Inge Famaey Email & Phone Number

Lead of incubator project. Bringing an innovative medical device from idea to market.

Responsible for international team with 4 to 8 direct reports of which 2 People Managers, in combination with my own development projects. Additional responsibilities as compared to Medical Device Development Manager role (paragraph below) such as:- Establishment of new disciplines within Materialise Medical unit: device research & innovation. This was achieved by creating an attitude shift in the team from routine development & regulation focused work to creative and entrepreneurial work. Obtained external funding for multiple projects.- Ownership of strategy and roll-out of Next Generation 3D Printing solutions Innovation Program. - Transition of Design Control procedures from Medical Devices Directive (EU-MDD) to Medical Device Regulation (EU-MDR). Implementation of updated procedures for all products.- Further expanded market scope from Orthopedic, Craniomaxillofacial and Respiratory markets to include projects within Cardiac and other fields. - People Management of Biosafety Team since April 2022.

Responsible for international team with 4 to 8 direct reports, in combination with my own development projects. Additional responsibilities as compared to Senior Device Development role (paragraph below) such as:- People & resource management including team strategy and objective setting- Process Owner of Design Control procedures (compliant to ISO13485 and EU-MDD). - Expanded market scope from exclusively Orthopedics to include Craniomaxillofacial and Respiratory markets. Correspondingly expanded product scope to portfolio of 27 different medical devices on the market and a handful more in pre-market phase.

The Device Development Engineer responsibilities (paragraph below) applied to increasingly complex products. Such as personalized titanium implants for acetabular reconstruction of severe (up to Paprosky IV) acetabular defects. Including its compatible components such as surgical guides, trial implants, bone models, etc.

Product development of personalized, 3D printed solutions for orthopedic bone and joint reconstruction. Such as:- Polymeric guides for partial and total knee replacement based on MRI, CT and X-ray images, intended to transfer a preoperative plan to the bone during surgery.- Personalized, lightweight polymeric insoles for different types of sports, now marketed by Materialise Motion.Daily activities include concept generation, CAD design, product testing (mechanical, cadaveric, animal, biosafety), setting of user needs & product requirements, risk analysis, optimization of clinical planning algorithms, collaboration with external partners (clinicians, test labs and medical device companies), opportunity spotting, IP generation, working as part of interdisciplinary teams, assisting other teams during pre-launch phase (regulatory submissions, process development, software implementation).

Development of a robotic device for upper-limb neurorehabilitation in stroke patients

Master Of Science In Biomedical Engineering, Magna Cum Laude

Master Thesis: Hand Gesture Recognition with Microsoft Kinect

Musculoskeletal Biomechanics

Bachelor Of Science In Engineering: Mechanical-Electrical Engineering, Cum Laude

Greek-Mathematics