the colossal clash - accenture · the colossal clash clinical and consumer health solutions are set...
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Clinical
$30B
$18B
$10B$6B
$3B$1B$0.5B$0.3B
Pacemaker
MethodologyAccenture assessed the number of digital health solutions that received FDA 510(k) clearance from 2010 through 2014. The analysis focused on devices and/or software created for indications that are regulated by the FDA, but incorporate consumer-driven principles (e.g. mobility, user experience / industrial design and always-on connectivity). The analysis predominantly excluded traditional medical devices and equipment (e.g. durable medical equipment, MRI machine). Analysis included review of secondary sources and examination of regulatory, clinical and other market trends.
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1 Consumer solution companies: Traditional product companies, not originally viewed as a healthcare stakeholders or operating within regulated markets.2 Clinical solution companies: Traditional medical device companies that often sell FDA regulated products within and across the continuum of care.3 Devices and/or software created for indications that are regulated by the FDA, but incorporate consumer-driven principles (e.g. mobility, user experience / industrial design and always-on connectivity).4 Net healthcare cost savings accounting for disease management / care management programming costs.5 BCC Research, Mobile Health (mHealth) Technologies and Global Markets, March 2014
Patient Engagement
The Colossal ClashClinical and consumer health solutions are set to collide, part of the Internet of Things (IoT) revolution set to disrupt the digital health landscape and the healthcare status-quo.
CLINICAL AND CONSUMER PRINCIPLES ARE COMING TOGETHER TO CREATE A NEW ERA OF DIGITAL HEALTH SOLUTIONS.
In this new age, it’s less about the device and more about healthcare service delivery – and driving value through cost and quality outcomes.
Consumer solution companies are entering regulated healthcare markets1
Clinical solution companies are adopting consumer design principles2
E.g. Mobile ECG
Clinical solution companies are increasingly focused on consumer-centric design,
while consumer solution companies are trying to show clinical value.
COST SAVINGS
THE FUTURE OF DIGITAL HEALTH
2017E2015E 2016E 2018E2010
FDA-
appr
oved
510
(k) s
olut
ions
2011 2012 20142013
Grew 21% a year
from 2010 to 2014
Will Triple by 2018
FDA-regulated digital health solutions, including devices and software applications, will save billions for US healthcare.
Cost savings will be driven primarily by:
• Medication Adherence
• ER Diversion
• Behavior Change
2010 2011 2012 2013 2014 2015E 2016E 2017E 2018E
Forecast2018:
4. Shifts towardsvalue-basedreimbursementReimbursement modernization and incentive alignment are creating fertile ground for adoption of new business models and clinical approaches that incorporate devices.
5. Empowered consumersPatient engagement is on the rise as consumers increasingly self-manage care:
• 72% of US consumers said the useof technology is important when itcomes to managing their health
• 57% of US consumers self-tracktheir health information
• ~100,000 mHealth smartphone appswere available for download in 20135.
Source: Accenture Analysis
Source: Accenture Analysis
US Healthcare Annual Net Cost Savings Attributed to FDA-regulated Digital Health Solutions 2010-20184
1. Smootherregulatory processMore clarity of FDA process, introduction of expedited regulatory pathways and more available devices reduce barriers to receiving FDA-approval.
2. Rapidly evolvinghealthcare IT andcommunicationsinfrastructure• Enables devices and solutions to be
integrated with EHR, PHR and otherclinical systems
• Movement towards advanced datatools and analytics platforms–concerns around security and riskexposure persist
3. Digital docsUS physicians’ use of eHealth is increasing:
• 65% e-prescribe
• 57% electronically sendlab orders
• 55% use electronictools to reduce administrative burdens
33%Track Health Indicators
34%Track Physical
Activity
37%Track Health
History
5 MARKET ACCELERATORS DRIVINGTHE COLOSSAL CLASH
of which:
E.g. WellnessTracker
E.g. BluetoothWeight Scale
COLOSSAL CLASH WILL HAVE BROAD IMPACT
Funding of digital health start-ups in the US will
double over the next three years, and reach
$6.5 billionby 2017.
Explosion in new devices and solutions will enable new health plan o�erings.
PayersGreater ability to manage their own health, plus more wearable devices in market, will speed up the emerging self-care model.
Patients
Opportunities to use new sources of data to improve healthcare delivery timing, quality and outcomes.
ProvidersDigitally-enabled device and service wrappers around therapeutics will facilitate the transition towards value-based reimbursement.
Life Sciences
DIGITAL HEALTHDISRUPTORS
Grew 90% a year
from 2010 to 2014
53% annual growth 2014-2018 forecasted
Forecasted 30% annual
growth 2014-2018
E.g. ContinuousGlucose Monitor
E.g. Pacemaker
ClinicalConsumer
1323 26 29 33
45
80
100
60
ClinicalConsumer
$50B
Rapid growth of annual 510(k)
FDA approvalsof digital
health solutions3 2010-2018
Consumer Solution Companies:Opportunities to apply skills in product design, user engagement and manufacturing will be curbed by the challenges of entering regulated, clinical markets.
Clinical Solution Companies:A challenging operating environment and a general shift from products to solutions may favor new well-funded start-ups and threaten revenues.