dp nökkvi sigurdarson, r&d engineerpd-symposium.org/archive/2017/files/rdd/sigurdarson keynote...
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Nökkvi Sigurdarson, R&D EngineerM.Sc. in Eng. Design and Applied Mechanics
Novo Nordisk Device R&D
1
FR
DPRobustSensitive
Contradictions Analysis – Robust Design Day 17
Novo Nordisk - Corporate Presentation 33
Novo Nordisk -Corporate Presentation
PRODUCTS MARKETED IN
165 COUNTRIES
STRATEGICPRODUCTION SITES
IN BRAZIL, CHINA, DENMARK, FRANCE AND US
SUPPLIER OF NEARLY
HALF OF THEWORLD’S INSULIN
28,000,000PEOPLE USE OUR PRODUCTS
AFFILIATES IN COUNTRIES
R&D CENTRESIN CHINA, DENMARK,
UK AND US
DKK 111.8 BILLIONIN TOTAL REVENUE
APPROXIMATELY
210,000SHAREHOLDERS
77
EMPLOYS APPROXIMATELY
41,400 PEOPLEDIABETES
OBESITY
HAEMOPHILIA
GROWTH DISORDERS
Device R&DWhat we do
4
In Device R&D we:
1. Support the drug pipeline with delivery systems
2. Mostly focus on mechanical, disposable devices
3. Ensure manufacturability
4. Mitigate almost all conceivable risk scenarios
Contradictions Analysis – Robust Design Day 17
When developing injection devices, properties such as accuracy,
size, manufacturability, mechanical efficiency and functional
sequencing are key
Presentation title Date 28
Why contradictions?
7
Keeping the competitive edgeMORE functionality
+ Functions
+ Cost/complexity
+ Lead time
++ Functions
++ Cost/complexity
++ Lead time
Contradictions Analysis – Robust Design Day 17
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When marketing wants more features, one either:
1. Increases the functionality driven by each part
2. Increases the amount of parts
Production wants less complexity – one must:1. Reduce the amount of parts
2. Avoid tight tolerances
3. Avoid sensitive processes
Challenges in robust design
Satisfying both often results in:
1. More functional requirements
2. More complex verification requirements
3. More iterative development work
4. More operating states and reliance on elasticity
5. More second order phenomena and interaction effects
Contradictions Analysis – Robust Design Day 17
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10
Robust by design or by tweaking?
Evaluate robustness
Identify core issue
Develop solution
New issue created
Concurrent optimisation
Decomposition of contributing effects
Contradictions Analysis – Robust Design Day 17
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The information incongruityHow do you imbue robustness early?
Contradictions Analysis – Robust Design Day 17
Time
Final robustness(or lack thereof)
Time
Ability to describe system
Hasenkamp et al (2009) A review of the practices for robust design methodology, Matthiassen, B. (1997) - Design for Robustness and Reliability – Ph.D. Thesis, DTU, Ebro, M. (2015) - Applying Robust Design in an Industrial Context, Ph.D. Thesis, DTU
Presentation title Date 28
Methodology and approachWhy and how does it work?
FR
DP
TF
min
Trade-offsThe influence of contradictions on medical devices
FR1E.g. Regret torque
DPE.g. Spring
sitffness
FR2E.g. Dosing force/speed
Min. acceptable regret torque:Beyond this limit, the pen will not be able to maintain a dose setting
Min. acceptable forceBeyond this limit, the pen will not be able dose, due to friction
Acceptable range for FR1 Acceptable range for
FR2
Acceptable range for FR1+FR2
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FR2E.g. Dosing force/speed
Min. acceptable forceBeyond this limit, the pen will not be able dose, due to friction
Contradictions Analysis – Robust Design Day 17
Parameter variationIf wide tolerance is
applied
FR1E.g. Regret torque
DPE.g. Spring
sitffness
FR2E.g. Dosing force/speed
Types of functions
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Min is best Nom is best Max is best
Max
Max
Min Min
DP
FR
DP
FR
DP
FR
Mostly related to noise
Mostly relates to accuracies
Mostly related to reliability, UX, and output functions
Contradictions Analysis – Robust Design Day 17
15Contradictions Analysis – Robust Design Day 17
Influence of parametersQualitative assessment of DP
2
1
0
-1
-2
Highly positive influence
Contributing positive influence
Nominal/unknown influence
Detrimental influence
Highly detrimental influence
These are used to assess the severity of trade-offs between functions
16Contradictions Analysis – Robust Design Day 17
Negative relation
min
Max
Min
DP
FR 1FR 2
DP
FR 1
Direct trade-offs Constrained trade-offs
FR 2
Min
Max
Min
DP
FR 1 FR 2
Min
Offset nominals
Max
Limiting relations
Positive relations
max
FR 2FR 1
Optimisationtargets
Functional interrelations
FR 2
min
Negative relation
DP
FR 1
Direct trade-offs
Min
DP
FR 1
Constrained trade-offs
FR 2
Limiting relations
Max
Min
DP
FR 1 FR 2
Min
Offset nominals
Max
Positive relations
max
FR 2FR 1
Optimisationtargets
ProcedureIdentifying and quantifying trade-offs
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Classify FRs and identify involved parts/
Identify functional requirements
Assess influences of DPs and resulting contradictions
Identify involved design parameters
Identify root cause and perform redesign
Prototype or analyse the
effect
Contradictions Analysis – Robust Design Day 17
1
Issue reductionIterative Pareto approach
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Issue no.
