Al Carolonza, MICRO’s Director of Marketing Research & Strategy

In the July issue of Medical Design Briefs, Al Carolonza, MICRO’s Director of Marketing Research & Strategy, discusses the aspects of the Grand View Research report—that providers are turning to disposable products as a safer alternative than reusable devices, which even if decontaminated properly can still lead to infection.

Echoing the findings in the report, Al Carolonza notes that with antimicrobial resistance and the rise in super-bugs, it is perhaps not surprising that disposable surgical instruments are gaining favor. “Since they are sterilized and individually packaged, they inherently reduce risk of infection. This is becoming a crucial consideration as healthcare moves toward an outcomes-based model,” says Carolonza, who is principal and director of market research and strategy for MICRO, a full-service contract manufacturer based in Somerset, NJ.

“While disposable devices are often perceived as creating more waste and are seen as less beneficial to the environment, reusable devices have their own environmental concerns as the energy, water, detergent, and electricity used to decontaminate combined with re- packaging and transportation can ultimately be more impactful on the environment,” he says.

Overall, disposable devices are proving that they can help to lower costs for specific procedures while also reducing patient risks related to cleaning and sterilization. “We believe this is the reason that so many OEMs have robust development pipelines aimed at the disposable market — which is in turn creating opportunities for creative, responsive contract manufacturing organizations to provide solutions to their needs,” says Carolonza.

Decreasing Risk, Reducing Errors

Single use surgical instruments.

“As the medical field continues to evolve and hospitals are forced to manage tight budgets while maintaining low healthcare-associated infection (HAI) rates, innovative manufacturers are needed to help create surgical devices that will support keeping the bottom line down while minimizing risk,” says Carolonza. He adds that re -usable surgical devices tend to come at a higher initial cost and require frequent maintenance to keep them in pristine condition. “Some have complex designs and intricate parts, which can be challenging to clean thoroughly of blood, tissue, or other biological debris, put-ting patients at possible risk for surgical site infections and contamination. Recent high-profile recalls have brought this issue back into the public eye.”

Precision Manufacturing

Medical device development has evolved in recent years to address unmet medical needs, cost efficiencies, tight deadlines, product volume, material selection, improved patient safety, and effective patient outcomes, notes MICRO’s Carolonza. Reusable devices, he explains, are designed and built to last indefinitely — assuming proper maintenance and cleaning. Disposable devices, by design, have less-demanding durability requirements. “While both devices require precision parts and must function similarly in practice, the design and durability requirements of disposable devices allow for more cost-effective mass production techniques. For instance, metal stamping can pro-duce precision parts that are less durable — but also far less costly — than the more time-consuming discipline of machining similar parts for reusable devices.”

Electrosurgical probes.

Metal tubing, for example, is the back-bone of virtually every handheld surgical device. “We have many options at MICRO that allow us to drastically re- duce tubing costs on disposable instruments. Our patented Rolled Tube Technology allows us to stamp a tube out of flat stock, resulting in a finished tube with complex features that leaves the press at a speed of one per second. We produce over 1 million of these tubes per year for leading OEMs in the disposable device marketplace,” says Carolonza.

We have also found that combining automation with material from our own tube mill allows for vastly improved efficiency in operations such as flaring and flanging, piercing and slotting, and laser cutting, welding, and marking. This translates to best-in-class quality and value — a strong value proposition for our single-use device clients.”

Read full article on Medical Design Briefs—click here & go to page 14.