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

8

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

13

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:nssd@novonordisk.comhttps://www.linkedin.com/in/nokkvi/