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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.

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slide1

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

objectives
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
slide3

Mainstream Technology Development Pipeline

Production

Manufac-turing & Marketing

Marketing & Sales

Research/ Develop -ment

Finance

Commercialization

Usability test

Seelman, 2010

slide4

Assistive Technology Development Pipeline

Production

Manufac-turing & Marketing

Service Delivery

Reimburse – ment/payment

Research/ Develop -ment

Finance

Commercialization

Usability test

Clinical Research

Seelman, 2010

slide5

Mainstream Pipeline: Distribution of Policy Resources

Finance

Production

Manufac-turing & Marketing

Marketing & Sales

Research/ Develop -ment

Commercialization

Usabilitytest

Tech Transfer

Tax credits and regulatory adjustments**

Orphan Drug Act of 1983

SBIR and STTR

Federal Laboratory (Federal Tech Knowledge Network and Information Flows)

Federal Technology Transfer Act of 1986 et al*

NIH Tech Transfer Office

Seelman, 2010

at pipeline distribution of policy resources
AT Pipeline: Distribution of Policy Resources

Production

Manufac-turing & Marketing

Service Delivery

Reimburse – ment/payment

Research/ Develop -ment

Finance

Commercialization

Usability test

Clinical Research

508/Procurement Policy

Access Board

Telecom Act

Regulation/FCC

ADA & ADAA, Rehab Act

Medicare & Medicaid

Sp. Ed & Medicaid

ATA

VR, VA

Out-of-pocket

Tech Transfer

SBIR & STTR

RERC & R&D Tech

Knowledge Networks &

Information Flows

ICDR

Seelman, 2010

mainstream incentive infusing life into the valley of death
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.
mainstream incentive con
Mainstream Incentive (con.)

http://www.xconomy.com/national/2010/03/24/healthcare-reform-gave-biotech-

everything-it-wanted-and-more/

  • 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.
barriers to at tech transfer product development and the valley of death
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

at barriers con
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

show tell qolt
Show & Tell: QoLT

autonomousvehicles

physical medicine & rehabilitation

robotics

assistive technology

Quality of LifeTechnology

(QoLT)

geriatrics

computer

vision

occupational /

vocational

rehab

human-computer interaction

© 2009 Carnegie Mellon University and the University of Pittsburgh Quality of Life Technology Center

intelligent mobility for a person with disabilities

perform for

assistwith

Intelligent Mobility for a Person with Disabilities

Navigating on different surfaces

Automated Transport and Retrieval System

(Freedom Sciences, LLC)

Improved interface for wheelchair (Cuitech)

Shared user/assistant/computer control

© 2009 Carnegie Mellon University and the University of Pittsburgh Quality of Life Technology Center

slide15
Show & Tell: Telerehabilitation RERC: Pediatric Physical Therapy Teleconsultation between US and Mexico using VISYTER

Conducted over slow Internet connections (below broadband). Can be used for International telerehabilitation.

mhealth telerehabilitation saving limbs saving lives
mHealth & Telerehabilitation . . . Saving Limbs-Saving Lives

http://www.rerctr.pitt.edu/

http://telerehabilitation.pitt.edu

  • 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
telerehabilitation saving limbs saving lives
Telerehabilitation Saving Limbs-Saving Lives

Swollen limbs

Foot and limb deformity

Ulcers with frequent infections

building an international model enhanced by mobile technology
Building an international model enhanced by mobile technology

http://www.rerctr.pitt.edu/

http://telerehabilitation.pitt.edu

  • 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
slide21

Saving Limbs-Saving Lives Project

Varvasovsky & Brugha 2000, WHO 2009, Post & Geyer, WOUNDS, 2010

case study from wheelchairs to the ibot at robotics tech transfer
Case Study. From Wheelchairs to the iBOT: AT Robotics Tech Transfer:

http://www.mindfully.org/Technology/2003/Wheelchair-iBOT13aug03.htm

case study ibot 4000 con
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
ibot con
iBOT (con.)

http://www.hizook.com/blog/2009/02/11/ibot-discontinued-unfortunate-disabled-perhaps-budding-robotics-opportunity

state level best practices in mainstream tech transfer
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
model partnerships government business and universities
Model Partnerships (Government, Business and Universities)

http://www.popcitymedia.com/features/plsg0819.aspx

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

model olympus as hub
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/

olympus con
Olympus (con.)

http://www.olympus.cs.cmu.edu/about/WhyItWorks.pdf

slide30

Olympus (con.)

http://www.olympus.cs.cmu.edu/about/BrochureReduced.pdf;

http://pittsburgh.tie.org/chapterHome/about_tie/viewInnerPagePT

model qolt foundry process
Model: QoLT Foundry Process

cultivateteam & prototype

QoLT Team,end-users,practitioners,& partners

identify

vet

developpreliminary biz plan

  • Metrics
    • IP status
    • customer interest
    • prototype
    • supporting data
    • inventor passion
    • market dynamics
    • ease ofproductizing

perform duediligence

formcompany

validate

licenses or

investments

QoLT Industry / PractitionerAdvisory Board & others

model qolt engineering research center we are the only center working on quality of life 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
    • do transformative R&D,
    • spawn new industry segments, and
    • train the people who will grow those segments.
  • How many are there?Currently 15 (47 since the program inception in 1985)
  • What do they work on?
    • biotechnology & healthcare
    • energy, sustainability & infrastructure
    • microelectronics, sensing & information technology
  • 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).
o pportunities t hreats markets
(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)
o pportunities t hreats markets1
(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)

o pportunities t hreats markets2
(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
o pportunities t hreats markets3
(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
o pportunities t hreats markets and public policy
(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)

o pportunities and t hreats markets and public policy
(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
o pportunities and t hreats public policy
(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
o pportunities t hreats public policy
(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….
o pportunities t hreats public policy1
(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)
slide42

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.comNIDRR RERC on Telerehabilitation: http://www.rerctr.pitt.edu/