To simplify drug delivery for patients and practitioners, drug-delivery devices are becoming more complex. Many of today’s devices include special features designed to ease self-dosing and encourage patient adherence with novel regimens. Wearable devices are further easing use by promoting active lifestyles. And some devices are offering connectivity to support digital health monitoring.
With so many possibilities, where do device developers and pharmaceutical companies begin? MD+DIasked Eric Resnick, vice president and chief technology officer, innovation and technology, West Pharmaceutical Services Inc., a few questions on market trends, regulations, container options, and delivery system designs, and more.
MD+DI: What are some current market needs for drug-delivery devices, and what is driving those needs?
Resnick: Current market trends include increased regulatory demands regarding combination products, digitalization, and new biologic drug innovation.
On the regulatory front, regulators are looking for data specific to the drug/device combination product performance and not just the device performance. This means they are taking a more holistic view of the combination product than did the previous standard 510(k) review. In other words, how does the device perform with the specific drug in question?
West is also seeing a trend toward digital aspects that have been added to devices and combination products to reinforce user experience and desirability. The digital experience is spreading into the drug-delivery device space in the form of apps for wellness, education, and adherence, helping to ensure that patients receive the proper therapeutic regimen for their particular condition. This is all tied to improving patient adherence as payers put pressure on pharma to demonstrate results from these especially costly drugs.