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, FPGAs, 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, FMEAs, 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
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