Manufacturers can optimize functionality, use and volume to deliver high-performing, high-quality single-use surgical instruments to customers.
Steve Santoro, MicroSurgeons and hospitals increasingly need single-use surgical instruments — as they offer several distinct advantages over reusable products.
Disposable instruments designed for single-use don’t need to undergo expensive and time-consuming cleaning, sterilization and reprocessing. Reusable instruments such as articulating laparoscopic devices with sophisticated, intricate parts also can be difficult to clean and thoroughly disinfect, thus increasing the risk of infection to patients.
Single-use medical instruments are pre-sterilized and individually packaged. Health providers can dispose or recycle them after use.
Unlike their reusable counterparts, single-use instruments aren’t subject to wear and tear, dulling, chipping, denting and rusting that can damage reusable products and impact functionality over time — an important consideration for products used frequently in the operating room. As a result, single-use scissors and other cutting instruments, for example, are optimally sharp every time, making surgery more efficient, safer and with better outcomes for patients.
Medical device manufacturers want to know that they can get disposables manufactured without sacrificing cost or quality. With advances in technology and materials like high-grade stainless steel, it’s possible to cost-effectively produce robust single-use instruments that meet all functional requirements.
One can achieve well-designed, high-quality, high-performing products using a design for manufacturability (DFM) process tailored to the intended use of the product. It’s important to identify from the outset whether an instrument will cut, dissect, seal, stitch, staple or insufflate — and understand whether it will need to articulate or stay rigid or be required for hot and cold cutting during surgery.
Once you identify functionality and the project’s overall goal, examine its commercial, technical, and compliance risk parameters. The next step allows you to select the optimal materials and processes that meet the needs of a project, ensuring the life and function of the product.
Design prototyping and feasibility testing are essential steps to complete early on in the process. Prototyping and testing a functional product design allow manufacturers to evaluate production material and refine design and production elements. As early as possible, use production style processes to make prototypes. As part of the DFM process, the prototyping and testing can determine the most efficient and effective production process needed to meet customer goals, resources and turn-around time.
Often customers focus on the back end, output and cost. With DFM, manufacturers can optimize designs upfront so they’re capable of being manufactured at high volumes. DFM also provides a blueprint for ramping up with a validated, evidence-based development process that saves time and money downstream.
For high-volume projects, automated processes like stamping dies, automated machining centers, laser cutters and welders with inline inspection vision systems are quite effective. It’s possible to amortize upfront equipment costs over time if technology investments are needed. Articulation joints are a great candidate for laser cutting in particular, but any number of processes can have advantages depending on specific design needs.
Lower volume projects are better suited for less automated technologies that can be quicker to market. If volume needs to increase as the product gains market acceptance, a manual process can be replaced by a more automated process without significant interruption. Considering alternative engineering processes during DFM will allow manufacturers to accommodate volume or other changes later on.
Stainless steel tubing is a primary support feature of single-use hand-held surgical devices. It’s possible to produce tubing efficiently and cost-effectively using a number of engineering processes, from manual production to fully automated systems.
Depending upon the device, volume and feature needs, one can use drawn or stamped and rolled tubing to manufacture metal tubes. An assessment of component size, tolerance, the thickness of the tubes, and whether the device will require the tube to move or remain static will help determine process selection. Another important factor is wall thickness. Most single-use medical tubing is thin-walled (typically 0.010 in.), and any number of processes can be effective. If a thicker wall (0.030 or 0.040 in.) is needed, a machining process may be required to accommodate features such as grooves and slots.
A progressive stamping process can effectively produce high-volume rolled tubing with complex features such as holes, slots, and windows. We can stamp a tube out of flat stock using this innovative method, resulting in a finished tube with complex features. The process helps reduce production time, as it’s possible to stamp and roll a finished tube in seconds using a power press versus drawing raw tube, cleaning and cutting to desired length and secondary processing. The method is well suited for single-use surgical devices, including scissors, graspers, dissectors and tissue-holding forceps.
Steve Santoro is EVP of Micro (Somerset, N.J.), a full-service contract manufacturer of precision medical devices, injection/insert/metal injection molding, fabricated tube assemblies, sub-assemblies and complete devices.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.