Agile Management in Healthcare product Industry
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
Introduction:
In this paper we will talk about how we can implement agile methodology in healthcare product industry from requirement phase till validation. Here the PI includes 6 sprints
Project Sprint:
Project sprint is kind of planning sprint for the project with minimum of two features to max of 4 features. duration is 2 weeks and details will be presented to team before program sprint
In project sprint we define
1. Goals
2. Definition of Done
3. Roles and Responsibilities
4. Test process
Goals:
Requirement from customer is given and the product owner gives details of requirements till sprint 3
Definition of Done
DOD is way of defining how the below can move it to done.
1. Developer process
2. Testing
3. Validation
4. Required document is done
Roles and Responsibilities:
Scrum Team should include Developer, tester, Product owner and scrum master.
Team should not more than 8 person
Roles:
Marketing manager plays Product Owner role
Team member plays Scrum master Role
Technical Lead plays Architect Role
Project manager plays RTE role
Test Process:
In this phase it will be decided whether validation happens for this feature or later depends on availability and readiness of feature.
Program Sprint:
In this phase PI planning happens.
In workflow workshop requirements will be discussed with product owner and workflow related to particular feature will be decided. Development team checks with PO for flexibility in code, like where the changes may happen in coming sprint
Story points will be assigned based on complexity, knowledge about feature, infrastructure available.
Requirement is analysed to some extent about the risk, if it is risk is related to safety and it will be decided to include in Risk management matrix which is needed for audit. RMM will be placed in common share and architect will be updating the same.
Given requirement/feature is split in to many stories. More technical spikes will be done on first sprint
Customer documentation like PNDT and ethical committee approval for validation starts from here
Delivery Sprint
Normal sprint process happens here.
Development, execution, testing, sprint meeting all normal sprint process happens here.
Based on the decision taken in Project sprint, system will be taken for validation
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
References & Appendix
- SAFe 4.0 Advanced Scrum Master
- ISO 13485: 2003, Medical devices – Quality Management Systems – System requirements for regulatory purposes
Author Biography
Author: Sharmila Devi Boopathi (Senior Technical Specialist, Philips India Ltd)
C0-Author: Balaji Gopalarathnam (Senior Technical Specialist, Philips India Ltd)
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