Sage Product Development
Sage Product Development is a leading medical device development company committed to transforming product ideas into successful, market-ready medical devices. With a focus on innovation, quality, and regulatory compliance, Sage offers comprehensive services from concept to commercialization, including design, development, testing, and low-mid volume manufacturing. The company values creativity, responsiveness, flexibility, and quality, and maintains strategic partnerships to enhance its capabilities. Sage is ISO 13485:2016 certified and has a proven track record of delivering innovative solutions across various clinical disciplines and medical technologies.
Industries
Nr. of Employees
small (1-50)
Sage Product Development
Patents
Products
Handheld inertial sensor-based surgical navigation system (case study)
Design improvements, ergonomics, manufacturability, software provisioning for a handheld inertial sensor navigation device; supported design verification and regulatory submission resulting in 510(k) clearance.
Catheter-delivered intracranial shunt system (case study)
End-to-end development of a minimally invasive catheter-delivered intracranial shunt and delivery system including materials selection, hemocompatibility testing, custom fixtures, and support through clinical trials and FDA IDE.
Minimally invasive carpal tunnel surgical device (case study)
Rapid design, build and test iterations, verification and validation support, and low-volume manufacturing to progress a minimally invasive carpal tunnel surgery device to regulatory clearance.
Endoluminal surgical and advanced endoscopic instrument development (case study)
Design and development of advanced endoluminal surgical instruments focused on ergonomic controls, flexible-channel manipulation, and verification testing toward regulatory submissions.
Tumor localization probe and handheld reader system (case study)
Engineering support for a tumor localization system using RFID probes and a handheld reader to enable precise localization of non-palpable tumors from design through commercialization.
Laminated Catheter Shafts
A laser cut PTFE lined hypotube with laminated shaft providing varying flexibilities by utilizing different cut patterns along the length of the shaft.
Handheld inertial sensor-based surgical navigation system (case study)
Design improvements, ergonomics, manufacturability, software provisioning for a handheld inertial sensor navigation device; supported design verification and regulatory submission resulting in 510(k) clearance.
Catheter-delivered intracranial shunt system (case study)
End-to-end development of a minimally invasive catheter-delivered intracranial shunt and delivery system including materials selection, hemocompatibility testing, custom fixtures, and support through clinical trials and FDA IDE.
Minimally invasive carpal tunnel surgical device (case study)
Rapid design, build and test iterations, verification and validation support, and low-volume manufacturing to progress a minimally invasive carpal tunnel surgery device to regulatory clearance.
Endoluminal surgical and advanced endoscopic instrument development (case study)
Design and development of advanced endoluminal surgical instruments focused on ergonomic controls, flexible-channel manipulation, and verification testing toward regulatory submissions.
Tumor localization probe and handheld reader system (case study)
Engineering support for a tumor localization system using RFID probes and a handheld reader to enable precise localization of non-palpable tumors from design through commercialization.
Laminated Catheter Shafts
A laser cut PTFE lined hypotube with laminated shaft providing varying flexibilities by utilizing different cut patterns along the length of the shaft.
Services
Concept generation, user needs and design input definition, prototyping, patent research, and early feasibility evaluation.
Detailed engineering, industrial design, materials selection, risk management, test method development, and design documentation through design transfer.
Project planning, execution and monitoring using industry-appropriate tools and Earned Value Analysis to control schedule and budget.
Early and low‑to‑mid volume manufacturing for verification/validation builds, clinical study units and initial market launches, including assembly, packaging and logistics.
Integrated regulatory strategy, quality management system support, design control, risk management, and preparation for regulatory submissions via a partnered regulatory services provider.
Concept generation, user needs and design input definition, prototyping, patent research, and early feasibility evaluation.
Detailed engineering, industrial design, materials selection, risk management, test method development, and design documentation through design transfer.
Project planning, execution and monitoring using industry-appropriate tools and Earned Value Analysis to control schedule and budget.
Early and low‑to‑mid volume manufacturing for verification/validation builds, clinical study units and initial market launches, including assembly, packaging and logistics.
Integrated regulatory strategy, quality management system support, design control, risk management, and preparation for regulatory submissions via a partnered regulatory services provider.
Expertise Areas
- Medical device product development
- Catheter and delivery system engineering
- Minimally invasive and endoscopic devices
- Electro-mechanical device development
Key Technologies
- CAD and rapid prototyping (3D printing)
- Catheter and guidewire systems
- Shape‑memory alloys (Nitinol)
- High-performance polyurethanes and hemocompatible coatings
News & Updates
Sage helped Lucid Diagnostics develop a non-invasive esophageal cell collection device, supporting clinical and regulatory pathways.
Sage contributed to the design, development, and FDA clearance of the Bolt Navigation System, a surgical navigation device for spine surgery.
Sage’s experience in design and manufacturing led to FDA clearance of PAVmed’s minimally invasive carpal tunnel device.
Sage’s creativity and expertise supported Lumendi in designing and obtaining FDA clearance for a novel endoluminal surgical device.
Sage’s engineering expertise helped develop RFID probes and a handheld reader for breast cancer tumor localization.
Sage developed a minimally invasive, catheter-based system for treating communicating hydrocephalus, now in clinical trials.
Sage helped Lucid Diagnostics develop a non-invasive esophageal cell collection device, supporting clinical and regulatory pathways.
Sage contributed to the design, development, and FDA clearance of the Bolt Navigation System, a surgical navigation device for spine surgery.
Sage’s experience in design and manufacturing led to FDA clearance of PAVmed’s minimally invasive carpal tunnel device.
Sage’s creativity and expertise supported Lumendi in designing and obtaining FDA clearance for a novel endoluminal surgical device.
Sage’s engineering expertise helped develop RFID probes and a handheld reader for breast cancer tumor localization.
Sage developed a minimally invasive, catheter-based system for treating communicating hydrocephalus, now in clinical trials.