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?
Leyden: 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.
Palinchik: 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.
Salvatori: 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.
Samson: 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.