On a typical Saturday afternoon in American suburbia, it wouldn’t be unusual to find a middle-aged mom trying a home version of the chemical peel in hopes of diminishing the crow’s feet cropping up at her temples, while her teen-aged son, secreted away in the downstairs bathroom, goes after a new burst of acne spots with the hand-held Zeno device.
The latter, which uses a thermal effect to “zap” blemishes before they fully erupt, has become hugely popular among teens — though its effectiveness may be limited. Likewise, popularity has grown for the emerging slew of devices targeting consumers willing to attempt home versions of many procedures, such as dermabrasion, formerly available only in physician’s offices. In short, the trend toward do-it-yourself skin treatments that employ “cosmeceuticals” is finding impetus from a new quarter: home-use devices for everything from acne to hair removal. (See sidebar below.)
Technology may be the driving factor behind the development, proliferation and consumer use of products such as the Zeno, the oddly named no!no! hair-removal device and the far pricier laser-like counterpart, Radiancy — not to mention the Wellbox cellulite-fighting device being touted by Hollywood stars. But convenience takes a close second, even if the devices are only modestly effective compared to those used in dermatologists’ offices, according to Murad Alam, M.D., Chief of Cutaneous Surgery in Northwestern
University’s Department of Dermatology.
“As things are miniaturized, there will probably be some degradation in their efficacy and their reliability, so there will be compromise,” he says. “Most people will accept that compromise in the interest of convenience and cost — and the reason is that it’s just too annoying to go to dermatologist’s office for laser hair removal.”
Consumers and A Growing Comfort with Technology
The at-home device development trend is also the natural extension of the general consumerism movement, fueled by the Internet and the anti-aging quest, some dermatologists suggest. As consumers become more comfortable in general with home remedies and hand-held devices, they’re becoming braver about what they will try out on their own, according to Melanie Grossman, M.D., a New York City dermatologist whose practice focuses on cosmetic dermatology and laser surgery.
“The trend is a combination of two things: baby boomers hitting their fifties and wanting to do anything they can to keep young, and the greater acceptance by the public that devices are helpful in aiding us with skin care and grooming,” she says.
Technology is improving, and the attendant pace of developing products that consumers can easily use is accelerating in tandem, she notes, creating a cross-over of sorts. “It’s a combination of consumer desire and electronic know-how,” Dr. Grossman says.
It’s tantamount to a natural progression, Dr. Alam maintains. “Given that people are using more sophisticated products, and that patients are using products that are seen as substitutes for what an in-office procedure might do, I think it’s a small leap for them to have a physical machine,” he says.
Future Rapid Expansion
Market forces are playing a major role, too, according to Dr. Alam. Not only are devices proliferating to fill consumers’ growing demand for cosmetic “fixes,” but the number of companies entering the market for home-use devices is likely to increase rapidly in the wake of the Food and Drug Administration’s clearance of the products. To date, the FDA has given its “compliance” stamp to the Zeno acne device and a handful of “laser-like” devices for hair removal and photorejuvenation. More such clearances are expected in the coming 2 years provided the products’ safety can be assured.
When that happens, Dr. Alam predicts, the well-funded cosmeceutical companies, rather than the current device makers serving the in-office market, are likely to move into the market quickly. It’s not in the interest of large laser companies to undercut their own market by making at-home products, he explains, because those firms tend to be little niche companies with limited capitalization. “The cosmeceutical companies, however, are extremely well capitalized and funded. They’re enormous global companies looking for the next new thing to market, and they’re uniquely well positioned because they already have consumer loyalty,” Dr. Alam says, referring to giants such as Neutrogena and Procter & Gamble.
The Effect on Dermatology Practices
Whether the trend toward use of at-home devices is a major blow or just a blip on the screen — that’s the effect most predict — for dermatology practices depends on several factors. The chief one is how effective the devices are. The second is how safe the user-friendly devices prove to be.
On the first issue, many cosmetic dermatologists are skeptical that the devices will supplant in-office procedures. That’s because, by design and in order to meet safety constraints, the devices will be only modestly effective. La Jolla, CA, Dermatologist Richard Fitzpatrick, M.D., who has assessed some of the devices in development, thinks that the marginal effectiveness of the current crop makes them a “non-threat” to physicians — at least at present.
“I haven’t seen any of these devices that, at least in theory, would have high enough efficacy to replace existing treatments. So I don’t see them as a threat to dermatologists’ practices,” says Dr. Fitzpatrick, Director of Cosmetic Dermatology at the La Jolla Cosmetic Surgery Centre. “The bar is a lot lower in terms of performance and efficacy for home-use devices.”
Dr. Fitzpatrick adds that patients, for the most part, understand that devices like the Zeno aren’t intended to replace but rather supplement office-based treatments and devices. Patients might be willing, for example, to use a device four or five times a week just to obtain a marginal effect, yet would expect far higher efficacy from even a single dermatologist-supervised treatment. That efficacy compromise is “much more acceptable when it’s a home-use device,” he adds.
For her part, Dr. Grossman expects the devices to boost dermatologists’ practices because of the growing awareness of treatments their use will propel. Whenever a technology or market development impinges on physicians’ practice turf, the tendency is to view it as a potential threat to livelihood. Yet in most cases, the worrisome encroachment rarely comes to pass, Dr. Grossman contends.
