Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Terry Hamm - Orthopedic Design & Technology

What are you searching for?

Sign in

Terry Hamm

Author Image

By: Michael Barbella

Managing Editor

No medical device manufacturer wants to put out an inferior product. It’s bad for business. It’s costly. Plus, it often leads to recalls, penalties, litigation and even wrongful-death lawsuits. A bad product is a big deal.

One production risk that tends to be underrated (but can lead to serious process mistakes, poor quality, and regulatory noncompliance) is the use of part-time employees who are not provided current good manufacturing practices (cGMP) training through an ISO 13485-certified employment agency, or do not know how to make medical devices according to 21 CFR Part 820 standards.

Because this temporary labor force is actually making or assembling medical devices or healthcare products, the medical device company is at risk of non-compliance if these workers have not been trained to cGMP or other regulatory requirements. The company with its name on the product always is responsible for the contract manufacturer—if the contract manufacturer releases flawed or dangerous products, the OEM is liable for the fallout, including lawsuits and penalties. Any lack of attention to 21 CFR Part 820 standards by employees (temporary or full-time), of course, can create big problems for the contract manufacturer and tarnish the reputation of the OEM.

Every company wants to reduce costs and maximize profits, but cutting corners on essential knowledge and training for the workers making the products is not the way to do it. The combined costs of poor performance, mistakes, flawed products, rework, and U.S. Food and Drug Administration (FDA) penalties and fines—as well as brand erosion and loss of market share—far outweigh the added cost of using cGMP-trained, part-time employees who thoroughly have been trained to produce and assemble medical devices. These workers can be provided by temporary agencies that specialize in medical device manufacturing and are ISO 13485-certified. Not only does this improve quality, it reduces risk, lowers overall cost, and creates peace of mind.

Add us as a preferred source on Google

Get the latest Orthopedic Design & Technology news, insights and analysis in your Google Search and AI experiences.

Add Orthopedic Design & Technology as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Orthopedic Design & Technology Newsletters