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MEDICINE AND THE MEDIA
Marketing wearable home baby monitors: real peace
of mind?
The peace of mind for which parents buy expensive but unregulated wearable monitors, and on
which their marketing depends, may be illusory, David King writes
David King clinical lecturer in paediatrics, Academic Unit of Child Health, University of Sheffield,
Sheffield S10 2TH, UK
Wearable devices for infants are a growing industry. In April
2014, the US company Owlet announced that it had raised
$1.85m (£1.2m; €1.5m) to develop and launch a “smart sock”
that can be attached to a newborn baby’s ankle to monitor its
vital signs.1Parents can use a smart phone to check heart rate,
oxygen concentrations, and skin temperature and to receive
alerts if the child rolls over.
Owlet’s chief executive, Kurt Workman, is ambitious. “We see
the wearable future will include every single baby coming home
from the hospital with a wearable monitor,” he told the
Telegraph.1The company states that these devices will give
parents “peace of mind and maybe even a full night’s sleep.”2
The product is still in development but can be reserved online
for $250.
Another company, Rest Devices, has developed Mimo, which
is available for $199.99. This is a baby grow with inbuilt sensors
that monitor a baby’s respiratory rate and temperature.3
Sproutling is another start-up company aiming to capitalise on
this market. It has released details of a device to be worn around
a baby’s ankle that can monitor heart rate and temperature and
will sell at a recommended price of $299.4
Sudden infant death syndrome
To older paediatricians this may sound familiar. In the 1980s
and 1990s a plethora of similar products was developed and
sold with the intention of reducing sudden infant death syndrome
(SIDS). Unfortunately epidemiological studies showed that such
devices had no effect on the incidence of SIDS in healthy
infants.5-7 The American Academy of Pediatrics states that home
cardiorespiratory monitors should not be used as a strategy to
reduce the risk of SIDS.8
Home monitoring may be justified in some situations, such as
for preterm infants or infants who need oxygen. But in these
cases parents and other caregivers should be trained in
observation techniques, operation of the monitor, and infant
cardiopulmonary resuscitation.9
Owlet, Rest Devices, and Sproutling do not claim that their
devices reduce the risk of SIDS. However, parental fears about
SIDS have driven the development of their products—and the
themes in their marketing. Workman, in a press release for the
Owlet monitor, said that part of the inspiration for the product
was that he “had a cousin pass away from [SIDS].”10 The chief
executive of Sproutling, Chris Bruce, was quoted in Time
magazine as saying that the idea for the product arose because
he was incessantly checking the baby monitor after the birth of
his first child to make sure she was still breathing.11
In its promotional video, Owlet shows a mother saying that she
is “one of the mums who puts my fingers in front of [my baby’s]
nose to make sure she is breathing and my hand on her chest to
make sure it is going up and down.”12 Rest Devices does not
mention SIDS in its marketing but does state that use of its
device gives “relief from that heavy anxious feeling” and “keeps
babies safe.”3
Both Sproutling and Rest Devices include a disclaimer on their
websites to say that there is no evidence that their devices can
reduce the risk of SIDS.3 4 However, in the case of Rest Devices
this disclaimer is in small print under its terms of service and
is not prominent.
Regulatory approval not needed in the US
None of these products requires approval from the US Food and
Drug Administration. They are not yet available in Europe, and
it is unclear whether regulatory approval will be needed here.
Owlet and Rest Devices originally wanted their products to be
sold as medical devices and were planning to gain FDA approval
before launch. However, representatives from both companies
have said that the time and expense that this process would have
required made it unfeasible.13 14
They both acknowledged that they modified their products so
that they could sell them direct to consumers without any need
to apply to the FDA. Owlet’s cofounder Jacob Colvin explained
that the alarm was removed so that it could be sold as an
d.a.king@sheffield.ac.uk
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BMJ 2014;349:g6639 doi: 10.1136/bmj.g6639 (Published 18 November 2014) Page 1 of 2
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unregulated monitoring device.12 Similarly, Dulcie Madden,
head of Rest Devices, said that by removing any alarms and
making the Mimo a product for consumers, rather than a medical
device, the company could circumvent the need to apply to the
FDA for regulatory approval.13
Owlet states on its website that the device “alerts you if
something appears wrong with your baby’s heart rate or the
amount of oxygen in his/her body.”1Rest Devices claims that
its product allows parents to see their “baby’s breathing patterns,
in real-time.”3Sproutling says that it will let you know “if your
baby is sleeping soundly or if something is wrong.”4No
published data support any of these claims, and because the
devices are being sold as consumer rather than medical devices
such data are not required. Ideally, manufacturers would be
required to undertake observational studies or randomised trials
to support any claims they make concerning the utility and
efficacy of wearable devices in infants—even if they are
categorised as consumer devices.
