The seventh National Conference INCOSEIL 2013 Requirements Engineering

The seventh National Conference INCOSE_IL 2013 • Requirements Engineering in embedded systems • Requirements Management initiation and deployment • Rafi Nave – Given Imaging 1

Requirements Management initiation and deployment Rafi Nave March 2013

Requirements Management initiation & deployment ■Context ■Approach ■Highlights ■The Given RAPID SW example ■User stories ■Adaptation to Agile development methodology ■Conclusions

Context ■ Roughly 12 years ago I drove the introduction of RMS [ Requirements Management System ] at NDS. ■ It is ‘the only way to work’ there nowadays. ■ About 24 months ago – a similar initiative took place at Given Imaging. ■ The first ‘wave’ of products has undergone the learning on how to apply RMS. Time to take inventory! ■Being a Medical company, subject to scrutiny and audits, brings additional importance to having adequate RMS.

Approach ■ We contemplated between 2 approaches: ■ Focusing on a new product development and starting from scratch following RMS. ■ Start with products that are half-way thru, that will serve as means of learning, as well as serve as baseline for future projects. ■ We opted for the 2 nd approach. ■ In retrospect – it brought benefits beyond expectations, both on product quality and on the ability to pass well audits. ■ We used external consultant: Golden Solutions, in the formation of the methodology and process.

Approach ( cont’d ) ■ 2 products were selected: ■ The SW flagship product: RAPID 8 ■ HW product: Bravo Recorder ■ A SW tool: QPACK, by Orcanos, was selected for the ALM [ Application Lifecycle Management ] ■The PRDs [ Product Requirements Docs ] the Specifications and Test plan specification were entered into the system ‘after the fact’ ■Full traceability was accomplished from PRD, through Spec to Test Plan on both products

Highlights ■The ‘exercise’ helped the quality of the products and especially improved their documentation. ■During the external ISO audit – the ability to demonstrate traceability from PRD thru Spec to Test coverage was highlighted by the auditors as an impressive capability ■The team underwent an incremental learning curve on how to use the tool and overcome its limitations, on how to locate mis-matches and correct them and, especially, on how to write better documents.

Highlights ( Cont’d ) ■The methodology was ironed out on the first projects, so that in the second wave most kinks were smoothened. ■The team appreciated the benefits of RMS to the point of needing no persuasion to apply it to the new products. ■We are still on a learning curve and the methodology and process are still being stabilized.

The Given Imaging Development Process 9 6/19/2021

Given Imaging Products ■Given develops, produces and distributes medical systems for the Gastro. Intestinal medical community. The priducts help diagnose pathologies through visualization of the GI tract ■Given products are distributed in more than 75 countries ■We just released our 8 th generation of the visualisation software [ RAPID ] ■This project was developed, for the first time, in an incremental approach (SCRUM) ■We just started a completely new big project

Given Imaging Product Development Workflow • Define features & effort PM MKT Clinical analysis Feasibility & Fine-tuning features Extensive QA & Final fine-tuning SW R&D AlgorithmsHW Clinical analysis PM MKT SQA CS SW R&D V&V= SQA + Clinical analysis (Alpha) PM MKT 3 rd level support & Field questions CS PM MKT

Coverage Flow/ Relations Map 12 6/19/2021

Moving Forward to a New Product ■Using SCRUM methodology “by the book”: ■User stories ■SCRUM ceremonies ■Continuous Integration ■Test Planning and Execution ■Tools (ALM) ■The most significant change was the introduction of user stories into the process.

The User Stories 14 6/19/2021

Why User Stories? ■ User stories ■ Emphasize the user’s goals, not the system’s attributes ■ Can be verified by SQA ■ Can be demo’d to stake-holders ■ Bridge the communication gap between PM, Dev & SQA ■ Support and encourage iterative development ■ Provide means for flexible and efficient planning ■ Each user story satisfies two goals at the same time: ■ It describes the software requirement in detail ■ It also describes a piece of development work for planning purposes ■ User stories bridge the gap between plans and specifications!

How User Stories Are Applied? ■ They are written collaboratively & incrementally by the entire team ■ Initial form may include a single sentence. ■ Details emerge during the sprint by discussions between developers, SQA & PM, and are written inside the User Story as “Conditions of Satisfaction” ■ The detailed user story serves as a first class Software Requirement ■ The list of “Done” user stories forms the software specification As a <role> I want to <goal> so that <benefit> Conditions of Satisfaction 1. … 2. … 3. …

User Story status workflow 17 6/19/2021

Software Design Spec ■Specify system architecture and application design in a software (functional subsystems). ■We are using this object to complete the coverage of the user story by using the RMS. ■Each developer is writing the SDD and is responsible to ‘translate’ requirements into a description of the software structure. 18 6/19/2021

The Agile Development Process 19 6/19/2021

The “Traditional” Process Implementation – R&D Verification - SQA Internal Val. (clinical staff) ‘last feature in’ full testing cycle vs. regression when to start? Clinical Trials when to end?

The Agile Work Flow Implementation + Verification R&D, PM, and SQA Bug fixing + Verification R&D, PM, and SQA ‘last feature in’ full testing cycle vs. regression Internal Val. (clinical staff) Clinical Trials

The Rapid 8 AGILE Scrum example ■ The 8 th generation of our main software product, “RAPID for Pill. Cam®”, was developed, for the first time, using an iterative approach, adopting Scrum methodology ■ 3 -week long sprints were executed, including: ■ Sprint planning ■ Bi-Weekly stand-up meetings ■ Allocating developers task to sprints ■ Task-oriented test execution using exploratory testing method ■ Sprint “retrospective” meetings ■ Releasing sprint SW version to internal clients (marketing), using Citrix Xen. App

Continuous Integration - Daily Process ■Every night, an automated script: ■Builds & deploys the current version of the software on a dedicated server ■Performs the following test sets: ■Unit level tests ■Component level tests ■System level tests ■Emails all relevant parties with the results ■ The daily updated server is used for exploratory testing and verification of user stories during the sprint

Conclusions ■ RMS is important to ensure product integrity and compliance to customers/market requirements. ■ You need to walk before you run! It is preferable to start with ‘path of least resistance’ and acquire team’s interest and collaboration gradually. ■ Over time the process, tool and practices will become ‘second nature’ and will be ingrained in the organic development process. ■ The process and methods must be updated to reflect the SW development process evolution [ In our case: Use stories and Agile/Scrum application ]

Thank you! 25 6/19/2021