Medical Device Manufacturers NAICS 339112, 339113

Jun 1, 2026 - Industry Remains In DOJ Crosshairs

• The US Department of Justice is maintaining its focus on medical device companies, according to Bloomberg Law. False Claims Act recoveries totaled $6.8 billion in fiscal year 2025, with more than 83% related to health-care matters. Medical device companies may face DOJ enforcement scrutiny for several reasons, according to Bloomberg Law. First, device companies often maintain close relationships with health-care professionals who may serve as direct purchasers, surgical partners during procedures, and participants in product design improvements. These relationships create inherent anti-kickback statute risks. Second, medical devices often undergo design changes after receiving Food and Drug Administration clearance. This process creates ongoing regulatory submission decisions and a dynamic manufacturing landscape. Finally, the device industry is less consolidated, meaning smaller companies with leaner teams and compliance budgets are key market participants.
• Cyberattacks targeting medical devices have impacted 24% of healthcare organizations in the US, UK, and Germany over the past 12 months, according to Infosecurity Magazine. Moderate to significant damage to patient care was observed in 80% of such incidents, according to a RunSafe Security report. Most healthcare organizations now invest in cybersecurity across procurement and operations but outdated and unsupported devices continue to pose security risks. Medical device manufacturers recently affected in these cyberattacks include Medtronic, which was allegedly extorted by ShinyHunters, and Stryker, which was hit by the Iran-backed Handala group, according to SC Media.

• Smart patches may be the next big focus area for tracking healthcare metrics, according to Richard Yang, CEO of Biolinq, a company specializing in diabetes biosensors. Smart watches and rings are now firmly a part of the mainstream, said Yang, "But what happens after the wrist and the finger? In my view, it’s going to be smart patches." The notable difference between smart patches and popular smartwatches is that while watches track digital biomarkers, smart patches track biomarkers intrinsically linked to the body’s internal chemistry. "Everybody should have an opportunity to understand their relationship with the foods they like to eat, their diet, exercise, sleep, and if we can provide that all on a patch that doesn’t draw blood or hurt, it’s a big opportunity to bring more insights to consumers," said Yang.
• Medical device manufacturing industry employment was unchanged and averages wages for nonsupervisory employees increased slightly during the first two months of 2026, according to the US Bureau of Labor Statistics (BLS). Miscellaneous durable goods inventories, which include medical devices, remain significantly above pre-pandemic levels in late 2025. The Producer Price Index for medical equipment & supplies manufacturers increased 2.88% year over year in March, according to the BLS.