When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of the factors to consider. Hence, the medical device manufacturing process and product development stage has to factor in various requirements. The entire production process from product design, materials to be used for construction to manufacturing and distribution is highly regulated. The regulations are in place to ensure safe, effective, and high-quality medical devices are consistently being manufactured. In this blog, we will discuss some common materials used for manufacturing medical devices. Additionally, we will touch upon some key points kept in mind when choosing materials used in medical device manufacturing.

Materials used for manufacturing medical devices

Medical device manufacturing material selection is a vital step in medical device design and development. The medical device manufacturing material considerably impacts safety and performance of the devices. Materials selection is based on the appropriateness of the material for the particular medical device. The key factors to consider are device design and material flexibility, biocompatibility, and cost-effectiveness. Also, product safety, quality, and performance along with regulatory requirements have to be factored in when selecting the construction material. Furthermore, the manufacturing process and intended use of the medical device are also critical factors. Additionally, functional requirements of the device and whether it will remain in direct contact with the patient should be taken into consideration. Hence, during the early phases of product development, the appropriate material for manufacturing the device should be selected. However, medical device developers may face various challenges while selecting materials used for manufacturing medical devices.

Furthermore, an in-depth understanding of the medical device construction materials is required. You need to check whether the properties and characteristics of the material will be appropriate for your medical device and its intended use. Physical performance, manufacturing constraints, budget limitations, and supply chain logistics are some of the additional factors that have a vital role in medical device material selection. You should predefine a set of selection criteria and parameters to guide the medical device manufacturing material selection process. As medical device developers, the best method to select the construction material would be to shortlist a range of materials. Then, zero down on two to three candidates depending on your selection criteria. After which, you should thoroughly analyse and test the material for appropriateness for your device.  

Selecting materials used for manufacturing medical devices: A vital step in medical device production

Regulatory bodies stringently regulate the medical device production and development process.  Medical device construction material selection is a critical step in the medical device production process. Notably, all the materials generally used for constructing devices in any industry cannot be used in the medical device industry. This is because the medical devices function in close proximity or in direct contact with the human body. Thus, regulatory bodies strictly regulate the materials used for manufacturing medical devices. Special emphasis is given to the device material biocompatibility. Notably, not every medical device requires very high level of biocompatibility. However, medical devices intended for internal use require high levels of biocompatibility. Thus, materials to be used to construct internal-use medical devices, such as pacemakers, stents, artificial hips, and prosthetics, have very strict regulations.

Furthermore, medical device material biocompatibility will affect patient health and wellbeing. Thus, ISO 10993 guidelines provide grounding principles and standards necessary for evaluating the biological safety of medical devices. Therefore, the medical device manufacturing material selection process should revolve around mitigating risks and liability as well as regulatory compliance. Hence, the medical device design and development team should prioritize biocompatible materials best-suited for device specific requirements and applicable regulations.  

Major factors to consider when choosing materials used for manufacturing medical devices

Metals, polymers, and ceramics some of the common materials used for manufacturing medical devices. Notably, these materials can be in contact with patient body parts for extended periods of time. Moreover, the safety and efficacy of medical devices partly depend on the materials used to manufacture them. Thus, medical device developers have to be extremely cautious when selecting medical device construction materials. Hence, we have listed some important factors taken into consideration when choosing materials used for manufacturing medical devices.

• Material properties
• Biocompatibility
• Device intended use and functionality
• Device design
• Cost effectiveness 
• Manufacturing process
• Regulatory compliance

Various materials used to construct medical devices

Medical devices have a vital role in the modern healthcare system. They are used to diagnose, treat, and monitor patients. It is vital to use appropriate materials for constructing medical devices. The safety, efficacy, and quality of the devices will depend on the construction materials. Hence, the materials indirectly impact the device’s healthcare applications. Thus, this warrants the need to regulate materials used for manufacturing medical devices.

We have listed some materials used for manufacturing common medical devices:

1. Surgical gowns: Non-woven fabric is used to make surgical gowns. The fabric is lightweight and breathable. Additionally, it provides an effective barrier against pathogens.
2. Gauze bandage: Cotton fabric is used to manufacture gauze bandage. Owing to its absorbency and softness, cotton is used. Also, it is ideal for wound care.
3. Gloves: Latex/vinyl/nitrile is used to manufacture gloves. These materials are used because of their flexibility, comfort, and protection that they provide during medical procedures.
4. Urine bag: Polyvinyl chloride (PVC) and polypropylene (PP) are used to make urine bags. They are preferred for their durability and flexibility for fluid collection.
5. Blood bag: The blood bag has various components, namely needle, bag, and rubber. The materials used have to be safe for storage and transfusion of blood. Stainless steel is used to construct the needle. Polyvinyl chloride (PVC), high-density polyethylene (HDPE), and polypropylene (PP) are used for the bag. Synthetic rubber is used for the rubber component.
6. Syringe and needle:  Polypropylene (PP) and thermoplastic elastomer (TPE) are used for the syringe component. Polypropylene is used for its durability and resistance to chemicals. Hence, it is often used to construct syringe barrels and plungers. Whereas, thermoplastic elastomer provides a flexible and comfortable grip, thus improving user experience. On the other hand, stainless steel is used to construct the needle. It provides strength and precision for injections.
7. Blood collection tube: Polypropylene (PP), low-density polyethylene (LDPE), and polyethylene terephthalate are used to construct the tube component. The tube is constructed using these materials due to their chemical resistance, clear visibility, and durability. Isobutyl rubber stoppers are used to provide an airtight seal. Also, it prevents contamination and preserves sample integrity. Furthermore, K2/K3 EDTA, potassium oxalate, lithium heparin, sodium heparin, etc. are used to stabilize blood samples stored in the tube.
8. IV set: For constructing the set components, acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC, DEHP-Free), and polypropylene (PP) are used. Also, for the extruded tube, PVC/silicone tube is used. Stainless steel needles are used to ensure safe and effective delivery of fluids. A 15-micron solution filter is used to construct the drip chamber filter.  
9. 3-Way stop cock: The materials used to construct 3-Way stop cock have to be durable and be able to withstand the pressures of fluid management in medical settings. Polypropylene (PP), high-density polyethylene (HDPE), and polycarbonate (PC) are commonly used to manufacture 3-Way stop cock.
10. IV cannula: The IV cannula is made of various components. The materials used to construct them should offer strength, flexibility, and biocompatibility for effective intravenous access. High-density polyethylene (HDPE), polypropylene (PP), linear low-density polyethylene (LLDPE), and polyoxymethylene (POM) are used for the cannula. Polyurethane (PU), Teflon, or PTFE is used for the catheter. Stainless steel is used to construct the needle. Also, silicone tubes are used to construct the small tube component of the IV cannula.

Pharmadocx Consultants: Your trusted regulatory partner

In this blog, we have summarized the factors taken into consideration while selecting materials used for manufacturing medical devices. Are you planning to manufacture medical devices in India? You will require the CDSCO medical device manufacturing license. Our team will ensure you have a smooth regulatory journey. Drop an email at [email protected] or call/Whatsapp on 9996859227 to let us help you easily secure the CDSCO manufacturing license.