316 Product Development, LLC

Mechanical and electromechanical design, computer-aided design, structural simulation, and complex surfacing.

• Advanced Computer Aided Design (CAD)

  3D modeling, detailed 2D drawings, assembly modeling, and bill of materials management.

• Finite Element Analysis (FEA) and Simulation

  Structural analysis and computational fluid dynamics to evaluate and optimize part performance.

• Dimensional and Tolerance Analysis

  Tolerance stack-up assessments to ensure precision fit-up and function of physical components.

• Mechanism and Motion Control

  Development of custom moving mechanisms, powertrains, and integrated motion control setups.

• Enclosure and Packaging Design

  Design of electronic enclosures, sheet metal, cast components, and sterile packaging systems.

Embedded hardware, custom printed circuit boards, and dedicated software development.

• Printed Circuit Board (PCB) Design

  Schematics, SMT layout, prototyping, and hardware diagnostics.

• Embedded and RTOS Systems

  Firmware engineering for specialized real-time operating systems, Linux, QNX, and embedded microcontrollers.

• Wireless Communications

  Integration of Bluetooth, Bluetooth LE, Wi-Fi, and cellular connectivity.

• Automated Test Systems

  Development of custom hardware and software systems for automated testing and validation.

• Mobile and Desktop Applications

  Custom GUI implementations and interface software for iOS, Android, and Windows systems.

Aesthetic, form development, and user-centered ergonomics that align physical products with brand identity.

• Aesthetic and Form Development

  Industrial design development starting from hand sketches through to 3D concept modeling.

• Usability and Human Factors

  Physical interface design focused on usability, ergonomic studies, and user workflows.

• Visualization and Rendering

  Photorealistic 3D renderings, form studies, and animations for design presentations.

In-house and partner rapid fabrication services to build functional and aesthetic models.

• Additive Manufacturing

  3D printing utilizing SLA, FDM, and SLS processes with various polymers and biocompatible materials.

• CNC Machining and Tooling

  High-precision machined prototypes and quick-turn aluminum tooling for plastic components.

• Castings and Moldings

  RTV urethane castings, vacuum-molded prototypes, and carbon fiber molded elements.

Regulated product development following strict quality and design control methodologies.

• Design Controls and Quality Systems

  Implementation of structured design controls, hazard analysis, and design risk mitigation.

• Regulatory and Testing Support

  Verification testing programs, regulatory pathway mapping, and GLP/GMP testing coordination.

• Systems Engineering

  Requirements definition, safety analysis, and complete system architecture engineering.

• Biocompatibility and Implantables

  Strategic guidance and testing oversight for implantable devices and biocompatible materials.

Transitioning designs from the lab to full production-scale assembly lines.

• Design for Manufacturing and Assembly (DFMA)

  Optimizing parts for molding, stamping, casting, and assembly to achieve targeted unit costs.

• Process Validation and Quality Systems

  Process validation studies, PFMEA development, capability studies, and Lean Six Sigma integration.

• Pilot and Low-Volume Manufacturing

  Initial low-volume builds, prototype assembly coordination, and production automation setups.

• Transfer to Manufacturing

  Sourcing coordination, toolmaker oversight, and supplier integration to hand off production.