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At-home Beauty devices

Written by Dr Godfrey Town Ph.D. on February 16th, 2017.      0 comments

At-home beauty devices

By Dr Godfrey Town Ph.D.
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From the safety razor to home waxing and electrolysis kits, the advent of light-based home-use devices (HUDs) marks the latest development in the consumer hair-removal market. But this is just one example of many technology-led developments occurring in the overall HUD market, which is set to boom in the coming years.

Aside from hair removal, which is currently the largest HUD category, consumers can already choose from anti-aging, body shaping, cleansing and anti-acne devices. In the future, multi-functional devices may well become the norm, and moves are afoot to develop HUDs to treat medical skin conditions such as eczema and actinic keratosis. Even the potential for diagnostic and “quantified self” capabilities is on the radar.

What does all this mean for professional service providers, such as specialised physicians and aestheticians? Too much competition or an opportunity to lead the way in a burgeoning market? Perhaps neither, but now is the time to position yourself strongly in the market and shape your destiny.

Current market overview
A recent Kline & Company report showed ‘steady growth’ (+11.5%) in the global HUD market in 2015, taking the total annual value up to nearly $2 billion USD. To put this figure into context, it represents less than 2% of the global skincare market (excluding hygiene), so the potential for HUD growth looks substantial.

The US currently tops global HUD sales with a 40% share, followed by Asia (36%) and Europe (15%). A mix of global, regional and local brands are currently battling for dominance across existing categories, but you can’t help feeling that, with the odd exception, the global companies will prevail in the majority of geographies and categories over time. In Asia, for example, Japan currently commands more than two-thirds of market value with the top two brands provided by local companies MTG and Ya-man. China, however, is experiencing exceptional market growth (+30% in 2014), being led by the established global player Nu Skin.

Market development
While the overall skincare market continues to achieve solid growth, higher-priced luxury brands are making the largest gains. It therefore seems appropriate for HUD manufacturers to focus on innovation and quality to develop the market while simultaneously establishing efficacy and safety credentials – the latter being the route to long-term success when borne out in practice.

New product offerings can be expected to be the key market driver for some time, with an almost endless array of aesthetic indications to satisfy. Up and coming trends to follow include developments for treating specific medical conditions, the emergence of multi-benefit devices, and the opportunity for growth male market category. Longer term, quantified self and the fashion aspect of devices are likely to help to sustain growth as brands mature.

An effective digital strategy to maintain a direct link with consumers, a large distribution network with a mix of trade presence and web availability, and ultimately professional endorsement, will contribute to retail success.

What do the professionals say?
Many leading dermatologists in USA, Europe and Australia see the rising popularity of HUDs as a valuable door opener to their aesthetic business. Rather than being seen as competing with office-based procedures, the use of HUDs may prove to be a stepping-stone for many consumers to seek medical help when otherwise it would have been a leap too far. What’s more, the possibility of HUDs acting as a companion to procedures between visits may help physicians to maintain long-term relationships with patients.

However, reasonable concern is being voiced about the lack of specific safety standards and appropriate regulations for HUDs, primarily motivated by the potential risk of eye and skin damage with device misuse. In lieu of this, the European Society for Laser Dermatology published guidelines in 2014 on the safety of light-based hair removal HUDs, in part to encourage manufacturers to adopt best practices. This interim measure highlights an urgent need for regulators to catch up with market developments and pin down suitable safety standards that apply to the breadth of devices available and in development. One new international standard was published in 2016: Household and similar electrical appliances - Safety - Part 2-113: Particular requirements for cosmetic and beauty care appliances incorporating lasers and intense light sources that provides the necessary design features, engineering controls, interlocks, skin pigment detection and suitable user instructions to ensure safe use by a consumer and serves a benchmark for manufacturers.

Once these are in place, the need for sufficient clinical evidence of safety and efficacy will come to the fore before professional endorsement can become a reality. A 2014 systematic review of published trials of light-based HUDs for hair removal found only seven prospective studies, only one of which was controlled and none were randomised. The data so far indicated that the devices tested provided short-term efficacy but further studies will be required to confirm and extend the results and to establish the incidence of adverse events in selected cohorts of patients. Longer-term surveillance studies will then be required to demonstrate the safety profile of HUDs in real-world use.

Embedded lasers – Class 1C
Home-use laser products have ‘Accessible Emission Limits’ from ‘embedded’ lasers that would result ordinarily in their having laser hazard classifications of Class 3R, 3B or 4, but because of interlocks and design features cannot emit hazardous radiation when the product is not in contact with the skin. With no ‘free’ emission, control measures, current standards do not make much sense. The IEC has therefore defined a new laser category, Class 1C in its draft revisions to IEC standard 60825-1 Ed.3 Safety of laser products - Part 1: Equipment classification and requirements which may be applied to the laser products that are being marketed for skin treatments in the home. The latest IEC 60825 Committee Draft ‘parent’ standard, whilst specifying the requirements for a Class 1C laser, clearly states that if an applicable IEC (‘daughter’) standard specifying engineering controls to prevent emission into the surrounding space or to the eye does not exist, then classification to laser Class 1C is not permitted. Typical Class 1C laser products would embrace those intended for home-use hair removal, skin wrinkle reduction and acne reduction.

The invention of the laser Class 1C opens the market for new products being offered by manufacturers of cosmetic light-based appliances, thus ‘enabling’ them. This seems to make sense, since the laser appliances otherwise classified laser Class 3B or 4 would be regarded as being very hazardous to the eyes (which they are not when interlocked) and hence suffer from strong regulation of their usage.

In similar cases, such as UV-emitting devices, in some countries national regulation comes into play. However, lasers and intense light sources discharging in the visible and infrared spectrum present no risk of cancer as compared with malignancy-provoking UV sources. The worst effect of visible and infrared light is skin burns which might include blistering. Although some adverse event cases may require medical care, most of them will heal over time. Permanent effects may consist of scarring and hyper/hypo-pigmentation. Although this risk seems tolerable, eye injury due to non-functioning of safeguards or due to misuse of the equipment is a serious concern. Apparently, there are only a few reports available about incidents of any type in the home-use area, although several million units have already been sold. This should not prevent those who are concerned from collecting data and evaluating the true risks.

Regulation outside the European Union and U.S.A.
International efforts continue to develop consistency in regulatory frameworks and as in the EU and the US, regulatory controls usually include a three-tiered approach: pre-market assessment, assuring quality and safety for sale; in-market monitoring of advertising, claims and labelling and post-market surveillance, to check adverse events and ensure continuing safety in use.

While Australia and New Zealand treat home-use light-based devices in a similar way to other household electrical appliances as in the EU, no clear pattern is seen in most other world markets.

We are dealing with a new and fast emerging market, worth multimillions of dollars annually. This home-use device category reflects the needs of an aging, wealthy and wellness-oriented population. The new miniaturized products and appliances entering the market employing powerful and complex technology do, however, raise some health concerns. Safety standardization and national regulation however, seems to be somewhat behind market development.
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