Disciplines

Engineering

Full product development engineering including:

• Plastic component design, development and processing including ultrasonic, heat and laser welding
• Design for manufacturability / assembly / test
• Structural analysis and testing
• Micro and macro fluidic control, sterile fluid pathways
• Advanced non-linear control systems
• Object-oriented to assembly-level software development
• Sensor assemblies including inertial and physiological sensing
• RF transmissions including R FID
• Complex electro-mechanical systems
• Advanced electronics design including embedded microcontrollers, FPGA’s, ASICS, wire-bonding
• Energy production, storage and transfer systems including batteries, power electronics and combustion science
• System architecture and design, including Failsafe and highly-redundant Fault-operational architectures
• Risk management including Safety Hazards Analysis, FMEA’s, product life-cycle support

Industrial Design

• 2D & 3D sketching, detailed solid modeling on multiple design packages
• Process-driven results stem from researching user needs
• Tightly integrated with Engineering team, acts as voice of user
• Human factors and user interface design, including GUI design
• Focus groups & design validation
• Complete model shop including CNC routers, wood shop, paint booth

Regulatory / Clinical Affairs / Quality Systems and Compliance

• QSR compliant product and process development
• FDA IDE, 510(k), PMA approvals
• Non-significant risk and significant-risk clinical studies
• ISO 13485 Certified

Validation and Verification

• Independent test group applies rigorous testing methods to ensure products meet requirements
• Using tracing toolsets, test group ensures test coverage of all design inputs
• Early involvement philosophy prevents late failures
• Regression testing applied as appropriate for product changes
• Environmental, HALT, and external 3rd-party testing

Manufacturing

• Over 6,000 sq. ft. configurable prototype assembly space
• 600 sq. ft. class 10,000 controlled environment for disposable set builds
• Prototype manufacturing technologies include laser and ultrasonic welding as well as test and assembly fixture development
• Environment provides manufacturing process development prior to final design transfer either externally or to in-house GMP manufacturing facility

Rapid Prototyping

• Over 10,000 sq. ft. of rapid prototyping, including state-of-the-art 5-axis mills & lathes
• 15 machinists including master tool makers
• 70-ton press injection molding
• 3D printing technology
• Vacuum forming, welding, and duct tape