1. 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 Johns Hopkins University Department of Biomedical Engineering

2. the education and development of the next generation of leaders in healthcare innovation and the 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. CBID’s Mission, 2 Key Elements

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

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

5.  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 Synergistic Undergraduate and Graduate Programs

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

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

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

10. Clinicans at JHMI Design Team: Core + Support 4 Students 2 Clinicians 1 Faculty Regulators  Mock 513g sessions  Mock IDE reviews  8-wk summer course Non-core Clinicans:  access to pts and labs  reviews  VoC 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 Legal Experts:  IP legal  startup legal  Regulatory strategy  Reimbursement strat Prof Engineering:  design reviews  DfM  Hosts teams in country  Deployment and testing Academics  sci and tech  suppl coursework Design Team

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

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

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

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

15. 15Hsu  Komanski  Luxon  Martinez 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 pedicle screws 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.

16.  Analogous to a drywall anchor for the spine  Major Components 1.Shaft – a cylindrically shaped component that connects the other four design features. 2.Lumen – an open space that provides room for the pedicle screw to be inserted. 3.Cap – a slotted head that is held in place with a hemostat as the screw is placed. 4.Hooks – projections that bridge the strong cortical bone to the center of the pedicle. 5.Wings – mechanisms that reconstruct the pedicle by bridging the strong cortical shoulder to the center of the pedicle. 16Hsu  Komanski  Luxon  Martinez Solution: The Cortical Anchor

17.  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 17Hsu  Komanski  Luxon  Martinez Competitive Advantages

18.  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 Pricing Strategy And Rationale 18Hsu  Komanski  Luxon  Martinez Device or Method for Improving Spinal Fusion in Osteoporotic Bone Estimated Cost Kyphoplasty Kit (Bone Cement)$3500 per level Expandable Screws$4200 per level Extend the Fusion (Additional Hardware)$2000 per add’l level Laminar Hooks, Clasps, etc.$1600 per level Average Cost$2825 per level "FAQs." Parallax Medical - Devices for Spine Procedures, Vertebroplasty, Bone Biopsy Needles, Bone Cement, Acrylic Resin with Opacifiers. Web..“; 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.

19.  Three aspects of reimbursement: Coding, Coverage, Payment  Instrumentation for Spinal Fusion  Lump Sum Reimbursement  Relevant Coding for Spinal Fusions 19Hsu  Komanski  Luxon  Martinez Reimbursement Environment and Creating Incentives MS-DRGMS-DRG Description Estimated Base Payment (CMS) 459Spinal Fusion Except Cervical with MCC$33,086 460Spinal Fusion Except Cervical without MCC$19,771 Source: Reimbursement and Coding Reference Guide. Zimmer Spine. Zimmer, Inc., 1 Jan. 2009. Web.. CPTCPT Code Description Estimated Base Payment 22840Posterior Non-Segmental Instrumentation$749 22942-22844Posterior Multi-Segmental Instrumentation$750 Source: Vaught, Margie S., Blair C. Filler, and M. B. Henley. "Coding spinal procedures: Part II." AAOS Online Service. Web...

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

21. Global Health Innovation

22. Drivers for This New Program  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 Global Health Innovation

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  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 Global Health Innovation

25. Our Approach  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 Global Health Innovation

26. IMPLEMENT IDENTIFY INVENT Day of Birth Alliance

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 o UG: hand-pick team leaders, then they choose their teams o 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