“There’s always a fear that … if things are taken to the consumer level, then maybe it will affect practice [volume],” she says. “But I think that, in fact, it will be the opposite. As consumers gain awareness and acceptance of technology, they will be more apt to go in to have procedures done.”
The thinking will be that “if this [home device] works a little, perhaps the treatment at the doctor’s office will be more effective,” Dr. Grossman adds. She qualifies that statement by acknowledging that as the devices themselves become better designed and more effective, they may initially encroach on the procedure market for dermatologists’ services. But eventually, that trend will be offset by patients choosing to go to the dermatologist’s office because, quite simply, “doing something oneself is just not as luxurious as having it done by someone else,” she says.
Like Dr. Grossman, Dr. Fitzpatrick sees the proliferation of home-use devices as having a beneficial effect on dermatologists’ practices. He cites a recent poll that found that about 80% of Americans have never been to see a dermatologist. “And even among those who have seen a dermatologist, awareness of available treatments is very low — so the big boon of this trend might be awareness,” he maintains.
And then there are the purely practical issues, especially when it comes to hair removal: Many parts of the body simply cannot be reached by the individual using a hand-held device. “There will always be places that can’t be treated, like the back, and patients will realize that certain treatments need to be done in the doctor’s office,” Dr. Grossman says.
Liability Issues, Hassles Certain to Arise with Device Sales
Dermatologists who decide to venture into the sideline of selling the at-home devices through their offices — taking the “if you can’t beat them, join them” attitude — may find a potential source of new revenue. But they’ll also entertain risk from two sources.
The first is the possibility that associating the practice with devices that are only modestly effective yet expensive (the Zeno is $200 and the Wellbox about $1,600) could damage the practice’s image.
The second, a possibly more important risk, is that if a patient is harmed by the device, whether it’s because of misuse or malfunction, dermatologists aren’t immune from liability.
“That’s the typical physician response: ‘I’m just the little guy, so if something goes wrong they [patients] can sue the company.’ In reality, that won’t work,” says David Goldberg, M.D., J.D., Director of Skin Laser & Surgery Specialists of New York & New Jersey and Adjunct Professor of Law at Fordham Law School in New York City.
Why aren’t dermatologists shielded by the manufacturer’s product liability? It’s because of a little known legal wrinkle known as the “learned intermediary” doctrine. That doctrine allows that if something goes awry with a drug or device sold to a physician who then passes it to the patient, the doctor assumes some liability. “Unless there is fraud from the manufacturer’s level, if a complication occurs, the doctor will be on the hook for that,” cautions Dr. Goldberg, who is also a Clinical Professor of Dermatology at Mount Sinai School of Medicine. “This has been seen in other [medical specialty] areas, but not in dermatology. But it will be seen in our field, too.”
Although dermatologists cannot protect themselves absolutely from this type of “product liability by association,” they can mitigate it with a few smart moves. Dr. Goldberg urges dermatologists eyeing in-office home-use sales to try the devices before offering them for sale — checking out not only how they work but also where things might go wrong. “Too often, doctors just give things to patients without knowing how they work or what they do,” says Dr. Goldberg, whose practice sells the Zeno acne treatment device. “There is no way to remove liability in a vacuum — all you can do is try it yourself and have your staff try it.”
Dr. Hruza recommends taking further steps, in the interest not only of protecting dermatologists’ practices but also to better inform patients. “If you’re going to sell devices in your office, I would definitely ‘undersell’ efficacy — by clearly explaining what the device can and cannot do,” he says, and urging patients to read the product use instructions closely.
Proceed with Caution
Even without the liability issue, dermatologists considering office sales should proceed cautiously, Dr. Hruza counsels, because of the potential downside of operating in any aspect of the retail environment. Besides the obvious hassle factors — dealing with returns, pricing competition from other sales outlets and the Internet — the issue of dissatisfied “customers” could be hugely problematic.
“The doctor who tries to sell and make money from these devices could face real problems that could actually hurt their practices,”
Dr. Hruza maintains. “Considering that some of these things sell for $1,000 or more, there will be high expectations from consumers.” And the patients who are unhappy with the devices’ performance might leave the practice or, worse, speak disparagingly about the dermatologist who sold them the product. As such, Dr. Hruza urges dermatologists who plan to sell the devices to write disclaimers that make it clear that the device won’t be as effective as those used in the office.
“The Zeno is modestly effective, but I know that many dermatologists who decided to stock the device have them sitting on the shelves now,” he says, because of their limited efficacy and associated cost (recharging the unit).
Dr. Fitzpatrick differs on this account. He views the at-home device sales as both a potential revenue booster and, ultimately, a way to increase procedure volume. “I actually think in-office sales is a good idea because I see these devices as a potential adjunct to existing treatments,” he says. “Some doctors ridicule the whole idea without even thinking about it. My advice is to take a closer look at these things because they do have a place in the overall treatment regimen.”
Dr. Fitzpatrick cites the reports his patients have given on the Zeno device as an example. “When I talk to patients about it [Zeno], they’ve been happy with it,” he says.
