Presentation on theme: "Education and Promotion of Translational Biomedical Engineering I Entrepreneurship and Product Development Programs: Emerging Best Practices CBID: A New."— Presentation transcript:
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
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
= + Industry and Government Partners + talented leaders and high impact innovations
not bench to bedside bedside to bench to bedside Our Approach not tech transfer innovation partnerships
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
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
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
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
~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
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
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!
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
Selected Spinouts & Startups From MSE Classes of 2010 & 2011 Class of 2012: sinusitis, biofilm, joints, stenting
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
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.
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
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
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.
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...
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
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
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
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
IMPLEMENT IDENTIFY INVENT Day of Birth Alliance
Global Health Innovation Antenatal Screening Kit
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
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