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The Last Mainstreaming Frontier: Innovative Science and Technology Policy for People with Disabilities

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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The Last Mainstreaming Frontier: Innovative Science and Technology Policy for People with Disabilities

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  1. 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

  2. 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

  3. Mainstream Technology Development Pipeline Production Manufac-turing & Marketing Marketing & Sales Research/ Develop -ment Finance Commercialization Usability test Seelman, 2010

  4. Assistive Technology Development Pipeline Production Manufac-turing & Marketing Service Delivery Reimburse – ment/payment Research/ Develop -ment Finance Commercialization Usability test Clinical Research Seelman, 2010

  5. 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

  6. 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

  7. Mainstream Barriers to Tech Transfer: Product Development and the Valley of Death

  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. Tech-Link Program :Vectoring Young People of All Abilities towards Technical Careers Tech-Link

  14. 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

  15. 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.

  16. Accessible mHealth using iMHere 33 5 4 3 2

  17. Accessible mHealth: People Who Are Blind and People with Motor Impairments

  18. 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

  19. Telerehabilitation Saving Limbs-Saving Lives Swollen limbs Foot and limb deformity Ulcers with frequent infections

  20. 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

  21. Saving Limbs-Saving Lives Project Varvasovsky & Brugha 2000, WHO 2009, Post & Geyer, WOUNDS, 2010

  22. Case Study. From Wheelchairs to the iBOT: AT Robotics Tech Transfer: http://www.mindfully.org/Technology/2003/Wheelchair-iBOT13aug03.htm

  23. 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

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

  25. Case Study (con.)

  26. 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

  27. 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

  28. 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/

  29. Olympus (con.) http://www.olympus.cs.cmu.edu/about/WhyItWorks.pdf

  30. Olympus (con.) http://www.olympus.cs.cmu.edu/about/BrochureReduced.pdf; http://pittsburgh.tie.org/chapterHome/about_tie/viewInnerPagePT

  31. 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

  32. 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).

  33. (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)

  34. (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)

  35. (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

  36. (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

  37. (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)

  38. (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

  39. (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

  40. (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….

  41. (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)

  42. 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/

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