FAQs
Manufacturing Capabilities
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We have manufacturing sites in South Korea and the United Kingdom. Our facilities there are both FDA and ISO Certified.
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Elevaris Medical makes needles in wholly owned manufacturing facilities in South Korea and the United Kingdom. We own three plants dedicated to making needles. These plants are focused on needle formation, including precision cutting and grinding, as well as assembly, including bending, gluing, marking, and cleaning. To begin the needle making process, we purchase raw stainless-steel tubing from one of a few qualified steel tube manufacturers. Those tubes are then processed at our needle formation and assembly facilities. We also own a dedicated plant that does injection molding for our hubs and caps.
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Yes. Elevaris Medical’s “Epi-Match” technology precisely grinds the cannula and stylet tips so there are no protruding edges.
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We employ a broad range of cutting technologies depending on the needs of the project. Examples include Laser, CNC, EDM, and Electro Chemical.
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Yes. We purchase raw stainless-steel tubing and form products, cutting and grinding tips to meet specifications. This also includes forming techniques like bending, flaring as well as welded flanges and tabs.
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Yes. We own a plant dedicated to injection molding. The plant primarily produces hubs for our cannulas and stylets but is capable of producing a wide range of products.
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Yes. We sell tubing on a stand-alone basis, either in a supplier’s standard length or cut as needed.
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Our products are sold and packaged in varying quantities. Most are priced individually, but many are packaged and sold in box quantities. Generally speaking, we rely on customer input and package as needed. Pricing and packaging units of measure will be specified in formal quotes.
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We manufacturer a wide range of precision micro-components, complex tubular components and sub-assemblies for the medical device industry. We offer DFM, prototyping and production solutions to our medical device customers. We manufacture for a wide range of medical applications primarily utilizing our advanced laser & EDM manufacturing technologies.
Development Services
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Yes. The vast majority of our business is making custom products or components, using customer drawings and regulatory certification. Custom Manufacturing is the foundation of our business at Elevaris Medical Devices.
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Yes. Over the years, Elevaris Medical has created designs and obtained regulatory certification for a wide range of needle types, both Bulk Non-Sterile and Sterile. Elevaris Medical designs are available for customers to use as is, or to enhance and make their own.
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Lead times vary dramatically depending on the type and quantity of needle. That said, our average manufacturing lead time is currently running 10-12 weeks. Elevaris Medical will provide specific lead time estimates with each quote we provide.
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Our rule of thumb is to add 1 month to the base lead time for a Bulk Non-Sterile needle. So on average, we would quote 14 -16 weeks lead time for a Sterile product.
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Custom development is an Elevaris Medical core competency. The process begins with design and drawing alignment, which normally involves an iterative information exchange. This includes DFM and advice on materials and methods to enable timely, economic manufacturing methods. Once we have aligned on a design/drawing, Elevaris Medical confirms capabilities, provides a price quote and estimates lead time for completion. If pricing and lead time are satisfactory, the customer would issue a Purchase Order for those parts. Elevaris would then manufacture the parts per the specifications, inspect them and release them to the customer.
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Custom development timing varies dramatically depending on product complexity, testing requirements, sample needs, qualification process, etc. A project can be completed in weeks, months or years depending on the iterative approach used. Examples include the traditional prototyping process, to a more timely and thorough “XLerator Day”. On average, our high-level estimate for development timing would be several months. That said, we stand ready to move as fast as our customers require.
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Yes. We primarily work with Design Engineers who work for our customers. However, we also offer a wide range of Engineering Services for customers who need them, ranging from technical design to testing.
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Yes. Rapid Prototyping for sample products not intended for human use can be completed very quickly and repeated as needed. We also offer an XLerator Service for quick turn prototyping, which can include an XLerator Day where our customers’ engineers have access to equipment and experts to accelerate design completion.
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Yes. We have a 3D Metal Printing Studio that allows for quick turn design development.
Our Products
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Elevaris Medical Devices makes a broad range of needles used in Pain Management, Oncology and Vascular Access procedures. Elevaris Medical makes Epidural, Peripheral Nerve Block (PNB), Radiofrequency, Spinal Cord Stimulator and Spinal needles for Pain Management procedures. We make Huber, Fine Needle Aspiration, and Bone Access biopsy needles for Oncology procedures. We also make Guidewire Introducers and an assortment of other Introducer cannulas and stylets for Vascular Access procedures.
