Education and Promotion of Translational Biomedical Engineering I

1. Johns Hopkins University Department of Biomedical Engineering Education and Promotion of Translational Biomedical Engineering I Entrepreneurship and Product Development Programs: Emerging Best Practices CBID: A New Model for Academic-Based Medtech Innovation and Global Health Innovation Youseph Yazdi Executive Director BMES Annual Meeting Hartford ~ October 13, 2011

2. CBID’s Mission, 2 Key Elements the education and development of the next generation of leaders in healthcare innovation andthe creation and early-stage development of healthcare solutions that have a transformational impact on human health around the world. ~ Our key measure of success is the positive impact our students and our technologies have on the quality and accessibility of healthcare.

3. = + + Industry and Government Partners  talented leaders and high impact innovations

4. Our Approach not tech transfer not bench to bedside bedside tobench tobedside • innovation partnerships

5. Synergistic Undergraduate and Graduate Programs • Undergraduate Design Teams • Program is 10 years old • 12 Teams x 5-8 students / team • hand-picked team leaders and teams • New 1-Year Biodesign MSE • first class graduated May 2010 • 121516 students • 4 teams of 4 “Developed World” Innovation • 4 teams of 4 “Global Health” Innovation

6. Three Key Stages of 1-Year CBID MSE Program • Objective: Ensure every Design Team project has high potential • Over Summer and Early Fall • Identification and Validation of Medical Need • Intensive clinical rotations • Clinical immersion, observations, interviews • Assessment of Commercial Viability • Input from internal and external experts • From ~ 900 potential projects  one per team • Team Formed, including Clinician Mentor IDENTIFY INVENT IMPLEMENT

7. Clinical Immersions: Observation, Needs Identification • At Johns Hopkins School of Medicine (June, July) • Cardiology • Gastroenterology • General Surgery • Interventional Radiology • Neurosurgery • Orthopedic Surgery • Obstetrics & Gynecology • Ophthalmology • Otolaryngology • Urology • International Rotations (August) new Global Health Innovation Program • India, Nepal, Tanzania, Ethiopia • 3 weeks, 1 site per team • Rural clinics and hospitals

8. CBID Clinical Immersion Program • educates both students and clinicians • generates clinical intuition in engineers • develops collaborative skills essential to successful design teams • identifies and assesses medtech innovation opportunities • launches partnerships • creates goodwill and working model for future MSE classes

9. Careful filtering process with early stakeholder input Clinician feedback/ Screening 48 Clinician Immersion Prelim Technical Feasibility Assessment 1 project per team ~900 raw needs observations 16 in-depth opportunity briefs 24 Prelim. Commercial & Market Assessments Clinical Impact Analysis & Validation June - July September

10. Clinicans at JHMI • Regulators • Mock 513g sessions • Mock IDE reviews • 8-wk summer course Design Team: Core + Support • Non-core Clinicans: • access to pts and labs • reviews • VoC • Prof Engineering: • design reviews • DfM • Academics • sci and tech • suppl coursework • Design Team • Legal Experts: • IP legal • startup legal • Regulatory strategy • Reimbursement strat 4 Students 2 Clinicians 1 Faculty • Industry Experts • mentorship of team • access to corp resources (mkt data, prototyping, funds) • follow-on development • Startup Experts • mentorship on startup issues and strategy • access to prof investors • follow-on funding • Hosts teams in country • Deployment and testing

11. Stage 2: Invent! • Objective: Create and Develop a Solution • High Clinical and Commercial Relevance • Fall and Spring • Team members research and brainstorm on a wide range of potential solutions • Considerable input from clinician on team, plus faculty and other advisors • Free to choose the best technology domain, not constrained by the focus of a particular lab • IP generation and reporting IDENTIFY INVENT IMPLEMENT

12. Stage Three: Implement • Objective: Build! Solution + Path to Market • Completed by May Graduation • Teams build multiple iterations of looks-like and works-like prototypes • Refined and focused by input from wide range of stakeholder perspectives: investment, regulatory, reimbursement, technical • Construct business plan for a startup based on their project IDENTIFY INVENT IMPLEMENT

13. Selected Spinouts & Startups From MSE Classes of 2010 & 2011 Class of 2012: sinusitis, biofilm, joints, stenting

14. Clinical Background • Instability of the spine may require surgical intervention • Standard of Care in Lumbar Spine is Posterior Fusion with Fixation • During Fixation, Screws are Placed in Pedicles of Vertebra • Osteoporosis causes the bones to become soft • Contraindication to pedicle screw fixation systems • Pedicle screw pullout = Catastrophic Failure • Hardware failure in osteoporotic bone: 10-25%

15. Commercial Opportunity • Target Market • Patients with low bone quality undergoing spinal fusion • Annual Market Growth • Osteoporosis : 1.7% increase • Spinal Fusions: 7% increase • Total Market • Osteoporotic spinal fusions: 90,000 (~25% of all fusions)* • Total of 720,000 pediclescrews at risk of failure • Potential Revenue: $300M *Chin et al. “Prevalence of osteoporosis in patients requiring spine surgery: incidence and significance of osteoporosis in spine disease.” Osteoporosis Int (2007) 18:1219-1224. Hsu  Komanski  Luxon  Martinez

