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 in the male market category. Longer term, quantified self and the fashion aspect of devices are likely to help 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 with an interest in aesthetics 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. Furthermore, 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 recently published guidelines on the safety of light-based hair removal HUDs, in part to encourage manufacturers to adopt best practices2. 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 both available and in development.
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 recent 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 randomised3. The data so far indicate 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.
The regulatory environment
Since their introduction, manufacturers of home-use lasers and IPL devices have relied on existing international standards and national regulations covering household electrical appliances to achieve safety compliance. In the absence of specific national regulations, in the European Union this would typically include compliance with the General Product Safety Directive (GPSD), Electromagnetic Compatibility (EMC) legislation, and international standards covering household and similar electrical appliances, such as the International Electrotechnical Commission (IEC) 60335 family of standards.
In order to obtain FDA marketing clearance for HUDs for over-the-counter sale in the USA, some consumer device manufacturers have sought to comply with existing laser and lamp standards, as far as they could be reasonably applied. These have included the current IEC ‘parent’ standard for lasers, 60825-1 and the IEC 60601 family of standards, which were largely formulated for professional medical, dental, diagnostic and cosmetic electrical equipment.
