Product development, prototyping, and fabrication of medical devices are critical processes that entail rigorous planning, design, and testing to ensure the safety and efficacy of the products. Given the significant impact on patients’ health, it is imperative that these products are reliable and meet stringent regulatory standards.
At Estes, one of our keys to success in medical equipment design and manufacturing is that we are a one-stop shop from conceptual design to manufacturing. Our in-house product development and prototyping team works with our business development and manufacturing teams to achieve the highest quality, product reliability, and manufacturability while meeting medical regulatory requirements.
This is what led to the success of an innovative wave tray we designed, patented, and manufactured for orthopedic sterilization cases.
Medical Product Development and Patent: The Wave Tray
Orthopedic sterilization trays typically feature a perforated design that allows steam or another sterilizing agent via an autoclave to penetrate the tray and reach the instruments placed inside it. The tray helps in holding the instruments, such as drills, saws, clamps, and other specialized tools, in place while ensuring they are effectively sterilized.
The tray is usually made of stainless steel or another material that can withstand high temperatures and pressure, which are common in sterilization processes.
A common problem in manufacturing these trays is loose brackets or rivets that fall off, causing the tray to be rejected.
Our Estes Accelerator team, who specializes in product development and prototyping, took on the challenge of how to design a tray with fewer parts. They engineered a new tray with an innovative wave design that reduced the rivets and brackets needed while also increasing the open area for instruments. The wave design and a wave variation are now patented.
Jay Engh, Product Development Manager at Estes, said it was a true team approach in developing the wave tray for the orthopedic industry.
“We got into a team, and we started with a white sheet of paper to map out our challenge,” he says.
From there, our team conducted extensive research and conceptualization. The prototyping phase was integral as it involved creating preliminary versions of the device, allowing our engineers and industrial designers to evaluate form, function, and user interaction.
The prototypes underwent drop testing and other tests to ensure compliance with regulatory requirements. Furthermore, the team took into consideration how to most efficiently manufacture the product at the highest quality to keep costs down and identify and resolve issues before it went into production.
“We are known for our quality, and we never sacrifice that,” Jay says.
The final design eliminated several components and sub-assemblies, resulting in fewer set-ups and fewer parts to insert and rivet into the tray, ultimately eliminating potential for errors and malfunction.
The new wave tray – at a higher quality with a more efficient manufacturability – went into production at Estes and is now sold nationwide.
Estes Medical Device Prototyping and Manufacturing
Along with the development of the wave tray for orthopedic sterilization, Estes also has manufactured X-ray shields and screens, sterilization equipment, latches, and other medical devices.
Let Estes take your medical product design to the next level! Contact Estes Medical Design to learn more.
