1. Healthcare product Industry
Agile Management in
Healthcare product Industry
Sharmila Devi Boopathi (Senior Technical Specialist)
Balaji Gopalarathnam( Senior Technical Specialist)
PHILIPS INDIA LTD

2. Abstract
Agile Management in Healthcare product Industry: Health care product industry is notoriously slow to embrace or adapt to change to agile methodology because of the risk management which is large and is a understandable concern, when developing devices that touches people life. Moreover industry should comply with FDA, IEC, HIPAA and other regulations for data security, reliability, specification, quality and design controls. In this paper we will talk about how agile management helps in complying with regulations, reducing the risk factors and discover potential failures before they arise or alter features due to changing demand in healthcare product industry. As per this concept, Agile management should provide three different levels 1. Project sprint 2.Program sprint 3.Delivery sprint In project sprint we define the goal, test process, Definition of Done and roles. Marketing person plays product owner role team member plays scrum master role, Tech lead plays architect role. Program sprint takes place during the Scrum “planning” This is the phase where we determine the level of risk and here we define requirement and risk related requirements separately and is incorporated in the product backlog. Workflow workshop happens in this sprint Delivery sprint: In Delivery sprint, feature development takes place, risk is analysed and testing will be completed. Traceability document and risk management document will be updated only with available requirements. These documents will be updated every sprint as it is needed for regulatory compliance. The feature will be taken to customers for feedback. Feedback will be incorporated in next sprint and testing in following sprint. Thus given few requirement is implemented, risk analyzed and finalized with customer feedback. Development and testing related documents needed for audit are done.
Keywords: Project sprint, Program sprint and Delivery sprint

3. Change in Requirements leads to sustaining release
Problem Statement
Change in Requirements leads to sustaining release
How to Handle Validation
How to handle regulatory documentation
Responsibility of the individual in team is less when program manager becomes scrum master

4. Project Sprint Roles and Responsibility Goal Setting Team member
Marketing Manager
Developer, tester, Architect
Requirements
Client/Hospitals
Definition of Done
Open up documents
Testing Process
Includes regulatory doc is validation needed ?

5. Customer interaction starts
Program Sprint
Workflow Workshop
Discuss the flexibility part in requirement
Customer interaction starts

6. I&A sprint to analyze the feedback
Delivery Sprint
Happens in second from last sprint
I&A sprint to analyze the feedback

7. Benefits
Time to Market
Quality product
Motivated and responsible team members

8. Challenges
Customer availability for Validation
Two PI features may be taken for validation at one time leads to an obstacle for new features
Sometimes ends-up in waterfall within scrum

9. References & Appendix SAFe 4.0 Advanced Scrum Master
ISO 13485: 2003, Medical devices – Quality Management Systems – System requirements for regulatory purposes

10. Author Biography
Sharmila Devi Boopathi
(Senior Technical Specialist, Philips India Ltd)
Balaji Gopalarathnam

11. Logo of your organization
Thank You!!!
Logo of your organization