Through careful engineering, welding, grinding, and sharpening, Ameri Surgical Instruments® makes the best surgical tools and instruments. With our comprehensive guide, you can get an in-depth look at how these instruments are made, from the selection of materials to the finishing touches.
Design Process Understand the design requirements and create a prototype to fit these needs.
Creating a prototype is the very first step to creating medical instruments and tools of any kind. Our team of highly experienced engineers has extensive knowledge in fabrication as well as a more than adequate understanding of the design requirements that these products face. The design process starts with initial consultation, followed by detailed sketches and computer-aided designs (CAD) that require skilled reviewing and editing. Once the plan has been approved, we will then review materials, items, and components to ensure they are appropriate for use in manufacturing the product.
After the components are selected, a prototype of the intended tool or instrument is created, which can then be tested to gauge performance. Utilizing 3D printing and advanced manufacturing technologies, we guarantee that each and every prototype meets the highest standards for medical devices before being able to be distributed in the market. Our team makes sure that the final product is highly functional, ergonomic, safe, and efficient for optimum results in any surgical setting. This process enables us to create reliable solutions for our partners through cost-effective production and increased overall convenience.
Using the design requirements for each product, we undertake extensive research and development to refine and enhance the necessary features needed for each implementation. Tool analysis, marker studies, field tests, and ergonomic analyses are conducted during the prototyping process to ensure maximum comfort and usability. We take into consideration all relevant standards in medical device production as well as local regulations in order to produce effective products that meet customer needs. Our teams utilize ISO 13034 and ISO 13485 accredited procedures while specializing in thermoplastic molding, die casting, and metal fabrication technologies. This step-by-step approach allows us to create clinically sound patient care solutions that exhibit excellent performance by ensuring customer satisfaction with quality materials and construction techniques.
During the prototyping phase, we utilize the latest design technologies like rapid tooling and FEMS, which enable precise manufacturing of critical features. Our in-house engineering and design teams are led by certified design personnel with over 20 years of experience in medical devices. We also empower specialized technicians who have vast experience with the production of various devices. By implementing a rigorous 2D/3D CAD system and verified processes for verification and validation, we create high-end product designs that leave no margin for doubt on safety standards or the end user. As part of our commitment to customer service and quality control, we offer continuous technical support throughout the entire process so our partners can benefit from a service-oriented approach to each project.
Manufacturing Process of the Ameri Surgical Instruments: Select the best materials that match the design specs and consider production costs, timelines, and quality assurance protocols when crafting all components of the instrument.
When producing the tool or instrument, it’s important to select and use materials that match the design specifications. This generally requires a combination of metals, plastics, rubber, and, of course, adhesives. Additionally, our production team must also consider any costs associated with the manufacturing process when aiming for an economically optimal balance between quality assurance, timeliness, and cost. We make sure to follow exacting protocols in order to meet or exceed client requirements so that the end result can be unsurpassed in quality.
To support this, we employ quality assurance measures throughout the entire process, starting with our raw material procurement and encompassing tool design, production guidance, and ongoing quality control reviews. After producing each instrument, the team performs a detailed inspection before packaging. We use only proven methods of manufacturing, including CNC machining, MIG/TIG welding, flame working, lapping, and grinding, to ensure each instrument is produced in accordance with client expectations. Our commitment to excellence demands that our products are not just of the highest quality but also reasonably priced, allowing us to guarantee their long-term performance.
The first step in making surgical instruments is to source high-quality raw materials, such as stainless steel. Ameri Surgical Instruments ensures that the raw material used for the instruments is of high quality and meets the required standards. We make all surgical instruments and tools from high-quality stainless steel due to its durability, corrosion resistance, and biocompatibility. Some surgical instruments may also be made from other materials such as titanium, cobalt-chromium alloys, or ceramics, depending on the specific instrument's intended use and requirements.
Ameri Surgical Instruments uses austenitic stainless steel grades 316L and 304L for surgical instruments and tools. 316L stainless steel is a low-carbon version of 316 stainless steel and has higher corrosion resistance, while 304L stainless steel is a low-carbon version of 304 stainless steel and It is commonly used in situations in which welding is needed.
