We support medical device companies with specialized materials expertise across a wide range of applications, from early-stage development through commercialization. Our team works across numerous device types, helping optimize material performance, ensure compliance, and reduce risk in highly regulated environments.
Explore our experience across select device categories below.
The medical device industry has long been a source of innovative concepts and devices. Recently, an increased focus on improved patient outcomes has generated a rapid advance in technologies and modern devices are pushing the limits on performance like never before. Today’s design and development processes focus on several key outcomes:
Achieving these challenging performance metrics relies on advanced materials and manufacturing methods. Understanding materials at a fundamental level, and how they behave in complex physiological environments, is critical for a medical device’s success.
Robust material selection and characterization goes beyond basic properties like strength or hardness. For example, the compatibility with contacting materials, the stability during shelf aging or in vivo, and the evolution of degradants and their safety profile are all critical considerations for materials that are not included in technical datasheets. Likewise, as the device dimensions shrink, material properties can change due to the dimensional constraints of the component geometry.
Our knowledgeable materials scientists, analytical chemists, and engineers partner with medical device companies across various industries to provide innovative solutions from device conception through regulatory submission and production:
Societal and regulatory pressures are also shaping the way medical devices are developed.
The FDA and similar organizations, as well as reimbursement agencies, rightly emphasize comparisons to existing devices. However, this position can be seen as a roadblock to innovation because it prioritizes past solutions to specific indications. Understanding how these agencies view innovation within a particular context is crucial for developing a seamless filing strategy.
As the industry strives to reduce environmental impacts, the demand for devices with long-term stability is extending beyond implantables to devices that were once considered disposable. Tools and devices are more frequently being designed to be reused or recycled. This shift necessitates evaluating the effects that multiple sterilization cycles or re-processing steps can have on the material performance.
Designing devices under the constraints of an ever-evolving regulatory environment can feel daunting. Advancements in the analytical techniques used to characterize devices often outpace a thorough understanding of the medical implications. In our current landscape, some of these advancements include:
Although regulatory agencies are placing an increased focus on particulates and PFAS chemicals, the regulatory guidance and acceptance levels are lacking or unclear, leaving medical device companies in a difficult position. Our team’s current experience with FDA feedback, in-depth knowledge of FDA guidelines, international standards, and emerging regulatory trends enables efficient navigation of this complex landscape.
Contact our experts today to take your concept or device to the next level.
