The Parenteral Drug Association’s Pre-Filled Syringes and Injection Devices Conference explores the future of pharmaceutical devices. We caught up with Manfred Maeder, Ph.D., Head of Device Dev. and Commercialization at Novartis International AG to get his thoughts on combination devices.
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Q&A With Manfred Maeder, PhD of Novartis International AG
Q1: With the increases in digital health, what are your thoughts on the transiting from low-tech mechanisms to smart (high-tech) combination devices?
Dr Manfred Maeder: This gives us a lot of opportunities to improve the life of the patients. First via clear instructions and digital support on how to use the medication. Also, to receive reminders, if the medication has to be taken somewhat infrequently e.g. Monthly, or quarterly.
Not to forget: for elderly patients the rule is: the easier the better. Providing very complicated connected systems to them might be annoying and/ or overwhelming! For that reason, the indication and therefore the corresponding patient population needs to be considered.
Q2: What do you see is the biggest hurdles in the development of a new combination device?
Dr Manfred Maeder: There are no hurdles. Topics to consider are the parallel, aligned development of the mechanic and electronic parts.
Furthermore, if from now on all disposable systems would come with electronic parts and batteries, it would be a sustainability nightmare. Therefore it would be very smart to work on combined systems containing a reusable part (electronics and battery) which can be used for 2-3 years and a disposable system (e.g. Cartridge with drug) for single use only.
Q3: What role does the supply chain play in helping to develop new “best of the best” combination devices?
Dr Manfred Maeder: Supply chain for single-use systems – rule today – is very straightforward. It is getting slightly more complicated if the reusable part as described above is a device (regulatory-wise) and therefore needs different distribution channels compared to the drug in a vial or cartridge. But these different distribution channels could also be a simplification since biologics now would need the cold chain distribution for the drug part only.