How companies can partner with research organizations to accelerate research and development, evaluation of products, enhance usability, and create value. Includes funding relevant to mobile health companies.
mHealth and Wireless Technology Conference Partnering with academic organizations
mHealth and Wireless Medical Technology Conference WorkshopPartnering with Academic OrganizationsKenyon Crowley, MBA, MS, CPHIMSMay 1, 2013
Agenda About Partnering with academic researchers/orgs Tech transfer Funding
StrategyTechnologyPolicyAbout CHIDSMission Research, analyze, and recommend solutions tochallenges surrounding the introduction andintegration of information and decision technologiesinto the health care system Improve the practice and delivery of health care byoffering researched solutions that impact safety,quality, access, efficiency, and ROIPartner Ecosystem Federal and state agencies (HHS, NSF, DoD, State ofMD) Private corporations (CNMC, J&J, CareFirst BlueCrossBlueShield, Cisco, Small and Mid-Size firms) Not-for-profits (CDT, eHealth Initiative)Resources Renowned scholars from multiple disciplines Research fellows, students3Lockheed Martin Briefing
Research Focus AreasImpact andComparativeEffectiveness ofHealth InformationSystemsNew Models ofCare (ACO, HIE,PCMH, CareTransitions)HealthcareAnalytics (Data-driven HealthServices Insights,Modeling,Operations)Consumers,Quality &Transparency, andSocial Media
Mobile Health Applications Diverse application of wireless and mobiletechnologies designed to improve healthresearch, health care services and healthoutcomes Not just mobile phones + apps A major focus for clinicians and policy makers May increase patient engagement, advancepatient monitoring, aid in chronic diseasemanagement, and potentially reduce healthsystem costs. Clinicians can track therapeutic effectivenessthrough remote monitoring applications (apps)that gather, transmit, and analyze a patient’sreadings. Limited number of apps are constructed ondesign 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 annualgrowth 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 ontheir phone. Exercise, diet, and weight apps are the mostpopular types. One in three cell phone owners (31%) have used their phoneto look for health information. (17% one year ago). According to a March 2013 study, the market for mHealthservices has now entered the commercialization phase andwill reach $26 billion globally by 2017. According to research by HIMSS Analytics, about half of alldoctors use mobile health apps, and a quarter of consumersdo.- Pew Mobile Health Survey 2012- Mercom 2013
Era of the Quantified Self and TrackersGraphic credit: Pew
University collaborations Technology research and development Evaluations Pilots and clinical trials Teaming on grants and contractsImpactResearchTeaching
Technology / Product Development Integrating cutting edge science and expertise fornew or enhanced productsUniversityLabs +CentersIndustryLiaison
Evaluation What is the effectiveness, impact + value of thissolution? 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
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 theprotection of the rights and welfare of human subjects If sponsored by HHS: Federal regulations at 45 CFR Part 46 require thatapplications and proposals involving human subjects research must beevaluated in accordance with those regulations, with reference to therisks to the subjects, the adequacy of protection against these risks, thepotential benefits of the research to the subjects and others, and theimportance of the knowledge gained or to be gained
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 predictivemodel Assess behavioral aspects and usability of current approach andrecommend improvements
PHR + secure messaging pilot Assess pilot implementation of secure messagingand 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 aspecialty-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 andcardiac nurses Assess policy: meaningful use, standards, relevant marketdevelopments 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 andcommercialization strategy. Assist in getting additional grant funding to furtherdevelop IP Create start-up company when appropriate vehicle forcommercialization. Assist in raising financing for company. Negotiate agreements with licensees.
LicensingTypical Agreement Terms and Conditions: Licensing (to start-ups or large corporations):- royalty paid to university based upon salesattributable to IP – typically around 5% ofsales. Milestones – if license is exclusive thenminimum royalties typically apply as well asdevelopment milestones (especially in drugdevelopment).
What’s in it for the researchers Royalties (Ranges broadly) Additional funding to do research Peer acknowledgement Equity in start-upDoes little to get tenure other than as a result of the papers that may bepublished on the on-going research, and sometimes publishing in itself isa huge problem in commercialization. Younger profs focus is usually getting tenure, which is gained through- Publishing papers- Doing more research- TeachingCommercialization of IP is not always high on their list – has implicationsfor businesses who want to license/buy the IP and move the IP forwardin conjunction with the researchers.
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 betweensmall businesses and research institutions; Increase private sector commercialization of innovationsderived from federal R&D Must be small business concern (< 500employees) 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 2years. Intellectual Property Agreement Allocation of IP rights and rights to carry out follow-on R&D andcommercialization Principal Investigator’s primary employment may be with either theSmall 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 operatedor At least 51% owned and controlled by another (one) business concern thatis at least 51% owned and controlled by one or more individuals Three Phase potential Principal Investigator’s primary employment must be with the SmallBusiness ConcernSBIR
MIPS The Maryland Industrial Partnerships (MIPS)program accelerates the commercialization oftechnology in Maryland by jointly fundingcollaborative R&D projects between companiesand 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 email@example.com Tel 919-649-2279Thank you!
Additional stuff Fun and interesting apps Hot areas
Aging in Place Problem: Assessment of and intervention foreveryday functional limitations of persons withearly-stage dementia without need of assistedliving (aging in place) Solution: Automated wireless and fixedmonitoring and assistance to help people copewith age-related limitations
Cardiac Disease Management Problem: Patients with CVD have symptoms thatfrequently bring them to emergency care wherethere is limited baseline data Solution: Remote monitoring to createphysiological cardiac activity “fingerprints” thatalert professionals and patient when there areirregularities based on their own cardiac patterns- Nilsen- Shusterman