Personal care devices - is it worth crossing the medical chasm?
This article is from the latest copy of our newsletter - The Gen Spring 2012
The personal care industry is worth over $300bn globally and recent reports have shown that many subsectors within this industry have not only resisted the recession but some such as premium skincare have actually shown significant increases in sales of around 15-20% and even up to 40% in the emerging markets. There is also a strong industry trend towards home-use beauty devices that promise consumers levels of efficacy normally associated with the medical and professional spa sectors.
The home-use device market has been estimated at $1bn in the US alone1
and consequently there is a significant opportunity for companies innovating within this device sector to capture and increase market share. Some of the more promising areas for this market include hair removers, anti-aging systems and anti-cellulite devices. This opportunity is further underlined when considering the high prices which the worried-well are prepared to pay to look good in parallel with how the cost of ‘medical’ devices is falling. This then lends a very strong argument in favour of commercialising a ‘medical device’ that not only legitimately claims real physiological changes that improve appearance, but is then sold at a price point that is normally associated with consumer products. Consequently there is a convergent price-point ‘sweet spot’ for medically-approved devices that deliver a pronounced visible improvement. So how should companies position these devices which fall into the grey area between consumer and medical in terms of marketing claims and regulatory positioning?
The cosmetic scenario – A path of least resistance?
Many companies assume that development and positioning of a new device to treat cosmetic conditions should be marketed exactly as that, ie a cosmetic device. The lower regulatory barrier to entry and speed to market are compelling drivers to get a product out into the massive cosmetic market as quickly as possible. However, to avoid any unwanted scrutiny by regulators such as the FDA and MHRA, such a product needs to comply with the definitions of a cosmetic, ie it must only ‘make contact with the external parts (eg epidermis, hair) of the human body’ with the aim to ‘clean, perfume or protect them in order to maintain their condition, change their appearance or correct body odours’. Clearly this is a definition that limits the allowable marketing and efficacy claims of a product that is trying to surpass its competitors. If the product is known to act through some form of applied energy or deliver substances more deeply than the superficial epidermis then the product will eventually attract the attention of regulators.2
If, having navigated the complex tangle of words and definitions, the company is still confident that the product will avoid medical device scrutiny, the challenges have not ended; it may still attract the attention of bodies such as the Advertising Standards Agency. Very careful wording for advertising campaigns for cosmetic products is critical and may only refer, for example, to the ‘relief of symptoms of the superficial signs of aging’ and must avoid words like ‘cure’ and ‘rejuvenation’. Even these sanitised claims must be substantiated from evidence gained from legitimate trials and testing such as randomised controlled trials. In short, a cosmetic product may be known by its manufacturers to effect a physiological change but the medical claims that would promote the product are strictly off-limits for the cosmetic product and therefore following this cosmetic route could be seen as a wasted opportunity.
The medical device scenario – worth the effort?
To win consumers’ confidence to buy a novel cosmetic device companies must maximise ‘visible’ efficacy delivered by their products, as well as making them safe, aesthetically appealing and enjoyable to use. This route can sufficiently differentiate the product from the multitude of cosmetic device products on the market by claiming real physiological changes, but this requires embarking on the more rigorous medical device development pathway.
A medical device is broadly defined by the FDA as ‘an instrument or apparatus for the purpose of diagnosis, monitoring or treatment of disease or the modification of the anatomy or of a physiological process’. However, the principle mode of action should not be pharmacological but may include a component that does have a chemical effect. This latter situation of a device and a substance having a ‘biochemical’ action is key to some cosmetic devices as, for example, the deeper delivery of topical skincare products to stimulate collagen production or lighten the skin not only conflicts with external surface limitations of a cosmetic but also claims to do more than just change the appearance.
If a company decides on the FDA medical device route for a cosmetic treatment then a pre-market notification (510k) route is usually chosen. Typically a medical device that achieves cosmetic changes will fall into medical device Class 2a or 2b; being more invasive than a Class 1 device, eg bandage, and less essential to sustain life than a Class 3 device, eg pacemaker. The Office of Device Evaluation (ODE) within the FDA ultimately grants clearance when the company has demonstrated substantial equivalence to several predicate devices already awarded 510k or PMA approval. Home devices are further scrutinised and must also prove that a lay person could ‘read the directions for use and safely and effectively use the device and not cause damage if used incorrectly’, highlighting the need to remove any possibility for misuse.
Of course device technologies that were previously the jurisdiction of the professional clinician don’t just suddenly appear on the shelf of the average retailer. For this to happen, such technologies are typically miniaturised, simplified, reduced in intensity and undergo rigorous clinical safety and efficacy testing. These products often will ‘ease’ their way towards the home-use over the counter (OTC) market via a ‘soft’ or controlled launch through spas and other managed outlets. Such strategies not only build-up a compelling track record of customer satisfaction but can inform the product design process to optimise features and benefits of the final retail product. Additional techniques to maximise the uptake of such innovative products also include professional endorsement by a clinician such as a leading dermatologist.
So what’s the opportunity?
The development of a medical device product for the OTC market clearly faces significant regulatory and design challenges; however these are not insurmountable when conducted by those familiar with the complexities. Fully ISO 13485 compliant medical device development and additional constraints for OTC home use such as ISO 62366 usability standards are routine pathways for groups developing medical devices and, once achieved, offer companies a wider audience captured by compelling claims of efficacy. These claims raise the product up above the background ‘noise’ of scientifically unproven cosmetic devices and meeting these standards demonstrates that the company adheres to high standards of design, materials and manufacturing quality.
Although development of a medical device has traditionally been an area that the consumer sector has shied away from, with careful planning and the appropriate resources, crossing this chasm is not as scary as it may seem and CPG companies can confidently navigate this route and reap the rewards.
Need help with your device strategy? Contact Peter.Luebcke@sagentia.com
At-Home Skin Care Devices 2011: U.S. Market Analysis and Opportunities, Kline Group, July 2011.
FDA’s Scrutiny of Personal Care Products in 2011, Household and Personal Products Industry, R.R.Pippins.