Core competence on Co-Development of Drug Delivery Systems
Röchling Medical has very strong expertise and capabilities in supporting – through our own R&D department – our customers on the development of their Drug Delivery Systems. Driven by Innovation as a core competence within the Group Divisions (Automotive, Industrial, Medical), Röchling Medical will employ cutting edge technology for development & manufacturing of products to ensure superior and cost effective solutions for our customers.
The first aspect of the Co-development will be to establish the input requirements based on:
- the customer needs (markets, drugs application, patient insight, target costings, IP screening and ownership, etc.)
- and our own knowledge of delivery systems, competitive products, manufacturing requirements and commercial requirements.
A Use Failure Modes and Effect Analysis (Use FMEA) will be drafted.
Next step will be to develop overall concepts (by using QFD matrix, Six sigma for design) until a single concept (or a limited selection) is shown to reduce all the identified risks to a reasonable level. The Use FMEA and the Product Requirements Document will be updated and a Design FMEA drafted.
Development of the System will follow our NPI (New Product Innovation) procedure and will include:
- Materials (plastic/metal) & processes selection
- Detailed product design 3D/2D and analysis on all functions of the system
- Tolerance & stack up analysis
- Rapid prototypes (3D printing) for product verification
- Manufacturing of Pilot tools in house or subcontracted depending on the project size/complexity
- Pilot parts (out of validated process) for potential clinical trials
- Development of the Industrial concept
- Development & Validation of Industrial molds (in house or subcontracted) and equipment
- Process validation (DQ, IQ, OQ, PQ)
- Transport & Sterilization validation
- Project Management to ensure stage gate delivery of detailed Work Plan & Deliverables Schedules
Our Project Team will be engaged & committed to deliver on its promises within agreed deadlines with our clients.