Glossary
Contact dispensing requires contact with the workpiece to apply adhesive and volume is controlled using time-pressure. Jetting dispensing does not require contact and uses an electrically actuated piezo to move small droplets of fluid at high velocity.
Deburring process using abrasive media to remove sharp edges.
Tensile Testing, Metrology, HiPot, Leak & Flow Testing, custom testing.
A process using a jet of compressed air to propel fine abrasive media at high velocity into a work surface to remove material on the micron level. This process is used to alter surface textures & remove sharp edges on bevels and other small features or parts.
Chemical etching, which is also referred to as photo etching or chemical milling, is a metal machining process that uses chemical etchants to create complex and highly accurate precision components, which is crucial when it comes to medical device manufacturing.
Chemical Polishing is a process used to deburr, polish, and passivate metal parts which creates a smooth surface for the workpiece to continue further surface finishing process. This is done using a combination of chemicals and mechanical forces. Chemical polishing is a good way to reduce the volume of the body of metal without sacrificing its structure and characteristics.
Ultrasonic Cleaning (sound induced micro-bubbles that separate contaminants from the working surface), Chemical Electro Polishing (remove metal selectively from high points on the working surface), Passivation (further cleaning of metal surfaces & improved corrosion resistance), Reverse Osmosis Water Cleaning & Drying (cleans surface using water that has been treated to remove dissolved solids).
CNC Swiss machining is the process of machining small and intricate parts with Computer Numerical Control, originally designed to manufacture Swiss watches. Spectra Medical uses this same technology and machinery to guarantee superior accuracy and attention to detail when we manufacture custom medical components for our customers.
Crimping is a process of joining pieces of metal or other materials together by deforming one or both pieces to hold the other, and this deformity is known as the “crimp”.
Deburring is a process used in medical device manufacturing that removes excess materials from metals to create smooth edges and consistent lines. Types of deburring can include cryogenic deburring, vibratory deburring and cryogenic deflashing.
Process of applying an array of concave recesses in a limited area on a surface to enhance detectability with ultrasound.
Electro-chemical cutting and grinding (ECG) is the quickest and most cost-effective process for cutting and grinding the strongest materials. Electro-chemical offers a low stress machining operation that can eliminate the risk of damage typically associated with conventional machining methods. This technique can be utilized on both thick and thin materials. Spectra Medical uses these processes to cut our raw materials and in products that require biopsy notches or notches used in our over-molding process.
Electropolishing an electrochemical process where surface materials are removed using anodic dissolution. The process of electropolishing removes surface material from the microscopic surface texture, typically beginning by removing the high points on the surface. Benefits of electropolishing include providing a smoother, more reflective surface that improves surface cleanability, which is crucial for any medical device manufacturer.
Mechanical forming of tubing ends to change diameter or profile.
Grit blasting refers to the roughened surface added to components by way of high pressure blasting with a type of media or particles. The particles hit the metal surface with high velocity, causing localized plastic deformation which creates surface texture.
Specially formulated tubing that has been mechanically expanded so that subsequent application of heat above the crystalline melting temperature will shrink the tube to the pre-expanded state (memory effect).
Thermoplastic Injection Molding is a manufacturing process that produces fully functional parts by injecting plastic resin into a pre-made mold. This process is ideal for medical device contract manufacturing due to the cost effectiveness and high-volume production capacity. Spectra Medical’s state-of-the-art Molding Department is supported by a Design Group, Plastics Engineering and a Support Tool Room. Our 21 Vertical Insert injection molding machines range from 10–50-ton presses.
We ensure all finished devices go through a rigorous inspection prior to packaging.
Knurling is a manufacturing process used to create a pattern on the surface of a material by displacing or deforming the surface. This process typically done on a lathe and involves rolling either a straight, angled or cross-hatched lines directly into the material’s surface. Knurling adds increased durability and offers a better drip than a smooth surface.
Full label printing or variable data printing on pre-printed Tyvek or label stock using thermal transfer or ink jet printers.
Thermal process using a focused laser beam to precisely remove metal to create slotted openings, cutting notches and other features.
Laser etching or laser marking is the preferred method for applying identification marks on medical devices, resulting in permanent, legible and accurate markings defined by government regulations. Laser etching is preferred because the identifying marks are corrosion resistant and withstand sterilization processes. Laser marking is a non-contact form of engraving and can produce high quality laser marks at high processing speeds, while reducing the stress that is applied to the medical devices being manufactured.
