Class 1 Assistive Device

Industry

Medical/Dental

Client Size

$40M

Engagement

$125k dev, $50k materials, 12 months

 

Problem

Already an all-star in their industry, this client came to BES to develop the next generation of a miniature medical-grade tool used by doctors across the world.
 

Solution

BES managed the product’s development program from industrial design (and some napkin sketches), through UL-type testing, and all the way to manufacture. BES’s expertise in optics, electronics miniaturization, and ergonomic design proved invaluable in creating a beautiful device.

 

Inputs

  • Existing product line standard for aesthetics and functionality
  • Preliminary MRD (marketing requirements document)
  • In house manufacturing capabilities

 

Program Phase

  • Discovery
  • Prototyping
  • Finalization

 

Standards & Certs

  • ISO 60601 3rd edition
  • UN38.3
  • FCC unintentional transmitter
  • CE

 

Outcomes

  • Engineering Requirements Document
  • Five iterations of prototypes
  • Multiple industrial design concepts
  • Manufacture ready designs and documentation
  • PCBA documentation
  • Cost optimized BOM
  • Price point validation
  • Domestic and international vendor sourcing and selection

 

Services Provided

  • Mechanical design
  • Electrical design
  • Supply chain setup
  • Oversight of certification testing
  • Firmware development
  • Overseas component sourcing
  • Battery selection and on site certification/inspection
  • Patent writing
  • Integration with marketing and sales teams

 

Special Technologies

  • Metal flex hybrid PCBAs
  • Thermal management
  • Optics design and integration
  • FDA compliant material selection
  • Ultra thin metal etching
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