Education and Promotion of Translational Biomedical Engineering IEntrepreneurship and Product Development Programs:

Emerging Best Practices

CBID: A New Model for Academic-Based Medtech Innovation and Global Health Innovation

Youseph YazdiExecutive Director

BMES Annual MeetingHartford ~ October 13, 2011

Johns Hopkins UniversityDepartment 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

inno

vatio

n pa

rtne

rshi

ps

Undergraduate Design Teams Program is 10 years old12 Teams x 5-8 students / team hand-picked team leaders and teams

New 1-Year Biodesign MSEfirst class graduated May 2010121516 students4 teams of 4 “Developed World” Innovation4 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 Fallo Identification and Validation of Medical Need

Intensive clinical rotations Clinical immersion, observations, interviews

o Assessment of Commercial Viabilityo Input from internal and external expertso From ~ 900 potential projects one per teamo 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

2416 in-depth opportunity briefs

1 project per team

Clinician feedback/ Screening

Clinical Impact Analysis & Validation

Prelim Technical FeasibilityAssessment

Prelim. Commercial & Market Assessments

Careful filtering process with early stakeholder input

Clinician Immersion

June - July September

Design Team:Core + Support

4 Students2 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 Solutiono High Clinical and Commercial Relevanceo Fall and Springo Team members research and brainstorm on a wide

range of potential solutionso Considerable input from clinician on team, plus

faculty and other advisorso Free to choose the best technology domain, not

constrained by the focus of a particular labo IP generation and reporting

Stage 2: Invent!

IMPLEMENT

IDENTIFY

INVENT

o Objective: Build! Solution + Path to Marketo Completed by May Graduationo Teams build multiple iterations of looks-like and

works-like prototypeso 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 & StartupsFrom MSE Classes of 2010 & 2011

Class of 2012: sinusitis, biofilm, joints, stenting

• Instability of the spine may require surgical interventiono Standard of Care in Lumbar Spine is Posterior Fusion with Fixationo During Fixation, Screws are Placed in Pedicles of Vertebra

• Osteoporosis causes the bones to become softo Contraindication to pedicle screw fixation systemso Pedicle screw pullout = Catastrophic Failureo Hardware failure in osteoporotic bone: 10-25%

Clinical Background

15 Hsu 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

1993 1996 1999 2002 20050

100000

200000

300000

400000

Spinal Fusions in the United States

YearN

umbe

r of P

roce

dure

s

*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 Components1. 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.

16 Hsu 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

17 Hsu 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

18 Hsu Komanski Luxon Martinez

Device or Method for Improving Spinal Fusion in Osteoporotic Bone

EstimatedCost

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. <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.

Three aspects of reimbursement: Coding, Coverage, Payment

Instrumentation for Spinal Fusion Lump Sum Reimbursement

Relevant Coding for Spinal Fusions

19 Hsu Komanski Luxon Martinez

Reimbursement Environment and Creating Incentives

MS-DRG MS-DRG Description EstimatedBase Payment (CMS)

459 Spinal Fusion Except Cervical with MCC $33,086

460 Spinal Fusion Except Cervical without MCC $19,771

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>.

CPT CPT Code Description EstimatedBase Payment

22840 Posterior Non-Segmental Instrumentation $749

22942-22844 Posterior Multi-Segmental Instrumentation $750

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>.

20 Hsu Komanski Luxon Martinez

Regulatory Environment: Substantial Equivalence Pathway

YES

YES

YES

YES

NO

NOYES

Global Health Innovation

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 solutionsproject selection by mid October, development thru May

Beyond product innovationnovel 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 BirthAlliance

Global Health Innovation

AntenatalScreening Kit

Summary, CBID Practices…

Team Empowerment rigorous screening of participants so this is perceived as a high-quality endeavoro UG: hand-pick team leaders, then they choose their teamsoMSE: 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