Designing drug devices

An increasing number of biopharmaceutical companies are looking at combination products, and there are many considerations in selecting device development partners. SHL argues that keeping it under one roof pays dividends.

Extensive project management expertise and logistical control knowhow are required when working on a combination product from the concept stage to eventual launch. Cross-functional teams from both the biopharmaceutical company and drug delivery device supplier must work together for several years to co-ordinate efforts in a collaborative manner, overcome related challenges and ensure the right steps are taken.

Taking into account the number of biologics coming to market and the entry of biosimilars, an increasing number of biopharmaceutical companies are finding themselves in need of the same services currently provided across various geographic areas by a broad number of suppliers and specialists.

Over the years, a few early-mover biopharmaceutical companies gained valuable experience producing their own devices, working with the suppliers of devices and by establishing a good rapport with companies providing related services. These early-movers have experienced first hand the extensive number of pieces within the combination product puzzle that need to be put together to move forward with a device such as an auto-injector.

Some of the choices that need to be made by the biopharmaceutical company include selecting a suitable primary container, filling supplier, regulatory consultants, human factors engineering [HFE] experts, final assembly integrators, and so on – all vital to the successful launch of the device. And the benefits of bringing an innovative device to market clearly make the investments of time, finance and resources worthwhile for biopharmaceutical companies.