Healthcare Compliance Issues for 3D Printing Medical Devices

Medicine is constantly working with technology to try to find different ways to help patients. Generally, when technology, such as 3D printing, is used – either in software or hardware – or both – the technology may be considered a medical device.  The Food and Drug Administration has the authority to regulate medical devices.

“FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.” “CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens, and color televisions.”

FDA categorizes medical devices as Class I, II, or III devices. The level of control increases from Class I to Class III.

The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval…”

In this article, we discuss 3D printers (including FDA oversight) which are used to manufacture or are components in many different types of medical devices –

“including those with complex geometry or features that match a patient’s unique anatomy.  FDA identifies medical devices that use 3D printing as devices that are either printed from a standard design (so multiple identical copies could be made) – or devices (known as patient-specific or patient-matched) devices that are created from a “specific patient’s imaging data.”

Some commercial 3D printed medical devices include instrumentation devices (such as guides to assist with the proper surgical placement of a device), implants (for hip joints, cranial plates, and other body parts) and external prostheses (for example, prosthetic hands or legs). New 3D printing research is working to even manufacture a heart, a liver, or another living organ.

The technology behind 3D printing for medical devices involves many different considerations such as the final use of the product and how easily someone can use the printer. FDA has its own 3D printers that the agency uses to understand how these different technologies work and “what parts of the printing processes and workflows are critical to ensure the quality of the finished medical device.”

3D printing technologies include:

• Powder bed fusion (which works with titanium, nylon, and other materials) used in medical devices.

“The powder bed fusion process builds a three-dimensional product from very fine metal or plastic powder, which is poured onto a platform and leveled carefully. A laser or electron beam then moves across the powder layer and melts the material it touches. Melted material fuses to the layer below it and to the powder around it to create a solid. Once a layer is completed, the platform moves down and one more layer of carefully leveled powder is placed on top.”

• Patient-matched devices. These devices are designed to match a specific part of a patient’s anatomy – for example, through a template model that is then matched to the patient using medical imaging.

The FDA regulation of 3D printed medical devices is achieved “through the same pathways as traditional medical devices.” This means the devices are “evaluated according to the safety and effectiveness information submitted to us by the manufacturer.” For patient-matched medical devices, FDA commonly examines the pre-defined minimum and maximum specifications – and then reviews the devices the same way they would review standard-sized devices. “For instance, the specification may define a minimum and maximum wall thickness or how sharp a curve can be to maintain device performance for its intended use.”

Patient-matched devices don’t automatically qualify for the “custom” exemption for FDA medical device review. The exemptions can be reviewed at the Custom Device Exemptions guidance.

FDA states that 3D printing is used in many other ways – besides for medical devices. The Department of Energy, for example, is researching how 3D printing may reduce the number of manufacturing steps. The DOE has a How 3D Printers Work webpage.

Common 3D Medicine Applications

According to Codete (a technology company), some of the uses of 3D printing for the medical profession include:

1. Prostheses and braces. This use of 3D printing helps design devices that are fine-tuned to the patient’s needs. Codete reports that UNYQ, a medical 3D printing company based in San Francisco, has developed a prosthetic leg socket and is now building custom prosthetics to fit into the socket. Another 3D printing company is working with professional sports teams to create devices that can “accommodate scars, burns, incisions, and postsurgical hardware.”

The traditional manufacture of prostheses is quite expensive. 3D printing could help by providing a better and more comfortable match (for arms and legs) at a lower price.

2. Reducing medical care costs. A Penn State University College of Engineering startup is using 3D printing technology to build healthcare facilities in Kenya. With portable 3D printers, the startup can create medical devices such as clamps, pumps, and braces inexpensively in America. The startup expanded the use of their technology to make the technology more easily available in remote locations. The Michigan Technological University is using 3D printing to “create adaptive aids for patients suffering from arthritis at a reduced cost.” These medical devices help patients open doors or dress themselves – at a price that is below alternative options.
3. Replacement tissue and organs. Another 3D printing application is the ability to print tissue and replace organs. Another Penn State University team “developed a 3D printing method that allows creating tissue building blocks with micropores.” The developed tissue can then allow fluids and nutrients to circulate in the body. The 3D printing offers “great potential for lab-generated tissues containing black blood vessels.”

Researchers from Tel Aviv in Israel have created the first 3D printed heart with vascularization. The researchers used a patient’s own cells along with other organic materials. The technology is considered a major breakthrough because it creates tissue with blood vessels.

