Scanning the press on the topic of Additive Manufacturing, there’s a lot said about the features and capabilities of equipment. Data shows the primary applications of additive manufacturing. The overwhelming use of the technology is in the form of prototyping/iterating. Of course, it makes total sense. Equipment performance is now to the point where we can iterate physical things almost as fast as we can iterate digital things.  

However, AM manufacturers and pundits strive to see additive manufacturing take on a more prominent role in end-use part production. Adoption in this role would be a shot in the arm for the AM industry as a whole as unit sales and consumables would dramatically increase. AM sales organizations are intimately involved in sales activities on the ground. They are pressured by manufacturers to pursue implementation of their equipment at production levels and pressured by potential customers to resist these initiatives.  

This blog asks, “Are We Asking the Wrong Questions?”

Minimum Viable Product (MVP) in Additive Manufacturing

Minimum Viable Product (MVP) – seeks to launch products that satisfy requirements without any ancillary features. In software, this could be something as simple as a website with a single button that just says, “buy”. It’s easy to pursue this in code as it’s “just” code. Changing is easy. Implementing this concept for physical products is a bit more challenging. Mechanical Engineers are challenged to let go of the perceived ‘industry practice’ that is considered the foundation of product development. Never mind that many of these perceptions are decades old and have never been put into question. Rather than accepting “This is how we’ve always done it”, MVP asks, “Do we need to do it that way?” For instance, take a device that has a number of injection molded parts. Several of these parts may exist internally. Things like fan brackets, routing clips, mounting fixtures, etc. may never see the light of day. Yet, it’s generally accepted that these components would be injection molded. In most instances, the choice of material is made with minimal consideration. Opting for PC-ABS is a common, effortless decision, as its capabilities usually exceed the necessary requirements. This material is readily available, and its affordability makes it an even more attractive option. An engineer’s time is expensive and taking a deeper look at such nominal components to see if other materials or processes could be used is not seen as valuable. In other words, seeing what the minimum viable design for this component is, may not seem viable in the grand scheme of the overall product. 

Engineers are hesitant to dive into other possibilities not just because it may take more time to analyze but also because the downstream functions including testing, quality control/inspection, assembly, etc. are more familiar with the performance of these ‘traditional’ materials and methods. Not to mention that certain industries have rigorous criteria for conforming to regulatory requirements. 

Capabilities of Additive Manufacturing

Manufacturers, industry press, and AM Sales organizations put a lot of effort into focusing on the features and benefits of their products. Rightly so. The AM product offerings today are staggering. Consider that there are over 2000 manufacturers of AM devices, many of which have very niche applications. The quality, accuracy, and performance of these machines rival (and sometimes exceed) traditional processes such as casting, injection molding, and machining. When someone makes the claim, “you can’t use 3D printed parts for production” they are likely basing their view on an experience they had with a consumer-grade solution and have not witnessed the capabilities that exist today in the commercial market.  

Sales organizations lead with capabilities. They ask potential customers about their current equipment capabilities and happily report how much better the capabilities are of the latest and greatest. And customers are grateful to hear about this. They are astounded to hear how this will increase their ability to iterate faster during development. Or, how much better their jigs/fixturing will be when they implement these improved capabilities. This approach does nothing to address the desire to transform volume production by implementing this technology. That’s because it is no longer about capabilities. 

A Shift in Additive Manufacturing

Sales and Marketing organizations need to re-tool their approaches. They need to take a more holistic approach to the industry to begin asking the right questions. Organizations that implement additive manufacturing see the benefits of their development efforts. The equipment is easily managed by a single person or a small team that doesn’t require full-time care. Small to medium-sized manufacturers may only print 10-15 parts/month. This is hardly fulfilling the promise of additive to be transformational.  

When the conversation turns to using this equipment for production devices, there is immediate pushback. For good reason. The sales pitch promises the ability to produce on the same machine that you proof. The ability to manage quality in line. And the ability to change quickly if needed. None of that is appealing to a manufacturer who has spent months/years developing a product, making sure it meets all requirements and conforms to all regulatory needs. 

When a product is developed, typically outside vendors are selected early in the process. These are vendors that appear on their “Approved Supplier” list. Getting on that list involved a great deal of effort on behalf of both parties. Often, manufacturers appear onsite with the vendor to ensure their processes and equipment are validated. Understanding their process control and inspection capabilities is important.  

The AM Industry is asking customers to become their own suppliers. To do this, manufacturers will need to acquire the equipment, spend time qualifying the machines and processes, establish rigorous processes to maintain that qualification as well as ensure the equipment is maintained. This requires employees, facilities planning, and ongoing expenses that they never had to worry about when just selecting an approved supplier. Not to mention the increased overhead required in their ERP/MRP systems to ensure the process runs smoothly. 

