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Agile Medical Device Development

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Agile Geräteentwicklung: Was wir von der Softwareentwicklung lernen können!
Dieser Workshop zeigt Möglichkeiten auf, Methoden der agilen Softwareentwicklung auf die Entwicklung von Systemen oder Geräten zu übertragen. Dabei werden verschiedene Aspekte der Einführung und der Durchführung von agiler Systementwicklung betrachtet, die auf langjährigen Erfahrungen aus unserer Projektpraxis beruhen. Neben methodischen Aspekten wie „iteratives Vorgehen“ oder „Scrum gelebt im System“, werden auch Themen der Teamorganisation, der disziplinübergreifenden Zusammenarbeit, der Selbstorganisation und Systemintegration erarbeitet.

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Agile Medical Device Development

  1. 1. © Zühlke 2015 Agile Medical Device Development Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 1
  2. 2. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Erik Steiner Dipl.-Ing. (FH) Erik.Steiner@zuehlke.com Senior Project Manager  > 17 yrs. professional experience  Project management agile and regulated  Focus on development of medical devices  Located at Eschborn 15. October 2015 Slide 3
  3. 3. © Zühlke 2015 Facts & Figures • Over 8000 projects to our credit • Turnover 119 Mio. CHF (2014) • 700 Employees (end 2014) • In Austria, Germany, Serbia, Switzerland and in the United Kingdom • Foundation 1968, now owned by a group of managing partners • ISO 9001 and 13485 certified Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 4
  4. 4. © Zühlke 2015 Product Development & Software Solutions • Creating innovative products all the way from the concept phase, through development and into mass production. • Developing bespoke software solutions which combine innovation with stability and link business with software. • Bringing experiences gained in many different industry sectors and disciplines. • Using tried and tested development processes Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 5
  5. 5. © Zühlke 2015 Agile device development – in feasibility and system design phases – with a cross-functional team – electronics, mechanics, software, microfluidics, optics, simulation, etc. – based on SCRUM Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 6
  6. 6. © Zühlke 2015 Time to market Moving target Undocumented requirements etc. Agile Medical Device Development | Erik Steiner, Thomas Weber Device under development EE/ME/SW Not an end to itself! 15. October 2015 Slide 7
  7. 7. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber The Method Daily Scrum Time Boxed Frequent Releases Reviews RetrospectivesPlanning 15. October 2015 Slide 8
  8. 8. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber The Mindset Act pragmatically! Fail early! Think and act in system context! Talk, discuss, and ask! Learn and adapt! Think positive! Don’t make assumptions! Drive team success! Define System-DoD! Draw a common picture! Act proactively! 15. October 2015 Slide 9
  9. 9. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber The Realization Where does the backlog come from? How to use automated testing? How to integrate continuously? How to organize the team? How to realize the flow of work? …? 15. October 2015 Slide 10
  10. 10. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber Integration Strategy 15. October 2015 Slide 11
  11. 11. © Zühlke 2015 Product Integr. Model Integr. Model Agile Medical Device Development | Erik Steiner, Thomas Weber Lab Model Lab Model Integr. Model Integr. Model Integr. Model Think and act in system context! Fail early! Learn and adapt! 15. October 2015 Slide 12
  12. 12. © Zühlke 2015 Product Integr. Model Integr. Model Lab Model Lab Model Integr. Model Integr. Model Integr. Model Agile Medical Device Development | Erik Steiner, Thomas Weber 4 weeks Continuous System Integration 15. October 2015 Slide 13
  13. 13. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Draw a common picture! Talk, discuss, and ask! Think and act in system context! Act pragmatically! How to realize the integration strategy??? 15. October 2015 Slide 14
  14. 14. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber User Scenarios System Architecture Integration Strategy Interfaces 15. October 2015 Slide 15
  15. 15. © Zühlke 2015 System Architecture Agile Medical Device Development | Erik Steiner, Thomas Weber Technical Function m Technical Function 5 Technical Function 2 User Szenario n User Szenario 2 User Scenario 1 Technical Function x Technical Function 2 Technical Function 1 Subsystem User Interface Subsystem Micro Controller Subsystem Motion Subsystem Sensing Subsystem Stimulation Technical Function 2 User Scenario 1 TF2 Test Scenario 1 Test Scenario 2 TF5 TFm 15. October 2015 Slide 16
  16. 16. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber User Scenarios System Architecture Technical Risk Matrix Integration Strategy Interfaces Mindset! 15. October 2015 Slide 17
  17. 17. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber 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 Sensing Motion Stimulation Microcontr. User Interface … Probability of technical failure Projectimpactincaseoftechnicalfailure Risk eval. of scenarios and functions Results in subsystem risk evaluation Defines order of subsystem integration 15. October 2015 Slide 18
  18. 18. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber User Szenarios System Architecture Technical Risk Matrix Degree-of- maturity-table Integration Strategy Interfaces 15. October 2015 Slide 19
  19. 19. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Laboratory Model LabMo_1 Integration Model IMo_1 Integr. Model Integr. Model Lab Model Lab Model Integr. Model Integr. Model Integr. Model 15. October 2015 Slide 20
