The process of designing the medical devices that clinicians use every day begins in the same places where these products eventually end up.

Companies that contract with OEMs to take on the job of designing surgical tools, patient monitors and imaging equipment, or the internal design departments of the OEMs themselves, all start the design process by observing procedures or the day-to-day workings of a hospital room.

‘Human-centered approach’
According to Dustin Boutet, the principal interaction designer for EPAM Continuum, which partners with medical device companies on the design process, this can be called a “human-centered approach” to product design.

“So much of what we do needs to be adaptive for either audience,” said Boutet.

For example, EPAM Continuum worked on the design of Mindray’s V Series patient monitoring system a few years ago, observing both caregivers and patients.

Susan McDonald, a senior human factors engineer for Ximedica, which also works with companies to design such products as injection devices, pumps and surgical robots based on either concepts or fully-fleshed-out plans, is on the research and strategy team that is credentialed and trained in such things as HIPAA and how to properly navigate a sterile zone.

“We do our best to record and be sort of flies on the wall,” McDonald said. “We look at lighting, temperature, how many different roles are in the room, is the room crowded, how much communication is required between clinicians. If the device has an alarm and the room has a lot of ambient noise, we might add a more visual or tactile alarm. We then present our findings to the design team and the client and say how they might affect the design.”

Farm, a Flex Company – which has worked with such large medical manufacturers as Covidien, Hologic and TransMedics – collaborated with startup NinePoint Medical on the NvisionVLE Imaging System, which allows clinicians to more precisely evaluate the tissue microstructure of the esophagus during a standard endoscopy procedure, by observing the procedures in several GI suites.

"We developed the cart system that adapts to its environment and its users" said Dan O'Sullivan, senior director of design at Farm, a Flex company. "We created features that improved the workflow. The system has a display for the physicians and a control tablet for the tech. There are little things that make their job easier as well, like a simple hook to hang the catheter packaging during setup."

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.

McDonald said Ximedica tries to make enough changes in the prototype during the formative process to avoid any surprises during human factors validation testing.

In-house or contracted out
The process is fairly similar for device manufacturers that choose to have in-house staff take on the design process.

During a panel on medical device development at MD&M East in New York City in June, in-house designers from Medtronic and Ethicon, a Johnson & Johnson company, noted that their companies also relied on clinical observation when beginning the design process, using 3D-printed parts and even virtual reality tools to quickly make prototypes for clinicians to test out.

Boutet of EPAM Continuum explained that the manufacturers who contract out their design process usually have decided to focus their resources on engineering, computer programming and marketing.

“We often provide a different perspective and a different approach than some of these companies would take,” Boutet said. The manufacturer is “focused on the engineering and technology and getting it into the box, and we’re focused on the people and their needs.”

Kevin Fitzgerald, senior manager within R&D at Medtronic, said his company designs and develops most of its products, including surgical instruments and software, in house, while partnering with outside companies on certain projects. For example, Medtronic partnered with Farm when it began developing its StealthStation S8 surgical navigation system, with Farm helping to provide an initial framework for the design that included some of the elements of consumer electronics that people use every day.

“When we want to make sure we’re aligned with the present-day best practices and take advantage of what people already know on their consumer electronics, that’s when we’ll consider seeking external help,” Fitzgerald said. “We want to make sure our products are modern and cutting edge.”