Fausto Sbaiz

• Founded and currently leading a MedTech startup focused on advanced solutions to improve gait performance and prosthetic socket fitting for lower-limb amputees.
• Defined corporate strategy, product roadmap, and clinical value proposition
• Led early-stage R&D, prototyping, supplier strategy, and regulatory positioning
• Hands-on experience with US-oriented clinical, reimbursement, and commercialization considerations
• US value: dimostra CEO mindset, non solo tecnica.
• MedTech Startup – Prosthetics

• Executive leadership of technology, R&D, and operations for a near-to-customized knee implant platform.
• Ownership of global product development strategy and technology roadmap
• Leadership of cross-functional teams across R&D, Operations, Quality, and external partners
• Alignment of innovation pipeline with regulatory, manufacturing scalability, and corporate objectives
• Nota US: CTO qui è equivalente a VP Engineering / VP NPD in molte corporate.
• Orthopedic Implants

Leveraging the scaling phase of Digital twin Start-up and its SaaS solutions with New business development and M&A initiatives,.

• Reported to the Vice President of Digital Transformation. Led strategic innovation initiatives focused on patient-specific solutions, digital platforms, and software-enabled medical devices.
• Executive responsibility for advanced development programs and software development teams
• Contribution to corporate innovation roadmap, portfolio prioritization, and investment decisions
• Budget responsibility and governance of cross-functional global initiatives
• Key Achievements
• Led development of the first EU MDR-certified custom orthopedic product
• Maintained full-year revenue during COVID disruption while reducing operating resources by 20%
• Established and scaled a US-based development and production team (New York)
• US lens: governance, investment, portfolio decisions.
• Global Orthopedic MedTech Company

• Founded and scaled ProMade, an internal startup delivering patient-specific implants and surgeon-specific instruments, transforming it into one of the company’s core global business units.
• Full P&L-like responsibility for ProMade portfolio, including product strategy, operations, regulatory, and customer-facing services
• Built and led global, multidisciplinary teams across R&D, manufacturing, software, and customer service
• Strategic collaboration with US and international clinical partners, KOLs, and subsidiaries
• Key Achievements
• Scaled annual production from 30 to 200+ patient-specific implants
• Achieved 150% year-over-year revenue growth
• Reduced production costs by 30% and lead-time by 3 weeks
• Launched the first in-hospital design and production facility (HSS, New York, USA)
• Implemented scalable digital workflows across design, regulatory documentation, and manufacturing
• Questo ruolo, così scritto, è da VP Global NPD senza discussioni.

• - Test Management, Lab and Machines Maintenance and improvement.
• - Evaluation and resolution of functional and mechanical products weaknesses through mechanical test and FEM analysis.
• - Product Failure analysis.
• - Young researcher F.I.R.B. (Found for base research investments) - Material Nanoscale modification technologies for the biomedical application – Biomedical application of Ti, Nb, Zr nanostructureed alloys.
• Key Achievements:
• Improved test capacity and quality standards

• Led global new product development programs within the Hip franchise.
• End-to-end responsibility for project execution, budgets, and cross-functional coordination
• Direct engagement with KOLs and clinical stakeholders
• Key Achievements
• Successfully launched 2 new product lines
• Delivered 3 major platform updates

• New products launch, Hip portfolio & KOL management, surgery coverage.
• Project management for New PD and Portfolio maintenance
• Key Achievements:
• Effective field support on Revision surgeries
• 2 new product Lines deployed on market from idea
• Completed 3 line switch on 6 markets

• Validation Testing laboratory management and transformation to validated Lab for all internal PD testings