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Agile Medical Device Development

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Presentation of Principal Consultant Dr. Thomas Weber at MedConf Süd 2018.

Veröffentlicht in: Ingenieurwesen
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Agile Medical Device Development

  1. 1. © Zühlke 2015 Agile Medical Device Development Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 1
  2. 2. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Thomas Weber Dr.-Ing. Thomas.Weber@zuehlke.com Principal Consultant > 15 yrs. professional experience Architecture and design of mechatronic devices Focus on agile development of medical and consumer devices Located at Frankfurt 19. October 2017 Slide 2
  3. 3. © Zühlke 2015 Agile device development with a cross-functional team – mechanics, electronics, software, fluidics, optics, ... – based on SCRUM Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 3
  4. 4. © Zühlke 2015 Time to market Moving target Undocumented requirements etc. Agile Medical Device Development | Thomas Weber, Erik Steiner Device under development EE/ME/SW Not an end to itself! Not an end to itself! 19. October 2017 Slide 4
  5. 5. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner The method Daily scrumDaily scrum Time-boxedTime-boxed Frequent releases Frequent releases ReviewsReviews RetrospectivesRetrospectives PlanningPlanning 19. October 2017 Slide 5
  6. 6. © Zühlke 2015 The method Proper Agile versus Pseudo Agile Disciplined planning & execution Regular releases Careful backlog refinement Every change is processed according to the rules Inviolable iterations Detail next steps Direct access to devs Attempts to discuss all details beforehand No definition of done; states of items not tracked Impact of changes not analyzed Iterations start with incomplete planning Only strategic releases at major milestones Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 6
  7. 7. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner The mindset Act pragmatically! Act pragmatically! Fail early!Fail early! Think and act in the system context! Think and act in the system context! Talk, discuss, and ask! Talk, discuss, and ask! Learn and adapt! Learn and adapt! Think positive!Think positive! Don’t make assumptions! Don’t make assumptions! Drive team success! Drive team success! Use DoDs on system level! Use DoDs on system level! Draw a common picture! Draw a common picture! Act proactively! Act proactively! 19. October 2017 Slide 7
  8. 8. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Applying it Where does the backlog come from? Where does the backlog come from? How to use automated testing? How to use automated testing? How to integrate continuously? How to integrate continuously? How to organize the team? How to organize the team? How to channel the workflow? How to channel the workflow? …?…? How to support systems engineering? How to support systems engineering? 19. October 2017 Slide 8
  9. 9. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner Integration strategy 19. October 2017 Slide 9
  10. 10. © Zühlke 2015 Product Integration Model Integration Model Agile Medical Device Development | Thomas Weber, Erik Steiner Lab Model Lab Model Integration Model Integration Model Integration Model Think and act in system context! Think and act in system context! Fail early!Fail early! Learn and adapt! Learn and adapt! 19. October 2017 Slide 10
  11. 11. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Draw a common picture! Draw a common picture! Talk, discuss, and ask! Talk, discuss, and ask! Think and act in the system context! Think and act in the system context! Act pragmatically! Act pragmatically! How to derive the integration strategy? How to derive the integration strategy? 19. October 2017 Slide 11
  12. 12. © Zühlke 2015 Product Integration Model Integration Model Lab Model Lab Model Integration Model Integration Model Integration Model Agile Medical Device Development | Thomas Weber, Erik Steiner 4 weeks Continuous System Integration 19. October 2017 Slide 12
  13. 13. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Integration strategy Interfaces 19. October 2017 Slide 13
  14. 14. © Zühlke 2015 System Architecture Subsystem Sense Temperature Agile Medical Device Development | Thomas Weber, Erik Steiner Technical Function m Technical Function m Technical Function 5 Technical Function 5 Technical Function 2 Technical Function 2 User Szenario n User Szenario n User Szenario 2 User Szenario 2 User Scenario 1 User Scenario 1 Technical Function x Technical Function x Technical Function 2 Technical Function 2 Technical Function 1 Technical Function 1 Subsystem Handle UI Subsystem Orchestrate Workflow Subsystem Actuate piston Subsystem Sense Force Technical Function 2 User Scenario 1 User Scenario 1 TF2 Test Scenario 1 Test Scenario 2 TF5 TFm 19. October 2017 Slide 14
  15. 15. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Technical risk matrix Integration strategy Interfaces Mindset! 19. October 2017 Slide 15
  16. 16. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Technical Risk Matrix Low < 30% Medium 30% … 70% High > 70% Critical potential project killer Major significant project delay Moderate acceptable project delay Minor negligible project impact Sense temperature Actuate piston Sense force Orchestrate workflow Handle UI … Probability of failure Projectimpactincaseoffailure 19. October 2017 Slide 16
