BioMed Resins Blog Image

Formlabs introduced two new elastomeric and biocompatible resins. The BioMed Flex 80A Resin and BioMed Elastic 50A Resin seamlessly blend flexibility with essential biocompatibility certifications that cater to a growing demand of specific requirements. Open the door to new applications in healthcare and manufacturing with Formlabs’ new biocompatible, flexible resins.

 

Why Medical Grade Materials Matter

Creating end-use flexible parts has posed significant cost challenges. These parts can include customized devices, patient-specific surgical models, and short-term wearable or skin-contact devices. Furthermore, many companies have been constrained to offering standardized options.

Several hospital researchers utilize flexible materials that are not biocompatible for training and educational purposes. However the problem is that they are unable to employ them in the operating room (O.R.) where hands-on learning is critical.

Implementing a flexible and biocompatible 3D printing workflow enables hospitals and medical service companies to incorporate these models into the O.R. and expand their array of producible parts. Additionally, this advancement enhances the quality of patient care and ensures incredible cost savings for providers. 

 

Meet the Trifecta: Flexibility, Transparency, and Biocompatibility

In the realm of producing biocompatible rigid components, numerous companies have discovered that 3D printing can offer a cost-effective production solution. However, when it comes to elastomeric parts, it has not proven viable. This is in part due to the limited availability of materials meeting the necessary shore hardness, elongation at break, and strict biocompatibility criteria.

Although previous materials like Formlabs Elastic 50A Resin and Flexible 80A Resin have been great for prototyping, tightly regulated workflows might have been holding you back. Traditionally, professionals within these sectors typically had to depend on cumbersome multi-step silicone molding procedures. This workflow is both labor intensive and very messy.

Alternatively, they had to resort to costly outsourcing with contract manufacturers. Now our customers can do more.

Biocompatibility approvals for long-term skin, and short-term mucosal contact opens doors to innovative workflows. Additionally, it allows for short production cycles, personalized wearables, and beyond. Both materials are ISO 10993 and USP Class VI tested, and produced in a Formlabs ISO 13485 certified facility, so you can print with confidence.

 

BioMed Flex 80A

Now, the BioMed Flex 80A resin streamlines workflows. Essentially select the STL file and print.

BioMed Flex 80A is the firmest flexible material in the Formlabs family of BioMed resins. Choose BioMed Flex 80A Resin to directly print patient-specific medical devices requiring flexibility. Additionally, it is great for firm tissue models that surgeons can reference in the O.R.

BioMed Flex 80A Resin has a Shore hardness (the measured hardness of a cured material) of 80A and elongation of 120% at break. This means that the printed parts will return to their original shape after deformation. Doing so allows the manipulation of the part during study or testing.

These parts can be used for flexible components on devices and patient-specific instruments such as short-term mucosal membrane tubes that can be customized to the patient’s anatomy. For surgeons, anatomical models that more closely resemble firm tissue can be brought into the O.R. for study and reference during a procedure. Accordingly, this been shown to improve outcomes and shorten patient recovery time. 

Furthermore, BioMed Flex 80A is ISO 10993 and USP Class VI certified material is produced in an FDA-registered, ISO 13485 facility and can be used in applications requiring long-term skin contact or short-term mucosal membrane contact.


Ultimate Tensile Strength

7.2 MPa

 

Tear Strength

22 kN/m

 

BioMed Flex 80A Resin Biocomps

Long-term skin (>30 days), short-term mucosal membrane contact(< 24 hours), and USP Class VI certifications.

 

Printer Compatibility

The BioMed Flex 80A resin is compatible with Formlabs’ Form 3B, Form 3B+, and Form 3BL. If you have an “early” Form 3 printer-  please contact us to check compatibility.

 

Curing Best Practices

First, place the part in a glass beaker that fits the part. Then, make sure the part is fully covered by the water. Formlabs says that tap water does work and any water on hand should be fine.

 

BioMed Elastic 50A Resin

BioMed Elastic 50A Resin is the softest elastomeric material in the Formlabs biocompatible family of BioMed resins. Before, customers were using silicone molds or using Elastic 50A Resin. However, the Elastic 50A Resin has no bio comp, and creating silicone mold processings and parts is cumbersome and time-consuming. Now, with BioMed Elastic 50A Resin, you can easily print flexible parts.

As a result, it is empowering healthcare professionals and medical device engineers with new design possibilities and efficiencies.

Customers can choose BioMed Elastic 50A Resin to directly print patient-specific medical devices with enhanced comfort or soft tissue models surgeons can reference in the O.R. By directly printing devices or models, BioMed Elastic 50A Resin eliminates labor time and cost.

The resin is equipped with a shore hardness of 50A and 150% elongation at break, meaning the parts can be easily bent, manipulated, and compressed, enabling components such as gaskets and seals or thin, flexible enclosures for medical device companies.

BioMed Resins 50A Blog Image

BioMed Elastic 50A Resin’s transparent properties mean that tube-like parts can show fluid moving through them. So customized, biocompatible fluidic devices can be manufactured cost-effectively in medical settings. 

BioMed Elastic 50A is ISO 10993 and USP Class VI certified material is produced in an FDA-registered, ISO 13485 facility. And it can be used in applications requiring long-term skin contact or short-term mucosal membrane contact. 

 

Ultimate Tensile Strength

2.3 MPa

 
Tear Strength

11 kN/m

 

BioMed Elastic 50A Biocomps

Long-term skin (>30 days), short-term mucosal membrane contact(< 24 hours), and USP Class VI certifications.

