With the expansion of Formlabs’ library of biocompatible materials, 3D printing is becoming an option for more and more workflows and applications, improving patient care, reducing costs and expanding possibilities.

The difficulty of producing flexible and biocompatible parts for the healthcare industry

For years, 3D printing has been improving the workflows of medical device companies and medical professionals. However, for applications that require both flexibility and biocompatibility, there has been no holistic 3D printing process for the Formlabs ecosystem.

For the production of biocompatible and rigid parts, many companies have now realized that 3D printing is a cost-effective means of production. For elastomeric parts, however, 3D printing is not a solution due to the lack of materials with the right Shore hardness and elongation at break that also meet strict biocompatibility requirements. Flexible end-use parts, such as custom devices, patient-specific surgical models and short-term wearable or skin-contact devices, have been extremely difficult to produce cost-effectively, and many companies only offer standardized options.

Medical device companies have traditionally been limited by the availability of elastomeric 3D printing materials at every stage of the design and manufacturing process. When prototyping, designers must either 3D print with non-biocompatible or rigid materials, create a 3D printed mold and cast medical-grade silicone by hand, or hire a company at a prohibitive cost. These workflows impact the design cycle, hurt the performance of the product and make it difficult for the company to get to market quickly.

At the point of care, the lack of flexible and biocompatible materials has limited the possibilities of 3D printing for hospitals and medical facilities, despite the tremendous benefits the technology offers. Several hospital researchers today use flexible, non-biocompatible materials for training and educational purposes, but cannot use them in the operating room. With a flexible and biocompatible 3D printing workflow, hospitals and medical service organizations can now bring these models into the OR and expand the range of parts they offer, improving the quality of patient care and reducing costs for the provider.

Flexibility, transparency and biocompatibility enable a new 3D printing application

With the introduction of BioMed Flex 80A Resin and BioMed Elastic 50A Resin, medical device companies, medical professionals and surgical planning offices finally have access to streamlined workflows that combine the best of 3D printing with the best of biocompatibility and materials. Formlabs’ commitment to maintaining regulated and certified workflows ensures that users can trust that these parts are ISO 10993 and USP Class VI tested and manufactured in an FDA-registered and ISO 13485 certified facility.

	Maximum tensile strength	Tensile strength	Shore hardness
BioMed Flex 80A Resin	7.2 MPa	22 kN/m	80A
BioMed Elastic 50A Resin	2.3 MPa	11 kN/m	50A

 

BioMed Flex 80A Resin has a Shore hardness of 80A and an elongation at break of 120%, which means that the parts will return to their original shape after deformation and allow manipulation of the part during examination or testing. These parts can be used for flexible components of devices and patient-specific instruments, such as short-term mucosal tubes that are customized to the patient’s anatomy. Surgeons can bring anatomical models that more closely resemble solid tissue into the OR for examination and reference during a procedure, which has been shown to improve patient outcomes and recovery time.

Dr. Prashanth Ravi, Assistant Professor in the Department of Radiology at the University of Cincinnati, has been working with Formlabs’ specialty resins for years and is excited about the new application possibilities of the BioMed Flex 80A Resin: “The BioMed Flex 80A Resin is a great tool because it is flexible and has all the ingredients to be biocompatible for various clinical indications.

At Northwell Health, a leading provider of advanced medical care, 3D printing has been part of the workflow for years. Until the release of these two new materials, Northwell’s Allison Neuwirth had to complete a multi-step silicone molding process for biocompatible, custom medical devices or components that come in contact with the patient.

“In the clinical environment, this material shines due to its ability to produce customized, malleable parts that can come into contact with the body. It also eliminates the need for prototyping using silicone molding, which is a costly and wasteful process.”

Allison Neuwirth, Project Manager, Northwell Health

The elastic properties of BioMed Elastic 50A Resin, a Shore hardness of 50A and an elongation at break of 150%, enable new 3D printing applications for biocompatible workflows. The parts are easy to bend, manipulate and compress, enabling components such as seals and gaskets or thin, flexible housings for medical device companies. The transparent properties of BioMed Elastic 50A Resin mean that tube-like parts can show the movement of fluid, enabling the cost-effective production of customized, biocompatible fluidic devices in medical fields.

BioMed Elastic 50A Resin is also ideal for 3D printing soft tissue models that surgeons can bring into the operating room for reference, or even for comfortable patient-specific parts with long-term skin contact such as nasal tubes, plasters and more. Dr. Ravi sees one specific application as a perfect use for the new elastomeric material: “One clear application is sizing for left atrial appendage closure to treat atrial fibrillation. If the cardiologist wants to take the sterilized 3D-printed anatomical model into the operating room to size the device and communicate with the surgical team before the procedure, the BioMed Elastic 50A resin is the material we would use.”

At Baystate Health, Greg Gagnon, a 3D printing specialist, prepares 3D printed bolus devices and other devices for physicians. Until working with BioMed Elastic 50A Resin, Gagnon could not directly 3D print elastomeric material.

“I was very excited about the material. The relative electron density was almost identical to that of water, which is 1.0 g/cm3, and that’s great for 3D printing boluses for patients. [We have] some designs ready for testing and can expand our use cases in the surgical field.”

Greg Gagnon, 3D Printing Specialist, Baystate Health

Optimized processes for flexible parts in medical quality

These two new flexible materials make biocompatible 3D printing more accessible, more functional and less labor-intensive for medical device manufacturers and the healthcare industry.

Formlabs’ Form 3B/+ and Form 3BL printers enable medical device manufacturers and healthcare professionals to produce models, devices and components easily and cost-effectively. The platform’s small footprint and low-touch workflow facilitate use in hospitals where space is at a premium and enable effective scaling in production facilities.

With these two new resins, medical professionals can save steps in their manufacturing process and streamline workflows. Direct 3D printing of biocompatible and flexible parts can now be done with the same consistency and reliability that Formlabs has already achieved in so many other applications.

BioMed Flex 80A Resin and BioMed Elastic 50A Resin can remove the obstacles that exist in medical device manufacturing and anatomical modeling workflows – allowing users to focus on what’s important and eliminate the need for tedious silicone molding. Watch our webinar to learn more about the two materials, or schedule a consultation with a medical 3D printing specialist to integrate them into your workflow.