Agile for Medical Product Development with Microsoft TFS Compliance with Shorter Time to Market NANCY VAN SCHOOENDERWOERT, LEAN-AGILE PARTNERS BRIAN SHOEMAKER, SHOEBAR ASSOCIATES CHRISTIAN HASSA, TECHTALK SOFTWARE AG Webinar, 17. September 2013.
Presenters Brian Shoemaker Originally an analytical chemist 15 y in clinical diagnostics (immunoassay): analytical support assay development instrument software validation 6 y as SW quality manager (5 in clinical trial related SW) 7 y as independent validation consultant to FDA-regulated companies mostly medical device Active in: software validation, Part 11 evaluation, software quality systems, auditing, training Nancy Van Schooenderwoert Originally an electronics and software designer 15 years safety-critical systems experience Flight simulation, industrial controls, medical devices 11 years agile team coaching 4 years agile enterprise coaching Industries: Aerospace, Medical Devices, Sonar Weaponry, Scientific Instruments, Financial Services Electrical Engineering and Software Engineering, embedded systems 3
Agenda Why the debate about using Agile? Making the technical change Making changes to interactions Making the procedural change Agile is superior but get help! 4
Village Rumors Hold us Back The standards say we must use a waterfall model Agile isn t suitable for safety-critical work! TRUE Agile means you don t plan and don t write documents. Agile is just an excuse for sloppiness! 5
Better / Faster Change A brief introduction to Agile for regulated medical SW 6
Agenda Why the debate about using Agile? Making the technical change Making changes to interactions Making the procedural change Agile is superior but get help! 7
Practices Include Control Loops Build the right thing! Build the thing right! (Validation) (Verification) Des Customers Team Req Risk Anal. 8 Test Trace Code, H/w IEC 62304, intro: This standard does not prescribe a specific life cycle model.
How? Deliver Working Increments Not This: But This: Time Time 9
The project: infusion pump Goal: To develop an infusion pump for hospital bedside use which has: a) Intuitive setup instructions provided in the on-screen UI b) Intuitive indications for monitoring therapy c) Functions standard to any infusion pump (continuous mode, pulse mode, bolus,...) d) Alarms which can be either audible at pump, communicated to hospital IT, or both e) Communication with hospital IT system, for drug library information f) Unambiguous input and output fluid connections 10
Infusion Pump - Examples 11
Players Persons and things of importance People Physical things Data entities IBU (Infusion Bedside Unit) Wand (barcode scanner wand) Patient Nurse Physician PO (Physician Order) Intk_DB (hospital intake database) Pt Record (Patient s med status & history) Barcode bracelet Pharma_ DB (drug inventory) 12
The Interaction: Impact Map 13
Impact Map structure Goal What is our goal? Streamline the correct and safe setup of Infusion Pump. Actors Impacts Deliverables Who can help/prevent us reaching our goal? Nurse, Patient, IT Behavioral change helping/obstructing our goal Nurse: Set up infusion pump without needing to refer separate (external) information Features supporting/preventing impact: Nurse: setup infusion pump without external info Instructions on screen Scan ID from barcoded patient ID bracelet Retrieve physician order from hospital IT 14
Agenda Why the debate about using Agile? Making the technical change Making changes to interactions Making the procedural change Agile is superior but get help! 15
Agile is working together The Four Pillars of Agile Adoption: Teams must be able to produce bug-free software sustainably. Teams must consist of empowered, engaged people. Workflow to the Agile teams must be controlled via a "pull" system. Lean portfolio management must be used to control workflow for the organization. 16
Making the Agile Transition Product Sponsor Product Champion (Product Owner) Lean-Agile Champion Coach (Scrum master) Team member 17
The Story for sub-goal a a) Intuitive setup instructions provided in the on-screen UI As a Nurse I want to correctly set up an infusion with only the instructions on the screen. Conditions of satisfaction I don't need to refer to anything else to complete the set up The Pump allows me to input Patient ID without error The pump finds correct order for Patient in IT system In event of a mistake, I am notified 18
Agenda Why the debate about using Agile? Making the technical change Making changes to interactions Making the procedural change Agile is superior but get help! 19
Natural States Make Sense Natural states exist in any project Market Evaluation Technical Feasibility Release Readiness Rollout Imposed states within development slow us down and let trouble hide Design Code Test Etc. Waterfall sequence 20
Capture knowledge as work proceeds SRS SDS Story 1 Story 2 Story 3 Story 4 Story 5 Story 6 Story 7 Product IEC 62304 5.1.1: processes can be performed iteratively or recursively V&V 21
Mapping the Stories Desired Impacts Feedback Supporting deliverables User Activities Likely order of events Release 1 t Release 2 User Stories Priority 22
User Feedback is Crucial! Before UX feedback After UX feedback Source: 23
Iterations Improve Risk Management Requirements Hazards Early in project Preliminary High-level Approximate ISO 14971 3.1: Mfr "shall establish, document and maintain throughout the lifecycle an ongoing process for analyzing, evaluating, and controlling risks. Requirements + Mitigations Late in project Refined Detailed Specific 24
