Industry is creating workflows for AM
The field of health care is often considered to be one of the most dynamic. The speed at which innovation is occurring—from the way surgeries are performed, to the development of new therapies—is moving evermore rapidly. We are also seeing tremendous changes in the way medical devices are manufactured. On a global scale, manufacturing is undergoing a transformation as companies introduce the power of additive manufacturing (AM) into workflows built upon traditional technologies. The medical device industry is no exception, and we’re seeing these specialized manufacturers really starting to embrace the benefits of AM in optimizing the design of implants and instruments. The industry is leveraging the power of additive solutions in the form of end-to-end workflows comprised of materials, hardware, software and services—to reduce the number of processing steps and components in a device and thereby reduce the overall cost of manufacturing.
We see this revolution happening in the spine industry right now where interbody fusion devices used to be almost exclusively made using materials like PEEK and manufactured using traditional subtractive manufacturing processes. The spine industry is now adopting 3D printing to introduce new revolutionary products that can promote bone ingrowth and thereby improve implant fixation to host bone. Printing these devices also reduces the number of manufacturing steps, making the additive process more cost effective in many cases.
The revolutionary idea of additive manufacturing is fueling innovation to bring highly effective products at reduced overall cost and improving the standard of care.
AM Moves Concept to Full Product Line in 365 Days
One such example is NuVasive, a medical device company that recognized the unique capability of AM to produce complex and optimized shapes could open new avenues in its design and manufacturing of minimally invasive, procedurally integrated spine solutions. According to NuVasive, the company’s goal was to provide the optimal spinal implant without making significant tradeoffs in the process. NuVasive quickly capitalized on the advantages of AM, going from design to market in just over one year with the 2017 launch of its trademarked Modulus—now a full implant line.
The Modulus line balances porosity with load sharing, and each independent SKU is optimized for improved permeability to X-Rays. This was achieved through topological optimization, an algorithm-based design strategy that removes excess material that serves no structural or functional purpose. A component that has been topologically optimized is lighter-weight with no adverse impact on strength. In the case of the Modulus line, topological optimization also facilitates better imaging characteristics across all shapes and sizes of implants, giving surgeons a better view into bone fusion during follow-up. In addition, the optimized lattice structure provides a fully porous architecture that creates an environment conducive for bone in-growth.
Multiple Players Require a Harmonized Approach
NuVasive is just one example of how additive manufacturing is changing the face of medical device production. Additively manufactured implants and surgical instruments exhibit excellent mechanical properties enabling accelerated product development without the long lead-times associated with traditional subtractive manufacturing. Recently, there have been numerous consolidations in the spine and orthopedic industries. Small and medium sized companies with innovative product portfolios are being acquired by large medical device manufacturers to leverage expertise and geographic reach to expand their footprint. While these medical device manufacturers are expanding, there are also many new contract manufacturers entering the market to help address these capacity demands in an outsourced fashion. As manufacturers and service bureaus employ additive technology platforms that best meet their needs, this results in a complex ecosystem of novice and experienced players using multiple technologies to make different kinds of implants and instruments. This necessitates guidelines for a harmonized validation approach such that we as an industry are able to create devices that meet the highest quality standards demanded by the health care industry. Robust process validations and build qualifications through witness coupons can result in elevated confidence that chemically and mechanically conforming parts are produced consistently.
Integrating AM into Your Medical Device Manufacturing Workflow
Medical device manufacturing is one of the most highly regulated processes, and as such, when you choose to integrate this game-changing technology into your own business, there are several considerations to ensure success.
The first—and most significant—is in regards to qualification and validation of your solution. This extends not only across your materials and hardware, but even to your supply chain.
Qualifying new materials for 3D printing technology in health care presents challenges at multiple levels. First, the material has to be qualified for its biocompatibility and ability to meet mechanical requirements for its application. The regulatory and financial burden of such qualification and the associated time can be substantial. Although still a challenging task from a logistics and technology standpoint, it is faster, easier and less-expensive to qualify already proven materials like 17-4 PH stainless steel and validate those for new printing applications. The second challenge is in regards to machine hardware engineering. Validating and optimizing parameters to run new materials can be challenging and costly unless there is a business case for a clinical application that requires large-scale manufacturing.
Third, securing a logistics ecosystem for reliable sourcing of such new materials at the quality required for healthcare applications can also be a challenging task.
While medical device manufacturers are well-versed in “manufacturing,” bringing AM into the workflow benefits from the expertise of an experienced partner. My recommendation is to look for a company well-positioned to help overcome these challenges. Experienced AM solutions companies blend deep expertise with a diverse, broad, library of biocompatible materials to assist in more easily streamlining these processes.
The Future of AM…Beyond Device Manufacturing
While I’ve spent quite a bit of time focused on medical device manufacturing, AM is also playing a key role in other applications such as creation of anatomic models and virtual surgical planning (VSP).
VSP—a service-based approach to personalized surgery combining expertise in medical imaging, surgical simulation and 3D printing—allows surgeons to essentially perform the surgery digitally before entering the operating room. Following an online planning session between biomedical engineers and the surgeon, patient-specific models, personalized surgical tools, and instruments are designed and 3D printed for use within the sterile field. In clinical applications where VSP is used today, the solutions have been shown to improve surgical accuracy and outcomes—saving time in the operating room which benefits both the surgeon and the patient.
As AM technologies expand their role in health care, we will also see the technology become integral to the delivery of personalized care at point of care sites. This has already started to take shape at some of the elite hospitals in the world where clinicians are able to create customized solutions for patient care by using technology available to them on campus. As the technology becomes more user friendly, a larger number of hospitals will be able to implement end-to-end solutions for personalized care, thereby changing the standard of care. Overall, AM has tremendous potential to shape the future of healthcare by unleashing innovation and disrupting existing models of manufacturing.