As a full-service CDMO for medical devices, we offer a suite of services: from device development and human factors engineering, to prototyping, mold tooling, injection molding, and device assembly.
Our end-to-end capabilities allow us to accelerate time-to-market while ensuring the highest standards of quality for our medical and pharmaceutical customers.
In this blog, we explore the process of bringing injection molded components to life for use in medical devices. First, let’s start with device design and prototyping:
Prototyping and Product Engineering for Injection Molding
Every successful product launch begins with a thoughtful and well-executed concept design process. Our full range of prototyping solutions helps customers quickly transform early ideas into validated, production-ready designs, accelerating development timelines while reducing risks from the start.
We begin with functional concept prototypes made from materials such as PLA, ABS, or resin, using in-house SLA and FDM 3D printers. These early-stage prototypes allow our engineers to identify and eliminate potential failure points before advancing to more costly stages of the design and manufacturing process.
Once a project enters design controls, where regulatory and engineering documentation becomes formalized, prototype activities shift from rapid iteration to production-representative builds. At this stage, parts used for testing or validation must reflect production intent in terms of both design and material.
Key highlights of our injection-molded device development services are:
- 3D printing and digital simulation for concept validation
- Formative and summative human factors studies
- Custom device testing to reduce risk and accelerate time to market
- Tooling for design validation and small-batch production
- In-house Design Transfer team to streamline transition to manufacturing
Each of these design and development services helps prepare for successful manufacturing. With a solid foundation and our Design Transfer team managing the handoff, projects move smoothly from development to full production with fewer problems and delays.
US-based Injection Molding and Manufacturing
Once the product design is ready to enter production, either for a small clinical batch or a mass production run, we verify and validate the tooling in one of our production facilities.
In the United States, our new Greensboro, NC facility is now operational and equipped to meet the growing demand for medical device injection molding and assembly.
Key highlights of this U.S. facility include:
- White room and ISO Class 7 and 8 cleanroom injection molding
- Expansion opportunities for automated and manual assembly
- Close proximity to existing design and manufacturing sites in North Carolina
As part of Sanner Group, Gilero operates within an expanded global footprint, leveraging over 300,000 square feet (28,500 sqm) of total production space and more than 115,000 square feet (11,000 sqm) of ISO Class 7 and 8 cleanrooms across North America, Europe, and Asia.
Together, our combined operations bring over 60 years of expertise in molding medical and pharmaceutical components using biocompatible materials such as polycarbonate (PC), polyethylene (PE), high-density polyethylene (HDPE), polypropylene (PP), and glass-reinforced composites (GFRCs). With our extensive molding expertise, we offer a full suite of injection molding services, including mold making, process validation, and mold flow analysis.
Alongside our new facility in Greensboro, our established manufacturing sites are fully equipped to support end-to-end production of finished medical devices. Our capabilities include assembly services such as ultrasonic welding, heat staking, curing, and annealing, as well as packaging services like pad and screen printing and form-fill-seal (FFS) packaging.
Start Your Next Medical Device Project with Confidence
Bringing a medical device from concept to full-scale production is a complex process, but it doesn’t have to be overwhelming.
At Gilero, a Sanner Group Company, we offer everything under one roof, from early prototyping and design validation to precision mold tooling and cleanroom injection molding.
With our new facility and our global capabilities, we’re equipped to support projects of any size, whether it’s a small clinical run or high-volume manufacturing. Our integrated approach helps speed up development, reduce risk, and ensure the highest quality every step of the way, so our customers can focus on delivering better outcomes for patients.
Ready to bring your medical device to market faster and with confidence? Get in touch with our team today to learn we can support your next project.