Addressing the entire ecosystem of Additive Manufacturing

Until the industry addresses the entire ecosystem around additive manufacturing and engineers become more comfortable with exploring contemporary alternatives to material and design, it’s going to be a challenge to fully adoption AM for production. 

A key component to making this happen will be establishing partnerships with leading, innovative organizations that can guide manufacturers through consultation and assessment of their current state. From there, a trusted partner can ensure viable equipment selection and process improvement will result in future success.

3D printing vs Additive Manufacturing

What is Additive Manufacturing

“Manufacturing” has been around for centuries. The basic definition, “the making of articles on a large scale using machinery” which is a good summary. There are myriad methods of manufacturing. Casting, sintering, machining, and molding are just a small sampling. With the advent of 3D printing, the term ‘Additive Manufacturing’ evolved as an umbrella to generally refer to all manufacturing methods that use 3D printing. 

Additive Manufacturing (AM) is a relatively inexpensive process to implement. The equipment is straightforward, for the most part, and does not require the extensive resources of equipment that traditional (i.e. casting, sintering, machining, molding) require. The materials available to Additive Manufacturing are comprehensive and growing. These include everything from plastics to metals, with plastics being the largest substrate by far. 

In addition, additive manufacturing offers not only innovative materials but also enhanced sustainability. By minimizing the amount of scrap generated, this manufacturing process contributes to a more sustainable approach. Unlike traditional manufacturing methods that often generate significant amounts of waste material, additive manufacturing builds objects layer by layer, utilizing only the necessary materials. This low cost of entry has made it possible to rapidly iterate product development. AM is so commonplace now that it’s easy to lose sight of what a major impact this has had on getting products to market.

What is 3D Printing

April 12, 1981, was the launch of STS-1 – the first Space Shuttle. That same year, Dr. Hideo Kodama invented the first 3D printing machine using a polymerized resin that could be laser-cured layer by layer. In 1984, Chuck Hull patented that technology as the first ‘Stereolithography Apparatus’ (SLA). Chuck would go on to found 3D Systems, today one of the leading SLA manufacturers in the world. In 1988, Scott Crump developed a plastic extrusion machine he called ‘Fused Deposition Modeling’ (FDM). His company, Stratasys, began selling FDM commercially in 1992. Back then, a 3D printer cost over $300k ($800k today).

3D Printing is a Commoditized Process

3D Printing has become a commoditized process that is accessible to anyone.

It’s that commoditization that equates the term ‘3D printing’ with a low-cost, hobbyist platform. Most implementations of these low-cost 3D printers in any commercial environment have little to no impact on overall business goals. It’s not uncommon to see a 3D printer sitting on the desk of a design engineer. It provides an easy way to manifest physical outputs to be used as a supplement to the development process. 

However, when considering commercial applications that are a part of overall business strategies, these consumer-grade (sub $2000) printers lack the ability to conform to the rigorous processes companies require when developing manufactured (end-use) parts. For instance, there is much more to medical device products than the product itself. There are overarching FDA and ISO requirements, supply chain requirements, and process control requirements such as receiving and inspection that need to be applied to production equipment.

The machines need to go through a lengthy characterization process that includes manufacturing documentation, performance monitoring, and understanding service level agreements from the equipment vendor. This is not something you will be able to develop for a $200 3D printer purchased from Amazon.

While 3D printers find a great deal of utility as a tactical, point solution. There is a coming-of-age that requires more from this equipment in order to realize its true strategic potential. That’s where Additive Manufacturing comes in.

The Difference Between Additive Manufacturing and 3D Printing

To get a sense of the implications for industrial-grade Additive Manufacturing solutions, consider a company like Cargill. You can be forgiven if you do not know who Cargill is. They are the single, largest privately held corporation you’ve never heard of. They provide all the basic ingredients for the food you eat. You would be hard-pressed to not consume a Cargill product.

Given their great importance to the entire world’s food supply, it’s no surprise they employ rigorous controls to automate production. These controls are very expensive. However, their function is simple. One of their representatives was asked something along the lines of, “you realize that Arduino and Raspberry Pi can do all the stuff you guys are doing at a fraction of the cost.” They agreed. Then replied, “sure, but if one of those devices fails and people die, who’s liable?”

Implementing a manufacturing solution is much less about the technology and more about mitigating risk while having a positive outcome on business goals. Bringing 3D printing into the business ecosystem as a strategic solution is the defining characteristic of Additive Manufacturing. 3D printing is a component of Additive Manufacturing.