16. Solution: The Cortical Anchor • Analogous to a drywall anchor for the spine • Major Components • Shaft – a cylindrically shaped component that connects the other four design features. • Lumen – an open space that provides room for the pedicle screw to be inserted. • Cap – a slotted head that is held in place with a hemostat as the screw is placed. • Hooks – projections that bridge the strong cortical bone to the center of the pedicle. • Wings – mechanisms that reconstruct the pedicle by bridging the strong cortical shoulder to the center of the pedicle. Hsu  Komanski  Luxon  Martinez

17. Competitive Advantages • Increases fixation by relying on hard bone instead of soft bone • Universally compatible with standard pedicles screws • Lower cost with respect to alternatives • Safer than alternatives • Designed for “on-the fly” use • Grows the spinal fusion market Hsu  Komanski  Luxon  Martinez

18. Pricing Strategy And Rationale • Manufacturing ≈ $0.45 per anchor • Pricing Points • Discussion with Experienced VC (Chris Shen) • $125 per unit ( $1,000 per procedure) • Comparables • Current Sales Price: $400 per cortical anchor "FAQs." Parallax Medical - Devices for Spine Procedures, Vertebroplasty, Bone Biopsy Needles, Bone Cement, Acrylic Resin with Opacifiers. Web. <http://www.parallax-medical.com/index.php?pageId=49>.“; Interview with Alphatec Engineer at NASS Conference." Personal interview. 13 Nov. 2009.; E. Cuartas et al. “Use of All-pedicle-screw Constructs in the Treatment of Adolescent Idiopathic Scoliosis.“ J Am Acad Orthop Surg. 2009 Sep;17(9):550-61. Hsu  Komanski  Luxon  Martinez

19. Reimbursement Environment and Creating Incentives • Three aspects of reimbursement: Coding, Coverage, Payment • Instrumentation for Spinal Fusion  Lump Sum Reimbursement • Relevant Coding for Spinal Fusions Source: Vaught, Margie S., Blair C. Filler, and M. B. Henley. "Coding spinal procedures: Part II." AAOS Online Service. Web.. <http://www2.aaos.org/ aaos/archives/bulletin/oct04/code.htm>. Source: Reimbursement and Coding Reference Guide. Zimmer Spine. Zimmer, Inc., 1 Jan. 2009. Web. <http://www.zimmer.com/web/enUS/pdf/ Dynesys_Family_of_Products_Coding_Reference_Guide_080409.pdf>. Hsu  Komanski  Luxon  Martinez

20. YES NO YES NO YES YES YES Regulatory Environment: Substantial Equivalence Pathway Hsu  Komanski  Luxon  Martinez

21. Global Health Innovation

22. Drivers for This New Program Global Health Innovation • Mission Critical • “Next generation of Leaders in Medtech Innovation” • How could we ignore the largest, fastest growing markets? • A Critical Skill • Frugal Design not a core skill in US-based engineers • HC costs unsustainable, skill will be in demand • A different kind of innovation challenge • Engagement and Passion • Seek impact, meaning, real value • Need is great, cries out for help • A worthy challenge

23. Drivers for This New Program Global Health Innovation • Labor Market Competition • Our graduates will be competing in a global high-end design labor market • Winning Combination: • Competence to succeed in both advanced and lower-cost markets • Differential will loose geographic context

24. Our Approach Global Health Innovation • Immersion in low-resource healthcare setting • Simply cannot be appreciated back in Baltimore! • Must be carefully managed to get real value • just “being there” not sufficient • Training to identify and assess needs and opportunities • market dynamics, and stakeholder analysis, in the local context • Field component: • three weeks in duration: India, Nepal, Tanzania, Ethiopia • Experienced Partners, in Country • Johns Hopkins School of Public Health, JHPIEGO, many more

25. Our Approach Global Health Innovation • Development component: • teams tasked develop market-appropriate novel technology solutions • project selection by mid October, development thru May • Beyond product innovation • novel solutions + potential for significant impact + commercial sustainability • Integration into Design Mentality • Eliminate “us” vs “them” mentality • bring Frugal, Value Driven, principles into mainstream design

26. IDENTIFY INVENT • Day of Birth • Alliance IMPLEMENT

27. Global Health Innovation Antenatal Screening Kit

28. Summary, CBID Practices… • Team Empowerment • rigorous screening of participants so this is perceived as a high-quality endeavor • UG: hand-pick team leaders, then they choose their teams • MSE: ability to contribute solidly technically, plus have the personality to succeed in partnerships • choose and own their projects • manage their budgets, including travel • keep their prize winnings, but not grants • Experienced Mentors • ensures quality of content, if not delivery • clinicians: Hopkins Medicine • medtech VCs: Aberdare, Synergy LSP, NEA, others • strategics: J&J, Medtronic, GE • law firms: Hogan & Lovells, Womble Carlyle • global health: Jhpiego, Laerdal Global Health • technical & scientific expertise: JHU Faculty, external

29. Summary, CBID Practices… • Coursework Essentials • regulatory • reimbursement • business of biomedical innovation • ethics of biomed innovation (see poster) • “insight informed innovation” • leadership training through mentorship of UG teams, now fellows • Stakeholders on CBID Team • a Medical Director • a tech transfer guy • external advisory board • Vision to Change Institution • “skating to where the puck is going to be…” academic, healthcare, and medtech business models are shifting • should be a positive influence on the whole institution