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Medical Devices & Diagnostics Global Strategies

Strategies and Operational Management for: 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”™

• S

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“Get it right the first time”TM

Value Added Expertise –We make you moneyAligning 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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Claim

Dev

ice

Func

tion

ality

Literature Background and Technical File

Longitudinal, non-interventional to

establish Sensitivity & Specificity

Longitudinal, non-interventional to

establish Sensitivity & Specificity

Case Control and/or Cohort studies (healthy/afflicted),

depending best applicability of either

Case Control and/or Cohort studies (healthy/afflicted),

depending best applicability of either

Usability, Reliability and Device Accuracy

Usability, Reliability and Device Accuracy

Design, Manufacturing & Engineering Data

Design, Manufacturing & Engineering Data

Literature, Background and Technical FileLiterature, Background and Technical File

Clin

ical

utilit

ySt

anda

rd o

f Car

e

Typical deliverable*: Value Dossier

Incr

easi

ngly

str

ong c

laim

s

Typical deliverable: ROC curve

Typical deliverable: Descriptive statistics and correlation of device readings to confirmed conditions

Typical deliverable: inter-device and inter-operator coefficient of variation

Typical deliverables: Bench test & regulatory standards data

Typical deliverables: Clinical Evaluation Report, per MedDev 2.7.1 Rev 3

Incre

asin

g V

alu

e

Decre

asin

g R

isk

Value Proposition2 Prong

Comparison and intervention vs. Gold Standard

Evidence

Convert Development into Organized

Success

Lean & Flexible Program Management - When it Counts

BUILDING THE RISK BASED VALUE PROPOSITION

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Dr. Alan J. Touch• 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

Biographical DetailsBiographical Details

• 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

ExpertiseExpertise

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Avodex Partners - Product Life cycle services© 2013 Avodex Partners, LLC

6

A seamless continuous processFrom concept through commercialization and post-market

Experience & Expertise

• Product Life Cycle • Indications Trials • Regulatory Strategies/Submissions• Human Factors and Usability Studies

Capabilities

• Device and Diagnostics Biostatistics Models• Clinical Trial Operational Oversight• Cost Sensitive Medical Device Budget Models• Expert Submission Medical Writing• Expert Marketing Medical Writing

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The Regulatory Continuum - Devices

© 2013 Avodex Partners 7

INC Research Clinical Development

Concept Design development Pre-IDE model Clinical Trial Regulatory

Submission

Regulatory Services

Study Design with Historical Controls

New Presentation New Indication

Marketing Application

Including Safety and Performance Dossier

Post-Market Life Cycle Surveillance

Medical Device Adverse Event

Reporting

Avodex Medical Device and Diagnostics Regulatory and Clinical Development

Biostatistics protocol developmentSAP/ Study Biometrics

Quality Assurance cGMP/QMS

Design Control Hand-Off

Regulatory Strategy and Intelligence

Clinical Trial DesignUsability Study Design

pre-IDE prep

Clinical Trial Applications or notifications to EC/IRB and

Study Start Up

510(k)/PMACE Mark

Other Safety and

Performance Dossier

510(k)/PMACE Mark

Other Safety and

Performance Dossier

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Medical Device Strategic Services• 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

• 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• 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• Strategic Acquisition Plan Formulation• Business Plan Drivers• Target List Development• Target Valuation Analysis• Risk Based Valuation Proposition Modeling• Market Segment Analysis• Major Customer Buyer Behavior• Competitive Landscape• SWOT Analysis Merger & Acquisition Due Diligence• Financial • Operations • Engineering/Research • Purchasing • Marketing and Distribution• Regulatory Status Analysis• Go to Market Status Analysis• Reimbursement Analytics and Strategies

Product Development Planning•Market Requirements Document•Program Development Analysis and Budgets•Cost Driver Analysis•Bench Top to Commercialization Management•Regulatory and Clinical Trials Management•Protocol Development•Clinical Trial Design•Project Management•Regulatory Strategies and Filings

Technology Transfer/Acquisitions• License Agreements Advisory•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 & ExpertiseIndications Trials Experience & Expertise Regulatory Strategies/Submissions ExpertiseDevice and Diagnostics Biostatistics ModelsClinical Trial Operational Oversight CapabilitiesHuman Factors and Usability Studies ExpertiseCost Sensitive Medical Device/Diagnostics Budget ModelsSubmission and Marketing Medical WritingEnsure your critical front end decisions are made with knowledgeBUILD THE RISK BASED VALUE PROPOSITION NOW

Make Avodex Partners your “Speed to Market” Team Today