About Stratec Synthes
Our Mission
At Stratec Synthes, we are dedicated to providing high-quality manufacturing solutions.
Bei Stratec Synthes widmen wir uns der Bereitstellung hochwertiger Fertigungslösungen.
Navigated Instruments, Implants and Systems
Navigierte Instrumente, Implantate und Systeme
We manufacture precision navigated instruments and implants designed to function reliably within image-guided and navigation-assisted surgical workflows. Hardware is engineered with a system-level mindset, recognizing the dependency between instruments, implants, software and imaging.
This includes support for implant designs that incorporate drug-eluting or pharmaceutical components, where mechanical performance, delivery characteristics and navigation compatibility must function together within defined clinical workflows.
Focus areas
- Navigated instrument manufacturing
- Navigation-compatible implants and components
- Drug-eluting and combination product considerations
- OEM-aligned and custom designs
- Hardware and software system integration
- Intraoperative reliability and usability
Medizinische Fertigung, Qualität und Compliance
Medical Manufacturing, Quality and Compliance
Our manufacturing approach reflects the rigor expected in regulated medical device and combination product environments. We operate with structured design controls, disciplined change management and a focus on traceability, consistency and risk management.
Quality practices are aligned to the regulatory and clinical risk associated with navigation-enabled systems, implants and technologies that incorporate pharmaceutical elements.
Focus areas
- Design controls and systems engineering
- Precision manufacturing and scalability
- Traceability and documentation
- Verification and validation support
- Combination product regulatory alignment mindset
- Lifecycle and post-market readiness
Clinical Translation and OR Integration
Technology succeeds when it fits real clinical workflows. We focus on translating engineering intent into operating room usability through workflow alignment, education readiness and continuous refinement.
This includes consideration for the clinical handling and use of drug-eluting implants and pharmaceutical-enabled technologies, ensuring integration does not disrupt procedural flow or safety.
Focus areas
- Engineering-to-OR workflow alignment
- Compatibility with existing OR infrastructure
- Education and onboarding readiness
- Adoption and utilization support orientation
- Feedback-driven system refinement
Pharmazeutische Herstellung
Pharmaceutical Manufacturing and Drug-Eluting Technologies
We support pharmaceutical manufacturing activities and combination product development where drug delivery is integrated with implantable or navigated medical technologies. Our capabilities focus on controlled manufacturing processes, consistency and integration with device systems rather than standalone drug commercialization.
This includes support for drug-eluting implants, localized drug delivery technologies and device-drug combination products, where mechanical performance, release characteristics and clinical workflow must function together reliably.
Manufacturing considerations emphasize formulation handling, process control and alignment with device manufacturing requirements to ensure predictable performance within regulated clinical environments.
Focus areas
- Drug-eluting implant and device-drug combination support
- Localized and site-specific drug delivery technologies
- Manufacturing process control for pharmaceutical components
- Integration of pharmaceutical elements with navigated devices
- Combination product quality and regulatory alignment mindset
