Sean Fenske, Editor-in-Chief, Medical Design Technology3D printing is one of those truly disruptive technologies that comes along very rarely. It is remarkable how many different industry sectors it can touch and impact significantly. Healthcare is just one area where it is making a difference; however, while I may be biased, I think it is also one of the most interesting.

When you have 3D printing innovators able to travel to third world countries to fabricate prosthetics for children who have lost limbs, that’s revolutionary medicine. When you can print human tissue and implant it into a patient in place of a graft, that’s extraordinary medicine. When you can combine today’s high resolution imaging capabilities with the functionality of a 3D printer, the possibilities for creation grow substantially. I anxiously await the next 3D printed breakthroughs that transform the quality of care we are able to provide.

Unfortunately, although it offers such a huge upside, the technology does not make such an impact without leaving lingering questions as we move forward. As more solutions in healthcare are able to be printed, who is developing these “blueprints?” If a stent can be 3D printed, who is providing the design for that? Do we think the doctors and surgeons who will be using the printed technologies are qualified to also design them? Will philanthropic developers emerge who will offer the designs for 3D printed solutions to anyone who is able to use them? Will an open-source resource be established such that developers from around the world can help tweak ideas to create a product that can actually be used for a patient?

Perhaps the design will come via the material supplier. Surely, an implantable stent would have to be fabricated with a specific type of material. Take that even further and a drug eluting stent could be 3D printed, which would require the inclusion of the pharmaceutical at the proper ratio. Might the material supplier license a 3D printable design from a stent OEM that it then includes as part of an entire 3D printing solution for implantables that is sold to a hospital?

Taking the discussion in this direction leads straight to liability. What if something goes wrong with a 3D printed stent? Who gets the blame? While a litigious patient may name everyone from the printer manufacturer to the material supplier to the doctor and hospital in a lawsuit, it certainly is unclear as to who is at fault for a problem with a 3D printed solution. Are doctors qualified to be printing an implantable device? What type of quality controls are in place for such a technology? How do we ensure the safety of any device that is 3D printed in a hospital and used immediately?

And that brings us to the FDA. How can the FDA be expected to reasonably ensure the safety of a device when it is printed in a hospital and has not gone through the typical safety measures? Sure, the design could have certainly been tested, revised, and tested again, before being submitted to the FDA for approval. But who can verify that what was designed and approved is the same thing as what is being output from a 3D printer in every single instance? If that type of assurance is unable to be achieved, will the FDA ever permit the 3D printing of a stent, for example, that is used in a human body? If the process for the manufacture of the stent in a healthcare facility has not been validated, will it ever actually be fit for use in the eyes of the FDA?

Do we then expect the FDA to put a healthcare facility through an inspection, similar to those performed at an OEM’s facility? The FDA can barely handle the inspection of current OEM facilities; adding hospitals interested in 3D printing devices that can be used in a medical procedure would certainly overload the system. Even if third parties are used, will hospitals suddenly start applying for ISO 13485 to help enable them to 3D print medical devices?

I think 3D printing is an incredible technology that continues to astound on a daily basis. The more innovations I hear about, both in healthcare and other industries, the more I believe that we’re only scratching the surface of where this technology is headed and how it will affect our lives. However, before the technology can make a substantially greater impact in the field of medicine, there are critical questions that need to be resolved. I’ve touched on several of them here, but what are the other questions when it comes to 3D printing and healthcare? What questions do you have? 

How might we resolve some of these? I invite you to share your thoughts and comments below. Let me know your thoughts on this topic.