Decades ago, we used to say technology was the wave of the future. Today, with technologies such as additive manufacturing, we are living in the future.
Additive manufacturing, or 3D printing, is being used increasingly across numerous industries, from automotive to entertainment to pharmaceutical and medical device.
According to a recent report, North America is expected to account for the largest share of the global 3D printing medical device market in 2017, a global market which is projected to reach USD 1.88 billion by 2022 from USD 0.84 billion in 2017.
While 3D printing is here, the future holds many questions. As the use of 3D printing continues to expand in the pharmaceutical and medical device space, how the FDA regulatory regime and traditional products liability principles will evolve are among these questions.
While its use is increasing, 3D printing has been in existence for over 30 years. Developed by engineer and physicist Charles “Chuck” Hull in the 1980s, the first 3D printing patent was issued in 1986. The 3D printing process and technology varies, but it generally begins with an electronic blueprint, typically a computer-aided design (CAD) file created by modeling software or a 3D scan of an existing object. The 3D printer is prepared by setting raw materials, such as powders, pastes, plastics, metals, or ceramics. The printer then builds the object according to the design specification, layer by layer, until the object is completed. In their early inception, 3D printers were large and expensive, which limited the technology to a small segment of the population. However, as new companies have entered the marketplace and the use of the technology has increased, 3D printers are becoming cheaper and more accessible to both small businesses and individuals, who can print objects from digital models created themselves or downloaded from the internet. Now available through retailers including Staples, Best Buy, and Amazon, the 3D printer may soon be a common fixture around the home.
The Food and Drug Administration (FDA) has approved one prescription medication and over 85 medical devices manufactured by 3D printing to date. The prescription medication is a disintegrating oral tablet for the treatment of seizures. Medications eventually manufactured on the same platform are sure to benefit both pediatric and elderly patients who struggle to swallow tablets. The medical devices include surgical instruments, external prosthetics, cranial implants, and titanium hips. In June of this year, the FDA approved one company’s denture material for the 3D printing of lifelike denture bases. Dentists and labs can use the material, along with the company’s already approved materials for the 3D printing of restorations simulating teeth, to print a full denture patients can wear for long-term use. This is one example of how 3D printing in the medical device space can be used to create patient-specific or patient-matched devices that were not possible under conventional manufacturing methods. 3D printing also can be used as an alternative manufacturing method for existing medical devices and device components.
When Tom Wilson, president, and CEO of Olympia Entertainment, was first trying to sell suites in Detroit’s soon-to-open Little Caesars Arena and leases in the surrounding buildings, it wasn’t always an easy deal. “We’re coming out of a tremendous period of upheaval in Detroit,” he says. “We’ve just come out of bankruptcy a few years ago; there wasn’t total confidence.” Wilson estimated it would take the better part of a year to sell out the stadium suites. Yet within 40 days of sales being open, his team had sold them all. Their unexpected aid? A 3D-printed model.
For its first time working with 3D modeling, Olympia had turned to Zoyes Creative Group, who used the state-of-the-art Stratasys Fortus 450mc 3D Printer to create a breathtakingly intricate model of the arena and the surrounding downtown district, all being developed by Olympia. Founder Dean Zoyes has been using 3D-printing technology since 2011, after years cutting his teeth hand-modeling buildings for architects and designers. Though Wilson may have been pleasantly surprised by the impact of the models, Zoyes wasn’t. “In terms of pre construction marketing, there’s no better tool than a physical model,” he attests. “This type of additive modeling has really changed the industry overnight.” Chuckling, he adds, “My developers and architects try not to make that a true statement—they use all other models, be it visual or verbal, but when it comes down to it, there’s really nothing like being able to see for yourself a physical display model on a table, and especially one this intricate. The type of quality you get from a physical display, the value is inherent in that. There becomes this visceral attachment to a physical piece.”
The model in question was no standard project: Zoyes calls it “if not the biggest or the best we’ve ever done, the closest to it.” Stratasys project lead Jim Vurpillat explains, “Olympia wanted to, in a sense, bring this project to light because it was broader than just a new arena; there was a much bigger scope. They very quickly realized the only way to really bring this to life in the time they had was to use 3D-printing.”
The model features a nearly unparalleled standard of detail for 3D models. Each building, street, and signpost is rendered in exact scale, allowing both developers and potential purchasers to get a virtual sense of the space, which was, at sale time, little more than a giant construction lot. “Potential developers could see on a real scale what things are going to look like and how they’re going to work,” Wilson says. “It makes everything so much easier. They could see, ‘Oh, there will be a mass of people outside my building coming from the arena every night—that makes for good business.'”
Speaking of masses of people, what’s an arena without fans? Not much, according to Zoyes’s team, who made the last-minute decision to fill the model stadium with tiny fans. “We wanted to add some excitement to the inside of the bowl,” recalls Zoyes. “So I said, could we 3D-print fans with their hands in the air? So we did that, and our client thought it was just the coolest thing, so we ended up printing several groupings of people and then hand-placing them in rows. That probably took a good week. Someone’s job was to categorize the groups and put them in, all by hand.”
As development has continued, that model has become an evolving structure. “Once we had the stadium, the ballpark, the Fox Theatre, Fillmore, all built perfectly to scale with all of the features that you recognize, we could start painting the picture of what this arena is going to do and mean,” explains Watson. “And as they assembled it, the story became very real and became a great scene-setter for the next phase. We would look at something and say, ‘No, that’s a bit off, we’ll have to move that,” and kind of develop the project that way.”
As a result, the project is far from slowing down. “They will continue to use this,” says Wilson of his sales team. “We’ll continue to tell these stories for all the leases for the smaller buildings; that will be going on for probably the next five years. Every time you come in, there will be another little building, and it creates a sense of urgency.”
For Wilson, Zoyes, and Vurpillat, all Detroit natives, the project has become far more than a standard development. It’s part of a larger story about revitalizing their beloved city. Says Vurpillat, “I’m from Detroit for 28 years; it’s very exciting to see this growth happening in your hometown.”
Buyers thought so, too: “Once everyone saw the arena, with the video and the whole presentation, almost everyone who bought a suite said part of the reason was that they really believed it would be a transformational change for the city,” Wilson recalls. “And they wanted to have a part of the city’s comeback.”
Adds Zoyes, “One of the things I don’t usually get to say is that I feel very lucky to be invited in on these projects. I’m the person that’s seen the inside of this arena before anyone else has. I can envision the spaces way faster with the advent of 3D printing, and we can help others visualize it as quickly as we do. It’s a real joy to be involved in Detroit. It’s on the move. Everyone calls it a revitalization, but it’s always been there. It’s just now coming to life.”
The government is eliminating a generous tax waiver for electric vehicles, giving Tesla cars little or no price advantage over a Mercedes.
Hong Kong has long been one of Tesla’s biggest markets, but it may not be for much longer—not a single newly purchased Tesla model was registered in April, according to data from Hong Kong’s transport department.
The plunge in interest in Tesla cars came after the government eliminated tax breaks for electric-vehicle (EV) owners, a policy that went into effect on April 1 and is expected to last until March next year. Now, the city has capped the tax waiver at HK$97,500 ($12,500) on private EVs, and is only applicable to first-time owners. There were 2,939 first-time Tesla registrations in March just before the new tax rules kicked in, around five times that of the number in February.
As a result, it now costs HK$925, 500 ($118,400) for a Tesla Model S 60, compared to HK$570,000 ($72,900) before the new tax policy—giving it little or no price advantage over a Mercedes-Benz.
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