Drug delivery
A popular combination
Drug-device combination products are rapidly gaining popularity as a result of the huge variety of benefits offered to patients. However, there are many opportunities to improve efficiencies in manufacturing these devices and optimise quality. Emma Green speaks to Paul Greenhalgh, director of design at Team, about best practices when developing drug-device combination products.
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ombination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products to create safer and more effective treatments. They offer precise drug targeting, local administration and therapies that can be personalised to the patient. These technologies are particularly beneficial for patients suffering from conditions such as cancer, heart disease, multiple sclerosis and diabetes.
Despite the numerous advantages, they also face unique challenges. Under EU law, combination products must be registered as either pharmaceutical products or medical devices. For drug-device combinations,
significant problems can occur when there is a lack of knowledge about the regulatory environment, product design and corporate collaborations, among other issues. It is imperative for manufacturers to fully understand each country’s specific requirements to ensure timely and accurate market access.
The increased complexity of the products brought to market over the past couple of decades has created a need for more collaborative working, drawing upon resources from both regulatory agencies and the pharmaceutical industry. Moreover, there is a need for additional innovative processes for developing more complex devices, which adequately addresses the needs and preferences of patients.
Packaging Insight /
www.worldpharmaceuticals.net
HelgaMariah/
Shutterstock.com
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