Sanmina’s deep expertise in manufacturing technologies for medical devices, as well as extensive experience in this highly regulated market sector, helped two customers achieve their profitability and product launch goals
Surgical Fiber Optic Cable System: Re-design Increased Lux Output by 40%
A tier one medical technology company needed to move production of a surgical fiber optic light system to a low cost location. They also needed to improve product performance by increasing brightness, reducing energy consumption and operating temperature. The existing design required a significant amount of manual processing and assembly which resulted in inconsistent product performance and cosmetic issues. The customer required an ISO 13485 certified manufacturing partner who could help select a new fiber-optic material and develop a robust manufacturing process.
Sanmina had been this OEM’s trusted electronics manufacturing partner for many years. The customer recognized Sanmina’s fiber-optic cable technology expertise. They wanted the benefits of both the fiber-optic and manufacturing knowledge of Sanmina’s engineers to develop a robust manufacturing process and improve product performance. Sanmina’s ISO 13485 certification was essential. Here’s how the process moved forward:
- One of Sanmina’s ISO 13485 certified facilities located in a low cost region was selected for design & manufacturing.
- A Sanmina fiber optics & cable systems engineer investigated the properties of numerous fiber optic materials.
- Several tests were conducted to analyze the light, connectivity and reliability properties of the materials.
- A recommendation for material choice was made based on the test results.
- The customer accepted the Sanmina engineer’s recommendation for new fiber optic material and design changes.
- An innovative manufacturing process was developed to consistently cut and separate 5,000 fibers into bundles of 2,500 and assemble them into a fiber-optic cable assembly with metal tubing and ACMI connectors.
- The fiber material was fixed in an epoxy to enable the introduction of additional fibers.
- A semi-automatic system for polishing the epoxy and fiber was developed to increase the light output and eliminate any scratch blemishes.
- A custom fixture was designed to hold the fiber-optic assembly during functional light testing.
- A measurement system and cross reference table was developed to predict the light performance of the system at the surgical site following six months of operational use.
This process resulted in the achievement of a 25% cost reduction and increased lux output of the fiber optic cable by 40%.
Regulatory Expertise Accelerates Time to Market
Another customer in the medical vertical is a global leader in skin rejuvenation and aesthetic products. The company had developed a new laser-based treatment product but did not have the resources to develop all of the documentation necessary to support regulatory and FDA approval. In order to get the product to market, the company realized they needed to engage with a global EMS partner with facilities certified for medical device manufacturing and the regulatory expertise to support the successful launch of their product. They chose Sanmina.
The medical aesthetic device market is experiencing double digit growth. Quickly launching new products to meet this demand is becoming more challenging as device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical device OEMs are partnering with the few EMS companies who have the expertise with FDA filings necessary to get new products to market in a timely manner.
Sanmina’s Medical Division includes a team of regulatory compliance personnel able to provide medical regulatory services to customers. These services helped this customer bring their product to market more quickly.
Onsite engineering and regulatory staff. Sanmina assigned a team of engineers together with a regulatory compliance officer and placed them onsite at the company to work with their designers and help prepare the required documents
Supply chain leverage. Sanmina manufactures a wide range of medical products and had prior experience producing aesthetic rejuvenation products, including critical experience with laser and high intensity light technology.
Regulatory documentation control. Early engagement in design and product engineering was supported by Sanmina’s proven and Part 11 compliant documentation control systems. Sanmina’s documentation system provides revision control and a secure repository for all product documentation, manufacturing instructions and processes. These systems are consistently deployed in Sanmina’s medical facilities all over the world.
ISO 13485-2003 Certified Facilities. Sanmina has more FDA and ISO-certified facilities than any other medical EMS company in the world. Sanmina has 21 ISO 13485-2003 Certified facilities including nine FDA registered facilities.
Robust Manufacturing Systems. Furthermore, Sanmina has robust systems in place for medical product manufacturing, refined over a period of more than 20 years. Sanmina’s production systems and software are also FDA Part-11 compliant.
After working side by side with the company’s engineering team, the new aesthetic rejuvenation product was successfully launched. Sanmina continues to make these products, has introduced another new product for this customer, and is in the early stages of product design and development for their next generation device.