Medical device manufacturing requires high precision and attention to detail to ensure their safety and effectiveness.
There are many critical aspects of medical device manufacturing you need to think about when choosing the right adhesive. In this article, we will discuss the main considerations you must be aware of during the decision-making process.
What to Consider When Choosing the Right Adhesive for Medical Device Manufacturing
Secure Attachment to the Patient
In wearable medical devices, such as sensors or patches, the adhesion strength between the device and the patient’s skin is crucial for multiple reasons:
- It must be securely attached to the surrounding area to prevent any movement or dislodgement, which can cause further complications.
- Depending on the application and length of time required, the adhesive needs to be strong enough to hold the device in place for extended periods or be comfortable enough to remove without pain if the wear time is only a few hours or a couple of days. You will also need to consider the size and weight of the device and whether the device is load bearing.
- It must be compatible with the area it is to adhere to. Does it need to just adhere to skin? Where on the body will the medical device be attached? What age group are you targeting? Is the device single- or multi-use where the adhesive patch needs to be replaced?
Ability to Withstand Stresses
Adhesion strength is critical in the manufacturing process of medical devices. The different components of the device must be securely bonded to one another to ensure that the device can withstand the stresses and strains it will encounter during use. Weak adhesion can lead to component failure, which can have serious consequences for the patient and the manufacturer.
Meet Strict Regulatory Requirements
Adhesives used in medical devices must meet strict regulatory requirements, such as biocompatibility and ISO 13485, to ensure that they are safe for the patient. Manufacturers must also follow rigorous testing procedures to verify the strength and durability of all components including the adhesion within or on the final product.
Overall, it is clear that the use of high-quality adhesives and bonding methods is essential in medical device manufacturing. There are a number of factors that are essential in guaranteeing the safety, effectiveness, and longevity of medical devices, as well as for the protection of patients. The use of high-quality adhesives and rigorous testing procedures are vital to ensure that medical devices are manufactured to the highest standards, and that they meet the strict regulatory requirements necessary for their use in healthcare.
Medical Device Manufacturing & BDK
At BDK and ATP, we provide comprehensive project management which consists of design, materials, prototyping and development, process validation and production. During our prototyping and development stage, we identify the right materials for your product development and undertake adhesive strength testing to provide a solution that meets your specification as well as these requirements.
Contact us today to find out more information and to discuss your project with us.