The complexities associated with developing combination products for drug delivery

14 April 2024
MediPhorum Drug Delivery
The complexities associated with developing combination products for drug delivery
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Combination products are increasingly important, especially for drug delivery applications. They are a cornerstone of healthcare progress, enhancing outcomes and improving patient experience through innovative and efficient treatment solutions that harness the synergies of pharmaceuticals and medical devices. They are a crucial component in navigating the intricate and ever-changing healthcare environment.

The combination products sector faces many challenges that, if overcome, will improve and accelerate drug-device development and positively impact patient lives. A starting point is to understand those challenges.

Discussions across MediPhorum and the broad combination products community have informed this ‘state of the nation’ report. It presents a comprehensive outline of the challenges associated with developing combination products for drug delivery.

The paper discusses issues such as the combination products landscape. For example, due to increasing competitive pressures as the market matures, the growth in biosimilars, and the experience of organizations when navigating the device-specific regulatory process, it is becoming common for novel medicine to be introduced initially as part of a combination product.

Other topics include regulatory frameworks; recruitment, retention, and training; organizational factors; and scheduling device development relative to drug development programs.

The combination products landscape is rapidly expanding and incredibly dynamic. These critical medical devices have an increasingly important role in the wider biopharmaceutical market. There are strong signs of improvement, but there is still room for optimization and better integration of device development and device providers into drug programs. Working together, we can make this happen.

Implementation of Article 117 of European Union Medical Devices Regulation (EU MDR) General Safety and Performance Requirements: a position paper