Success Story
Leading Medical OEM Drives Exponential Growth while Meeting Demand and Environmental Compliance Pressures
Medical Technology
FDA Class I / II / III
ISO 13485
RoHS Compliance
EMS Partner
Built for High-Stakes Innovation
A US-based Medical Device OEM with a history of customer focus. With millions of dollars invested in R&D and billions of dollars in annual revenues on the line, it needed an EMS partner with flexible delivery solutions and high reliability.
Navigating Modern Healthcare Pressures
Today’s Medical Device manufacturers face an evolving landscape of market pressures. These include tight government regulatory standards, a heightened focus on patient protection, and affordable healthcare.
For Creation’s customer—a global company focused on improving the quality of patient care and health outcomes around the world—success required a long-term vision and an partner capable of scaling alongside them. It demanded an electronics design and manufacturing partner with the agility to shrink time-to-market, navigate rigorous compliance, and support complex applications ranging from Imaging, Surgical Robotics, and Lab Diagnostic Equipment to Cardiovascular and Therapeutic Devices.
Services Delivered
Functional Test Development
RF Validation
System Integration
Production Support
Scaling High-Risk, Complex Technologies
For a sophisticated new product line, the customer was seeking a long-term manufacturing partner whose capabilities could scale alongside evolving regulatory definitions. Because the changes in the medical marketplace represented a significant growth opportunity, the OEM expanded its focus on research and development under a tight timeline. Key criteria for partner selection included:
01
Operational and Technological Expertise
Including lean manufacturing and process engineering
02
Design and test development
Supplemental support
03
Proven FDA Class I, II, and III Experience
To confidently handle high-reliability, life-saving medical devices
Creation has been an excellent partner. Your team is very professional, responsive and proactive for us. Our Customer-Focused Team Leader’s support exceeds...Plus!!
Accelerating Innovation from Concept to Deployment
Parallel Product + Test Development
Advanced RF Validation 600 MHz – 6 GHz
11-Month Full Deployment
12 On-Site Installations & Training
Trusted Partner for 3 Additional Programs
Proven Results.
Measurable Impact.
Our end-to-end product development and manufacturing expertise delivers measurable improvements across speed, quality, supply chain resilience, and regulatory compliance.
Following launch success, the customer awarded Creation support for three additional systems over the next two years, establishing Creation as a trusted strategic partner for future programs.
Accelerated Development
Shortened Product Timeline
Product development timeline shortened through Creation’s cross-functional Medical Design and Engineering expertise.
Flexible Delivery Model
Optimized Supply Chain
Supply chain optimized through a customized Tailored Product Supply program and global supply chain solutions.
Uncompromising Quality Standards
12 Certified Facilities
Strict regulatory criteria met across 12 strategically located facilities featuring ISO 13485 certification, FDA registration (5 locations), and 21 CFR Part 820 compliance.
Advanced Compliance
RoHS Conversion
Product redesigned to meet environmental compliance requirements for Medical Devices, converting the product to RoHS-compliance at the onset of European Union Directive exemption expirations
Thank you for the terrific customer support that you provide. Each of you has responded quickly and efficiently to all requests from my team: RoHS, fixture improvements, NCEPs, yield improvements, etc. Your attention to detail and willingness to help is very much appreciated by me and the Manufacturing Engineering team. It is easy to get overwhelmed with the volume of projects for sustaining and NPI and yet you always remain professional and responsive.
Thank You for a job well done. I have worked with many contract manufacturers in my career including the big guys like Foxconn; however, I prefer doing business with a smaller, more responsive team like yours. It is a pleasure working with you and your teammates.
Facing similar scaling
& compliance challenges?
Let's discuss your next program.