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From Bench to BedsideRapid Medical Device DevelopmentRapid Medical Device Development
Strategies
OCTANe Foundation for InnovationBuilding Blocks SeriesBuilding 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 2007 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 Devicesg 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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10/07/2010 4-” Medical Device Development Models” Stanford Biodesign 2007
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Phase I - Initiation
Market Opportunity Competitive Analysisp 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 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 AnalysisRi k G id D t ISO 14971 2007 Risk Guidance Document – ISO 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? 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?
C t f M di & M di id S i (CMS) Centers for Medicare & Medicaid Services (CMS) 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 Reductiony 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 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 obsolecenceelectronic 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
•Brainstorming•Multiple Test Outcomes
Development
•Design Controls•Pass Fail Test OutcomesMultiple Test Outcomes
•Rapid Change •Limited Change
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Design Paradigms - Research
Marketing Technology
ProductRe-
Idea
Approach
ProductDefinition
Reimbursement IP
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RegulatoryVoice of Customer
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Design Paradigms - Development
DesigniDesign Design
OutputDesign Inputg
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Design Paradigms - Development
R l t
Designi
Technology
Regulatory
Design OutputDesign Input
M k ti
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Marketing
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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?
I di id l C l T ? Individual Consultants or 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
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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 upg p p Marketing branding Establish distribution channels Obtain regulatory approval Finalize reimbursement strategy Finalize reimbursement strategy
Product enhancements Post market surveillance Continued clinical validation 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
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Source: Aubrey Group, Inc.
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Typical Phase III Breakdown
7%14%
Requirements Definition
9%
Engineering Design
Prototype test, V ifi i d
49%21%
Verification and Validation
Manufacturing Development & Transfer
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Project Managemnt, Quality & Support
Source: Aubrey Group, 2010
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Functional Breakdown per Phase
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Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign
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FDA Approval Type Distribution
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-”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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Source: InHealth Institute for Health & Technology Studies and Stanford BioDesign (From FDA Data)
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Average Time for PMA
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-”Office of Device Evaluation Annual Performance Report FY09” FDA
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Average Time for 510(k)
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-”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 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 earlyy 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 [email protected]
Blaine Murakami – Project Manager [email protected]
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Questions?
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