Newsletter | February 24, 2016

2.24.2016 -- Biologic Combo Products: A Device Development Roadmap

 
Biosimilar Development
 
DFM Guidelines For Early Combination Product Design
By Bill Welch, Chief Technology Officer, Phillips-Medisize   By Bill Welch, Chief Technology Officer, Phillips-Medisize
It's a given that next-generation medical devices will be smaller and smarter. But to achieve such designs, improve patient adherence, and limit the risk of product recalls, manufacturers will need to follow Design for Manufacturing (DFM) principles aimed at creating more usable, intuitive, and desirable devices for patients.

Learn how having an integrated product development process combining Human-Centered Design (HCD) principles with a DFM philosophy can make a dramatic difference in the outcomes of combination product design. 
Choosing The Right Rapid Prototype Source For Device Development
  Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
Device Development For Pharmaceutical And Biologic Combo Products
  Combination products are therapeutics combining two or more products that are regulated and sold as a single unit. When developing a combination product, there are many aspects that need to be considered.

Read this white paper to learn about the regulatory and clinical development strategies that help define pharmaceutical and biologic combination products, the need for early establishment of regulatory and clinical strategies, and how to best understand user needs and determine product requirements.
Wireless Dose-Compliance Monitoring In Drug-Delivery Devices
  Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm.

Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.
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