In the medical world most products can be grouped into one of two main categories—disposable and non-disposable. For Product Engineers this is the first fork in the road for designing attachment or fastener solutions. To decide the assembly medium that holds together the components of a medical device you have to ask - is the product single-use disposable or multi-use durable?
- Disposable products are designed for one-time use and might include products such as test strips, tape and gauze to cover wounds, or medical device components.
- Reusable items include things like test equipment, instruments, health monitors or dental / medical devices which must be able to be cleaned and sterilized effectively for reuse.
How do you choose a fastening solution?
With numerous options in fasteners, including woven and non-woven, it can be helpful to consult the experts early in this decision process. Converters are the experts that help you select the blend of tape and adhesive products for your application, and point out options that create a true bond-line solution.
New products are coming onto the market at a rapid pace, and products are often combined into complex solutions, so it can be difficult to keep up without guidance from a tape and adhesive product expert. A good Converter should be able to help you find the right attachment solution and bonding method whether your project involves durable devices or disposables.
What about Sterility?
Some medical devices are required to be maintained in a sterile condition. Disposable products make it easy to maintain sterility standards, because they’re used once and then discarded. Non-disposable devices are subjected to various treatments that must be taken into account. These sterilization exposures are just some of the factors that will determine the characteristics of the bonding materials that are ultimately combined to fasten A to B.
Sterility requirements may also dictate clean standards begin at the point of component manufacturing. This clean-manufacturing standard can apply to the converted tapes and fasteners that hold your device together. The best Converters have "clean room production" capabilities with a dust, temperature, and humidity controlled environment. Only these Converters can support the exacting standards required for precision electronics and medical devices.
Considerations to disucss with your Converting partner:
To help your Converter suggest adhesive or tape options you’ve got to provide them with detailed information about your product needs. This means asking the right questions. Listed below are questions your converter will ask in order to suggest the correct tape or adhesive samples for prototype testing:
- Do regulatory compliance issues affect your material’s configuration?
- To which levels of sterilization will the product be exposed?
- How many units will you produce, over what time-table?
- Are you using high-speed production methods or manual assembly?
- Which configurations such as rolls, sheets or kiss-cutting make your materials more user-friendly at the assembly line?
Ultimately a strong relationship with your Converter can ensure that you end up with the finished product that meets the high standards you are looking to achieve. Gleicher can help answer your questions with our handy guide to help you design your medical device bond lines.
How do we know?
Gleicher Manufacturing Corp. is a 3M Preferred Converter with strong relationships with 3M.
Having spent nearly half a century working in the healthcare industry, we understand healthcare rules and regulations and can provide you with the support you need to ensure your product satisfies those mandates, and that your product is safe and comfortable for patient use.