• Product Discovery

• Market Identification and Market Research

• Competitive Product/Gap Analysis

• Voice of Customer (VOC) Surveying

• Expedited Design and Development 

• User Oriented Iterative Design Process 

• Design for Manufacturing in Milling, Turning, Injection Molding, Thermoforming, and Photo-Chemical Etching 

In-House Rapid Prototyping Capabilities including:

• CNC Milling and Turning

• FDM and SLA 3D printing 

•  NITI Forming 

Design Controls Support Including: 

• Design Input Identification 

• Specification Development 

• Design Outputs

• Design Verification & Design Validation 

• Custom Manufacturing Equipment Design & Development

• Inspection Method Development & Qualifications

• Equipment Qualifications

• Line Qualifications

• Line Transfer & Scaling 

• Cleaning Validations

• Process Validations

• Qualification Protocol Development (IQ, OQ, PQ)

• Qualification Execution

• Test Method (TM) Development 

• Test Method Validation (TMV)

• Supplier Quality Auditing

Design Control Remediation Support:

• Updating Design Outputs – Print Notes / Callouts 

• Compliant TMs/TMVs 

• Line Qualifications

• CAPAs/Line Remediations 

• dFMEA Development 

•  uFMEA Development 

• pFMEA Development 

• Hazard Analysis 

• Risk Mitigation