Manufacture of medical device components
Surgical instruments, medical items
The medical devices industry is driven by innovation, in medical treatments, medicine and medical engineering. The development of a medical device requires frequent modifications. Compliance with high quality requirements and short lead times requires strict management and efficient manufacturing processes. Furthermore, the manufacture of surgical instruments and ancillary accessories for minimal invasive surgery procedures requires high precision and controlled manufacturing capability.
Hamavlet, in conjunction with STI Laser Industries, Ltd., has the comprehensive manufacturing capability to manufacture precision prototypes using EDM wire cutting or laser cutting and the operational flexibility to effect the frequent modifications in the models based on customer instructions. Hamavlet's rapid response enables companies developing medical devices to shorten the R&D stage and take advantage of the short window of opportunity to introduce their products into the market.
Typical medical devices industry requirements
- Precision manufacturing (0.005-0.01 mm) of various sized items
- Corrosion resistance, durability under recurring sterilizations and optimal surface
- Special raw materials, such as: Medical stainless steel (302, 316, 416, 420), nitinol, titanium
- Approved, controlled and documented manufacturing process compliant with ISO 13485 quality management standard.
Manufacturing solutions
- Precision manufacturing of prototypes and small to medium sized series using EDM wire cutting and drilling
- Laser welding assembly of products and mechanisms
- Assistance in the transition process from R&D to serial production
- Serial manufacturing using stamping or EDM wire cutting, for example: Mechanism parts and medical pumps
- Coating and finishing, such as: Passivation, electro-polishing
- ISO 13485 compliant manufacturing, quality assurance and cleanroom product assembly through STI Laser Industries, Ltd.
Applications and products
- Surgical instruments
- Mechanical parts (Medical pump components, clamps, electrodes, springs, miniature gears, handles, supports)
- Marker tags for surgical instruments
- Disposable products: Surgical clips, scalpel blades, pins
- Medical implant shape setting jigs.