mHealth and Wireless Medical Technology Conference Workshop Partnering with Academic Organizations

Kenyon Crowley, MBA, MS, CPHIMS

May 1, 2013

Agenda About

Partnering with academic researchers/orgs

Tech transfer

Funding

Strategy

Technology Policy

About CHIDS Mission

Research, analyze, and recommend solutions to challenges surrounding the introduction and integration of information and decision technologies into the health care system

Improve the practice and delivery of health care by offering researched solutions that impact safety, quality, access, efficiency, and ROI

Partner Ecosystem

Federal and state agencies (HHS, NSF, DoD, State of MD)

Private corporations (CNMC, J&J, CareFirst BlueCross BlueShield, Cisco, Small and Mid-Size firms)

Not-for-profits (CDT, eHealth Initiative)

Resources

Renowned scholars from multiple disciplines

Research fellows, students

3

Lockheed Martin Briefing

Research Focus Areas

Impact and Comparative

Effectiveness of Health Information

Systems

New Models of Care (ACO, HIE,

PCMH, Care Transitions)

Healthcare Analytics (Data-

driven Health Services Insights,

Modeling, Operations)

Consumers, Quality &

Transparency, and Social Media

Mobile Health Applications Diverse application of wireless and mobile

technologies designed to improve health research, health care services and health outcomes

Not just mobile phones + apps

A major focus for clinicians and policy makers

May increase patient engagement, advance patient monitoring, aid in chronic disease management, and potentially reduce health system costs.

Clinicians can track therapeutic effectiveness through remote monitoring applications (apps) that gather, transmit, and analyze a patient’s readings.

Limited number of apps are constructed on design principles that are theoretically derived, and little is known about their effectiveness.

Image: Rock Health

Mobile Health Market Market forecasted to grow at a CAGR (compound annual

growth rate) of 40.4 % through 2015.

85% US adults own mobile phone; 53% own smartphone.

19% of smartphone owners have at least one health app on their phone. Exercise, diet, and weight apps are the most popular types.

One in three cell phone owners (31%) have used their phone to look for health information. (17% one year ago).

According to a March 2013 study, the market for mHealth services has now entered the commercialization phase and will reach $26 billion globally by 2017.

According to research by HIMSS Analytics, about half of all doctors use mobile health apps, and a quarter of consumers do.

- Pew Mobile Health Survey 2012 - Mercom 2013

Era of the Quantified Self and Trackers

Graphic credit: Pew

University collaborations Technology research and development

Evaluations

Pilots and clinical trials

Teaming on grants and contracts

Impact

Research

Teaching

Technology / Product Development Integrating cutting edge science and expertise for

new or enhanced products

University Labs + Centers

Industry Liaison

Evaluation What is the effectiveness, impact + value of this

solution?

Research with a capital “R”

Economic Inefficiencies in hospital communications

Process Time and motion

Workflow analysis

Impact of nursing call systems

Clinical Defining measures

Usability

http://healthit.ahrq.gov/developmentmethodsguide

Usability

Pilots & Clinical Trials Research design

Site selection

Agreements

Cohort management

Data Analysis

Institutional Review Board (IRB) navigation IRB is a committee designated by an institution to help assure the

protection of the rights and welfare of human subjects

If sponsored by HHS: Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained

Teaming for opportunities Grants

Contracts

Contract vehicles

GWAC, IDIQ, Consortium

Alignment!

Algorithms and modeling Modeling ICU systems and throughput

Nurse call systems

Predictive models for early identification diabetes “jumpers”

Fraud identification algorithms

University role:

Assess and document the effectiveness and value of solution

Explore, refine and test next generation advances to the predictive model

Assess behavioral aspects and usability of current approach and recommend improvements

PHR + secure messaging pilot Assess pilot implementation of secure messaging

and PHR

University role

Design research and analytical strategy

Manage trial

Publish results and lessons learned

Mobile EHR for Cardiologists Company has an existing basic EHR and is seeking to build a

specialty-specific product

Market assessment by MBA team

Software requirements by research group

University role:

Financial and qualitative assessment of potential markets

Design, manage and conduct focus groups including cardiologists and cardiac nurses

Assess policy: meaningful use, standards, relevant market developments

Document technical, functional requirements

University Tech Transfer Role Brings solutions to marketplace Pay to Protect IP – patents, trademarks, copyrights. Assist in the development of Business Plans and

commercialization strategy. Assist in getting additional grant funding to further

develop IP Create start-up company when appropriate vehicle for

commercialization. Assist in raising financing for company. Negotiate agreements with licensees.

