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. The convergence of drugs and medical devices is well established, yet the disconnect between the pharmaceutical and medical device industries is evident. Different commercial propositions, regulatory and compliance routes, skill sets and the need for different development infrastructures, cultures and processes continue to confound those attempting to realise the value of these products.
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 of their development to be factored in.
Late decisions restrict companies to standard solutions that miss the commercial advantage that innovation brings. Drug companies, however, are reluctant to invest resources in a 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.
In particular, drug companies struggle to develop the ‘front-end’ business case for drug-device combinations. Since the value of the 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 devices and inputting significantly at the very early stage of development.
To discuss how PA can help with drug device innovation for your organisation, please contact us now.
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