A new biomaterial company, Â FibreTuff,Â has announced plans to begin manufacturing cellulose-based biomaterials that are biocompatible, absorbable, and nondegradable for Class I and II medical devices. The companyâ€™s PAPC ingredients can be compounded into pellets to make 3D printing filament that can be used to print a variety of medical devices and implants.
â€œFibreTuff compounds biomaterials that contain celluloseÂ and blends them with thermoplastics branded as PAPC (polyamide, polyolefin, and cellulose) compositions for use in Class I [and]Â IIÂ and eventually Class III permanent implants for the medical industry,â€� explainedÂ FibreTuff founder and president Robert Joyce. â€œWeâ€™ve now brought on partners, purchased manufacturing equipment, and now leased space in a facility located in West Unity, Ohio.â€�
FibreTuffâ€™s PAPC filament can be used in 3D printers without the odors traditionally associated with the printing process. The biomaterial will also cost about 30% less for device makers in need of things like cervical spacers and other implantable devices. The material also has the huge advantage of being â€œradiopaque,â€� meaning it can be seen onÂ an x-ray without requiring additives like other products on the market.
â€œYou can see in an x-ray where the tissues and bone grow into the implant made with PAPC,â€� Joyce said. â€œOur FibreTuff PAPC is a hydrophilic compound that is coating friendly to support a printed circuits design and construction through an ink process by nScrypt located in Orlando, Florida. Even the specific gravity of the compound is 20% lighter than [that of] other materials currently on the market, which can translate into lower material costs to produce 3D printed parts.â€�
Among the other characteristics of the FibreTuff filament are that it will not dissolve inside the bodyÂ and has already passed USP Class VI testing performed by NAMSA for implantation, the company reported in a news release. The filament also has a weight and composition very similar to actual human bone, which could suit it for 3D printing bones for academic use in medical school.
â€œThe human bones that are 3D printed with FibreTuff PAPC offer similar features to an actual human experience, having good screw retentionÂ and sawing and cutting ability,â€� Joyce said. â€œOther 3D printed resins have challenges with these types of features, but we have the flexibility to print different sizes of human bone that actually resemble real human bones. A local university has been using pig and cow bones for their medical students to practice on, but we are aiming to have the students 3D print bones with FibreTuff PAPC that they can actually practice on.â€�
While the company officially launched operations within the last week, the company has spent the last four years not only developing the technology, but also recruiting partners and taking orders. Now that it is moving toward a new phase in sales and marketing, Joyce saidÂ that the company hopes to begin producing PAPC implants within the next 16 months.
â€œApproximately 16 months from now we hope to have PAPC in permanent implants for spine, trauma, and sports medicine that can show much improved osseointegration versus PEEK and metal implants,â€� he said. â€œWe also hope to begin reducing the cost to produce these types of implants by 30%. We want to work with hospitals, colleges and universities, and medical device manufacturers to develop a new way to deliver education and functional tools and models to the medical market.â€�
The global 3D Printing Medical Devices market anticipated around USD 0.84 Billion in 2017 and is predicted to reach USD 2.21 Billion by 2023, at a growing CAGR of 17.80% by 2018-2023. This report is equipped on the basis of various standards through several ways of 3D Printing Medical Devices research methods.
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Major key players of the 3D Printing Medical Devices market: EOS GmbH Electro Optical Systems, SLM Solutions Group AG, Organovo Holdings Inc., 3D Systems Corporation, Carbon Inc., Anatomics Pty Ltd., Materialise NV, Envisiontec GmbH, 3T RPD Ltd., Concept Laser GmbH, Renishaw plc, Biomedical Modeling Inc., Stratasys Ltd., Arcam AB and Prodways Group
The 3D Printing Medical Devices market report covers up various segments that include product types as:Â Droplet Deposition Or Extrusion-Based Technologies, Electron Beam Melting, Laser Beam Melting, Photopolymerization, and Three-Dimensional Printing (3DP) Or Adhesion Bonding? Or Binder Jetting
On the basis of 3D Printing Medical Devices end-users applications: Porous Scaffolds, Dental Restorations, Prosthetics, Manufacturing Surgical Guides and Implants
The Worldwide 3D Printing Medical Devices market report that involves geographical regions such as:
â€” North America- (The US, Canada)
â€” Europe- (UK, Germany, France)
â€” Asia Pacific- (Australia, China, India, Japan)
â€” Latin America
â€” The Middle East and Africa
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The China Food and Drug Administration (CFDA) has published new guidance into the registration requirements for 3D printed medical devices.
The draft guidance is intended to address industry questions into how the CFDA will approach the regulation for 3D-printed medical devices on the Chinese market.
The guidance covers 3D-printed implantable devices for orthopaedic and dental applications; biomaterials and pharmaceuticals produced using additive manufacturing.
The CFDA will also require validation testing for 3D printing manufacturing equipment and processes, as well as materials, software and final products.
Other key proposals of the guidance include environmental parameters which should include temperature, pressure, humidity, gas composition, printing speed, energy density and related factors.
The guidance also proposes that Product validations should include usability tests, that clinicians and healthcare professionals be involved in the design of 3D printed devices and that the use of 3D-printed medical implants should involve contracts between patients, manufacturers and healthcare providers.
It also states that additive manufacturers must conduct cleaning processes which may not be outsourced given the complexity of 3D printed medical devices.
The CFDA is awaiting comments from the industry and is aiming to issue a final version of the guidance to address the 3D printing sector.