sv hardware startup to scale - files.meetup.comfiles.meetup.com/6303542/sv hardware startup...
TRANSCRIPT
SV Hardware Startup to ScaleSV Hardware Startup to ScaleApril 17, 2014
Nevro MedTech StorySV Hardware Startup-to-Scale- Pg 1
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
SV Hardware Startup-to-Scale- Pg 2
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
SV Hardware Startup-to-Scale- Pg 3
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
SV Hardware Startup-to-Scale- Pg 4
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
SV Hardware Startup-to-Scale- Pg 5
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
SV Hardware Startup-to-Scale- Pg 6
Standard of practice
Products Regulated by FDAg y
SV Hardware Startup-to-Scale- Pg 7
FDA Device Classification
SV Hardware Startup-to-Scale- Pg 8
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
SV Hardware Startup-to-Scale- Pg 9
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
SV Hardware Startup-to-Scale- Pg 10
Product Realization Core Process
SV Hardware Startup-to-Scale- Pg 11
Overview of Design Control“Waterfall Diagram”Waterfall Diagram
Release process
ReviewUser Needs
Phase gates
Design Input
Design Process
Design OutputVerification g pVerification
ProductValidationUnit test
SV Hardware Startup-to-Scale- Pg 12
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
SV Hardware Startup-to-Scale- Pg 13
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
SV Hardware Startup-to-Scale- Pg 14
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
SV Hardware Startup-to-Scale- Pg 15
g y