For more than a decade, the medical field has leveraged additive manufacturing (AM) technology to push the boundaries of patient treatment. From 3D tracheal splints that treat tracheobronchomalacia (TBM) – threatening the breathing of 1 in every 2,000 children worldwide – to 3D printing tissues to test pharmaceuticals, there’s no denying the capabilities and potential of AM.
According IDTechEx, the market for 3D-printed medical devices will be worth $6.1 billion by 2029. Some segments will grow at a compound annual growth rate (CAGR) of 18%. Medical equipment manufacturers who aren’t using 3D printing in some capacity are behind the competition.
Customized care
Personalized solutions for patients and medical staff are rapidly growing because AM can develop products, tools, and devices that cater to the physiological and functional characteristics of patients and individual providers.
Every patient has unique complex geometries, creating individualized challenges for designs of equipment and tools, functional integration, financial restraints, and compressed delivery times. AM allows healthcare providers to overcome these challenges with personalized patient care.
Custom foot orthotics producer Aetrex captures hundreds of data points from a person’s feet – arch analysis, pressure points – and uses that information to create 3D-printed foam shoe inserts that provide more highly targeted comfort and pressure relief. Applying that type of personalization to a patient confined to a hospital bed or wheelchair means replacing mass-produced products created to meet a broad spectrum of patient specifications, with individual medical equipment fitting their personalized needs. These use cases may exist soon, especially since 3D-printed casts for broken bones already exist.
Similarly, there’s a growing opportunity for medical professionals to experience the same type of customization. A surgeon whose natural way of holding a tool might not necessarily conform to the standard way those tools are created. Tools designed to meet doctors’ unique techniques or patient populations could improve job performance.
Polymer AM enables patient-specific surgical guides and functional prototypes, which can be quickly developed for surgeon design meetings and other testing scenarios.
The flexible printing process allows device providers to easily create equipment customized for each patient or surgeon’s preferred technique by transforming digital files into physical parts.
New AM metal materials with a history of clinical use, such as 17-4PH stainless steel, could support printed-on-demand surgical instruments with the same quality, mechanical properties, and heat treatment used by vendors.
As this space matures, healthcare providers are looking for clarity in keeping up with technology advancements. They’re also seeking the right partners.
Potential hurdles
One common issue among medical equipment manufacturers is understanding how to implement 3D printing more broadly, not just within certain departments. Organizations typically focus on one need or product line instead of approaching AM more holistically. The most successful organizations have upper management in AM decision-making and roll-out and have multiple department heads representing several disciplines or product lines. This approach better identifies key areas where AM can make a significant impact on operations across the board.
Another hurdle faced during AM implementations is the misconception that materials are cleared by regulatory bodies for general use. The U.S. Food and Drug Administration (FDA) clears devices independently of the manufacturing method. The final finished sterilized device is what is considered biocompatible. AM material suppliers can reduce the legal risk to device manufacturers by testing the biocompatibility of the as-built scenario. However, they don’t have visibility to additional processes that the workpiece touches, so they can’t provide information about the finished device’s biocompatibility.
Setting up for success
Medical equipment manufacturers serious about taking advantage of AM’s benefits need an equally engaged partner who brings more to the table than just 3D printers. The right partner will help an organization implement the technology and accompanying procedures to operate more efficiently, better serving client needs.
AM is relatively new and lack of standards to reference can be an impediment. Therefore, it’s important to find a knowledgeable consultant team to ensure success when communicating with regulatory bodies and identifying gaps in quality systems.
If companies can identify products or situations where AM can be applied, they can better set up quality systems to leverage data for fast-follower products in their AM pipeline.
Much of this groundwork is done before production begins. A partner must offer a high degree of engagement on the front end to understand what the producer is trying to accomplish and how to help get there. At EOS, we call this Additive Minds – human-centered design and innovation experts who work to minimize risks while quickly getting to serial production with the greatest possible design freedom.
Once systems are operational, the right partner will help producers think toward future applications and ensure platforms are built to sustain future production needs.
Ideally, an expert partner will also offer education and training opportunities. Whether learning the fundamentals and safety measures or more advanced capabilities of AM machines, they’ll ensure producers get the most out of their investments.
The history of quality offered by experienced AM technology partners, as well as the technology’s ability to create complex geometrical structures, makes it ideal for high-value applications within medical settings. For medical equipment manufacturers, it's important to recognize the powerful capabilities of 3D printing to better serve clients now and into the future.
Elizabeth Engler Modic
