– new regulations, new materials, new opportunities.
3D Printing at Point of Care (3DP-POC) is a synonym for successful interaction between hardware and software, physicians and engineers, materials and clinical applications, regulatory and individual patients´ needs. 3D Printing at Point of Care starts with very low investment. However, 3D Printing at Point of Care is easily scalable and requires a fundamental understanding of the framework. This article provides an overview of the key success factors to establish 3D Printing at Point of Care (3DP-POC).
Hardware and Materials
Numerous 3D printing technologies have been introduced into the hospital environment. Resin SLA (Stereolithography) printing technology has a large installed base and benefits from broad acceptance in the clinical environment. Hardware sizes range from desktop printers to larger models. The accuracy and the price for SLA desktop printers speak for themselves. However, careful material handling and required postprocessing shall not be underestimated to reduce toxicity risks  for patients, physicians, and engineers.
Filament printers is available in desktop format, too. The main application for current filament printers are basic anatomical models printed in PLA. Latest developments for FLM (Fused Layer Modelling) or FDM printing (Fused Deposition Modelling)  support also more complex applications such as surgical guides or even implants and offer a much broader scale of polymer filaments  to be manufactured on industrial standards. The enclosed table  provides an overview about non-degradable medical grade filaments (including ISO 10993 documentation) compatible to selected FLM printers (Kumovis R1):
PolyJet and Objet technology complete the portfolio of printers for anatomical models. High resolution and multicolor / -material allow further simulation of clinically relevant structures and an enhanced surgical understanding of anatomical situations. Pricing normally is higher than filament desktop printers, but still affordable for hospitals and R&D budgets.
SLM Printers producing medical devices with (titanium or Polyamid) powder will not find their way into the hospital environment in short term. Both financial investment and complex material handling are hurdles to overcome before establishing such technology for 3D Printing at Point of Care.
Beside printer hardware and material, Software is a key component when planning budgets for 3D Printing at Point of Care. Numerous licensing models are available on the market as well as open-source and free software solutions. Even though all software solutions will be able to export an STL file, the quality of this STL file may vary dramatically. Printing medical devices and treating patients differentiates significantly from rapid prototyping: The design is based on anatomical data, the outcome defines the success of the healing process and the physician`s responsibility of proper usage of the device is a key success factor. Pre-surgical planning with dedicated software with medical features is highly recommended. Certified software packages provided by vendors such as Materialise , 3D Systems  or other vendors promote different pricing and licensing packages. Studies publish annual costs of 20,000 US$ for software . Depending on the clinical application and vendor this price may vary but shall never be underestimated.
Physicians and Engineers
3D Printing at Point of Care opens up new interfaces between physicians and engineers. Easy-to-handle desktop printers combined with wizard guided software might be used by physicians. The more complex the hardware, the material handling and the pre-operative planning gets, the higher the probability that engineers are involved.
Different mindsets and educational backgrounds shape the communication between the physician and the engineer .
The physician requesting the patient-specific implant, facing an engineer interacting in a technical environment, designing an individual solution fulfilling the surgeon`s and the patient`s expectations. Different scenarios have been established in the past few years and will be more visible for 3DP-POC in the upcoming months:
- The hospital qualifies the surgeon to operate both software and printer hardware and combines the skillset of the engineer and the treating physician in one employee.
- A (biomedical) engineer employed by the hospital brings additional competence to the surgical skills of the physician and adds another headcount to the team working in the hospital. The chance to add engineering skills to the medical skillset in the hospital environment scales up the qualification and raises the probability of successful 3D prints.
- The hospital invites medical device companies with expertise in 3D-printing to join forces and run a 3D Printing Lab on the hospital campus. This means the physician benefits from direct interaction with professional (industry-employed) engineers but the hospital takes limited ownership and risk in owning a 3D Printing Lab. An agreement on financial aspects, printed quantities, fulfilled timelines, potential exclusivity and other responsibilities is the base for this cooperation.
