Gilero, LLC
Gilero is a trusted partner for medical device and pharmaceutical companies, providing innovative design solutions and comprehensive end-to-end services in design, development, and manufacturing. With a global footprint and a history of over two decades, Gilero supports projects from concept to commercialization, emphasizing quality, regulatory compliance, and scalability to meet industry needs.
Industries
Nr. of Employees
medium (51-250)
Gilero, LLC
Morrisville, North Carolina, United States, North America
Patents
Products
Bone dust collector (case study)
Design and development of a surgical device to aseptically capture bone particulate for allograft sampling; work included concept development and prototype-to-production support.
Hemostasis device (case study)
Development of an instrument to apply consistent pressure after arterial access procedures while preserving arterial flow; included device design and validation support.
Sterile topical anesthetic spray (case study)
Product development of a sterile topical skin anesthetic spray intended to reduce procedure pain; work included achieving sterility and product design.
Closed system drug transfer device (case study)
Design and user-informed development of a closed system to protect healthcare workers from cytotoxic exposure during drug preparation and delivery.
Face shield (PPE production)
Rapidly developed CAD and 3D-printed face shield components and assembly instructions; produced at scale in response to PPE shortages and transitioned to injection molded prototypes for higher volume.
Emergency ventilator concept and manufacturing support
Development of an emergency ventilator design powered by facility air or portable compressors; includes open-source intent and offer of manufacturing capacity for suppliers with limited capacity.
Bone dust collector (case study)
Design and development of a surgical device to aseptically capture bone particulate for allograft sampling; work included concept development and prototype-to-production support.
Hemostasis device (case study)
Development of an instrument to apply consistent pressure after arterial access procedures while preserving arterial flow; included device design and validation support.
Sterile topical anesthetic spray (case study)
Product development of a sterile topical skin anesthetic spray intended to reduce procedure pain; work included achieving sterility and product design.
Closed system drug transfer device (case study)
Design and user-informed development of a closed system to protect healthcare workers from cytotoxic exposure during drug preparation and delivery.
Face shield (PPE production)
Rapidly developed CAD and 3D-printed face shield components and assembly instructions; produced at scale in response to PPE shortages and transitioned to injection molded prototypes for higher volume.
Emergency ventilator concept and manufacturing support
Development of an emergency ventilator design powered by facility air or portable compressors; includes open-source intent and offer of manufacturing capacity for suppliers with limited capacity.
Services
Cross-functional engineering for medtech, diagnostics and drug delivery including concept generation, detailed design, risk analysis, and prototyping.
Flexible small-batch production and clinical build services with regulatory support for combination products and drug-led devices.
Design and integration of mechanical, electrical, firmware and software subsystems for electromechanical medical devices and drug delivery systems.
User research, formative studies and summative validation testing aligned to FDA human factors guidance to reduce use-related risk.
Regulatory planning, 510(k) preparation support, CE/market strategy and management of regulatory communications across product lifecycle.
High-volume and complex product manufacturing including process development, assembly automation, inspection and final product release testing.
Cross-functional engineering for medtech, diagnostics and drug delivery including concept generation, detailed design, risk analysis, and prototyping.
Flexible small-batch production and clinical build services with regulatory support for combination products and drug-led devices.
Design and integration of mechanical, electrical, firmware and software subsystems for electromechanical medical devices and drug delivery systems.
User research, formative studies and summative validation testing aligned to FDA human factors guidance to reduce use-related risk.
Regulatory planning, 510(k) preparation support, CE/market strategy and management of regulatory communications across product lifecycle.
High-volume and complex product manufacturing including process development, assembly automation, inspection and final product release testing.
Expertise Areas
- Medical device design and development
- Electromechanical and integrated systems
- Human factors and usability engineering
- Regulatory strategy and 510(k) submissions
Key Technologies
- 3D printing and rapid prototyping
- Computer-aided design (CAD)
- Injection molding and tooling
- Cleanroom assembly (ISO Class 7/8)
News & Updates
Gilero has begun manufacturing in Greensboro, North Carolina, expanding its production capabilities.
Gilero, as part of the Sanner Group, opened its first U.S. injection molding facility in Greensboro, NC.
North Carolina is collaborating with local manufacturers, including Gilero, to produce critical medical supplies during the COVID-19 pandemic.
North Carolina's governor visited Gilero’s Pittsboro facility to see the company's efforts in manufacturing PPE and COVID-19 related products.
Gilero responded to the COVID-19 pandemic by designing and manufacturing PPE such as face shields, developing an emergency ventilator, and other related products.
An article discussing the significance of cGMPs in ensuring quality and safety in medical device manufacturing.
Gilero has begun manufacturing in Greensboro, North Carolina, expanding its production capabilities.
Gilero, as part of the Sanner Group, opened its first U.S. injection molding facility in Greensboro, NC.
North Carolina is collaborating with local manufacturers, including Gilero, to produce critical medical supplies during the COVID-19 pandemic.
North Carolina's governor visited Gilero’s Pittsboro facility to see the company's efforts in manufacturing PPE and COVID-19 related products.
Gilero responded to the COVID-19 pandemic by designing and manufacturing PPE such as face shields, developing an emergency ventilator, and other related products.
An article discussing the significance of cGMPs in ensuring quality and safety in medical device manufacturing.