As a single source manufacturer, Ranfac handles everything from raw material to ﬁnal packaging in one location. We’re proud to boast that our products have been 100% manufactured in the U.S. since 1888. We enjoy our wonderful partnerships in the healthcare and medical device industries and are happy to celebrate 2018 and its accomplishments, even a couple of months into the year. It’s never too late to get excited about innovation! We wanted to take an opportunity to look back at some of the wins of 2018 and share our plans for 2019 in the areas of operational improvements, regulatory and quality developments, and sales and marketing achievements.
In 2018, Ranfac celebrated some important operational improvements. We completed the design and build of our part payoff systems to feed the UR5 robot for pick-and place-secondary operations, as well as a new Ultrasonic Cleaning line. The innovative new cleaning line offers real-time monitoring of critical levels of process fluids for soaps and rinsing operations: a state-of-the-art triple cascade rinse with continuous Deionized water flow. The installation of a HEPA filter dryer was employed to eliminate the use of isopropyl alcohol as a drying agent, making for a greener operation. In addition, the company installed a cutting-edge electrolytic needle grinder, typically capable of producing parts 3X faster than conventional grinding while producing a burr-free part in a single operation. To round out 2018, Ranfac added epoxy floor surfacing to our Ultrasonic Cleaning room and our Molding departments to further protect and prevent particulates while providing a more contemporary finish to our manufacturing spaces.
Looking forward to 2019, Ranfac is installing a new laser welder that uses autonomous feature recognition to put the weld on the required seam, regardless of component size variance. A fully programmable 4-axis machine, the new welder has built-in data logging for critical laser output parameters. Furthermore, a lean manufacturing initiative is underway to remove defunct items from warehouse and manufacturing spaces. The company will welcome a proliferation of robotic manufacturing in our molding department for three shifts of continuous production. Offering clear cost benefits, the molding cycles will equally advance to Scientific Molding Standards with more consistent processing times of plastic through molding feed throats.
Regulatory and Quality Developments
In 2018, while continuing to provide superior products to the European markets and maintaining a robust technical file for each product, Ranfac once again proved our ability to adapt to the more stringent CE certification requirements. We’ve also seen tremendous growth in human resources. New staff acquisitions have proven to be successful fits within the company, and our team of highly qualified professionals has the necessary skills to propel continued progress. Ranfac has also successfully executed a cleaning re-validation, reflecting that our products meet the requirements of implantable grade products, and exemplifying that our water system is as clean as pharmaceutical grade water. The system can now be monitored for process parameters that will inform us when detergents or DI water are outside specifications, allowing Ranfac to react before there are any digressions.
In 2019, we are launching new products within our newly revised design process, which will yield more robust Design History Files that can be utilized to more easily register products through the FDA and the EU. In addition, Ranfac is purchasing and validating a new laser welder. Furthermore, 2019 will see the procurement of HEPA filtration in molding, QC, and assembly to increase the number of controlled environments within the walls of Ranfac and increase the cleanliness of our devices.
Sales and Marketing Updates
2018 was an impressive year for our company in terms of sales and marketing. Last year, Ranfac launched our proprietary Lipo-Pro™ Adipose Processing System, which received excellent feedback from early adaptors and is expected to see tremendous growth in 2019. Additionally, Ranfac published critical data on Marrow Cellution and began a partnership with Dr. Saleh.
We also anticipate important new product development in 2019. We will begin testing on a proprietary Platelet Rich Plasma (PRP) System with a planned launch in the 3rd quarter of 2019. Ranfac also hopes to round out our autologous biologic portfolio, offering best-in-class solutions for Bone Marrow Aspirate, Fat Grafting, and PRP. We will finalize the development of our next generation Bone Marrow Harvesting Product and incorporate Marrow Cellution™ technology to better target stem cell niches along the inner-bone surface. And, of course, we are looking forward to strengthening current partnerships and forming new relationships with pioneers in the medical device industry and throughout the healthcare ecosystem.
Ranfac oﬀers integrated solutions for product design & development, manufacturing process development, regulatory approval, and single source manufacturing. Further, eschewing outsourcing, we handle each phase of product design and development ourselves right here in America.
At Ranfac, we offer integrated solutions for product design & development, manufacturing process development, regulatory approval, and single source manufacturing. Click here to follow the exciting developments at Ranfac for 2018, 2019, and beyond!