Department of Rehabilitation Science and Technology
The Last Mainstreaming
Frontier: Innovative Science
and Technology Policy for
People with Disabilities
Katherine D. Seelman, Ph.D., Associate Dean and Professor
Innovation and Robotics: The Future of AT
National Center for Technology Innovation
Washington, D.C.
November 15, 2010
School of Health and Rehabilitation Sciences
Department of Rehabilitation Science and Technology
Department of Rehabilitation Science and Technology
Objectives
• Explore incentives and disincentives for innovative *AT
quality of life technology to transfer from R&D to market
by
– Comparing federal and state policies and strategies
for mainstream innovation and AT/orphan products
– Show & Tell
– Analyze a robotics AT case study—iBot
– Providing examples of state-level best practices
• Identify opportunities & threats
•
*Smart technology for independent living, rehabilitation and prevention
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Department of Rehabilitation Science and Technology
Mainstream Technology Development Pipeline
Research/
Develop ment
Finance
Usability test
Seelman, 2010
3
Production
Commercialization
Manufacturing &
Marketing
Marketing
& Sales
Department of Rehabilitation Science and Technology
Assistive Technology Development Pipeline
Research/
Develop ment
Finance
Production
Usability test Commercialization
Clinical Research
Seelman, 2010
Manufacturing &
Marketing
Service
Delivery
Reimburse –
ment/payment
Department of Rehabilitation Science and Technology
Mainstream Pipeline: Distribution of Policy Resources
Research/
Develop ment
Finance
Producti
on
Manufacturing &
Marketing
Marketing
& Sales
Commercialization
Usability test
Tech Transfer
Federal Laboratory (Federal Tech
Knowledge Network and Information
Flows)
Federal Technology Transfer Act of
1986 et al*
NIH Tech Transfer Office
Seelman, 2010
Tax credits and regulatory
adjustments**
Orphan Drug Act of 1983
SBIR and STTR
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Department of Rehabilitation Science and Technology
AT Pipeline: Distribution of Policy Resources
Research/
Develop ment
Finance
Manufacturing &
Marketing
Production
Service
Delivery
Reimburse –
ment/paymen
t
Commercialization
Usability test
Clinical Research
Tech Transfer
RERC & R&D Tech
Knowledge Networks &
Information Flows
ICDR
Seelman,
2010
SBIR
&
STTR
508/Procurement
Policy
Access Board
Telecom Act
Regulation/FCC
ADA & ADAA, Rehab Act
Medicare & Medicaid
Sp. Ed & Medicaid
ATA
VR, VA
Out-of-pocket
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Department of Rehabilitation Science and Technology
Mainstream Barriers to Tech Transfer:
Product Development and the Valley of Death
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Department of Rehabilitation Science and Technology
Mainstream Incentive: Infusing Life
into the Valley of Death
• Biotech Industry and Patient Protection
and Affordable Care Act 2010
– tax breaks for smaller biotechnology companies
• an amount equal to 50 percent of the qualified
investment for such taxable year with respect to any
qualifying therapeutic discovery project,” permitting
some of the costs for pre-clinical research, clinical
trials and other research protocols to be reduced. It
appears that it will be limited to organizations with
fewer than 250 employees. The total amount of the
credit is $1 billion.
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Department of Rehabilitation Science and Technology
Mainstream Incentive (con.)
• Biotech Industry and Patient Protection
and Affordable Care Act 2010
– Approval pathway for biosimilar biological
products
• Provides clarity on regulatory issue. This section
permits biologics—the complex therapeutics
produced by most biotechnology companies—to
maintain 12 years of market exclusivity after
FDA approval.
http://www.xconomy.com/national/2010/03/24/healthcare-reform-gave-biotecheverything-it-wanted-and-more/
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Department of Rehabilitation Science and Technology
Barriers to AT Tech Transfer: Product
Development and the Valley of Death
• Prevalence of small firms in the AT industry
• Problems in hiring and retaining a trained
workforce
• Difficulties in attracting venture capital and
other forms of investment
• Disconnect between the AT industry and the
resources of the federal laboratory system
Source: U.S. Department of Commerce/BIS AT Survey
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Department of Rehabilitation Science and Technology
AT Barriers (con.)
• The first challenge (i.e. market size) impacts the
production cost of AT since it is typically not
possible to take advantage of high-volume
production savings.
