3D Printing Of Body Parts But Regulations Are Not Ready

3D Printing Of Body Parts But Regulations Are Not Ready

3D printing has seen a huge increase in medical use over the past few years. Engineers and medical professionals routinely use 3D printing to create surgical tools and prosthetic hands. However, 3D printing is only the beginning of a revolution in this field.

Bioprinting, an emerging technology that is rapidly changing the landscape of manufacturing, is poise for further advancements. Bioprinting is a technique that uses 3D printers to create three-dimensional structures from biological materials. This includes cells and biochemicals. It also employs precise layer-by-layer positioning. The ultimate goal of bioprinting is to reproduce functioning tissue and materials, such as organs. This can then transplant into humans.

In collaboration with Saint Louis University and Bournemouth University, we have been mapping the adoption 3D printing technology in the field health care and bioprinting. Although the future seems promising from both a technical and scientific standpoint, it is not clear how bioprinting will be regulate. This uncertainty could prove to be problematic for both patients and manufacturers, and could hinder bioprinting’s ability to live up its promise.

From 3D Printing To Bioprinting

3D printing is the origin of bioprinting. 3D printing is a general term that refers to technologies that combine materials, often layer upon layer to create objects from data in a 3D model. Although initially limited in its applications, 3D printing is now widely used across many industries. 3D printing is now a common method of manufacturing parts for cars, educational tools such as frog dissection kits, and even 3D-printed homes. British Airways and the United States Air Force are both developing 3D printing methods for airplane parts.

3D printing is used by doctors and researchers in medicine for many purposes. It can be used for exact replicas of patient’s body parts. Implants can be customized to fit the needs of patients in reconstructive and plastic surgery using biomodels that are made possible by software tools. For example, human heart valves are being 3D printed using several processes, but none have been transplanted yet. In dentistry, there have been many advances in 3D printing methods over the years.

Bioprinting is a rapidly growing industry that uses 3D printing technology to create a variety of products using biological components. This includes human tissue, and more recently vaccines

Although bioprinting isn’t a new field, as it is based on general 3D printing principles it is an innovative concept for legal and regulatory purposes. Regulators may not know how to approach the field, and this is where things could go wrong.

The Latest Printing Technology

Scientists are still far away from 3D-printed organs as it is difficult to connect the printed structures to the vascular system that carries life-sustaining blood and lymph throughout our body. They have succeeded in printing certain types of non-vascularized tissue, such as cartilage. They are also able to create metal and ceramic scaffolds that support bone tissue using different types bio printable materials such as gels or nanomaterials. There are a number of promising animal studies that have done, including ones that involve blood vessels, cardiac tissue, and skin. These results suggest that this field is closer to its ultimate goal, which is transplantable organs.

Bioprinting technology will continue to advance at an accelerated pace, even though there are limitations in current technology. This could potentially improve the lives of many patients. Numerous research groups reported numerous breakthroughs in 2019. For example, hydrogels were use by bioengineers at Rice University and Washington Universities to print the first complex vascular networks. The first 3D-print human heart was create by scientists at Tel Aviv University. It contain cells and blood vessels, ventricles, chambers, and made using cells and biological material from a human patient. A team from Swansea University in the UK developed a bioprinting method to create artificial bone matrix using durable, regenerative biomaterial.

Clone Printing

Although the future is promising, there are still many hurdles to overcome in bioprinting regulations. It is difficult to define what bioprinting is from a conceptual perspective. Take the example of a 3D-printed heart. Is it better to call an organ or a product? Should regulators consider it a medical device or an organ?

There are many questions that regulators need to answer. They must decide whether bioprinting should have to be regulate under existing or new frameworks and, if so, which ones. They should apply regulations to biologics, which is a class that includes complex pharmaceuticals such as treatments for cancer or rheumatoid, since biologic materials are involve. Is there a better regulatory framework for medical devices that can be use to custom-make 3D-print medical devices, such as splints for babies with life-threatening medical conditions?

Bio Printed Materials

Scholars and commentators in Europe and the U.S. have debate whether bio print materials should be grant patent protection due to the moral issues they raise. A parallel can drawn from Dolly the sheep, 20 years ago. The U.S. Court of Appeals, Federal Circuit ruled that patentable cloned sheep could not be grant because they were identical to naturally occurring sheep. This case is an example of the similarities between cloning, bioprinting, and other forms of cloning. Many people speculate that clone printing will become a reality in the near future. This has the potential to revive extinct species and solve the shortage of organ transplants.

Dolly, the sheep’s case illustrates the court’s unwillingness to follow this path. Based on current law, a patent application for this nature could be reject if bioprinters, or even clone printers, can be use to reproduce not only organs, but also humans using cloning technology. Bournemouth University is leading a study fund by European Commission that will be complete in 2020. It aims to provide legal guidance regarding the various issues related to intellectual property and regulation.

However, European regulators could classify bioprinting products as medical devices. This is because there has been a long-standing regulatory system for medical devices. The FDA in the United States has published guidance regarding 3D-printed medical devices but not the details of bioprinting. Importantly, this guidance is not binding. It represents only the thoughts of one agency at a time.