Design and manufacturing engineers strive to develop high-quality devices in a budget-conscious and timely manner. The problem is that a variety of challenges occur in the design and assembly processes that can present functionality issues of the finished device. Some challenges, if not taken into account beforehand, can potentially prevent the device from going to market. One of the most significant challenges on the front-end is complying with ISO 10993, which is published by the International Organization for Standardization (ISO), the largest developer and publisher of international standards in the world.
There are many ISO standards for the medical device industry, one of the most important being compliance with ISO 10993. Virtually every medical device must be tested to comply with this standard before it can go to market. Testing can take several months to a year to complete, depending on the device’s intended use.
Compliance with this standard cannot be overlooked. ISO 10993 tests a product’s biocompatibility and determines the potential toxic response of materials coming in contact with body tissues. Because there are different levels of bodily contact, ISO has developed a variety of testing levels. The more levels necessary for completion, the longer certification takes. A device intended for transient use, for example, requires around four to five months to complete.
Fortunately, there are medical grade certified materials available for use on transient devices that can help assure compliance with this standard. By using materials that are certified in advance, designers and manufactures can be confident that the completed device will successfully pass biocompatibility standards without compromising functionality of the finished device.
Mitigate Challenges with Certified Lubricants
For transient, single-use surgical devices, a certified lubricant can mitigate common functionality challenges while saving time and money in getting to market. One of the most common functionality challenges that medical device designers and manufacturing engineers face are stacked tolerances.
Tolerances are the expected variation of a component’s physical dimensions. They cause problems when they begin to “stack up” against one another causing imperfect fits between mating parts and a break down in device function. This is particularly common with complex mechanical assemblies, including surgical staplers and arthroscopic devices.
Many design engineers create flawless devices in the new product design stage, but oftentimes underestimate the impact of stacked tolerances when those same new products are released for full production. It’s not until production that stacked tolerances become the most prevalent. Here, mating parts often fit imprecisely and present noticeable variation in the operation of the finished device from one production run to another. Ill-fitted parts increase friction and ultimately compromise device functionality.
Foreseeing potential issues with stacked tolerances in the design phase will help mitigate common challenges when a new product is released for production, which in turn improves processes and the bottom line. There are a variety of products and processes available that can help. One that is proven to provide consistent results with maximum quality in device performance is the use of dry polytetrafluoroethylene (PTFE) lubricants.
Specifying dry PTFE lubricant coatings in the design stages can alleviate stacked tolerance issues during assembly. Dry lubricants typically reduce the force needed to actuate a device by 25 to 30 percent, and help to produce a device with optimal quality, consistency, and performance. An added benefit is that some dry lubricants, such as Duraglide dry lubricant coatings, are ISO 10993 certified. Specifying a pre-certified lubricant reduces extended delays for testing, and means one less component within the device that engineers have to worry about passing the final certification tests.
Certified Products Improve Efficiencies
All too often, it’s during a product’s initial production stages that glitches caused by stacked tolerances become apparent. This frequently causes significant delays in the introduction of a new product as engineers troubleshoot issues. Having access to products that are already certified provides medical device manufacturers confidence that biocompatibility requirements will be met, and production stays on schedule with limited setbacks. For suppliers, having ISO certified products means helping customers get their devices to market on time. That’s what matters most.
On a structured schedule, you can’t afford to gamble whether or not the device will be certified. So, look to a supplier that can become a true business partner throughout the design and manufacturing processes by offering pre-certified products, improving your efficiencies, and reducing your costs.