The Faster Path to Market

Due to the increase in chronic diseases and the emergence of biological drug formulations over the last 15 years, self-administered treatment and self-injection devices have continued to see strong and consistent growth. With the momentum expected to continue and with more biosimilars entering the market, pharmaceutical companies are looking to shorten the development time and the path to market of their innovative and novel therapies. While a preconfigured device offering is often considered the solution, the reduced flexibility of non-customized designs might be seen as a threat to market acceptance that could extend commercialization timelines.

From a design perspective, a preconfigured device must have a robust and patient-friendly industrial design that supports a variety of patient conditions. To accommodate the myriad forms of drug preparations, the device needs to have a broad range of primary container characteristics and a compatibility with various drug formulations, all the while ensuring stable, safe and effective drug delivery. The device developer also needs to provide robust engineering expertise, deep regulatory insights and extensive in-house manufacturing capabilities in order to achieve high-volume production and regulatory acceptance.

Meanwhile, recent changes in market trends and advances in technology have brought about rapid changes to the regulatory landscape. This means that device developers need to align their device strategies with the regulatory changes in order to support the entire product life-cycle. It requires a strong and experienced device development team that is up to date with the latest regulatory requirements, to meet the various and often frequent challenges of bringing the final product to market.

With more and more pharmaceutical companies leveraging preconfigured offerings to increase efficiency, reduce costs and ultimately shorten time-to-market, this webinar will explore the challenges, opportunities and key traits of a successful device. Join Thomas to learn more about how to turn your innovative drug into a winning combination product.