Innovative drug delivery devices are valued by users, but to fully realise the commercial opportunity, pharmaceutical companies must embrace device innovation earlier in the drug development process.
The drug delivery device and drug development worlds have historically been separate, with only a select handful of companies having a successful and substantial track record in both camps.
Different commercial propositions, regulatory and compliance routes, skill sets and the need for different development infrastructures, cultures and processes in the pharmaceutical and medical device industries continue to confound those attempting to realise the value of innovative device-drug combinations.
To extract the full commercial value from the device element, the business case and high-level product requirements for the drug-device combination must be developed when the drug is in early development, ideally before phase IIb clinical trials. For example, if the clinical outcome is reliant on patient compliance, then the nature of the compliance features need to be identified early enough for the implications on the drug delivery device to be factored in.
Pharmaceutical companies are usually reluctant to invest resources in a drug delivery device at an early stage of drug development, when they feel that all efforts should be devoted to the drug and there is still a significant risk that the drug will not make it to the market. But late decisions restrict companies to standard drug delivery solutions that miss the commercial advantage that innovation brings.
In particular, pharmaceutical companies struggle to develop the ‘front-end’ business case for drug-device combinations. Since the value of the drug delivery device is in its attractiveness to users and payers there is a higher demand on the commercial group early on to understand the specific product requirements that will realise this value.
Pharmaceutical marketers are unused to developing requirements for drug delivery devices and providing significant input at the very early stage of development.
To discuss how PA can help with drug delivery innovation for your organisation, please contact us now.