Medical Device Testing Services Risk Report

⚖️ Legal & Regulatory

The medical device testing landscape presents several regulatory challenges. There have been multiple legal and compliance issues affecting various companies and regulatory bodies, resulting in lawsuits and policy changes. Overall, the regulatory environment remains dynamic and complex, requiring continuous attention to compliance and legal obligations.

• The FDA's regulation of laboratory-developed tests (LDTs) faced substantial legal obstacles, resulting in a Texas judge overturning the FDA's LDT regulation on 🗓 April 1, 2025.
• On 🗓 March 11, 2025, the FDA admonished a Chinese device testing lab for falsified studies and copied data, highlighting significant legal and compliance risks.
• Former Magellan Diagnostics CEO pleaded guilty over lead-test device defects on 🗓 March 10, 2025, underscoring ongoing industry challenges.
• The federal judge vacated the FDA's final rule on reclassifying LDTs as medical devices on 🗓 May 6, 2025, reflecting ongoing legal battles.
• On 🗓 February 18, 2025, personnel changes at the FDA, including terminations affecting device safety teams, underscored operational and regulatory concerns.

📜 Innovation & R&D

Innovation continues to be a key driver in the medical device testing services industry, with numerous advancements and developments enhancing the sector. This continuous innovation pipeline supports product quality and regulatory compliance, providing a competitive edge to companies embracing change.

• A new communications and compliance tool to address device data integrity concerns was debuted by the FDA on 🗓 March 12, 2025.
• Nelson Labs launched rapid sterility testing, accelerating product release for medical devices and pharmaceuticals on 🗓 March 4, 2025.
• On 🗓 March 10, 2025, Betterway Blood Testing won the 2025 SXSW Innovation Award, illustrating the recognition for pioneering advancements in testing.
• ZwickRoell unveiled Pharmed360 to innovatively approach pharmaceutical and medical device testing equipment and services on 🗓 June 10, 2025.
• A new point-of-care device promising accuracy in bilirubin testing was introduced on 🗓 July 2, 2025.

🏗️ Operational & Business Continuity

Operational challenges are evident in the medical device testing sector, impacted by external factors such as regulatory changes and political decisions. These factors influence the supply chain and potentially disrupt business continuity, requiring proactive risk management strategies.

• On 🗓 April 23, 2025, it was noted that Donald Trump’s tariffs were choking the vital supply chain for medical devices, posing significant operational risks.
• The FDA's internal changes, with key teams affected by terminations on 🗓 February 18, 2025, raised operational concerns impacting medical product review programs.