The FDA Weighs In
Because the at-home devices being developed treat valid medical claims, such as acne and abnormal hair growth, they must receive clearance from the FDA before their marketers can bring them to the market. That entails assuring the agency that consumers can use the devices safely and understand the instructions. That’s no small feat, according to Richard Felten, a Senior Reviewer in Device Evaluation for the FDA’s Center for Devices and Radiological Health.
“Companies have to demonstrate to us that people can read the material, select themselves appropriately and perform the intended use of the device safely,” Mr. Felten says. That means, ultimately, that “over-the-counter” devices will of necessity be less powerful than their physician-use counterparts, even though some manufacturers go to the trouble of staging randomized controlled trials to support their products’ claims and safety.
Even though manufacturers must meet those criteria, FDA clearance is a much lower level of approval than what’s required for drugs, and efficacy is not a chief consideration. However, it’s worth noting that the U.S. Army is funding development of a hand-held device that would manage pseudofolliculitis barbae, as so-called razor burn causes significant discomfort and disability among military personnel.
In the end, Dr. Goldberg reminds dermatologists that FDA clearance is precisely that — permission to market — and it’s a far cry, generally speaking, from the approval that’s afforded physician-prescribed drugs or in-office medical devices that have gone through the agency’s regulatory hoops. “It’s important to recognize that the FDA trials on these devices will never be as stringent as they are for the true doctor [operated] devices,” Dr. Goldberg explains, “and that approval doesn’t create any protection for anybody — it simply allows the company the beauty of saying it has a medical device that’s been cleared by the FDA.”
Pushing Dermatologists Toward Innovation
From the economic perspective, the proliferation of at-home devices will, at the least, push forward-thinking dermatologists toward practice innovation, Dr. Alam suspects.
“I think all of us will be forced to innovate and stay abreast of latest technological advances because it will create market segmentation,” he says, and push dermatologists to make their procedures more convenient for patients. In the early years, too, devices will be poorly understood and best used under a physician’s direction. “That will be the business opportunity for dermatologists.”
“The bottom line is that these [home-use] devices won’t work as well as what we use in the office — and that will expand the market,” Dr. Goldberg suggests, for dermatologist services for the medical problems devices attempt to treat. “It’s a foolish, protectionist view to look at this trend as hurting us. I don’t think that will be the case.”
Sidebar:
Home-use Device Marketplace Heating Up
Consumers are flocking to the Internet, spas, dermatologists’ offices and a host of other outlets to purchase home-use devices intended to treat dermatological conditions. Following is a sampling of those on the market now, and their claims and approximate costs:
Zeno (www.myzeno.com). Treats early acne lesions with thermal effects. Costs about $200.
DermaNew (www.dermanew.com). Battery-powered microdermabrasion tool that comes with “multi-crystal” cream. Costs about $130.
Epila Laser SI-808. Marketed on eBay and elsewhere, it promises “faster,
easier hair removal.” Sells for upwards of $100.
HairMax LaserComb (www.lasercomb.net). Touted as low-level laser therapy to improve hair appearance. Costs about $550 from manufacturer.
Nulase (www.nulase.com). Company’s Soft Touch Laser promises increased collagen levels and acne improvements. Costs about $180.
Radiancy (www.radiancy.com). Light-based skincare treatment for rejuvenation, acne and hair removal; home-use Clear Touch Lite cleared by the FDA. Price varies depending on sale outlet, but starts at about $500.
Wellbox (www.wellbox.com). Uses “tissular rolling” technique to reduce
cellulite and improve complexion. Costs approximately $1,600.
On a typical Saturday afternoon in American suburbia, it wouldn’t be unusual to find a middle-aged mom trying a home version of the chemical peel in hopes of diminishing the crow’s feet cropping up at her temples, while her teen-aged son, secreted away in the downstairs bathroom, goes after a new burst of acne spots with the hand-held Zeno device.
The latter, which uses a thermal effect to “zap” blemishes before they fully erupt, has become hugely popular among teens — though its effectiveness may be limited. Likewise, popularity has grown for the emerging slew of devices targeting consumers willing to attempt home versions of many procedures, such as dermabrasion, formerly available only in physician’s offices. In short, the trend toward do-it-yourself skin treatments that employ “cosmeceuticals” is finding impetus from a new quarter: home-use devices for everything from acne to hair removal. (See sidebar below.)
Technology may be the driving factor behind the development, proliferation and consumer use of products such as the Zeno, the oddly named no!no! hair-removal device and the far pricier laser-like counterpart, Radiancy — not to mention the Wellbox cellulite-fighting device being touted by Hollywood stars. But convenience takes a close second, even if the devices are only modestly effective compared to those used in dermatologists’ offices, according to Murad Alam, M.D., Chief of Cutaneous Surgery in Northwestern
University’s Department of Dermatology.
“As things are miniaturized, there will probably be some degradation in their efficacy and their reliability, so there will be compromise,” he says. “Most people will accept that compromise in the interest of convenience and cost — and the reason is that it’s just too annoying to go to dermatologist’s office for laser hair removal.”
Consumers and A Growing Comfort with Technology
The at-home device development trend is also the natural extension of the general consumerism movement, fueled by the Internet and the anti-aging quest, some dermatologists suggest. As consumers become more comfortable in general with home remedies and hand-held devices, they’re becoming braver about what they will try out on their own, according to Melanie Grossman, M.D., a New York City dermatologist whose practice focuses on cosmetic dermatology and laser surgery.
