|
Design Optimization
Optimization is the most essential aspect of product iteration. Fathom can help to design your product for functionality, cost minimization, and differentiation.
Manufacturability
With decades of experience manufacturing medical devices, Fathom can design your device for full-scale manufacturing readiness.
Prototyping
Visualization and basic testing of design iterations is performed through our in-house and partner manufacturing facilities.
Supplier Qualification
In an age of sub-contracting, it is essential that partner organizations are qualified and can withstand the rigors of medical device manufacturing requirements.
Product Specifications
Fathom can create design drawings and product specifications that will contain all pertinent requirements to ensure that manufacturing partners deliver only the most superior-quality products that are used in the manufacture of your medical device.
Equipment Design
Whether manufacturing a handful of prototypes or thousands of parts in full-scale production volume, our team can design equipment for rapid and cost-efficient manual or automated manufacturing and inspection.
Process Development
Fathom can design processes for assembly, cleaning, packaging, and labeling your products to ensure biocompatibility and safety.
Inspection Protocols
Alignment between your quality and manufacturing team requires relevant protocols for inspecting and approving product taking into account downstream performance requirements. Fathom will create inspection protocols that ensure the highest quality products are manufactured with minimal inspection costs.
Sterilization
Gamma radiation, ethylene-oxide, and autoclaving can all be specified through our affiliate sterilization partners.
Quality Systems
Let Fathom develop a robust, auditable quality system that is required of all medical device companies prior to commercialization.
Validation
Manufacturing costs can be greatly reduced following a successful validation of your manufacturing processes. Fathom can assist in the creation and execution of validation protocols.
Design History File
Good manufacturing practices require a well-documented chronicle of the permutations that led to design freeze. Let Fathom create your complete DHF.
|
|
