Bioprinting on horizon for 3-D printing
In the late 1980s, “Star Trek: The Next Generation” introduced viewers to the replicator, which could make food, beverages and other items materialize out of thin air.
The idea of Captain Picard instantaneously getting his favorite brew by telling a machine “Tea, Earl Grey, hot” won’t happen any time soon. But with the advent of 3-D printing, it’s a lot closer to reality than one might think.
Three-dimensional printing at retail is an idea still in its infancy. At the National Association of Chain Drug Stores’ Total Store Expo in August, the show floor featured an Innovation Zone with a 3-D printer that created sample products like sculptures and bracelets. But its potential applications go far beyond a few knick-knacks.
The market itself is still relatively small, but it’s growing rapidly. According to IBIS-World, 3-D printer manufacturers’ 2012 sales were $2 billion, with 10.2% growth from 2008, while 3-D printing services hit $800 million as of March 2013, growing at 10.3%. It’s in those services where retailers might find the most opportunity.
Cincinnati-based 3DLT, which launched last year, maintains a library of designs across multiple categories that can be purchased and printed at home or in a store. In an interview with Drug Store News, co-founder and chief marketing officer John Hauer explained why the company recently pulled out of a planned deal with an online retailer. “We got to the finishing line and felt there was a missing ingredient, and brick-and-mortar was that missing ingredient,” Hauer said. Currently, the company is in talks with eight major retailers, Hauer said.
Hauer sees 3-D printing as a way to give brick-and-mortar a competitive edge against online by allowing stores to have entire libraries of designs they could print on demand. “Our idea is that you could flip Amazon’s model and drive cost out of your equation,” he said. Hauer envisions retailers storing tens of thousands of SKUs digitally for printing in store, with 3-D printing departments resembling full-service photo departments. Such libraries — as opposed to simply having customers come in with designs of their own, as UPS did earlier this year in a pilot program at several of its retail stores — also would solve some potential intellectual property issues, he said.
Most 3-D printable products fit in the general merchandise category, such as toys, decorations and housewares, as well as personal care products like combs and brushes. Further on the horizon, researchers already are experimenting with 3-D “bioprinting” of organs and implants using patients’ own DNA. Still, Isaac Katz, a Mexico City-based artist and designer who in September spoke at Mediabistro’s Inside 3-D Printing Conference and Expo in San Jose, Calif., sees the technology as still in a phase more suitable for prototypes and aiding in design rather than for large-scale manufacturing. “It still has to trickle down,” Katz told DSN. But he also compares its present phase to that of personal computers in the 1980s and the Internet in the 1990s.
But retail pharmacies could still find some potential uses much sooner than later. Hauer cited customizable shoe inserts as one example. Another is customized durable medical equipment. In the 2012 Paralympics in London, some members of the U.K. basketball team used wheelchairs with 3-D printed seats specially tailored to their bodies and disabilities. The main problem with that kind of work is it’s really expensive and requires 3-D scanning of the user’s bodies and movements. But smaller, simpler applications may be more feasible for now. Recently, Enabled By Design, a U.K.-based organization that promotes functionally designed products for people with disabilities, sponsored a design contest that included 3-D printed products for the disabled like a fork that’s easier to grip for people with dexterity problems and a set of thimble-like pronged “finger cactuses” for picking up food.
In terms of more complex healthcare products, Katz said 3-D printed versions of durable medical equipment — such as canes, crutches, walkers and manually powered wheelchairs — may take a while to reach the market due to economic limitations. In addition to scanning technology, printers that use metal and high-durability plastics can be prohibitively expensive, costing tens of thousands each. But that could soon change, as researchers at Michigan Technological University recently unveiled a design for a metal-based 3-D printer that can be built for about $1,500.
At the same time, such DME products might be easily made from a regulatory standpoint because they’re usually exempt from the Food and Drug Administration’s 510k clearance requirements — certainly easier than a 3-D printed artificial jaw made from titanium. Three-dimensional scanning technology also is becoming more advanced; Hauer noted that Microsoft has experimented with 3-D scanners on mobile phones.
Three-dimensional printing is, as Katz suggested, following a trajectory not unlike computers in the 1980s, jumping from the realm of hobbyists and hardcore enthusiasts to mainstream industry and retail. And with the race to get products in the hands of consumers faster and faster, it could be a boon for brick-and-mortar retailers — including pharmacy retailers.
FDA pushes back target date for review of Takeda drug in patients with ulcerative colitis
DEERFIELD, Ill. — The Food and Drug Administration has postponed the time it will decide whether or not to approve an experimental treatment under development by Takeda Pharmaceutical Co. for ulcerative colitis, the company said.
Takeda said the FDA had extended the Prescription Drug User Fee Act priority review action date for vedolizumab as a treatment for UC until May 20, 2014, essentially meaning the date has been pushed back. The FDA’s action date for the drug as a treatment for Crohn’s disease, June 18, 2014, remains unchanged. Takeda said the delay would give the agency enough time for a full review of the application.
"This short delay in the action date allows the FDA sufficient time to complete review of the vedolizumab file and provide action on the application," Takeda head of global regulatory affairs Tom Harris said. "We appreciate the work of the FDA and remain confident in the potential of vedolizumab as an additional, important treatment option for patients with the physicians who treat them for these serious conditions."
Actavis subsidiary seeks approval for generic version of NuvaRing
DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.
Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck’s NuvaRing.
In response to the filing, Merck and Dohme B.V. filed a patent-infringement lawsuit against Warner Chilcott Tuesday in the U.S. District Court for the District of Delaware in an effort to prevent the generic product from being marketed; the lawsuit puts an automatic stay of FDA approval on the generic for 30 months, unless the companies settle the matter sooner.
NuvaRing had sales of about $560 million during the 12-month period that ended in October, according to IMS Health.