Expertise


Product Development

  • Product development of medical disposable and reusable devices, instruments, and accessories.
  • Catheter development for implant, invasive, and non-invasive applications. 
  • Metal instrument design:  surgical electrodes, needles, stylets, blades, trocars, cannulae, guide wires, medical probes, and spring applications.  Design metal stampings and components for progressive die tooling.
  • Electro-mechanical equipment design of plastic and sheet metal enclosures from Industrial Design concepts, including incorporation of printed circuit boards, cable interfaces, components, graphic panel overlay and switch designs.
  • Project Engineering using FDA and ISO design controls guidelines with expertise in creating design plans and product specifications, task scheduling, risk analyses (DFMEA), design documentation, and supplier management.  Compile and manage a Design History File and technical file.
  • Develop test methods and product testing capability for design verification and validation.
  • Emphasis in design for manufacturability.
  • Specify and design manufacturing fixtures and tooling.  
  • Technical writing and grant writing for SBIR-NIH approved projects.
  • Engineering disciplines knowledge:  strength of materials, stress analyses, kinematics, statics and dynamics analyses, heat transfer, fluid flow and pneumatics.


Plastic Part Design

  • Plastic part design for injection molding, extrusions, thermoforming, casting, dipping, and blow molding utilizing SolidWorks 3D solid modeling software.
  • Knowledge in medical polymers to meet FDA and ISO 10993 biocompatibility requirements and all sterilization methods.
  • Design and perform beam stress analyses on snap-fit assemblies with resources to provide complex FEA.
  • Design plastic assemblies involving RF welding, ultrasonic welding, thermal sealing, and solvent bonding.
  • Modeling and prototyping capabilities through the use of stereolithography, machining, casting, and molding.


Medical Packaging

  • Medical and pharmaceutical packaging design of products utilizing thermoformed trays, pouches, breather bags, and boxes/cartons considering all sterilization methods.
  • Specify manufacturing equipment for lidded trays, form-fill-seal, pouch sealing, and bottle sealing methods.
  • Manufacturing tool design for packaging applications.
  • Design labeling and barcoding to meet regulatory requirements.
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