The MDD (Medical Device Directive) has been released in 1993 and is now replaced by the MDR (Medical Device Regulatory) which was introduced in 2017. The MDR has a major impact on CE marked medical products and will show full impact in May 2020. MDR defines new standards for both industrial 3D printing and 3D Printing at Point of Care. Not all details provide a unique definition, however, clear regulations have become necessary as 3D printing became more and more popular and the medical market is a strictly regulated market which require guidance and high-quality standards.
The MDR deserves a dedicated focus, however this article tries to summarize the essential requirements to successfully establish 3DP-POC. According to the latest information 3D printing in hospitals is aligned to the CE Medical Device Regulatory 2017 if the following aspects are respected:
- A review of the experience gained from the use of 3D printed devices must be granted (post-market surveillance).
- The output must not be commercialized.
- An inhouse Quality Management (QM) System must be established and SOPs are controlled
- The hospital must be able to able to provide evidence that there is no alternative in the market
Regulatory hurdles are often used to explain why 3DP-POC will not be established as fast as technically possible. It is true that QM-requirements for a medical device manufacturer is high. A clear framework and legal assurances would then be even more important, benefiting not only the Hospitals but also their patients. With the recent advancements in the 3D-printing space in Healthcare (artificial intelligence, semi-automated software support, mobile applications for viewing diagnostic images, etc.), there exist hurdles for quickly developing new QM-systems for hospitals. I encourage physicians and quality managers to embrace the change and further develop strategies in cooperation with industries for implementing 3DP-POC.
Clinical Applications and Future Outlook
3D Printing at Point of Care supports a broad range of clinical applications and raises patients’ and the physicians’ expectations. Most popular applications  include anatomical models, but also surgical instruments and guides. While anatomical models include both bony and soft tissue anatomies such as cardiovascular applications, guides and implants mainly rely on bone structures and focus on craniomaxillofacial and orthopedic applications.
With new materials pushing into the 3D Printing market, the opportunity for resorbable implants increases. In the past, 3D Printing (in industry as well as in hospitals) has been compared to existing manufacturing technologies such as injection molding or milling. While these established technologies have set the standard for implant manufacturing with conventional materials, 3D Printing may set the benchmark for resorbable 3D Printing. The enclosed table  shows degradable Evonik materials used for filament printing in medical applications.
Temperature and pressure occurring during processing can lead to the degradation of these polymers. To measure this degradation, the inherent viscosity (IV) can be determined. The higher the IV loss the higher the degradation of the polymer has been.
While injection molding of resorbable polymers can lead to an IV loss ranging from 15% to 20% the 3D Printing technologies with filaments reduce this factor to 9%. This improved manufacturing method sets new benchmarks for implant manufacturing in the future and opens up new applications and treatment possibilities for physicians and patients.
3DP-POC has just started to be implemented in hospitals and will find its way meeting regulatory requirements, selecting the right experienced industry partners to run 3D Printing Labs, and fulfilling expectations from physicians and patients. Today, while there are no well-defined standards for hospital 3D printing in terms of technology or materials, polymer 3D printing seems to play a large role due to ease of handling, competitive pricing, and design possibilities that can satisfy technical and clinical requirements from hospitals` expectations.
 Evaluation of Resins for Stereolithographic 3D-Printed Surgical Guides: The Response of L929 Cells and Human Gingival Fibroblasts, Volume 2017 |Article ID 4057612 | 11 pages | https://doi.org/10.1155/2017/4057612
 Kumovis internal document
 Kumovis internal document
Martin Herzmann started his MedTech career in 1999 when he joined Brainlab. After 8 years and numerous positions in Sales, Product Management and Business Development Martin accepted a new role as Director Global Marketing at Ziehm Imaging. After 8 years working in Marketing for capital equipment he decided to change his position again: In 2015 Martin joined Materialise Medical as Sales Manager and became part of the 3D Printing community. Since December 2019 Martin supports Kumovis in Business Developer and accelerates the innovation in medical polymer printing both for MedTech industry as well as for hospitals directly at print of care. Kumovis will be an exhibitor at 3DHEALS2020.
Ideas to Implementation: What Is A Typical 3D printing Digital Workflow For Pre-surgical Application