Manufacturing requirements for optical devices used in the data and telecom industries have a lot in common
with
those for medical devices. Both
industries demand precision manufacturing practices, stringent quality standards, guaranteed IP protection, and complete traceability. Both require high-mix, low-volume manufacturing solutions with a more flexible manufacturing approach that guarantees product delivery on time and at the right cost.
Medical device manufacturing, like optics, benefits from the focus of a dedicated, multi-disciplinary engineering team. Working closely with the
customer, Fabrinet creates such cross-functional teams, comprised of professionals experienced in both the manufacturing processes and industry-specific focus of a particular product. This team maintains responsibility for the product womb-to-tomb – starting with design in the early phases, followed by DFM, DFT, through process development and failure analysis. This ensures flawless product transfers and overall execution throughout the product lifecycle.
With these processes and experience in place, Fabrinet was able to establish and very quickly launch its medical division in 2007. ISO 13485 certification was secured in only six months – a process that normally takes years. Today, in addition to ISO-certification, Fabrinet is FDA-approved for many of the medical products shipped to customers. As well, Fabrinet facilities have been audited and approved for volume shipments by JDSU, Coherent and Newport's Spectra-Physics laser system divisions.
Many of the new medical lines are housed in the brand new Building 5 on the Fabrinet campus. Built from the ground-up to accommodate Fabrinet’s trademark “factory within a factory” infrastructure, the 300,000 square foot facility hosts a “hospital” feel with large “bays.” Each bay can be quickly and uniquely configured to securely house each customer’s specific processes, clean room size and designation (ISO Class 5, 6, 7, 8), facilitating rapid product transfers and ramps.
Each bay is comprised of 10,000 sq. ft. of manufacturing space with independent controls to meet cleanliness, temperature and humidity requirements. The entrance to each bay is controlled and limited to authorized personnel only via biometric security measures.
“While we were able to leverage our existing expertise in many areas, we also invested to add industry-specific focus and equipment in others,” said Fabrinet Chief Operating Officer, Dr Harpal Gill. “Quality control is an example. It is an area in which we were already extraordinarily proficient, with well-established procedures and a seasoned team with experience dating back to the ultra-demanding requirements of the disk drive industry. However, when we launched the medical division, we expanded our quality controls to address specific medical industry requirements, achieving very rapid success. We sought and quickly received ISO 13485 certification covering the medical industry’s requirements, a major milestone in ensuring we met federal and cGMP requirements. Soon after that, we received FDA approval for some of the medical products manufactured at Fabrinet. We’ve developed and implemented a number of tools critical for managing very high-mix/ low-volume manufacturing and can tap our extensive in-house failure analysis, material and process labs to assist customers with highly specific responses when problems occur.”
In the event of a product failure or a problem in the field, it’s important for companies to determine immediate containment and corrective action plans. Root cause failure analysis can isolate the problem to a faulty part, design or manufacturing defect, or field application. Companies need this
information to scale the problem ascertaining the scope and location of the affected products. “We offer customers a web-based, 24/7 traceability system. The system provides instant and comprehensive information on the affected product as well as the information they need to rapidly identify corrective solutions to fix the problem,” said Gill. “Customers tell us our traceability system is one of the best in the industry.”
The traceability system offers real-time shop floor visibility and product/component traceability down to the supplier, lot number, and delivery date of the component. Components can be traced through every step of the build process, including which employee worked with which component in every step.
Quality is also controlled at the sourcing level. “We have long-standing, well-established relationships with our supply base. We have rigorous incoming quality assurance (IQA) procedures in place throughout the supply chain. Vertical integration solutions from our subsidiaries, Casix and Vitrocom, provide bulk optics and glass products, giving us an advantage over others in terms of both quality and delivery in the sourcing and management of these critical components,” said Dr Gill.
- In addition, Fabrinet's supply chain team continues to provide optimal solutions for managing material cost, quality and lead time requirements. The result is cost and lead time reductions as well as consistent delivery to customer expectations.
Fabrinet’s experience in ultra-precise manufacturing, with extraordinary focus on quality, reliability and life-cycle traceability throughout its operations have propelled it with unusual speed into the specialized field of medical device and instrumentation manufacturing. Its ability to compartmentalize businesses into discrete units with its “factory within a factory” infrastructure means that it can engage in very different types of manufacturing without affecting resources or the processes of existing business lines.
“Customers are surprised by our flexibility, given the complexity of our business,” said Dr Gill. “This is a capability that serves us as well as our customers.”
Product photographs courtesy of LumaSense Technologies, Inc.
Many of the new medical lines are housed in the brand new Building 5 on the Fabrinet campus. Built from the ground-up to accommodate Fabrinet’s trademark “factory within a factory” infrastructure, the 300,000 square foot facility hosts a “hospital” feel with large “bays.” Each bay can be quickly and uniquely configured to securely house each customer’s specific processes, clean room size and designation (ISO Class 5, 6, 7, 8), facilitating rapid product transfers and ramps. 