The document provides an overview of rapid medical device development strategies. It outlines the typical medical device development model, which includes 5 phases: initiation, feasibility, design and development, product launch, and post-market activities. Key points discussed include reducing risks early, distinguishing between research and development paradigms, planning for prototypes, and developing a product pipeline. Statistics are also presented on resources required and typical approval times. The goal is to help entrepreneurs strategize to accelerate medical device development and commercialization.

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From Bench to Bedside
Rapid Medical Device Development
Strategies
OCTANe Foundation for Innovation
Building Blocks Series
October 7, 2010
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Overview
 Define the medical device product development model
 Statistics
 Takeaway Points
 Goal: Help entrepreneurs develop strategies that
accelerate their medical device development and
commercialization
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Medical Device Development Model
 “Study on Medical Device Development Models.”
 Prepared for InHealth – The Institute for Health Technology Studies
 September,
September 2007
 Stanford Biodesign (Linehan J.H., Pate-Cornell E., Yock P., Pietzsch
J.B. )
 Link: http://www.inhealth.org/doc/PDF.asp?PageID=DOC000016
 Stage-Gate Process for the Development of Medical Devices
g p
 Journal of Medical Devices
 Pietzsch J.B., Shluzas L.A
 June 2009 (Vol 3, Issue 2)
 Link:
http://asmedl.aip.org/getabs/servlet/GetabsServlet?prog=normal&id=JMDOA4000003000002021004000001&idtype=cvips&gifs=Yes&ref=
no
 Stanford Biodesign
 Link: http://biodesign.stanford.edu/bdn/index.jsp
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-” Medical Device Development
Models” Stanford Biodesign
2007
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Phase I - Initiation
 Market Opportunity
 Competitive Analysis
p y
 IP Freedom to Operate
 Regulatory Approach
 Reimbursement Path
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Regulatory Review – FDA (US)
 Classification
 Class I, II or III
 Design Control Requirements Based on Classification
 Link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/UCM051668
 Regulatory Pathway
 Exempt
 510(k)
 Traditional, Special, Abbreviated, De Novo
, p , ,
 Predicate Device
 Clinical Data Required
 Pre-Market Approval
 Humanitarian Device Exemptions (< 4000 new cases/yr)
 Risk Analysis
 Risk G id
Ri k Guidance Document – ISO 14971 2007
D t 14971:2007
 FDA – Medical Device Reporting (MDR) Review of Similar Devices
 Link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm?searchoptions=1
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Regulatory Review – Europe
 Medical Devices Directive 93/42/EEC (MDD)
 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF
 Active Implantable Medical Devices Directive 90/385/EEC (AIMDD)
 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF
 In-Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD)
 Link: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1998L0079:20090807:en:PDF
 Classification (Annex IX)
 Class I, IIa, IIb, III
 CE Mark
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Marketing/Reimbursement Review
 What you should consider:
 Who will pay for your product?
 Patient paid
 User paid
 Medicare/Medicaid/Insurance Reimbursement
 How are they incentivized to purchase your product?
 How will you distribute your product?
 What is the distribution business model?
 What is the purchased good?
 Pay per use?
 Disposable or capital equipment + disposable?
 Reusable?
 What is your reimbursement plan?
 Is there an existing reimbursement code?
 CCenters f M di
t for Medicare & Medicaid Services (CMS)
M di id S i
 American Medical Association – Current Procedural
Terminology (CPT)
 CPT Lookup Link: https://catalog.ama-assn.org/Catalog/cpt/cpt_home.jsp
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Phase II - Feasibility
 Core Team
 Feasibility and Risk Reduction
y
 Voice of the Customer
 Clinical Advisory Board
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Risk Reduction
 Technology Risk
 Define the high risk technical challenges and address those risks first
 Sometimes risks should be addressed individually instead of at the system
level
 Manufacturing Risk
 Integrate design for manufacturing requirements into product design
 Develop supply chain requirements including audit of critical suppliers
 Determine long-lead time parts and materials and investigate potential
electronic part obsolecence
 Regulatory Risk
 Initiate preliminary meetings with FDA prior to submission of approval
material
 Meet with safety agency representative to review development strategy
 Adoption Risk
 Solicit feedback from clinical reviewers (voice of the customer)
 Intellectual Property Risk
 Reimbursement Risk
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Voice of the Customer
 Clinician/User Review Board
 Solicit early feedback on use of the device
 Involve clinicians/users in cadaver/animal/bench studies
 User Workflow
 Surgeons are increasingly impatient with device operation
 Think end-to-end
 How does the device get to the user?