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We produce tubular component sub-assemblies and complete assemblies.
We employ a wide range of methods using laser cutting, welding and marking based on customer requirements and design.
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Yes. The vast majority of our business involves manufacturing Bulk Non-Sterile needles, components, sub-assemblies and complete assemblies for OEMs, Contract Manufacturers, and Kit/Tray Assembly companies.
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Yes. We produce Sterile products for customers who need Sterile products. It takes about 1 month to complete a Sterile product run once we have the Bulk Non-Sterile needle in hand.
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Yes. We make both cannulas and hubs in our owned manufacturing facilities in South Korea and the United Kingdom. Cannulas and hubs can be purchased separately or together as needles.
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Yes. We create echogenic needles by either grit blasting or dimpling the cannula. Dimpling is our recommended method because of its high clarity image under ultrasound. Elevaris Medical’s dimpling process does not disturb the inner diameter of the cannula.
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Yes. Elevaris Medical makes a broad range of Introducer needles that involve guidewires and catheters. Elevaris Medical’s Guide Glide technology grit blasts the bevel heel to mitigate catheter damage.
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We are one of the largest made to spec procedural needle companies. We also fabricate tubular components, sub-assemblies and complete assemblies. In addition, Elevaris Medical sells a variety of complementary products, including Pharmaceuticals (e.g., Lidocaine, Sodium Chloride) and Instruments (e.g., scalpels, scissors, forceps, etc.).
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Elevaris Medical’s products are used in wide range of medical specialties including Pain Management, Oncology, Cardiology, Ophthalmology, Orthopedics, Drug Delivery and many more.
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You can email orderentry@elevarismedical.com and be connected with one of our customer service team. They will confirm the product is available and then provide a quote and lead time for that product.
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You can email sales@elevarismedical.com and be connected with one of our National Account Directors. They will ask for a technical drawing and volume estimate and that will begin your engagement with our company.
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Our products are generally shipped Ex Works or FCA from our headquarters in Wilmington, Massachusetts. We are able to arrange Direct Shipment from our plants in certain situations where product is destined for locations outside the US.
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Yes. We have available inventory for a wide range of products. This includes Elevaris proprietary product as well as customer stocked inventory based on contractual agreement. You can check inventory by contacting our customer service groups at customerservice@elevarismedical.com.
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You submit a Purchase Order to orderentry@elevarismedical.com.
About Elevaris
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Yes. Our US, Korean and UK operations are all ISO 13485 certified.
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Yes. Our US, Korean and UK operations are FDA certified.
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Accessibility Statement - Elevaris Medical is committed to providing a website that is accessible to the widest possible audience, regardless of technology or ability. We are actively working to increase the accessibility and usability of our website and in doing so adhere to many of the available standards and guidelines.
Measures Taken
Our website features alt text for all images, aiding users who rely on screen readers to navigate.
We ensure compatibility with screen readers and other assistive technologies.
Keyboard navigation is fully supported throughout the site.
We have designed our website with high contrast colors and clear typography to improve readability for users with visual impairments.
Ongoing Commitment - Elevaris Medical is dedicated to maintaining accessibility compliance and regularly reviewing our practices to ensure that all users, including those with disabilities, can access and interact with our website without barriers.
Contact Information - If you have any questions or suggestions regarding the accessibility of this site, or if you encounter any difficulty using the site, please contact us.
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Our primary customers are Medical Device Manufacturers, other Contract Manufacturers, and Kit/Tray Assembly companies.
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Elevaris Medical has been in business since 1995.
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Elevaris Medical does business in 50+ countries in North, Central and South America as well as Europe and Asia.
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We are CE/MDD registered and are pursuing CE/MDR registration.
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Elevaris Medical is a privately held company.
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Elevaris Medical is headquartered in Wilmington, Massachusetts. The headquarter operations include quality inspection, warehousing and shipping, along with traditional headquarters functions.
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The company employs roughly 400 people in the US, South Korea and the United Kingdom.