  17. 17. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Technical risk matrix Degree-of- maturity table Integration strategy Interfaces 19. October 2017 Slide 17
  18. 18. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Laboratory Model LabMo_1 Integration Model IMo_1 Integr. Model Integr. Model Lab Model Lab Model Integr. Model Integr. Model Integr. Model 19. October 2017 Slide 18
  19. 19. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Integration Step LabMo_1 LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Motor moves reliable and exact Sensing works basically as designed Motor integrates with controller and evaluation board Sensor System integrates with Microcontr. Actuating and Sensing integrate with developed mainboard User Scenario 1 User Scenario 2 Model Setup Motor+gear Sensors+Elect. Motor+Evalbrd +Sensors Eval Mainbrd IMo_3 IMo_3 Release Date tbd tbd tbd tbd tbd tbd tbd Test Check Oscillogramme Check Oscillogramme Check Oscillogramme Check sniffed Data Check regression, … Test Scenario 1, 2 Test Scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Actuate Piston TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sense pressure TF2 (10%) TF2 (80%) TF2 (100%) Sense force TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Control process Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 User Interface TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Equipment & Deliveries OTS-Controller Oscilloscope Oscilloscope Oscilloscope Oscilloscope, Sniffer … Delivery by customer, … Delivery by customer, … Integration StepsIntegration Steps Integration Model Integration Model Lab Model Lab Model Integration Model Integration Model Integration Model Detailed description of degree of maturity and acceptance criteria per integration step and subsystem Detailed description of degree of maturity and acceptance criteria per integration step and subsystem SubsystemsSubsystems Scenarios to be provided by integration stepScenarios to be provided by integration step 19. October 2017 Slide 19
  20. 20. © Zühlke 2015 Integration Step LabMo_1 LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Motor moves reliably and precisely Sensing concept works Motor integrates with controller and evaluation board Sensor System integrates with microcontr. Actuating and Sensing integrate with dedicated mainboard User scenario 1 User scenario 2 Model setup Motor+gear Sensors+elect. Motor+evalbrd +Sensors Eval Mainbrd IMo_3 IMo_3 Release date tbd tbd tbd tbd tbd tbd tbd Test Check oscillogram Check oscillogram Check oscillogram Check sniffed data Check regression, … Test scenario 1, 2 Test scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Actuate piston TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sense temp. TF2 (10%) TF2 (80%) TF2 (100%) Sense force TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Orch. workflow Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 Handle UI TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Equipment & deliveries OTS-controller oscilloscope Oscilloscope Oscilloscope Oscilloscope, sniffer … Delivery by sponsor, … Delivery by sponsor, … Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 20
  21. 21. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Technical risk matrix Degree-of- maturity table Integration strategy Interfaces Integration steps Backlog & estimation 19. October 2017 Slide 21
  22. 22. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Technical PBI Technical PBI Technical PBI Technical PBI Backlog Items LabMo_1 Technical PBI Technical PBI Backlog Items LabMo_2 Technical PBI Technical PBI Technical PBI Backlog Items IMo_1 Technical PBI Technical PBI User Story PBI Technical PBI Backlog Items IMo_2 User Story PBI Technical PBI User Story PBI User Story PBI Technical PBI Backlog Items IMo_3 User Story PBI User Story PBI Technical PBI User Story PBI User Story PBI Backlog Items IMo_4 User Story PBI User Story PBI User Story PBI Backlog Items IMo_5 Degree-of- maturity table Risk-driven technical focus Value-driven feature focus Subsystem Teams Functional Teams Feature Teams Learn and adapt Learn and adapt 19. October 2017 Slide 22
  23. 23. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Product Backlog Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI User Story PBI Technical PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI User Story PBI 19. October 2017 Slide 23
  24. 24. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Technical risk matrix Degree-of- maturity table Integration strategy Interfaces Integration steps Backlog & estimation Team staffing Deliveries Integration step plan 19. October 2017 Slide 24
  25. 25. © Zühlke 2015 Product Backlog Agile Medical Device Development | Thomas Weber, Erik Steiner Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI User Story PBI Technical PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI User Story PBI LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 LabMo_1 DeliveryforLabMo_1 Time 19. October 2017 Slide 25
