• The only medical device manufacturer exclusively exploiting nanotechnology & microsystems design, and fabrication processes for Active Implantable Medical Device (AIMD) development and production
• Proven track record in developing injectables & minimally invasive Class II/III AIMDs
• Have created two of the smallest IPGs in the world with first in humans
• Designed one of the most complex implants in the world
• Deep rooted MEMS expertise
• A novel system architecture that enables miniaturization
Complete System Design that mitigates engineering, regulatory, and manufacturing risks from the beginning
• Seamless integration of all aspects of hardware, software, firmware, cybersecurity, and cloud space
• Engineering team with decades of design experience in microsystems and nanosystems design including miniature AIMDs
• Electrical design expertise with experience in near-field communication (NFC), far-field communication (BLE), Microcontroller implementation, ASIC specification and complete circuit design for miniature implants
• Mechanical design expertise with extensive experience in miniature AIMD system design, some as small as a grain of rice
• Software expertise adhering to IEC 62304
• Specialized in firmware for Class II/Class III devices that is compliant with FDA cybersecurity guidelines
Prototyping to Production expertise specifically for minimally invasive and injectable AIMDs
• Manufacturing using wafer level fabrication process that saves time and money for early-stage development
• Inbuild parallel paths for multi-design prototyping using single wafer, saving time and resources for our customer
• Design for manufacturing that eliminates valley of death between prototyping and production
• Adaptive customer specific manufacturing arrangement that can use existing external supply chain or move manufacturing inhouse
• Order of magnitude reduction in fabrication costs by exploiting parallel wafer processing
• Quality management system (QMS) that is certified to ISO 13485:2016 and ISO 9001:2015 for design, development, and manufacturing of medical devices
• Our commitment to continuous improvement to increase reliability and consistency of final product
• Complete Design history file (DHF) documentation for your AIMD
