Ypsomed recognizes the mounting challenges posed by ever-increasing regulatory requirements, intricate project planning, and the demand for top-tier expertise in the realm of combination drug product development, particularly for achieving successful regulatory approvals. In response to these complexities, Ypsomed is introducing a comprehensive array of end-to-end Human Factors (HF) services to its pharmaceutical partners, marking a pivotal shift in their device turn-key HF offerings. This move underlines Ypsomed's unwavering dedication to facilitating efficient and successful device deployment in the market, providing an all-encompassing solution for its clients.
The integration of HF services empowers Ypsomed to equip pharmaceutical and biotech customers with the necessary expertise to minimize regulatory risks and expedite the device customization process, ultimately contributing to accelerated time-to-market. These services encompass formative evaluation, the creation of custom Instructions for Use, assistance in formulating FDA approval strategies, and summative human factors validation testing.
Ulrike Bauer, Chief Business Officer at YDS, explains that the seamless coordination between HF and device development optimizes projects, allowing pharmaceutical partners to embark on device development with enhanced agility and efficiency.
To ensure sustained access to leading-edge HF capabilities and testing facilities, Ypsomed has entered into a strategic collaboration with Interface Analysis Associates LLC (IAA), led by Dr. Anthony D. Andre, a distinguished expert in HF for medical devices and drug delivery combination products. This partnership empowers Ypsomed to leverage specialized resources with a strong track record in guiding the HF journey throughout combination product development, including effective FDA correspondence and successful HF dossier submission.
As Ypsomed unveils this significant milestone, it remains committed to fostering innovation and service transformation to enhance the potential of cutting-edge device platforms and streamline access to them.
Ulrike Bauer emphasizes the pivotal role of this partnership, stating that it represents the next step in providing comprehensive solutions that cater to all aspects of their pharmaceutical partners' combination product development requirements.
Ypsomed's innovation lies in the integration of comprehensive HF services into its self-injection device platforms, thereby championing a holistic approach to combination product development. By offering end-to-end HF services as part of their device platform, Ypsomed aims to de-risk the regulatory approval process and expedite time-to-market for its partners.
This forward-thinking initiative is made possible through a strategic partnership with Interface Analysis Associates LLC (IAA), an esteemed HF service provider renowned for its extensive experience in guiding the pharmaceutical sector through the entire combination product development journey. Ypsomed's collaboration with IAA underscores its commitment to excellence and its dedication to supporting its partners in navigating the evolving landscape of healthcare technology.