Speed and Production-Equivalency Lead Prototyping Demands

Prototyping is a critical factor in the design stage and end functionality of an orthopaedic device or instrument. When executed optimally, it can facilitate a smooth transition to final production. Executed poorly, it can force a manufacturer to reevaluate and revamp the final design.

As competition in the industry and regulatory guidelines intensifies, speed to market, production-equivalency and the emergence of 3D printing are three increasingly common themes in the prototyping conversation.

What else is shaping this stage? BONEZONE spoke with four prototyping providers to find out.

Roundtable participants included:
Matt Leyden, Design Engineer, Primordial Soup
Jennifer Palinchik, President, JALEX Medical
AJ Salvatori, Account Executive, GPI Prototype & Manufacturing Services
François Samson, Sales Engineer, In’Tech Medical

BONEZONE: What’s new in prototyping orthopaedic devices?

Matt Leyden Primordial Soup webLeyden: A great deal has changed since I was a young engineer, but I don’t think things have changed too much in the last few years. Orthopaedic prototypes are often precise, long, thin-walled devices that have fairly demanding strength requirements. Newer prototyping processes like 3D printing don’t yet do a great job of producing those kinds of devices.

Orthopaedic companies are beginning to realize the tremendous contribution that well-executed industrial design has on the success of a product, but that is not new to us.

Jennifer Palinchik Jalex Medical web
: There are a lot of 3D printing technologies emerging and they’re moving toward not just use for prototypes, but also for production. We can provide our customers with 3D printed polymer and metal prototypes, which is a lot faster and typically less expensive for just one-off prototypes vs. the other traditional manufacturing methods.


AJ Salvatori GPI Prototype web
: Direct Metal Laser Melting or 3D metal printing has been around for over ten years now, but companies are using this technology more to speed the R&D process, ultimately bringing products to market more quickly and sometimes saving on cost. Traditional CNC machining and other processes can take four to eight weeks, whereas 3D metal printing can take just a few days or up to a week, depending on the project.

Francois Samson InTech Medical webSamson
: The new trend in orthopaedics is the rapid prototyping of production-equivalent instruments and implants, as well as early-stage involvement of suppliers for practical Design for Manufacturability.

Production-equivalency is essential to our customers as part of their verification and validation process. It ensures that the cadaver lab evaluation devices and instruments, as well as associated cleaning and sterilization validations, are performed on parts representative of large-scale production with validated and consistent manufacturing equipment and processes. That way, there is no disconnect between the prototype and the production part.

BONEZONE: How has prototyping for orthopaedic devices changed over the years?

Leyden: The definition of what constitutes a raw material has changed.

It used to be that the prototyping of an instrument started with a plate, rod or tube of stainless steel. Now, we might start by buying some other company’s instrument off of eBay, or a tool we find on McMaster-Carr, and customizing it for our application in a process we call “hack and whack.” We’ll buy existing instruments or implants, whack off their business ends and tack on business ends designed and built by us. There is often a better starting point for a prototype out there than a plate of stainless steel.

We might also start with a 3D-printed object and machine it for improved accuracy. Or, we might 3D print wax master patterns, investment cast near net shape objects and finish machine those into nearly production quality devices.

Methods for permanently attaching parts together have improved a great deal, as well. Laser welding and modern adhesives allow us to make a cannulated instrument by attaching a custom-made business end to one end of off-the-shelf tubing and attaching a user-interface end to the other.

Salvatori: Instead of traditional manufacturing, companies are finding faster ways to prototype, like 3D metal printing. The market is coming out with bigger, faster machines, which will eventually save time and money. Additional materials, such as different grades of titanium, tungsten and hastelloy, are being introduced and are readily available in powder form.

Samson: The market is evolving quickly. Time-to-market is becoming more critical for our customers. This is why we launched The Prototype Garage in 2015, a standalone prototype-dedicated cell embedded at the heart of our manufacturing facilities and isolated from our production lines to facilitate and guarantee this rapid delivery setting.