Spectra Medical offers both Multi-Axis Fully Automated and Semi-Automatic Laser Cutting and Laser Welding Systems. These systems were designed and built to our specific and stringent controls. We own this technology which allows us to design as implemented. Our control uses the newest motion controls and HMI interface technology and components. Built around fiber optic laser power supplies, these systems include a multitude of other capabilities like automatic product inspection, with reject and accept capability, concentricity verification, etc. Our capabilities also include semi-automatic Laser engraving systems which have been fully updated with the latest control software packages.
Cannula are fabricated in house from tubing, secondary operations, passivation, cleaning, through assembly and packaging.
For Contract Medical Device Manufacturing, many devices and components require precision forming to ensure the specific shape that each customer requires. Our Metal Forming department offers different processes to bend, swage, flare, coin, EDM, Mill, Ball Weld and shape our customer’s products to meet their required specifications. We offer fully automated multi-axis end forming, swaging, cap drilling and buffing systems that allow for “lights out” operation without operator interface.
Having produced medical device needles for over 25 years, Spectra Medical employees needle point grinding as one of our core specialties and we have produced just about every needle point geometry imaginable. We accomplish this using various grinding systems to accomplish a wide array of needle points that our customers require.
Medical Device Overmolding is a manufacturing process that involves two or more materials molded together to become one part. Overmolding is an injection molding process that eliminates the need for fasteners and adhesives and provides flexibility to create more complex shapes when manufacturing medical devices.
We use internal test resources combined with test labs to perform package distribution stimulation and integrity testing.
Passivation is a post-fabrication process that is performed after welding, grinding, cutting and other machining operations that involve stainless steel manipulation. This process involves coating a material so that it becomes “passive” or less susceptive to eroding from the environment.
Plasma welding, or plasma arc welding (PAW) is an arc welding process similar to tungsten arc welding. An electric arc is formed between an electrode and the workpiece, typically metal when it comes to medical device manufacturing. The plasma is forced through a fine-bore copper nozzle which constricts the arc and the plasma exits the orifice at high velocities and temperatures. A major benefit of plasma welding is that the focused arc can be adjusted to any size depending on the amperage requirements and the specific application the welding is being applied to.
Injection Molding: experts in insert molding for patient critical medical devices including automation & manually loading presses.
Polymer & Metal Hubs: we partner with mold and die shops locally and overseas to provide quick turnaround SPI class 101, 102, & 103 molds for plastic hubs & high-volume CNC fabricators for metal hubs.
We can create a custom solution depending on your specific needs, including our Tyvek pouch with print-on pouch capability. For low volume operations our team can hand pack your product into Tyvek pouches that then can be labeled and sterilized.
Automated and manual assembly of components and devices in-line with a molding press or on a separate flexible or dedicated assembly line.
Conditioning oven for accelerated aging, controlled storage for real time aging.
Coating applied using dipping or jetting to needle tips, bodies, and other components to reduce friction.
Pouch, tray, and blister filling & sealing using impulse or band sealers, tray sealers, and form, fill, seal machines performed in a controlled environment to limit contamination from particulate & bioburden.
Sterilization is one of the most important aspects of the medical device manufacturing process which is carried out in the final phase of production. Our team of experts can provide you with a complete end-to-end medical device packaged, labeled, and sterilized. We can evaluate the adoption of the device into our existing EO validated cycle or work with your design teams for your own specific validation. If you require Gamma Sterilization, we can work with your team to gamma sterilize your medical device.
Needle Tip Swaging is a process used to move the shape of metal through cold forming. Tip swaging ‘moves’ the metal rather than removing the metal, resulting in a scrap-less forming process. Tip swaging usually involves heat and force and is the method of choice for precious metals as o material is lost in the process.
Mechanical removal of material to divide stock tubing to custom lengths.
Ultrasonic welding is an industrial manufacturing process where high-frequency ultrasonic acoustic vibrations are applied locally to materials being held together under pressure to create a solid-state weld. This is a common process used for plastics and metals, particularly when it comes to joining together dissimilar materials.
EDM or Electrical Discharge Machining is a manufacturing process that uses an electrode to precisely remove material from conductive materials. The EDM system has two major components, a machine tool, and a power supply. The process is based on supplying power to the process via a series of electrical spark discharges between the electrode (power supply) and the product being processed. The metal is then removed by thermal erosion or vaporization caused by the electrical discharges. EDM is a critical capability for manufacturing precise medical devices. EDM also provides manufacturing advantages like precision, consistency, and repeatability. Spectra Medical also uses CNC controlled Wire EDM capabilities used to process multiple products simultaneously while also producing “burr free” precision machined products.