HIGH-MIX MEDICAL DEVICE MANUFACTURING
FOR SPECIALIZED APPLICATIONS
GET TO MARKET AND SCALE WITH RELIABILITY AND REPEATABILITY.
Ranfac’s focus on Class I and II single use devices combined with over a century of experience provides a unique relationship to our customers. No matter the size of your company or the scope of your project, you will be able to take advantage of Ranfac’s highly automated, flexible manufacturing platform, which allows us to scale production volumes from the needs of a small startup to the demands of a blue-chip OEM. Within our Avon, Massachusetts facility you will find full source capabilities through each stage of production – from the machining of raw materials through the assembly and packaging of sterile product. Having full in-house control over the operation assures the quality and efficiency that your product requires.
Single Source High-Mix Medical Device Manufacturing for Scaled Production
Original Equipment Manufacturing (OEM)
Ranfac offers a tried and true 4-phase development platform to bring your custom or private labeled medical device through regulatory and to market utilizing our cloud-based quality system and manufactured under one roof in our Avon, MA facility.
Contract Manufacturing
Ranfac is experienced operating under the most stringent quality standards of multiple blue chip medical device companies who rely on Ranfac for our product expertise, vertically integrated platform, and the ability to scale production.
Ranfac Products
Ranfac offers a range of minimally invasive, hypodermic based medical devices for specialized applications across multiple therapeutic categories including Spine, Orthobiologics, General Surgery, Hematology and Radiology.
OUR PROCESS
All new projects begin with a sit-down with Ranfac’s senior leadership. Here, we can get to know each other and determine if there is mutual interest in partnering. By having a clear understanding of your needs, we will determine the best solutions to get your product to market as efficiently as possible. Every device has its own unique challenges. That’s why Ranfac does not operate under a one-size-fits-all model.
TAKE A PEEK INSIDE OUR BUILDING
Consistently growing and improving to provide for our customers’ needs, our Machine Shop’s core capabilities include cutting, grinding points, laser welding, and preparing steel for over-molding. We are constantly on the forefront of technology and enabling software evident by our array of automated equipment and our creative integration of robotics used to increase scale and efficiency.
Operating out of a Class 8 clean room environment, we offer both over-molding (also known as insert molding) and injection molding. Customers can take advantage of many standard mold tools, including luer lock, stylet, and cannula handles or work with Ranfac on a custom tooling project. We utilize Battenfelds and Arburgs along with the use of automation, adding capacity and accuracy while reducing the cost and time to develop a new product.
We employ ultrasonic cleaning methods using common types of acidic, neutral, and alkaline cleaners along with neutralizers and triple cascading deionized water rinsing and heated HEPA filtered dryers. We offer descaling and passivation to bolster the formation of Chromium Oxide on stainless steel, and to remove manufacturing process oxides. We clean assemblies and mitigate risks of entrapped spaces which can lead to unwanted residues on parts.
Ranfac’s Class 7 clean room for assembly offers a controlled environment for preparing product for sterilization. Built for high-mix production, our assembly room can quickly switch between diverse types of jobs. We use a mobile barcode scanning system that links directly to our ERP system and allows for real-time insights into the workflow of the manufacturing process.
Ranfac guarantees finalized sterile product by managing the entire ethylene oxide (EO) sterilization process, including all requisite testing and validations. We oversee all elements from assembly to final packaging with thorough inspection and documentation. Once sterile, Ranfac transports products back to our facility for validation and for products to be packed accurately to the customers' specifications using a range of different packaging methods to ensure product integrity.
Ranfac’s utilization of satellite warehouses throughout the facility brings our product to the point of use, increasing both speed and accuracy. Having the products already organized based on usage streamlines the process and allows for more efficient handling. Furthermore, Scanco Warehouse 100 keeps a record of all items and is easily accessible. With all products documented and sorted, the storage and delivery of all products is guaranteed.
CASE STUDY
HEALTH BEACONS
Health Beacons, a virtual medical device development company, came up with the idea for a device in 2015, to deploy a miniature radio frequency identification (RFID) Tag for a wire-free breast lesion guidance system. The purpose of this invention was to change the traditional process of using a localization wire for breast lesion marking.
CLIENT TESTIMONIALS
Without Ranfac, I would have failed. Failed to change a process that was affecting women negatively all around the world. Ranfacʼs COO, Barry Zimble, knew the importance of this. He knew the initial process as they were already working in this space, he could use the names of the original inventors but he understood the importance of changing the manufacturing. It was their deep experience in this field that was a really important reason to go for Ranfac. Bringing a new device is a journey and it is not a straight line, you canʼt plan everything and have it all to fall in line. It is a very bumpy process, and Ranfac really was there for us with every one of these bumps. They really stuck with us and were very creative with the solution to get us back on track. We kept throwing curveballs at them and they were incredibly resilient.