  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 reliable and exact Stimulation and sensing works basically as designed Motor integrates with controller and evaluation board Sensor System integrates with Microcontr. Motion and Sensing integrate with developed mainboard User Scenario 1 User Scenario 2 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 Motion TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sensing TF2 (10%) TF2 (80%) TF2 (100%) Stimulation TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Microcontroller 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, … Agile Medical Device Development | Erik Steiner, Thomas Weber Integration Steps Scenarios to be provided by integration step Subsystems Integr. Model Integr. Model Lab Model Lab Model Integr. Model Integr. Model Integr. Model Detailed description of degree of maturity and acceptance criteria per integration step and subsystem 15. October 2015 Slide 21
  21. 21. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Integration Step LabMo_1 LabMo_2 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Motor moves reliable and exact Stimulation and sensing works basically as designed Motor integrates with controller and evaluation board Sensor System integrates with Microcontr. Motion and Sensing integrate with developed mainboard User Scenario 1 User Scenario 2 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 Motion TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sensing TF2 (10%) TF2 (80%) TF2 (100%) Stimulation TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Microcontroller 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, … 15. October 2015 Slide 22
  22. 22. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber User Szenarios System Architecture Technical Risk Matrix Degree-of- maturity-table Integration Strategy Interfaces Integration steps Backlog & Estimation 15. October 2015 Slide 23
  23. 23. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber 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-TeamsFunctional-Teams Feature-Teams Learn and adapt Learn and adapt 15. October 2015 Slide 24
  24. 24. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber 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 15. October 2015 Slide 25
  25. 25. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber User Szenarios System Architecture Technical Risk Matrix Degree-of- maturity-table Integration Strategy Interfaces Integration steps Backlog & Estimation Team staffing Deliveries Integration step plan 15. October 2015 Slide 26
  26. 26. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber 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 15. October 2015 Slide 27
  27. 27. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber 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 Delivery times from suppliers Calculated readiness times Excel magic incl. staffing 15. October 2015 Slide 28
  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 reliable and exact Stimulation and sensing works basically as designed Motor integrates with controller and evaluation board Sensor System integrates with Microcontr. Motion and Sensing integrate with developed mainboard User Scenario 1 User Scenario 2 Release Date CW 14/2015 CW 12/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015 Equipment & Deliveries Check Oscillogramme Check Oscillogramme Check Oscillogramme Check sniffed Data Check regression, … Test Scenario 1, 2 Test Scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Motion TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sensing TF2 (10%) TF2 (80%) TF2 (100%) Stimulation TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Microcontroller Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 User Interface TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Test OTS-Controller Oscilloscope Oscilloscope Oscilloscope Oscilloscope, Sniffer … Delivery by customer, … Delivery by customer, … Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 29
  29. 29. © Zühlke 2015 Integration Step LabMo_2 LabMo_1 IMo_1 IMo_2 IMo_3 IMo_4 IMo_5 Scenario(s) covered Stimulation and sensing works basically as designed Motor moves reliable and exact Motor integrates with controller and evaluation board Sensor System integrates with Microcontr. Motion and Sensing integrate with developed mainboard User Scenario 1 User Scenario 2 Release Date CW 12/2015 CW 14/2015 CW 15/2015 CW 16/2015 CW 24/2015 CW 26/2015 CW 32/2015 Equipment & Deliveries Check Oscillogramme Check Oscillogramme Check Oscillogramme Check sniffed Data Check regression, … Test Scenario 1, 2 Test Scenario 1, 2, 3, 5 Degreeofmaturityofsubsystems Motion TF8 (70%) TF8 (100%) TF9 (40%) TF9 (100%) TF8 (change) Sensing TF2 (10%) TF2 (80%) TF2 (100%) Stimulation TF5 (50%) TF5 (80%) TF5 (90%) TF5 (100%) Microcontroller Evalboard Evalboard Mainboard V0.8 Mainboard V0.9 User Interface TF12 (15%) TF12 (85%) TF15 (20%) … TF… TF … TF … Test Oscilloscope OTS-Controller Oscilloscope Oscilloscope Oscilloscope, Sniffer … Delivery by customer, … Delivery by customer, … Agile Medical Device Development | Erik Steiner, Thomas Weber 15. October 2015 Slide 30
  30. 30. © Zühlke 2015 Mindset! Agile Medical Device Development | Erik Steiner, Thomas Weber User Szenarios System Architecture Technical Risk Matrix Degree-of- maturity-table Integration Strategy Interfaces Integration steps Backlog & Estimation Team staffing Deliveries Integration step plan 15. October 2015 Slide 31
  31. 31. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Much more aspects! Iteration Metaphor Estimation Method Planning Poker Earned Value Analysis Self- organization Team skill Composition Meeting Structure Planning & Reviews with Customer Team Retrospectives Office Organisation …! Technical Infrastructure Customer’s mindset for deliveries 15. October 2015 Slide 32
  32. 32. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Conclusions Degree-of-Maturity Table as Core of Agile Device Development  Communication with customer  Team communication  Learn and adapt Continuous work and improvement of team mindset Continuous assessment and adaption of planning 15. October 2015 Slide 33
  33. 33. © Zühlke 2015Agile Medical Device Development | Erik Steiner, Thomas Weber Zühlke. Empowering Ideas. 15. October 2015 Slide 34

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