Department of Rehabilitation Science and Technology The Last Mainstreaming Frontier: Innovative...

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 SciencesDepartment 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

2


Research/ Develop -

mentFinance Production

Manufac-turing &

MarketingMarketing

& Sales

Commercialization

Mainstream Technology Development Pipeline

3

Usability test

Seelman, 2010


Research/ Develop -


Manufac-turing &

MarketingService

DeliveryReimburse –

ment/payment

Commercialization

Assistive Technology Development Pipeline

Usability testClinical Research

Seelman, 2010


Research/ Develop -

mentFinance Producti

on

Manufac-turing &

MarketingMarketing

& Sales

Commercialization

Mainstream Pipeline: Distribution of Policy Resources

Usability test

Seelman, 2010

Federal Laboratory (Federal Tech Knowledge Network and Information Flows)Federal Technology Transfer Act of 1986 et al*NIH Tech Transfer Office

Tech Transfer

Tax credits and regulatory adjustments**Orphan Drug Act of 1983SBIR and STTR

5


6

AT Pipeline: Distribution of Policy Resources

Research/ Develop -


Manufac-turing &

Marketing

Service Delivery

Reimburse – ment/payment

Commercialization Usability testClinical Research

Seelman, 2010

ADA & ADAA, Rehab ActMedicare & MedicaidSp. Ed & MedicaidATAVR, VAOut-of-pocket

508/Procurement PolicyAccess BoardTelecom ActRegulation/FCCRERC & R&D Tech

Knowledge Networks &Information FlowsICDR

Tech Transfer

SBIR & STTR


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

7


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.

8


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-biotech-everything-it-wanted-and-more/ 9


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 10


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

11


© 2009 Carnegie Mellon University

and the University of PittsburghQuality of Life

Technology Center

Quality of LifeTechnology

(QoLT)

robotics

autonomousvehicles

computervision

human-computer

interaction

physical medicine &

rehabilitation

assistive technology

occupational /vocational

rehab

geriatrics

Show & Tell: QoLT


Tech-Link

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


© 2009 Carnegie Mellon University

and the University of PittsburghQuality of Life

Technology Center

Intelligent Mobility for a Person with Disabilities

Automated Transport and Retrieval System(Freedom Sciences, LLC) Improved interface for

wheelchair (Cuitech)

Navigating on different surfaces

Shared user/assistant/computer control

assistwith

perform for

QuickTime™ and aCinepak decompressor

are needed to see this picture.


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.

04/19/23 15


Accessible mHealth using iMHere

2 333 4 5

04/19/23 16


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

04/19/23 17


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

04/19/23

18


Telerehabilitation Saving Limbs-Saving Lives

Foot and limb deformity Ulcers with frequent infections

Swollen limbs

04/19/23 19


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

04/19/23

20


Saving Limbs-Saving Lives Project

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

04/19/23

21


Case Study. From Wheelchairs to the iBOT: AT Robotics Tech Transfer:

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

22


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

– Remote23


iBOT (con.)

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


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

25

Case Study (con.)


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

26


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

27


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/28


Olympus (con.)

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

29


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

Olympus (con.)


identify

vet

perform due

diligence

validate

developpreliminary

biz plan

cultivateteam &

prototype

formcompany

QoLT Industry / PractitionerAdvisory Board & others

licenses orinvestments

Model: QoLT Foundry Process

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

productizing

QoLT Team,end-users,practitioners,& partners

31


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).

32


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)


(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)

34


(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

35


(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

36


(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)

37


(O)pportunities and (T)hreats (markets and public policy)

38

• 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)• 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

39


(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….

40


(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)

41


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Kate Seelman University of Pittsburgh [email protected] Quality of Life Technology Engineering Research Center: www.qolt.comNIDRR RERC on Telerehabilitation: http://www.rerctr.pitt.edu/

To Look for interesting robotics, telerehab and other innovations:

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