The Regulatory Scrutiny Influencing Surface Treatment in the Orthopedic Device Industry

Posted June 21, 2018
By Jack Tetrault

Exploring the Impact on EOMs, Surgical Equipment Coating Companies, and Patient Outcomes 

Orthopedic Design & Technology (ODT) magazine recently posted an article that speaks to the increasing regulatory scrutiny that is the driving force behind medical device manufacturers evaluating new coatings and surface treatment technologies. 

MICRALOX Lumina Coated Surgical Probe Handle_PCCIThe 2016 FDA science priorities involve taking a stronger look at the reprocessing cycle and the impact on reusable medical devices. The aim of the regulations is to enhance technologies associated with reprocessing as well as the related design of the medical devices. And as reprocessing gets more focus and attention, this development will naturally lead to a closer examination of the device design characteristics and relation to life-cycle and fit-for-use properties.  

These have far-reaching ramifications within the orthopedic device industry. The regulations impact suppliers, OEMs, medical personnel, and of course, patients. Adhering to them requires, from inception through to coating, that the entities involved in the manufacturing process anticipate (as much as possible) the performance thresholds of their products.   

The ODT article explores surface treatment considerations for orthopedics and includes commentary from Precision Coating, along with others in the industry. An excerpt from the article reads: 

“Typically, surgical equipment companies are investing in in-house capabilities to simulate the real-life product conditions seen by their products in respect to cleaning and sterilization, to evaluate how their products perform,” said Tim Cabot, president of Precision Coating Company, a Boston, Mass.-based provider of fluoropolymer and anodic coatings for medical manufacturers.  

Supporting trends, he noted, include the desire by major OEMs to have global vs. regional product lines, which requires the ability to meet the very aggressive, high alkaline (> pH 10) cleaning chemistries commonly used in Europe and elsewhere, even if these are not the approved methods in legacy markets. “This is in part based on the perceived risk of prion diseases in these markets,” said Cabot. 

As the article explains, predictions indicate that the global orthopedic device market will reach $44 billion by 2022, with much of this demand being driven by the need for implants. As such, ODT says, “Surface coatings and modifications continue to be a major part of both the implant and instrument business for orthopedic OEMs. To improve functionality and performance, forward-thinking companies seek out advancements in the design, functionality, and manufacturing of devices, tools, and instruments, including the use of additive manufacturing and 3D printing.” 

Topics discussed in the article cover what OEMs want, technological advances, printing capabilities, new coatings and materials, and what to expect moving forward. It’s a comprehensive read that touches upon supply chain challenges—and solutions that, ultimately, deliver a better patient experience. We think you’ll find interesting. Click here to read the full article on ODT’s website. 

Precision Coating has created an advanced, revolutionary coating technology for medical device components: MICRALOX® and MICRALOX® Lumina and MICRALOX® Ultra. This proprietary technology produces a long lasting, virtually indestructible surface, which delivers dramatically superior chemical and corrosion resistances and eliminates color-fading due to super-heated steam. Contact us to find out how we can help you with your next medical device anodizing project.

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