Speeding up the Delivery of Innovative Medical Devices

The
Medical Device
Development
Journey

1.

Feasibility
Study

  • Define project requirements
  • Analyse capital development costs, FTE’s required, lead time, labour, development costs
  • Project gets go ahead, project team assigned

3.

Design
Specification

  • Material selection
  • Design FMEA
  • Detailed drawings, assembly specifications, bill of materials
  • Design output file
  • Approve tooling PAR
  • Prototype testing
  • Quality plan

2.

Concept
Verification

  • Risk identification and mitigation
  • Brainstorm – Concepts – Pugh Matrix
  • Proof of principle modelling
  • 3D models, animation, finite element analysis, moldflow

2.

Concept
Verification

  • Risk identification and mitigation
  • Brainstorm – Concepts – Pugh Matrix
  • Proof of principle modelling
  • 3D models, animation, finite element analysis, moldflow

3.

Design
Specification

  • Material selection
  • Design FMEA
  • Detailed drawings, assembly specifications, bill of materials
  • Design output file
  • Approve tooling PAR
  • Prototype testing
  • Quality plan

4.

Verification
& Validation

  • Design validation
  • Process FMEA
  • Process validation

5.

Commercialisation

At the final stages of NPI, the Advant team cooperate with manufacturing to successfully begin process installation. With our ISO Class 8 manufacturing facilities in the Americas and Ireland, Advant can support manufacturing ramp up and manufacture volume parts on both our sites.

4.

Verification
& Validation

  • Design validation
  • Process FMEA
  • Process validation

5.

Commercialisation

At the final stages of NPI, the Advant team cooperate with manufacturing to successfully begin process installation. With our ISO Class 8 manufacturing facilities in the Americas and Ireland, Advant can support manufacturing ramp up and manufacture volume parts on both our sites.

Start typing and press Enter to search