Frederik Mortier talks about design to cost in the Fujirebio tendigo project. Verhaert innovation day 2015.

1. Fujirebio Tendigo™: An Assay Processing Instrument: Design To Cost
Template Innovation Day presentationCONFIDENTIAL
FUJIREBIO TENDIGO™,
AN ASSAY PROCESSING
INSTRUMENT: DESIGN TO COST
Frederik Mortier
Consultant applied Physics & Systems
frederik.mortier@verhaert.com
MEDICAL: CONVERGENCE IN HEALTH CARE

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Frederik Mortier
Consultant Applied Physics & Systems 2012- now
Researcher @ Ghent University 2011-2012
MSc. in Engineering – Electro-Mechanical 2009-2011
MSc. in Industrial Sciences – Electro-Mechanical 2005-2009
frederik.mortier@verhaert.com

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CONTENT
Introduction Fujirebio
Business case TENDIGO™
From case to product
Design to Cost methodologies
Conclusions

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Fujirebio
Company introduction

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Introduction
Fujirebio Europe N.V.
• Healthcare company
• Formerly Innogenetics N.V.
• Located in Zwijnaarde
Core business Fujirebio Europe
• R&D and production of in vitro diagnostics
(IVD) testing solutions
Collaboration with Verhaert
• Mid 2012  now
• Device development
• Manufacturing of devices

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Introduction
IVD testing solution: assay
• Strip based diagnostics
• 5-6 different liquids
• Infectious diseases (HIV, Syphilis, ..)
Assay processing
• Precise liquid dosing
• Correct timing
• Highly accurate temperature profile
Verhaert & Fujirebio
• Development & production of assay processor
(automation)
• Product browser Fujirebio

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Business case
TENDIGO™ assay processor

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Business case
Business model Fujirebio  Development & sales of assays
Development of an assay processor as a facilitator for
• Regional expansion
• New customers
• Sales through distributor network
• Leverage current product portfolio
• Increase ease of use
• less time consuming  potential of more tests/customer
• Market focused offering
• Existing small, manual customer could be offered automation
• strong requirement for automation (cost & quality)
 TENDIGO™is a delivery system!
It’s not about the device,
it’s about the consumables

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Business case
How to define the perfect product?
Landscaping of current automation solutions
• Expensive, high end device for high throughput uses
• Medium throughput device is phased out
Investigate market segmentation
• Automated vs. Manual users  519 vs. 900
• Kits/user  >50% buys less than 10kits/year
• User per region
Benefits manual  automation
• 2-3h to 20mins hands-on time
• Increased quality (27% of complaints are user mistakes)
• One-stop shopping
Convergence in health care  Solution thinking!

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From case to product
from market need to product definition

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From case to product
Product definition
Focus on convergence manual  automation
• Low cost device: € 3-5k ex-works(high end device €15-20k)
• Low throughput: 10 strips/run (1/2 kit)
• 100runs/year typical use
• 100 devices/year
Low cost does not mean low quality  medical device!
Need for Design to Cost methodologies!

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From case to product
Main functions
• Accurate heating of liquids & strips
• Accurate pick & place of liquid doses
Building blocks
• Modular building blocks defined

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Design to Cost
Insights

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Project approach
Design to cost

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Project approach
Design to cost

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Project approach
• Design to cost starts right away!
• 2/3 of life cycle cost is committed by design
Design to cost
Most significant cost influence!

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Design to cost
Project approach
FFE
Feasibility
study
1st design
1st prototype
testing
Redesign
2nd prototype
testing
Manufacturing
mid
2012
mid
2015

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Project approach
Cost can be influenced by more than design alone – 3 fold management
 Design to Cost = Risk management
Design to cost
Performance
Planning
Risk
management
Price

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Fujirebio Tendigo ™ case
Very inelastic circumstances
1. Planning Planning was ‘fixed’
2. Price Instrument price was ‘fixed’, development budget was ‘fixed’
3. Performance Medical device limitations
 Significant need for Design to Cost!
Design to cost

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Design to Cost
Practical tools

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Different project phases = different techniques
Design to cost
Design freedom knowledge
Development cycle
FFE
Feasibility study
1st design
1st prototype testing
Redesign
2nd prototype testing
Manufacturing
mid 2012 mid 2015

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Project start (fuzzy front end & feasibility)
• Lack of information &
• Largest influence on project cost
 Important choices to be made!
Approach
• Gain information through early stage feasibility testing!
• focus on architectural level
• Split up in modules / functions
• KISS: ‘keep it simple & stupid’ methodology
• Trade offs
• Total product cost ~ part quantity x part cost
• Reduce part quantity
• Reduce part cost
• Value engineering
Design to cost

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Project start (fuzzy front end & feasibility)
Examples
• Overall system architecture
• Trade off
• Visualization
• Criteria definition
• Cost
• Performance
• Timing
Design to cost

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Project start (fuzzy front end & feasibility)
Examples
• Heating:
 Temperature function reduced to dry aluminium block heater
• Dosing:
 Multiple peristaltic pumps reduced to single syringe
• Mechanical:
 Simple flat plate design (low sales volume)
• Robotics:
 Number of axes reduced to minimum, simple feed forward stepper drives
Design to cost

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Project start (fuzzy front end & feasibility)
Value engineering
Value = Function / Cost  evaluation of value!
Examples
 Determine perceived value through mockup evaluation
• Device height
• Display position
• ..
 Question instrument specifications
• Rocking of RT tray
• Heat up time RT tray
• ..
Design to cost
FOTO MOCKUP

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Design freedom knowledge
Development cycle
Different project phases = different techniques
Design to cost
FFE
Feasibility study
1st design
1st prototype testing
Redesign
2nd prototype testing
Manufacturing
mid 2012 mid 2015

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1st design & prototype tests
• System architecture already chosen
• Detailed cost information available
• Feasibility tests conducted  gained knowledge
 Design changes wrt feasibility study are often cost or performance driven
Approach
• BOM structuring & detailing
• Split up in function / modules / building blocks
• Identify per part type (buy, custom, electronics…)
• Estimate high & low price  cost range!
• ..
• BOM analysis
• Pareto analysis  80/20
• Min – Max instrument cost estimation
• Supplier grouping
• Building block cost comparison
• ..
Design to cost

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1st design & prototype tests
BOM analysis
Design to cost
Module split up Part type
Cost range (high vs low)
Cost ranking
Supplier sourcing
BOM analysis proved to be a very useful tool!
Effort focussed for maximum efficiency
Clear oversight of cost distribution

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Design freedom knowledge
Development cycle
Feasibility study 1st prototype testing 2nd prototype testing
mid 2012 mid 2015
Different project phases = different techniques
Design to cost
FFE 1st design Redesign Manufacturing

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2nd design & prototype tests
• First prototype tests conducted
• First user experience
 Design changes mainly test result or user input driven
Approach
• Action list  trade off (value engineering)
• Cost vs. added value of change!
• Distinctions between nice to haves & musts
Design to cost

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2nd design & prototype tests
Design to cost

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Conclusions

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Design to cost
• Very useful design methodology
• Based upon plain & simple common sense
• Different approaches for different project phases
Early stage vs. finalization
• Design methodology & risk management technique
• Many useful tools available
Case study Fujirebio Tendigo™
• Methodology is way of thinking of entire team
• Design to Cost was essential in achieving our goal!
• Production started July 2015
• First sales past month
Conclusions
Design freedom knowledge
Development cycle

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Conclusions

35. Fujirebio Tendigo™: An Assay Processing Instrument: Design To Cost
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