Speaking on the opening day of Medtec Europe in Stuttgart, Lawrence Acquarulo, CEO of US group Foster Corporation delivered an essential presentation for firms considering launching a drug/device combination product
Combination products and devices are defined by the FDA as any two or more regulated products in use together. Combining drugs and devices is a technique increasingly used in many treatments, allowing the patient more control over aspects of their therapy, such as controlled release dosage.
Typical examples include polymer patches used for drug delivery via the skin, as well as insulin delivery products in diabetes care.
"Before you start these programmes, we advise you to start off with a checklist. You need to know what kind of problems you may encounter, for example polymer costs, quality systems, facilities, resources, legal issues etcetera", explained Acquarulo.
In terms of costs, consultancy fees can be draining, so early financial planning is a key part in planning.
Development of the combination can also potentially be hindered by availability of the drug itself. Acquarulo explained that costs and availability often mean that only very limited quantities of the drug to be delivered can be acquired for testing.
APIs can also present challenges, depending on their type. The more complex they are, the less thermally stable they become, meaning that thermal process of manufacturing (extrusion, moulding etc) are not always suitable.
"This isn't the time for people to keep quiet. You want the people in your team and in your clients' team to share their experiences. If they have some knowledge of the problems that can occur, you need to have those discussions," he said.
"You need a good team. Most important is a good team leader - someone who makes sure everyone is working together. That's extremely important".
Foster will be on-hand throughout the show on stand 3D02 to discuss challenges and opportunities in drug/device combination products.