Our Services

What Does Desert Platforms Have to Offer?

Medical Device Design

  • Brainstorming, Brainwriting, and Mind-mapping techniques/facilitated sessions for idea generation
  • Engineering Requirements Definition
  • 3D Design via Computer-Aided Design Software
    • Certified Solidworks Professionals (CSWP)
    • Finite Element Analysis (FEA)
    • Design for Manufacturability (DFM)
  • Component Selection and Bill of Materials (BOM) development
  • Drawing and Specification Development
  • Prototype Construction and Vendor Selection

Design Control and Quality Engineering

  • Quality System Development and Licensing
  • Design Control and Design History File (DHF) Management
    • Project Management including Phase-Gate Reviews
    • Translation of User Needs to Design Inputs
      • Design Input-Output Verification/Validation Matrices (DIOV)
    • Translation of Design Inputs to Design Outputs
      • Product Specification Development
      • Material Specification Development
    • Design Verficiation
      • Verification Master Plan
      • Design Verification Test Protocols
      • Test Fixture Development (Instron, Anatomical Models, etc.)
      • Execution of Testing and Sourcing of Test Partners
    • Design Validation
      • Validation Master Plan Development
      • Validation Protocols/ User Studies
      • Performance of Validation and Protocols
    • Design Transfer
      • Manufacturing Process Creation
      • Incoming Inspection Development
    • Release to Market
      • Support for Technical File Creation and Regulatory Submisions
  • Sustaining Quality and Remediation
    • Manufacturing Qualifications
      • Installation Qualifications (IQ)
      • Operational Qualifications (OQ)
      • Performance Qualifications (PQ)
      • Robust Statistical Analysis (CPK, PPK, ANOVA, etc.)
    • Corrective Action-Preventetive Action (CAPA) Analysis
      • Root Cause-Failure Analysis and Investigations
      • DMAIC Processes
      • Correction Definition and Implementation
      • Defining measures to ascertain and track improvements
    • Risk Management Files
      • Hazards Analysis (Device works OK but fails with environment)
      • Design Failure Mode and Effects Analysis (Device Fails during use)
      • ISO Standards adherence and Essential Requirements Tables (ERT)
      • Risk Management Reports and Mitigation

User Needs Gathering and Product Management

  • User Needs identification and Translation to Requirements
  • Business Plan Development and ROI Analyses
  • Physician Surveys, Focus Groups, and Other Interactions
  • Go-to-Market Strategy Development
  • Representation/Public Speaking at Worldwide Congresses
  • In-Vivo (Pre-Clinical Testing)
  • Clinical Study coordination and performance
  • Multi Generational Product Plans and Product Roadmap Development
  • Product Aesthetics, Labeling, IFUs, and Packaging

Technologies Serviced

We service all medical device products and technologies including:

  • Consumer Disposables: Contact Lens Manufacturing
  • Ultrasound: Breast Cancer Detection Devices, Aesthetic Skin Lift Devices, Transducers
  • Cardiovascular: Deployment Catheters, Balloon Accessories, Endoprosthesis/Stents, VADs, Introducers
  • Urinary: Catheters, Introducers
  • Electro-Mechanical: Radiofrequency, Generators, PCB Development
  • Capital Accessories: Medical Carts, Pumps
  • Equipment Validation and Test Fixture Design and Development
  • Aesthetics: RF, Micro-needling, Ultrasound, and Electro-mechanical

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