Ursula Nollenberger, product line director and Kevin Ehlert, segment manager, Trelleborg Healthcare & Medical discuss the necessary steps to launching a succesful drug/device combination product.
Product launch
For decades, silicone has been used for short- and long-term implantable applications due to its high level of biocompatibility. Today, a further characteristic—exceptional permeability—holds the key to the next generation of combination products, as the ability of long-term silicone-based drug-eluting implants to improve patient outcomes is beginning to be realised.
However, these combination products are notoriously challenging to design, manufacture, and shepherd through the regulatory process.