How do you choose a supplier for your Optical Fiber needs for your medical device application? When I’m working with medical device manufacturers on new products, I almost always think "Why have they chosen OFS?" Each time I come up with the same answer. OFS processes and procedures are in-line with FDA Good Manufacturing Practices. Moreover, OFS employs lean manufacturing principals, which ultimately helps our customers get to market faster, by planning and doing more in the beginning; eliminating waste when it’s time to go to market.
You can argue this makes it easier for device manufacturers to do business with OFS, but truly it’s about getting to market with the right supply chain that will support a successful device development, introduction, and a sustain production with few or no hiccups. Here are a number of criteria you should look for when selecting a supplier and standards you’ll find at OFS:
- Experience in the field: OFS legacy offers over 25 years of application knowledge, design experience and optic know-how – in the medical market – assisting customers in producing research-driven medical device technologies.
- A robust development process: OFS invests in and is committed to the medical device development cycle, supporting development with a robust plan-do-check-act process and rigorous use of proven methodologies such as design, process, and production validation and qualification.
- Vertical integration: OFS core technology and expertise starts with optical fiber. OFS takes that expertise and applies it to the performance of the rest of the device. Whether it is simply an optical fiber cable, or a complex in-vivo optical fiber probe.
- The right manufacturing environment: OFS offers a range of services and manufacturing environments including certified bio-burden rooms. OFS factories practice Lean Manufacturing principles, continually looking for ways to improve production and manage to a lower cost structure.
- Adherence to regulatory criteria: The OFS Connecticut manufacturing facility is certified to both ISO 13485 and 9001 Quality Systems Standards. OFS optical fiber products are certified biocompatible following ISO 10993 and UPS Class VI.
- A strong quality system: The OFS Quality Management System helps ensure manufacturing repeatability of conforming products and processes as well as vendor evaluation and lot tractability.
- A working partner relationship: this directly impacts product quality, value, and time to market. A strong partnership will significantly contribute to identifying requirements critical to product quality and performance sooner verses later. OFS strives for a true partnership in the beginning during development, and continued throughout production.