Novel Approaches for Accelerating Pediatric Device Development Gwenyth Fischer, Jodi Rebuffoni, Karen Kaehler, Tucker LeBien, Sandra Wells

Our challenge: – Lack of incentives to pursue pediatric medical device development at an academic institution The larger challenge: – Lack of innovation and commercialization in the pediatric medical device space worldwide Our solution: – Building partnerships to lengthen the runway for pediatric device incubation at academic institutions – Create incentives to pursue pediatric device innovation

No financial disclosures

Pediatric LVAD Adult LVAD Pediatric Medical Devices are 10 years Behind

FDA Approved Devices AbioCor TAH Novacor PC HeartMate IP Novacor PCq HeartMate VE Syncardia TAH HeartMate XVE Thoratec IVAD Thoratec PVAD HeartMate II Heartware HVAD Investigational Devices Jarvik 2000 Reliant Heart Evaheart Heartware MVAD HeartMate III ADULT OPTIONS Market CAP $2.5B Market CAP $80M FDA Approved Devices Berlin Heart EXCOR PEDIATRIC OPTIONS Investigational Devices Jarvik Infant Syncardia 50 cc TAH Gap Between Pediatric and Adult VAD Technology

The Pediatric Market and Testing Pool are Much Smaller

Peds versus Adult Device Market Adult Global Heart Valve Market: $1.2 billion Pediatric Heart Valve Market: $ million Circulation Research.2005; 97

The UMN Collaborative Approach to Pediatric Medical Device Development

CTSI’s Office of Discovery and Translation (ODAT) Provides funding and project management support Focuses on development of commercializable technologies Received 224 applications for support from Only 2% addressed pediatric-specific health needs

Office for Technology Commercialization (OTC) Manages University intellectual property Exits technology via licensing and start up companies Hosts MN-IP program to improve industry access to UMN intellectual property Received 1857 invention disclosures <1% of filings address pediatric- specific health needs

Pediatric Device Innovation Consortium (PDIC) Mission to accelerate pediatric-specific medical device technology to market Started in 2011 with a volunteer advisory board – Industry leaders – Pediatricians – Engineers – Parents/Child health advocates Offers free advice and feedback to pediatric inventors on a quarterly basis

UMN’s Collaborative Approach to Solving the Pediatric Gap PDIC strengths – Medical device industry based Advisory Team – Medical device trained leadership – Connection to UMN Medical Devices Center ODAT strengths – Funding infrastructure – Experienced project management – Academic guidance OTC – Intellectual property protection and technology exit strategies – Business Advisory Group for assistance with commericalization

Collaboration 1: Grant Program (Faculty Focused) Launched in 2014 Resulted in 18 new applications for development of pediatric specific technology Examples of Projects: – Medical software development – Animal testing of a valve – Safety study of a respiratory device – Neonatal drug delivery device with outside company

Collaboration 2: Breakthrough Event (Industry Focused) Total attendees: 75 from 6 states Representatives from 30 organizations April 2016 Event Goal: collaborative partnerships between industry and inventors Several industry-inventor connections made at this event Kick Starter funding available to support UMN-industry collaborations

Collaboration 3: Community Discovery Program (Patient Focused) Launched April

Community Discovery Program Need Identified by Community Initial Evaluation by PDIC Leadership Evaluated by Advisory Team for Funding and Track PDIC Incubator UMN Expert Industry Collaboration Announced Funding Opportunity

Future Collaboration: Incubator Will provide an internal development option for projects from the Community Discovery Program Created by merging with DesignWise Medical- a local pediatric device company