How Additive and Subtractive Manufacturing Are Revolutionizing the Medical Device Industry

The healthcare sector is currently facing a critical juncture in determining the optimal approach to delivering the highest quality care to a population with increasing surgical needs, a growing incidence of chronic illnesses, and a significant aging demographic. As a result of these current and future conditions, the medical device manufacturing industry has experienced an increase in demand for more specialized medical products and individual part designs that can better serve more complex individual patient needs.
 
When combined with an increasingly strained supply chain, uncertain macroeconomic conditions, and industry-wide consolidation, medical device engineers, designers, and manufacturers are implementing innovative technological solutions centered around additive and subtractive manufacturing. These technologies streamline the medical manufacturing production process, reduce costs, and accelerate time-to-market, paving the way for improved healthcare experiences and enhanced patient outcomes.

Additive Manufacturing: 3D Printing Intricate, Fully Completed Medical Devices

Additive manufacturing technologies, like 3D printing, refer to the process of using compact computer-numerical-control (CNC) machinery to create an object by building it one layer at a time. The flexibility of this tech enables designers to collaborate with engineers, manufacturers, and providers to easily make changes without additional equipment or tools.
 
These capabilities enable organizations to create device prototypes in-house and on-demand, rather than relying on external outsourcing and its accompanying risks. Rapid prototyping can deliver functional prototypes in turnarounds ranging from hours to days, rather than weeks to months, allowing more time for testing and informed decision-making among stakeholders to best ensure safe, high-quality device rollouts. Further, compact additive manufacturing machinery allows users to employ bridge manufacturing, where a compact 3D printer is used to design and create low-volume production runs of a part, tool, or completed device, before more confidently moving to more conventional mass production processes.
 
Additive manufacturing solutions are used to meet evolving patient needs head-on and in-house, with hospitals, clinics, rehab centers, pharmacies, and more using compact 3D printers to create complete medical devices such as:
 

• Medical phantoms
• External prosthetics, such as hearing aids
• Orthopedic and cranial implants
• Surgical instruments, such as scalp handles, forceps, and clamps
• Prescription drug pills and tablets

 
Whether medical providers or manufacturers are 3D printing complete devices, individual parts, or manufacturing tools such as fixtures and jigs, taking the production process in-house enables organizations to keep pace with the evolving and complex needs of the medical sector while maintaining a healthy bottom line. Compact additive manufacturing machinery streamlines on-demand device prototyping and manufacturing, using specialized materials traditionally inaccessible to in-house designers and engineers. Ultimately, medical professionals can worry less about supply chains and instead focus their attention on providing patients with the best possible treatment options and health outcomes.

Subtractive Manufacturing Solutions Avoid Outsourcing and Facilitate Rapid Prototyping

While additive manufacturing is a more recent development in medical device manufacturing, subtractive manufacturing machinery has undergone similar technological advancements to provide an even greater range of production capabilities. Subtractive technology offers more precise designs, higher quality finishes, and is compatible with certain plastics and metals that 3D printers are unable to manufacture due to process restrictions. Traditionally, subtractive manufacturing machines are both inaccessible to and incompatible with in-house production teams due to their cost, large footprint, and waste material, leaving outsourcing as the only option. Outsourcing can take weeks or even months, creating costly bottlenecks and disrupting the engineering process.  However, the recent emergence of compact, digital subtractive manufacturing machinery is reversing this trend.
 
One of the most common subtractive manufacturing processes is waterjet cutting, with new compact CNC waterjet machines offering exceptional accuracy, allowing the creation of intricate designs and precise cuts on a wide range of materials. Waterjet cutters allow manufacturers to work with metals, plastics, and composites used in surgical instruments, implantable devices, prosthetics, and customized medical components. These subtractive manufacturing solutions streamline the production process, enable product customization, and are not small and affordable enough to be located in engineering labs and even on-site at medical facilities.
 
This subtractive machinery enables manufacturers to accelerate in-house, on-demand prototyping and proofs of concept, avoiding outsourcing and significantly reducing the time required for iterations and alterations. In-house prototyping fosters close collaboration between engineers, designers, manufacturers, and providers, which drives innovation, creates tools to keep future volume production lines running, and delivers increasingly localized and customized treatments. This collaborative system ensures all stakeholders are aligned and actively involved in refining the design, leading to more robust and market-ready medical devices.

Hybrid Manufacturing Maximizes Capabilities

Both additive and subtractive manufacturing offer innovative solutions to the medical sector: Compact 3D printers can produce completed designs in resin materials while desktop waterjets are able to cut prototype and functional parts out of metals and other materials.
 
Hybrid manufacturing, the integration of additive and subtractive techniques, utilizes both the intricate designs of 3D printing while leveraging the versatility and speed of waterjet cutters to enable complete in-house production. This integrated approach offers multiple advantages, including reducing the amount of required starting material, shortening the cycle time to create finished products, and lowering total production costs by eliminating rough machining processes. Overall, to have the most extensive range of in-house prototyping capabilities, best-in-class manufacturers and medical professionals utilize a combination of compact additive and subtractive machinery.
 
Compact additive and subtractive manufacturing technologies enable manufacturers and providers alike to meet the medical device industry’s constantly evolving demands for innovation, quality, speed to market, and cost-effectiveness. These technology solutions work together to streamline the prototyping process, meet unique production demands in-house, and facilitate more personalized patient treatments and outcomes.
 

---

Nisan Lerea is the Co-Founder and CEO of WAZER and an inventor of the world’s first desktop waterjet cutter. A consummate “maker,” Nisan spent many hours in the machine shop during his time at the University of Pennsylvania working on projects including a Formula 1-style race car. He needed to cut sheet metal but only had access to laser cutting, which could only cut soft materials. Nisan set out to solve the problem, inventing the first small-scale waterjet that would become WAZER. While working as a mechanical engineer, Nisan realized that other designers and engineers still faced barriers to waterjet cutting, so he teamed up with former colleague and fellow Penn Engineering student Matt Nowicki to launch WAZER in 2016.