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Medical technology companies have laid off more than 14,000 people in the past 18 months
Medical device companies have continued to lay off workers over the past 18 months, cutting more than 14,000 positions in total. MedTech Dive's analysis of state WARN filings found that the diagnostics industry laid off over 5,000 people, with companies like Cue Health shutting down, and giants such as Johnson & Johnson and Medtronic also on the list.
FDA's Laboratory-Developed Test Rule May Become First Test of Agency Power After Chevron Overturned
In late June, the U.S. Supreme Court overturned the Chevron doctrine by a 6-3 vote, meaning courts are no longer required to defer to federal agencies' interpretations of ambiguous statutes. This ruling could trigger more challenges to FDA regulatory rules, with litigation surrounding laboratory-developed tests (LDTs) seen as a bellwether. Industry lawyers point out that the judicial deference the FDA receives on LDT rules will significantly decrease, but areas involving scientific decision-making such as product approvals remain harder to overturn. Meanwhile, test developers are preparing for compliance, and the VALID Act pushed by Congress may regain momentum.
Ethylene oxide is linked to cancer, medical device sterilization industry accelerates search for alternatives
In March, the U.S. Environmental Protection Agency issued new regulations requiring commercial sterilization facilities to reduce ethylene oxide (EtO) emissions by more than 90%. Facing tighter regulations and supply risks, the medical device sterilization industry is exploring alternative technologies such as hydrogen peroxide, nitrogen dioxide, supercritical carbon dioxide, and electron beams, but experts point out that in the short term, no single method can fully replace EtO.
Can New Medical Device Cybersecurity Regulations Withstand Escalating Cyberattacks in the Healthcare Industry?
Amid ongoing cyberattacks on the healthcare industry, the U.S. strengthened medical device cybersecurity requirements in 2023 through legislation and FDA guidance. However, vulnerabilities in legacy devices, evolving attacker techniques, and new risks posed by AI put the regulations to the test. Experts remain cautiously optimistic about the regulations' effectiveness over the next 5 to 10 years.
Cigna sets annual price increase cap for high-cost GLP-1 weight-loss drugs
Cigna announced it will cap annual price increases for GLP-1 weight-loss drugs at 15% in its pharmacy benefit management program EncircleRx, aiming to provide financial certainty for employers and potentially expand drug coverage. The cap is based on agreements with Novo Nordisk and Eli Lilly, but experts question whether it is sufficient to address drug affordability issues.
Orthopedic Industry Leaders Look Ahead to 2024: Surgery Backlogs, New Technologies, and Market Shifts
After the disruptions caused by the pandemic, the orthopedic industry is gradually returning to normal. In 2024, executives and surgeons are focusing on the persistence of surgery backlogs, device pricing, robotic-assisted surgery, growth in outpatient procedures, and M&A consolidation in the spine sector.
Five Major Trends in Medical Technology for 2024
In 2023, medical technology companies gradually emerged from the pandemic's shadow and resumed growth. Looking ahead to 2024, the industry will face key trends including accelerated M&A activity, higher financial comparison baselines, regulatory controversies over laboratory-developed tests, accelerated commercialization of pulsed field ablation technology, and the dissipation of GLP-1 drug panic. This article synthesizes perspectives from Wall Street analysts and industry experts to outline five noteworthy developments.
