FAQs
Yes. The vast majority of our business is making custom needles, using customer drawings and regulatory certification. Custom Manufacturing is the foundation of our business at Spectra Medical.
Yes. Over the years, Spectra Medical has created designs and obtained regulatory certification for a wide range of needle types, both Bulk Non-Sterile and Sterile. Spectra Medical designs are available for customers to use as is, or to enhance and make their own.
Spectra Medical makes a broad range of needles used in Pain Management, Oncology and Vascular Access procedures. Spectra 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.
Our Needles are virtually all made in South Korea, in suburban Seoul. Our facility there is both FDA and ISO Certified.
Yes. The vast majority of our business is manufacturing Bulk Non-Sterile needles for OEMs, and Kit/Tray Assembly companies.
Yes. We produce Sterile products for customers who need Sterile products. Sterigenics currently sterilizes our products. It takes about 1 month to complete a Sterile product run once we have the Bulk Non-Sterile needle in hand.
Lead times vary fairly dramatically depending on the type and quantity of needle. That said, our average manufacturing lead time is currently running 10-12 weeks. Spectra Medical will provide specific lead time estimates with each quote we provide.
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 for a Sterile product lead time.
Yes. We make both cannula’s and hubs in our owned manufacturing facilities in South Korea. Cannulas and hubs can be purchased separately or together as needles.
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. Spectra Medical’s dimpling process does not disturb the inner diameter of the cannula.
Yes. Spectra Medical’s “Epi-Match” technology precisely grinds the cannula and stylet tips so there are no protruding edges.
Yes. Spectra Medical makes a broad range of Introducer needles that involve guidewires and catheters. Spectra Medical’s Guide Glide technology grit blasts the bevel heel to mitigate catheter damage.
Yes. Both our US and Korean operations are ISO 13485 certified.
Yes. Both our US and Korean operations are FDA certified.
Yes. Spectra Medical sells a variety of complementary products, including Pharmaceuticals (e.g., Lidocaine, Sodium Chloride) and Instruments (e.g., scalpels, scissors, forceps, etc.).
Spectra Medical makes needles in owned manufacturing facilities in South Korea. We own a dedicated plant that does injection molding for our hubs. We also own two plants dedicated to making needles. The first does initial needle formation, including precision cutting, grinding and blasting. The second focuses on 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 Korean or Japanese steel manufacturers. Those tubes are then processed at our dedicated needle facilities.
Custom development is a Spectra Medical core competency. The process begins with design and drawing alignment, which normally involves an iterative information exchange. Once we have aligned on a design/drawing, Spectra 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. Spectra would then manufacture the parts per the specifications, inspect them and release them to the customer.
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. 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.
We employ a broad range of cutting technologies depending on the needs of the project. Examples include CNC, EDM, and Electro Chemical.
Yes. We purchase raw stainless-steel tubing and form needles, cutting and grinding tips to meet specifications.
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.
Yes. To be candid, 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.
Yes. Rapid Prototyping for sample products not intended for human use can be completed very quickly and repeated as needed.
Spectra Medical’s needles are primarily used in Pain Management, Oncology and Vascular Access procedures.
Accessibility Statement
Spectra 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
Spectra 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
Our primary customers are Original Equipment Manufacturers (OEMs) and Kit/Tray Assembly companies.
Spectra Medical has been in business since 1995
You can email [email protected] 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.
You can email [email protected] 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.
Spectra Medical does business in 50+ countries primarily in North, Central and South America as well as Europe.
We are CE/MDD registered and are pursuing CE/MDR registration.
Our primary tubing suppliers are Fuji Seiko (Japan) and Woojin (Korea). Sterigenics provides our sterilization services.
Yes. We sell tubing on a stand-alone basis, either in a supplier’s standard length or cut as needed.
Our products are sold and packaged in varying quantities. Most are priced individually, but many are packaged and sold in box quantities. Pricing and packaging unit of measure will be specified in formal quotes.
Spectra Medical is a privately held company.
Spectra Medical is headquartered in Wilmington, Massachusetts. The headquarter operations include quality inspection, warehousing and shipping, along with traditional headquarters functions.
The company employs roughly 300 people in the US and South Korea.
All products are shipped Ex Works from our headquarters in Wilmington, Massachusetts.
Yes. We have available inventory for a wide range of products. You can check inventory by contacting our customer service groups at [email protected].
You submit a Purchase Order to [email protected].