“The trend is a combination of two things: baby boomers hitting their fifties and wanting to do anything they can to keep young, and the greater acceptance by the public that devices are helpful in aiding us with skin care and grooming,” she says.
Technology is improving, and the attendant pace of developing products that consumers can easily use is accelerating in tandem, she notes, creating a cross-over of sorts. “It’s a combination of consumer desire and electronic know-how,” Dr. Grossman says.
It’s tantamount to a natural progression, Dr. Alam maintains. “Given that people are using more sophisticated products, and that patients are using products that are seen as substitutes for what an in-office procedure might do, I think it’s a small leap for them to have a physical machine,” he says.
Future Rapid Expansion
Market forces are playing a major role, too, according to Dr. Alam. Not only are devices proliferating to fill consumers’ growing demand for cosmetic “fixes,” but the number of companies entering the market for home-use devices is likely to increase rapidly in the wake of the Food and Drug Administration’s clearance of the products. To date, the FDA has given its “compliance” stamp to the Zeno acne device and a handful of “laser-like” devices for hair removal and photorejuvenation. More such clearances are expected in the coming 2 years provided the products’ safety can be assured.
When that happens, Dr. Alam predicts, the well-funded cosmeceutical companies, rather than the current device makers serving the in-office market, are likely to move into the market quickly. It’s not in the interest of large laser companies to undercut their own market by making at-home products, he explains, because those firms tend to be little niche companies with limited capitalization. “The cosmeceutical companies, however, are extremely well capitalized and funded. They’re enormous global companies looking for the next new thing to market, and they’re uniquely well positioned because they already have consumer loyalty,” Dr. Alam says, referring to giants such as Neutrogena and Procter & Gamble.
The Effect on Dermatology Practices
Whether the trend toward use of at-home devices is a major blow or just a blip on the screen — that’s the effect most predict — for dermatology practices depends on several factors. The chief one is how effective the devices are. The second is how safe the user-friendly devices prove to be.
On the first issue, many cosmetic dermatologists are skeptical that the devices will supplant in-office procedures. That’s because, by design and in order to meet safety constraints, the devices will be only modestly effective. La Jolla, CA, Dermatologist Richard Fitzpatrick, M.D., who has assessed some of the devices in development, thinks that the marginal effectiveness of the current crop makes them a “non-threat” to physicians — at least at present.
“I haven’t seen any of these devices that, at least in theory, would have high enough efficacy to replace existing treatments. So I don’t see them as a threat to dermatologists’ practices,” says Dr. Fitzpatrick, Director of Cosmetic Dermatology at the La Jolla Cosmetic Surgery Centre. “The bar is a lot lower in terms of performance and efficacy for home-use devices.”
Dr. Fitzpatrick adds that patients, for the most part, understand that devices like the Zeno aren’t intended to replace but rather supplement office-based treatments and devices. Patients might be willing, for example, to use a device four or five times a week just to obtain a marginal effect, yet would expect far higher efficacy from even a single dermatologist-supervised treatment. That efficacy compromise is “much more acceptable when it’s a home-use device,” he adds.
For her part, Dr. Grossman expects the devices to boost dermatologists’ practices because of the growing awareness of treatments their use will propel. Whenever a technology or market development impinges on physicians’ practice turf, the tendency is to view it as a potential threat to livelihood. Yet in most cases, the worrisome encroachment rarely comes to pass, Dr. Grossman contends.
“There’s always a fear that … if things are taken to the consumer level, then maybe it will affect practice [volume],” she says. “But I think that, in fact, it will be the opposite. As consumers gain awareness and acceptance of technology, they will be more apt to go in to have procedures done.”
The thinking will be that “if this [home device] works a little, perhaps the treatment at the doctor’s office will be more effective,” Dr. Grossman adds. She qualifies that statement by acknowledging that as the devices themselves become better designed and more effective, they may initially encroach on the procedure market for dermatologists’ services. But eventually, that trend will be offset by patients choosing to go to the dermatologist’s office because, quite simply, “doing something oneself is just not as luxurious as having it done by someone else,” she says.
Like Dr. Grossman, Dr. Fitzpatrick sees the proliferation of home-use devices as having a beneficial effect on dermatologists’ practices. He cites a recent poll that found that about 80% of Americans have never been to see a dermatologist. “And even among those who have seen a dermatologist, awareness of available treatments is very low — so the big boon of this trend might be awareness,” he maintains.
And then there are the purely practical issues, especially when it comes to hair removal: Many parts of the body simply cannot be reached by the individual using a hand-held device. “There will always be places that can’t be treated, like the back, and patients will realize that certain treatments need to be done in the doctor’s office,” Dr. Grossman says.
Liability Issues, Hassles Certain to Arise with Device Sales
Dermatologists who decide to venture into the sideline of selling the at-home devices through their offices — taking the “if you can’t beat them, join them” attitude — may find a potential source of new revenue. But they’ll also entertain risk from two sources.
The first is the possibility that associating the practice with devices that are only modestly effective yet expensive (the Zeno is $200 and the Wellbox about $1,600) could damage the practice’s image.
