3D printing technology has the power to revolutionize healthcare by developing innovative clinical solutions and creating new therapies adapted to the unique needs of patients. But as traditional medical device manufacturers partner with healthcare providers to bring the printing process closer to the point of care (PoC), stakeholders must grapple with a minefield of health laws, both at the state and federal levels.
3D printing is an additive manufacturing technique that creates three-dimensional products through successive layers of raw material. 3D printing of medical devices allows healthcare providers and medical device manufacturers to design custom devices that exactly match a patient’s needs and physical anatomy.
3D-printed medical devices direct-to-consumer
Direct-to-Consumer (DTC), the most widely used model in the market today, takes advantage of the recent widespread adoption of telehealth to bring personalized medical devices directly to the patient.
The DTC model is the result of contractual partnerships between telehealth platforms, healthcare providers and traditional medical device manufacturers. Patients are virtually matched with clinicians to order the specifications of their personalized device – the camera on a patient’s phone can often be used to take measurements and measurements and send specifications to the manufacturer. The manufacturer can deliver the final product directly to the patient (by post) without face-to-face interaction.
You can imagine that a patient with foot pain can set up a virtual visit to a network of podiatrists via an app. Via a subsequent consultation (virtual or in person), the podiatrist prescribes a tailor-made orthotic, specifically for the patient. The 3D printed medical grade insoles come to the patient’s home and relieve the patient’s heel and arch pain.
3D printing at the point of care
When the printing process takes place at PoC, there are better opportunities for healthcare facilities to innovate and produce personalized, patient-oriented devices.
Healthcare facilities can use 3D printing to offer rapid and flexible production of devices such as prosthetics, implants and anatomical models for surgical planning. These relationships may be structured through a joint venture entity or joint operating agreement.
FDA Oversight: Printing DTC v. PoC Medical Devices
The Food and Drug Administration regulates medical devices based on the product’s intended use and the potential risks to patients. While the FDA does not regulate 3D printers, the medical devices made using 3D printing are subject to FDA oversight.
In December 2021, the FDA published a Discussion paper related to PoC 3D printing of medical devices. The FDA’s risk-based framework identifies that the biggest challenge to PoC development is the close coordination required between the traditional manufacturer and a healthcare facility and the role each plays.
Importantly, PoC 3D printing raises a question about the compliance obligations between the traditional manufacturer and the healthcare facility where the device is manufactured. The key, from the federal agency’s perspective, is to determine whether devices 3D printed at PoC are safe and effective.
At one end of the spectrum, traditional manufacturers can create 3D printing medical device production systems (MDPSs) for use by healthcare facilities, in which case the manufacturer takes full responsibility for FDA compliance.
At the other end of the spectrum, healthcare facilities may take on limited manufacturing functions and be under FDA oversight. The FDA also envisions the manufacturer co-location at the facility, raising complex questions about the regulatory responsibilities between the manufacturer and the healthcare facility.
The practice of medicine is regulated by state law, so restrictions on who can prescribe, administer, deliver, or even assess the fit of a 3D-printed device depend on the state where patient care takes place.
In some states, mid-level physicians are required to be supervised by physicians, including through written protocols describing the circumstances in which the physician is authorized to prescribe a device. These laws may not dictate the delegation power of the provider prescribing a 3D-printed device, or whether a virtual fit assessment meets the standard of care.
Also, bringing the finished printed medical devices to the patient’s home can activate state pharmacy laws regarding the shipping, storage, and handling of a “dangerous device.”
When the device is printed at PoC, institution licensure, medical business practice, and bribe laws may imply the relationship between the manufacturer collaborating with a health system or outpatient clinic or otherwise collaborating.
The licensed healthcare facility may be required to monitor and supervise all aspects of its operations, including ensuring that the 3D printed devices are safe, which may conflict with the manufacturer’s oversight responsibility in the traditional sense.
Practical aspects of 3D Printing PoC and DTC
State restrictions on business practices and laws designed to protect the independence of clinical decision-making can dictate corporate structure and funding for schemes that bring 3D-printed devices to patients. The PoC approach offers the most patient-centric way to accelerate adoption and access to this revolutionary technology, but may be held back by the evolution needed within the existing regulatory framework.
Given the resources needed to bring these products to market, new entrants to PoC for 3D printing may be limited to partnerships between major device manufacturers and major health systems. Continued innovation in healthcare technology will present ongoing challenges as regulators struggle to balance innovation and consumer safety. Applicable regulatory frameworks at the federal and state levels must constantly evolve, ideally proactively, to accommodate the benefits of new technology.
This article does not necessarily represent the opinion of The Bureau of National Affairs, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or their owners.
Harsh P. Parikho is a healthcare partner at Nixon Peabody LLP. He guides stakeholders, including non-profit and for-profit health systems, physician groups, life science companies and other healthcare providers, on a wide variety of regulatory, reimbursement and transactional issues.
Meghna Vink currently works as a consultant at Carbon Health, a unicorn-status healthcare startup, where she focuses on clinic operations, group medical and physician practices, and negotiates advanced agreements between payers, providers, and hospital systems.