OPERATIONS
We believe in a practical approach to operations management. Our solutions are tailored to your organization and your project to ensure durable and sustainable success long after we are gone.
The scope of “Operations” in medical technology companies is so broad that it deserves to be considered from several dimensions.
Design Transfer
The design transfer perspective is focused on the path of a new product through manufacturing process development, validation, implementation, and release to production. Note that this perspective is part of a larger design control process and depends heavily on effective collaboration of team members across multiple functions including not only operations, but also product development and quality. We help companies with design transfer.
Production
The production perspective is focused on the conversion of raw materials into a finished product. This includes strategic decisions on the degree of process outsourcing, development and execution of actual manufacturing processes, and day-to-day management of resources such as facilities, equipment, operators, and inventory. We help companies with production activities.
Supply Chain
The supply chain perspective spans the planning, execution, and results of the chain of activities from purchasing raw material and components from suppliers through order fulfillment and delivery of finished product to the customer. Ineffective planning and controls anywhere in this supply chain can put a business at risk, particularly in the med-tech space where the cost of a missed milestone or missed sale can go far beyond lost revenue. We help companies with supply chain optimization.
Stillwater MedTech Consulting Services related to operations include:
Transferring Designs from Product Development to Production
Risk Assessments for Manufacturing Processes, e.g. PFMEA
Manufacturing Process Design, Implementation, and Validation
Establishing Process Controls, Device Master Record, and Device History Record
Satisfying Unique Device Identifier Requirements
Planning and Managing Activities to support Release to Production.
Establishing, Managing, and/or Improving Production Operations
Strategic Planning & Architecture (Operations timeline, scope of internal versus external activities)
Manufacturing Process Development and Improvement
Manufacturing and Warehouse Facility Design
Planning Demand, Inventory, Capacity, Production, Procurement, and other Resources
Production Operations Management (internal or external)
Inventory Management
BOM Review & Analysis (for accuracy, cost, risk, etc.), Modeling COGS
Establishing, Managing, and/or Improving Supply Chain Operations
Supply Chain Review & Analysis
Supply Chain Strategy (architecture and evolution)
Materials Requirements Planning
Supplier Selection and Performance Management
Procurement Processes
Purchased Product and Supplier Quality
Project/Program Management
Project Charters and Executive Approvals
Work Breakdown Structure/Activity Planning
Gantt Charting/Critical Path Identification
Risk Identification and Mitigation
Project Team Management and Progress Reporting
Issue Tracking & Resolution