3D printing, also known as additive manufacturing (AM), is the process of making a three-dimensional physical object from a digital file by depositing material layer-by-layer.
The process is ideally suited to creating complex, customised medical devices and components, which could improve quality and effectiveness in many areas of healthcare.
3D Printing is already being used for training and research purposes and in medical procedures with many new applications in development. Current uses include:
The response to COVD-19 accelerated the development of some applications such as:
The technology is developing fast. Future possibilities include 3D printed organs that could be used in transplant operations and personalised pharmaceuticals that could be printed in the doctor’s office.
“Future possibilities include 3D printed organs that could be used in transplant operations and personalised pharmaceuticals that could be printed in the doctor’s office.”
Sarah Triggs | WTW
The global market for medical 3D printing is expected to reach $5.8 billion by 2030.4
Demand is being driven not just by large healthcare providers, but individual medical and dental practices, which can use 3D printing on a smaller scale.
In most countries, 3D printed products are regulated if they fall under the definitions of a medical device or PPE.
Regulators face challenges in keeping up with the highly decentralised and bespoke nature of 3D printing production (see How are 3D-printed items made for clinical settings? below).
Current regulatory frameworks in major markets include:
U.S.
Europe
Australia
UK
There are a number of business models, including:
The point of care model is becoming more popular, driven by regular demand for items such as prosthetics, implants and training aids.
Currently, two models of point of care printing have emerged:
3D printing has the potential to blur traditional distinctions between manufacturing and the practice of medicine.
In particular, those that build in-house 3D printing labs may be taking on the role, and thus the liability, of manufacturer in the eyes of regulators and the law.
This means they could be subject to product liability if their product causes harm.
In many countries strict liability applies to product faults, which would allow patients to sue for compensation without having to demonstrate medical negligence.
“Other liabilities may come into play, depending on the type of product, contractual arrangement, or the role and behaviour of the clinicians involved.”
Sarah Triggs | WTW
Other liabilities may come into play, depending on the type of product, contractual arrangement, or the role and behaviour of the clinicians involved.
These could include:
Further complications could arise if litigation involves multiple stakeholders, such as the software designer, the printer manufacturer and the materials manufacturer.
So far, there is little legal precedent for how liability would be decided in such a case.
1 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic, US Food and Drug Association
2 Meet The Italian Engineers 3D-Printing Respirator Parts For Free To Help Keep Coronavirus Patients Alive, Forbes Media LLC.
3 The role of 3D printing during COVID-19 pandemic: a review, Longhitano et al.
4 3D Printing in Healthcare Market Expected to Reach $5.8 Billion by 2030, Allied Market Research
