With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.
The 3M Medical Materials and Technology group is working on innovative applications such as wearables and lab-on-a-chip diagnostic products.
Manufacturers that make custom devices must move beyond conventional engineering practices to an automated and collaborative engineer-to-order process.
A new generation of wearable medical devices, miniaturized “lab-on-a-chip” diagnostic tests and other life-enhancing innovations are being made possible, in part, through the use of technologies provided by the newly-relaunched 3M Medical Materials and Technologies group (formerly 3M Medical Specialties).
Differing approaches to risk could hamper further growth of combination products.
3M Medical Materials & Technologies helps health care manufacturers design and build more reliable, innovative and feature-rich medical devices. Choose from a variety of transparent, nonwoven, or conformable double sided tapes for your medical device needs.
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.