Research Nugget #4

Scholarly Article

APA Citation: FENSKE, S. (2014). 3D Printing a Healthcare Revolution. Medical Design Technology, 18(4), 6.

Live Link to Article: 3D Printing a Healthcare Revolution

Sean Fenske in his article states his view of 3D printing on the world along with the many lingering questions that it produces. Fenske takes a more practical look at the effect of 3D printing on the medical field. He points out that 3D printing is a remarkable piece of technology but then identifies the components of a failed implant occurring. In addition he leaves you with these two questions that remain unanswered. If something were to happen who would be blamed, the printer manufacturer, material supplier, doctor, or hospital? Since this deals with liability can the FDA be expected to ensure the safety?

Fenske then closes by reiterating what he had stated in the beginning of this article. He agrees that 3D printing will continue to shock the world in many industries including the medical field. We are just scratching the surface of this technology but before we proceed there are many questions that need to be resolved.

“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 is 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 health- care 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 print- ed 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?”

Similar to Hampson, Fenske also indicates the problems 3D printing will cause in the future but in the short run and asks many questions that can only be answered as time goes by. They both also agrees that 3D printing technology is going to touch and impact the medical field significantly, but Fenske highlights on the fact that a transplant is bound to fail. Hampson in his article states problems we will face socioeconomically. What Fenske states in this article is very similar since it but deals with liability uprising topic 3D printing presents. Fenske is right a failure is inevitable and liability is a problem that needs to be solved before the procedures can occur.

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 health- care 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?”

fdalogodhhsIn terms of liability Fenske generates the conclusion that the FDA will soon have to be involved. Derived from the questions Fenske is stating the FDA seems to be the most suitable agency for a task like this. The FDA is obviously already in charge of a lot, does this problem mean there has to be a new agency to inspect this area of medicine and is this even under there jurisdiction of inspection? Equivalent to the means of living and socioeconomic effects stated by Hampson, liability seems to be another problem that comes along with 3D printing’s success.

3D printing again proves to be once of the most successful pieces of technology but along with success comes its problems. Is there an area 3D printing effects that is close to hitting the problem free surface?

2 thoughts on “Research Nugget #4

  1. Your topic is very interesting, are you interested in the medical field as well? I feel with the use of the 3D technology the whole field can be changed. Just think about all the benefits that 3D technology can create, like the one mentioned above, the use of the 3D technology in third world countries where medical resources are so low. But you do raise an important question, who will design the different equipments. I feel that the doctors should be the one since they are the once using it. If they create it then they know exactly how it was created and if need be the can modify it so it fits their patient.

  2. Yeah but do doctors have the time or skills to do such a thing? From what I know doctors are already overwhelmed with the fact that they have to learn a lot of clinical things. Adding engineering and all the planning might be impossible for them to comprehend but I am sure doctors will work along side other specialists.

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