Medical device design done right

Last week, PlasticsToday published an interview of Bryce Rutter, PhD, founder and CEO of Metaphase Design Group (St. Louis, MO), in which he exposed the fatal flaw in medical device design. In particular, he argued that more attention must be paid to human factors. “I’m amazed by how many fascinating products with exceptional technology get to market where the human factors are so poorly articulated and resolved that the user—be it a surgeon, nurse, anesthesiologist or whomever—has great difficulty accessing the full potency of the technology,” said Rutter. “Healthcare’s biggest challenge is to tame the technology.”

On the flip side of that coin are some remarkable advances in materials and other constituent elements of medical technology that are enabling the development of elegantly designed life-saving medical devices. In this follow up to that article, Rutter and Giridhar Thiagarajan, R&D Engineer at Bard Access Systems (Salt Lake City, UT), share examples of innovative medical device design. Both of them have been involved in the Medical Design Excellence Awards (MDEAs), an annual program that recognizes outstanding achievements in medical product design and engineering. Rutter has been a juror in previous years and Thiagarajan is a first-time juror this year. The 2016 MDEA winners will be announced at MD&M East, co-located with PLASTEC East in New York, NY, during a ceremony on June 14, 2016. The trade shows and conferences run from June 14 to 16.

“What I find fascinating in the MDEA and other awards programs is the opportunity they provide to learn about state-of-the-art technology that is just hitting the market,” Rutter told PlasticsToday. “It doesn’t get any more fascinating than being on the front lines of innovation.” A great deal of that is happening on the materials side, he adds.

“The explosion of nanotechnology promises more advances in materials in the next five to 10 years than we have seen in the past 50 to 100 years,” says Rutter. Graphene, also, will be a game changer, he adds. “The strength and conductive properties graphene brings to the table, just in terms of flexible displays, is tremendous.” More immediately, Rutter has been impressed by the adoption of elastomers in medical applications.

“When [Metaphase] designed the M4 Microdebrider for Medtronic in 1999 or thereabouts, it was the first autoclavable surgical instrument that combined stainless steel with an elastomer. Now, look around at the number of soft-touch materials that allow me, as an industrial designer and human factors expert, to be more detail oriented to the ergonomic fit and performance of grips and controls. That will continue to grow.”

For Thiagarajan at Bard, “our world revolves around plastics, since I deal with catheters made of polyurethane.” One of the interesting entries in this year’s MDEA, he adds, replaces metal with PEEK in an orthopedic application. “The device does not have the drawbacks of metal implants. Plastics have a lot of advantages in terms of flexibility. There is a steady movement to replace materials with plastics in medical applications, notes Thiagarajan.

“At Bard Access Systems, we work in vascular access, and a major focus is in preventing device infections and thrombosis. We try to address this through improvements in biomaterials,” says Thiagarajan, adding that he can’t go into any details as these products are not yet in the marketplace.

As for medical devices on the market today that illustrate design excellence, Rutter and Thiagarajan each pointed to a couple of products.

One of them is BacterioScan’s 216Dx UTI system, which has the potential to be disruptive in the rapid diagnostics space, and, in particular in urinary tract infection testing, according to Rutter. Current procedures for urinary tract infections involve peeing in a cup and waiting three days for lab results, explains Rutter. “The false negatives are shockingly high, and, in the meantime, you’ve had three days of living hell taking medication while your doctor tries to figure out what’s wrong to prescribe the right drugs. The BacterioScan device uses laser technology to shorten the test cycle to 120 minutes or less. It will dramatically change turnaround times and cost,” says Rutter. The device has won multiple awards including an Edison Award in the patient care category this month.

Rutter also lauds the new Medtronic M5 high-speed microdebrider. “It’s a handheld surgical power tool with suction and irrigation that has shavers in different sizes on the business end of the device,” explains Rutter. The device is designed to remove cartilage and to open sinuses in the nasal cavity. The Medtronic guys nailed it, says Rutter, both in terms of performance and ergonomics. “The package fits comfortably in the surgeon’s hand and the ergonomic design eliminate stress and strain in the wrist and forearms that ENT surgeons typically experience. It’s making a killing in the marketplace,” says Rutter.

The industrial design and human factors of both the M4 and M5 microdebrider devices were developed by Metaphase in collaboration with Medtronic R&D. Rutter and Dana Oliver, Senior Director of R&D for Medtronic ENT/NT Restorative Technologies, will share insights into ways to drive design excellence across an organization and, by example, illustrate how best practices were applied to Medtronic’s M4 and M5 designs at MD&M East 2016.

Thiagarajan limited his selections to products that reside within his area of expertise. One device that impressed him recently is an enteral feeding product from Alcresta Pharmaceuticals, Relizorb. “It’s a neatly designed cartridge that attaches to the feeding tube and breaks down feeding formulation for patients who are unable to process complex food types,” explains Thiagarajan. Currently, an enzyme mix obtained from a porcine source is used. “The cartridge is inline to feeding, so the body never sees the enzyme but it is still effective,” says Thiagarajan.

Thiagarajan also likes Clear Guard HD from Pursuit Vascular Inc. “It’s an end cap for catheters with a small rod inserted in the lumens of the catheter that is coated with chlorhexidine. It prevents infections that originate at the catheter hub, which is extensively handled by the clinician,” says Thiagarajan. Other approaches include coating the entire device with chlorhexidine, and thus exposing the patient to more drugs. FDA created a new product code (PEH) for this novel technology “for use in hemodialysis catheters to reduce hub infection.”

Have you been impressed with a recently introduced medical device? Share your discovery with the PlasticsToday audience by commenting below.