• The second (i.e. market diversity), reduces the profit
margin of AT developers since significant resources
must be spent in tailoring particular products to
individual needs or providing personalized support.
http://inclusiveworkshop.ca/index.php?page=the-high-cost-of-at
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Department of Rehabilitation Science and Technology
Show & Tell: QoLT
autonomous
vehicles
physical
medicine &
rehabilitation
robotics
assistive
technology
Quality of Life
Technology
(QoLT)
geriatrics
computer
vision
humancomputer
interaction
© 2009 Carnegie Mellon
University and the
University of Pittsburgh
occupational /
vocational
rehab
Department of Rehabilitation Science and Technology
Tech-Link Program :Vectoring Young People
of All Abilities towards Technical Careers
Tech-Link
Department of Rehabilitation Science and Technology
Intelligent Mobility for a Person with
Disabilities
Navigating on different surfaces
Automated Transport
and Retrieval System
(Freedom Sciences, LLC)
Improved interface for
wheelchair (Cuitech)
QuickTime™ and a
Cinepak decompressor
are needed to see this picture.
Shared user/assistant/computer control
perform
for
© 2009 Carnegie Mellon
University and the
University of Pittsburgh
assist
with
Department of Rehabilitation Science and Technology
Show & Tell: Telerehabilitation RERC:
Pediatric Physical Therapy Teleconsultation
between US and Mexico using VISYTER
Conducted
over slow Internet connections (below broadband). Can be
4/13/2015
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used for International telerehabilitation.
Department of Rehabilitation Science and Technology
Accessible mHealth using iMHere
3
2
4/13/2015
5
334
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Department of Rehabilitation Science and Technology
Accessible mHealth: People Who
Are Blind and People with Motor
Impairments
4/13/2015
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Department of Rehabilitation Science and Technology
mHealth & Telerehabilitation . . .
Saving Limbs-Saving Lives
• Data collection where patients live
• Communication
• Mobile technology linked to
intelligent backup system
– Education, mentoring, decision support
for health workers/footwear businesses
– Increased adherence to new medical
protocols
– Medical guide & companion to health
workers & footwear businesses
http://www.rerctr.pitt.edu/
http://telerehabilitation.pitt.edu
4/13/2015
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Department of Rehabilitation Science and Technology
Telerehabilitation Saving LimbsSaving Lives
Swollen limbs
Foot and limb deformity
4/13/2015
Ulcers with frequent infections
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Department of Rehabilitation Science and Technology
Building an international model enhanced
by mobile technology
• 75% of all mobile phone users live
in the developing world
• By 2012, 50% of all individuals in
remote areas of the world will
have cell phones
• Mobile technology for data
collection, communication,
education, decision support
http://www.rerctr.pitt.edu/
http://telerehabilitation.pitt.edu
4/13/2015
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Department of Rehabilitation Science and Technology
Saving Limbs-Saving Lives Project
Varvasovsky & Brugha 2000, WHO 2009,
Post & Geyer, WOUNDS, 2010
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4/13/2015
Department of Rehabilitation Science and Technology
Case Study. From Wheelchairs to the
iBOT: AT Robotics Tech Transfer:
http://www.mindfully.org/Technology/2003/Wheelchair-iBOT13aug03.htm
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Department of Rehabilitation Science and Technology
Case Study: iBot 4000
(con.)
• Introduced to the market on July 26, 2005 by
Johnson & Johnson Corp. and removed from the
market in 2009.
• Designed with five operating functions:
– Standard
– Four-wheel
– Balancer
– Stair
– Remote
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Department of Rehabilitation Science and Technology
iBOT (con.)
http://www.hizook.com/blog/2009/02/11/ibot-discontinued-unfortunate-disabled-perhaps-buddingrobotics-opportunity
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Department of Rehabilitation Science and Technology
Case Study (con.)
Factor
Problem Description
Population Size
Narrow demographic
Reimbursement
CMS decision to reimburse the
approximately $22,000 iBOT like a regular
wheelchair—at about $6,000.
Industry structure
J & J’s decision to bypass the traditional
rehab supplier network
Assessment and training
Extensive need for practitioner and end
user training
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Department of Rehabilitation Science and Technology
State-level Best Practices in
Mainstream Tech Transfer
• Strategic tech initiatives
– States acting as policy incubators
• Rust Belt states like Indiana and Pennsylvania
pioneered a new approach to economic
development with expanded financial incentives
and public private partnerships
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Department of Rehabilitation Science and Technology
Model Partnerships (Government,
Business and Universities)
• Pittsburgh Life Sciences Greenhouse was born, a
public-private initiative, led by then Gov. Tom Ridge,
shaped from the state's piece of the tobacco settlement
money. Armed with a $33 million share and the
support of the University of Pittsburgh, Carnegie
Mellon University, UPMC health system and
Pittsburgh's regional foundation community, a vision
emerged for building the region into a biotechnology
powerhouse
http://www.popcitymedia.com/features/plsg0819.aspx
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Department of Rehabilitation Science and Technology
Model: Olympus as HUB
• Attractor, connector, incubator, micro-investor,
accelerator, creator
• Seed money from foundation, government,
corporate and university sources
• CMU initiative to bridge gap between world-class
research and innovation, and economy-promoting
commercialization
– Key project is to augment and accelerate the process
of moving basic research and great ideas to the
marketplace through licensing, creating start-ups, and
through corporate collaboration and strategic
partnerships
http://www.olympus.cs.cmu.edu/
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Department of Rehabilitation Science and Technology
Olympus (con.)
