and December. The feedback on the podcast has also been excellent. A huge thank you once again for that, as it shows that we’re on the right track with the podcast. We’ll be continuing with this podcast. Whether we’ll maintain the weekly schedule remains to be seen. Perhaps we’ll switch to every two weeks, but our aim is at least to release one episode a week. Of course, the whole thing involves a great deal of work and a lot of time. As a result, it isn’t always possible to produce a new episode every week, but we’ll give it a go. However, I can promise you right now that a really great podcast will be released next week – an interview with a Covid-19 patient, a former Covid-19 patient from the so-called first wave, and the physiotherapist Christian (unv.) from Stolberg near Aachen, because last year we released two episodes on the topic of post-Covid therapy – specifically, what options does microcurrent therapy offer after Covid to treat these performance deficits in patients, and the symptoms that arise afterwards? And these podcasts have been extremely popular, which I think is absolutely brilliant, and now we also have an actual patient treated by the physiotherapist Christian (unv.), who treated this patient using frequency-specific microcurrent therapy. He himself has completed various training courses with Dr Karen McMakin, so he’s a genuine expert in the field of frequency-specific microcurrent therapy and has been practising microcurrent therapy for over 15 years – so it’s really fascinating! And I think I’ll just give you a very brief clip from this very episode, a very short excerpt, as a little teaser for next week:

00:12:35
Patient: And then, in the summer, I came here for treatment with Christian – I’d been here quite often before, and I’d already successfully undergone microcurrent therapy years ago using various devices to treat specific symptoms. We got talking, and the CT scan from June showed that there were still ground-glass opacities visible as remnants of this inflammation, as well as scarring. That had frightened me – the word makes you think immediately of pulmonary fibrosis, and of course you want to prevent any rapid progression in that direction – so we got talking, and then he said that microcurrent therapy might perhaps be an option.

00:13:24
Patrick Walitschek: Yes, that was a short excerpt from the next episode on the topic of post-Covid-19 care – specifically, post-Covid-19 treatment following a coronavirus infection using frequency-specific microcurrent. Stay tuned – it was a really fascinating interview, and the atmosphere was absolutely lovely; it was brilliant. So, it’s coming next week. Another topic I’d like to touch on briefly towards the end is live streaming: lots of people do live streams, particularly therapists – especially those active on Instagram and Facebook – though I don’t see it there quite as much – but especially on Instagram, where there’s Instagram Live, YouTube Live, and so on. And we thought to ourselves, we’d like to do that too; we’ve actually done some live segments in the past, a while back now, and put out short live episodes. The idea is that we might like to try doing a live stream on the Twitch channel. It’s probably not 100 per cent the right channel for microcurrent therapy, but let me put it this way: you’ve got to be the first mover somewhere – the first to give it a go – and some of you might be familiar with Twitch – it’s mainly for the gaming scene, with those live streams where people play computer games online, broadcast the whole thing live, provide commentary and so on. But it’s also becoming increasingly prevalent in the business world. There are lots of companies – more so in America – for example, Tesla’s founder Elon Musk has a channel where he does regular live streams that attract very, very high viewership. And the great thing is that you can link the whole thing to YouTube, which means that the video is then also made available on YouTube as an archive, so to speak. We now have a Twitch channel, which you can find at www.twitch.TV/Luxxamed, and we’ll certainly be launching a few live events there in the near future, simply to gauge the response in that area, and we’ll then be broadcasting the whole thing on YouTube as well. We do, after all, have a very successful YouTube channel with loads of YouTube videos. Our podcast is also hosted on YouTube, albeit with just a still image, but it’s a start – and we’ll just have to compare the two: which one brings in more? Or we’ll also try broadcasting a live video on both channels simultaneously. I’ve already tested the technical set-up for this, and it works. It’s even possible to go live simultaneously on YouTube, Twitch and Facebook, but we’ll have to see if it all works out that way. So this will still be a bit of a test in the live streaming department. The live streams are publicly viewable by anyone. We also have a separate ‘Live’ section on our internal training platform, which means anyone with access there can watch it live directly on our website. But as I said, it’ll also be on Twitch, YouTube, Facebook, Instagram and so on. So we’ll try broadcasting live across all these channels and see where the biggest response comes from. Where can we find the most active users of microcurrent therapy to engage with? Initially, this isn’t planned as a formal seminar or training course, but simply as a way to exchange ideas, get to know one another, build relationships, strengthen those ties and foster customer loyalty, so to speak. And just see how we can improve the whole thing through live content – how can we go about doing that? Of course, what we’re doing – what I’m going to try – is to turn this into a podcast episode. That means I’ll be doing a livestream on Twitch, YouTube or Facebook – or all three – and the audio track will be posted online afterwards via this podcast. So, as you can see, we’ve really been delving deep into this, particularly when it comes to these online platforms, to see how we can best reach you, how we can reach everyone, and how we can strengthen the community – the German community and, beyond that, micro-streaming users? I mean, we’ve got a very strong presence in Italy, Austria and Switzerland too, and I can see from our podcast that we’ve got very high listener figures from America. So don’t be surprised – there will definitely be English-language podcasts this year, because we have a large audience in America in particular, and naturally we don’t want to provide them with German content alone, but also with English content. Perhaps this podcast will also be released in English sometime next week. I’m not sure yet – we’ll have to see – but there will definitely be English episodes, which will, of course, also be published in German. Right, that brings us to the end of this episode, which has served as a brief introduction to 2021. I hope you’ve had a very good and healthy start to the year and will continue to stay well, and that you’ll also overcome the challenges we’re currently facing – if I may put it that way – and I’m delighted to announce that next week we’ll be bringing you an interview on post-Covid therapy using frequency-specific microcurrent, featuring a patient – a former Covid patient – and physiotherapist Christian (unv.) discussing this topic. Yes, and now for the usual request: please rate our podcast when you listen to it, no matter which platform you use. You’re also very welcome to share it on Facebook, Instagram or Twitter – or wherever you like. You’re also welcome to write a review, for example on iTunes, and tell us what you particularly like about our podcast. On that note, thank you for tuning in. I wish you all the best and we’ll be back next week. Until then, ciao!