Prototyping new product designs will always be necessary in the medical device industry.

Computer simulation of a device’s mechanical performance has come a long way, but simulation doesn’t reveal everything. For starters, users need a physical prototype in order to give feedback. They must physically hold or interact with device in order to provide the subjective (but nonetheless invaluable) insights which are useful for refining the appearance or even the function of a new medical device. Prototypes are also necessary for validating the manufacturing capabilities of a production line—a regulatory requirement. Lastly, making, testing, and examining prototypes can help an OEM identify unknown issues that weren’t caught in the digital model of the design.

Prototyping then plays a pivotal role in moving innovative medical device concepts from the idea stage to the marketplace. Those innovative concepts in turn require modernizations in prototyping technology and materials. Let’s explore a few of these innovations.

Smart polymers

One material advance that medical device prototypes are incorporating is smart polymers. What makes these polymers “smart” is their ability to change their shape, electrical conductivity, size, or other characteristic in response to stimuli like light, pH change, or temperature. Currently, the use of smart polymers is limited to targeted drug delivery, but future medical devices like wearables could leverage them as sensors for personalized and preventive healthcare.

Online Quotes and Ordering

Advances in CAD/CAM software are largely responsible for a recent process innovation when it comes to prototyping: rapid prototype price quoting and ordering. By uploading the digital files and material requirements of a new design, OEMs can hand off all the information that the CM engineer needs, to quickly review the requirements and estimate a price.

The speed and ease of this process for OEMs allows them to submit prototype designs for quote to many CMs, enabling them to “shop around” in a completely digital way. Besides helping them find the best price, the material, dimensional, and surface capabilities of multiple prototyping vendors can all be compared, helping the OEM make an informed decision quickly. In turn, the total turnaround time for an OEM to receive those prototype parts also drastically shortens, leading to faster design iterations and a better final design before high volume production begins.

Additive Manufacturing (3D Printing)

Additive manufacturing (better known as 3D printing) refers to a slew of different fabrication technologies well-suited for low-volume manufacturing, including producing prototypes. Due to the fact that the 3D printing of medical device prototypes is still relatively new, there is a lot of research and development activity in new materials, processes, and process improvements. Medical devices pile on their own challenges: biocompatibility, more stringent safety requirements, and in some cases the need to withstand repeated sterilization.

Despite these challenges and often conflicting requirements, the medical device 3D printing market’s value was estimated to be $750 million in 2016 and is expected to grow 17.5% from 2017 to 2025. As existing heavyweights in the general 3D printing industry continue to market their offerings even more into the medical device industry, the unique benefits of 3D printed prototypes will continue to unlock novel, innovative products and therapies. From 3D printed jawbones to titanium spinal implants, additive manufacturing already is a key enabler of medical device innovation.

The key 3D printing technologies to keep an eye on are:

  • FDM (Fused Deposition Modeling): A molten material (usually thermoplastic resin) is extruded into a very fine thread which is then laid down in successive layers, building up the part.
  • Stereolithography: Short wavelength (e.g. blue or UV) light selectively illuminates a pool of photopolymerizing resin from the bottom, causing each layer of the part to solidify as it is drawn up and out of tank.
  • Metal Laser Sintering: A very intense laser beam is directed at a bed of metal powder. The high power of the beam rapidly heats the powder, causing the metal grains to fuse. By fusing layers and layers of metal powder, a complete 3D object is fabricated.

One hurdle FDM, stereolithography, and other additive manufacturing technologies will have to clear is reliably making parts out of silicone rubber—a dominant material in medical devices, especially implantables. Current elastomeric materials commercially available for 3D printing don’t match true silicone rubber’s mechanical properties. This is a major reason why ProMed’s rapid prototyping service uses aluminum injection molds and real, production-grade liquid silicone rubber (LSR) –the close match between the performance of the prototypes and that of production parts adds tremendous value to engineers developing their next new design.

The materials and methods used to create prototypes of tomorrow’s medical devices are advancing rapidly and in many directions. These advances push medicine and healthcare forward by providing a steady stream of new solutions for the problems patients face.

By keeping up with the latest medical device prototyping and production innovations, ProMed is able to remain the leader in medical silicone molding.

Our rapid tooling capabilities and quick quote turnaround time save both the time and money of our customers, helping them launch new medical innovations into the marketplace faster. What breakthrough are you trying to bring to the market?

Prototype Advancements for Innovative Medical Device Designs
Article Name
Prototype Advancements for Innovative Medical Device Designs
Prototyping new product designs will always be necessary in the medical device industry.
Publisher Name
ProMed Molding
Publisher Logo