The second, a possibly more important risk, is that if a patient is harmed by the device, whether it’s because of misuse or malfunction, dermatologists aren’t immune from liability.
“That’s the typical physician response: ‘I’m just the little guy, so if something goes wrong they [patients] can sue the company.’ In reality, that won’t work,” says David Goldberg, M.D., J.D., Director of Skin Laser & Surgery Specialists of New York & New Jersey and Adjunct Professor of Law at Fordham Law School in New York City.
Why aren’t dermatologists shielded by the manufacturer’s product liability? It’s because of a little known legal wrinkle known as the “learned intermediary” doctrine. That doctrine allows that if something goes awry with a drug or device sold to a physician who then passes it to the patient, the doctor assumes some liability. “Unless there is fraud from the manufacturer’s level, if a complication occurs, the doctor will be on the hook for that,” cautions Dr. Goldberg, who is also a Clinical Professor of Dermatology at Mount Sinai School of Medicine. “This has been seen in other [medical specialty] areas, but not in dermatology. But it will be seen in our field, too.”
Although dermatologists cannot protect themselves absolutely from this type of “product liability by association,” they can mitigate it with a few smart moves. Dr. Goldberg urges dermatologists eyeing in-office home-use sales to try the devices before offering them for sale — checking out not only how they work but also where things might go wrong. “Too often, doctors just give things to patients without knowing how they work or what they do,” says Dr. Goldberg, whose practice sells the Zeno acne treatment device. “There is no way to remove liability in a vacuum — all you can do is try it yourself and have your staff try it.”
Dr. Hruza recommends taking further steps, in the interest not only of protecting dermatologists’ practices but also to better inform patients. “If you’re going to sell devices in your office, I would definitely ‘undersell’ efficacy — by clearly explaining what the device can and cannot do,” he says, and urging patients to read the product use instructions closely.
Proceed with Caution
Even without the liability issue, dermatologists considering office sales should proceed cautiously, Dr. Hruza counsels, because of the potential downside of operating in any aspect of the retail environment. Besides the obvious hassle factors — dealing with returns, pricing competition from other sales outlets and the Internet — the issue of dissatisfied “customers” could be hugely problematic.
“The doctor who tries to sell and make money from these devices could face real problems that could actually hurt their practices,”
Dr. Hruza maintains. “Considering that some of these things sell for $1,000 or more, there will be high expectations from consumers.” And the patients who are unhappy with the devices’ performance might leave the practice or, worse, speak disparagingly about the dermatologist who sold them the product. As such, Dr. Hruza urges dermatologists who plan to sell the devices to write disclaimers that make it clear that the device won’t be as effective as those used in the office.
“The Zeno is modestly effective, but I know that many dermatologists who decided to stock the device have them sitting on the shelves now,” he says, because of their limited efficacy and associated cost (recharging the unit).
Dr. Fitzpatrick differs on this account. He views the at-home device sales as both a potential revenue booster and, ultimately, a way to increase procedure volume. “I actually think in-office sales is a good idea because I see these devices as a potential adjunct to existing treatments,” he says. “Some doctors ridicule the whole idea without even thinking about it. My advice is to take a closer look at these things because they do have a place in the overall treatment regimen.”
Dr. Fitzpatrick cites the reports his patients have given on the Zeno device as an example. “When I talk to patients about it [Zeno], they’ve been happy with it,” he says.
The FDA Weighs In
Because the at-home devices being developed treat valid medical claims, such as acne and abnormal hair growth, they must receive clearance from the FDA before their marketers can bring them to the market. That entails assuring the agency that consumers can use the devices safely and understand the instructions. That’s no small feat, according to Richard Felten, a Senior Reviewer in Device Evaluation for the FDA’s Center for Devices and Radiological Health.
“Companies have to demonstrate to us that people can read the material, select themselves appropriately and perform the intended use of the device safely,” Mr. Felten says. That means, ultimately, that “over-the-counter” devices will of necessity be less powerful than their physician-use counterparts, even though some manufacturers go to the trouble of staging randomized controlled trials to support their products’ claims and safety.
Even though manufacturers must meet those criteria, FDA clearance is a much lower level of approval than what’s required for drugs, and efficacy is not a chief consideration. However, it’s worth noting that the U.S. Army is funding development of a hand-held device that would manage pseudofolliculitis barbae, as so-called razor burn causes significant discomfort and disability among military personnel.
In the end, Dr. Goldberg reminds dermatologists that FDA clearance is precisely that — permission to market — and it’s a far cry, generally speaking, from the approval that’s afforded physician-prescribed drugs or in-office medical devices that have gone through the agency’s regulatory hoops. “It’s important to recognize that the FDA trials on these devices will never be as stringent as they are for the true doctor [operated] devices,” Dr. Goldberg explains, “and that approval doesn’t create any protection for anybody — it simply allows the company the beauty of saying it has a medical device that’s been cleared by the FDA.”
Pushing Dermatologists Toward Innovation
From the economic perspective, the proliferation of at-home devices will, at the least, push forward-thinking dermatologists toward practice innovation, Dr. Alam suspects.