http://www.olympus.cs.cmu.edu/about/WhyItWorks.pdf
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Department of Rehabilitation Science and Technology
Olympus (con.)
http://www.olympus.cs.cmu.edu/about/BrochureReduced.pdf;
http://pittsburgh.tie.org/chapterHome/about_tie/viewInnerPagePT
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Department of Rehabilitation Science and Technology
Model: QoLT Foundry Process
QoLT Team,
end-users,
practitioners,
& partners
cultivate
team &
prototype
identify
vet
perform
due
diligence
licenses or
investments
Metrics
• IP status
• customer interest
• prototype
• supporting data
• inventor passion
• market dynamics
• ease of
productizing
validate
QoLT Industry / Practitioner
Advisory Board & others
develop
preliminary
biz plan
form
company
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Department of Rehabilitation Science and Technology
Model: QoLT Engineering Research Center
(We
are the only center working on Quality of Life Technology)
• What is an Engineering
Research Center?
A multi-university
organizations funded by NSF to
• What do they work on?
– biotechnology & healthcare
– do transformative R&D,
– energy, sustainability &
infrastructure
– spawn new industry
segments, and
– microelectronics, sensing &
information technology
– train the people who will
grow those segments.
• How many are there?
Currently 15 (47 since the
program inception in 1985)
• How are they funded?
10 years x ~$4M/yr from NSF
+ 20% cost sharing + industry
• After 10 years? industrial
funding and other Federal
grants (e.g., NIH, DARPA).
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(markets)
• Innovative technologies may travel down private
and/or publically subsidized R&D pathways(O/T)
• There is no QoLT industry for innovations in
prevention, rehab and community integration to
support inclusion in education, employment,
housing and ICT and community(T)
• Large companies such as DEKA and J&J have
entered the health robotics market but may be
conservative, perceiving high risk due to lack of
public reimbursement—in response to the iBOT
experience (T)
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(markets)
• Large companies, such as Time Warner
Cable/aol are entering the eHealth
market (O)
• AT professionals and people with
disabilities are not well represented in
the mainstream private sector (O/T)
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(markets)
• States have model programs to stimulate tech transfer
and support small companies (O)
– State tech economic development programs could join
together with the AT community to sponsor a business plan
competition for a particular AT challenge
• Winner would receive funding to develop their tech and
one criterion would be to highlight mass market
application potential
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(markets)
• Some mainstream products and
materials have innovative AT
applications, such as the iPAD and
AAC(O)
– Limited end-user population size
– Minimal clinical and end user input
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(markets and public policy)
• CMS will not reimburse laptop
computers, desktop computers, personal
digital assistants or other devices that
are not dedicated speech generating
devices because they do not meet the
Medicare definition of durable medical
equipment (DME) (T)
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Department of Rehabilitation Science and Technology
(O)pportunities and (T)hreats
(markets and public policy)
• Some wheelchair and hearing aids companies
are pursuing commoditization to increase
market size and lower costs(T)
– Prices are lowered, in part, by eliminating therapy
services costs, e.g., Scooter Store and Wal-Mart
– Impact of commoditization and lack of
reimbursement are threats to innovation for
complex rehab equipment such as the iBOT
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Department of Rehabilitation Science and Technology
(O)pportunities and (T)hreats
(public policy)
• Innovative prevention, rehabilitation and
community support technologies lack
representation in national tech transfer law,
federal R&D infrastructure and knowledge
networks and information flows (T)
– AT Innovation efforts are particularly vulnerable
– NIDRR, unlike NIH & NSF, has insufficient budget
to mount major tech transfer efforts
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(public policy)
• NIH’s Tech Transfer Office and STTR and
SBIR programs are responsive to the NIH
mission of making important medical
advances such as those in Biotech. No parallel
infrastructure exists for innovative
prevention, rehab and community support
tech industries (T)
– NIDRR may have been established to serve
this purpose but lacks the budget….
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Department of Rehabilitation Science and Technology
(O)pportunities & (T)hreats
(public policy)
• CMS requires evidence of product efficacy
(can it work?) and effectiveness (for whom will
it work?) for reimbursement but insufficient
incentives exist to support the costs of studies
to generate evidence to move AT to market (T)
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Department of Rehabilitation Science and Technology
To Look for interesting robotics, telerehab and other innovations:
Kate Seelman University of Pittsburgh kds31@pitt.edu
NSF Quality of Life Technology Engineering Research Center:
www.qolt.com
NIDRR RERC on Telerehabilitation: http://www.rerctr.pitt.edu/
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