 How is it un-packaged and presented to the user?
 Is it compatible with other common devices/tools?
 How is it cleaned?
 User Interface
 Similar to existing tools, technologies aids acceptance
 Simple!
 Compliance to required standards (alert, alarm requirements, etc.)
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Phase III – Design Dev. And V&V
 Define Requirements
 Allocate Resources
 Device Design and Development
 Research Vs. Development Paradigm
 Operating Under Formal Design Controls – Design History
File
 Design For Manufacturing
 Verification and Validation
 Regulatory/Safety Submission
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Design Paradigms
Research Development
•Brainstorming •Design Controls
•Multiple Test Outcomes
Multiple •Pass Fail Test Outcomes
•Rapid Change •Limited Change
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Design Paradigms - Research
Marketing Technology
Idea
Approach
Re
Re- Product
Definition
IP
imbursement
Voice of
Regulatory
Customer
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Design Paradigms - Development
Design
g Design
Design Input
i
Output
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Design Paradigms - Development
Regulatory
R l t
Technology
Design
Design Input
i
Output
Marketing
M k ti
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Allocate Resources
 What resources do I need?
 Capabilities?
 Systems?
 Approvals?
 Do I hire or do I outsource?
 What to look for?
 Individual Consultants or T
I di id l C l Team?
?
 Manufacturing Capability?
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Prototypes/Builds
 Understand the purpose of prototypes/builds
 Different uses require different levels of control
 Clinical prototypes require traceability
 Determine minimum required features for product release
 Determine features that can be added as letters to file vs.
new approval submission to FDA
 When is a new 510(k) necessary?
 Link: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080243.pdf
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Industrial Design
Source: Aubrey Group, Inc. Source: Aubrey Group, Inc.
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Phase IV and V – Product Launch and Post Market Activities
 DHF Complete
 Manufacturing and Operations scale up
g p p
 Marketing branding
 Establish distribution channels
 Obtain regulatory approval
 Finalize reimbursement strategy
 Product enhancements
 Post market surveillance
 Continued clinical validation
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Planning for Features
 Are you a one product company?
 Differentiate “new features” from “new products”
p
 Be planning the evolution of your product
 Market future add-ons?
 Develop a Next Generation Product?
 Develop a Product Platform?
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Some Statistics
 Design Controls
 20-30% of the total development resources
 Development Time
 3 to 9 months for a Class I device
 6 to 12+ months for a Class II device
 24 to 36+ months for a Class III device
Source: Aubrey Group, Inc.
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Typical Phase III Breakdown
7% Requirements
14%
Definition
Engineering Design
9%
Prototype test,
Verification d
V ifi i and
Validation
Manufacturing
49% Development &
21% Transfer
Project
Managemnt,
Quality & Support
Source: Aubrey Group, 2010
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Functional Breakdown per Phase
Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign
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FDA Approval Type Distribution
-”Office of Device Evaluation Annual Performance Report FY09” FDA
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FDA Approval Type Distribution
Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign (From FDA Data)
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Average Time for PMA
-”Office of Device Evaluation Annual Performance Report FY09” FDA
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Average Time for 510(k)
-”Office of Device Evaluation Annual Performance Report FY09” FDA
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Average Time for IDE
-”Office of Device Evaluation Annual Performance Report FY09” FDA
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Role of Funding
 When to Raise Money?
 How far will your initial funding even take you?
 What are the expected milestones for increasing valuation?
 Technology (Bench Top) Demonstration
 Successful Clinical Trial
 FDA Approval
 First Revenue Generating Sale
 Generally you will be reducing risks and putting more money
to work as you complete each phase
 Venture Capital Trends
 Rounds
 Tranches
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Takeaways
 Have a clear regulatory/reimbursement strategy
 Reduce risks early
y
 Research vs. development paradigm
 Have a plan for prototypes
 Develop a product pipeline/portfolio
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Contact Information
 Aubrey Group
 6 Cromwell Suite 100, Irvine, CA 92618
 PH: 949-581-0188
 FAX: 949-581-0177
FAX 949 581 0177
 Jahnavi Lokre – Director of Software Engineering/Marketing
 jlokre@aubreygroup.com
 Blaine Murakami – Project Manager
 blainemurakami@aubreygroup.com
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Questions?
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