Other types of stainless steel, such as martensitic stainless steel and precipitation-hardening stainless steel, may also be used for some surgical instruments and tools that require higher strength or hardness. But these types of stainless steel tend to be less compatible with living things and may be harder to sterilize. Following is the step-by-step process of how Ameri Surgical Instruments® make surgical instruments and tools after selecting raw material.
The raw material is heated to a high temperature and then forged into the desired shape using specialized equipment such as a forging hammer or press. This step helps creating the basic shape of the instrument.
The forging process involves shaping a metal by applying pressure and heat to deform it into the desired shape.
Here are the general steps involved in the forging process of a surgical instrument:
- Heating: The raw material, usually a stainless steel billet, is heated to a specific temperature to make it malleable and easy to shape.
- Forming: The heated billet is placed on a forging press, where it is subjected to compressive force to deform it into the desired shape. This can be done using various forging techniques, including open-die forging, closed-die forging, and impression-die forging.
- Trimming: Once the forged shape is achieved, excess material is trimmed away to give the final shape.
- Heat Treatment: The forged instrument is then heat-treated to improve its strength, hardness, and other physical properties. This process may involve quenching, tempering, or annealing, depending on the instrument's specific requirements.
- Inspection: The forged instrument is inspected to ensure that it meets the required specifications, dimensions, and quality standards.
The forging process is an important step in the manufacturing of surgical instruments, as it can impart specific mechanical properties to the instrument that make it suitable for its intended use. Forged instruments are generally stronger, more durable, and have better performance characteristics than those made by other manufacturing methods.
Once the basic shape of the instrument is created, it is then machined using specialized equipment such as CNC machines. This step helps to create the fine details of the instrument.
Milling is another process that is used to create complex shapes and patterns on the instruments. Ameri Surgical Instruments uses advanced milling machines to create intricate designs on the instruments.
After machining and milling, the instruments are inspected again to ensure that they meet the required specifications.
Some surgical instruments require filling or welding to create a smooth surface or to join two parts together. Ameri Surgical Instruments has specialized equipment to fill or weld the instruments as required.
After filling, the instruments are inspected again to ensure that the filling has been done correctly and that there are no defects.
Binding and Temper
Binding and tempering are processes used to harden the instruments and make them more durable. Following is the Standard Operating Procedure of Ameri Surgical Instruments for binding and tempering Surgical Tools:
- Heat Treatment:
The forged instrument is heated to a specific temperature to improve its strength, hardness, and other physical properties. This process may involve quenching, tempering, or annealing, depending on the instrument's specific requirements.
The heated instrument is rapidly cooled by immersing it in a quenching medium such as oil or water. This process hardens the instrument by "freezing" the metal's microstructure in a high-energy state.
The hardened instrument is then reheated at a lower temperature to soften and relieve some of the internal stresses that were created during the quenching process. This process also helps to improve the instrument's toughness and ductility.
The instrument is inspected to ensure that it meets the required specifications, dimensions, and quality standards.
The binding and temper process is critical in the manufacturing of surgical instruments, as it can impart specific mechanical properties to the instrument that make it suitable for its intended use. The specific heat treatment and quenching process used will depend on the instrument's material, shape, and intended use.
Snaffling is a process used to remove any burrs or rough edges from the instruments. Once snaffling is completed, the instruments are fitted together to ensure that they function properly.
Plant or Heat Treatment
After snaffling fitting, the instruments are subjected to heat treatment or a specific plant process to make them more durable.
Polishing / Instrument Finish
Once the instruments are heat-treated, they are polished to create a smooth and shiny finish. Ameri Surgical Instruments uses specialized polishing equipment and techniques to create a consistent finish on all their instruments.
Q. A Inspection 2%
After polishing, 2% of the instruments are randomly selected and inspected to ensure that they meet the required standards.
The instruments are then cleaned using ultrasonic cleaning machines that use high-frequency sound waves to remove any dirt, oil or debris.