“I think all of us will be forced to innovate and stay abreast of latest technological advances because it will create market segmentation,” he says, and push dermatologists to make their procedures more convenient for patients. In the early years, too, devices will be poorly understood and best used under a physician’s direction. “That will be the business opportunity for dermatologists.”
“The bottom line is that these [home-use] devices won’t work as well as what we use in the office — and that will expand the market,” Dr. Goldberg suggests, for dermatologist services for the medical problems devices attempt to treat. “It’s a foolish, protectionist view to look at this trend as hurting us. I don’t think that will be the case.”
Sidebar:
Home-use Device Marketplace Heating Up
Consumers are flocking to the Internet, spas, dermatologists’ offices and a host of other outlets to purchase home-use devices intended to treat dermatological conditions. Following is a sampling of those on the market now, and their claims and approximate costs:
Zeno (www.myzeno.com). Treats early acne lesions with thermal effects. Costs about $200.
DermaNew (www.dermanew.com). Battery-powered microdermabrasion tool that comes with “multi-crystal” cream. Costs about $130.
Epila Laser SI-808. Marketed on eBay and elsewhere, it promises “faster,
easier hair removal.” Sells for upwards of $100.
HairMax LaserComb (www.lasercomb.net). Touted as low-level laser therapy to improve hair appearance. Costs about $550 from manufacturer.
Nulase (www.nulase.com). Company’s Soft Touch Laser promises increased collagen levels and acne improvements. Costs about $180.
Radiancy (www.radiancy.com). Light-based skincare treatment for rejuvenation, acne and hair removal; home-use Clear Touch Lite cleared by the FDA. Price varies depending on sale outlet, but starts at about $500.
Wellbox (www.wellbox.com). Uses “tissular rolling” technique to reduce
cellulite and improve complexion. Costs approximately $1,600.
On a typical Saturday afternoon in American suburbia, it wouldn’t be unusual to find a middle-aged mom trying a home version of the chemical peel in hopes of diminishing the crow’s feet cropping up at her temples, while her teen-aged son, secreted away in the downstairs bathroom, goes after a new burst of acne spots with the hand-held Zeno device.
The latter, which uses a thermal effect to “zap” blemishes before they fully erupt, has become hugely popular among teens — though its effectiveness may be limited. Likewise, popularity has grown for the emerging slew of devices targeting consumers willing to attempt home versions of many procedures, such as dermabrasion, formerly available only in physician’s offices. In short, the trend toward do-it-yourself skin treatments that employ “cosmeceuticals” is finding impetus from a new quarter: home-use devices for everything from acne to hair removal. (See sidebar below.)
Technology may be the driving factor behind the development, proliferation and consumer use of products such as the Zeno, the oddly named no!no! hair-removal device and the far pricier laser-like counterpart, Radiancy — not to mention the Wellbox cellulite-fighting device being touted by Hollywood stars. But convenience takes a close second, even if the devices are only modestly effective compared to those used in dermatologists’ offices, according to Murad Alam, M.D., Chief of Cutaneous Surgery in Northwestern
University’s Department of Dermatology.
“As things are miniaturized, there will probably be some degradation in their efficacy and their reliability, so there will be compromise,” he says. “Most people will accept that compromise in the interest of convenience and cost — and the reason is that it’s just too annoying to go to dermatologist’s office for laser hair removal.”
Consumers and A Growing Comfort with Technology
The at-home device development trend is also the natural extension of the general consumerism movement, fueled by the Internet and the anti-aging quest, some dermatologists suggest. As consumers become more comfortable in general with home remedies and hand-held devices, they’re becoming braver about what they will try out on their own, according to Melanie Grossman, M.D., a New York City dermatologist whose practice focuses on cosmetic dermatology and laser surgery.
“The trend is a combination of two things: baby boomers hitting their fifties and wanting to do anything they can to keep young, and the greater acceptance by the public that devices are helpful in aiding us with skin care and grooming,” she says.
Technology is improving, and the attendant pace of developing products that consumers can easily use is accelerating in tandem, she notes, creating a cross-over of sorts. “It’s a combination of consumer desire and electronic know-how,” Dr. Grossman says.
It’s tantamount to a natural progression, Dr. Alam maintains. “Given that people are using more sophisticated products, and that patients are using products that are seen as substitutes for what an in-office procedure might do, I think it’s a small leap for them to have a physical machine,” he says.
Future Rapid Expansion
Market forces are playing a major role, too, according to Dr. Alam. Not only are devices proliferating to fill consumers’ growing demand for cosmetic “fixes,” but the number of companies entering the market for home-use devices is likely to increase rapidly in the wake of the Food and Drug Administration’s clearance of the products. To date, the FDA has given its “compliance” stamp to the Zeno acne device and a handful of “laser-like” devices for hair removal and photorejuvenation. More such clearances are expected in the coming 2 years provided the products’ safety can be assured.
When that happens, Dr. Alam predicts, the well-funded cosmeceutical companies, rather than the current device makers serving the in-office market, are likely to move into the market quickly. It’s not in the interest of large laser companies to undercut their own market by making at-home products, he explains, because those firms tend to be little niche companies with limited capitalization. “The cosmeceutical companies, however, are extremely well capitalized and funded. They’re enormous global companies looking for the next new thing to market, and they’re uniquely well positioned because they already have consumer loyalty,” Dr. Alam says, referring to giants such as Neutrogena and Procter & Gamble.
