The work is structured into three thematic pillars l:
Optimization. WP1: Optimization of functional properties of MP-1TM and WP2: Nail and dentations production.
In WP1 we will elaborate the specific properties of MP-1TM for trauma and conduct testing (wear debris and tissue biocompatibility testing). Afterwards the WP2 will be dedicated for preparing the nail and screw by compression molding and characterizing it
Testing. WP3: Prototype manufacturing and testing (initial study) and WP4: Multi-centre study.
We will first in WP3 prepare the first batch of MP-ORIF and conduct the first clinical implants. WP4 will then represent the multi-centre comparative study where we will conduct 40 comparative implantations (20 with MP-ORIF, 20 using the standard Titanium kit).
Horizontal activities. WP5: Certification, WP6: Exploitation and pre-commercialization, WP7: Dissemination and communication and WP8: Project management.
The latter two WPs start at M1 and end at M24 and are the umbrella WPs for all activities. The objective of WP5 is to accomplish the CE medical classification class IIb while the overall objective of WP6 is to prepare for sales and marketing as well as to set up the IPR strategy.
List of deliverables
|D1.1||Report on MP-1 properties for trauma||WP1||MMATECH||R||CO||M8|
|D2.1||Report of nail and screw preparation||WP2||MMATECH||R||CO||M10|
|D3.1||Nails and screws production report||WP3||MMATECH||R||CO||M10|
|D2.2||Work instructions for preparing a nail||WP3||MMATECH||R||CO||M12|
|D3.2||Initial study clinical report||WP3||MMATECH||R||CO||M18|
|D4.1||Multi-centre study clinical report||WP4||MMATECH||R||CO||M22|
|D4.2||Multi-centre study CRA report||WP4||MMATECH||R||CO||M22|
|D5.1||CE mark for medical device certification dossier||WP5||MMATECH||DEC||CO||M24|
|D6.1||Updated commercialization plan||WP6||MMATECH||R||CO||M24|
|D6.2||IPR management report||WP6||MMATECH||R||CO||M24|
|D7.2||Report on the dissemination activities||WP7||MMATECH||R||CO||M24|
List of milestones
|M1||Functional near-net shape mold||WP2||M10||Working mold prepared for the nail/screw (D2.1) as designed in T2.1, T2.2 and D1.1|
|M22||Successful 6 months’ follow-up of 20 patients with MP-ORIF implants (D4.1) based on the results from the initial clinical study (D3.2)|
|M3||Final product certification documentation||WP5||M22||The certification guarantees the placement on the market (D5.1)|