Proto Labs is the world’s fastest source for on-demand, low-volume manufacturing. We make quick-turn prototypes and production parts including device handles, housings, strain reliefs and other medical application components. Tony Holtz, Proto Labs Technical Specialist, offers insights into how medical device developers are accelerating their time to clinical trials through rapid manufacturing.
How is rapid manufacturing being utilized in medical device development?
Tony Holtz: Time and cost of manufacturing parts is becoming more critical now than probably ever before. With heavy demands on receiving FDA 510K submission for verification and validation, you need to get to this point sooner and with less expense than your competitors. We have seen traditional manufacturing taking over eight months to reach this point as where rapid manufacturing may be able to cut this time down to only eight weeks saving you six months or more of total design time.
Why risk unnecessary time and money with a much longer traditional manufacturing method of producing parts when you can use rapid manufacturing to test parts for failure beforehand. You can produce several iterations using rapid manufacturing upon repeated failure proofing out the design sometimes before the first part is produced using traditional methods. This saves valuable time and money, now who doesn’t like that?
Holtz: There are several methods that are available for receiving a low quantity of parts in a matter of days – 3-D printing, CNC machining and injection molding are three of the large contributors. Within each of these services you will have a lot of options available that can produce you a wide range of material selections.
3D printing is going to be able to offer you plastic like parts, thermoplastic parts as well as metal printed parts. You are able to now test out micro fluidic slides before proceeding on with injection molding using Stereolithography (SL) as well as complex difficult to manufacture metal parts. Direct Metal Laser Sintering (DMLS) breaks traditional manufacturing by producing the impossible to machine and mold parts in aluminum, stainless steel and even titanium.
Low-volume injection molding allows you to obtain sample parts in actual materials that will be produced in your production tooling in a fraction of the time. PEEK and PEI (Ultem) are just two of the thermoplastic materials that are molded for medical applications as they offer excellent mechanical properties, resistances to chemicals and can withstand repeated sterilization processes. These materials are also strong enough to withstand abuse in hand held devices such as ratcheting teeth and are also creep resistant.
Metal Injection Molding (MIM) and Liquid Silicone Rubber (LSR) are also becoming more popular for medical applications. MIM provides small stainless parts in larger quantities that what machining and 3-D printing can provide you with greater repeatability while LSR is replacing many of your thermoplastic rubbers. LSR has more design flexibility that thermoplastics due to the ability to break the rules with thick and thin concerns as well as being able to support extensive undercuts due to excellent part memory and elasticity (near 400%).