The Effect on Dermatology Practices
Whether the trend toward use of at-home devices is a major blow or just a blip on the screen — that’s the effect most predict — for dermatology practices depends on several factors. The chief one is how effective the devices are. The second is how safe the user-friendly devices prove to be.
On the first issue, many cosmetic dermatologists are skeptical that the devices will supplant in-office procedures. That’s because, by design and in order to meet safety constraints, the devices will be only modestly effective. La Jolla, CA, Dermatologist Richard Fitzpatrick, M.D., who has assessed some of the devices in development, thinks that the marginal effectiveness of the current crop makes them a “non-threat” to physicians — at least at present.
“I haven’t seen any of these devices that, at least in theory, would have high enough efficacy to replace existing treatments. So I don’t see them as a threat to dermatologists’ practices,” says Dr. Fitzpatrick, Director of Cosmetic Dermatology at the La Jolla Cosmetic Surgery Centre. “The bar is a lot lower in terms of performance and efficacy for home-use devices.”
Dr. Fitzpatrick adds that patients, for the most part, understand that devices like the Zeno aren’t intended to replace but rather supplement office-based treatments and devices. Patients might be willing, for example, to use a device four or five times a week just to obtain a marginal effect, yet would expect far higher efficacy from even a single dermatologist-supervised treatment. That efficacy compromise is “much more acceptable when it’s a home-use device,” he adds.
For her part, Dr. Grossman expects the devices to boost dermatologists’ practices because of the growing awareness of treatments their use will propel. Whenever a technology or market development impinges on physicians’ practice turf, the tendency is to view it as a potential threat to livelihood. Yet in most cases, the worrisome encroachment rarely comes to pass, Dr. Grossman contends.
“There’s always a fear that … if things are taken to the consumer level, then maybe it will affect practice [volume],” she says. “But I think that, in fact, it will be the opposite. As consumers gain awareness and acceptance of technology, they will be more apt to go in to have procedures done.”
The thinking will be that “if this [home device] works a little, perhaps the treatment at the doctor’s office will be more effective,” Dr. Grossman adds. She qualifies that statement by acknowledging that as the devices themselves become better designed and more effective, they may initially encroach on the procedure market for dermatologists’ services. But eventually, that trend will be offset by patients choosing to go to the dermatologist’s office because, quite simply, “doing something oneself is just not as luxurious as having it done by someone else,” she says.
Like Dr. Grossman, Dr. Fitzpatrick sees the proliferation of home-use devices as having a beneficial effect on dermatologists’ practices. He cites a recent poll that found that about 80% of Americans have never been to see a dermatologist. “And even among those who have seen a dermatologist, awareness of available treatments is very low — so the big boon of this trend might be awareness,” he maintains.
And then there are the purely practical issues, especially when it comes to hair removal: Many parts of the body simply cannot be reached by the individual using a hand-held device. “There will always be places that can’t be treated, like the back, and patients will realize that certain treatments need to be done in the doctor’s office,” Dr. Grossman says.
Liability Issues, Hassles Certain to Arise with Device Sales
Dermatologists who decide to venture into the sideline of selling the at-home devices through their offices — taking the “if you can’t beat them, join them” attitude — may find a potential source of new revenue. But they’ll also entertain risk from two sources.
The first is the possibility that associating the practice with devices that are only modestly effective yet expensive (the Zeno is $200 and the Wellbox about $1,600) could damage the practice’s image.
The second, a possibly more important risk, is that if a patient is harmed by the device, whether it’s because of misuse or malfunction, dermatologists aren’t immune from liability.
“That’s the typical physician response: ‘I’m just the little guy, so if something goes wrong they [patients] can sue the company.’ In reality, that won’t work,” says David Goldberg, M.D., J.D., Director of Skin Laser & Surgery Specialists of New York & New Jersey and Adjunct Professor of Law at Fordham Law School in New York City.
Why aren’t dermatologists shielded by the manufacturer’s product liability? It’s because of a little known legal wrinkle known as the “learned intermediary” doctrine. That doctrine allows that if something goes awry with a drug or device sold to a physician who then passes it to the patient, the doctor assumes some liability. “Unless there is fraud from the manufacturer’s level, if a complication occurs, the doctor will be on the hook for that,” cautions Dr. Goldberg, who is also a Clinical Professor of Dermatology at Mount Sinai School of Medicine. “This has been seen in other [medical specialty] areas, but not in dermatology. But it will be seen in our field, too.”
Although dermatologists cannot protect themselves absolutely from this type of “product liability by association,” they can mitigate it with a few smart moves. Dr. Goldberg urges dermatologists eyeing in-office home-use sales to try the devices before offering them for sale — checking out not only how they work but also where things might go wrong. “Too often, doctors just give things to patients without knowing how they work or what they do,” says Dr. Goldberg, whose practice sells the Zeno acne treatment device. “There is no way to remove liability in a vacuum — all you can do is try it yourself and have your staff try it.”