 

Printer Compatibility

BioMed Elastic 50A works with the Formlabs Form 3B printer, the Form 3B+, and the Form 3BL too. If you have an “early” Form 3 printer-  please contact us to check compatibility.

 

Helping Medical Device Manufacturers and Healthcare Professionals Succeed

In conclusion, ​​adapting to evolving needs using Formlabs Medical 3D printers and biocompatible resins in-house is easier than ever before. The lack of flexible and biocompatible material choices has limited the use of 3D printing within hospitals and medical service bureaus, despite the considerable advantages 3D printing offers.

With the growing options of biocompatible materials from Formlabs, combining 3D printing into a broader range of workflows and applications is now possible. In fact, this improves patient care, and saves money. And lastly, it broadens the scope of possibilities.

Whether it’s research and development, production tooling, or creating biocompatible end-use parts, harness the power of 3D printing to introduce advanced, custom patient devices to the market.

 

Order a free sample from us or talk to an Additive Manufacturing Specialist to order your resin today.

Repeatedly in life, you hear the phrase “practice what you preach.” A charge to show the world what you’re saying is true and viable. Well, that’s exactly what we did and continue to do here at EAC headquarters.

THE PROBLEM

EAC’s popcorn machine recently had a broken part rendering it difficult to produce popcorn that wasn’t blackened to a crisp. 

The Right Product Design Solution: Onshape

Our design engineers took one look at the problem and took action. Using PTC’s cloud-based Onshape, one engineer began the initial CAD design of the part off-site simultaneously as another designer was able to edit the part geometry on-site. This increased collaboration and excelled design iteration with updates in real-time.


With the initial design completed in Onshape, minor tweaks were made and work through versions 2 and 3 were finished in just a matter of days. The CAD file alone, however, was not going to fix the burnt popcorn issue – it was time for prototyping.

The Right Prototype Solution: Formlabs

Unfortunately, the original part had deteriorated over time which made it difficult to capture accurate measurements. Adjustments to the prototype would have to be made along the way to make sure that it fit just right.


Using our Formlabs 3D printers, the designers printed V1 and V2 on the Form 3+ printer due to the accuracy and speed in which they could turn around a prototype. Since our team wanted to test out their iterations quickly, they took advantage of the new and improved software and hardware offerings on this printer. The off-site designer was able to print the prototype after the on-site designer prepped the printer before leaving the office that same day. As a result they produced functional, high-quality prototypes and end-use parts in record time.


The prototype material used accelerated necessary edits, but was not used for the final product due to the level of heat it would take on sitting above the popcorn kettle. The final piece was printed with Nylon resin on the Fuse 1 printer. This new SLS printer not only sped up the production process, but allowed for long-lasting results using an incredibly durable material. It was time to install the ready-made part – our popcorn machine was going to pop again. 

THE FINAL PRODUCT

By using modern collaborative design tools in Onshape, our team was able to seamlessly work together remotely and also quickly iterate a quality design ready for prototyping. Formlabs’ connected printers with remote access, printing, and monitoring created an accurate and durable part that was ready to be put to use.

Together, the two solutions streamlined design, prototyping, and part production processes. Our design engineers saw a problem and practiced what they preach – filling the halls of EAC with the smell of fresh popcorn once again!

Formlabs new 3D printer, the Form 3B, is an advanced stereolithography (SLA) desktop 3D printer optimized for biocompatible (thus, the ‘B’ in Form 3B) materials (resins) and validated workflows.

Form 3B vs Form 3: Which one should I use?

If you are an early adopter and you have already purchased a Form 3 before November 12th of 2019, then you can print all compatible resins on your Form 3 (or Form 2). If you purchase a Formlabs 3D printer AFTER November 12th of 2019, then you have two options.

Form 3B: Exclusively prints ONLY biocompatible resins (surgical guides, hearing devices, etc.)

Form 3: Prints only non-biocompatible resins (anatomical models, device prototypes, etc.)

Form 3B Price

The Form 3B is a little more expensive than the Form 3 – The Form 3 Basic Package starts at $3,499, whereas the Form 3B Basic Package starts at $4,999.

The Form 3B Basic Package includes the 3D printer, Finish Kit, Build, and Tank.

New Surgical Guide Resin

The newest surgical guide resin is an autoclavable, biocompatible resin for 3D printing surgical guides for implant placement. This next generation 3D printing material is for premium-quality surgical implant guides.

This resin is only available for the Form 2, Form 3B, and early 2019 Form 3 printers.

When speaking to beta testers, we found they enjoyed the print clarity, superior mechanical properties, and improved accuracy of the Surgical Guide Resin.

The Surgical Guide Resin is sold at $249.00 per liter and is ideal for:

  • Surgical guides
  • Drilling templates
  • Pilot drill guides
  • Device sizing templates

Available for the Form 3 (Early 2019), Form 3B, and the Form 2. It is not available with the Form 3 (non-biocompatible, purchased after Nov 12).

What does this look like in PreForm software?

Formlabs 3D printing software, PreForm, will update with the PreForm 3.1.3 version and will include print setting for the following resins on Form 3B and early 2019 Form 3:

  • Surgical Guide Resin, 100 microns
  • Grey Resin, 160 microns

The PreForm software will also include the following printer model options:

  • Form 2
  • Form 3 (early 2019)
  • Form 3B

The 'regular' Form 3 (model released after Nov 12, 2019) will come at a later date.

Form 3B