As therapies become more complex and shift towards self-administration, you’re pressed to bring more intricate devices to market that are also easy to use. Against this backdrop, evolving regulations require you to prove your drug, containment and delivery system are reliable and safe.
Design with the patient in mind
When working with West, you will have the benefit of West’s extensive expertise to help you in selecting the right product for delivering an improved patient experience and in gathering the information you need to meet regulatory requirements.
Having the ability to understand each unique combination product application and build the data to support product development is critical. With proper documentation of the containment and the delivery system, you can select the ideal presentation from the beginning. You’ll be able to navigate regulatory guidelines for combination devices, plus take advantage of user-centered design and testing to deliver a truly patient-centric product.
When you do this, you mitigate the safety and usability risks that usually come with a new drug-delivery system, including meeting the increasing expectations of regulatory agencies.