Medical Device Design and Development
We provide complete design and development services for medical devices. We take on designs at any phase, working toward your quality targets and cost goals while creating the best path to commercialization.
End-to-end Engineering Solutions
Your Vision, Fast-Tracked
At Sterling Industries, we work with you on your medical device design whether it’s a new product (NPI), refining an existing design, or developing the next generation. We design with manufacturing in mind from the outset.
Our Design Services
From Concept to Commercialization
Product Design
We bring deep medical device design expertise to your project, whether you have a concept or a nearly finished product.
- Full design & development
- New product introduction
- Next-gen device development
- Packaging & labeling
Design Transfer & DFM
We optimize your design for efficient, high-quality production – new device or a transfer from another source.
- Design for Manufacturing
- Design for Assembly
- Manufacturing transfer
- Cost reduction strategies
- Quality assurance integration
Process Development
Our manufacturing processes ensure consistent quality, regulatory compliance, and efficient production.
- Process development & validation
- Production line design
- Automation integration
- Sustainment & process Improvements
- Risk assessment
- Cycle time study and line balancing
Prototyping & Testing
We support your development process with research, prototyping, and iterative testing at every stage.
- Concept prototyping
- Component & material testing
- Design V&V
- Risk analysis and FMEA
Regulatory Support
We help you navigate complex regulatory requirements so your device reaches market faster and on budget.
- Regulatory planning & strategy
- Risk management file development
- Submission support
- Design file maintenance
- ISO 13485 and FDA 21 CFR 820 alignment
Commercialization
As your CDMO partner, we scale your device from development to full production, managing every step of the way.
- Production ramp-up planning
- Supply chain optimization
- Scalability assessments
- Post-launch support
We manufacture success.
People, Process & Technology
Strategic configuration of these elements creates the foundation for any successful manufacturing project.
People
Our cross-functional teams move from design through production without handoff delays. Each project has access to the expertise that ensures success.
Process
Repeatable quality – on time and on budget – is never an accident. We focus on scalability, repeatability, and regulatory compliance with continuous improvement.
Technology
Our technology capabilities are built for manufacturing a wide range of medical devices. We take your device from design all the way to packaged products ready to market.
Our Approach
A Proven Development Process
We follow a structured, stage-gate approach that ensures transparency, efficiency, and alignment at every phase of your medical device development.
How It Works
Each stage has clear deliverables and quality checkpoints, so you know exactly where your project stands and what comes next.
Research
We start by understanding your device requirements, target market, user needs, and regulatory pathway. This sets the foundation for every decision we make through the project.
Concept Creation
We translate your requirements into viable design concepts. Our engineers evaluate each concept against performance, manufacturability, and cost targets before moving forward.
Product & Process Development
We develop and refine your device design alongside the manufacturing process. Designing both together reduces costly changes later and keeps your timeline on track.
Verification & Validation
We test your device and manufacturing process against your design requirements. This confirms your device performs as intended and is ready for regulatory submission.
Launch
We scale production while maintaining the quality and consistency established during development. Your device reaches market on time and built to spec.
Expertise & experience
100% Medical Device Focused
Medical device design and manufacturing is all we do. From single-use sterilized products to complex endoscopes and imaging devices, OR and ICU equipment to patient safety solutions, sensors and test kits to aesthetic instruments and wearable devices. Every engineer, every process, and every decision on your project is shaped by deep industry knowledge. You work with a team that understands the stakes.
Get in touch
Let's Talk About Your Device
Every medical device has its own unique path to market. Sometimes a good conversation can moves things forward faster.
Frequently Asked Questions
What are the advantages of working with a contract manufacturer that offers both medical device design and manufacturing services?
When your medical device design and manufacturing is handled by one partner, your device is built with manufacturing knowledge behind every decision. Your specifications, tolerances, and materials are chosen with real production experience in mind. Medical device companies that choose a single partner for both design and manufacturing get to market faster, with fewer unexpected costs and a smoother path from design to full scale production.
What is included in medical device design and development services?
Medical device design and development services cover the full process of taking a device from concept to a product ready for manufacturing. This includes product design, prototyping, design verification and validation, regulatory documentation, and design transfer to production. Medical device companies work with a design and development partner to make sure their device meets performance requirements, passes regulatory review, and can be manufactured consistently at scale. At Sterling Industries, our medical device design and development services are built to reduce the time, cost, and risk of bringing your device to market, from early design all the way through full scale manufacturing and post launch support.
Who does Sterling Industries offer medical device design and contract manufacturing services to?
Sterling Industries is a medical device contract development and manufacturing organization (CDMO) serving clients across North America and globally. We have been delivering design and manufacturing services for over 40 years, supporting medical device companies at every stage from strategic OEMs to startups launching their first device.
