Transcript Power Point version of Initial Introduction

 Medical Devices & Diagnostics Global Strategies
 Strategies and Operational Management for:
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Product Development – Concept through Commercialization
Global Regulatory Strategies and Submission
Clinical Trial Design and Clinical Development
Medical Device and Diagnostics Budget Models
Medical Device and Diagnostics Biostatistics Models
Quality Management including Audits
Consulting and Contracting to Other CRO’s and Sponsors
Strategic Guidance When It Counts
“Get it right the first time”™
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 Medical Devices & Diagnostics Global Strategies
 Specialty sectors:
 Wound Care and Ophthalmology Device and Pharma
 Neurology and Oncology Diagnostics and Devices
 Women’s Health Diagnostics and Devices
 Infectious Disease Diagnostics
 Biomarkers Sample Collection and Nanotechnology
 Drug Delivery Device Studies – Combination Products, Human
Factors Engineering, Instructions for Use
 Feasibility and Site Qualification Expertise - SiteID™
 Pre-FDA Inspection Audits ,and QMS Audits
 Clinical Trial Supply Chain Audits
Strategic Guidance When It Counts
“Get it right the first time”™
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“Get it right the first time”TM
Value Added Expertise –We make you money
Aligning Business, Regulatory and Clinical Trial Objectives
• Our mission is to support your company to build the Value Proposition
• We provide direct access to C-level experts for the Sponsor
• We provide a senior team from Product Development through
Regulatory Review, Clinical Trial, Submission and Post-Market
• We imbed with your team early to assess how the technical mission is
designed to support the ultimate Value Proposition goals
• We also provide Strategic Guidance on a selected basis
• We build the specific Value Proposition sequence of stakeholder needs
• We provide the infrastructure to carry out the regulatory and clinical trial
mission interfacing with the appropriate Sponsor team members
• We build the cost-effective Roadmap “up the Pyramid”
• We are on your side - the strategic and operational glue for you to:
“Get it right the first time”
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Lean & Flexible Program Management - When it Counts
BUILDING THE RISK BASED VALUE PROPOSITION
Evidence
Claim
2 Prong Comparison
and intervention vs.
Gold Standard
Longitudinal, noninterventional to establish
Sensitivity & Specificity
Case Control and/or Cohort
studies (healthy/afflicted),
depending best applicability of
either
Convert Development
into Organized
Success
Value Proposition
Typical deliverable*:
Value Dossier
Typical deliverable: ROC
curve
Typical deliverable: Descriptive
statistics and correlation of device
readings to confirmed conditions
Usability, Reliability and Device Accuracy
Typical deliverable: inter-device and
inter-operator coefficient of variation
Design, Manufacturing & Engineering Data
Typical deliverables: Bench test
& regulatory standards data
Literature Background and Technical File
Literature, Background and Technical File
Typical deliverables:
Clinical Evaluation Report, per
MedDev 2.7.1 Rev 3
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Dr. Alan J. Touch
Biographical Details
• Over 35 years senior-level multi-national and entrepreneurial operating management and
consulting experience including global CRO executive leadership
• Device, Diagnostics, Wound Care and Ophthalmology Product Development Strategist
‒ Founder, CEO and Principal Strategist of Avodex Partners
‒ Prior Principal Strategist, INC Research
Expertise
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Device and IVD and pharmaceutical development, regulatory strategies and clinical trials
Discovery, design, development, design control and validation, clinical trial, regulatory submissions
Ophthalmology drug development including formulation and bioavailability
Ophthalmology medical device and IVD clinical trial protocol development and oversight
Medical device and diagnostics developer at the operational and C-Level
Device and drug manufacturing scale-Up, QMS and production oversight
Understanding of cGMPs, GCPs, essential principles and MDD compliance
Post-approval CLIA, US and EU reimbursement strategies and management
Drug Delivery Device Related Issues – Human Factor, Dosing, Design, Instructions for Use
Clinical trial management and oversight
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Avodex Partners - Product Life cycle services
© 2013 Avodex Partners, LLC
A seamless continuous process
From concept through commercialization and post-market
Regulatory
Strategies and
Business
Outcome
Objectives
Design
Control
Development
QSR and ISO
Validation and
Verification
Testing
Capabilities
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Device and Diagnostics Biostatistics Models
Clinical Trial Operational Oversight
Cost Sensitive Medical Device Budget Models
Expert Submission Medical Writing
Expert Marketing Medical Writing
Clinical Trial
Mgmt
Risk
Assessment
Regulatory
Submissions
and Approvals
Post – Market
Requirements
or Actions
Experience & Expertise
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Product Life Cycle
Indications Trials
Regulatory Strategies/Submissions
Human Factors and Usability Studies
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The Regulatory Continuum - Devices
Avodex Medical Device and Diagnostics
INC Research Clinical Development
Regulatory and Clinical Development
Study Design with
Historical Controls
Biostatistics protocol development
