Accelerating Innovation Through Collaboration
Building the Team to Build Your Device
MD&M West - 2016
Marc Habib
Byron Wilson
Gino Banco
Steve Maylish
Marc Habib
Byron Wilson
Executive Director,
Operations and Product
Development
CEO and President
Empty Set Design
The Innovation Lab
Gino Banco
Steve Maylish
Principal R&D Engineer,
Medical Devices
Strategic Business
Development
Parker Hannifin Corporation
Triple Ring Technologies
You
Someone From the Outside
Your Team
Engineering &
Prototyping
Research &
Design
Marketing &
Transaction
Health System
Members
Global Healthcare
Innovation Alliance
#6
#7
Corporate / Academic Partners
Nationwide Collaboration
A network of 16 health systems across 23 states
Marc Habib
Byron Wilson
Executive Director,
Operations and Product
Development
CEO and President
Empty Set Design
The Innovation Lab
Gino Banco
Steve Maylish
Principal R&D Engineer,
Medical Devices
Strategic Business
Development
Parker Hannifin Corporation
Triple Ring Technologies
f in d in g “ t h e r igh t ” d es ign er par t n er
trysts, dating, and long-term partnerships
Byron Wilson
Empty Set LLC
illustration courtesy of Federica Bordoni
Marc Habib
Byron Wilson
Executive Director,
Operations and Product
Development
CEO and President
Empty Set Design
The Innovation Lab
Gino Banco
Steve Maylish
Principal R&D Engineer,
Medical Devices
Strategic Business
Development
Parker Hannifin Corporation
Triple Ring Technologies
TIPS FOR SUCCESSFUL
MANUFACTURING PARTNERSHIPS
GINO G. BANCO, PH.D.
PRINCIPAL ENGINEER, MEDICAL DEVICES
PARKER HANNIFIN
Medical Systems
SELECTING THE RIGHT PARTNER(S)
STEP 6
COMMITMENT
STEP 5
SELECT FULL SERVICE
PROVIDER(S)
STEP 4
MANUFACTURING
SITE AUDIT
STEP 3
AVOID RUSHING TO LOWEST
INITIAL COST; COMPARE
APPLES TO APPLES
STEP 2
STEP 1
INITIAL CAPABILITIES
EVALUATION &
REQUEST FOR
PROPOSAL
INTERNAL ASSESSMENT &
OUTSOURCING STRATEGY
Medical Systems
THREE KEY ELEMENTS OF SUCCESS
ENGAGE EARLY
DEVELOP THE PARTNERSHIP
SUCCESS
COMMUNICATE EFFECTIVELY
Medical Systems
ENGAGE EARLY
Feasibility
Concept
Validation
Development
•
•
•
•
•
•
Design for Manufacturing
Material Selection
Cost Management
More Effective Supply Chain Management
Regulatory/Compliance Support
Ancillary Needs (Packaging, Labelling, etc.)
Launch
• Increased Speed to Market
• Lower Overall Costs
Medical Systems
DEVELOP THE PARTNERSHIP
$
Win-Win
Solutions
$
$
Continuous
Improvement
$
$
$
Innovation
$
IP
Security
Supply
Stability
$
Trust
Integrity
Openness
Dependability
Professionalism
Medical Systems
COMMUNICATE EFFECTIVELY
• Critical in all Relationships
(Success vs. Failure)
• Communication Early and Often
• Designated Personnel
• Clearly Define Roles
and Responsibilities
• Share Device Function with
Requirements
• Clear Understanding of
Expectations on Both Sides
Medical Systems
The manufacturing partnership can be a critical
contributor to the financial success of your device.
•
•
•
•
Select the Right Partner
Engage Early
Develop the Partnership
Communicate Effectively
Medical Systems
Marc Habib
Byron Wilson
Executive Director,
Operations and Product
Development
CEO and President
Empty Set Design
The Innovation Lab
Gino Banco
Steve Maylish
Principal R&D Engineer,
Medical Devices
Strategic Business
Development
Parker Hannifin Corporation
Triple Ring Technologies
Building the Team to Build your Device
Steve Maylish
February, 2016
© 2014 Triple Ring Technologies
Triple Ring Technologies
 Facility in Silicon Valley, CA (85,000 sq. ft.)
 Large flexible engineering and science spaces (clean rooms, optics and biology labs)
 Pilot manufacturing capability
 ISO13485 certified
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100+ engineers and scientists on staff
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25 PhD’s, 9 former VP’s of R&D
Regulatory & Legal Groups
ME, EE, SW, FW, System Architecture, Optical
Physicists, Mathematicians, Chemists, Biologists
 Leverage deep product and technology development experience
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Napkin Sketches to Pilot Scale Manufacture
Applied Research Group – fuzzy front-end
Lean Engineering Practices & Data Driven Design (modeling & analysis)
Design for Assembly & Manufacture – low to high volume
 Silicon Valley Innovation Hub
 Incubation
 Research collaboration
 Co-development
Product Launch
 When is the product ready to launch?
 Design History File, FDA Clearance, Device Master Record, Pilot Production & Process
Validation, Device History Record
 System validation completed with input from users, clinical trials completed, and
environmental or life-cycle testing.
 Product is manufacturable and scalable, reliable and robust, intuitive & easy to use, and easy
to service.
Product Launch Decisions
 Established firm vs Startup
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Inventory and transfer-to-manufacturing investment
Sales forecasts and long-term contracts
Volume vs Pricing (early units are always more expensive)
Target high profit segments for launch
 Disposables, Reagents, Hardware or all three?
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Tooling decisions – low or high volume
Setup charges and obsolescence
Plan service spares with manufacturing
Manufacturing fine tuning, optimizing and validation (vendors)
 Direct Sales, Distributors, Limited Launch, Service
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Direct Sales Force (experience & compensation)
Distributors (sales or expanded role)
Inventory Management (demos, distributors, build to order)
Launch by sales territory, by office distance, by key clients
Service Department, Call Desk, Device Reporting