Work Plan

The work is structured into three thematic pillars l:
AdvicePic 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

NO NAME WP LEAD TYPE LEVEL DATE
D7.1 Web page WP7 MMATECH R CO M1
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
D8.1 Interim report WP8 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
D8.2 Final report WP8 MMATECH R CO M24
   

List of milestones

NO NAME WP DATE VERIFICATION
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
M2 Successful implantations WP3, WP4 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)
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