Discussion of hazards What can go wrong (in Infusion Setup)? Give infusion to wrong Patient Pt record not found in intk_db Intk_DB associates wrong name with our Pt s bracelet barcode There is no PO for giving infusion for this Pt Drug ordered is not available Wand isn t working correctly Could it accidentally give barcode match? 25
Specification (traditional narrative) Setup Patient ID: The IBU (Infusion Bedside Unit) shall display the Patient s full name as retrieved from Hospital Intake Database, and with Physician Order. Within 30 seconds the patient s barcode shall be input via the handheld scanner otherwise this step is aborted (timeout). The inputted barcode is matched with hospital Intake Database Intk_DB. If match is successful, user is prompted for verbal confirmation by checkbox appearing on-screen for 2 minutes else timeout. When the user checks the box, and gives secondary confirmation, the system flags Patient ID Completed as true for this Infusion Order. If a timeout occurs the system shall allow Setup Patient ID to be restarted without requiring that preceding steps be redone. Note: Patient ID Completed is a system internal state that is referenced in other parts of the specification. 26
Split specification into scenarios Identifying patient should be aborted if patient's bar code is not scanned within 30 seconds Scanned patient Id should be verbally confirmed within 2 minutes Patient's full name should be displayed from hospital intake record after successful scan Patient's physician order should be displayed after successful scan Error should be displayed when patient is unknown Error should be displayed when there is no physician order present for the patient 27
BDD: scenarios examples automated tests arrange act assert 28
Capture requirements Product Design with Impact Maps and Story Maps Iterative refinement of requirement details 29
Manage team flow Requirements synced from SpecLog to TFS work items Electronic Task board and Burn Down Charts Fully integrated ALM Suite (Source Control, Test Mgmt, ) Cross-Platform (Java/Eclipse) 30
Automate AC validation Business readable, automated acceptance tests 31
Application Life Cycle Management Link requirements to TFS work items Traceable Specification Capture knowledge, design increments Support interactions, manage flow Automate acceptance criteria validation Document specification details as living documentation 32
Agenda Why the debate about using Agile? Making the technical change Making changes to interactions Making the procedural change Agile is superior but get help! 33
Agile performance: Quality Team Defects/FP Process Follett Software (1) 0.0128 Agile, XP co-located BMC Software (1) 0.048 Agile, Scrum distrib. GMS (2) 0.22 Agile, XP for embedded Industry Best (3) 2.0 traditional Industry Average (3) 4.5 traditional Co-located agile XP team achieved 100X the defect performance of the best traditional waterfall teams! 1. M. Mah, How Agile Projects Measure Up and What This Means to You, Cutter IT Journal vol 9, no. 9, Sep 2008. 2. N. Van Schooenderwoert, Embedded Agile Project by the Numbers With Newbies, Agile 2006 conference report. 3. Capers Jones, Software Quality in 2002: A Survey of the State of the Art, presentation to Boston SPIN, Oct 2002 34
Simple Things Can Be Difficult Easy Difficult Complex String Theory Explain Dark Matter Recognize Faces Invent Light bulb Run a Business Rocket Science Biologically wired Walk Stop Smoking Simple Hit a Baseball Watch TV Visit The Pub Feed Birds Implement Agile Behavioral change is hard! Make Breakfast Send a Tweet Plant flowers Simple + Hard Behavioral Actors, top Athletes use a coach for Avoiding own blind spots Fast improvement You should too 35
Take-Aways Agile methods: not only compatible with medical work, but superior Implementing Agile requires several kinds of changes (technical, interactions, procedural) Agile transitions are smoothest with a coach Microsoft TFS and SpecLog/SpecFlow offer an end-end solution for building compliant documentation iteratively Looking for Deeper Discussion? Don t miss our detailed course: Agile for Medical Product Development with Microsoft Team Foundation Server: Compliance with shorter time-to-market 18-Nov 20-Nov 2013, Zürich, Switzerland For more information and link to register, visit: http://techtalk.ch/agile-business/agile-medical-sector/workshop 36
Presenters Contact Information Nancy Van Schooenderwoert Lean-Agile Partners, Inc. 162 Marrett Rd., Lexington, MA 02421 781-860-0212 NancyV@leanagilepartners.com http://www.leanagilepartners.com Brian Shoemaker, Ph.D. Principal Consultant, ShoeBar Associates 199 Needham St, Dedham MA 02026 781-929-5927 bshoemaker@shoebarassoc.com http://www.shoebarassoc.com Lean-Agile coaching for software and hardware teams Safety-critical, regulated coaching is our specialty Lean-Agile coaching for stakeholders and senior managers Software quality systems Software validation consulting Software documentation Software quality auditing Electronic records & signatures consulting 38
About TechTalk Software AG Agile Training, Coaching and Delivery Offices in Zurich, Vienna, Budapest welcome@techtalk.ch www.techtalk.ch www.speclog.net Agile Requirements Management Story Maps and Impact Maps Integration with Microsoft TFS www.specflow.org ww.specrun.net Business Readable Test Automation Specification-By-Example Also available on Java, PHP, Ruby 39