ƒPorcine tissue use in medical device manufacturing is becoming increasingly common, partially due to the fact that porcine tissue and organs have a close anatomical and mechanical similarity to human tissue. Porcine tissue is also a popular choice because of its existing use in many medical devices, giving it a proven track record and giving manufacturers previously established guidelines and sources to work with. Compared to other tissue and organ options, as well as some synthetic options, porcine models are more readily available and often have a lower cost.
Although the industry has an interest in synthetic alternatives, there are many benefits to choosing a natural source like porcine tissue. Material choice impacts a medical device’s performance, durability, regulatory path, supply chain risk, and more, making this an important decision for medical manufacturers. In this article, we’ll break down real-world device applications, what the manufacturing process and timeline could look like when using porcine tissue in medical devices, key factors to consider, and future trends and sourcing strategies in an ever-changing medical environment.
Real-World Porcine Tissue Use in Medical Devices
Porcine Tissue in Bioprosthetic Heart Valves
When looking at the medical device industry today, one does not have to look far to find examples of porcine tissue in use. One common area for porcine tissue use is bioprosthetic heart valves, with studies showing that porcine pericardium is a viable candidate for surgical heart valve development. This concept is not just theoretical, as many medical manufacturers are already using porcine tissue in this application. Porcine-derived heart valves can be used to replace damaged or diseased native aortic valves, as well as previously implanted valves that are damaged or failing. Tissue valves (as opposed to mechanical valves) often don’t require long-term blood thinners, don’t make noticeable sounds, and don’t cause pregnancy complication risks. Although valves made from organic tissue may not last as long, they offer many benefits to a patient’s health and wellness.
Porcine Tissue in Surgical Tissue Implants
Porcine tissue is also used to produce surgical implants to reinforce soft or weak tissue, repair damaged or ruptured tissue, and provide support in tissue reconstruction. There are over 200 surgical meshes available, categorized as synthetic or biologic. Synthetic mesh options often come with negative effects such as chronic pain, infections, and adverse body sensations. Because of these complications, many medical professionals choose biologic tissue products as a safer option, with porcine dermal meshes gaining increasing preference due to safety and effectiveness.
Porcine Tissue in Medical Production
These are just two of the most common uses, as porcine tissue has many applications in medical devices. Additionally, porcine tissue is used in many closely related fields, such as pharmaceutical and vaccine production. When porcine tissue is sourced from trusted, high-quality providers, it opens the door to many new technological advancements in the medical field.
Benefits of Porcine Tissue in Medical Devices
When medical manufacturers consider material options, porcine tissue is often compared to other natural options (such as bovine tissue) and synthetic options. Many manufacturers choose to use porcine tissue for multiple reasons. First, porcine tissue (including porcine pericardium, porcine valves, porcine lungs, and more) often has a close anatomical and mechanical structure to human tissue. This makes it an easier match when developing medical devices, as the structure is already a close match.
Additionally, one research study found that porcine pericardial leaflets were able to be used to produce surgical heart valve designs. Bovine pericardium often has a multi-layered structure, which is more expensive and may lead to more potential failure points. This study examined porcine tissue as a thinner and more flexible alternative, finding positive results. In many cases, researchers are now choosing porcine tissue over other natural alternatives.
Porcine tissue (and other natural tissues) is often a preferred choice over synthetic alternatives as well, for multiple reasons. Biologic, natural tissue often has better cell-adhesion, a more natural mechanical response, and in some cases, even a better host response. In many studies, natural tissues (including porcine tissues) provide more favorable responses than synthetic options. As previously mentioned, natural tissues can also help eliminate risks, noises, and long-term dependencies on medication.
Finally, because porcine tissue is already used in medical manufacturing applications, manufacturers who choose porcine tissue may face fewer unknown factors in the sourcing and quality-control processes. There is an established precedent in this area of the industry, as long as you choose to work with a trusted porcine tissue supplier.
Medical Device Development and Approval Process
Before a new medical device can be brought to the market, it must first go through a thorough approval process. In the United States, this process can take three to seven years. The process includes a discovery and proof of concept phase, in which researchers must consider regulatory and safety requirements. After formulating the concept and considering market feasibility, researchers begin working on prototype design and testing.
It’s important to engage with the FDA or other regulatory agencies early in the process to ensure the appropriate trials are completed. After the FDA approves the device, there is still post-market safety monitoring to ensure user safety. The success of a device through this entire pathway is dependent on the quality of materials used in development. High-quality porcine tissues can help this process move smoothly and make the difference between approval and rejection. Learn more about phases of the development and approval process.
Key Considerations When Utilizing Porcine Tissue
Choosing high-quality porcine tissue can make all the difference in medical device manufacturing processes. When choosing a porcine tissue supplier, there are multiple factors to keep in mind.
Tissue Origin and Specifications
When choosing a porcine tissue supplier, consider the age, breed, and health of the animals being sourced from. Additionally, consider which tissue and organs are required and whether the supplier can provide them. It’s also important to consider harvesting location, consistency, traceability, and quality control processes.
Harvesting and Handling
Quality of porcine tissue can be directly related to the time between harvest and tissue processing, the conditions of harvesting, the packing and shipping methods, temperature control, processing treatments, and sterilization methods. Choose a trusted porcine tissue supplier that has a proven Quality Management System.
Customization and Customer Service
To ensure a smooth purchasing process, work with a tissue supplier that provinces custom animal specifications and traceability options — such as offering a choice of live weight range, choice of gender, traceability, and more. Host animal custom specifications, and a team that puts your needs first, will make the medical device manufacturing process much smoother.
Tissue Source is a porcine derived raw material supplier that can procure and supply porcine tissues tailored to your needs. We offer the highest levels of customer service and tissue quality control, ensuring that your research, manufacturing, and medical applications are treated with the highest priority and respect. By choosing Tissue Source, you gain a partner dedicated to the success of your medical device needs. Contact us today to learn how our porcine tissues can support your next study, production, or medical application needs today.