by Kaylan A. Baban, MD MPH
Icahn School of Medicine at Mount Sinai
After years of promising but expensive and elementary applications, 3D printing has finally matured into its adolescence, with some truly noteworthy accomplishments and a more affordable profile that allows tremendous potential for more.
This was my take-away from the comprehensive, multi-faceted immersion experience that was the recent Inside 3D Printing Conference at the Javits Center. The medical track was organized in part by NYC Health Business Leaders (full disclosure: they paid for my attendance to cover the show). From bone graft scaffolds to intricate sugar palaces, from printing supply chains to current and future FDA regulations, this conference offered an in-depth exposure to the state of the art in 3D printing.
In the style of a truly successful event, there were too many brilliant minds and creations to innumerate here (check out the conference schedule for proof!), but a few particularly notable products and players to keep an eye on include:
Powerhouse CEO of the 3DP orthotics manufacturer SOLS, Kegan Schowenburg, is a sharp mind on the rise, and taking her company with her. Though her product may seem pedestrian (excuse the pun), her incisive and practical understanding of this industry is anything but. Currently sold through medical offices, SOLS will soon be bringing the full potential personalized 3DP footwear directly to the consumer. Users can snap a few photos of each foot with their smartphone app, share it with SOLS to be rendered as a three-dimensional image, and await the arrival of their new orthotics. Even better, feedback currently collected at a population level from their providers can in the future be gathered directly at the source, as fodder for machine learning and constant iterative improvement on their algorithm. Will sensors be incorporated to offer yet more granular feedback? The possibilities are seemingly endless. As Ms. Schowenburg says, “We are at the inception of 3D printing. We are going to look back and laugh. And that gets me excited.”
Pharma’s Marc Durante of Merck was a participant in the Future of Medical Innovation via 3DP panel, led by NYCHBL’s president Bunny Ellerin. I was frankly surprised to see Pharma on the program, highlighting how many use cases for 3DP are still brand new or waiting to be discovered. Mr. Durante’s professional work lies with prescription pharmaceuticals, and he described that “what was an exploratory effort not too long ago has already matured, and is likely to be part of our core business in the future.” In fact, they’re already putting their money where their mouth is. Wonder why? Consider a new facet of personalized medicine – on-demand production of your dosage (no need for 5mg increments or scored tablets), and your blend of medications (take one pill instead of four, and never wonder if you took them all or took one twice). Keep an eye on how this develops; 3DP promises to revolutionize this industry and the way we prescribe and take medicine.
Dr. Hod Lipson, a roboticist (and TED speaker) who now runs a 3DP food lab at Cornell, provided an excellent history of 3DP from the million-dollar proprietary printers with a single white plastic ink of 20 years ago to today’s few hundred-dollar consumer printers that can print with almost anything (including cheez wiz!), also describing the different techniques that make various products and textures possible. In the middle of a tour of stunningly gorgeous and shocking innovations (3DP grapefruit, anyone?), Dr. Lipson slipped in a thrilling suggestion: What if our 3D printers not only created the no-fuss meals that we crave, but also coordinated with our wearable devices and electronic health records to give us just the right nutrient balance and total calories, and avoid our allergies and contraindications? Imagine a world in which digital health and the quantified self merge with 3DP and cuisine to form what amounts to a personal chef and family doctor rolled into one. The list of ailments attributed in large part to dietary habits is seemingly endless, and the time and effort of food preparation, responsible decision-making, health literacy and simple biology are perennial barriers to a healthy American diet. Though this concept of truly personalized meals may still lie in the future (3DP is still a slow and methodical process – it takes 10 minutes to print one cookie), the component pieces exist now. As a public health and prevention physician – and appreciator of delicious guilt-free meals – the implications of Dr. Lipson’s concept are incredibly exciting.
In order to fully realize these innovations outside the lab and on a large scale, of course, regulatory concerns must be addressed. One issue is the anticipated “Napster stage” of 3DP, in which it is widely expected that consumers will illegally download and share commercial 3DP product files (enabling a teenager to print custom Nike Air Jordans in his living room, as Harvard graduate student David Kolesky predicts, at an obvious loss to industry). Panelist Derek Mathers of Worrell and the University of Minnesota believes the arc of digital music is instructive, and foresees that this marketplace reversal will be followed by an industry shift towards something akin to “iTunes secure product streaming” to consumer printers, for a fee. In contrast, there were several and varied opinions from the gathered printeratti regarding the future of FDA regulations for medical devices, but they seemed to fall primarily into two camps: 1) In an industry where each and every item is a one-off, the regulatory approach will have to change to focus on the process (as is seen in biotech) rather than the item. 2) Regulating the process can never be the path forward, as it would hold 3D printed items to a lower standard. The onus is correctly placed instead on manufacturers to prove the quality and safety of their products. (It’s worth noting that the woman who voiced this second opinion most passionately and eloquently is herself an owner and manufacturer of 3D printed medical devices.)
Despite any disagreements and uncertainties, it was clear that realizing the potential of 3DP will mean developing new insights into human nature, and new understandings of what is possible. Like the purple broccoli-flavored jello cube, we will find that some innovations – though marvelous feats of technology – miss the mark. Others, like the carefully-calibrated scrumptious and healthful gourmet meal prepared only for you, will be just what we’ve been waiting for.
Inside 3D Printing Conference – Medical Track Quotes
Like the evolution in the music industry, 3D printing is a digital revolution of physical goods. The software and hardware will exponentially progress, most likely leading to a Napster-like era of pirating physical goods. After that, we will see secure and verified streaming physical products—like the iTunes of 3D printing—that enables users to download and print products from their favorite brands.
It’s interesting that healthcare doesn’t get much attention, since some of the best selling medical products in the world—like Invisalign and hearing aids—are 3D printed. There is an over focus on the machines themselves rather than the materials and applications. Printing enables one-off devices to be economically feasible. We need to start teaching doctors to think this way.
Scientific advances that challenge the FDA are not new; gene therapy, stem cells, mobile applications and biosimilars are examples of innovations that have all endured the regulatory process. The 3D printing industry should be encouraged that the FDA is engaging with stakeholders early on to foster innovation and develop a transparent process.
The industry currently has a limited set of choices when it comes to the materials that can be used to create a device, but the materials make all the difference and can take us beyond merely replicating shapes to achieving high-performance attributes such as biocompatibility and precision.
In one case, we met with the surgeon on a Wednesday. We 3D printed the trachea implant on a Thursday and delivered it on Friday. The surgery took place the following week. This is one of the incredible reasons why 3D printing has come into vogue in medicine.
The future of 3D printing will be rooted in the healthcare industry where the price point and value proposition supports mass customization. With 3D printing, we can now move beyond expensive “Lamborghini” healthcare products to customized devices priced at a fraction of the cost.