A Conversation with Jose Gomez Marquez,Little Devices Lab,MIT

For this quarter's Editorial Interview, I sat down to talk with Jose Gomez-Marquez who co-directs the Little Devices Lab, a research lab at MIT dedicated to exploring the design, invention, and policies around DIY health technologies across the globe. Jose is pioneering a new perspective on medical technologies that can be personalized, customized, and fabricated by doctors, nurses, and even patients themselves. This approach leads to creative solutions that are potentially lower cost, more customizable, and readily accessible, going against the high cost, complexity, and one-size-fits-all mentality of today's healthcare sector.

A quick reminder that the Editorial Interview Series highlights short conversations each quarter from colleagues within industry, academia, and government with the aim of giving various insider perspectives on 3DP+ and what's next.

Skylar Tibbits: Where do you think 3DP+ is going from your perspective on medical technologies?

Jose Gomez-Marquez: What I find most interesting within what we call institutional makerspaces and fabrication facilities that are accessible to everybody is how 3D printing is eliminating the human element required for the design and engineering of medical devices. That is exciting because now you can go from a device that would be $10,000 once you add engineering, trials, oversight, and manufacturing, to a device that is $50 from the initial idea. There's no pressure to make 10,000 of them or to break even financially—you can just walk away with one. This is a big change that I have seen. Making one is okay, and making one can save a life.

An example of that is the experience of Dr. Sohum Desai at UTMB Texas Medical Center. Traditionally when he would do a cranioplasty, which involves a machined cap on your skull, you would wait 3 weeks for the cap to arrive from a medical device company and it would cost approximately $10,000. What he is doing now is taking MRI and CT data, converting the information into a file, printing it to make an inverted mold, and then molding the final piece for the patient (Fig. 1). This process would not exist or otherwise be financially feasible. It's an example of an n-of-1 medical device, only made possible because of printing.

OPEN IN VIEWER

FIG. 1.

Neurosurgeon Dr. Sohum Desai molds over a 3-D printed replica of a patient's skull for just-in-time skull implants in a MakerHealth medical makerspace. Reprinted with permission from Dr. Sohum Desai.

ST: That can reduce the cost of medical devices today and allows for patient customization, correct?

JGM: Exactly. We typically hear of personalized medicine and personalized diagnostics. But when we talk about personalized devices, medical device companies will commonly charge an exorbitant amount. Printing really has changed the game in that respect.

As a community, we need to be alert about keeping that access open because those were the roots of 3D printing. We need to make sure that the policies don't change. We know we can make custom devices, so it shouldn't cost any more. What is really magic about this is that more and more people are seeing the option of their medical devices being custom-made for their needs.

ST: What do you think about the headlines and latest developments in printed organs, or printing drugs or printing diagnostics?

JGM: It is mixed. I think we are more likely to print a tumor in the near term than we are to print a functioning organ. People typically underestimate how difficult biological constructs are. When you print a voxel out of a polymer, it behaves (Fig. 2). Even when you 4D print something, you program it and it behaves. When you print a piece of biology, it has multiple signaling pathways. That cell can do many different things. Researchers are working very hard at this but just aren't there yet. We can print the equivalent of food structures like scaffolds where the cells just bind to the scaffolds. But that is very different from an organ that needs to replenish itself. The left side of a kidney needs to know that it needs to be replaced with certain cells, and the other side of the kidney needs to be replaced with other cells. That is still very difficult to achieve.

OPEN IN VIEWER

FIG. 2.

Ampli blocks serve as biological voxels for plug and play diagnostic systems. Credit: Melanie Golnick, MIT.

On the other hand, great work has been coming out of the UK on 3D-printed pharmaceuticals, for instance. For example, dissolving structures and finding ways that those compounds can be replicated using very basic FDM printers is really remarkable. The individuals doing this work are submitting reports to the proper peer-reviewed journals in the 3D printing community as well as those in their own pharmaceutical fields. These are pharmacists who have discovered printers, as opposed to printing technologists who've gotten bored with plastics and decided to print aspirin. I find this very interesting because then we don't have to deal with drug shortages and generic price increases like we have seen in the last few years. I believe we can expect everyone to make pharmaceuticals in the near future. That is a project we are currently working on, and we think that is important because it is how we collectively get better.

ST: What are the safety and regulation concerns. Are they any greater than other industries?

JGM: Unfortunately, the medical field, for the longest time, has used the perception and public understanding of regulation requirements as an offensive competitive tool. This is the same reason why the big tech companies were generally okay with European privacy regulations because they realized it would take an army of lawyers and high costs to comply with them so it would wipe out startups and small competitors—only the largest can survive. The same thing happens in medical devices. The Food and Drug Administration (FDA) actually doesn't require certain devices to be FDA regulated, but many companies seek it as a badge for competitiveness and marketing. Understanding this can help balance the perception of overregulation.

On the other hand, we absolutely do need quality control and safety for medical devices. However, the medical community has a long tradition and a very rigorous process with a reputation-based system of community enforcement. Similarly, one of the things we will see in 3D printing and other technologies is the notion of community-based regulation and self-regulation, instead of only responding to a few centralized actors that tell us to trust them. And by the way, those centralized actors, even though those devices have their badge of approval, they often still fail. So it is up to the community to call out good work and to call out bad work instead of just looking away because that is what can help create a healthy ecosystem.

As we engage nurses and doctors in the use of 3D printing, what is really exciting is that they are going beyond the traditional applications of printed surgical guides or anatomical models or even printing instruments. Now they are asking us, can the material detect something, can the material change based on something else? Because they are not in the typical printing community, they are asking unusual questions that lead to new possibilities. They open up an entirely new possibility. We are seeing everything from materials that can be embedded in a soft bandage to detect if a patient has a fever, to infection detection embedded in printed parts. I think that materials are going to be one of the most exciting areas of development that we will see in the coming months.

Want to hear more from Jose? Feel free to reach out to him at jfgm@mit.edu or follow his work at https://littledevices.mit.edu

In this September 2018 issue of 3D Printing and Additive Manufacturing, we have an incredible lineup of work from high-resolution multimaterial printing with digital light processing, zonal plasma treated scaffolds, co-printed liquid metals for stretchable electronics, printed electrodes for gas reactor transport, a low-temperature chemical sintering method, a review of X-ray Micro CT technologies in additive manufacturing, and modeling of a motionless printing process. I would like to thank all of our authors and reviewers for their amazing contributions that make this journal possible! Look for our next issue of the journal to be published in December 2018.

As always, we welcome your comments, feedback, and direct contributions to the journal—send your thoughts to our Managing Editor, Craig Ryan at: CRyan@liebertpub.com