Criticality
23
4 5 6
78 9
Work required
Focus
Level at milestone
Contradictions Analysis – Robust Design Day 17
Issue no.
Criticality
4 5 6
78 9
Work required
Level at milestone
Focus
Issue no.
Criticality
4 6
78 9
Work required
Level at milestone
Time to tweak
Presentation title Date 28
Some examplesThe cause and influence of a contradiction
Leadscrew vs. rack and pinionWhy one is better than the other
20Contradictions Analysis – Robust Design Day 17
FR1: Mechanical efficiency
FR2: Accuracy efficiency
DPs: Thread diameter, pitch, thread
angle, axial play, radial play, secondary
bearing diameter, leader hight
DPs: Thread diameter, pitch, thread
angle, axial play, radial play, secondary
bearing diameter, leader hight
Leadscrew vs. rack and pinionWhy one is better than the other
21Contradictions Analysis – Robust Design Day 17
DPs: Module, pressure angle, bearing
diameter, pitch diameter, rack support,
backlash/axial play
FR1: Mechanical efficiency
FR2: Accuracy efficiency
DPs: Module, pressure angle, bearing
diameter, pitch diameter, rack support,
backlash/axial play
Which is best?
ExampleA slip-clutch driven gearbox
22Contradictions Analysis – Robust Design Day 17
Functions:
Transfer rotation in one direction only,
prevent overload, change state to reset
mechanism
ContradictionA slip-clutch driven gearbox
23Contradictions Analysis – Robust Design Day 17
Critical design parameters:
DP1: Spring stiffness
DP2: Spring pretension
DP3: Contact diameters
DP4: Tangential play in tooth interfaces
Functional requirements
FR1: Accuracy (nom is best)
FR2: Slip clutch disengagement accuracy (nom is best)
FR3: Mechanical loss (rotational) (min is best)
FR4: Return mechanism accuracy (nom is best)
FR5: State change force (min is best)
FR1FR2FR3FR4FR5
=
2−2
02−2
0−2
20
2 −21 0−20
2−12
DP1 DP2 DP3 DP4
Issues
Presentation title Date 24
Parasitic loads on gearbox
Substantial play
requirements
Variable efficiency
between states
Stiff spring needed to provide return and
slip-clutch functionalities
SolutionA slip-clutch driven gearbox
25Contradictions Analysis – Robust Design Day 17
A radial system - In essence, the
force loop has been changed, and
the functionality redistributed
1. Excessive integration of functions in single parts
2. Opposing or unintended load paths
3. Contradictions when changing from one functional state to another
4. Asymmetry - e.g. eccentric loads, improper moment balancing
5. Opposing stiffness requirements between directions – aspect ratio
1. Excessive integration of functions in single parts
2. Opposing or unintended load paths
3. Contradictions when changing from one functional state to another
4. Asymmetry - e.g. eccentric loads, improper moment balancing
5. Opposing stiffness requirements between directions – aspect ratio
6. Inherent trade-offs in energy converting interfaces
Typical causes
26Contradictions Analysis – Robust Design Day 17
Presentation title Date 28
Uses and experiences
Concept SelectionStrategic part reduction
Identifying conceptual robustness issues
Fast, system level robustness screenings Prioritisation
of analyses
Contradiction driven redesignSuccesses and impact
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The 2nd design performs better, on numerous parameters:
1. Degree of contradiction reduced by more than 30 % (despite new functionality and increased analysis detail)
2. Three parts removed (12,5 %)
3. Static strain on engine reduced from 6 % to 0.5 %
4. Contributors to activation force reduced by 30 %
5. Drive train friction reduced by 27 %
6. 25 tolerance and kinematic analyses removed through design
7. Most DfMA issues removed
Contradictions Analysis – Robust Design Day 17
Solving contradictions
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1. Change the distribution of functionality on parts – change the concept
2. Reorient a functions axis of operation – change the kinematic intent
3. Introduce or remove parts – differentiate or integrate functionality
4. Decrease the severity of the trade-off – optimise the design
5. Find and exploit nonlinearities – “invent”
Contradictions Analysis – Robust Design Day 17
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Trade-off avoidanceTo sum up
Presentation title Date 28
FR
DPRobustSensitive
Thank you!
Interested? Feel free to contact me:[email protected]://www.linkedin.com/in/nokkvi/