3D-Printed Medical Devices: Grappling With Legal Issues
3D-printing technology has the power to revolutionize health care by developing innovative clinical solutions and creating new therapies adapted to patients’ unique needs. But, as traditional medical device manufacturers collaborate with health-care providers to bring the printing process closer to the point of care (PoC), stakeholders must grapple with a minefield of health-care laws both on 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 medical devices allows health-care providers and medical device manufacturers to design custom devices that match a patient’s exact needs and physical anatomy.
3D-Printed Medical Devices Direct-to-Consumer
Direct-to-Consumer (DTC), the most common model currently used in the market, leverages the recent widespread adoption of telehealth to bring personalized medical devices directly to the patient.
The DTC model is a creature of contractual partnerships between telehealth platforms, health-care 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 dimensions and transmit specifications to the manufacturer. The manufacturer can dispense the finished product directly to the patient (through the mail) without in-person interaction.
You can imagine that a patient with foot pain can set up a virtual visit with a network of podiatrists through an app. Through subsequent consultation (either virtual or in-person), the podiatrist prescribes a custom orthotics specifically for the patient. The 3D-printed medical grade insoles arrive in 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 enhanced opportunities for health-care facilities to innovate and produce personalized patient-matched devices.
Health-care facilities may utilize 3D printing to offer rapid and agile production of devices, such as prosthetics, implants, and anatomical models for surgical planning. These relationships can be structured through a joint-venture entity or a joint operating arrangement.
FDA Oversight: DTC v. PoC Printing Medical Devices
The Food and Drug Administration regulates medical devices based on the intended use of the product and the potential risks posed to patients. Although 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 regarding PoC 3D-printing medical devices. The FDA’s risk-based framework identifies that the major challenge to PoC development is the close coordination required between the traditional manufacturer and a health-care facility and the role each plays.
Importantly, PoC 3D printing presents a question about compliance obligations between the traditional manufacturer and the health-care facility where the device is manufactured. The key, from the federal agency’s perspective, is determining whether devices 3D printed at PoC are safe and effective.
On one end of the spectrum, traditional manufacturers can create 3D-printing medical device production systems (MDPSs) for use by health-care facilities, in which case the manufacturer takes on complete responsibility for FDA compliance.
On the other end of the spectrum, health-care facilities can assume limited manufacturing functions and may be subject to FDA oversight. The FDA also envisions the manufacturer co-locating at the facility, creating complex questions regarding regulatory responsibilities between the manufacturer and the health-care facility.
State Law Challenges
The practice of medicine is regulated under state law, so restrictions on who can prescribe, administer, dispense, or even assess the fit of a 3D-printed device will depend on the state where the patient care occurs.
In some states, mid-level practitioners must be supervised by physicians, including through written protocols that articulate the circumstances when the practitioner is authorized to prescribe a device. These laws may not dictate the delegation ability of the provider prescribing a 3D-printed device or whether a virtual assessment for fit meets the standard of care.
Also, in bringing the finished printed medical devices to the patient’s home, state pharmacy laws on shipping, storing, and handling of a “dangerous device” may be triggered.
When the device is printed at PoC, facility license, corporate practice of medicine, and kickback laws may imply the relationship between the manufacturer that co-locates or otherwise collaborates with a health system or outpatient clinic.
The licensed health-care entity may be required to maintain control and oversight over all aspects of its operations, including ensuring that the 3D-printed devices are safe—which may conflict with the oversight responsibility of the manufacturer in the traditional sense.
Practicalities of 3D Printing PoC and DTC
State restrictions on corporate practice and laws intended to protect the independence of clinical decision-making may dictate the corporate structure and funds flow for arrangements that bring 3D-printed devices to patients. The PoC approach offers the most patient-centric way to expedite adoption and access to this revolutionary technology, but it may be stalled by the evolution needed within the existing regulatory framework.
Given the resources required to bring these products to market, entrants to 3D printing PoC may be limited to partnerships between major device manufacturers and large health systems. Continued innovation in health-care technology will present ongoing challenges as regulators struggle to balance innovation and consumer safety. Applicable federal and state-level regulatory frameworks must continually evolve, ideally pro-actively, to accommodate the benefits that new technology affords.
This article does not necessarily reflect the opinion of The Bureau of National Affairs,Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.
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Harsh P. Parikh is a health care partner at Nixon Peabody LLP. He guides stakeholders, including nonprofit and for-profit health systems, physician groups, life sciences companies, and other health-care providers, on a wide range of regulatory, reimbursement, and transactional matters.
Meghna Vink currently serves as counsel at the unicorn-status health-care startup Carbon Health, where she focuses on clinic operations, medical group and physician practice matters, and negotiating cutting-edge agreements between payors, providers, and hospital systems.