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
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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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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