  26. 26. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 LabMo_1 DeliveryforLabMo_1 Time Product Backlog Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI Technical PBI User Story PBI Technical PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI Technical PBI User Story PBI User Story PBI User Story PBI User Story PBI User Story PBI 19. October 2017 Slide 26
  27. 27. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Effort per Integration Step [PD] LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Electrical Engineering 46 8 11 4 55 9 16 Mechanical Engineering 45 39 16 6 3 38 0 Software Engineering 187 22 0 22 31 54 21 Test Engineering 8 38 0 7 6 16 4 Expected Delivery Time [weeks] LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Electrical Engineering 7 4 3 0 4 4 4 Mechanical Engineering 12 4 2 0 0 4 0 Software Engineering Test Engineering Expected Readiness LabMo_1 Lab_Mo2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Electrical Engineering CW11/15 CW10/15 CW11/15 CW9/15 CW24/15 CW26/15 CW29/15 Mechanical Engineering CW14/15 CW11/15 CW12/15 CW10/15 CW14/15 CW16/15 CW13/15 Software Engineering CW09/15 CW12/15 CW15/15 CW15/15 CW19/15 CW24/15 CW32/15 Test Engineering CW10/15 CW11/15 CW12/15 CW16/15 CW18/15 CW20/15 CW25/15 Estimated backlog Estimated backlog Delivery times from suppliers Delivery times from suppliers Resulting dates of availability Resulting dates of availability ‘Excel-magic’ incl. staffing ‘Excel-magic’ incl. staffing 19. October 2017 Slide 27
  28. 28. © Zühlke 2015 Integration Step LabMo_1 LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Motor moves reliably and precisely Sensing concept works Motor integrates with controller and evaluation board Sensor system integrates with microcontr. Actuating and Sensing integrate with dedicated mainboard User scenario 1 User scenario 2 Model setup Motor+gear Sensors+Elect. Motor+Evalbrd +Sensors Eval Mainbrd IMo_3 IMo_3 Release date CW 14/2015 CW 12/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015 Test Check oscillogram Check oscillogram Check oscillogram Check sniffed data Check regression, … Test scenario 1, 2 Test scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Actuate piston TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sense temp. TF2 (10%) TF2 (80%) TF2 (100%) Sense force TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Orch. workflow Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 Handle UI TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Equipment & deliveries OTS controller oscilloscope Oscilloscope Oscilloscope Oscilloscope, … Delivery by sponsor, … Delivery by sponsor, … Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 28
  29. 29. © Zühlke 2015 Integration Step LabMo_2 LabMo_1 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Sensing concept works Motor moves reliably and precisely Motor integrates with controller and evaluation board Sensor System integrates with microcontr. Actuating and Sensing integrate with dedicated mainboard User scenario 1 User scenario 2 Model setup Sensors+Elect. Motor+gear Motor+Evalbrd +Sensors Eval Mainbrd IMo_3 IMo_3 Release date CW 12/2015 CW 14/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015 Test Check oscillogram Check oscillogram Check oscillogram Check sniffed data Check regression, … Test scenario 1, 2 Test scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Actuate piston TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sense temp. TF2 (10%) TF2 (80%) TF2 (100%) Sense force TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Orch. workflow Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 Handle UI TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Equipment & deliveries Oscilloscope OTS-controller oscilloscope Oscilloscope Oscilloscope, sniffer … Delivery by sponsor, … Delivery by sponsor, … Agile Medical Device Development | Thomas Weber, Erik Steiner 19. October 2017 Slide 29
  30. 30. © Zühlke 2015 Mindset! Agile Medical Device Development | Thomas Weber, Erik Steiner User scenarios System architecture Technical risk matrix Degree-of- maturity-table Integration strategy Interfaces Integration steps Backlog & estimation Team staffing Deliveries Integration step plan 19. October 2017 Slide 30
  31. 31. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Many more aspects! Iteration metaphor Iteration metaphor Estimation method Planning Poker Estimation method Planning Poker Earned value analysis Earned value analysis Self- organization Self- organization Team skill composition Team skill composition Meeting structure Meeting structure Planning & reviews with Sponsor Planning & reviews with Sponsor Team retrospectives Team retrospectives Office organisation Office organisation …!…! Technical infrastructure Technical infrastructure Customer’s mindset for deliveries Customer’s mindset for deliveries 19. October 2017 Slide 31
  32. 32. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Conclusions Degree-of-maturity table as core of agile device development Communication with sponsor Team communication Learn and adapt Continuous improvement of team mindset Continuous assessment and adaption of planning 19. October 2017 Slide 32
  33. 33. © Zühlke 2015Agile Medical Device Development | Thomas Weber, Erik Steiner Zühlke. Empowering Ideas. 19. October 2017 Slide 33

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