A Dutch company and Maastricht University have used 3D printing to create kidney tissue for scientific testing. And a hospital in Bulgaria “replaced a rib that contained a tumor with a 3D printed prosthetic to save their patient’s life.”

4. Surgical preparation. 3D printing is helpful for surgeons because researchers are working on replicating patient-specific organs – as a teaching tool so doctors can practice before the operation occurs.  The surgeons will also be able to examine the patient’s anatomy from different angles to better anticipate complications during the surgery. Another benefit of 3D surgical preparation is to reduce costs and save time.

“Such an application is far more accurate and prepares doctors much better than the materials they use today, such as CT scans, MRIs, and X-rays. Ultimately, the method could accelerate procedures and minimize patient trauma.”

This type of 3D printing technology could potentially be used to repair spinal cord damage, “heart and vital organ transplants, scanning and repairing fractures or cracks, as well as birth complication operations.” The technology could also help doctors assess the compatibility of organ transplants more accurately.

5. Breast reconstruction. A company in France is working with doctors in France to help women who need breast implants. Instead of using traditional silicone implants, the company uses a technique called lipofilling that is a fat transfer technique. The problem with lipofilling has been that if too much fat is injected into the breast region, the fat could be absorbed by the body over time forcing another surgical procedure. By using a 3D printed shell “with a lace shape,” the prosthesis is “bioresorbable, so it will be absorbed by the body just like stitches.” This process allows for a natural reconstruction – and can be “customized to match the unique needs of the patient.” The process generally requires just one surgery instead of two.
6. Dental applications. Possible 3D printing applications currently in use include “customized and accurate braces, castable crowns, dental bridges, dental restorations, and denture frameworks and bases.” 3D printing can create a better fit, at a reduced cost, with less wait time.
7. Pharmacology and medication dosage. 3D printing “could” help simplify pharmacology and drug administration. Ideally, a 3D pill would contain the patient’s different medications – each equipped with a different release time. “This idea is called polypill, and it has already been tested for diabetic patients.” This type of pill “would mean the elimination of exhaustive monitoring of drug intake, especially when their medications have different schedules.” In addition, 3D-printed pills would be cost-effective and help poorer people and poorer countries obtain the medications the people/countries need.
8. Medical tools and devices. As discussed in the FDA section, 3D can be used for many types of medical devices such as clamps, forceps, scalpel handles, and other tools. 3D printing would be cost-effective and more sterile, according to Codete. For example, surgeons will be able to use new tools quickly.
9. Bioprinting. This is a slower type of 3D printing that uses “bio-inks, a material that allows the fusion and proliferation of all living cells.” Bioprinting has different possibilities such as allowing physicians “to print real human skin to test new drugs without having to test them on animals.”

Additional legal compliance issues for 3D printing technology

In addition to FDA medical device compliance, our lawyers review the healthcare compliance issues that the manufacturer and the medical practice need to understand. These issues include:

• HIPAA. Since the technology is computer-based and may be targeted to the patient, there may be HIPPA compliance issues to protect the patient’s data and electronic information.
• Corporate practice of medicine. Prescribing and administering 3D technology devices may be governed by your state’s corporate practice of medicine laws.
• Supervision. A skilled lawyer will review which medical professionals (nurses, technicians, and other healthcare professionals), aside from an authorized physician can administer or use the 3D printing technology.
• FTC review. Medical practices need to be truthful about what claims are made about the 3D printing devices and products. The FTC can shut your business or practice down if your advertising is false or misleading.
• Compliance with Stark Law, the AKS, and other anti-referral statutes. Recommendations about using 3D printing products or services must be based on the best interests of the patient – not the medical developer or medical practice.

3D printing has numerous applications. That’s why there is so much research being done and so much interest in the medical community. In addition to the possible medical benefits, there are cost, time, and other benefits. The developers and users of the 3D printing need to review the compliance issues with an experienced healthcare lawyer. For starters, your lawyer will review whether the product requires FDA approval or oversight. The lawyer should also discuss the other legal and business issues that apply starting with the relationship between the developer and the physician.

3D printing developers and the medical practices that use 3D medical devices should contact Cohen Healthcare Law Group, PC to review the federal and state legal compliance issues. Our experienced healthcare attorneys advise manufacturers, doctors, and other healthcare providers about healthcare compliance laws and regulations