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FDA released its anticipated discussion paper on point-of-care 3D printing of medical devices. The document outlines three scenarios in which FDA anticipates hospital or outpatient facilities using 3D printing.
With the paper, FDA states that innovation in manufacturing and product delivery are as important as device design and function. One of the most promising and well-known advanced manufacturing technologies used in medical devices, and especially orthopedics, is 3D printing.
“3D printing at the point of care may serve an important public health purpose, and may provide for rapid and agile production of devices, including but not limited to patient-matched devices and anatomical models for surgical planning,” FDA writes in the paper. “This technology has the potential to help a healthcare facility quickly respond to patient needs, bring personalized care to patients in a timely manner, and lead to new innovations in patient care and treatment.”
The Agency notes that point-of-care 3D printing is the future. It also acknowledges that regulatory responsibilities and risk must be firmly outlined to move forward.
The Regulatory Lens
FDA points out that healthcare facilities possess a different knowledge and appetite than manufacturers for regulatory capabilities and risk. The Agency’s concern for risk is both in the 3D printing of the device and the use of the device. With that in mind, FDA is considering the following concepts in developing its point of care 3D printing approach:
- Employ a risk-based approach – FDA oversight should correspond with the risks associated with the printed device and 3D printing of the device.
- Device specification should not change based on location of manufacture – The manufacturing location should not alter the manufacturer’s ability and obligation to ensure that a device meets its predetermined specifications.
- Capabilities available at the point-of-care facility can help mitigate production risks – The capabilities, oversight, training and experience of the hospital in 3D printing influences the ability to successfully make a device at the point of care.
- Entities should understand their responsibilities – Point-of-care 3D printing can raise confusion about who is responsible for a device’s total product life cycle. Stakeholders should understand their regulatory responsibilities and apply them and their activities.
- Leverage existing controls – A least burdensome approach should be used to provide assurance that safe and effective devices are being 3D printed.
Point-of-care 3D Printing Scenarios
FDA notes in its discussion paper that as 3D printing and additive manufacturing become more available and accessible, hospitals are likely to engage with the technology in different ways. This evolution could present unique regulatory questions. Therefore, FDA outlined the three scenarios, each of which gives providers a different level of risk.
- Scenario 1: Healthcare facilitating using a 3D printing medical device production system. Essentially, the hospital conducts point-of-care 3D printing on an already FDA-510(k) cleared product. The medical device production system, e.g. the traditional manufacturer, assumes responsibilities for FDA regulatory requirements.
- Scenario 2: Traditional manufacturer on or near the healthcare facility. The hospital itself does not engage in 3D printing of implants and instruments. Instead, they work with a traditional manufacturer that is “co-located” on or near the hospital. In this scenario, the traditional manufacturer is responsible for compliance with FDA’s regulatory requirements.
- Scenario 3: Healthcare facility to assume all responsibilities, whereby they would engage in the activities of traditional manufacture, including 3D printing devices and complying with all applicable regulatory requirements.
FDA outlines deeper examples and poses questions for each scenario in the 19-page paper. The scenarios are outlined at a high level below.
| Scenario 1 | Scenario 2 | Scenario 3 | |
|---|---|---|---|
| Entity designing and developing the device | Traditional manufacturer | Traditional manufacturer | Healthcare facility |
| Entity using the 3D printing system to produce devices | Healthcare facility | Traditional manufacturer, including any potential contract manufacturer | Healthcare facility |
| Entity responsible for complying with applicable regulatory requirements | Traditional manufacturer | Traditional manufacturer, including any potential contract manufacturer | Healthcare facility |
FDA’s Next Steps
The newly published paper is not a draft or final guidance. The paper is meant to facilitate early input from individuals outside of the Agency in order to develop future guidance. In addition, FDA is collecting comments on the paper until February 8.
It’s likely to be some time before FDA publishes draft guidance. The Agency told us back in 2018 that they were working on the just-released discussion paper. Orthopedic companies and additive manufacturing companies should closely follow FDA’s moves. Orthopedics already has experience with point-of-care 3D printing. Academic institutions and top hospitals use 3D printing or additive manufacturing to create 3D models for surgical planning, prototypes for device ideas and, more recently, point-of-care labs for custom implants. The expansion of point-of-care 3D printing has the potential to revolutionize the commercialization of orthopedic implants and instruments.
