WP03: Development and production of a medical hydrogel compression device

Objectives

The objectives of WP03 are:

  • Produce a Device Specification Document for hydrogel press, defining process input and output quality measures.

  • To verify that a device made to the Device Specification produces high quality dermal grafts (denovoDerm & denovoSkin)

  • To ensure that the device complies with the correct GMP regulation and can be approved for use in a clinical environment

  • To design & manufacture a cost effective equipment kit to enable an operator with basic skill level to be able to produce consistent quality skin graft tissue.

  • To develop the design into the product of choice for clinicians in this field.

Workpackage Description

The workpackage will use the following skills and capabilities to carry out a planned range of activities.  Design, Specification, Prototyping, Production Engineering, Packaging and Sterilization.

Task 1: Produce a specification for the collagen hydrogel compression device.

Task 2: Produce a device design that meets all the requirements of the Device Specification.

Task 3: Review the design in collaboration with all involved participants.

Task 4: Ensure manufacture and sterilization of a prototype device to the approved design.

Task 5: Observe the Prototype undergoing laboratory testing – assess the performance of the prototype against the existing Device Specification

Task 6: Prototype validation signoff

Task 7: Produce the Clinical Device Batch. Design control, manufacture, sterilization & distribution of 4 units.

Task 8: Device Performance revision & update, produce 3D virtual models, 2D detailed drawings and illustrations for the design of a product capable of being manufactured, source quotations for manufacture of Volume Clinical Device, define suppliers and produce manufacturing plan.