But until that time medical professionals and consumers need
to be aware that such devices have no proved use in safeguarding
infants or detecting health problems, and they certainly have no
role in preventing SIDS. Healthcare professionals should not
recommend these products to reduce parents’ fears of SIDS but
should instead focus on interventions that have been proved to
work, such as encouraging parents to put infants on their back
to sleep.8
Despite disclaimers in small print on the companies’ websites
saying that the products are not medical devices, parents may
not be fully aware of the implications of this when spending
several hundred dollars on these products. Manufacturers should
place prominent disclaimers at the point of sale to emphasise
that they are not medical devices and that no evidence shows
that they reduce the risk of SIDS or have any other health
benefits.
Workman told me that Owlet was planning to place a disclaimer
on its website saying that the device did not reduce the risk of
SIDS. He was keen to emphasise that its main function was to
offer parents “reassurance.” In addition, he wished to highlight
that some small trials were ongoing and that the company
eventually planned to apply for FDA approval. Rest Devices
and Sproutling did not reply to my attempts to contact them.
Are the manufacturers of these wearable devices for infants
being completely transparent with their future customers? If
they are not, the risk is that the substantial amounts of money
that parents pay for such devices might lull them into a false
sense of security.
Competing interests: I have read and understood the BMJ Group policy
on declaration of interests and declare the following interests: none
Provenance and peer review: Not commissioned; not externally peer
reviewed.
1 Peck S. Baby monitor 2.0 is born: but does it spell the end of maternal instinct? Telegraph
2014 Apr 24. www.telegraph.co.uk/women/mother-tongue/10785072/Baby-monitor-2.0-
is-born-but-does-it-spell-the-end-of-maternal-instinct.html.
2 Owlet. Introducing the Owlet smart sock. www.owletcare.com. Accessed 10 Nov 2014.
3Rest Devices. Stay connected with the Mimo baby monitor. http://mimobaby.com. Accessed
10 Nov 2014.
4 Sproutling. Meet Sproutling. The smarter baby monitor. www.sproutling.com. Accessed
10 Nov 2014.
5Hodgman JE, Hoppenbrouwers T. Home monitoring for the sudden infant death syndrome:
the case against. Ann NY Acad Sci 1988;533:164-75.
6 Ward SL, Keens TG, Chan LS, Chipps BE, Carson SH, Deming DD, et al. Sudden infant
death syndrome in infants evaluated by apnea programs in California. Pediatrics
1986;77:451-8.
7Ramanathan R, Corwin MJ, Hunt CE, Lister G, Tinsley LR, Baird T, et al. Cardiorespiratory
events recorded on home monitors: comparison of healthy infants with those at increased
risk for SIDS. JAMA 2001;285:2199-207.
8 Task Force on Sudden Infant Death Syndrome, Moon RY. SIDS and other sleep-related
infant deaths: expansion of recommendations for a safe infant sleeping environment.
Pediatrics 2011;128:e1341-67.
9 Committee on Fetus and Newborn. American Academy of Pediatrics. Apnea, sudden
infant death syndrome, and home monitoring. Pediatrics 2003;111:914-7.
10 Owlet Press Release. Owlet baby care creates the first wearable tech for babies, sending
heart rate & oxygen levels to a parent’s smartphone. 26 Aug 2013. www.owletcare.com/
Media%20Kit.zip.
11 Begley S. The Sproutling is like Fitbit for your baby—but better. Time 2014 Aug 7. http://
time.com/3086806/sproutling-baby-monitor.
12 Owlet Care. Owlet vitals monitor—see your child’s heart and oxygen levels on your
smartphone. www.youtube.com/watch?v=q-5YDBp63uk.
13 Rollins Center for Entrepreneurship and Technology. IBMC 2013: team Owlet—1st place.
www.youtube.com/watch?v=rS6fHW9pRek.
14 Startup Bootcamp. Dulcie Madden (Rest Devices). www.youtube.com/watch?v=-
GxILsGkRAc.
Cite this as: BMJ 2014;349:g6639
© BMJ Publishing Group Ltd 2014
For personal use only: See rights and reprints http://www.bmj.com/permissions Subscribe: http://www.bmj.com/subscribe
BMJ 2014;349:g6639 doi: 10.1136/bmj.g6639 (Published 18 November 2014) Page 2 of 2
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