SV Hardware Startup to ScaleSV Hardware Startup to ScaleApril 17, 2014

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Nevro MedTech Story

Meetup Intro – Michael Keer p

Introduction of Mike Keer & Product Realization Group

Th k t Ch i Al i d H t T h l f Thanks to Chris Alessio and Hunter Technology for facilities and tour

Hand off to Andre Walker from Nevro and Geetha Rao Sr. Regulatory Expert

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Speakers Introductionp

A d W lk i f d d S i VP t N t t• Andre Walker is a founder and Senior VP at Nevro, a startup focused on implantable devices to treat chronic pain

• For the last 25 years he has been in the medical device business at various companies H t t d hi i th i d t i d t i• He started his career in the semiconductor industry as a micro-chip designer

• Dr. Geetha Rao is an internationally recognized expert in medical device risk and quality management

• In additional to providing consulting, she serves as CEO of Technology Frontiers Collaborative providing collaborativeTechnology Frontiers Collaborative, providing collaborative forums for stakeholders at the frontiers of science and technology

• She has a Ph.D. in Engineering from MIT and a Master’s in Business from Stanford Business School

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Business from Stanford Business School

US Medical Technology Industrygy y

US leads the world in medtech productionUS leads the world in medtech productionUS is largest medtech consumer (~40%)2012 k t l > $110B billi2012 market value > $110B billion

Also a major export sectorContinued high growthContinued high growth

Major investment sectorSignificant R&D spend (twice average for Significant R&D spend (twice average for manufacturing)But shifts in key parameters

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Technology Driversgy

Microelectronics & instrumentationMicroelectronics & instrumentationNovel materials

Novel manufacturing processesNovel manufacturing processesNanotechnology and MEMS

Biotechnology and genomicsBiotechnology and genomicsSoftware

Enterprise and infrastructurepCloud and big dataWeb-based and secure mobile apps

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Telecommunications

The “Big 3” for Medical Devices g

RegulatoryRegulatoryApproval (varies internationally)Quality management and reportingQ y g p g

Reimbursement (US is most complex)Procedure (CPT) codesCoverageIncorporated within bundled payments

Clinical AdoptionKOL endorsements

f

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Standard of practice

Products Regulated by FDAg y

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FDA Device Classification

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FDA Device-Related Regulationsg

Pre-market Submissions: 510(k) for lower risk, PMA for higher risk

Device labeling

Quality System Regulations/Risk Management Expectations

Establishment Registration& Device Listing

Quality System Regulations/Risk Management Expectations

Medical Device Reporting

Requirements Product Production Post-MarketMarket

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Requirements Definition

Product Design

Production of units

Post Market Activities

Market Assessment

Quality System Processes (ISO 13485)

Maintaining the effectiveness of the quality management system

Customers&

RegulatoryA th iti

Management responsibility

Feedback

Authorities Customers

& RegulatoryAuthorities

Resource management

Measurement,analysis and improvement

Requirements Product realization

ProductInput Output

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Product Realization Core Process

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Overview of Design Control“Waterfall Diagram”Waterfall Diagram

Release process 

ReviewUser Needs

Phase gates

Design Input

Design Process

Design OutputVerification g pVerification

ProductValidationUnit test

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Unit testSystem testField test

Common Pitfalls

U d i i l h dl Underestimating regulatory hurdles

Not controlling safety and / or g ytechnical risks

Poorly defined product requirements Poorly defined product requirements

Last minute changes in product f tfeatures

Unrealistic timeframes for

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development, testing, and transfer

Strategies for regulatory success g g y

Define your device carefullyDefine your device carefullyKnow your compliance strategy on Day 1Day 1Have clear handoffs with all your d l t tdevelopment partnersKeep good documentation

Focus on critical elementsClearly show the trail (records of

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y (meetings and reviews)

Medical Device Product -

Tips for SuccessTips for Success

Define Regulatory Strategy

Focus on Basic Requirements – mitigate highest risks first!

Proof-of-Concept– use rapid prototyping

Process Validation and Control– resource accordingly

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g y