Why is your new product launch behind schedule?

Robert Packard, Consultantwww.MedicalDeviceAcademy.com

[email protected] 12, 2014

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Why is your new product launch behind schedule?

A frozen bubble created at -9F by Angela Kelly using homemade bubble solution near her home in Arlington, Washington.

http://bit.ly/Anatomy-of-DesignPlan

http://www.medicaldeviceacademy.com/






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4 Biggest Mistakes

1. Procrastination of Tasks

2. Flexible Phases of Design

3. Incorrectly Defining Inputs

4. Repeating Past Mistakes





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Writing Your 510(k)Section # Guidance Document for 510(k)

4 Indications for Use Statement5 510(k) Summary or 510(k) Statement6 Truthful and Accuracy Statement7 Class III Summary and Certification8 Financial Certification or Disclosure Statement9 Declarations of Conformity and Summary Reports

11 Device Description12 Substantial Equivalence Discussion13 Proposed Labeling14 Sterilization and Shelf Life15 Biocompatibility18 Performance Testing – Bench19 Performance Testing – Animal20 Performance Testing – Clinical





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Regulatory Affairs“The Anti-Sales Team”

Marketing Me Regulatory Me

Design Plan Should

Include Section 13

(i.e., labeling)





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What’s Left?Section # Guidance Document for 510(k)

1 Medical Device User Fee Cover Sheet (Form FDA 2 CDRH Premarket Review Submission Cover Sheet3 510(k) Cover Letter

10 Executive Summary16 Software17 Electromagnetic Compatibility and Electrical Safety21 Other





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Design Controls

Clause 7.3 – “Waterfall Diagram”User Needs

Design Input

DesignProcess

DesignO utput

MedicalDevice

VALIDAT ION

VERIFICAT ION

REVIEW

Equivalent to21 CFR 820.30





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Examples

• User Need = Implant must fit expected range of adult patient anatomy

• Input = ISO/IEC 62366:2007, Application of usability engineering to medical devices

• Output = Tabulated drawing showing 10 different sizes

• Verification = In silico analysis of fit between patient anatomy and different sizes

• Validation = cadaver studies and clinical studies





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Typical Phases of Design

8

DHFBegins

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

DR





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Phase / Gate Design Process

Gate Gate Gate Gate





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6 Recommended Gates

• 7.3.1 – Design Plan Approval

• 7.3.2 – Design Inputs Approval

• 7.3.3 – Design Outputs Approval

• 7.3.5 & 7.3.6 / 1st in Humans Study Approval

• Pilot Launch Approval

• Commercial Launch Approval

Each Gate is a Design Review Meeting





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When to Start Your DHF?

• After the design plan has been developed

• Upon approval of the design project

• It’s not uncommon to start a DHF late and to retroactively assemble the file from documents that were already created in team meetings. X





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Design Inputs

User Need Typical Design Input Better Design Input

Biocompatible Material = Teflon ISO 10993-1

Easy to Use Pictorial User Interface IEC 62366-1

Won't Puncture Nylon Reinforced Pouch ISTA 2A

Connects with Monitor RS232 Connection Protocol P123





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Design Planning Requirements• Clause 7.3.1• The plan shall…

– Define stages of design & development– Define the review, verification, validation & transfer

activities for each stage– Define responsibilities & authorities

• Management shall manage interfaces• Document planning output and update as

needed

ConceptPhase





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Design Plan Contents

• Team Charter

• Strategic Marketing Plan

• Business Justification

• Reimbursement Strategy

• Gantt Chart

• Regulatory Pathway





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Team CharterRole in project Name, Role Project Leader Approval of Commercial File documents This is most applicable for contract design

work. Approval of Design Plan Approve of Risk documents Refer to Risk Plan for this project Approval of all other documents May require further breakdown, or may refer

to another document that lists such approval authorities generically

Participants in Design Review (minimum):

Break this down further if required, e.g. to capture a requirement that the R&D Manager shall always be present at the final review before product release

Independent participant at Design Reviews:

May be different for different types of review





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Strategic Marketing Plan

• Which markets have unmet needs?• What is the market size?• Is the market growing or shrinking?• Who are the competitors?• Do we have a sustainable competitive

advantage? (e.g., patents)





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Business Justification

• Competitive Analysis– Regulatory Can Help with TPLC database searches

• Recent 510(k)• Product Malfunctions• Adverse Events• Recalls

• Pricing (outright purchase, per use, etc.)• Distribution Models (stocking, consigned, etc.)





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Reimbursement Strategy

• CMS – Medicare / Medicaid• Private Payers• Global Purchasing Organizations (GPOs)• Large Hospital Chains (e.g., Kaiser)





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Gantt Chart

• Identify each stage / gate in the project• Identify cost of each stage• Identify resources• Identify the critical path• Create buffers

“Theory of Constraints”





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Regulatory Pathway

• Classification Rationales• Guidance Documents• Harmonized Standards• Predicate Device• Languages• Country of Origin• Performance Testing

Each is Country Specific





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Auditing Design withAdjacent Link / Turtle Diagrams

Metrics

Process OutputsProcess Inputs

Who?

How Done?

With What EquipmentFacilities & Materials?

Describe the Process





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Audit Agenda

Conclude with Sampling of DHF

& TF/DD





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Standardize Work & Trend Analysis

• Standardize your format for:– Every section of a regulatory submission– Every protocol– Every report– Every design plan

• Measure task variability and duration





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Lessons Learned

• Just because management wants it completed by March doesn’t it mean it can be.

• How long did it take last time?• What is the variability of tasks?• What is the longest task?• Which tasks are critical path items?

– e.g., how long will it be before we have molded parts?





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Q&A





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Need help with yourRegulatory Strategy?

Rob Packard

[email protected]

+1.802.258.1881

rob13485