Dr. Hruza recommends taking further steps, in the interest not only of protecting dermatologists’ practices but also to better inform patients. “If you’re going to sell devices in your office, I would definitely ‘undersell’ efficacy — by clearly explaining what the device can and cannot do,” he says, and urging patients to read the product use instructions closely.
Proceed with Caution
Even without the liability issue, dermatologists considering office sales should proceed cautiously, Dr. Hruza counsels, because of the potential downside of operating in any aspect of the retail environment. Besides the obvious hassle factors — dealing with returns, pricing competition from other sales outlets and the Internet — the issue of dissatisfied “customers” could be hugely problematic.
“The doctor who tries to sell and make money from these devices could face real problems that could actually hurt their practices,”
Dr. Hruza maintains. “Considering that some of these things sell for $1,000 or more, there will be high expectations from consumers.” And the patients who are unhappy with the devices’ performance might leave the practice or, worse, speak disparagingly about the dermatologist who sold them the product. As such, Dr. Hruza urges dermatologists who plan to sell the devices to write disclaimers that make it clear that the device won’t be as effective as those used in the office.
“The Zeno is modestly effective, but I know that many dermatologists who decided to stock the device have them sitting on the shelves now,” he says, because of their limited efficacy and associated cost (recharging the unit).
Dr. Fitzpatrick differs on this account. He views the at-home device sales as both a potential revenue booster and, ultimately, a way to increase procedure volume. “I actually think in-office sales is a good idea because I see these devices as a potential adjunct to existing treatments,” he says. “Some doctors ridicule the whole idea without even thinking about it. My advice is to take a closer look at these things because they do have a place in the overall treatment regimen.”
Dr. Fitzpatrick cites the reports his patients have given on the Zeno device as an example. “When I talk to patients about it [Zeno], they’ve been happy with it,” he says.
The FDA Weighs In
Because the at-home devices being developed treat valid medical claims, such as acne and abnormal hair growth, they must receive clearance from the FDA before their marketers can bring them to the market. That entails assuring the agency that consumers can use the devices safely and understand the instructions. That’s no small feat, according to Richard Felten, a Senior Reviewer in Device Evaluation for the FDA’s Center for Devices and Radiological Health.
“Companies have to demonstrate to us that people can read the material, select themselves appropriately and perform the intended use of the device safely,” Mr. Felten says. That means, ultimately, that “over-the-counter” devices will of necessity be less powerful than their physician-use counterparts, even though some manufacturers go to the trouble of staging randomized controlled trials to support their products’ claims and safety.
Even though manufacturers must meet those criteria, FDA clearance is a much lower level of approval than what’s required for drugs, and efficacy is not a chief consideration. However, it’s worth noting that the U.S. Army is funding development of a hand-held device that would manage pseudofolliculitis barbae, as so-called razor burn causes significant discomfort and disability among military personnel.
In the end, Dr. Goldberg reminds dermatologists that FDA clearance is precisely that — permission to market — and it’s a far cry, generally speaking, from the approval that’s afforded physician-prescribed drugs or in-office medical devices that have gone through the agency’s regulatory hoops. “It’s important to recognize that the FDA trials on these devices will never be as stringent as they are for the true doctor [operated] devices,” Dr. Goldberg explains, “and that approval doesn’t create any protection for anybody — it simply allows the company the beauty of saying it has a medical device that’s been cleared by the FDA.”
Pushing Dermatologists Toward Innovation
From the economic perspective, the proliferation of at-home devices will, at the least, push forward-thinking dermatologists toward practice innovation, Dr. Alam suspects.
“I think all of us will be forced to innovate and stay abreast of latest technological advances because it will create market segmentation,” he says, and push dermatologists to make their procedures more convenient for patients. In the early years, too, devices will be poorly understood and best used under a physician’s direction. “That will be the business opportunity for dermatologists.”
“The bottom line is that these [home-use] devices won’t work as well as what we use in the office — and that will expand the market,” Dr. Goldberg suggests, for dermatologist services for the medical problems devices attempt to treat. “It’s a foolish, protectionist view to look at this trend as hurting us. I don’t think that will be the case.”
Sidebar:
Home-use Device Marketplace Heating Up
Consumers are flocking to the Internet, spas, dermatologists’ offices and a host of other outlets to purchase home-use devices intended to treat dermatological conditions. Following is a sampling of those on the market now, and their claims and approximate costs:
Zeno (www.myzeno.com). Treats early acne lesions with thermal effects. Costs about $200.
DermaNew (www.dermanew.com). Battery-powered microdermabrasion tool that comes with “multi-crystal” cream. Costs about $130.
Epila Laser SI-808. Marketed on eBay and elsewhere, it promises “faster,
easier hair removal.” Sells for upwards of $100.
HairMax LaserComb (www.lasercomb.net). Touted as low-level laser therapy to improve hair appearance. Costs about $550 from manufacturer.
Nulase (www.nulase.com). Company’s Soft Touch Laser promises increased collagen levels and acne improvements. Costs about $180.
Radiancy (www.radiancy.com). Light-based skincare treatment for rejuvenation, acne and hair removal; home-use Clear Touch Lite cleared by the FDA. Price varies depending on sale outlet, but starts at about $500.
Wellbox (www.wellbox.com). Uses “tissular rolling” technique to reduce
cellulite and improve complexion. Costs approximately $1,600.
