As an ISO 13485-certified supplier of engineered plastic components and devices, Roncelli Plastics works closely with medical facilities and professionals to construct custom designs that overcome complex challenges. Its product line has been tested and approved by medical device experts requiring faultless quality. Roncelli Plastics has built a name for innovative technologies, high-quality products and responsive customer service. Its 42,000ft² facility engineers a variety of plastic components and devices via 3D printing, cleanroom assembly, CNC machining, engineering and design support, rapid prototype machining and non-compromising QA processes.

Typically, the company’s medical device components are derived of peek optima, virgin peek, carbon-filled peek, Ultem (pei), pps, Rade (ppsu), ultra-high-molecular-weight pe, Noryl (ppe) and others. Its current line of products includes spinal implants, surgical tools, endoscopy instruments and medical instruments.

Corrosion, wear and patient metal hypersensitivities are prominent issues with metal spinal implants. Several medical researcher studies reveal metal spinal implant failures, metal staining of skin, unexplained pain and neurological effects. Plastic spinal implants have proved to be the future due to their biocompatibility, load capacity, radiolucency and stress-crack resistance. Roncelli Plastics’ spinal implant line is comprised of peek optima, virgin peek and Zevina za-600 cf30 materials. The latter material is twice as strong as natural peek. Zevina za-600 cf30 offers radiolucency, helps implants lessen bone density reduction and, since the material can be modified in size and scale, it is less intrusive and more cost-efficient. The company’s product list includes cervical sizers and spacers, spinal fusion cages and thoracolumbar sizers.

Life-sciences-grade plastic surgical tools

Successful life-changing surgeries hang in the balance of skilled surgeons and precise surgical tools. A significant hurdle facing surgical teams is the degradation of instrumentation. Life-sciences-grade plastics address problems that metals endure under autoclave cycling. Roncelli Plastics offers autoclavable surgical handles with finishes that balance comfort and convenience for surgeons with a vast range of hand sizes. Every handle Roncelli engineers is made of Radel (ppsu) and peek (30% glass filled), giving them superior durability and impact resistance. Each handle is offered in multiple colour schemes and undergoes expansive testing measures.

Regularly replacing endoscopic instruments is a substantial cost. Medical institutions conscientiously seek out endoscopy tools with maximum durability. Roncelli has found that endoscopic components composed of peek and Ultem vastly improve their resilience. Roncelli Plastics manufactures endoscopic camera-head couplers, covers, handles, spacers and trays that can exceed 1,000 steam-sterilisation cycles at high temperatures. Additionally, these components are chemical-resistant and lightweight.

During heart-related surgeries, keeping the valves clean is vital to ward off infection and to prevent tissue damage. Roncelli’s heart valve retainers are meticulously designed and manufactured to aid the medical community in this endeavor. Each heart valve retainer is comprised of Ultem 1,000, which is quite resilient under steam sterilisation. The trauma target guides the company to incorporate peek and carbon-filled peek to satisfy the need for biocompatibility, rigidness and radio opaqueness.

Roncelli’s work within the medical and life sciences spectrum often calls for services beyond product engineering assistance and manufacturing. Its customer services are tailored to the specific needs of each client. Sometimes this necessitates customising QA strategies that meet or exceed client specifications. The company always takes firm measures to guarantee on-time product delivery, and its engineering team works with clients to research the best methodologies for product construction before full product runs.

Since 1969, Roncelli Plastics has continually provided finished components to world-renowned organisations. The company’s personnel is comprised of leading machinists, QA professionals, engineers and industry advisers, and its commitment to safety, quality and extreme ownership is shown by its investments in robotic production and industry-leading processes.