After cleaning, the instruments are lubricated to ensure smooth movement and prevent corrosion.
Tuck checking is a process used to ensure that the instruments are properly assembled and that there are no loose parts.
Etching is a process used to mark the instruments with a unique identification number or brand name. Ameri Surgical Instruments uses specialized equipment to etch their instruments.
Assembly process: put all pieces together with extreme precision in a sterile environment for optimal performance of each element.
During the assembly process, each piece needs to be placed in the most precise and accurate way for optimal performance. We utilize their own trained technicians that use proprietary processes to ensure the best possible outcome. All products are assembled in a sterile environment to maintain cleanliness during production. After assembly has been completed, our quality control team tests each individual tool or instrument with rigorous scrutiny to guarantee its performance meets or exceeds our stringent standards.
We are the best in the business when it comes to the making of surgical tools and instruments. We control every step of the process, from design and prototyping all the way to assembly and testing. Our commitment to quality is evident in our attention to detail, our maintenance of sterile working conditions, and the rigorous testing protocol that allows us to confidently provide products that are renowned for their unparalleled superiority.
Quality Control Testing: Conduct various rounds of inspections and tests to guarantee product safety and effectiveness, highlighted with traceability information for total customer satisfaction!
Quality control tests are an integral part of ensuring product safety and effectiveness. Our technicians perform rigorous inspection and testing procedures to guarantee that craftsmanship and specs meet our quality standards as well as customer preferences. Tests also include traceability information (serial numbers, dates, and initials) for total customer satisfaction with every product delivered!
Beginning with material assessment, our technicians will check that all stainless steel and other materials meet our quality requirements. Then, with dimensional inspection, we'll review the overall shape, size, and structure to ensure accurate and reliable construction of specific medical instruments and tools. Finish and form factor are next to pass, where we make sure surface finishes are smooth with no rough edges and check the form factor matches what product performance requires. Also, final pressure tests are done to guarantee deflection frequency stays within a set range, while sterilization checks confirm no adverse reactions at high temperatures.
With our stringent quality-control testing, you can rest assured knowing that all our products are manufactured with the utmost care for safety and effectiveness. All the materials used will be inspected for free iron before being processed with heat treatments and finished with electropolishing to give them a smooth, sterile surface. Machining accuracy is ensured by using only precision industrial machines alongside calibrated measuring tools, while testing procedures include manual function tests as well as instrument inspections to make sure they are performing as expected. Each step of this process also comes with paperwork traceability information, giving our customers full confidence in their purchasing decisions when it comes to surgical tools and instruments!
Finalizing Process: Ensure accuracy in all aspects before the last inspection and packaging prior to shipment.
Our final process ensures all aspects of the crafted surgical tools and instruments, such as material, design, dimensions, and tests, have been completed as defined by our rigid quality standards and customer specifications. The last step for our technicians is to inspect every piece for accuracy before it's packaged and prepared for shipment. Every product is then stamped with Ameri Surgical Instruments® certification, which ensures that each instrument adheres to the highest quality control procedures prior to being used in medical applications.
The final process is an important part of our manufacturing procedures. We use state-of-the-art equipment, such as CNC machines, for precision and accuracy. Our product also has markings, grooves, and finishes that all have to meet the customers’ needs and expectations based on their requirements. To guarantee that these specifications are met before the instrument reaches the customer, we undertake an extensive final inspection process that checks the fitment tolerance levels and verifies any necessary layers of insulation. Every single detail is checked before the item is cleared for packaging with a sign-off from our expert technicians. This rigorous process results in top-quality standard medical care ensured by Ameri Surgical Instruments®. Following is our step-by-step finalizing process.
Cleaning and Checking
After etching, the instruments are cleaned again to remove any debris or residue left by the etching process. They are then checked to ensure that they meet the required standards.
Q. A. Inspection: 4%
4% of the instruments are randomly selected and inspected again to ensure that they meet the required standards.
Once the instruments have passed all the required inspections, they are carefully packed to protect them during shipping.
Each instrument is labeled with a unique identification number and information about the instrument, such as the size and type.