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September 25-27,2024 | SWEECC H1&H2

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The 4 Essential Elements of Device Design Today

The 2017 Medical Design Excellence Awards finalists prioritized ease of use, patient centricity, and increasing value to the healthcare system. 

The Medical Design Excellence Awards (MDEAs) attract entries from a wide variety of therapy areas, everything from over-the-counter products to cardiovascular technology to imaging devices. Yet every year, a few common refrains about what matters most in medical device design emerge from these disparate categories. No matter what disease or which patient group a product is intended for, there are some unifying themes to good device design, like ease of use, wider access, and putting the patient first.

These are four key features medical device makers are keeping in mind to create products that benefit patients, clinicians, and the healthcare system.

Theme 1: A Simple, Elegant User Interface

Many of the MDEA jurors have expertise in device design and human factors engineering, so it’s no surprise that they always notice whether a device incorporates an optimal user interface or seems intuitive to use. After all, a product that is simple to operate is likely to reduce errors and encourage regular use.

FinalistTowerView Health from Elytone, aims to solve the common issue of low rates of patient adherence to prescription drug regimens. The product, described as a “connected pillbox,” sends patients medication trays with their drugs sorted according to dosing instructions. The service determines when doses are missed, sends reminders, and offers coaching for patients who repeatedly miss doses. 

The TowerView Health system is designed to increase adherence to prescription drug regimens.

Making such a product straightforward is key to continued use. “The system appears very easy to use,” said MDEA juror Michael Wiklund, general manager of the human factors engineering practice at Underwriters Laboratories (UL).

Diabetes is another area of healthcare that can benefit from reduced complexity. Disease management is a huge burden on people with diabetes. According to maker Companion Medical, theInPen Smart Insulin Delivery System, an MDEA finalist, is a smart insulin pen that incorporates the functions of dose calculation, dose alarms, and electronic logging of doses.

Wiklund described the product as “streamlin[ing] the injection and tracking process.”

In some cases, a technology’s user interface is closely linked to its performance. A finalist in the category of rehabilitation and assistive-technology products, the Linx fully integrated, microprocessor-controlled lower limb system for above-the-knee amputees is one such device. Although prosthetics improve mobility, a well-known drawback of the product category is the unnatural gait that often occurs when patients wear the device.

Basingstoke, UK-based Blatchford Group, maker of the Linx system, set out to address that challenge. The Linx system is designed to make walking look and feel natural across diverse terrain. This is achieved through master control across both joints, hydraulic ankles, sensors in the knee and ankle, and automatic detection and switching for different user modes.

“When walking quickly or up ramps, the plantar flexion resistance increases allowing for more optimal energy storage and return. This aids forward momentum and minimizes the effort required to walk fast or uphill,” Blatchford Group explained in its submission. “Linx also adjusts to match the users’ selected walking speed.”

“It seems to do a remarkable job of replicating natural motion and even allowing athletic activities,” said MDEA juror Stephen Wilcox, PhD, FIDSA, principal and founder of Design Science.

Theme 2: Keeping Patients at the Center of It All

Patients are becoming more informed consumers of healthcare and know their needs should be at the forefront during a care episode. Some of the finalists put patients first by bringing the technology directly to the patient in a way that prioritizes their comfort.

The Hologic Affirm Prone Biopsy Table transforms the familiar breast biopsy platform by allowing the patient to stay in a prone position during the procedure. In addition to enabling 2-D and 3-D image-guided biopsies, the Affirm Prone system automates some steps of the biopsy procedure, allows for easier access, and is “designed to reduce the patient’s time under compression and deliver a more comfortable biopsy experience,” according to the company’s submission.

“In this day and age of patient satisfaction, the focus of the Affirm system to take a patient-centered approach and couple it with more flexibility in use by practitioners, resulting in improved outcomes, makes this device a standout,” said MDEA juror David Copeland, director of human factors industrial design at Ximedica. 

