3D Printing: Third Industrial Revolution or Productivity Stalemate?

When additive manufacturing gained recognition in the 1980s, it was hailed by some as the start of the “Third Industrial Revolution.” The technology enabled the user to synthesize a three-dimensional object, with layers of material formed under computer control.

Almost any shape can be produced from a digital model, so the applications are limited only by the imagination. What’s more, costs for the required machinery have dropped over the past three decades from hundreds of thousands of dollars to a few thousand dollars; a geeky “do-it-yourselfer” can now afford to add a 3D printer to the tool shed for home projects.

Naturally, innovators in the medical device industry are putting it to good use. Thanks to the flexibility and adaptive nature of additive manufacturing, an MRI scan can be a starting point for a custom, 3D-printed medical device that’s easy to tweak.

According to the U.S. Food and Drug Administration (FDA) website, as of December 2015, the agency has cleared more than 85 3D-printed medical devices, including orthopedic and cranial implants, surgical instruments, dental restorations, and external prosthetics. The site states that FDA recognizes the process has medical applications in biologics, drugs, and other devices regulated by The Center for Devices and Radiological Health.

The potential benefit to the end user is significant—implants that fit exactly into an individual’s body like a missing puzzle piece suggest a level of patient care we’ve worked toward since the dark ages. But from the perspective of small business owners like myself and Jeremi Leasure, owner of engineering services firm mdevdev, the 3D printing industry has not quite reached the point where the technology is consistently a more effective alternative to a traditional manufacturing route.

“For as long as I can remember, I’ve been told to use 3D printing, that it’s the future,” he said. “What I’m seeing in medical devices, orthopedic, and surgical devices is that for the startups, we’re just not there yet. [It’s useful] for the innovators, for the smaller groups that are trying to come up with something disruptive; 3D printing is not an option for us yet.”

The technology isn’t lacking; clients can and sometimes must use 3D printing for certain medical devices. But getting a medical device to market is about more than just technology. It’s also about standards of care, mature manufacturing methods, finishing processes, time, costs, expectations, and the current regulatory climate.

“Working with smaller companies, everyone involved wears multiple hats,” Leasure said. “My customers ask for me to design something and provide specifications for it. But I’m also in charge of the supply chain—vendors, contract manufacturers—that will produce the components or assemblies.”

When working with traditional device manufacturers, that type of outsourcing is simpler, he said. They’ll machine, weld, assemble, finish, passivate, laser mark, and document the entire process. It’s essentially a turnkey process for a single price per implant.

But that’s not the case for clients who need additive manufacturing, he noted.

“The traditional guys speak the language of medical devices,” he explained. “When you talk to a 3D printer and bring up secondary processes such as thread-cutting or quality controls such as certificates or material conformance, sometimes they respond as though they’ve never been asked the questions before. They don’t have their internal operations aligned to provide those critical quality documents or secondary processes.”

That sometimes requires Leasure to find additional vendors or even purchase equipment so the devices can be finished properly. This can add costs and significant delays to the device development process, he said. He mentioned that some devices have been delayed by as much as year.

Keep in mind it’s not necessarily a simple yes-or-no decision to go the traditional manufacturing route.

“It’s not as easy as picking non-3D printing to 3D printing,” he cautioned. “Some customers push me to design things that I know cannot be traditionally manufactured, cannot be machined.”

Those are the clients that send Leasure on the elusive hunt for a 3D printing vendor that knows and understands the medical device industry.

“I’ve been searching for 3D printers for over a decade,” Leasure recalled. “I am continually searching and trying to find the printer that will provide the same list of services as the traditional contract manufacturers. Some are trying and doing a great job, but no one is doing it well enough that I feel confident enough to bring anything beyond limited market release business to them.”

Leasure still holds out hope that existing providers will educate themselves and step up their game to better compete in the medical device arena.

“There needs to be a 3D printing vendor that is not just ISO 13485-certified who can speak the language of startup medical devices,” he suggested. “I think a vendor like that would be met with a lot of interest—somebody who can offer all of the services of the traditional contract manufacturers. But somebody needs to learn that, and maybe its up to us medical device engineers to teach them or provide a roadmap.”

Does this open up a space in the market for someone to jump ship from traditional manufacturing to 3D printing specializing in medical devices? A potential additive manufacturer catering to the medical device industry has a considerable learning curve to tackle if they’re coming into our field from the outside.

On top of the financial costs of the actual equipment, there has to be a commitment and investment in long-term partnerships. In addition to learning the 3D printing jargon, they’d have to understand concerns from design and regulatory perspectives. To achieve long-term success in this space—in addition to ISO 13485 certification—developers have to understand the regulatory pathway in terms of reproducibility processes for manufacturing.

A few vendors with large-scale manufacturing capabilities are entering the void Leasure and other small-scale innovators find frustrating. During a recent ASTM Internatiional workshop on additive manufacturing for medical applications, presenters discussed design, manufacturing, and cleaning of 3D printer components, the mechanical characterization and testing of those components, and development of future standards. I’m hopeful these emerging experts will soon offer services that benefit Leasure’s clients, as well as the innovators who come to the Empirical family of companies as part of their medical device development.

Why aren’t more medical industry insiders jumping in to fill the void? It’s a daunting prospect involving more than the financial risk of equipment and launching a new business. Industry insiders know questions and issues exist that could affect the regulatory climate for additive manufacturing. Application of titanium additive manufacturing is so new, the process to a finished product and mechanical performance will likely face new levels of regulatory scrutiny. Concerns over potential regulatory roadblocks could stifle ambitions from medical device experts to meet the needs of smaller companies and individual innovators.

There’s no quick solution to this gap in the process for smaller companies that require additive manufacturing to perfect or even produce their product. It will take time, money, appropriate regulation, and global thinking from solid partners focused on the big picture for medical device manufacturers and ultimately patients to benefit from this potentially revolutionary process. 

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Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting LLC, and Empirical Machine LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch, and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within ASTM and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the FDA’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.