Licensing Typical Agreement Terms and Conditions: Licensing (to start-ups or large corporations): - royalty paid to university based upon sales

attributable to IP – typically around 5% of sales.

Milestones – if license is exclusive then minimum royalties typically apply as well as development milestones (especially in drug development).

What’s in it for the researchers Royalties (Ranges broadly)

Additional funding to do research

Peer acknowledgement

Equity in start-up

Does little to get tenure other than as a result of the papers that may be published on the on-going research, and sometimes publishing in itself is a huge problem in commercialization.

Younger profs focus is usually getting tenure, which is gained through

- Publishing papers

- Doing more research

- Teaching

Commercialization of IP is not always high on their list – has implications for businesses who want to license/buy the IP and move the IP forward in conjunction with the researchers.

Funding opportunities…

Zombies, Run! • Top paid health and fitness apps #4 • Key = Fun

STTR / SBIR The programs’ goals are to:

Stimulate technological innovation

Foster technology transfer through cooperative R&D between small businesses and research institutions;

Increase private sector commercialization of innovations derived from federal R&D

Must be small business concern (< 500 employees)

3 Phases

Reference: http://grants.nih.gov/grants/funding/sbirsttr1/2013-2_SBIR-STTR-topics.pdf

STTR Applicant is a Small Business Concern Formal Cooperative R&D Effort

Minimum 40% by small business Minimum 30% by U.S. research institution

U.S. Research Institution College or University Other non-profit research organization Federal R&D center

Phase 1 normally does not exceed $100,000 total costs for 1 year. Phase II awards normally do not exceed $750,000 total costs for 2

years. Intellectual Property Agreement

Allocation of IP rights and rights to carry out follow-on R&D and commercialization

Principal Investigator’s primary employment may be with either the Small Business Concern or the research institution

Small Business Concern Organized for-profit U.S. business 500 or fewer employees, including affiliates Must be:

At least 51% U.S.- owned by individuals and independently operated

or At least 51% owned and controlled by another (one) business concern that

is at least 51% owned and controlled by one or more individuals Three Phase potential

Principal Investigator’s primary employment must be with the Small Business Concern

SBIR

MIPS The Maryland Industrial Partnerships (MIPS)

program accelerates the commercialization of technology in Maryland by jointly funding collaborative R&D projects between companies and University System of Maryland faculty.

mHealth Successes

WellDocs

TelCare

Open opportunities NSF Smart and Connected Health

May 28, $170K direct costs/yr for 3 years

Maryland Industrial Partnerships October 1

SBIR/STTR HHS (NIH, FDA, CDC): August 5, December 5

NIH and AHRQ

R21 Research and Demonstration Grants: October 16

$275K in direct costs over 2 years, max of $200k/yr

TEDCO

DARPA and other DoD

Questions + Contact Kenyon Crowley

kcrowley@rhsmith.umd.edu

Tel 919-649-2279

Thank you!

Additional stuff Fun and interesting apps

Hot areas

Health Gaming

Cloud, API’s

Aging in Place Problem: Assessment of and intervention for

everyday functional limitations of persons with early-stage dementia without need of assisted living (aging in place)

Solution: Automated wireless and fixed monitoring and assistance to help people cope with age-related limitations

Cardiac Disease Management Problem: Patients with CVD have symptoms that

frequently bring them to emergency care where there is limited baseline data

Solution: Remote monitoring to create physiological cardiac activity “fingerprints” that alert professionals and patient when there are irregularities based on their own cardiac patterns

- Nilsen - Shusterman