We turn early concepts into functional systems ready for testing, validation, and transfer into manufacturing. Our team is equipped to manage projects and programs to meet regulatory expectations and prepare for scale-up.
Our Process
We bring innovations to life with manufacturing in mind.

Verification & Validation
Ensure every design meets specifications, performance requirements, and standards.

Device Design & Engineering
Transform product concepts into functional systems refined for performance and manufacturability.

Concept Development
Explore early-stage ideas through user needs analysis, feasibility studies, and rapid prototyping.

Transfer Design to Production
Seamless design transfer processes enable efficient scale-up and smooth transition to manufacturing.
Rooted in design for manufacturing (DFM)
Our design and development team transforms product ideas into functional systems. These efforts support a smooth transition into manufacturing, with outputs aligned to long-term scale-up.
Cross-functional engineering teams integrate manufacturing expertise to design sophisticated products optimized using Design for Manufacturing principles (DFM).
We begin Design History File preparation early and guide the process to meet strict U.S. and global regulatory requirements.


Integrated Human Factors Engineering
We integrate human-centered design and human-factors engineering into our design & development process to identify and resolve use-related issues early, reducing costs and enabling a smoother transition to manufacturing.
Our industrial designers work alongside design engineers from the start to create ergonomic and user-friendly device interfaces.
We conduct formative and summative usability studies throughout the development process to identify risks and address them through changes in the device design and instructions for use (IFU).
Robust In-House Testing Methods
We use custom and standard tests to confirm whether a device meets safety, performance, and regulatory requirements. Our development team supports validation and pre-compliance testing throughout development.
In-house testing methods support international testing standards to ensure success in compliance testing.
Teams validate existing methods or create custom test protocols as needed.

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Products Engineered for Manufacturing Success
Bone Dust Collector
Allow surgeons to easily and aseptically capture a clean, quality sample of patients’ bone particulate for allograft.


Products Engineered for Manufacturing Success
Hemostasis Device
The device stops bleeding after arterial access while maintaining normal blood flow.


Products Engineered for Manufacturing Success
Sterile Topical Anesthetic Spray
This product is a sterile, single patient use vapocoolant spray developed and manufactured by Gilero.
Products Engineered for Manufacturing Success
Bone Dust Collector
Allow surgeons to easily and aseptically capture a clean, quality sample of patients’ bone particulate for allograft.
Products Engineered for Manufacturing Success
Hemostasis Device
The device stops bleeding after arterial access while maintaining normal blood flow.
Products Engineered for Manufacturing Success
Sterile Topical Anesthetic Spray
This product is a sterile, single patient use vapocoolant spray developed and manufactured by Gilero.
Why Clients Prefer Gilero

Agile Product Development
Our team navigates challenges quickly and efficiently, adapting to design changes, timelines, and manufacturing needs without compromising quality or compliance.

Seamless Transition to Manufacturing
Our integrated design transfer process ensures a truly seamless transition from development to our pilot and production facilities.

DFM Experts for Injection Molding
On-staff experts bring deep experience in Design for Manufacturability (DFM) specific to injection-molded components and plastic assembly technologies.
Locations
Design centers located across the United States
Our HQ and Main Design Center
Our Durham HQ functions as our primary hub for device development and design transfer. The facility features dedicated wet lab areas, prototyping labs, an on-site human factors suite, and specialized electromechanical prototyping space.
The Durham site is in close proximity to manufacturing in Pittsboro and Greensboro, enabling seamless design transfer.
This site specializes in concept design, DFM, prototyping, DV&V testing, package engineering, human factors, clinical builds and regulatory services.

Located in Chicago's HardTech Innovation Center
Gilero’s design center in Chicago, IL has allowed for us to expand and maintain our presence in the Midwest. This design center has access to prototyping space, machining capabilities, test labs, and additional equipment to help you bring your medical device to market.
Backed by a local team of engineers, designers, and project managers, we offer comprehensive support to bring groundbreaking medical technologies to life.
This site offers services in concept design, DFM engineering, prototyping, DV&V testing, package engineering and human factors.

Our Office in the Southern California Medtech Hub
Southern California is a hub of innovation across many industries, and medical technology is rapidly becoming one of its most dynamic sectors. Our Carlsbad office connects West Coast clients with over two decades of expertise in medical device design and development.
Backed by a local team of engineers, designers, and project managers, we offer comprehensive support to bring groundbreaking medical technologies to life.
This site offers services in concept design, DFM engineering, prototyping, DV&V testing, package engineering and human factors.

What Clients Are Saying
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“Gilero is excellent at generating creative solutions for complex drug delivery issues. They have been a great partner throughout the device design and development process.”
Senior Vice President of CMC & Operations
Oyster Point Pharma

“From early stage, fundamental device iteration addressing all key inputs, through regulatory hurdles, and now towards manufacturing scaling and support. Gilero has been the best partner and extension of the Linear team possible.”
President & Founder
Linear Health Sciences

“The highly motivated personnel assigned to the project were very well trained and showed high levels of expertise. For specific aspects, trained experts from within the organization were allocated to the project.”
Vice President, Corporate Development
Midas Pharma
“Gilero is excellent at generating creative solutions for complex drug delivery issues. They have been a great partner throughout the device design and development process.”
Senior Vice President of CMC & Operations
Oyster Point Pharma
“From early stage, fundamental device iteration addressing all key inputs, through regulatory hurdles, and now towards manufacturing scaling and support. Gilero has been the best partner and extension of the Linear team possible.”
President & Founder
Linear Health Sciences
“The highly motivated personnel assigned to the project were very well trained and showed high levels of expertise. For specific aspects, trained experts from within the organization were allocated to the project.”
Vice President, Corporate Development
Midas Pharma

Talk to an Expert
Gilero combines engineering expertise, advanced manufacturing capabilities, and regulatory support from concept to commercialization to bring your ideas to life. Ready to turn your vision into reality? Talk to an expert today.














