This led Farm PD’s design team to add places on the cart where the clinicians could clip those items.
Making prototypes and a reliance on 3D printing
The next step of the design process includes making inexpensive prototypes for end users to try out and test.
Ximedica goes through what is called a heuristic review, a formal review conducted by one or more design or human factors experts.
“We will go through the steps of use of the device to understand if there are usability issues,” McDonald said. “Is there enough feedback in the device so a user knows what to do next? How challenging is it to complete the task?”
Ximedica also conducts simulated use studies, taking the prototype to the facility or a simulated environment – Ximedica even has a simulation OR, a room with OR lighting and a surgical bed that researchers can inconspicuously observe from another room via a one-way mirror.
Design and development companies and manufacturers have started to use 3D printing to create prototypes quickly and inexpensively.
O'Sullivan of Farm noted that 3D printing is often used for rapidly producing prototypes and models that once took days to craft by hand.
Boutet of EPAM Continuum said 3D printing is one tool in the company’s prototyping arsenal. For some projects, the company creates fully embedded prototypes that include physical and digital interactions, with capacitive touch screens, onboard computers, articulating 3D-printed cases and wired physical buttons.
“We actually source the touch screens the client would be using for production so we can get realistic interactions, Boutet said. “They're usually driven by a small onboard computer, something like a Raspberry Pi, so we can get detailed feedback on touchscreen interactions. Where digital interactions and physical inputs intersect are really interesting and also important to get right. … Some companies will spend a tremendous amount of resourcing to get to that point where the experience is really fleshed out.”
The path to approval
The design and development companies will often work with manufacturers through FDA 510(k) clearance for Class II devices or premarket approval for Class III devices.
Ximedica can conduct human factors validation tests, which include a greater number of end users conducting simulated use testing, with the company tracking any use errors and close calls. That becomes part of a company’s application to the FDA, with Ximedica putting to use its expertise in navigating the FDA approval process.
