Medical devices are some of the biggest innovations that have pushed the medical industry forward. Through these products, many patients have recovered from illnesses, while others have effectively managed their symptoms and lived with less pain and discomfort. These devices also help advance medical research and allow scientists to come up with new innovations that further improve healthcare practices. These, in turn, enhance the quality of life of patients.
Medical device design is an important and profitable field. Ever-improving manufacturing technologies are opening new doors for innovative entrepreneurs and designers. But what exactly are medical devices made of? Are they built using the same processes that make other products? Let’s take a closer look.
Choosing Manufacturing Materials for Medical Devices
The materials used to make medical devices depend on how the products will be used. They are chosen based on the following factors:
Mechanical Requirements
Some medical devices are frequently exposed to intense heat, while others are used in cold or even freezing environments. Certain products need to be soft, flexible, and pliable, while others must be strong and rigid. The materials that are used in these devices should correspond to the required properties and allow them to have excellent performance.
Cost
Just like any other business, medical device manufacturers need to develop a wide profit margin if they want to survive and grow. Because of this, they need to choose materials that won’t only allow them to make their desired product but also keep their costs low. Some manufacturers opt for lower-performance materials that can still do the job, while others use more expensive materials that allow for lower overall part counts. Both methods are acceptable as long as they result in a high-quality and high-performance medical device that are safe for patients and healthcare staff to use.
Compatibility to manufacturing process
A single device can be made using various methods, depending on what manufacturing stage it is on. For instance, a product that’s still in the prototyping stage can be made using thermoplastics which might not resemble the intended final production material but give developers the chance to examine the design for form, fit, and function. Once the design has been improved, a second-generation prototype of the product can be made using the same materials that will be used in final production, whether they be metals, plastics, or liquid silicone rubber.
Availability
Some materials can be difficult to source because they are too expensive, have limited supply, or need to be imported. If this is the case, manufacturers have two major choices: increase their budget for the materials (and recoup the cost later on by raising product prices) or use a lower-cost alternative (and be able to sell their product at competitive rates).
To make the right decision, they need to examine just how essential the material is to their product design. If the medical device simply cannot function without the material, they have no choice but to fork out the funds for it. If they can use a cheaper alternative, they must make sure that the product will have the same level of performance even when the alternative material is used.
Another factor they should consider is the future availability of the material. Will they be able to source it in the coming months, years, and decades? The answer should be “Yes” since it’s important to use a material that will be available throughout the product’s life-cycle. If it gets discontinued, manufacturers would have to use another material, which means they’d have to adjust the manufacturing process and potentially go through another lengthy round of approval and certification processing with the FDA and other governing bodies.
Patient safety
This is one of the most important factors to consider, especially for medical devices that will be implanted inside the body. Manufacturers have to look for materials that are not just durable but also won’t be rejected by the body’s immune system. Some examples are titanium and surgical steel, which have excellent biocompatibility and are used to make plates, screws, and pins to repair bone fractures.
It’s important to check the safety of materials for medical devices, even if they’re not implanted inside the patient’s body. Whether they’re used externally or inserted into the body for a short period of time, these products should still be made of high-quality materials that are biocompatible and won’t irritate or damage tissues.
Ease of maintenance
When it comes to medical devices, sanitation is one of the top priorities. This is especially true for non-disposable products that are used in a clinic or hospital setting and are shared by various patients. Because of this, medical device manufacturers need to choose materials that are easy to clean. They must be able to withstand autoclaving, gamma sterilization, and other methods that are used to remove bacteria and other contaminants from medical devices. In the case of items with electrical components that cannot be sterilized through heating and other methods, they should have surfaces that are made of liquid silicone rubber or other materials that can withstand chlorine and other industrial-strength, antimicrobial cleaning products.
Types of Manufacturing Materials
There are certain materials that can fulfill the requirements above and help manufacturers create high-quality and cost-effective medical devices. These include:
Metals
Certain types of metals are ideal for medical devices that need to implanted inside the body. Surgical steel, as mentioned above, is the metal of choice for implants that are used to repair bone fractures. Titanium, (which is also a good choice for bone implants), is used to make pacemaker casings, although these can also be made with a titanium alloy.
Plastics
The malleability of plastics, which has caused them to be a popular material for various everyday items, makes them highly valuable in the medical device industry. A wide range of biocompatible plastics have been developed, and they’re now used in countless applications.
Polyurethane, for instance, is used to insulate the metal lead in pacemakers, while polyvinyl chloride (PVC) is used to make blood tubing and blood bags. Polyetherimide (PEI) is the material of choice for surgical skin staples, while polyetheretherketone (PEEK) is used to make rigid tubing for various purposes. PEI and PEEK are a favorite of medical device manufacturers since they can withstand the heat from autoclaving without losing their rigidity.
The biocompatibility of plastics is determined by USP Class VI and ISO 10993. Medical device manufacturers who want to ensure that they’re using the best materials should look for plastics that pass the standards of these tests.
Liquid silicone rubber
Medical grade liquid silicone rubber is preferred by many manufacturers because of its thermosetting property. Liquid silicone rubber complies with USP Class VI and ISO 10993 standards, and it can be sterilized using autoclaves as well as E-beam and gamma radiation processes. It also stays stable and maintains its resiliency and flexibility even when exposed to high temperatures.
Learning More from the Experts
If you’re planning to enter the medical device industry, one of your top priorities is to choose the right materials for your products. By using the best possible materials, you’ll increase your chances of obtaining FDA approval and certification and getting your product out to the market as soon as possible. You’ll also keep your costs low while maintaining product quality and performance, which can lead to a wide profit margin.
Another thing you can do is to work with people who are experts in the medical device sector. If you’re still in the design phase, for example, you can get the help of Cad Crowd freelancers. We have a large network of medical device designers who have years of experience in the industry and are highly familiar with the materials used to make medical products. With their assistance, you can choose the best materials that fit your purpose and help your product have excellent performance.
Our design experts can review your existing designs or start a new one from scratch, ensuring that all your requirements and specifications are met and that your product can be made at the lowest manufacturing cost. By hiring Cad Crowd freelancers, you’ll have experts who’ll work on your product design process and will leave you free to focus on other tasks. It’s a great way to ensure product quality while reducing costs and growing your business at the same time!