Healthcare innovation is moving rapidly. Globally, manufacturing is transforming as companies introduce the power of additive manufacturing (AM) into workflows built upon traditional technologies. This trend is evident in the medical device industry, where specialized manufacturers are using AM to optimize implant and instrument design. The industry is leveraging AM solutions comprising materials, hardware, software and services to reduce the number of processing steps and components in a device, thereby reducing the overall cost of manufacturing.
We see this adoption of AM play out in the spine industry. Interbody fusion devices were almost exclusively manufactured using materials like PEEK and traditional subtractive manufacturing processes. Now, AM solutions are being adopted to introduce revolutionary products that can promote bone ingrowth1 and thereby improve implant fixation to host bone. Additively manufacturing these devices also reduces the number of required steps, thus making the process more cost-effective in several cases.
Integrating advanced technologies to fuel innovation is revolutionary. Industry leaders that have adopted AM solutions are delivering highly effective products at a reduced overall cost and helping improve the standard of care.
365 Days from Concept to Full Product Line
NuVasive is one example of a company innovating. The orthopedic device company recognized the unique capability of AM to produce complex and optimized shapes that 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 Modulus®—now a full implant line.
The Modulus line balances porosity with load sharing, and each independent SKU is optimized for improved radiolucency. 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 of bone fusion during post-operative patient follow-up. In addition, the optimized lattice structure provides a fully porous architecture that creates an environment conducive for bone in-growth.1
Multiple Players Require a Harmonized Approach
Recently, numerous company consolidations have taken place in the spine and orthopedic industries. Large orthopedic device manufacturers are acquiring small and medium-sized companies with additive manufacturing product portfolios to leverage their technical expertise and geographic reach. While these OEMs are expanding, contract manufacturers are entering the market to help address capacity demands in an outsourced fashion.
As manufacturers and service bureaus employ AM solutions that best meet their needs, the result is a complex ecosystem of novice and experienced players using multiple technologies to make different kinds of implants and instruments. This work necessitates guidelines for a harmonized validation approach such that we can create devices that meet the highest quality standards demanded by the healthcare 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. When you integrate game-changing AM technology into your own business, there are several considerations to ensure success.
The first is in regard to the qualification and validation of your entire solution, including not only materials and hardware, but even your supply chain. Qualifying new 3D printing materials for healthcare applications presents multiple challenges. First, the material must be qualified for its biocompatibility and ability to meet mechanical requirements for the 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 them for new printing applications.
The second challenge is in regard 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 orthopedic device companies are well-versed in ”manufacturing,” integrating AM into the workflow benefits from the expertise of an experienced partner. Leading 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 this article focused on medical device manufacturing, AM is also playing a key role in other healthcare applications.
Virtual surgical planning (VSP®) – a service-based approach to personalized surgery combining expertise in medical imaging, surgical simulation and 3D printing – allows surgeons to perform the surgery digitally before entering the operating room. Biomedical engineers and the surgeon engage in an online planning session that results in the design and 3D printing of 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. These offerings save time in the operating room, which benefits both the surgeon and the patient.2,3,4
As healthcare expands its adoption of AM, the technology will become integral to delivering personalized care at point of care sites. This is already taking shape at some of the world’s elite hospitals where clinicians can create customized solutions for patients 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, thereby changing the standard of care. AM has tremendous potential to shape the future of healthcare by unleashing innovation to disrupting existing models of manufacturing and patient care.
1. Gupta, G: OsseoTi porous metal for enhanced bone integration – an animal study. Study completed August 2012.
2. Sink J, Hamlar D, Kademani D, Khariwala SS: Computer-aided stereolithography for presurgical planning in fibula free tissue reconstruction of the mandible. J Reconstr Microsurg 28:395-404, 2012
3. Patel A, Levine J, Brecht L, Saadeh P, Hirsch DL: Digital technologies in mandibular pathology and reconstruction. Atlas Oral Maxillofacial Surg Clin N Am 20:95-106, 2012
4. Roser SM, Ramachandra S, Blair H, Grist W, Carlson GW, Christensen AM, Weimer KA, Steed MB: The accuracy of virtual surgical planning in free fibula mandibular reconstruction: comparison of planned and final results. J Oral Maxillofac Surg 68:2824-2832, 2010
Gautam Gupta is Vice President, Global Go to Market, Healthcare, 3D Systems.