Many drug–device combination products can be developed to achieve the therapeutic goal and still face significant challenges in the manufacturing phase. Laboratory performance might be different from ...

We know that getting a medical device to market from ideation to market launch is a project requiring tremendous skill, knowledge, time, money, and, often, some luck. When focus is on the road to ...

For years, manufacturers relied on a table-based approach to determine allowable ethylene oxide residual limits, an approach that didn't adequately account for vulnerable patient populations or device ...

Compendial standards rarely change without consequence for testing laboratories, and the recent revision to USP <788>, Particulate Matter in Injections, is no exception. Written by Lori Graybill, ...

In micro manufacturing, successfully molding a part is only one piece of the challenge. When components feature extremely small dimensions and tight tolerances, the entire production system must be ...

Building certainty under uncertainty is the defining challenge of drug and device development. Whether the work starts with formulation strategy or design reviews, the underlying priorities converge ...

For years, Chile has occupied a strange position in Latin American medtech strategy. It was sophisticated, stable, commercially attractive, and comparatively easy to enter. For many medical device ...

The intersection of healthcare and software engineering has fundamentally transformed the life sciences industry. Software is no longer merely a supportive tool; it is increasingly the primary ...

Explore how OEMs optimize instrument performance with precision fluidics, optical technologies, and integrated subsystems that improve reliability and accelerate development. Teams must assess the ...

India’s Ministry of Health and Family Welfare published a draft notification in its Official Gazette (G.S.R. 515(E), dated June 23, 2026) ¹ proposing amendments to the Medical Devices Rules, 2017 that ...

The most expensive decision a U.S. medical device company makes in Latin America is rarely the one its leadership team has on the agenda. It is not the choice of country. It is not the product ...

FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections. Early FDA findings ...