Component, packaging and assembly enquiries with compatibility and product classification reviewed for the program.
Define the product before the presentation
A pen-device image is a development packaging concept. It does not establish a dosing accuracy claim, clinical suitability, sterile manufacturing qualification or regulatory approval. A drug-device program needs evidence and responsibilities defined for its exact configuration.
Device brief
Describe the device architecture, materials and component requirements without relying on a visual mockup.
Compatibility
Specify container, component and formulation interfaces and the relevant mechanical or compatibility tests.
Project responsibilities
Agree who provides components, who assembles, who evaluates performance and who owns regulatory submissions.
Packaging & traceability
Review identifiers, labels, instructions, shipping protection and the documentation needed for the intended market.
From prototype to an agreed specification
Begin with the technical brief and destination market. Agree sample objectives, review milestones, analytical needs and packaging decisions. Changes to composition, construction or use claims should be reflected in the approved specification. OEM, ODM, CRO and CDMO scope can be discussed according to the stage and responsibilities of the program.
Prepare your project brief
- Material identity and composition brief.
- Format, dimensions and packaging goals.
- Prototype evaluation criteria.
- Target quantities and destination market.
- Required documentation and responsible reviewers.