From a regulatory standpoint, we are seeing more stringent requirements from FDA to ensure that processes and equipment are validated.

BONEZONE: What makes an efficient process?

Leyden: An efficient process is one in which the surgical team is communicating regularly with the design team, and the design team is communicating regularly with the manufacturing team. When prototyping, manufacturers should not only strive to “meet print,” they should strive to help solve the clinical problem.

Palinchik: An efficient process basically means that we have a solid design idea to start with, the CAD models and drawings and all of the functionality and specifications that are required for the prototype. An understanding of what the prototype will be used for is also important. A company can create more of a makeshift device for fit and function. However, if the intent of the prototype is for verification and validation testing, a production-intent prototype will be required. Once the prototype application is defined, we take budget and timeframe into consideration and the best process that we can use to create the prototype.

Prototyping has multiple steps, and people don’t take that into consideration. They think they’ll take the concept and then get a prototype and everything will work perfectly the first time, and that’s unrealistic. When it comes to our clients, we educate them on the process of the steps that will get them to the final product. The efficiency starts with being able to utilize the 3D printing process in order to get something in their hands, relatively inexpensively and quickly, and then going from there to review the design and make modifications before getting into manufacturing for the final product.

Salvatori: Education about this technology (3D metal printing). We can spend several months in iterations while our customers learn how to design their parts for this process. Refining the part and their understanding of the technology, ultimately, speeds up the design process for future R&D opportunities.

Samson: Let me give you the recipe for an efficient process, from the OEM perspective. First, try bringing the supplier onboard prior to freezing design so suppliers can bring expertise to the table in terms of manufacturability, and guide the customer toward optimal cost/design trade-off. Second, state upfront the nature of the prototype (e.g., cadaver lab, surgery) to outline the required level of quality and associated paperwork, as this can also impact cost and delivery timeframe. Third, provide all prints or models as the purchase order is placed.

BONEZONE: What are you seeing from your customers? What are they asking for, in prototyping?

Leyden: Fewer design cycles and little lag between a proven prototype and human use-capable devices. This means that you can’t solve the problem sequentially. First, get the device to function. Then, get it to look nice and feel right, and then make it manufacturable. You must solve all issues in parallel. Things work best if you can avoid the design transfer issues and have the company that builds your prototypes be the company that builds your first human use devices.

Salvatori: Customers seek faster lead times and device designs that are more complex and not easy to machine, which is why additive manufacturing is a good fit.

Samson: They want to simplify the supply chain process to maximize productivity. We have turned this challenge into an opportunity by providing our customers with “one-stop-shop” solutions.

BONEZONE: What are the biggest challenges in prototyping?

Leyden: Choosing the right amount of fidelity to build into the device. If you insist on making prototypes with production level precision, you could expend a great deal of time and money chasing a bad idea. On the other hand, if you prototype with too little precision, you may reject a genuinely good idea that was poorly executed.

Palinchik: Because there are a lot of materials you can manufacture with 3D printing, with some of the smaller, more intricate devices, the challenge we have is being able to remove those from a platform. For instance, one of the challenges with the Direct Metal Laser Sintering (DMLS) technology is that when the part is made, you have to remove it from a plate. In that process, with these thin prototypes or intricate features, you can end up breaking it.

It really just depends on the material, and some of the structural requirements that a prototype needs. If special processing is required, like post-processing, you have to balance and weigh the advantages of just doing traditional machining. Are you gaining enough by prototyping it with 3D printing? If you’re going to ultimately have to do a ton of post-processing work, that negates the cost and timeframe.

Salvatori: Customers’ lack of understanding is a challenge. Prototypes won’t always be perfect on the first attempt. There are many factors, machine and metallurgical related, that determine a successful build or part.

Samson: Minimally invasive is definitely a growing trend across all segments of orthopaedics. That typically means even more intricate assemblies, with tight geometries requiring snug assemblies with implants and/or different instruments. The technology in place for prototyping needs need to be in line; that is why you will find Electrical Discharge Machining (EDM) in each one of our prototyping cells.

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Photo courtesy of In'Tech Medical