SAP/ Study Biometrics
Concept
Design
development
Pre-IDE model
Clinical Trial
Regulatory
Submission
New Presentation
New Indication
Marketing
Application
Including Safety and
Performance Dossier
Clinical Trial Applications or
notifications to EC/IRB and
Study Start Up
Regulatory
Services
Regulatory
Strategy and Intelligence
Clinical Trial Design
Usability Study Design
pre-IDE prep
Quality Assurance
cGMP/QMS
Design Control
Hand-Off
510(k)/PMA
CE Mark
Other Safety
and
Performance
Dossier
Post-Market Life
Cycle Surveillance
Medical Device
Adverse Event
Reporting
Page © 2013 Avodex Partners
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Medical Device Strategic Services
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Regulatory Consulting Services
Design and Validation Consulting and Management
Quality Management Systems Consulting
Protocol Development and Review
Clinical Development including project specific budgets
Clinical Trials Management and Oversight
Device and Diagnostics Internal Global Consulting
Due Diligence and M&A Support – Consulting
Post Approval Voluntary and Mandated Surveillance
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Strategic and Operational Services for Diagnostics
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Safety and Performance Study Strategies
ROC Curve / Verification Study Design and Budget Models
Validation of Interventional Claims – Specialized Models
Biomarker/ IVD Performance Sample Collection Models
Biomarker/IVD Clinical Trial Models tied to Performance
Global Compliance Regulatory Strategies and Tactics
Device Centric Biostatistics/Data Management Models
Risk Based Medical Monitoring Decisions and Rationale
MDR Reporting requirements assessment and strategies
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Clinical Development Services
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Study/Protocol Design and Review
Sample size Calculations and Biometrics
Site Selection Feasibility Questionnaires
Assure that Prototype Sensitivity, Specificity and
Reproducibility results can be carried over to the
Manufacturing Floor
• Optimize Clinical Trial Design for Indication
• Establish Statistically Based Pre-Clinical and
Clinical Trial Study Procedures
• Ensure world-wide device regulatory and clinical
trial integrated processes
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M&A, Product Development & IP Advisory Services:
Due Diligence, Capital Formation , Acquisition or Exit
Mergers & Acquisitions/Sales
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Strategic Acquisition Plan Formulation
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Business Plan Drivers
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Target List Development
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Target Valuation Analysis
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Risk Based Valuation Proposition Modeling
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Market Segment Analysis
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Major Customer Buyer Behavior
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Competitive Landscape
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SWOT Analysis
Product Development Planning
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Market Requirements Document
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Program Development Analysis and Budgets
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Cost Driver Analysis
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Bench Top to Commercialization Management
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Regulatory and Clinical Trials Management
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Protocol Development
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Clinical Trial Design
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Project Management
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Regulatory Strategies and Filings
Merger & Acquisition Due Diligence
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Financial
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Operations
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Engineering/Research
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Purchasing
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Marketing and Distribution
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Regulatory Status Analysis
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Go to Market Status Analysis
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Reimbursement Analytics and Strategies
Technology Transfer/Acquisitions
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License Agreements Advisory
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Business Plan Assessment and Writing
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Value Proposition Build ~
Speed to Market Specialists
Strategic Interventional Management
Time to Value Proposition Always a Factor
Product Life Cycle Experience & Expertise
Indications Trials Experience & Expertise
Regulatory Strategies/Submissions Expertise
Device and Diagnostics Biostatistics Models
Clinical Trial Operational Oversight Capabilities
Human Factors and Usability Studies Expertise
Cost Sensitive Medical Device/Diagnostics Budget Models
Submission and Marketing Medical Writing
Ensure your critical front end decisions are made with knowledge
BUILD THE RISK BASED VALUE PROPOSITION NOW
Make Avodex Partners your “Speed to Market” Team Today
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