Differing approaches to risk could hamper further growth of combination products.
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The creation of the Office of Combination Products more than a decade ago may have been a big step forward, but frustrations surrounding policy-making and coordination between CDRH, CDER and CBER remain.
One of the key enabling technologies in the miniaturization trend is micro injection molding. The constant shrinking of devices has put a lot of pressure on designers and manufacturing services to produce more complex, tighter tolerances, and smaller components.
Device Meet Drug: Integrating Combination Products Into Your Portfolio
Combination products are a major growth area for life science companies and in the future, many companies have or will have combination products in their portfolio. Combination products are made of drug, device and/or biologics constituent parts. Each constituent part has its own set of regulations to which it must adhere. For example, even if…
For 3D printing to thrive in the medical device space, the use of biomaterials must be expanded.
Putting the Lab in the Patient, MIT Device Assesses Best Drugs to Treat Cancer
A tiny implant developed at the Massachusetts Institute of Technology aims to take the guesswork out of which drugs work better than others when treating cancer patients.
Additive Manufacturing Collaboration Brings 3D-Printed Arms to Kids Worldwide
The University of Central Florida and Limbitless Solutions partner to develop the technology and move it into commercialization.
Who’s Liable for 3-D Printed Medical Devices?
As additive manufacturing comes to the forefront as a disruptive technology, industry continues to speculate about how liability will be shared.
Three Mistakes That Can Kill Your Time to Market
Developing next-generation technology for medical devices is only half the battle when it comes to being first to market in today’s fast-paced global environment.