The Open Area Support System (OASUS) provides assistive support and mobility to patients outside the rehabilitation center.

Another product that puts patients at the center—literally—is theOpen Area Support System (OASUS)assistive technology from ENLITEN LLC. OASUS, a large, free-standing frame that allows the harness-wearing patient to move around an open area in a safe way, takes assistive support and rehabilitation out of the specialized center and into the patient’s home and workplace.

“The OASUS, and the concept of area mobility, benefits patients because it opens the opportunity for constant therapy . . . Active participation in home living provides a level of rehabilitation that is not often duplicated in the clinic,” ENLITEN explained in its MDEA submission.

“It allows people to be supported while they perform a real task anywhere,” Wilcox pointed out.

Arthur Erdman, PE, professor of mechanical engineering and director of the Medical Devices Center at the University of Minnesota, echoed that. “It has the ability to provide PT [physical therapy] any place and any time and change lives.”

Theme 3: Simplifying Procedures

Surgery is often a collaborative effort performed by a team, but some companies are focused on reducing the number of hands needed during a procedure. This could make it easier or quicker to perform a surgery or in-office procedure.

ThePrecisionPoint Transperineal Access Systemis a clear example of this trend. The product, from Corbin Clinical Resources, LLC, is billed as the first freehand transperineal access system for prostate biopsy. When used with a transrectal ultrasound probe, the system provides visualization of the prostate and realignment to make it easier to reach the targeted tissue.

The PrecisionPoint Transperineal Access System enables clinicians to perform freehand prostate biopsy procedures.

“The PrecisionPoint’s ability to reduce the chance for infection is a benefit to caregiver, patient, and clinic alike,” Copeland said. “The system offers a much more direct-line-of-sight access to biopsy the prostate that allows the physician to do less hunting and pecking, and guide the procedure in a much more improved manner.”

TheRigidloop Adjustable Cortical Fixation Systemfrom DePuy Synthes is a “one-size-fits-all implant” system for arthroscopic soft tissue cruciate ligament reconstruction. “Surgery is simplified as there is no need to perform multiple calculations to determine implant loop size or remaing depths—the implant simply adjusts to the depth that you ream,” according to the product’s MDEA submission.

Wilcox noted that the Rigidloop System “reduces the number of people required for tensioning the implant.”


Theme 4: Impact on the Overall Healthcare System

Several of this year’s MDEA submissions emphasized the ways the technology would cut costs and increase efficiency for hospitals. With healthcare consistently in the reform spotlight, products are being positioned to prevent complications, shorten hospital stays, and save healthcare system spending.

TheivWatch Model 400 uses sensors for continuous peripheral IV monitoring to detect infiltrations earlier. The technology aims to avoid this issue, ensuring patients receive IV medications correctly and don’t experience the complications of infiltration or extravasation.

“Potential cost savings related to decrease in complications from infiltration would equate to significant benefits to healthcare system and decreased suffering for patients,” said juror Mary Kay Smith, PhD, MSN, RN, CHSE, director of the Learning and Assessment Center at Michigan State University.

The Carebag bedpan and commode pail liner has an absorbent pad to capture bodily fluids.

Though more low-tech, theCarebagbedpan and commode pail liner from Cleanis Inc. is aimed at reducing hospital-acquired infection (HAI) rates. The product incorporates a pad that is designed to absorb the body fluids and convert it into a gel. Noting that missing HAI objectives can impact a facility’s Medicare reimbursement, the MDEA submission described the Carebag as “a solution to safely confine and dispose of feces, [a] known vector of transmission of the deadlyC. diffinfection . . .”

In some cases, the cost benefits may accrue directly to the patient. Hearing aids are often an out-of-pocket expense for users.Eargo, a rechargeable, smaller hearing aid designed to be suspended in the ear canal, has the potential to save wearers money by eliminating the need for replacement batteries.  

“It is likely to prompt individuals to use hearing aids earlier than in years past,” Smith said of the Eargo.