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  • Writer's pictureRanfac

High-Mix Medical Device Manufacturing: Tailored Solutions for Startup Success

Startups face unique challenges in the complex and rapidly-evolving MedTech sector. The convergence of cutting-edge technology, regulatory compliance, and patient-centric design demands a manufacturing approach that is equally adaptable and efficient. That’s where high-mix manufacturing comes into play, providing scalable custom medical device solutions that pave the way for startup success.

The Expert Partner Startups Need to Launch

Startups bring a fresh perspective to the MedTech sector, introducing new ideas and leading-edge technology to healthcare industry solutions. However, these organizations typically operate with limited resources and tighter budgets, making it critical to invest in the right manufacturing partner. Ranfac has decades of experience not only helping startups manufacture their devices, but also providing the seasoned product expertise that smaller companies need to perfect and launch their designs.

Ranfac helps startups maximize their investment in four key ways:

  1. Customize product design. Every Ranfac partnership begins with a design collaboration. During this discussion, our design team pieces together customer ideas to craft a production-ready design history file. Ranfac’s unmatched medical device expertise helps bring startup product visions to life, leveraging decades of technical know-how and single source manufacturing capabilities.

  2. Keep production under one roof. Ranfac stands apart as one of the only medical device manufacturers offering single source production. With engineering, manufacturing, quality, and supply chain all operating under one roof, we eliminate the delays and extra costs that result from fragmented workflows. Likewise, each project leader can easily track production, ensure proper documentation, and guarantee compliance with regulatory requirements. Our expertise in multi-cavity tools, implementing automation, and the ability to maintain one-piece flow optimize our manufacturing output and get devices to market even faster.

  3. Streamline regulatory filing. From start-up contract manufacturing to OEM medical device production, filing for regulatory clearances without expert help can be a challenge. Ranfac’s single source process alleviates this burden from startups by recording, storing, and submitting all necessary documentation during every step in the manufacturing process. Our quality and regulatory teams stay current on shifting requirements to ensure our devices obtain FDA approval and steer clear of compliance violations.

  4. Adapt and scale with ease. When we accept a new project, the intake process primarily focuses on lower level planning. Our team works diligently to build a solid foundation by performing initial setup tasks and quality inspections on a smaller scale, as well as manufacturing entry level quantities and putting safety stock aside for future surges in demand. Likewise, we work with customers to plan ahead for larger production volumes, allowing us to reduce piece costs and streamline manufacturing when it’s time to scale up production.

Planning, Experience & Scalability: Three Keys for Success

Ranfac understands the demands of putting a device on the market. That’s why our medical device manufacturing process was built to plan upfront, create efficiencies, and seamlessly adapt to evolving industry and customer demands. This scalable production approach is crucial for startups and small companies to get the most out of their manufacturing investment. Whether you’re looking to brainstorm device design or are ready to initiate production, Ranfac is here to meet your organization’s unique needs and help you launch industry-leading devices.



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.
Health Beacons Logo.png
CEO, Health Beacons (Acquired by Hologic)
Ranfac has supplied my company for over twenty years. We have developed a number of new products together and overcame many manufacturing and supplier issues over the years. It was always teamwork to resolve whatever challenge we incurred - no finger pointing or negotiation. It is so refreshing to share open discussions with the Ranfac team to provide quality solutions to our customers. Of course, Ranfac CO ,Barry Zimble, was always actively involved as the quarterback for the Ranfac team. He's always been realistic, pragmatic and candid as we worked through our challenges. His integrity is beyond reproach. If he commits his team to a goal, you can count on them.Over the years, Ranfac has continually re-invested in their equipment, facilities and their people. When I chose Ranfac as our primary supplier, it was one of the best business decisions that I ever made.
CEO/ Owner ProAct, Ltd.


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