The medical equipment industry has its roots in intravenous (IV) glass base materials, rubber tubing, and metal instruments. The development of plastics in the 1930s, 1940s, and 1950s enabled the development of medical devices that used newer and better materials such as polyvinyl chloride (PVC) for IV bags and tubing, silicone tubing for catheters, and balloons. Polyolefins were used for trays and bottles and fluoropolymers for IV catheters. New developments in polymeric materials continued to enable the production of devices and tools that could rely on the superior properties offered by engineering polymers, newer plastics, and improved processing technologies.

As new products continue to grow and become available, so does the healthcare industry, leading to improved health. The widespread availability of quality, clean, and sterile products at reasonable prices led to the widespread growth of smaller hospitals and clinics where the sick and injured could receive medical treatment.

Advancing health care trends with the development of polymer medical devices

Any survey of the medical device industry will quickly reveal that there are several emerging trends that are shaping the advancement of medical devices. The three things we will mention are:

1. The tendency towards minimally invasive surgeries (MIS)
2. Increasing treatment progress
3. Strong movement towards prevention versus treatment of disease

Minimally invasive surgeries

Not so long ago, when a heart patient presented with blocked or narrowed arteries, the only treatment was open heart surgery or coronary artery bypass graft surgery (CABG). This surgery was complicated, expensive and traumatic.

The development of cardiac catheters capable of delivering vascular stents or scaffolds changed the landscape of treating occluded vessels. Using these balloon catheters inserted through an artery in the groin, cardiovascular surgeons were suddenly able to access the blocked artery. Other products, such as multiple access ports, allow minimally invasive surgery to be performed inside the peritoneal cavity through an incision in the abdomen.

The port is placed through the incision by inflating the cavity using a process called intubation, and the surgeon can view the inside of the body using an endoscope or viewing instrument. The surgeon can then perform procedures such as biopsy, appendectomy, hernia repair, and hysterectomy without opening the abdomen and with a small incision. Recovery time is also greatly reduced, blood loss is much less, the risk of infection and other complications from open procedures is greatly reduced, and the added benefit is that healthcare costs are also reduced.

Increasing treatment progress

Performing healthcare in places other than hospitals brings other opportunities for the medical device industry. The products used must be of the same quality as those provided by the hospital. Also, in some cases, since health care providers may not have as much experience as hospital staff, medical devices and equipment must be manufactured. So that new or inexperienced users can reliably and effectively use the desired product. Products intended for use in non-hospital settings should be easy to use and instructions for use should be easy to read and understand.

A strong move toward prevention versus treatment of disease

The trend towards disease prevention rather than treatment refers to the increasing demand for diagnostic products. From the instruments that perform the analysis to the containers and reagents that are consumed during the test to the devices that are used to collect blood, fluid and tissue samples, all these require precision medical devices, which are well designed and manufactured. This is a rapidly growing part of the industry.

Specialized polymers for medical devices

Medical devices ranging from single use (SUD) to reusable devices to hardware such as pumps, ultrasound instruments, cardiac monitors and even (MRI) equipment are all available from commodity polymers or inexpensive polymeric materials.

The raw materials used are still four main polymers: polyvinyl chloride (PVC), polypropylene (PP), polyethylene (PE) and polystyrene (PS) with ABS and styrene copolymers. SAN But more devices are made of other materials that offer better performance. Some of these materials include PC (polycarbonate), polyethylene terephthalate (PET), or any of the available polyesters, thermoplastic urethanes, polyamides, traditional nylons, and amorphous nylons.

Due to the continuous development of new devices, the need for new parts and new specialized materials continues to increase. New polymers and polymer formulations available for use continue to grow. Suppliers also continue to develop new options that meet the need for improved performance, enable the use of new technology, and expand the scope of the latest treatments.

The components of the devices must be made in such a way that the resulting device or tool can be used without operational problems. Newer polymers allow multiple features to be designed into one molded component, which may, for example, replace metal components or multiple smaller parts. Product redesign and design to manufacture with the latest materials can bring improved performance to a medical device while reducing device cost.

The performance of the medical device is inextricably linked to the characteristics of the plastic used. Advanced features such as strength, flexibility, transparency, biocompatibility, temperature and chemical resistance ensure patient safety. They must also be based on the strict regulations and classifications of the Food and Drug Administration (FDA).

However, the molder’s knowledge must extend beyond materials and design, manufacturing processes, and part geometry to ensure that medical grade resins are best used to provide:

Durability

Medical devices used at home or in emergency vehicles. These devices are characterized by their portability and reliable performance when used by healthcare workers or inexperienced people.

Chemical resistance

Medical devices must withstand repeated disinfection and sterilization using harsh chemicals and exposure to oils, greases, and other lubricants during medical procedures.

 Antimicrobial agents

Antimicrobial agents, such as ionic silver, can be mixed with the plastic melt. Therefore, injection molding plastic components and medical devices have antimicrobial surfaces that effectively kill bacteria. Implants made from resins containing antimicrobial agents continuously resist bacteria without affecting other resin properties.

Thermal and electrical properties

Attention should be paid to determining the properties of plastic materials at melting temperature, sterilization temperature and exposure to environmental conditions that include temperature and humidity. Electrical factors such as conduction and insulation or the need to dispose of accumulated static charge must also be considered.

Polyether ether ketone (PEEK) is a popular and effective choice. It has excellent mechanical and chemical resistance that allows sterilization by steam, gamma radiation, ethylene oxide (EtO) and electron beam (E-beam).

It is imperative that any review of the medical device market not only includes existing medical device materials, but also new materials, new processing technologies, and ever-changing market needs. We live in a global economy that is constantly changing, and only by being aware and up-to-date of the influences affecting our industry can a company keep its product mix at the forefront of healthcare delivery.

ncbi