Medical Device Innovation: Translating Ideas into Reality
LEARNING SESSION PROJECT STORY EVENT SPOTLIGHT
Clinical Trials Scaffold Fabrication XrayTo3D wins awards
Clinicians test the device, after necessary approvals (depending on class of risk), leading to certification or further improvements.

1. Establish device classification (based on risk and duration of contact).

2. Prepare detailed protocol of proposed testing, and get ethical clearance.

3. Conduct the tests in partnership with a clinical research organization.

4. Collect results, prepare reports and submit to certification authority.

5. Provide clarifications, if needed, to the authority.

The main aim of the project is scaffold fabrication for patient specific bone defect using inverse casting methodology. Desired microstructure of scaffold was first modeled in CAD environment, the structure is the negative mould of the actual inner microstructure. The CAD file is saved in STL file format and is directly sent for 3D printing using ABS as the model material.
3D printed ABS molds were then filled with ceramic slurry composed of 30% Hydroxyapatite & 70% B TCP Beta tricalcium phosphate biphasic powder & Carboxymethyl cellulose as binder soln. Molds were kept in blower @ 800C for 48 hrs to completely evaporate H2O content in slurry & then sintered in steps with controlled temp. (12000C). ABS mold gets completely evaporated & HA-B TCP scaffold is obtained
XrayTo3D technology developed by Vikas Karade, which reconstructs 3D models of bone from their X-ray images, was recognized by 'Gandhian Young Technological Innovation Award' in 2014, and is among the top 10 innovations in India for President Scholar in Residence Program 2015