Manufacturing has traditionally been a lengthy process from initial design to finished part. And given regulations, medical device manufacturing has been cast as a pretty conservative one. But industry’s use of stock component offerings and the rise of industrial-grade 3D printing could be propelling medtech toward an on-demand approach to manufacturing.

Annie Cashman, global segment manager/business development-medical for Protolabs, an on-demand, quick-turn contract manufacturer, believes most of the medical industry is using an on-demand business model today in some fashion. “Look at companies like Qosina or any distributor that simply buys parts and keeps them in inventory for any engineer to procure and put into his or her design. The customer doesn’t have a minimum-order quantity, which is a version of on-demand manufacturing (ODM) that has been around for many years,” she told MD+DI.

Today, advances in medtech prototyping are driving new manufacturing capabilities. When it comes to prototyping, Cashman said, “There are many changes, but the main one is the adoption of additive manufacturing in terms of materials and services offered. And additive manufacturing technologies are developing rapidly. For example, at Protolabs, we offer five different 3D printing processes. This technology has enabled medtech companies to prototype parts much faster and sometimes more cost effectively than injection molding a part. That being said, we have seen a huge uptick in our CNC machining services, and I believe that is because speed is still the number-one driver for prototyping, especially when you are working with a pre-revenue customer that is not yet to market.”

On-demand manufacturing “involves all of the same processes that we use for our prototyping services,” continued Cashman. “There are different options as far as secondary operations that we can offer or different pricing models that may be more attractive to customers. This depends on what they are trying to achieve with their project and when they are using Protolabs in their product development cycle.”

Above: Direct Metal Laser Sintering (DMLS) parts right off the printer. 

Timelines could shorten significantly in on-demand approaches. “The game-changing technology that is starting to get traction and where we fit is that we can make a custom part that’s unique to one specific customer’s needs and have a part in that customer’s hands in hours for CNC machining, and days for a molded, printed, or sheet metal part,” said Cashman. “That is truly transformational, and as companies like Protolabs continue to offer more to the regulated industries for production, we believe it could revolutionize manufacturing in those industries—medical, aerospace, and auto, for example.”

Additive manufacturing offers specific benefits. “3DP enables products to get to market faster and to have improved designs through increased design iterations,” said Cashman. In addition, “3DP can produce parts with complex geometries and organic shapes, perfect for unique or customized applications.” Such capabilities could benefit the medical device industry in particular, as “nothing is more customized than the human body,” she added.

Protolabs augments such on-demand production with digital manufacturing, a “technology-enabled, automated approach to manufacturing,” Cashman told MD+DI. “Through our ecommerce portal, once a customer uploads a 3D CAD file, our system analyzes it and delivers design for manufacturability feedback and a pricing quote within a few hours. This system enables designers and engineers to rapidly iterate their product designs. The ability to provide feedback in hours and parts in days is a game changer for the manufacturing industry. It enables real-time inventory monitoring, which allows companies to master their whole production line and intervene when it is necessary to adapt the product to the changing market.”

Above: A stereolithography microfluidics part. 

Such a “digital” approach could serve medtech companies as “we apply this digital thread across multiple services [such as] 3D printing, CNC machining, injection molding and sheet metal fabrication,” she said. “If a customer were using a traditional method, which would most likely involve sending a part drawing to an engineer at the receiving company, just the quote alone could take days or weeks to send back depending on availability and capacity of the quoting team on the receiving end. Once the quote is generated and accepted in the traditional format, a company then has to manually block time in its schedule for the mold or part to be built. By comparison, Protolabs’ proprietary software creates a digital thread that seamlessly runs from upload to quoting to scheduling to production, which creates efficiencies that are not possible without it.”

There are some implementation challenges in terms of using 3D printing for market-ready components or finished devices. “I still believe the largest barrier to entry is the lack of clinical data in the additive space,” said Cashman. “Also, very few 3D printing materials are USP Class VI compatible, and few 3D printing shops are ISO 13485 compliant. We are ISO 9001, which is good for prototypes and some end-use applications. The FDA regulations are only about a year old and are still evolving.”

On-demand manufacturing is also driving the need for new skills. “I visit many customers that tell us one of the most important skills any new engineer must have is they need to have a fundamental understanding of how to design for digital manufacturing,” she said.

Above: An injection-molded part.

3D printing is enabling new innovators to step into the medical device market, such as doctors or other clinicians. “We often have surgeons making their own surgical tools that will potentially commercialize in to the market,” she said. “3D printing lowers the barrier of entry for surgeons with good ideas to bring their ideas to reality.”

When asked whether medical devices will one day be printed closer to the point of care, Cashman said they are already seeing this in dental. “Many industries are looking to simplify supply chains and move to a distributed model – they also want to look to suppliers with the capacity and expertise to help them. However, the expertise to run such a wide variety of geometries/machine maintenance/material handling could prove to be a challenge.”

SOURCE:MDDI