Peter Haller
How IoT Is Transforming The Way Medical Products Are Developed Peter Haller Medtec Europe 2017 1
1. Understanding why Lean and Agile can be used for medical device product development 2. Definition of Lean and Agile 3. Overview of Related Standards 4. Customer Success Story 5. Questions
2
3
Lean Processes
Lean is a systematic method to eliminate waste • Focuses on identifying value added activities and remove waste • Removing waste frees resources to create more valuable products, faster Lean / Kanban Task management, visualisation, WIP (overload)
4
Agile Processes Scrum Agile planning, Sprint, Daily stand up, Retrospective
Agile is a set of principles in which environments and solutions evolve through collaboration within cross-functional teams Individuals and interactions
over
Processes and tools
Customer collaboration
over
Contract negotiation
Working software
over
Comprehensive documentation
Responding to change over
5
Following a plan
FDA 21 CFR 820 Expectations
FDA guidance: Design Control Guidance for Medical Development Manufacturers
6
•
The development process depicted in the example is a traditional waterfall model. … In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of the product development.
•
Although the waterfall model is a useful tool for introducing design controls, its usefulness in practice is limited. The model does apply to the development of some simpler devices. However, for more complex devices, a concurrent engineering model is more representative of the design processes in use in the industry.
Industry Regulations and Standards o Industry standards influencing the
manufacturing of medical devices: o IEC 62304 – Medical device software lifecycle processes o ISO 14971 – Application of risk management to medical devices o FDA regulations
7
Medtronic Customer Case Study • Deep Brain Stimulation Systems • 350 Developers
Relevant standards: • IEC 62304 • IEC 82304 • IEC 62366 – 1 • AAMI TIR45 • IEC 60601 – 1 • ISO 13485 • ISO 14971 • FDA Title 21 CFT Part 11 8
Product Development Lifecycle
9
XLM Lifecycle Management
10
Adopting Agile and Continuous compliance
11
Goals:
Benefits:
• Process control • Automation • Documentation
• Reduce risks • Reduce the time to market • Increased efficiency and product quality • Gapless traceability
ALM System Components
12
FDA Compliant Approvals
• • • •
13
http://intland.com/video/advanced-workflows/approval-processes-withe-signatures/
E-Signature Approval tasks Automatic state transitions Chained workflow
Validation and Verificaton of Requirements
14
Risk Management and FMEA
15
End-to-end Traceability
16
Implementing Agile while Maintaining IEC/FDA Compliance Agile Project Management
17
Who we are Some facts about Intland Software
• Founded in 1998
• Headquarters in Stuttgart, Germany • Office in Silicon Valley, USA • Partners: Lufthansa Industry Solutions • Resellers in UK, China, Korea, Taiwan, France, Italy
18
Our Clients 2016 Medical
Automotive
Aviation & Defence High Tech & Embedded Other
19
Thank you for your attention! Any questions?
If you like to get to know more, please visit as at: Hall 1 A 46 20
1. Understanding why Lean and Agile can be used for medical device product development 2. Definition of Lean and Agile 3. Overview of Related Standards 4. Customer Success Story 5. Questions
2
3
Lean Processes
Lean is a systematic method to eliminate waste • Focuses on identifying value added activities and remove waste • Removing waste frees resources to create more valuable products, faster Lean / Kanban Task management, visualisation, WIP (overload)
4
Agile Processes Scrum Agile planning, Sprint, Daily stand up, Retrospective
Agile is a set of principles in which environments and solutions evolve through collaboration within cross-functional teams Individuals and interactions
over
Processes and tools
Customer collaboration
over
Contract negotiation
Working software
over
Comprehensive documentation
Responding to change over
5
Following a plan
FDA 21 CFR 820 Expectations
FDA guidance: Design Control Guidance for Medical Development Manufacturers
6
•
The development process depicted in the example is a traditional waterfall model. … In practice, feedback paths would be required between each phase of the process and previous phases, representing the iterative nature of the product development.
•
Although the waterfall model is a useful tool for introducing design controls, its usefulness in practice is limited. The model does apply to the development of some simpler devices. However, for more complex devices, a concurrent engineering model is more representative of the design processes in use in the industry.
Industry Regulations and Standards o Industry standards influencing the
manufacturing of medical devices: o IEC 62304 – Medical device software lifecycle processes o ISO 14971 – Application of risk management to medical devices o FDA regulations
7
Medtronic Customer Case Study • Deep Brain Stimulation Systems • 350 Developers
Relevant standards: • IEC 62304 • IEC 82304 • IEC 62366 – 1 • AAMI TIR45 • IEC 60601 – 1 • ISO 13485 • ISO 14971 • FDA Title 21 CFT Part 11 8
Product Development Lifecycle
9
XLM Lifecycle Management
10
Adopting Agile and Continuous compliance
11
Goals:
Benefits:
• Process control • Automation • Documentation
• Reduce risks • Reduce the time to market • Increased efficiency and product quality • Gapless traceability
ALM System Components
12
FDA Compliant Approvals
• • • •
13
http://intland.com/video/advanced-workflows/approval-processes-withe-signatures/
E-Signature Approval tasks Automatic state transitions Chained workflow
Validation and Verificaton of Requirements
14
Risk Management and FMEA
15
End-to-end Traceability
16
Implementing Agile while Maintaining IEC/FDA Compliance Agile Project Management
17
Who we are Some facts about Intland Software
• Founded in 1998
• Headquarters in Stuttgart, Germany • Office in Silicon Valley, USA • Partners: Lufthansa Industry Solutions • Resellers in UK, China, Korea, Taiwan, France, Italy
18
Our Clients 2016 Medical
Automotive
Aviation & Defence High Tech & Embedded Other
19
Thank you for your attention! Any questions?
If you like to get to know more, please visit as at: Hall 1 A 46 20
