Feature Article

By: Brian Buntz

In his book The World Is Flat, Thomas Friedman proposed that globalisation has altered central economic principles and has “flattened” the global marketplace. In other words, the barriers to international trade have been evened out, resulting in a more-level playing field for global commerce. This trend has been visible for some time in the medical device industry. Despite international regulatory hurdles, many companies face increased pressure to use global supply chain techniques, move production offshore, and respond to the evolving international marketplace. According to a report released earlier this year by PricewaterhouseCoopers that provides further evidence of this trend, the United States and Europe may still be the current global leaders of medical technology innovation, but they are steadily losing ground to countries such as China and India. Not surprisingly, the influence of globalisation was also evident in this year’s Medical Design Excellence Awards (MDEA) programme. Of the 36 award-winning products, 12 either came from companies based overseas or were the result of an international partnership. Several of these entries drew the most acclaim from MDEA jurors.

 

In January, the Economist published an article titled “Life Should Be Cheap: How China and India Can Help Cut Western Medical Bills.” It described how those countries might eventually help reduce our medical bills by selling us inexpensive medical devices. A growing number of Chinese and Indian firms are doing just that. In most cases, devices being produced in these countries are not simply inexpensive knock-offs. They are frequently just as effective as the expensive technologies found in the West.

 

Mindray, which is headquartered in Shenzhen, China, is a prominent example of a device firm that focuses on relentlessly reducing the cost of its products without sacrificing quality or efficacy. The company’s V Series patient-monitoring system wowed MDEA judges this year, owing to its immaculate design and impressively low price—it costs about 50% less than comparable systems. “The cost alone made it worthy of a nomination,” says MDEA juror John Sinacori, Assistant Professor in the department of otolaryngology at Eastern Virginia Medical School (Norfolk, VA, USA).

 

The industrial design of the device also caught the attention of the jurors. “Every little detail is really well thought out,” says juror Bryce Rutter, founder and CEO of Metaphase Design Group (St. Louis, MO, USA). “The manufacturing and the precision of the tooling are flawless. That tool-set is just perfect,” he adds.

 

The manufacturer redesigned the user interface from the ground up to optimise it for a clinician’s workflow. The firm tested the unit in hospital environments, relying on end-users knowledgeable about the complexities of patient monitoring. Designed with flexibility and modularity in mind, the system can function both as a portable and bedside monitor. It can be undocked to facilitate quick transport. “It’s so flexible,” says juror Anne Miller, Assistant Professor at the Vanderbilt University Medical Center (Nashville, TN, USA). “The number of contexts in which you can use it is just really, really amazing.” The configurable parameter modules mounted at the back of the unit can rotate 180° to facilitate cable management. Juror Sean Hägen, founder of BlackHägen Design (Dunedin, FL, USA), was especially impressed by how the unit provides a high amount of freedom with regard to cable placement. “The cables can come out from whichever side they need to come out,” he says. “That’s pretty innovative. Other systems out there force you to one side.” 

 

Although China has become almost synonymous with low-cost manufacturing, India is giving the country a run for its money in many ways. The Radiant Heat Warmer (RHW) 3000 series from Zeal Medical Pvt. Ltd. (Mumbai, India) provides an example of Indian ingenuity in cutting costs whilst preserving quality. Designed for the Indian marketplace, the open-bed radiant heat warmer for infants is 50% less expensive than other competing products in the market, according to the manufacturer. “Achieving that level of cost savings in a device like this is pretty significant,” Hägen says. “But the manufacturer didn’t sacrifice any important features by going there.” 

 

Hägen believes that much of the unit’s costs savings stem from the manufacturer’s attention to design for manufacturing and assembly. “The tubing cross sections are all standardised sizes,” he says. “Construction methods also are very standardised.”

The jurors also praised the clean form language of the unit’s design. “The design language is very consistent across all aspects: the hardware, the software, the design detail,” Rutter says. “There’s a nice rhythm and harmony when you look at it.” By contrast, many neonatal heating units look complicated. “Consider the neonatal intensive care units or any of the environments where you find these heating beds. When you think of it from the standpoint of the patient’s parents, all of that complication makes everyone a little bit nervous,” Rutter explains. “So we just thought it was nice that this unit could convey a kind of peaceful image back to the family.”

 

One of the principal innovations of the device is that it offers a unique reflector design that ensures uniform heating to the infant without excessively heating the surrounding environment. Zeal Medical uses a dual parabola radiant heater that evenly distributes warmth across the entire cradle while redirecting heat away from the periphery of the unit. 

 

Cost reduction was a common theme among companies submitting entries this year, but so was ease of use and improved user experience, says juror Jay Goldberg, Director of the healthcare technologies management programme at Marquette University (Milwaukee, WI, USA). One product exemplifying this trend is the Cranial Loop from Neos Surgery S.L. (Donostia-San Sebastián, Spain), a plastic high-strength cranial fixation device that is used after a craniotomy has been performed. The device enables a standard cranial fixation procedure to be performed in less than one minute, according to the manufacturer. “When closing a craniotomy, fixating that piece of skull to the surrounding bone can be challenging,” explains juror Peter Denk, a surgeon based in Fort Myers, FL, USA, who specialises in minimally invasive surgery. “And this product has a really great, simple way of dealing with the issue.” 

 

In a craniotomy, a section of the skull known as a bone flap is removed, giving surgeons access to the brain. The bone flap is normally replaced using metal plates and screws. This requires a number of tools to be used in the operating room and increases the risk of surgeons cutting themselves during the procedure, explains Sinacori. By contrast, the Cranial Loop, which is made of PEEK-Optima, uses a double-locking mechanism to close the bone flap. This design does not have any sharp points and can be locked in place without the use of tools. When closing the skull with the device, a single Cranial Loop unit is placed underneath each side where the cranium was cut. The handle of the device is pulled, tightening the loop portion, which compresses the upper part of the locking mechanism until a solid level of fixation is achieved. At this point, both sides of the loop are cut. The remaining strips are then bent back and forth until they break off at the base. This self-cutting functionality results in a low-profile finish that improves the safety of patients by minimising the risk of soft-tissue damage.

 

MDEA jurors also praised the A.P. Advance video laryngoscope from Venner Medical Singapore Pte. Ltd. (Singapore) for improving the user experience. According to Industrial Design Consultancy Ltd. (Datchet, UK), the handheld endoscopic instrument is said to make endotracheal intubation so easy to perform that a nonprofessional can do it with some instruction. The device features a 9-cm LCD view screen that is positioned at the head of the unit, giving physicians direct visual feedback for eye-hand coordination. “The nice thing with this device design is that the screen placement enables you to always be focused on the patient,” Sinacori says. By contrast, some laryngoscopes have the video screen positioned to the side. “In the case of devices like those, when you are putting a laryngoscope in a patient’s mouth to intubate them, you have to turn your head,” he says. “That is a problem. When you are looking at that monitor and trying to put the scope in, you’re taking your attention away from the patient’s mouth.”

 

The device is offered with a patented airway blade that has special tips that bend through a sharp angle. A special guide plate directs the tube towards the glottis. The company reports that trials have shown that it is much faster when intubating difficult airways with its device than with other devices. “For me, it does seem to guide the tube better than some of the other intubation systems that are out there,” Sinacori says.

 

The device is substantially smaller than traditional laryngoscopes, has an ergonomic design and can be powered by a single AA battery. “You have to make sure that some laryngoscopes are plugged in or charged before use. There have been times when we’ve brought a laryngoscope into a room and it wasn’t charged. That can easily be a dangerous situation. With this device, it’s just a matter of popping in a new battery and you’re ready to go.”