As a solution provider, the team at EAC is more interested in the broader implications of Additive Manufacturing. We have decades of experience in the design, development, and implementation of products. This gives us a unique perspective with the ability to understand how Additive Manufacturing fits within our already extensive offering. It is a natural extension of development. 

Why Should I Implement Additive Manufacturing

A ‘paradigm shift’ is defined as “a fundamental change in approach or underlying assumptions.” We have seen several paradigm shifts in the last 50 years. Mobile phones weren’t much of a paradigm shift when they were introduced in the 70s. They were exclusive to the few who could afford them. The infrastructure did not exist to make them ubiquitous. While that quickly changed in the 90s, it wasn’t until phones took on many other tasks beyond being a phone with the advent of the iPhone. That device ushered in a major paradigm shift that we are currently experiencing. 

Manufacturing is currently experiencing a paradigm shift. We are still in the early stages. The early stage of a paradigm shift is characterized by creativity, confusion, and ‘solution saturation’. Additive Manufacturing is a major component of that paradigm shift. With over 2000 manufacturers of Additive Manufacturing equipment, it can be daunting to figure out what direction to take when implementing an AM solution (or whether implementing AM even makes sense). It begs the question, “why bother?”. For many manufacturers, this is uncharted territory.

Computer Numerically Controlled (CNC)

As a manufacturer, you will not want to carry the overhead of managing an entire Computer Numerically Controlled (CNC) machining floor or invest in a room full of injection molding equipment. The specialized nature of this equipment requires extensive resources and expertise that impacts the bottom line of your retail sales of vacuum cleaners. As a result, it has been a tradition to outsource the fabrication of components to providers who perform these specialized operations. While this is cost-effective, there are other considerations such as lead times and quality control that manufacturers have to contend with. This is especially challenging when developing new products as it is difficult to have design iterations using these traditional providers. The time and expense of creating tooling for products that may not work is not practical. 

This desire to quickly iterate through a design is what has driven the implementation of 3D printers in manufacturing environments. 3D printing was used as a bridge to a final product that was machined or injection molded. While this is a very useful process for development, there’s still a gap between the iterative prototyping phase and the final production phase. Unfortunately, that gap can be quite costly when the final product does not conform to the results of the 3D printed prototyped product.

3D printing was relegated to this stage in development for a number of reasons. From an aesthetic standpoint, 3D printing left a lot to be desired. For FFF (Fused Filament Fabrication – remember, the term ‘FDM’ is owned by Stratasys), the stair-stepping of layer lines is apparent. Resin-based printers are capable of very smooth surface finish but there are often artifacts left behind due to support structures. SLS does not have to worry about support, but the surface finish is described as ‘grainy’, and highly detailed features are difficult.

3D Printed Parts and Isotropy

In addition to that, 3D printed parts exhibit poor isotropy. Meaning they do not perform the same across all axes of the part. FFF parts in particular have less strength in the z direction than in the x and y direction. SLA, on the other hand, has 100% isotropy, yet resins have not demonstrated the same kinds of strength that traditionally manufactured parts exhibit.

Now, as this paradigm shift picks up speed, all of that is changing. Especially in regards to SLA and SLS. There are SLA resins that can create incredibly strong structures from silicone to polyurethane. For SLS, new postprocessing equipment is capable of reducing or even eliminating the graininess of powder-based prints. The implications of this are enormous. It means that design iterations can be performed using the same equipment and materials that are used for final production parts.

With the relatively low cost of entry and skill requirements, AM equipment can be reasonably implemented within the walls of final production. Lead times for production parts can now be a matter of days (or even hours) rather than months. The lack of tooling (AM is often referred to as ‘tool-less’ manufacturing), eliminates major costs. One major aspect of AM is the fact that each part can be unique. Not only does this mean each part can be personalized. It also means that changes can be implemented with no impact on production (other than appropriately documenting the change). 

How EAC Additive Can Help

EAC Additive is your go-to partner for all things Additive Manufacturing from hardware to consumables, and even services. While there are many AM providers in the industry, our company that’s been providing engineering solutions for over 27 years, EAC has the expertise in all aspects of manufacturing that companies require in order to be successful. We understand the implications that AM has on product development, quality assurance, supply chain, and production. 

To that end, EAC offers the AM Assessment, which is a comprehensive analysis of your company’s current state of utilizing Additive Manufacturing, and then gives you a roadmap and actionable steps to improve and integrate this innovative technology into your operations.

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.