Challenges & Approaches to Implementing Structured System architecture in the Medical Device Industry

Transcription

1 Sumit Gupta, May 2018 Challenges & Approaches to Implementing Structured System architecture in the Medical Device Industry Page 1

2 About Siemens Healthineers Page 2

3 About Siemens Healthineers Page 3

4 About Siemens Healthineers Imaging Diagnostics Advanced Therapies Services Page 4

5 Diagnostics 14,000 employees 30,000 customers in 120 countries Broad spectrum of testing systems to cover 900 different tests: immunoassay chemistry hematology molecular urinalysis blood gas Automation and Informatics solutions Services Page 5

6 Transformation Process Platform-based development Structured System Architecture Design to Shelf Multi-BOM Management Change Management Closed loop manufacturing Design controls Set-based design Agile Development Integrated Test Management People (aligned to process) Digitalization (to connect people and process) Page 6

7 Digitalization Approach Documents Structured and integrated data model Common Tool Landscape Simcenter NX PLM mbom ERP Mentor Microsoft Page 7

8 Structured System architecture Approach System Architecture Template (Structured Data Model) Features Functions Logical Physical Feature 1 Feature 1 Feature 2 Feature 3 Feature 2 Feature 3 Functional Decomposition Logical Decomposition Physical Design Requirements & Architecture Feature Feature Interfaces PLM Page 8

9 Structured System architecture V- Model Feature 1 Architecture Solution Feature 2 Feature 3 Feature Feature 1 Functional Decomposition Logical Decomposition Validation Platform Product Feature 2 Feature 3 Design Sub-Systems Assembly Part Feature Interfaces Physical Design Integration Verification Page 9

10 Benefits Rapid development to respond to fast evolving market needs Re-use of proven design assets Accurate impact analysis of design changes Improved test coverage via comprehensive system interface characterization Features provide a vehicle for communication with marketing Trade-offs based on cost and value of a feature Visual architecture facilitates communication within engineering Collaboration between configuration management and architecture Improve accuracy and planning of new development project Optimize modularity of system to resolve complex architectural dependencies Quality Cost Accuracy Time to market Competition Page 10

11 Challenges Organization: Need for continuous and repetitive education at all levels (user, manager, executive) Functional divide between architecture (SW, HW) and requirements Need a collaborative approach between departments versus transactional Increased level of complexity of: Product information organization Management of traceability between design inputs and design outputs Regulatory standards and risks definition are requirements oriented Impact analysis during development is partial due to missing relationship Inefficient configuration management during development Lack of standards - architecture views and artifacts that are important for PLM Lack of architecture tools integrated with PLM system Definition of MVP is continuously challenged during adoption of the PLM processes and tools Page 11

12 Structured System architecture Key Aspects of the Transformation Before: Document Centric Project Based Requirement Driven Physical Architecture (HOW?) New Product for New Needs or New Market Difficult to identify Re-use opportunities Feasibility testing in every project Difficult to plan accurately Functional silos Relatively simpler document management After: Knowledge Centric Platform Based Feature Driven Functional Architecture (WHAT?) New configuration for New Needs or New Market Facilitates Re-use Minimal feasibility which is based on added technical risks Fast and accurate development iteration planning Facilitate cross-team collaboration Increased complexity of product information management Page 12

13 Q&A?? Sumit Gupta Director, Global Engineering Head of PLM Systems, Tools, & Infrastructure Siemens Healthineers Page 13 This Photo by Unknown Author is licensed under CC BY