In an increasingly competitive landscape, pharma companies need to focus on their core competence of drug development. Hence, device manufacturers need to support their customers with a range of services beyond the development and manufacturing of the injection device. This article provides some in-depth insights into the Extended Services provided by Ypsomed and how these help pharma companies to stay one step ahead of their competition.
With the large number of new biologics and the surge in biosimilar product launches, the demand for self-injection devices continues to grow. As the number of devices reaching the market increases, pharmaceutical and biotech companies are looking to source state-of-the-art devices that are available quickly and at low risk. Responding to these emerging requirements, Ypsomed has built up a comprehensive range of platform products including their manufacturing infrastructure allowing faster and simpler customization projects while shortening time-to-market and minimizing project risks.
Strong IP position
One of the key criteria for minimizing risks is a profound understanding of the injection device IP landscape to ensure that all device solutions are covered by appropriate intellectual property protection and do not infringe third party patents.
Freedom by design – differentiation
Pharma companies strive to differentiate their self-injection devices through individual design options. Ypsomed either modifies the look and feel of its ergonomically proven and tested platforms or offers an entirely new outer shape implemented by using an outer shell structure that allows freedom to generate a unique design (see YpsoMate® and YpsoMate® Design). The final design of the device does not interfere with the 2-step handling concept of the underlying platform.
Human factors engineering is key
In order to ensure that the expectations of the patients are met it is essential that human factors engineering is part of the development process. Ypsomed conducts early and late-stage formative studies as part of each platform development. This further supports patient specific studies once the platform is customized for a specific patient group. Ypsomed fully supports its customers during these human factor studies, thus contributing significantly to the success of the submission process.
Successful Registration Submissions
In order to streamline the registration process and allow pharma companies to concentrate on the drug-related part of the dossier, Ypsomed provides all device-related documentation. With dossier support being an integral part of customer projects, Ypsomed employs a dedicated team of regulatory experts that provides dossier support for each project, following either the Common Technical Document (CTD) or the Master File (MAF) approach. Ypsomed makes a crucial contribution to the successful submission of the overall combination product.
Shorter time-to-market and reduced project risks with Ypsomed Custom Products
Flexible final drug & device assembly
Many pharma companies decide to perform final drug and device assembly at the filling site of the drug to reduce time, risk and transportation costs. Ypsomed works closely with reputable equipment manufacturers to provide state-of-the-art and ready to order final assembly solutions. Assembly systems for high (>1 million p.a.), mid (<1 million p.a.) and low (<150’000 p.a.) demands are readily available.
The trend to longer acting formulations and less frequent injections means that some patients may not be used to the routine of their therapy. This is where reusable trainer devices allow patients to practice in a clinical or home environment before performing their injections. Ypsomed offers trainer devices for the successful instruction of clinicians and patients.
Extended services – tailored to different needs
Ypsomed not only provides innovative, reliable and easy to use injection devices, but also a range of extended device services, tailored to the needs of each project: From industrial design, human factors engineering and IP landscape management to trainer devices, final assembly infrastructure and registration support. With this offering Ypsomed contributes to the success of the drug by allowing its customers to focus on their core competence of drug development.