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.
This is why MediPhorum has published The complexities associated with developing combination products for drug delivery.
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 – 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
- Regulatory frameworks – the importance of bringing drug-device combination products to market is not optimally reflected in regulatory frameworks. There needs to be appropriate clarity and consistency in approaches, taking into account the time and cost to market and safety
- Recruitment, retention, and training – there are challenges in recruiting skilled, device-focused talent into biopharmaceutical organizations due to perceived limited career opportunities and relatively low levels of seniority. These are exacerbated when recruiting into highly technical areas, e.g., 3D modeling of fluid dynamics
- Organizational factors – those above the senior director level often do not have direct device experience, only pharmaceutical. As well as causing recruitment and retention challenges, this can mean that significant decisions are made without a full understanding of the complexity of device development
- Scheduling device development relative to drug development programs – device development programs may only start once it is clear that the therapeutic program would enjoy a successful phase 2B study, which puts the device development schedule under pressure and on the critical path.
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.
MediPhorum provides an agile networking environment connecting medical technology industry experts to enhance effective collaboration and develop progressive solutions to shared industry challenges. It does this by providing a safe space for companies to build their expertise through networking and sharing real-world experiences and case studies.